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Sample records for blind comparative trial

  1. Double-Blind Comparative Trial of Parenteral Lorazepam and ...

    African Journals Online (AJOL)

    Lorazepam, a new sedative drug of the benzodiazepine group, was compared in a double-blind study with a papaveretumjhyoscine mixture in a series of 50 patients awaiting surgery. No difference between the drugs in terms of sedation or side-effects was detected. S. Afr. Med. J., 48, 862 (1974).

  2. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    OpenAIRE

    Beenen, L.F.M.; Lindeboom, J.; Kasteleijn-Nolst Trenite, D.G.; Heimans, J.J.; Snoek, F.J.; Touw, D.J.; Ader, H.J.; Alphen, van, H.A.M.

    1999-01-01

    OBJECTIVE—To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy.
METHODS—A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg p...

  3. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted...... in the STN and GPi of 12 patients with focal, multifocal, or generalized dystonia. Each patient was randomly selected to undergo initial bilateral stimulation of either the STN or the GPi for 6 months, followed by bilateral stimulation of the other nucleus for another 6 months. Preoperative and postoperative...

  4. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L. F.; Lindeboom, J.; Kasteleijn-Nolst Trenité, D. G.; Heimans, J. J.; Snoek, F. J.; Touw, D. J.; Adèr, H. J.; van Alphen, H. A.

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  5. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy : efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  6. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  7. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

    Directory of Open Access Journals (Sweden)

    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  8. A double blind randomized control trial, comparing effect of drospirenone and gestodene to sexual desire and libido.

    Science.gov (United States)

    Oranratanaphan, Shina; Taneepanichskul, Surasak

    2006-10-01

    Oral contraceptive is the most commonly used method of fertility control. Yasmin is a combination of a novel progestogen with anti-androgenic and anti-mineralcorticoid activities (3 mg Drospirenone (DRSP) and 30 microg ethinylestradiol (EE)). It has been shown in many clinical trials that Yasmin is an efficacious oral contraceptive, lacking undesired effects as with other oral contraceptives such as weight gain. However the effects of Yasmin on sexual desire and libido have not been intensively investigated so far Investigate the effects of Yasmin on sexual desire, libido and changes in the free androgen index (FAI) compare to Meliane (75 microg gestodene + 20 microg ethinylestradiol). The authors' report the results of a double blind randomized controlled study using a translated version of the Female Sexual Function Index questionnaire (FSFI) for the assessment of the sexual function. The free androgen index was calculated from measurements of testosterone and sexual hormone binding globulin. The result shows statistically significant improvements regarding sexual desire, arousal and overall satisfaction in the Yasmin group. Additionally, an increased frequency of orgasms in the Meliane group was reported. Statistically significant differences between the two treatments regarding changes in the FSFI score and changes in the free androgen index have not been observed. The novel oral contraceptive containing drospirenone (Yasmin) and the non-anti-androgenic progestin containing oral contraceptive (Meliane) do not show unfavorable effects on sexual response and libido.

  9. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  10. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects.

    Science.gov (United States)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-10-01

    To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50 patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg phenytoin/day or 1500 mg sodium valproate/day. During the study period patients were seen in the outpatient clinic at 1.5, 3, 6, and 12 months, when medical history, adverse events, and drug plasma concentrations were evaluated. Neuropsychological functioning and quality of life were assessed on the last three visits. In cases of a seizure an EEG was performed, drug plasma concentration assessed, and medication subsequently increased. Of the 100 included patients 14 (seven in each group) experienced one or more postoperative seizures. Severity of the seizures was comparable in the two groups. In all patients, drug plasma concentrations were in the low or subtherapeutic ranges at the time of the first postoperative seizure. Five patients in the phenytoin group and two in the valproate group had to stop their treatment due to drug related adverse events. Sixty patients completed the 12 month period. Analysis of neuropsychological and quality of life data showed no significant differences. For efficacy, tolerability, impact on cognitive functioning, and quality of life, no major differences were found between phenytoin and valproate prophylaxis. Valproate is an alternative for anticonvulsant prophylaxis in patients after craniotomy.

  11. Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Cubeddu, Luigi X; Cubeddu, Roberto J; Heimowitz, Todd; Restrepo, Beatriz; Lamas, Gervasio A; Weinberg, Gloria B

    2006-11-01

    Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.

  12. Randomized double-blind clinical trial comparing two anesthetic techniques for ultrasound-guided transvaginal follicular puncture.

    Science.gov (United States)

    Oliveira, Gilvandro Lins de; Serralheiro, Fernando Cesar; Fonseca, Fernando Luiz Affonso; Ribeiro, Onésimo Duarte; Adami, Fernando; Christofolini, Denise Maria; Bianco, Bianca; Barbosa, Caio Parente

    2016-01-01

    To compare the anesthetic techniques using propofol and fentanyl versus midazolam and remifentanil associated with a paracervical block with lidocaine in performing ultrasound-guided transvaginal oocyte aspiration. A randomized double-blind clinical trial (#RBR-8kqqxh) performed in 61 women submitted to assisted reproductive treatment. The patients were divided into two groups: anesthetic induction with 1mcg/kg of fentanyl associated with 1.5mg/kg of propofol (FP Group, n=32), in comparison with anesthetic induction using 0.075mg/kg of midazolam associated with 0.25mcg/kg/min of remifentanil, and paracervical block with 3mL of 2% lidocaine (MRPB Group, n=29). Main outcome measures: human reproduction outcomes, modified Aldrete-Kroulik index, hemodynamic parameters, and salivary cortisol. The results revealed a higher number of embryos formed in the FP Group (p50=2 versus 1; p=0.025), gestation rate two times higher in the FP Group (44.4% versus 22.2%; p=0.127), less time to reach AK=10 in the MRPB Group (p50=10 versus 2; panestesia com 1mcg/kg de fentanil associada com 1,5mg/kg de propofol (Grupo FP, n=32), em comparação com ao grupo submetido à indução da anestesia utilizando 0,075mg/kg de midazolam associada com 0,25mcg/kg/min de remifentanil, e bloqueio paracervical com 3mL de lidocaína a 2% (Grupo MRBP, n=29). Foram avaliados os resultados reprodutivos, índice modificado de Aldrete e Kroulik, parâmetros hemodinâmicos e cortisol salivar. Foi encontrado um número mais elevado de embriões formados no Grupo FP (p50=2 versus 1; p=0,025), taxa de gestação duas vezes mais elevada no Grupo FP (44,4% versus 22,2%; p=0,127), menos tempo para alcançar AK=10 no Grupo MRBP (p50=10 versus 2; panestesias (com fentanil e propofol, e com midazolam, remifentanil e bloqueio paracervical) ofereceram condições anestésicas satisfatórias na realização de procedimentos realizados em reprodução assistida, proporcionando conforto para o paciente e médico.

  13. A prospective, randomized, double blind controlled trial

    African Journals Online (AJOL)

    Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: A prospective, randomized, double blind controlled trial.

  14. Prevention of postoperative hypotension following spinal anesthesia for TURP: a double-blind randomized controlled trial comparing ephedrine with placebo.

    Science.gov (United States)

    Verdeyen, J; Ory, J P; Wyckmans, W; Vandermeersch, E; Jamaer, L; Van Assche, A

    2008-01-01

    Spinal hypotension (SH) is a common side effect of spinal anesthesia and may also occur after the surgical procedure. In this double-blinded, placebo-controlled, randomised clinical trial fifty patients undergoing transurethral prostatectomy under spinal anesthesia received 10 mg of ephedrine IV before being transferred from the operating table into their bed after the procedure, whereas fifty controls received saline IV. The number of per- and postoperative hypotensive episodes and vasopressor use, time delay between the administration of the study medication and the first hypotensive episode, level of spinal blockade at the start of surgery, pre- and postoperative hemoglobine and sodium concentration, cardiovascular co-morbidity and chronic medication were registered. There was no statistically significant difference in the incidence of postoperative hypotension between the two groups, but Poisson regression of the expected number of postoperative hypotensive episodes per patient showed a protective effect of ephedrine (p hypotension was a risk factor for developing postoperative hypotension (p hypotension, except for a correlation between preoperative alpha-receptor blocking drugs and peroperative hypotension (p hypotension (recorded incidence 31%) was almost as common as peroperative hypotension (recorded incidence 37%) and occurred as late as 190 minutes after the end of surgery. Ephedrine IV at the end of surgery reduced the number of postoperative hypotensive episodes per patient but did not reduce the overall incidence of postoperative SH.

  15. Celecoxib Monotherapy Maintained Small Intestinal Mucosa Better Compared With Loxoprofen Plus Lansoprazole Treatment: A Double-blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Fujimori, Shunji; Hanada, Ryuzo; Hayashida, Mari; Sakurai, Toshiyuki; Ikushima, Ippei; Sakamoto, Choitsu

    2016-03-01

    The aim of this study was to compare celecoxib with loxoprofen for protection of small intestine. RCT studies report that COX-2 selective inhibitor celecoxib induces fewer small intestinal injuries than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Loxoprofen is a prodrug nonselective NSAID developed to protect upper gastrointestinal tract. A total of 150 healthy volunteers (40 to 70 y) were enrolled. After medical checkup including laboratory data, subjects were randomly assigned to celecoxib (200 mg daily) or loxoprofen (180 mg daily) plus lansoprazole (15 mg daily). All drugs were prepared using inactive capsules. After randomization, all subjects were first examined by baseline capsule endoscopy (CE). After 14 days, subjects underwent posttreatment CE. We compared baseline and posttreatment CE findings of the 2 groups. All CE data were evaluated blindly by 3 reviewers. Pretreatment and posttreatment laboratory variables were also compared. A total of 74 subjects (49±6 y, F/M: 36/38) were enrolled in celecoxib group and 76 subjects (49±7 y, F/M: 39/37)in loxoprofen group. Five in celecoxib group and 4 in loxoprofen group were excluded from CE analysis mainly due to incomplete CE. The percentage of subjects with at least 1 posttreatment mucosal break was lower in celecoxib group (10%) than in loxoprofen group (49%) (Plansoprazole combination therapy (UMIN: 000007936).

  16. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation.

    Science.gov (United States)

    Mace, Sharon E

    2017-10-01

    Painful diagnostic and therapeutic procedures are common in the health care setting. Eliminating, or at least, minimizing the pain associated with various procedures should be a priority. Although there are many benefits of providing local/topical anesthesia prior to performing painful procedures, ranging from greater patient/family satisfaction to increased procedural success rates; local/topical anesthetics are frequently not used. Reasons include the need for a needlestick to administer local anesthetics such as lidocaine and the long onset for topical anesthetics. Vapocoolants eliminate the risks associated with needlesticks, avoids the tissue distortion with intradermal local anesthetics, eliminates needlestick pain, have a quick almost instantaneous onset, are easy to apply, require no skills or devices to apply, are convenient, and inexpensive. The aims of this study were to ascertain if peripheral intravenous (PIV) cannulation pain would be significantly decreased by using a vapocoolant (V) versus sterile water placebo (S) spray, as determined by a reduction of at least ≥1.8 points on numerical rating scale (NRS) after vapocoolant versus placebo spray, the side effects and incidence of side effects from a vapocoolant spray; and whether there were any long term visible skin abnormalities associated with the use of a vapocoolant spray. Prospective, randomized, double-blind controlled trial of 300 adults (ages 18-80) requiring PIV placement in a hospital ED, randomized to S (N=150) or V (N=150) prior to PIV. Efficacy outcome was the difference in PIV pain: NRS from 0 (none) to worst (10). Safety outcomes included a skin checklist for local adverse effects (i.e., redness, blanching, edema, ecchymosis, itching, changes in skin pigmentation), vital sign (VS) changes, and before/after photographs of the PIV site. Patient demographics (age, gender, race), comorbidity, medications, and vital signs; and PIV procedure variables (e.g., IV needle size, location

  17. Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.

    Science.gov (United States)

    Yang, Jaewon; Bahk, Won-Myong; Cho, Hyun-Sang; Jeon, Yang-Whan; Jon, Duk-In; Jung, Hee-Yeon; Kim, Chan-Hyung; Kim, Hee-Cheol; Kim, Yong-Ku; Kim, Young-Hoon; Kwon, Jun-Soo; Lee, Sang-Yeol; Lee, Seung-Hwan; Yi, Jung-Seo; Yoon, Bo-Hyun; Kim, Seung-Hyun

    2010-07-01

    The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 +/- 19.73 for the blonanserin group and -25.40 +/- 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.

  18. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine

    Directory of Open Access Journals (Sweden)

    Larysa Sokolova

    2014-01-01

    Full Text Available A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years were randomly assigned to double-blind treatment with EGb 761 (240 mg per day or betahistine (32 mg per day for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated “very much improved” or “much improved” in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.com ISRCTN02262139.

  19. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis.

    Science.gov (United States)

    Miehlke, Stephan; Hruz, Petr; Vieth, Michael; Bussmann, Christian; von Arnim, Ulrike; Bajbouj, Monther; Schlag, Christoph; Madisch, Ahmed; Fibbe, Christiane; Wittenburg, Henning; Allescher, Hans Dieter; Reinshagen, Max; Schubert, Stefan; Tack, Jan; Müller, Michaela; Krummenerl, Patrick; Arts, Joris; Mueller, Ralph; Dilger, Karin; Greinwald, Roland; Straumann, Alex

    2016-03-01

    To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE). Adults with active EoE (n=76) randomly received 14 days' treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm(2 )hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation. Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients. BET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation. NCT02280616; EudraCT number, 2009-016692-29. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial.

    Directory of Open Access Journals (Sweden)

    Kim S Thomas

    2017-04-01

    Full Text Available The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care for the management of eczema in children with moderate to severe disease.This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1 to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI, which was log-transformed for analysis (intention-to-treat analysis. A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015: 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94% children (n = 141 in each group. The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]. Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43. This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25% and 39/141 (28% of children in the silk clothing and standard care groups

  1. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

    Science.gov (United States)

    Thomas, Kim S; Bradshaw, Lucy E; Sach, Tracey H; Batchelor, Jonathan M; Lawton, Sandra; Harrison, Eleanor F; Haines, Rachel H; Ahmed, Amina; Williams, Hywel C; Dean, Taraneh; Burrows, Nigel P; Pollock, Ian; Llewellyn, Joanne; Crang, Clare; Grundy, Jane D; Guiness, Juliet; Gribbin, Andrew; Mitchell, Eleanor J; Cowdell, Fiona; Brown, Sara J; Montgomery, Alan A

    2017-04-01

    The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups

  2. Professional brushing study comparing the effectiveness of sonic brush heads with manual toothbrushes: a single blinded, randomized clinical trial.

    Science.gov (United States)

    Pelka, Anna-Kristina; Nagler, Tonia; Hopp, Imke; Petschelt, Anselm; Pelka, Matthias Anton

    2011-08-01

    The aim of this study was to evaluate the plaque removal efficacy of four toothbrushes: the Philips Sonicare Elite with medium and mini brush heads, the Elmex Sensitive, and the American Dental Association (ADA) reference toothbrush. This study was a randomized, controlled, investigator-blinded, four-brush crossover design study, which examined plaque removal following a consecutive repeated use. All brushes were used on each participant in a randomly assigned quadrant of the mouth. A total of 90 subjects participated in the study. Prior to the experiment, they received a professional prophylaxis and were requested to refrain from toothbrushing for 48 h. Teeth were professionally brushed consecutively for 10 to 90 s per quadrant. A Turesky-modified Quigley Hein Index score was assessed at baseline and after each brushing interval by one blinded investigator. Results showed reduction of mean plaque scores for all brushes with time from 10 to 90 s. After 30 s (2-min whole mouth equivalent) of brushing, the Sonicare brushes cleaned 19, the ADA brush 16, and the Elmex Sensitive 10 of in average 28 tooth surfaces. With time, the number of additional cleaned surfaces decreased. Time is an important variable in the evaluation of plaque-removing efficacy since absolute efficacy increases with time and differs per toothbrush. No differences could be found between the two brush heads of the Sonicare.

  3. Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

    Directory of Open Access Journals (Sweden)

    Sandip Shah

    2011-01-01

    Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

  4. Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

    Directory of Open Access Journals (Sweden)

    Plaschke K

    2011-02-01

    Full Text Available Abstract Background Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. Methods/Design A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. Discussion Organisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and Good Clinical Practice (GCP. The Interdisciplinary Endoscopy Center (IEZ of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed

  5. COMPARATIVE ANALYSIS OF EFFECTIVENESS AND SAFETY OF PHYTO- AND ANTIBIOTIC THERAPY OF ACUTE BRONCHITIS IN CHILDREN: RESULTS OF A MULTICENTER DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. S. Namazova-Baranova

    2014-01-01

    Full Text Available Although viruses cause most cases of acute bronchitis, antibacterial drugs are still widely used to treat children with such diseases; this results in development of antibiotic resistance. Therefore, one of the key objectives of clinical medicine is now an effort to reduce unreasonable use of antibacterial agents. A multicenter double blind randomized clinical trial (E-BRO-PCT involved 182 2-6-years-old children and was aimed at assessing effectiveness and safety of phytotherapy (the syrup characterized by a fixed combination of thyme herb and ivy leaf extracts of acute bronchitis. Patients were divided into groups according to the type of therapy: phyto-, antibacterial or multimodal therapy. The level of procalcitonin (PCT – a bacterial inflammation marker – was measured retrospectively in the blood samples of all the children obtained at inclusion to the study. Therapy effectiveness was assessed by means of overall assessment of response to treatment on day 7. The share of children with low PCT and positive response to phytotherapy was comparable to the share of children subjected to antibiotic therapy. This is also true for all the patients included in the study regardless of the PCT level. Phyto- and antibacterial therapy featured a comparable safety profile; however, according to the researchers, the former one came out slightly better. Results of this study convincingly demonstrate that phytotherapy is an effective and well-tolerated type of treatment of acute bronchitis in children. 

  6. A Double-Blind Randomized Trial Comparing Implants with Laser-Microtextured and Machined Collar Surfaces: Microbiologic and Clinical Results.

    Science.gov (United States)

    Guarnieri, Renzo; Rappelli, Giorgio; Piemontese, Matteo; Procaccini, Maurizio; Quaranta, Alessandro

    2016-01-01

    The purpose of this study was to compare the clinical outcome of and determine the differences in periodonto-pathogenic microbiota around two types of implant collar surfaces: laser-microtextured (test) vs machined (control). Seventeen patients (11 periodontally healthy, and 6 periodontally compromised) were selected to receive the two different implants, placed randomly, in two edentulous sites. Six months following the surgical placement of the dental implants, subgingival plaque samples were collected using paper points from the peri-implant sulcus and from the sulcus of an adjacent tooth. The presence of five putative periodontal pathogens, namely, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythensis, was assessed using real-time polymerized chain reaction (RT-PCR). Peri-implant parameters and intraoral radiographs were recorded up to 1 year after abutment connection. In the main population, and in the periodontally compromised subgroup, the total number of periodontal pathogens around test implant sites was lower than control implant sites and adjacent tooth sites, with a statistically significant difference (P < .05). In periodontally healthy patients, the mean probing pocket depth for the test implant was 1.31 ± 0.51 mm, compared with 2.66 ± 0.83 mm for the control implant, while in periodontally compromised patients, it was 1.61 ± 0.58 mm for the test implant, compared with a mean value of 2.84 ± 1.0 mm for the control implant. Implants with a laser-microtextured collar surface are not more vulnerable to pathogenic microflora colonization than implants with a machined collar surface. In both of the subgroups of patients (periodontally healthy and periodontally compromised), implants with a laser-microtextured collar surface have a better clinical outcome at 1 year of loading, compared with implants with a machined collar surface.

  7. Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.

    Science.gov (United States)

    KandaSwamy, Gokul Vignesh; Dhanasekaran, Ananda Kumar; Elangovan, Aravindhan; John, Bobby; Viswaroop, Bobby; Vedanayagam, Kandasami Sangam

    2015-04-29

    To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic. One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs. Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim. The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.

  8. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine.

    LENUS (Irish Health Repository)

    Baker, Joseph F

    2011-06-07

    Abstract: The optimum anaesthetic and analgesic management following hip arthroscopy is yet to be determined. There is, in addition, some concern over the use of intraarticular local anaesthetic. We compared the analgesic efficacy of intra-articular infiltration compared with portal infiltration of bupivacaine following hip arthroscopy. Patients were randomised to receive either 10ml of 0.25% bupivacaine either into the joint or around the portal sites following completion of surgery. 73 patients were recruited (40 intra-articular). The portal infiltration group required significantly more rescue analgesia immediately after surgery (2.33mg vs.0.57mg, p=0.036). Visual Analogue Scale pain scores were not significantly different at 1 and 2 hours following surgery, but at 6 hours the portal group had significantly lower VAS scores (p=0.0036). We believe that the initial pain following surgery results from capsular injury and this explains the need for more rescue analgesia in the portal infiltration group. Further work is needed to establish the ideal regimen. A combination of portal and intra-articular infiltration may be the most efficacious.

  9. TORPEDO: Prospective, double blind, randomized clinical trial comparing the use of Ketorolac verse placebo during live donor nephrectomy for kidney transplant

    Directory of Open Access Journals (Sweden)

    Jeffrey Campsen

    2017-06-01

    Full Text Available The aim of this pilot study was to determine if the use of Ketorolac for donor nephrectomies could decrease the use of narcotics. Methods: This is a prospective, double blind, randomized trial involving patients undergoing nephrectomy for live donor kidney transplantation. Three arms: 1. Ketorolac 30 mg IV×1 in the OR, then ketorolac 15 mg IV every 6 h for 7 doses. 2. Ketorolac 30 mg IV×1 in the OR, then placebo IV every 6 h for 7 doses. 3. Placebo IV×1 in the OR, then placebo IV every 6 h for 7 doses. Outcomes: blood loss, mortality, renal function, cumulative narcotic use, length of hospital stay (LOS, and urinary retention. Results: There were no patient deaths, blood transfusions or renal dysfunction in any study arm. Arm 1 had less narcotic use, reduced length of stay, and reduced urinary retention than Arm 3. Conclusion: There was reduced LOS, less narcotic use and less urinary retention in the Ketorolac group (Arm 1 versus the placebo group (Arm 3. Based on these results we will proceed with a larger study to compare the use of non-opioid analgesics in donor nephrectomies.

  10. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial.

    Science.gov (United States)

    Sahebjamee, Mahnaz; Mansourian, Arash; Hajimirzamohammad, Mohammad; Mohammad, Haji Mirza Mohammad; Zadeh, Mohsen Taghi; Bekhradi, Reza; Kazemian, Ali; Manifar, Soheila; Ashnagar, Sajjad; Doroudgar, Kiavash

    2015-01-01

    To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69±7.77 days, benzydamine 15.85±12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38±10.75 days, benzydamine 23.54±15.45 days). Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time (p=0.09). Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects. The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers.

  11. Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults.

    Science.gov (United States)

    Papp, Kim A; Papp, Alexine; Dahmer, Betty; Clark, Christina S

    2012-07-01

    Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis. We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial. Adult patients were enrolled in a 12-week study. Subjects were randomized to tacrolimus 0.1% ointment (n = 16) or hydrocortisone 1% ointment (n = 14) applied twice daily to symptomatic regions of the face. The primary efficacy measure was the severity of facial seborrhea at the end of treatment (day 84) as measured by the Seborrhea Area and Severity Index-Face. Secondary efficacy measures included physician and patient assessment of seborrhea, the frequency of medication application, and adverse events. The severity of facial seborrhea was similarly improved in both treatment groups (P = .86). Tacrolimus 0.1% ointment was used on significantly fewer days than 1% hydrocortisone ointment (mean missed doses per patient at first visit: 15.6 vs 7.6, P seborrheic dermatitis. Tacrolimus was generally well tolerated. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  12. Double-blind randomized controlled trial comparing misoprostol and oxytocin for management of the third stage of labor in a Nigerian hospital.

    Science.gov (United States)

    Musa, Abdulkarim O; Ijaiya, Munir'deen A; Saidu, Rakiya; Aboyeji, Abiodun P; Jimoh, Abiodun A; Adesina, Kikelomo T; Abdul, Ishaq F

    2015-06-01

    To compare the efficacy of oral misoprostol with that of oxytocin for active management of the third stage of labor (AMTSL). A double-blind randomized control trial was undertaken at a center in Ilorin, Nigeria, between January and June 2013. Every other eligible patient (in the first stage of labor at term, to have a spontaneous vaginal delivery, and no/low risk of postpartum hemorrhage [PPH]) were randomly assigned with computer-generated random numbers to receive oral misoprostol (600μg) plus placebo injection or oral placebo plus oxytocin injection (1mL of 10IU) in the third stage of labor. The primary outcome was amount of blood loss during delivery. Mean postpartum blood loss was 325.85±164.72mL in the 100 patients given misoprostol and 303.95±163.33mL in the 100 patients given oxytocin (P=0.391). PPH (≥500mL blood loss) was recorded in 15 (15.0%) patients given misoprostol and 14 (14.0%) given oxytocin (P=0.841). Shivering, pyrexia, and diarrhea were all significantly more common in the misoprostol group (Pmisoprostol was similar to that of intramuscular oxytocin. Adverse effects associated with misoprostol were transient and self-limiting. Thus, oral misoprostol is efficacious and a good alternative to oxytocin for AMTSL. Pan African Clinical Trials Registry:PACTR201407000825227. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  13. Immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine in infants: a comparative, observer-blind, randomised, controlled trial.

    Science.gov (United States)

    Sáez-Llorens, Xavier; Clemens, Ralf; Leroux-Roels, Geert; Jimeno, José; Clemens, Sue Ann Costa; Weldon, William C; Oberste, M Steven; Molina, Natanael; Bandyopadhyay, Ananda S

    2016-03-01

    Following the proposed worldwide switch from trivalent oral poliovirus vaccine (tOPV) to bivalent types 1 and 3 OPV (bOPV) in 2016, inactivated poliovirus vaccine (IPV) will be the only source of protection against poliovirus type 2. With most countries opting for one dose of IPV in routine immunisation schedules during this transition because of cost and manufacturing constraints, optimisation of protection against all poliovirus types will be a priority of the global eradication programme. We assessed the immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine (mIPV2HD) in infants. This observer-blind, comparative, randomised controlled trial was done in a single centre in Panama. We enrolled healthy infants who had not received any previous vaccination against poliovirus. Infants were randomly assigned (1:1) by computer-generated randomisation sequence to receive a single dose of either mIPV2HD or standard trivalent IPV given concurrently with a third dose of bOPV at 14 weeks of age. At 18 weeks, all infants were challenged with one dose of monovalent type 2 OPV (mOPV2). Primary endpoints were seroconversion and median antibody titres to type 2 poliovirus 4 weeks after vaccination with mIPV2HD or IPV; and safety (as determined by the proportion and nature of serious adverse events and important medical events for 8 weeks after vaccination). The primary immunogenicity analyses included all participants for whom a post-vaccination blood sample was available. All randomised participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02111135. Between April 14 and May 9, 2014, 233 children were enrolled and randomly assigned to receive mIPV2HD (117 infants) or IPV (116 infants). 4 weeks after vaccination with mIPV2HD or IPV, seroconversion to poliovirus type 2 was recorded in 107 (93·0%, 95% CI 86·8-96·9) of 115 infants in the mIPV2HD group compared with 86 (74·8%, 65·8

  14. A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and ciclosporin for the control of atopic dermatitis in client-owned dogs

    Science.gov (United States)

    Little, Peter R; King, Vickie L; Davis, Kylie R; Cosgrove, Sallie B; Stegemann, Michael R

    2015-01-01

    Background Ciclosporin is approved for the treatment of atopic dermatitis (AD) in dogs and has been shown to be safe and effective. Placebo-controlled studies suggest that oclacitinib is a safe and effective alternative therapy. Hypothesis/Objectives To evaluate the efficacy and safety of oclacitinib, in comparison to ciclosporin, for the control of AD in a blinded, randomized clinical trial, incorporating a noninferiority test at day 28. Animals A total of 226 client-owned dogs with a history of AD from eight sites were enrolled. Methods Enrolled animals were randomized to receive oral oclacitinib (0.4–0.6 mg/kg twice daily for 14 days, then once daily) or oral ciclosporin (3.2–6.6 mg/kg once daily) for 12 weeks. Owners assessed pruritus using an enhanced visual analog scale (VAS), and veterinarians assessed dermatitis using the Canine Atopic Dermatitis Extent and Severity Index (CADESI)-02. Results On days 1, 2, 7, 14, 28, 56 and 84, the percentage reduction from baseline for owner-assessed pruritus changed from 25.6 to 61.0% in the oclacitinib group compared with 6.5 to 61.5% in the ciclosporin group; differences were significant at all time points up to day 28. On day 56, ciclosporin-treated dogs showed a similar decrease in pruritus to oclacitinib-treated dogs. On day 14, the percentage reduction from baseline CADESI-02 was significantly greater in the oclacitinib group (58.7%) than in the ciclosporin group (43.0%). Three times as many adverse events attributed to gastrointestinal signs were reported in the ciclosporin group compared with the oclacitinib group. Conclusions and clinical importance In this study of treatment for canine AD, oclacitinib had a faster onset of action and a lower frequency of gastrointestinal side effects compared with ciclosporin. PMID:25496303

  15. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial

    NARCIS (Netherlands)

    Appelhof, Bente C.; Fliers, Eric; Wekking, Ellie M.; Schene, Aart H.; Huyser, Jochanan; Tijssen, Jan G. P.; Endert, Erik; van Weert, Henk C. P. M.; Wiersinga, Wilmar M.

    2005-01-01

    Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5: 1 or 10: 1 with LT4 monotherapy. We conducted a double-blind, randomized,

  16. Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment

    Directory of Open Access Journals (Sweden)

    van Someren Eus JW

    2008-07-01

    Full Text Available Abstract Background Depression frequently occurs in the elderly. Its cause is largely unknown, but several studies point to disturbances of biological rhythmicity. In both normal aging, and depression, the functioning of the suprachiasmatic nucleus (SCN is impaired, as evidenced by an increased prevalence of day-night rhythm perturbations, such as sleeping disorders. Moreover, the inhibitory SCN neurons on the hypothalamus-pituitary adrenocortical axis (HPA-axis have decreased activity and HPA-activity is enhanced, when compared to non-depressed elderly. Using bright light therapy (BLT the SCN can be stimulated. In addition, the beneficial effects of BLT on seasonal depression are well accepted. BLT is a potentially safe, nonexpensive and well accepted treatment option. But the current literature on BLT for depression is inconclusive. Methods/Design This study aims to show whether BLT can reduce non-seasonal major depression in elderly patients. Randomized double blind placebo controlled trial in 126 subjects of 60 years and older with a diagnosis of major depressive disorder (MDD, DSM-IV/SCID-I. Subjects are recruited through referrals of psychiatric outpatient clinics and from case finding from databases of general practitioners and old-people homes in the Amsterdam region. After inclusion subjects are randomly allocated to the active (bright blue light vs. placebo (dim red light condition using two Philips Bright Light Energy boxes type HF 3304 per subject, from which the light bulbs have been covered with bright blue- or dim red light- permitting filters. Patients will be stratified by use of antidepressants. Prior to treatment a one-week period without light treatment will be used. At three time points several endocrinological, psychophysiological, psychometrically, neuropsychological measures are performed: just before the start of light therapy, after completion of three weeks therapy period, and three weeks thereafter. Discussion If BLT

  17. Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

    Directory of Open Access Journals (Sweden)

    Almér Lars-Olof

    2007-09-01

    Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

  18. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

    Science.gov (United States)

    Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

    2012-08-01

    To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. Comparing the effects of aromatherapy massage and inhalation aromatherapy on anxiety and pain in burn patients: A single-blind randomized clinical trial.

    Science.gov (United States)

    Seyyed-Rasooli, Alehe; Salehi, Feridoon; Mohammadpoorasl, Asghar; Goljaryan, Sakineh; Seyyedi, Zahra; Thomson, Brian

    2016-12-01

    Anxiety and pain are recognized as major problems of burn patients; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs, nonpharmacological nursing interventions were considered for this group of patients. This led to the present study aimed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients. This single-blind clinical trial was carried out on 90 patients with burns aromatherapy massage, inhalation aromatherapy, and control group. The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils, while a blend of rose and lavender aroma was used for the inhalation aromatherapy group. Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale (VAS) scale was used for measuring pain. The results showed that three groups were equal in terms of demographics, disease characteristics, and scores of anxiety and pain at the baseline. The mean decreases of anxiety scores were -0.04±5.08, 6.33±12.55, and 6.43±10.60 in the control group, aromatherapy massage group, and inhalation group, respectively (p=0.007). The mean decrease of pain scores were -0.10±0.96, 1.70±1.84, and 0.97±1.56 in the control group, aromatherapy massage group, and inhalation group, respectively (paromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients. Therefore, both interventions, which are inexpensive, and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  20. Comparing Formation or Non-Formation of Bladder Flap at Cesarean Section on Perioperative and Postoperative Complications: Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farideh Akhlaghi

    2018-03-01

    Full Text Available Objective: To investigating formation or non-formation of bladder flap at Cesarean section on the complications during and after surgery.Materials and methods: This is a double-blind clinical trial study conducted during February 2014 to May 2015 on 64 pregnant women with gestational age of 36 weeks or more who were delivered by Cesarean section for the first time. They were randomly divided into two groups (intervention group: non-formation of bladder flap; control group: formation of bladder flap. The time to cut out the baby by Cesarean section, total duration of operation, bladder injury, intraoperative bleeding, hematocrit changes expected prior to during and following operation, postoperative pain, macroscopic and microscopic hematuria, postoperative complications and duration of  hospitalization were compared between two groups. The data were analyzed with SPSS version 16 using and statistics tests. p < 0.05 was considered significant.Results: Time to cut out the baby for the intervention group (124.9 ± 40.5 seconds and for control group 155.1 ± 42.9 seconds and total duration of the operation (intervention group: 27.7 ± 5.2 min and control group: 34 ± 4.73 min were significantly different (p = 0.000. Number of gauze consumption during operation and postoperative hematocrit drop in the intervention group was significantly lower in the intervention group compared the control group (p = 0.000. The postoperative pain score in the intervention group (4.8 ± 1.1 and in control group (6.3 ± 0.9 were significantly different (p = 0.000.Conclusion: Omission of the bladder flap at Cesarean section leads to short-term benefits such as reducing the time to cut out the fetus, duration of surgery, decreasing postoperative bleeding and lowering pain.

  1. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome.

    Science.gov (United States)

    Min, Kyong Su; St Pierre, Patrick; Ryan, Paul M; Marchant, Bryant G; Wilson, Christopher J; Arrington, Edward D

    2013-05-01

    The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac in the treatment of external shoulder impingement syndrome. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the steroid group or nonsteroidal anti-inflammatory drugs (NSAID) group. The steroid syringe contained 40 mg triamcinolone; and the NSAID syringe contained 60 mg ketorolac. Each patient was evaluated in terms of arc of motion, visual analog scale (VAS) for evaluating pain, and the UCLA (The University of California at Los Angeles) shoulder rating scale. At 1 month follow-up, both treatment arms resulted in increased range of motion and decreased pain. The steroid group decreased in active abduction while the NSAID group increased (steroid: 134°, NSAID: 151°, P = .03). The mean improvement in the UCLA shoulder rating scale at 4 weeks was 7.15 for the NSAID group and 2.13 for the steroid group (P = .03). Subgroup analysis of the UCLA scale demonstrated an increase in both forward flexion strength (P = .04) and patient satisfaction (P = .03) in the NSAID group. No significant difference could be seen in all other outcome measures. In this study, an injection of ketorolac resulted in greater improvements in the UCLA shoulder rating scale than an injection of triamcinolone at 4 weeks follow-up. While both triamcinolone and ketorolac are effective in the treatment of isolated subacromial impingement, ketorolac appears to have equivalent if not superior efficacy; all the while decreasing patient exposure to the potential side-effects of corticosteroids. Published by Mosby, Inc.

  2. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and efficacy of ...

  3. Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Carmignani, Lucio O; Pedro, Adriana Orcesi; Montemor, Eliana B; Arias, Victor A; Costa-Paiva, Lucia H; Pinto-Neto, Aarão M

    2015-07-01

    This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women. In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using χ(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used. Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar. This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness.

  4. Microbiological analysis of a prospective, randomized, double-blind trial comparing moxifloxacin and clindamycin in the treatment of odontogenic infiltrates and abscesses.

    Science.gov (United States)

    Sobottka, Ingo; Wegscheider, Karl; Balzer, Ludwig; Böger, Rainer H; Hallier, Olaf; Giersdorf, Ina; Streichert, Thomas; Haddad, Munif; Platzer, Ursula; Cachovan, Georg

    2012-05-01

    The objective of this study was to identify the oral pathogens found in odontogenic infections, to determine their susceptibilities to amoxicillin-clavulanic acid (AMC), clindamycin (CLI), doxycycline (DOX), levofloxacin (LVX), moxifloxacin (MXF), and penicillin (PEN), and to search for associations between specific pathogens and types of infection. Swabs from patients enrolled in a randomized, double-blind phase II trial comparing MXF with CLI for the treatment of odontogenic abscesses or inflammatory infiltrates were cultured on media for aerobes and anaerobes. All bacterial isolates were identified at the species level. Overall, 205 isolates were cultured from 71 patients: 77 viridans group streptococci, 56 Prevotella spp., 19 Neisseria spp., 17 Streptococcus anginosus group isolates and hemolytic streptococci, 15 other anaerobes, and 21 other bacteria. Ninety-eight percent of pathogens were susceptible to MXF, 96% to AMC, 85% to LVX, 67% to PEN, 60% to CLI, and 50% to DOX. S. anginosus group and hemolytic streptococci were found significantly more frequently (P = 0.04) in patients with abscesses (12/95) than in patients with infiltrates (5/110). In four patients with infiltrates who failed to respond to CLI therapy, three isolates of the Streptococcus mitis group and four Neisseria spp. resistant to CLI were found. In this study, S. anginosus group and hemolytic streptococci were clearly associated with odontogenic abscesses. Our analysis suggests that viridans group streptococci and Neisseria spp. play a decisive role in the etiology of odontogenic infiltrates. The high in vitro activity of MXF against odontogenic bacteria corresponds well to its clinical results in the treatment of odontogenic abscesses and infiltrates.

  5. Effect of Dill (Anethum graveolens on the severity of primary dysmenorrhea in compared with mefenamic acid: A randomized, double-blind trial

    Directory of Open Access Journals (Sweden)

    Reza Heidarifar

    2014-01-01

    Full Text Available Background: Dysmenorrhea has negative effects on women′s life. Due to side-effects of chemical drugs, there is growing trend toward herbal medicine. The aim of this study was to assess the effect of Dill compared to mefenamic acid on primary dysmenorrhea. Materials and Methods: This double-blind, randomized, clinical trial study was conducted on 75 single female students between 18 and 28 years old educating in Nursing and Midwifery School and Paramedical Faculty of Qom University of Medical Sciences of Iran in 2011. They were allocated randomly into one of the three groups: In Dill group, they took 1000 mg of Dill powder q12h for 5 days from 2 days before the beginning of menstruation for two cycles. Other groups received 250 mg mefenamic acid or 500 mg starch capsule as placebo, respectively. Dysmenorrhea severity was determined by a verbal multidimensional scoring system and a visual analog scale (VAS. Students with mild dysmenorrhea were excluded. Data were analyzed by SPSS using the descriptive statistic, paired-samples t-test, Wilcoxon signed-rank test, Mann-Whitney test, and Kruskal-Wallis test. Results: There were no significant differences between three groups for demographic or descriptive variables. Comprising the VAS showed that the participants of Dill and mefenamic acid groups had lower significant pain in the 1 st and the 2 nd months after treatment, whereas in the placebo group this was only significant in the 2 nd month (P < 0.05. Conclusion: Dill was as effective as mefenamic acid in reducing the pain severity in primary dysmenorrhea. Further studies regarding side-effects of Dill and its interactivity are recommended.

  6. Microbiological Analysis of a Prospective, Randomized, Double-Blind Trial Comparing Moxifloxacin and Clindamycin in the Treatment of Odontogenic Infiltrates and Abscesses

    Science.gov (United States)

    Sobottka, Ingo; Wegscheider, Karl; Balzer, Ludwig; Böger, Rainer H.; Hallier, Olaf; Giersdorf, Ina; Streichert, Thomas; Haddad, Munif; Platzer, Ursula

    2012-01-01

    The objective of this study was to identify the oral pathogens found in odontogenic infections, to determine their susceptibilities to amoxicillin-clavulanic acid (AMC), clindamycin (CLI), doxycycline (DOX), levofloxacin (LVX), moxifloxacin (MXF), and penicillin (PEN), and to search for associations between specific pathogens and types of infection. Swabs from patients enrolled in a randomized, double-blind phase II trial comparing MXF with CLI for the treatment of odontogenic abscesses or inflammatory infiltrates were cultured on media for aerobes and anaerobes. All bacterial isolates were identified at the species level. Overall, 205 isolates were cultured from 71 patients: 77 viridans group streptococci, 56 Prevotella spp., 19 Neisseria spp., 17 Streptococcus anginosus group isolates and hemolytic streptococci, 15 other anaerobes, and 21 other bacteria. Ninety-eight percent of pathogens were susceptible to MXF, 96% to AMC, 85% to LVX, 67% to PEN, 60% to CLI, and 50% to DOX. S. anginosus group and hemolytic streptococci were found significantly more frequently (P = 0.04) in patients with abscesses (12/95) than in patients with infiltrates (5/110). In four patients with infiltrates who failed to respond to CLI therapy, three isolates of the Streptococcus mitis group and four Neisseria spp. resistant to CLI were found. In this study, S. anginosus group and hemolytic streptococci were clearly associated with odontogenic abscesses. Our analysis suggests that viridans group streptococci and Neisseria spp. play a decisive role in the etiology of odontogenic infiltrates. The high in vitro activity of MXF against odontogenic bacteria corresponds well to its clinical results in the treatment of odontogenic abscesses and infiltrates. PMID:22354306

  7. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  8. Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Tammachote, Nattapol; Kanitnate, Supakit; Yakumpor, Thanasak; Panichkul, Phonthakorn

    2016-06-01

    The treatment of knee osteoarthritis with hyaluronic acid or corticosteroid injection has been widely used. The purpose of this study was to compare the efficacy of hyaluronic acid (hylan G-F 20) with triamcinolone acetonide as a single intra-articular injection for knee osteoarthritis. This study was a prospective, randomized, double-blind clinical trial. Participants with symptomatic knee osteoarthritis were recruited. They were randomized to receive a single-shot, intra-articular injection of either 6 mL of hylan G-F 20 or 6 mL of a solution comprising 1 mL of 40-mg triamcinolone acetonide and 5 mL of 1% lidocaine with epinephrine. The primary outcomes were knee pain severity, knee function, and range of motion at 6 months. Ninety-nine patients were assessed before injection and underwent a 6-month follow-up. Patients and evaluators were blinded. Multilevel regression models were used to estimate differences between the groups. At the 6-month follow-up, compared with patients who took hylan G-F 20, patients who took triamcinolone acetonide had similar improvement in knee pain, knee function, and range of motion. The difference in mean outcome scores between groups was, with regard to knee pain, a visual analog scale (VAS) score of 3 points (95% confidence interval [95% CI], -6 to 11 points); with regard to knee function, a modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of 0 points (95% CI, -8 to 6 points); and, with regard to range of motion, flexion of -1° (95% CI, -5° to 2°) and extension of 0° (95% CI, -0.5° to 0.5°). However, patients who took triamcinolone acetonide had better pain improvement from 24 hours until 1 week after injection; the mean difference between groups with regard to the VAS score was 12 points (95% CI, 5 to 20 points; p = 0.002) at 24 hours and 9 points (95% CI, 1 to 15 points; p = 0.018) at 1 week. At 2 weeks after injection, patients who took triamcinolone acetonide also had better knee

  9. The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability.

    Science.gov (United States)

    Parr, Jeremy R; Weldon, Emma; Pennington, Lindsay; Steen, Nick; Williams, Jane; Fairhurst, Charlie; O'Hare, Anne; Lodh, Raj; Colver, Allan

    2014-02-17

    Drooling saliva is a common problem in children with neurodevelopmental disorders. The negative consequences of drooling include skin breakdown, dehydration, and damage to clothing and equipment. Children and families often suffer social embarrassment due to drooling. There is no evidence about the relative effectiveness, side effect profiles or patient acceptability of the two medications most commonly used to reduce drooling - glycopyrronium and hyoscine. Consequently, there is no consensus or guideline to aid clinical decisions about which drug to use, and at what dose. A multi-centre, randomised trial of treatment with glycopyrronium or hyoscine in children with problematic drooling and non-progressive neurodisability. Ninety children aged between 3 and 15 years who have never received medication for drooling will be stratified by severity of drooling and care centre. Randomisation to receive treatment with glycopyrronium or hyoscine will be computer generated from the trial randomisation website. Dose adjustment and side effect monitoring will occur via telephone consultation. Medication arm will be known to participants and clinicians but not the Trial Outcome Assessor.The primary outcome measure is the Drooling Impact Scale score at four weeks, at which time all children will be on the maximum tolerated dose of their medication. Secondary outcome measures include change in Drooling Impact Scale score between baseline, 4, 12 and 52 weeks, change in Drooling Severity and Frequency Scale score and difference between groups in the Treatment Satisfaction Questionnaire for Medication score. A structured interview with children and young people of sufficient age, cognitive and communication ability will explore their perceptions of drooling and the effectiveness and acceptability of the medications. The primary objective of the study is to identify whether glycopyrronium or hyoscine is more effective in treating drooling in children with non

  10. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  11. A randomized double-blind controlled trial comparing extra virgin coconut oil with mineral oil as a moisturizer for mild to moderate xerosis.

    Science.gov (United States)

    Agero, Anna Liza C; Verallo-Rowell, Vermén M

    2004-09-01

    Xerosis is a common skin condition (1) characterized by dry, rough, scaly, and itchy skin, (2) associated with a defect in skin barrier function, and (3) treated with moisturizers. People in the tropics have effectively used coconut oil as a traditional moisturizer for centuries. Recently, the oil also has been shown to have skin antiseptic effects. A moisturizer with antiseptic effects has value, but there are no clinical studies to document the efficacy and safety of coconut oil as a skin moisturizer. This study aimed to determine the effectivity and safety of virgin coconut oil compared with mineral oil as a therapeutic moisturizer for mild to moderate xerosis. A randomized double-blind controlled clinical trial was conducted on mild to moderate xerosis in 34 patients with negative patch-test reactions to the test products. These patients were randomized to apply either coconut oil or mineral oil on the legs twice a day for 2 weeks. Quantitative outcome parameters for effectivity were measured at baseline and on each visit with a Corneometer CM825 to measure skin hydration and a Sebumeter SM 810 to measure skin lipids. For safety, transepidermal water loss (TEWL) was measured with a Tewameter TM210, and skin surface hydrogen ion concentration (pH) was measured with a Skin pH Meter PH900. Patients and the investigator separately evaluated, at baseline and at each weekly visit, skin symptoms of dryness, scaling, roughness, and pruritus by using a visual analogue scale and grading of xerosis. Coconut oil and mineral oil have comparable effects. Both oils showed effectivity through significant improvement in skin hydration and increase in skin surface lipid levels. Safety was demonstrated through no significant difference in TEWL and skin pH. Subjective grading of xerosis by the investigators and visual analogue scales used by the patients showed a general trend toward better (though not statistically evident) improvement with coconut oil than with mineral oil

  12. Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture: Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks.

    Science.gov (United States)

    Aspenberg, Per; Malouf, Jorge; Tarantino, Umberto; García-Hernández, Pedro A; Corradini, Costantino; Overgaard, Søren; Stepan, Jan J; Borris, Lars; Lespessailles, Eric; Frihagen, Frede; Papavasiliou, Kyriakos; Petto, Helmut; Caeiro, José Ramón; Marin, Fernando

    2016-11-16

    Osteoporosis drugs might affect fracture-healing. We therefore studied the effects of teriparatide in comparison with risedronate on recovery after pertrochanteric hip fractures. The study was a randomized, multicenter, active-controlled, 78-week trial comparing teriparatide (20 μg/day) with risedronate (35 mg/week) initiated within 2 weeks after fixation of a low-trauma pertrochanteric hip fracture (AO/OTA 31-A1 or 31-A2). The main inclusion criteria were a bone mineral density T-score of ≤-2.0 and 25-OH-vitamin D of ≥9.2 ng/mL. During the first 26 weeks, patients received study medication with oral or injectable placebo plus calcium and vitamin D in a double-blinded fashion. Secondary (Timed Up-and-Go [TUG] test, hip pain, Short Form [SF]-36 health status, and safety) and exploratory (radiographic outcomes and ability to walk) 26-week end points are reported. Of the 224 patients who were randomized, 171 (86 teriparatide, 85 risedronate) were included in the analysis. The mean age was 77 ± 8 years, 77% were female, and 26% had a prior history of low-trauma fracture. The teriparatide group completed the TUG test in a shorter time at 6, 12, 18, and 26 weeks (differences of -5.7, -4.4, -3.1, and -3.1 seconds, respectively; p = 0.021 for the overall difference). They also reported less pain on a visual analog scale immediately after the TUG test at 12 and 18 weeks (adjusted absolute differences of 10.6 and 11.9 mm, respectively; p teriparatide, 7; risedronate, 8), loss of reduction (teriparatide, 2; risedronate, 4), and nonunion (0 cases) were not significantly different. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide. Teriparatide was associated with less pain and a shorter time to complete the TUG test between 6 and 26 weeks compared with risedronate. Other fracture-recovery outcomes were similar. The results should be interpreted with caution as these were secondary end points. Therapeutic Level II. See Instructions for Authors for

  13. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial

    OpenAIRE

    Malhotra, Parul Uppal; Thakur, Seema; Singhal, Parul; Chauhan, Deepak; Jayam, Cheranjeevi; Sood, Ritu; Malhotra, Yagyeshwar

    2016-01-01

    Background: Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Objective: Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam–ketamine in a group of children with uncooperative behavior requiring dental treatment. Materials and Methods: This was a prospective, randomized, double-blind study that included patients 3–9 years old with American...

  14. Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

    Science.gov (United States)

    Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

    2016-08-02

    Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

  15. Prospective, Randomized, Double-Blind, Parallel-Group, Comparative Effectiveness Clinical Trial Comparing a Powder Vehicle Compound of Vitamin D With an Oil Vehicle Compound in Adults With Cystic Fibrosis.

    Science.gov (United States)

    Hermes, Wendy A; Alvarez, Jessica A; Lee, Moon J; Chesdachai, Supavit; Lodin, Daud; Horst, Ron; Tangpricha, Vin

    2017-08-01

    There is little consensus on the most efficacious vehicle substance for vitamin D supplements. Fat malabsorption may impede the ability of patients with cystic fibrosis (CF) to absorb vitamin D in an oil vehicle. We hypothesized that vitamin D contained in a powder vehicle would be absorbed more efficiently than vitamin D contained in an oil vehicle in patients with CF. In this double-blind, randomized controlled trial, hospitalized adults with CF were given a one-time bolus dose of 100,000 IU of cholecalciferol (D 3 ) in a powder-based or oil-based vehicle. Serum D 3 , 25-hydroxyvitamin D, and parathyroid hormone concentrations were analyzed at 0, 12, 24, and 48 hours posttreatment. The area under the curve for serum D 3 and the 12-hour time point were also assessed as indicators of D 3 absorption. This trial was completed by 15 patients with CF. The median (interquartile range) age, body mass index, and forced expiratory volume in 1 second were 23.7 (19.9-33.2) years, 19.9 (18.6-22.6) kg/m 2 , and 63% (37%-80%), respectively. The increase in serum D 3 and the area under the curve was greater in the powder group ( P = .002 and P = .036, respectively). Serum D 3 was higher at 12 hours in the powder group compared with the oil group ( P = .002), although levels were similar between groups by 48 hours. In adults with CF, cholecalciferol is more efficiently absorbed in a powder compared with an oil vehicle. Physicians should consider prescribing vitamin D in a powder vehicle in patients with CF to improve the absorption of vitamin D from supplements.

  16. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial.

    Science.gov (United States)

    Garland, Sheila N; Carlson, Linda E; Stephens, Alisa J; Antle, Michael C; Samuels, Charles; Campbell, Tavis S

    2014-02-10

    Our study examined whether mindfulness-based stress reduction (MBSR) is noninferior to cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia in patients with cancer. This was a randomized, partially blinded, noninferiority trial involving patients with cancer with insomnia recruited from a tertiary cancer center in Calgary, Alberta, Canada, from September 2008 to March 2011. Assessments were conducted at baseline, after the program, and after 3 months of follow-up. The noninferiority margin was 4 points measured by the Insomnia Severity Index. Sleep diaries and actigraphy measured sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency. Secondary outcomes included sleep quality, sleep beliefs, mood, and stress. Of 327 patients screened, 111 were randomly assigned (CBT-I, n = 47; MBSR, n = 64). MBSR was inferior to CBT-I for improving insomnia severity immediately after the program (P = .35), but MBSR demonstrated noninferiority at follow-up (P = .02). Sleep diary-measured SOL was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in WASO were observed for both groups. TST increased by 0.60 hours for CBT-I and 0.75 hours for MBSR. CBT-I improved sleep quality (P treatment of insomnia.

  17. A single-blind randomised trial comparing adrenaline 1.0% with dipivalyl epinephrine (propine) 0.1% in the treatment of open-angle glaucoma and ocular hypertension.

    Science.gov (United States)

    Mills, K B; Jacobs, N A

    1988-01-01

    The results of this single-blind randomised trial comparing adrenaline 1% with dipivalyl epinephrine (Propine) 0.1% confirm that both have a significant effect in lowering the intraocular pressure in patients with open-angle glaucoma and ocular hypertension, but it is generally insufficient to warrant their use as the first line medical treatment of these two conditions. There was no significant difference between the intraocular lowering effect of the two preparations, and 60% of patients receiving Propine and 66% of those receiving adrenaline noted side effects. PMID:3291940

  18. Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip

    NARCIS (Netherlands)

    Van Oldenrijk, J. (Jakob); V.A. Scholtes (Vanessa); Van Beers, L.W.A.H. (Loes W.A.H.); Geerdink, C.H. (Carel H.); Niers, B.B.A.M. (Bob B.A.M.); Runne, W. (Wouter); M. Bhandari (Mohit); R.W. Poolman (Rudolf)

    2017-01-01

    textabstractObjectives Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial. Design A prospective blinded

  19. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  20. Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial.

    Science.gov (United States)

    Irwin, Michael R; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Nicassio, Perry; Ganz, Patricia A; Bower, Julienne E

    2017-08-10

    Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.

  1. [Tracheal intubation quality under remifentanil-propofol with sevoflurane compared with remifentanil-propofol with rocuronium: a randomized double-blind clinical trial].

    Science.gov (United States)

    González Obregón, M P; Rivera Díaz, R C; Ordóñez Molina, J E; Rivera Díaz, J S; Velásquez Ossa, L F; Pineda Ibarra, C; Serna Gutiérrez, J; Franco Botero, V

    2010-01-01

    To determine whether intubation conditions under remifentanil-propofol plus sevoflurane rather than a nondepolarizing neuromuscular blocker are similar to those obtained when a neuromuscular blocker is used. In this double-blind controlled trial, 100 patients undergoing outpatient surgery were randomized to 2 groups. Intubation in one group was performed under remifentanil, propofol and sevoflurane. In the other, intubation was performed under remifentanil, propofol, and the nondepolarizing neuromuscular blocker rocuronium. We recorded dysphonia at 24 hours, Cormack-Lehane classification at laryngoscopy, mandibular relaxation, vocal cord position and mobility, and cough or movement during laryngoscopy, on intubation and on cuff inflation. Blood pressure and heart rate before and after tracheal intubation were also recorded. No significant between-group differences were observed in dysphonia 24 hours after surgery, Cormack-Lehane classification at laryngoscopy, mandibular relaxation, the position or mobility of vocal cords, or cough or movement during laryngoscopy, intubation or cuff inflation. After intubation the mean (SD) systolic blood pressure was 119.7 (75.4) mm Hg in the rocuronium group and 97.5 (54.5) mm Hg in the sevoflurane group. Mean heart rate was 80.7 beats/min in the rocuronium group and 66.7 beats/min in the sevoflurane group. The differences were significant (P < .05). Adequate doses of remifentanil, propofol, and sevoflurane provide intubation conditions that are similar to those achieved by using a nondepolarizing neuromuscular blocker, without exposing patients to additional risk. Avoiding use of a neuromuscular blocker would circumvent the development of complications associated with use of these agents or their antagonists and costs would be lower.

  2. A multicentre, prospective, randomised, blinded clinical trial to compare some perioperative effects of buprenorphine or butorphanol premedication before equine elective general anaesthesia and surgery.

    Science.gov (United States)

    Taylor, P M; Hoare, H R; de Vries, A; Love, E J; Coumbe, K M; White, K L; Murrell, J C

    2016-07-01

    Buprenorphine, a μ-agonist opioid, has recently been licensed for equine use, but butorphanol, a κ-agonist opioid, is more commonly used in horses. The effect of the 2 opioids has not previously been compared in a large clinical study. To compare post operative analgesia and physiological variables in horses undergoing elective surgery following premedication with either buprenorphine or butorphanol in a conventional clinical setting. Multicentre, prospective, randomised, blinded clinical investigation. Eighty-nine healthy horses admitted for elective surgery to one of 6 UK equine veterinary clinics were premedicated with acepromazine, a nonsteroidal anti-inflammatory drug, and romifidine followed by intravenous (i.v.) buprenorphine or butorphanol. Anaesthesia was induced with diazepam/ketamine and maintained with isoflurane in oxygen. A range of surgical procedures were performed and supplementary anaesthetic agents given as required. Physiological variables were monitored during anaesthesia and pain, ataxia, sedation and vital function were assessed post operatively. Data were analysed using t-tests, ANOVA, Mann-Whitney U-test and Chi-squared test as appropriate and Pbuprenorphine than after butorphanol. Horses experienced less post operative pain after buprenorphine than after butorphanol premedication. Compared with butorphanol, buprenorphine did not cause any different effects on vital function. © 2015 The Authors. Equine Veterinary Journal published by John Wiley & Sons Ltd on behalf of British Equine Veterinary Association.

  3. An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol.

    Science.gov (United States)

    Baillie, Andrew J; Sannibale, Claudia; Stapinski, Lexine A; Teesson, Maree; Rapee, Ronald M; Haber, Paul S

    2013-07-30

    Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. Australian New Zealand Clinical Trials Registry: ACTRN12608000228381.

  4. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial.

    Science.gov (United States)

    Malhotra, Parul Uppal; Thakur, Seema; Singhal, Parul; Chauhan, Deepak; Jayam, Cheranjeevi; Sood, Ritu; Malhotra, Yagyeshwar

    2016-01-01

    Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam-ketamine in a group of children with uncooperative behavior requiring dental treatment. This was a prospective, randomized, double-blind study that included patients 3-9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg) with ketamine (5 mg/kg) mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg) and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale. Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications. Oral midazolam-ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

  5. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Parul Uppal Malhotra

    2016-01-01

    Full Text Available Background: Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Objective: Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam–ketamine in a group of children with uncooperative behavior requiring dental treatment. Materials and Methods: This was a prospective, randomized, double-blind study that included patients 3–9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg with ketamine (5 mg/kg mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale. Results: Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications. Conclusion: Oral midazolam–ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

  6. Effect of intraarticular glycosaminoglycan polysulfate treatment on patellofemoral pain syndrome. A prospective, randomized double-blind trial comparing glycosaminoglycan polysulfate with placebo and quadriceps muscle exercises.

    Science.gov (United States)

    Kannus, P; Natri, A; Niittymäki, S; Järvinen, M

    1992-09-01

    To compare the effects of intraarticular (IA) injections of glycosaminoglycan polysulfate (GAGPS) plus basic conservative treatment with the effects of placebo injections plus conservative treatment and with the effects of conservative treatment alone in patients with chronic patellofemoral pain syndrome (PFPS). We treated 53 patients who presented with chronic PFPS in 1 knee, according to 1 of the 3 protocols, in a prospective, randomized, double-blind study. Basic conservative treatment consisted of a 6-week program of quadriceps muscle exercise, elimination of symptom-producing activities, and oral doses of nonsteroidal antiinflammatory drugs. Physiologic saline served as placebo for injection. During the 6-week treatment period, 5 injections were given 1 week apart. Along with measurements of quadriceps strength, standardized subjective, functional, and clinical assessments were performed at presentation, after 6 weeks of treatment, and after 6 months. Results at 6 months indicated that IA injections of GAGPS or saline did not result in significant improvement beyond the good results achieved by the basic conservative treatment alone. More than two-thirds of the patients in each group experienced complete recovery. Neither the GAGPS injections nor the physiologic saline injections are more effective than conservative therapy in the treatment of chronic PFPS. Restoration of normal quadriceps muscle function to the affected knee seems to be crucial in treating PFPS.

  7. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  8. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder

    DEFF Research Database (Denmark)

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F.

    2017-01-01

    ). METHOD: Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. RESULTS: SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants...... perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo......BACKGROUND: The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD...

  9. The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial.

    Science.gov (United States)

    Chiu, Pin-Chi; Chan, Chih-Chieh; Lin, Hui-Min; Chiu, Hsien-Ching

    2007-12-01

    Kinetin and niacinamide are used in the cosmetic industry as anti-aging agents. Neither the interactive/additive effects of these compounds nor the anti-aging efficacy on Asian skin has been studied. Objective To assess the clinical anti-aging effects and efficacy differences between kinetin plus niacinamide and niacinamide alone vs. vehicle placebo in an Asian cohort. Fifty-two Taiwanese subjects were enrolled in a randomized, double-blind, placebo-controlled, split-face comparative study. Group 1 subjects were treated with kinetin 0.03% plus niacinamide 4%, whereas group 2 subjects received niacinamide 4%. The treatment formulation was applied on one side of the face, whereas a placebo was applied on the other for a period of 12 weeks. We used noninvasive biometrological instruments to evaluate a variety of skin parameters at baseline and at weeks 4, 8, and 12. Persistent and significant reductions in spot, pore, wrinkle, and evenness counts were found at weeks 8 and 12 in group 1. A significant increase in corneal hydration status was also evident at week 12, whereas persistent decreases in erythema index were apparent at 8 and 12 weeks. In group 2, significant reductions in pore and evenness counts at week 8 and wrinkle counts at week 12 were noted. We found kinetin and niacinamide exert a synergistic anti-aging effect. Our data suggest that these compounds have multiactive, multifunctional, and pluripotent effects on skin. They are also both promising to be included in the cutaneous anti-aging cosmeceuticals in the future.

  10. A double-blind randomized controlled trial comparing dexamethasone and clonidine as adjuvants to a ropivacaine sciatic popliteal block for foot surgery

    Directory of Open Access Journals (Sweden)

    Vermeylen K

    2016-05-01

    Full Text Available Kris Vermeylen,1 Joris De Puydt,2 Stefan Engelen,3 Eva Roofthooft,3 Filiep Soetens,1 Arne Neyrinck,4 Marc Van de Velde4 1Department of Anesthesia and Intensive Care, AZ Turnhout, Turnhout, 2Department of Anesthesia, University Hospital Antwerp, Antwerp, 3Department of Anesthesia, ZNA Hospital Network Antwerp, Antwerp, 4Department of Cardiovascular Sciences and Anesthesiology, Catholic University Hospitals, Louvain, Belgium Background and aims: A popliteal block is effective in managing postoperative pain for foot surgery, but since the duration of analgesia is limited following a single-shot popliteal fossa block technique, methods to prolong effective postoperative analgesia are mandatory. The aim of this study was to assess the effect of adjuvants to ropivacaine on the duration of sensory and motor block.Methods: In this double-blind randomized placebo-controlled study, we evaluated the analgesic effect of clonidine or dexamethasone (DXM when added to ropivacaine for hallux valgus surgery. After obtaining institutional ethics research board approval and written informed consent, a total of 72 patients were randomly allocated. Fifty-seven of these patients were statistically analyzed. All patients received an ultrasound-guided single-shot popliteal fossa block with 30 mL of ropivacaine 0.75%, supplemented with saline, clonidine 100 µg, or DXM 5 mg. The primary end point was time to first pain sensation. Secondary end points were time to complete sensory and motor block regression.Results: Compared to saline, duration to first pain sensation was prolonged by 9 hours (mean ± standard deviation: 31±9 hours (42% in the DXM group (P=0.024 and by 6 hours (28±10 hours (27% in the clonidine group (P=0.024. Compared to saline, DXM prolonged both complete sensory and motor blockade by 12 hours (25±7 hours (46% and 13 hours (36±6 hours (55%, respectively, while clonidine prolonged complete sensory and motor blockade by 7 hours (30±7 hours (27% and

  11. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer

    DEFF Research Database (Denmark)

    Devroey, Paul; Pellicer, Antonio; Nyboe Andersen, Anders

    2012-01-01

    OBJECTIVE: To compare the efficacy and safety of highly purified menotropin (hphMG) and recombinant FSH (rFSH) for controlled ovarian stimulation in a GnRH antagonist cycle with compulsory single-blastocyst transfer. DESIGN: Randomized, open-label, assessor-blind, parallel groups, multicenter......, noninferiority trial. SETTING: Twenty-five infertility centers in seven countries. PATIENT(S): Seven hundred forty-nine women. INTERVENTION(S): Controlled ovarian stimulation with hphMG or rFSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer on day 5 in one fresh or subsequent frozen......MG versus 27% with rFSH for the per-protocol (PP) population and 29% versus 27% for the intention-to-treat (ITT) population. Noninferiority of hphMG compared to rFSH was established. Considering frozen cycles initiated within 1 year, the cumulative live birth rate for a single stimulation cycle was 40...

  12. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

    2017-08-01

    The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

  13. Clinical efficacy of Spasmofen® suppository in the emergency treatment of renal colic: a randomized, double-blind, double-dummy comparative trial

    Directory of Open Access Journals (Sweden)

    Yakoot M

    2014-05-01

    Full Text Available Mostafa Yakoot,1 Amel Salem,2 Sameh Yousef,2 Sherine Helmy31Green Clinic and Research Center, 2Alexandria Helmy Medical Center, 3Pharco Corporation, Alexandria, EgyptBackground: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen® is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in the renal system, hepatobiliary system, or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous (IV ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic.Methods: A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into two treatment groups: an experimental group (Spasmofen group who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution; and a control group (ketorolac group who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using the chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale (VPAS scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions.Results: Successful treatment at 60 minutes occurred in 35 of 40 (87.5% of Spasmofen-treated patients and in 33 of 40 (82.5% of ketorolac-treated patients. The difference was not statistically significant by Fisher's exact test

  14. A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers.

    Science.gov (United States)

    Driver, Vickie R; Reyzelman, Alexander; Kawalec, Jill; French, Michael

    2017-04-01

    Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health care providers. Although hyperbaric oxygen therapy is well-known as an adjunct option, less is known about the efficacy of transdermal continuous oxygen therapy (TCOT). A prospective, randomized, blinded, multicenter, parallel study was conducted from October 2009 to November 2012 to evaluate healing time and the proportion of DFUs healed after 12 weeks of moist wound therapy (MWT) with or without TCOT. Study participants (persons with type 1 or type 2 diabetes and a nonhealing [>1-month but treatment consisted of continuous administration of 98+% oxygen to the wound site using a 15-day device with dressings changed every 3 to 7 days per care plan or more often when clinically required. Potential participants completed demographic and clinical screening and wound and laboratory evaluations at baseline, and wound evaluations, evaluation of adverse events, debridement, and treatment once weekly until the wound healed or up to 12 weeks. The primary endpoint was defined as complete wound closure by week 12. Wound measurements were made utilizing acetate tracings. Original tracings were collected at approximately 6-week intervals and analyzed upon study closure. Data were collected via paper Case Report Forms and entered into an electronic database after the patient's final visit. Statistical analysis was performed on datasets exported from the electronic database. Wound measurement data were analyzed using chi-squared. Time to complete closure was analyzed using Kaplan-Meier analysis in conjunction with the log-rank test. Of the 130 potential participants, 8 with protocol violations were excluded from analysis. In the intent-to-treat (ITT) population (N = 122, average age 59 years [range 28-85 years]), the majority were male (74%), Caucasian (81%), and had a plantar ulcer (76%). Mean baseline wound area was 2.3 ± 1.7 cm² (range 0.4-8.9 cm2) and 2.0 ± 1.7 cm² (range 0

  15. Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis

    Directory of Open Access Journals (Sweden)

    Stange R

    2017-03-01

    predefined criteria. During the follow-up period, one relapse occurred in each group. Both treatments were well tolerated. Conclusion: This clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of future trials. Issues that led to the premature trial discontinuation were considered. Keywords: urinary tract infection, herbal medicinal product, cystitis, horseradish, nasturtium herb, co-trimoxazole, randomized clinical trial

  16. Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial

    Science.gov (United States)

    Im, Jong Pil; Kim, Su Hwan; Koh, Seong-Joon; Kim, Byeong Gwan; Lee, Kook Lae; Kim, Sang Gyun; Kim, Joo Sung; Jung, Hyun Chae

    2016-01-01

    Background Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution. Methods This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered. Results A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01). Conclusions Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution. Trial Registration ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708 PMID:27588943

  17. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels : a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144)

    NARCIS (Netherlands)

    Nolen, Willem A.; Weisler, Richard H.

    Nolen WA, Weisler RH. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels: a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144). Bipolar Disord 2012:

  18. Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program.

    Science.gov (United States)

    Zondervan, Daniel K; Friedman, Nizan; Chang, Enoch; Zhao, Xing; Augsburger, Renee; Reinkensmeyer, David J; Cramer, Steven C

    2016-01-01

    Individuals with chronic stroke have limited options for hand rehabilitation at home. Here, we sought to determine the feasibility and efficacy of home-based MusicGlove therapy. Seventeen participants with moderate hand impairment in the chronic phase of stroke were randomized to 3 wk of home-based exercise with either the MusicGlove or conventional tabletop exercises. The primary outcome measure was the change in the Box and Blocks test score from baseline to 1 mo posttreatment. Both groups significantly improved their Box and Blocks test score, but no significant difference was found between groups. The MusicGlove group did exhibit significantly greater improvements than the conventional exercise group in motor activity log quality of movement and amount of use scores 1 mo posttherapy (p = 0.007 and p = 0.04, respectively). Participants significantly increased their use of MusicGlove over time, completing 466 gripping movements per day on average at study end. MusicGlove therapy was not superior to conventional tabletop exercises for the primary end point but was nevertheless feasible and led to a significantly greater increase in self-reported functional use and quality of movement of the impaired hand than conventional home exercises. ClinicalTrials.gov; "Influence of Timing on Motor Learning"; NCT01769326; https://clinicaltrials.gov/ct2/show/NCT01769326.

  19. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine®) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial

    Science.gov (United States)

    Grewal, Navneet; Salhan, Rubica; Kaur, Nirapjeet; Patel, Hemal Bipin

    2016-01-01

    Background: Considering the biological concerns of calcium hydroxide (CH) as a pulpotomy agent, an alternative silicate based dentin substitute i.e. Biodentine (Ca3SiO5) was evaluated clinically and radiographically. Aims: To evaluate the effectiveness of dentin substitute (Biodentine) in regenerative pulpotomy of vital primary teeth that would giv a biological base to its use in forming reactive dentin bridge and overcoming the drawbacks of calcium hydroxide. Material and Methods: Randomised clinical trial on 40 bilateral carious primary molars in 20 participant children (aged 5-10 years) was carried out by same operator using Ca3SiO5(group-1) and CH (group-2) as vital pulpotomy agents. Blinded clinical and radiographic outcomes were observed at 3, 6 and 12 months interval. Results: Clinical outcomes of both protocols were analysed using Pearson's chi-square test applied at P < 0.05. Descriptive statistics were expressed as mean increase in dentin bridge formation in mms from two reference points in standardized radiographs using paired ‘t’- test at baseline and 12 months and found to be statistically significant (P < 0.05) in group-1 when compared with group-2. Conclusion: Group-1 revealed statistically favourable regenerative potential along with clinical success compared to group 2 thereby sharing both indications and mode of action with CH, but without its drawbacks of physical and clinical properties. PMID:27994411

  20. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine® and calcium hydroxide (pulpdent in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Navneet Grewal

    2016-01-01

    Full Text Available Background: Considering the biological concerns of calcium hydroxide (CH as a pulpotomy agent, an alternative silicate based dentin substitute i.e. Biodentine (Ca3SiO5 was evaluated clinically and radiographically. Aims: To evaluate the effectiveness of dentin substitute (Biodentine in regenerative pulpotomy of vital primary teeth that would giv a biological base to its use in forming reactive dentin bridge and overcoming the drawbacks of calcium hydroxide. Material and Methods: Randomised clinical trial on 40 bilateral carious primary molars in 20 participant children (aged 5-10 years was carried out by same operator using Ca3SiO5(group-1 and CH (group-2 as vital pulpotomy agents. Blinded clinical and radiographic outcomes were observed at 3, 6 and 12 months interval. Results: Clinical outcomes of both protocols were analysed using Pearson's chi-square test applied at P < 0.05. Descriptive statistics were expressed as mean increase in dentin bridge formation in mms from two reference points in standardized radiographs using paired 't'- test at baseline and 12 months and found to be statistically significant (P < 0.05 in group-1 when compared with group-2. Conclusion: Group-1 revealed statistically favourable regenerative potential along with clinical success compared to group 2 thereby sharing both indications and mode of action with CH, but without its drawbacks of physical and clinical properties.

  1. A multicentre, prospective, randomised, blinded clinical trial to compare some perioperative effects of buprenorphine or butorphanol premedication before equine elective general anaesthesia and surgery

    OpenAIRE

    Taylor, P. M.; Hoare, H. R.; de Vries, A.; Love, E. J.; Coumbe, K. M.; White, KL; Murrell, J. C.

    2016-01-01

    Reasons for performing study: Buprenorphine, a μ-agonist opioid, has recently been licensed for equine use, but butorphanol, a κ-agonist opioid, is more commonly used in horses. The effect of the 2 opioids has not previously been compared in a large clinical study. Objectives: To compare post operative analgesia and physiological variables in horses undergoing elective surgery following premedication with either buprenorphine or butorphanol in a conventional clinical setting. Study design: Mu...

  2. Efficacy of hypnotherapy compared to cognitive-behavioural therapy for mild-to-moderate depression: study protocol of a randomised-controlled rater-blind trial (WIKI-D).

    Science.gov (United States)

    Fuhr, Kristina; Schweizer, Cornelie; Meisner, Christoph; Batra, Anil

    2017-12-01

    Despite a substantial number of studies providing evidence for the efficacy of psychological treatment for mild-to-moderate depression, maximally only 50% of participants respond to treatment, even when using gold-standard treatments such as cognitive-behavioural therapy (CBT) and interpersonal therapy. New approaches such as the 'third wave' psychotherapies have provided promising results; however, studies concerning the comparison with evidence-based treatments are lacking. This study aims to compare the efficacy of clinical hypnotherapy (HT) with gold-standard psychotherapy (CBT) in the treatment of mild-to-moderate major depressive episodes. The present study comprises a monocentric, two-armed, randomised-controlled, rater-blind (non-inferiority) clinical trial. A total of 160 participants with mild-to-moderate major depression episode will be randomly assigned to either CBT or HT involving 20 sessions of psychotherapy over a period of 24 weeks. We predict that the average improvement in the Montgomery-Åsberg Depression Rating Scale score will not be inferior in HT compared with CBT (non-inferiority hypothesis).Further outcome parameters will include the number of participants responding to treatment following the completion of treatment and 1 year after. Additionally, quality of life, treatment expectations and hypnotic susceptibility before and after end of treatment will be assessed. The study protocol and the documents for the informed consent have been approved by the Ethics Committee of the University Hospital Tuebingen (061/2015B02). The results of this trial will be submitted for publication in peer-reviewed journals, and will be presented at national and international conferences. NCT02375308; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial.

    Directory of Open Access Journals (Sweden)

    Ji Eun Kwon

    Full Text Available Two liters of polyethylene glycol (PEG solution administered with ascorbic acid (Asc can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution.This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group. The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered.A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96 of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10. There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01.Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution.ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS KCT0000708.

  4. Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial

    NARCIS (Netherlands)

    Brans, J. W.; Lindeboom, R.; Snoek, J. W.; Zwarts, M. J.; van Weerden, T. W.; Brunt, E. R.; van Hilten, J. J.; van der Kamp, W.; Prins, M. H.; Speelman, J. D.

    1996-01-01

    Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind

  5. Low-Volume Brachial Plexus Block Providing Surgical Anesthesia for Distal Arm Surgery Comparing Supraclavicular, Infraclavicular, and Axillary Approach. A Randomized Observer Blind Trial

    DEFF Research Database (Denmark)

    Vazin, Mojgan; Jensen, Kenneth; Hjort, Mathias

    2016-01-01

    Background. Distal arm surgery is widely performed under regional anesthesia with brachial plexus block. The preponderance of evidence for the efficacy relies upon injection of local anesthetic in excess of 30 mL. We aimed to compare three different ultrasound-guided brachial plexus block techniq...

  6. A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis

    OpenAIRE

    Aapro, M. S.; Thuerlimann, B.; Sessa, C.; de Pree, C.; Bernhard, J.; Maibach, R.

    2017-01-01

    Background: The prophylactic use of 5-HT3 receptor antagonists (setrons), after the first 24 h (acute phase) of exposure to emetic chemotherapy, to decrease the incidence of ‘delayed phase' emesis increases costs. We designed a study to evaluate the efficacy of a setron (granisetron) in the delayed phase, compared with metoclopramide, each combined with a corticosteroid. Patients and methods: Patients on their first course of single-day emetic chemotherapy (cisplatin, carboplatin, doxorubicin...

  7. Comparative preemptive analgesia evaluation of ibuprofen and etoricoxib in third molars surgery: a randomized, double-blind, placebo-controlled, crossover clinical trial

    OpenAIRE

    Fabio Wildson Gurgel Costa

    2013-01-01

    Third molar surgery is a frequent procedure in dentistry related to variable degrees of postoperative pain. In this context, non-steroidal anti-inflammatory drugs have been commonly used in studies that evaluated the efficacy of preemptive analgesia as a strategy for pain control. Thus, the aim of the present study was to evaluate the preemptive analgesic efficacy and anti-inflammatory effect of ibuprofen and etoricoxib in mandibular third molar surgery, compared with a placebo. A randomized,...

  8. Comparing three-year extension of early intervention service to regular care following two years of early intervention service in first-episode psychosis: a randomized single blind clinical trial.

    Science.gov (United States)

    Malla, Ashok; Joober, Ridha; Iyer, Srividya; Norman, Ross; Schmitz, Norbert; Brown, Thomas; Lutgens, Danyael; Jarvis, Eric; Margolese, Howard C; Casacalenda, Nicola; Abdel-Baki, Amal; Latimer, Eric; Mustafa, Sally; Abadi, Sherezad

    2017-10-01

    This study aimed to determine if, following two years of early intervention service for first-episode psychosis, three-year extension of that service was superior to three years of regular care. We conducted a randomized single blind clinical trial using an urn randomization balanced for gender and substance abuse. Participants were recruited from early intervention service clinics in Montreal. Patients (N=220), 18-35 years old, were randomized to an extension of early intervention service (EEIS; N=110) or to regular care (N=110). EEIS included case management, family intervention, cognitive behaviour therapy and crisis intervention, while regular care involved transfer to primary (community health and social services and family physicians) or secondary care (psychiatric outpatient clinics). Cumulative length of positive and negative symptom remission was the primary outcome measure. EEIS patients had a significantly longer mean length of remission of positive symptoms (92.5 vs. 63.6 weeks, t=4.47, pyears has a positive impact on length of remission of positive and negative symptoms compared to regular care. This may have policy implications for extending early intervention services beyond the current two years. © 2017 World Psychiatric Association.

  9. A double-blind randomized control trial of diazepam

    OpenAIRE

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.

  10. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin.

    Science.gov (United States)

    Equils, Ozlem; da Costa, Christopher; Wible, Michele; Lipsky, Benjamin A

    2016-09-06

    The presence of diabetes mellitus increases the risk of several severe infections, but data on its effect on treatment outcomes in patients with nosocomial pneumonia (NP) caused by methicillin-resistant Staphylococcus aureus (MRSA) are limited. We retrospectively analyzed data from a double-blind, randomized, multi-center, international clinical trial of culture-confirmed MRSA NP that compared treatment with linezolid to vancomycin. Specifically, we evaluated the clinical and microbiologic outcomes of patients with and without diabetes in the modified intent to treat population at end-of-treatment (EOT) and end-of-study (EOS, 7-30 days post-EOT). Among 448 enrolled patients 183 (40.8 %) had diabetes mellitus, 87 (47.5 %) of whom received linezolid and 96 (52.5 %) vancomycin. Baseline demographic and clinical characteristics were similar for the two treatment groups. Clinical success rates at EOS were 57.6 % with linezolid and 39.3 % with vancomycin, while microbiological success rates were 58.9 % with linezolid and 41.1 % with vancomycin. Among diabetic patients, rates of mortality and study drug-related adverse effects were similar between the treatment groups. Overall day 28 mortality rates were higher among diabetic patients compared to non-diabetic patients (23.5 vs 14.7 %, respectively: RD = 8.8 %, 95 % CI [1.4, 16.3]). Among diabetic patients with MRSA NP, treatment with linezolid, compared to vancomycin, was associated with higher clinical and microbiologic success rates, and comparable adverse event rates. NCT00084266 .

  11. The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

    DEFF Research Database (Denmark)

    Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

    2017-01-01

    INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

  12. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements.

    Science.gov (United States)

    Smith, David H; Neutel, Joel M; Lacourcière, Yves; Kempthorne-Rawson, Joan

    2003-07-01

    This meta-analysis aimed to determine whether ambulatory blood pressure monitoring (ABPM) results from double-blind, placebo-controlled (DBPC) and prospective, randomized, open-label, blinded-endpoint (PROBE) hypertension trials are statistically comparable. Two DBPC and three PROBE parallel-group studies were selected from an angiotensin II receptor blocker clinical programme. These were fixed-dose studies involving similar mild to moderate hypertensive patient populations. All used SpaceLabs 90207 ABPM devices, and each comprised a 4-week placebo period and a 4-8-week treatment period. Data from patients receiving telmisartan 80 mg were used to compare the results of DBPC (126 patients) and PROBE (734 patients) trials. The analysis had approximately 87% power to show equivalence between the two design types in terms of ruling out differences of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. Office blood pressure was also compared. The change from baseline in mean 24-h ambulatory SBP was -12.2 mmHg in DBPC trials and -12.3 mmHg in PROBE trials, a rounded difference of 0.2 mmHg [95% confidence interval (CI): -1.8, 2.1]. The change from baseline in mean 24-h ambulatory DBP was -7.7 mmHg in DBPC trials versus -7.9 mmHg in PROBE trials, a difference of 0.2 mmHg (95% CI: -1.1, 1.5). Ambulatory pulse pressure results were identical. Thus, changes in mean 24-h ambulatory blood pressure from the DBPC and PROBE trials in this meta-analysis are statistically equivalent in terms of ruling out a difference of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. This supports the validity of the PROBE design in assessing antihypertensive efficacy based on blinded ABPM measurements.

  13. Protein supplements after weight loss do not improve weight maintenance compared with recommended dietary protein intake despite beneficial effects on appetite sensation and energy expenditure: a randomized, controlled, double-blinded trial.

    Science.gov (United States)

    Kjølbæk, Louise; Sørensen, Lone Brinkmann; Søndertoft, Nadja Buus; Rasmussen, Carrie Klestrup; Lorenzen, Janne Kunchel; Serena, Anja; Astrup, Arne; Larsen, Lesli Hingstrup

    2017-08-01

    Background : High-protein diets increase weight loss (WL) during energy restriction; therefore, it has been suggested that additional protein intake may improve weight maintenance (WM) after WL. Objective: We investigated the effect of protein supplements from either whey with or without calcium or soy on WM success after WL compared with that of a control. Design: In a randomized, controlled, double-blinded trial, 220 participants aged 18-60 y with body mass index (in kg/m 2 ) from 27.6 to 40.4 were included. The study was initiated with an 8-wk WL period followed by a 24-wk WM period. During WM, participants consumed the following isocaloric supplements (45-48 g/d): whey and calcium (whey+), whey, soy, or maltodextrin (control). Data were collected at baseline, before WM, and after WM (weeks 0, 8, and 32, respectively) and included body composition, blood biochemistry, and blood pressure. Meal tests were performed to investigate diet-induced-thermogenesis (DIT) and appetite sensation. Compliance was tested by 24-h urinary nitrogen excretion. Results: A total of 151 participants completed the WM period. The control and 3 protein supplements did not result in different mean ± SD weight regains (whey+: 2.19 ± 4.6 kg; whey: 2.01 ± 4.6 kg; soy: 1.76 ± 4.7 kg; and control: 2.23 ± 3.8 kg; P = 0.96), fat mass regains (whey+: 0.46 ± 4.5 kg; whey: 0.11 ± 4.1 kg; soy: 0.15 ± 4.1 kg; and control: 0.54 ± 3.3 kg; P = 0.96), or improvements in lean body mass (whey+: 1.87 ± 1.7 kg; whey: 1.94 ± 1.3 kg; soy: 1.58 ± 1.4 kg; and control: 1.74 ± 1.4 kg; P = 0.50) during WM. Changes in blood pressure and blood biochemistry were not different between groups. Compared with the control, protein supplementation resulted in higher DIT (∼30 kJ/2.5 h) and resting energy expenditure (243 kJ/d) and an anorexigenic appetite-sensation profile. Conclusion: Protein supplementation does not result in improved WM success, or blood biochemistry after WL compared with the effects of

  14. Randomised, double-blind trial of intravenous diltiazem versus glyceryl trinitrate for unstable angina pectoris

    NARCIS (Netherlands)

    Gobel, EJAM; Hautvast, RWM; vanGilst, WH; Spanjaard, JN; Hillege, HL; DeJongste, MJL; Molhoek, GP; Lie, KI

    1995-01-01

    The effect of dihydropyridines in patients with unstable angina is discouraging. To find out the effect of the non- dihydropyridine-like calcium-channel blocker diltiazem, a randomised, double-blind trial was conducted comparing diltiazem with glyceryl trinitrate. both given intravenously, in 129

  15. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder.

    Science.gov (United States)

    Rele, Shilpa; Millet, Robert; Kim, Sungman; Paik, Jong-Woo; Kim, Seonghwan; Masand, Prakash S; Patkar, Ashwin A

    2015-01-01

    Vilazodone, a selective and potent 5-HT1A partial agonist and 5-HT reuptake inhibitor, has been approved for treatment of major depressive disorder (MDD) in adults. The primary objective of the study was to compare the efficacy and tolerability of switching to 3 different doses of vilazodone from an equivalent dose range of generic selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) in adult subjects with MDD. This was an 8-week, randomized, double-blind, parallel-group, 3-arm trial to compare vilazodone 10 mg/d, 20 mg/d, and 40 mg/d as starting doses. Data were collected from December 2012 to December 2013. There was no washout phase, prior medications were stopped at the baseline visit, and vilazodone was started the next day in adults with MDD (DSM-IV criteria). The 10-mg/d and 20-mg/d dose was increased to 40 mg/d by week 3 and week 1, respectively, and the 40-mg/d initiation dose continued unchanged. The primary efficacy measure was change in Montgomery-Asberg Depression Rating Scale (MADRS) score between the 3 dose groups. The secondary efficacy measures were changes in Clinical Global Impressions-Severity (CGI-S), CGI-Improvement (CGI-I), and Hamilton Anxiety Rating Scale (HARS) scores. Safety measures were obtained by spontaneously reported adverse events, vital signs recording, and laboratory tests. Multivariate tests were used for statistical analysis. Seventy subjects were randomized, and 60 subjects completed the study (n = 20 in each group). Overall, there was a significant reduction in MADRS score from baseline (26.08 ± 1.1) to week 8 (9.86 ± 1.2) in the entire sample (P serious adverse events were reported. The present study indicates the potential benefit of switching to vilazodone in patients with MDD who are inadequate responders to SSRIs or SNRIs. There were no meaningful differences in efficacy or tolerability between the 3 different dose-initiation strategies with vilazodone; however

  16. Blinded sample size re-estimation in crossover bioequivalence trials.

    Science.gov (United States)

    Golkowski, Daniel; Friede, Tim; Kieser, Meinhard

    2014-01-01

    In drug development, bioequivalence studies are used to indirectly demonstrate clinical equivalence of a test formulation and a reference formulation of a specific drug by establishing their equivalence in bioavailability. These studies are typically run as crossover studies. In the planning phase of such trials, investigators and sponsors are often faced with a high variability in the coefficients of variation of the typical pharmacokinetic endpoints such as the area under the concentration curve or the maximum plasma concentration. Adaptive designs have recently been considered to deal with this uncertainty by adjusting the sample size based on the accumulating data. Because regulators generally favor sample size re-estimation procedures that maintain the blinding of the treatment allocations throughout the trial, we propose in this paper a blinded sample size re-estimation strategy and investigate its error rates. We show that the procedure, although blinded, can lead to some inflation of the type I error rate. In the context of an example, we demonstrate how this inflation of the significance level can be adjusted for to achieve control of the type I error rate at a pre-specified level. Furthermore, some refinements of the re-estimation procedure are proposed to improve the power properties, in particular in scenarios with small sample sizes. Copyright © 2014 John Wiley & Sons, Ltd.

  17. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  18. Superior efficacy of St John's wort extract WS® 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298

    Directory of Open Access Journals (Sweden)

    Dienel Angelika

    2006-06-01

    Full Text Available Abstract Background The aim of the current study was to assess the antidepressant efficacy and safety of Hypericum perforatum (St. John's wort extract WS® 5570 at doses of 600 mg/day in a single dose and 1200 mg/day in two doses. Methods The participants in this double-blind, randomized, placebo-controlled, multi-center clinical trial were male and female adult out-patients with an episode of mild or moderate major depressive episode (single or recurrent episode, DSM-IV criteria. As specified by the relevant guideline, the study was preceded by a medication-free run-in phase. For the 6-week treatment, 332 patients were randomized: 123 to WS® 5570 600 mg/day, 127 to WS® 5570 1200 mg/day, and 82 to placebo. The primary outcome measure was the change in total score on the Hamilton Rating Scale for Depression (HAM-D, 17-item version between baseline and endpoint. Additional measures included the number of responders, the number of patients in remission, and several other standard rating scales. Efficacy and safety were assessed after 2 and 6 weeks. The design included an interim analysis performed after randomization with the option of early termination. Results After 6 weeks of treatment, mean ± standard deviation decreases in HAM-D total scores of 11.6 ± 6.4, 10.8 ± 7.3, and 6.0 ± 8.1 points were observed for the WS® 5570 600 mg/day, 1200 mg/day and placebo groups, respectively (endpoint analysis. Secondary measures of treatment efficacy also showed that both WS® 5570 groups were statistically superior to placebo. Significantly more patients in the WS® 5570 treatment groups than in the placebo group showed treatment response and remission. WS® 5570 was consistently more effective than placebo in patients with either less severe or more severe baseline impairment. The number of patients who experienced remission was higher in the WS® 5570 1200 mg/day group than the WS® 5570 600 mg/day group. The incidence of adverse events was low in

  19. Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Heger, Patrick; Zaschke, Steffen; Knebel, Phillip; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-03-24

    Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT. A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration's tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %. Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT. PROSPERO 2015: CRD42015026837.

  20. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

    Science.gov (United States)

    Cole, Graham D; Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-09-20

    To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Blinded case-control study. Journals in PubMed. 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); Pretracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); Pretracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. © Cole et al 2015.

  1. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial.

    Science.gov (United States)

    Ramsauer, Katrin; Schwameis, Michael; Firbas, Christa; Müllner, Matthias; Putnak, Robert J; Thomas, Stephen J; Desprès, Philippe; Tauber, Erich; Jilma, Bernd; Tangy, Frederic

    2015-05-01

    Chikungunya is an emerging arthropod-borne disease that has spread from tropical endemic areas to more temperate climates of the USA and Europe. However, no specific treatment or preventive measure is yet available. We aimed to investigate the immunogenicity and safety of a live recombinant measles-virus-based chikungunya vaccine. We did a randomised, double-blind, placebo-controlled, active-comparator, phase 1, dose-escalation study at one centre in Vienna, Austria. Healthy men and women aged 18-45 years with no comorbidities were randomly assigned, by computer-generated block randomisation (block size of 14), to receive either one of three escalating doses of the measles-virus-based candidate vaccine (low dose [1·5 × 10(4) median tissue culture infection doses (TCID50) per 0·05 mL], medium dose [7·5 × 10(4) TCID50 per 0·25 mL], or high dose [3·0 × 10(5) TCID50 per 1·0 mL]), or the active comparator-Priorix. Participants were additionally block-randomised to receive a booster injection on either day 28 or day 90 after the first vaccination. Participants and study investigators were masked to group allocation. The primary endpoint was the presence of neutralising anti-chikungunya antibodies on day 28, as assessed by 50% plaque reduction neutralisation test. Analysis was by intention to treat and per protocol. This trial is registered with EudraCT, number 2013-001084-23. Between Nov 22, 2013, and Feb 25, 2014, we randomly assigned 42 participants to receive the low dose (n=12), the medium dose (n=12), or the high dose (n=12) of the measles-virus-based candidate vaccine, or Priorix (n=6), of whom 36 participants (86%; n=9, n=12, n=10, n=5, respectively) were included in the per-protocol population. The candidate vaccine raised neutralising antibodies in all dose cohorts after one immunisation, with seroconversion rates of 44% (n=4) in the low-dose group, 92% (n=11) in the medium-dose group, and 90% (n=10) in the high-dose group. The

  2. The effects of extrinsic motivation on signature authorship opinions in forensic signature blind trials.

    Science.gov (United States)

    Dewhurst, Tahnee N; Found, Bryan; Ballantyne, Kaye N; Rogers, Doug

    2014-03-01

    Expertise studies in forensic handwriting examination involve comparisons of Forensic Handwriting Examiners' (FHEs) opinions with lay-persons on blind tests. All published studies of this type have reported real and demonstrable skill differences between the specialist and lay groups. However, critics have proposed that any difference shown may be indicative of a lack of motivation on the part of lay participants, rather than a real difference in skill. It has been suggested that qualified FHEs would be inherently more motivated to succeed in blinded validation trials, as their professional reputations could be at risk, should they perform poorly on the task provided. Furthermore, critics suggest that lay-persons would be unlikely to be highly motivated to succeed, as they would have no fear of negative consequences should they perform badly. In an effort to investigate this concern, a blind signature trial was designed and administered to forty lay-persons. Participants were required to compare known (exemplar) signatures of an individual to questioned signatures and asked to express an opinion regarding whether the writer of the known signatures wrote each of the questioned signatures. The questioned signatures comprised a mixture of genuine, disguised and simulated signatures. The forty participants were divided into two separate groupings. Group 'A' were requested to complete the trial as directed and were advised that for each correct answer they would be financially rewarded, for each incorrect answer they would be financially penalized, and for each inconclusive opinion they would receive neither penalty nor reward. Group 'B' was requested to complete the trial as directed, with no mention of financial recompense or penalty. The results of this study do not support the proposition that motivation rather than skill difference is the source of the statistical difference in opinions between individuals' results in blinded signature proficiency trials. Crown

  3. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  4. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.

    Science.gov (United States)

    Jørgensen, Kristin K; Olsen, Inge C; Goll, Guro L; Lorentzen, Merete; Bolstad, Nils; Haavardsholm, Espen A; Lundin, Knut E A; Mørk, Cato; Jahnsen, Jørgen; Kvien, Tore K

    2017-06-10

    TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up. Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation. Patients with informed consent were randomised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment, with unchanged dosing regimen. Data were collected at infusion visits in 40 Norwegian study centres. Patients, assessors, and patient care providers were masked to treatment allocation. The primary endpoint was disease worsening during 52-week follow-up. 394 patients in the primary per-protocol set were needed to show a non-inferiority margin of 15%, assuming 30% disease worsening in each group. This trial is registered with ClinicalTrials.gov, number NCT02148640. Between Oct 24, 2014, and July 8, 2015, 482 patients were enrolled and randomised (241 to infliximab originator, 241 to CT-P13 group; one patient was excluded from the full analysis and safety set for CT-P13) and 408 were included in the per-protocol set (202 in the infliximab originator group and 206 in the CT-P13 group). 155 (32%) patients in the full analysis set had Crohn's disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis. Disease worsening occurred in 53 (26%) patients in the infliximab originator group and 61 (30%) patients in the CT-P13 group (per-protocol set; adjusted treatment difference -4·4%, 95% CI -12·7 to 3·9). The

  5. Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mazzolari Rita

    2011-10-01

    Full Text Available Abstract Background Low back pain (LBP is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH® system (system for automatic thermomechanic massage in health is a new medical device (MD that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP. Methods/design This paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH® versus sham therapy (medical device without active principles determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ scores after 4 weeks of treatment (end of treatment. Major secondary outcome will be effectiveness of SMATH® determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm. The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010. Discussion Compared to other medical specialties, physical and rehabilitation medicine (PRM has not yet received

  6. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  7. Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

    Science.gov (United States)

    van Oldenrijk, Jakob; Scholtes, Vanessa A B; van Beers, Loes W A H; Geerdink, Carel H; Niers, Bob B A M; Runne, Wouter; Bhandari, Mohit; Poolman, Rudolf W

    2017-10-16

    Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial. A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis. 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7). the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem. The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate. No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%. Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible. NTR1560. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  8. The challenges of control groups, placebos and blinding in clinical trials of dietary interventions.

    Science.gov (United States)

    Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin

    2017-08-01

    High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

  9. Blindness

    Science.gov (United States)

    ... Specific Prevalence Rates for Blindness by Age and Race/Ethnicity Table for 2010 U.S. Age-Specific Prevalence ... Race/Ethnicity 2010 Prevalence Rates of Blindness by Race Table for 2010 Prevalence Rates of Blindness by ...

  10. Comparative clinical trial of two antigingivitis mouthrinses.

    Science.gov (United States)

    Witt, Jon J; Walters, Patricia; Bsoul, Samer; Gibb, Roger; Dunavent, John; Putt, Mark

    2005-07-01

    To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses. A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance. Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated. This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized

  11. Comparative study of the efficacy and safety between blonanserin and risperidone for the treatment of schizophrenia in Chinese patients: A double-blind, parallel-group multicenter randomized trial.

    Science.gov (United States)

    Li, Huafang; Yao, Chen; Shi, Jianguo; Yang, Fude; Qi, Shuguang; Wang, Lili; Zhang, Honggeng; Li, Jie; Wang, Chuanyue; Wang, Chuansheng; Liu, Cui; Li, Lehua; Wang, Qiang; Li, Keqing; Luo, Xiaoyan; Gu, Niufan

    2015-10-01

    This randomized, double-blind study compared the efficacy and safety of blonanserin and risperidone to treat Chinese schizophrenia patients aged ≥18 and risperidone using a gradual dose-titration method (blonanserin tablets: 8-24 mg/day; risperidone tablets: 2-6 mg/day), twice daily. Treatment populations consisted of 128 blonanserin-treated patients and 133 risperidone-treated patients. Intention-to-treat analysis was performed using the last observation carried forward method. Reductions of PANSS total scores by blonanserin and risperidone treatment were -30.59 and -33.56, respectively. Risperidone treatment was associated with elevated levels of serum prolactin (67.16% risperidone versus 52.31% blonanserin) and cardiac-related abnormalities (22.39% risperidone versus 12.31% blonanserin), and blonanserin patients were more prone to extrapyramidal side effects (48.46% blonanserin versus 29.10% risperidone). In conclusion, blonanserin was as effective as risperidone for the treatment of Chinese patients with schizophrenia. The overall safety profiles of these drugs are comparable, although blonanserin was associated with a higher incidence of EPS and risperidone was associated with a higher incidence of prolactin elevation and weight gain. Thus, blonanserin is useful for the treatment of Chinese schizophrenia patients. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Penicillin for acute sore throat : randomised double blind trial of seven days versus three days treatment or placebo in adults

    NARCIS (Netherlands)

    Zwart, S; Sachs, APE; Ruijs, GJHM; Gubbels, JW; Hoes, AW; de Melker, RA

    2000-01-01

    Objective To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo. Design Randomised double blind placebo controlled trial. Setting 43

  13. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

  14. Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  15. Randomized blinded trial of standardized written patient information before total knee arthroplasty.

    Directory of Open Access Journals (Sweden)

    Benedicte Eschalier

    Full Text Available The effect of patient education before total knee arthroplasty (TKA is controversial. No consensus exists about the optimal content of educational interventions. In a previous study, we developed and validated an educational booklet on the peri-TKA management of knee osteoarthritis.Our primary purpose was to evaluate the impact of the educational booklet on knowledge among patients awaiting TKA.This randomized controlled single-blind trial evaluated standard information by the surgeon with or without delivery of the educational booklet 4-6 weeks before primary noncomplex TKA in patients aged 55-75 years with incapacitating knee osteoarthritis. Patients were enrolled at a French surgical center between June 2011 and January 2012. A patient knowledge score was determined at baseline, on the day before TKA, and 3-6 weeks after TKA, using a self-administered questionnaire developed for our previous study. The assessor was blinded to group assignment.Of 44 eligible patients, 42 were randomized, 22 to the intervention and 20 to the control group, all of whom were included in the analysis. The groups were comparable at baseline. The intervention was associated with significantly better patient knowledge scores.An educational booklet improves knowledge among patients awaiting TKA. A study assessing the impact of the booklet combined with a exercise program would be helpful.Level I, randomized controlled double-blind trial; see S1 CONSORT Checklist.clinicaltrials.gov #NCT01747759.

  16. The FINISH-3 Trial : A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis

    NARCIS (Netherlands)

    Bochicchio, Grant V.; Gupta, Navyash; Porte, Robert J.; Renkens, Kenneth L.; Pattyn, Piet; Topal, Baki; Troisi, Roberto Ivan; Muir, William; Chetter, Ian; Gillen, Daniel L.; Zuckerman, Linda A.; Frohna, Paul A.

    BACKGROUND: This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical

  17. Blinded sample size re-estimation in three-arm trials with 'gold standard' design.

    Science.gov (United States)

    Mütze, Tobias; Friede, Tim

    2017-10-15

    In this article, we study blinded sample size re-estimation in the 'gold standard' design with internal pilot study for normally distributed outcomes. The 'gold standard' design is a three-arm clinical trial design that includes an active and a placebo control in addition to an experimental treatment. We focus on the absolute margin approach to hypothesis testing in three-arm trials at which the non-inferiority of the experimental treatment and the assay sensitivity are assessed by pairwise comparisons. We compare several blinded sample size re-estimation procedures in a simulation study assessing operating characteristics including power and type I error. We find that sample size re-estimation based on the popular one-sample variance estimator results in overpowered trials. Moreover, sample size re-estimation based on unbiased variance estimators such as the Xing-Ganju variance estimator results in underpowered trials, as it is expected because an overestimation of the variance and thus the sample size is in general required for the re-estimation procedure to eventually meet the target power. To overcome this problem, we propose an inflation factor for the sample size re-estimation with the Xing-Ganju variance estimator and show that this approach results in adequately powered trials. Because of favorable features of the Xing-Ganju variance estimator such as unbiasedness and a distribution independent of the group means, the inflation factor does not depend on the nuisance parameter and, therefore, can be calculated prior to a trial. Moreover, we prove that the sample size re-estimation based on the Xing-Ganju variance estimator does not bias the effect estimate. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  18. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  19. Poor Reliability between Cochrane Reviewers and Blinded External Reviewers When Applying the Cochrane Risk of Bias Tool in Physical Therapy Trials

    OpenAIRE

    Armijo-Olivo, Susan; Ospina, Maria; Da Costa, Bruno R; Egger, Matthias; Saltaji, Humam; Fuentes, Jorge; Ha, Christine; Cummings, Greta G.

    2014-01-01

    OBJECTIVES To test the inter-rater reliability of the RoB tool applied to Physical Therapy (PT) trials by comparing ratings from Cochrane review authors with those of blinded external reviewers. METHODS Randomized controlled trials (RCTs) in PT were identified by searching the Cochrane Database of Systematic Reviews for meta-analysis of PT interventions. RoB assessments were conducted independently by 2 reviewers blinded to the RoB ratings reported in the Cochrane reviews. Data on...

  20. Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.

    Science.gov (United States)

    Langhorst, J; Varnhagen, I; Schneider, S B; Albrecht, U; Rueffer, A; Stange, R; Michalsen, A; Dobos, G J

    2013-09-01

    The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC). To compare the efficacy of the two treatments in maintaining remission in patients with ulcerative colitis. We performed a randomised, double-blind, double-dummy study over a 12-month period in patients with UC. Primary endpoint was non-inferiority of the herbal preparation as defined by mean Clinical Colitis Activity Index (CAI-Rachmilewitz). Secondary endpoints were relapse rates, safety profile, relapse-free times, endoscopic activity and faecal biomarkers. A total of 96 patients (51 female) with inactive UC were included. Mean CAI demonstrated no significant difference between the two treatment groups in the intention-to-treat (P = 0.121) or per-protocol (P = 0.251) analysis. Relapse rates in total were 22/49 patients (45%) in the mesalazine treatment group and 25/47 patients (53%) in the herbal treatment group (P = 0.540). Safety profile and tolerability were good and no significant differences were shown in relapse-free time, endoscopy and faecal biomarkers. The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis. EudraCT-Number 2007-007928-18. © 2013 John Wiley & Sons Ltd.

  1. Comparison of laparoscopic and mini incision open donor nephrectomy: Single blind, randomised controlled clinical trial

    NARCIS (Netherlands)

    N.F.M. Kok (Niels); M.Y. Smits-Lind (May); B.M.E. Hansson (Birgitta); D. Pilzecker (Desiree); I.R.A.M. Mertens Zur Borg (Ingrid); B.C. Knipscheer (Ben); E.J. Hazebroek (Eric Jasper); I.M. Dooper (Ine); W. Weimar (Willem); W.C.J. Hop (Wim); E.M.M. Adang (Eddy); G.-J. van der Wilt (Gert-Jan); H.J. Bonjer (Jaap); J.A. van der Vliet (Adam); J.N.M. IJzermans (Jan)

    2006-01-01

    markdownabstractOBJECTIVES: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. DESIGN: Single blind, randomised controlled trial. SETTING: Two university medical centres, the Netherlands. PARTICIPANTS: 100 living

  2. Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

    NARCIS (Netherlands)

    Kok, N.F.; Lind, M.Y.; Hansson, B.M.; Pilzecker, D.; Mertens zur Borg, I.R.; Knipscheer, B.C.; Hazebroek, E.J.; Dooper, P.M.M.; Weimar, W.; Hop, W.C.J.; Adang, E.M.M.; Wilt, G.J. van der; Bonjer, H.J.; Vliet, J.A. van der; Ijzermans, J.N.M.

    2006-01-01

    OBJECTIVES: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. DESIGN: Single blind, randomised controlled trial. SETTING: Two university medical centres, the Netherlands. PARTICIPANTS: 100 living kidney donors.

  3. Homoeopathic pathogenetic trial of Withania somnifera: A multicentric, double-blind, randomised, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Pritha Mehra

    2017-01-01

    Full Text Available Background: Homoeopathic drug proving being the first step in finding the pathogenetic powers of a drug is an integral part of Homoeopathic system of medicine. Objective: To elicit the pathogenetic response of Withania somnifera in homoeopathic potencies on healthy human provers. Materials and Methods: A multicentre, randomised, double-blind, placebo-controlled trial was conducted at four centres under Central Council for Research in Homoeopathy. Proving was conducted on 63 relatively healthy provers. All the provers were given 12 doses of placebo divided into 4 doses/day for 3 days during the first phase of the trial. After randomisation, 43 provers in the intervention group were given W. somnifera in 6C and 30C potencies in two phases. In the placebo group, 20 provers were administered unmedicated globules. The symptoms and signs manifested during the trial were noted down by the provers, elaborated by the proving masters and the data compilation on W. somnifera was done at proving-cum-data processing cell. Results: Out of 43 provers who were on actual drug trial, only 15 provers manifested 39 symptoms. The symptoms have been manifested predominantly in 30C potency. Among the objective findings, the drug has shown its effect on kidney, ovaries and helminthic infestation. Conclusion: The pathogenetic response elicited during this trial expands the scope of the use of W. somnifera and needs to be further validated by clinical verification study.

  4. Efficacy of oral cholecalciferol on rhododendrol-induced vitiligo: A blinded randomized clinical trial.

    Science.gov (United States)

    Watabe, Akiko; Yamasaki, Kenshi; Asano, Masayuki; Kanbayashi, Yumi; Nasu-Tamabuchi, Mei; Terui, Hitoshi; Furudate, Sadanori; Kakizaki, Aya; Tsuchiyama, Kenichiro; Kimura, Yutaka; Ito, Yumiko; Kikuchi, Katsuko; Aiba, Setsuya

    2018-02-05

    Rhododendrol (RD), 4-(4-hydroxyphenyl)-2-butanol, inhibits melanin synthesis and has been used for skin-whitening cosmetic products. RD has been very effective in lightening skin pigmentation, but some persons have developed so-called RD vitiligo, in which vitiligo starts on the face, neck and hands where topical RD has been applied and even extended over skin areas where RD has not been applied. RD vitiligo lesions in some patients have lasted for years and have been resistant to conventional vitiligo treatments. We examined the effects of cholecalciferol on RD vitiligo in a blinded randomized clinical trial. Forty-eight female RD vitiligo patients were recruited for the trial and were randomized into two groups: the vitamin D (VD)-intervention group that received daily 5000 IU cholecalciferol for 5 months and the control group. Three blinded investigators scored vitiligo improvement by comparing photographic images of baseline and at 5-month observation. Serum 25(OH)D3 of RD vitiligo patients was not significantly different from age-matched healthy volunteers. Twenty-two in the VD-intervention group and 23 in the control group completed the 5-month observation. Serum 25(OH)D3 levels were significantly increased after the 5-month VD intervention, while the control group did not change. The improvement scores were significantly higher in the VD-intervention group than the control group. The improvement scores were positively correlated with the serum 25(OH)D3 levels after the 5-month intervention period but not before the treatment. This blinded randomized clinical trial showed favor in administrating 5000 IU cholecalciferol daily to RD vitiligo patients. © 2018 Japanese Dermatological Association.

  5. Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

    Energy Technology Data Exchange (ETDEWEB)

    Achenbach, Stephan [Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Department of Cardiology, Erlangen (Germany); Paul, Jean-Francois [Centre Chirurgical Marie Lannelongue, Department of Radiology, Le Plessis Robinson (France); Laurent, Francois [University of Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux (France); CHU de Bordeaux, Service d' Imagerie Thoracique et Cardiovasculaire, Pessac (France); Becker, Hans-Christoph [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Rengo, Marco [Sapienza - University of Rome, ICOT Hospital, Department of Radiological Sciences, Oncology and Pathology, Latina (Italy); Caudron, Jerome [University Hospital of Rouen, Department of Radiology, Rouen (France); Leschka, Sebastian [Saint Gallen Hospital, Department of Radiology, Saint Gallen (Switzerland); Vignaux, Olivier [Cochin Hospital, Department of Radiology, Paris (France); Knobloch, Gesine [La Charite, Department of Radiology, Berlin (Germany); Benea, Giorgio [Ospedale del Delta, Ferrara (Italy); Schlosser, Thomas [Elisabeth-Krankenhaus Hospital, Essen (Germany); Andreu, Jordi [Hospital Vall d' Hebron, Barcelona (Spain); Cabeza, Beatriz [Hospital Clinico San Carlos, Madrid (Spain); Jacquier, Alexis [La Timone Adult Hospital, Department of Radiology, Marseille (France); Souto, Miguel [Complejo Hospitalario Universitario, Santiago de Compostela (Spain); Revel, Didier [Louis Pradel Hospital, Department of Radiology, Lyon (France); Qanadli, Salah Dine [University of Lausanne, Department of Radiology, Lausanne (Switzerland); Cademartiri, Filippo [Giovanni XXIII Hospital, Department of Radiology, Monastier di Treviso (Italy); Collaboration: X-ACT Study Group

    2017-02-15

    To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. (orig.)

  6. Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Suh Sang-Yeon

    2012-01-01

    Full Text Available Abstract Background Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004; fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p Conclusion Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration The clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.

  7. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Emanuelsson, Frida; Skou Thomsen, Ann Sofia

    2014-01-01

    . There was a larger effect size difference in 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control...

  8. Causes of Severe Visual Impairment and Blindness: Comparative Data From Bhutanese and Laotian Schools for the Blind.

    Science.gov (United States)

    Farmer, Lachlan David Mailey; Ng, Soo Khai; Rudkin, Adam; Craig, Jamie; Wangmo, Dechen; Tsang, Hughie; Southisombath, Khamphoua; Griffiths, Andrew; Muecke, James

    2015-01-01

    To determine and compare the major causes of childhood blindness and severe visual impairment in Bhutan and Laos. Independent cross-sectional surveys. This survey consists of 2 cross-sectional observational studies. The Bhutanese component was undertaken at the National Institute for Vision Impairment, the only dedicated school for the blind in Bhutan. The Laotian study was conducted at the National Ophthalmology Centre and Vientiane School for the Blind. Children younger than age 16 were invited to participate. A detailed history and examination were performed consistent with the World Health Organization Prevention of Blindness Eye Examination Record. Of the 53 children examined in both studies, 30 were from Bhutan and 23 were from Laos. Forty percent of Bhutanese and 87.1% of Laotian children assessed were blind, with 26.7% and 4.3%, respectively, being severely visually impaired. Congenital causes of blindness were the most common, representing 45% and 43.5% of the Bhutanese and Laotian children, respectively. Anatomically, the primary site of blinding pathology differed between the cohorts. In Bhutan, the lens comprised 25%, with whole globe at 20% and retina at 15%, but in Laos, whole globe and cornea equally contributed at 30.4%, followed by retina at 17.4%. There was an observable difference in the rates of blindness/severe visual impairment due to measles, with no cases observed in the Bhutanese children but 20.7% of the total pathologies in the Laotian children attributable to congenital measles infection. Consistent with other studies, there is a high rate of blinding disease, which may be prevented, treated, or ameliorated.

  9. Quality management of a large randomized double-blind multi-centre trial: the ACTION experience.

    Science.gov (United States)

    Kirwan, Bridget-Anne; Lubsen, Jacobus; de Brouwer, Sophie; van Dalen, Frederik J; Pocock, Stuart J; Clayton, Tim; Danchin, Nicolas; Poole-Wilson, Philip A

    2008-03-01

    The ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) study was an independent, investigator-initiated, multi-national trial comparing nifedipine GITS to placebo in 7665 patients with stable angina pectoris. The trial was sponsored by the manufacturer of the medication concerned. 291 centers in 19 countries participated. Results have been published. We defined quality management (QM) as all activities directed at ensuring data integrity and consistency; and ensuring appropriate trial conduct, including pro-active prevention of deviations from protocol. We describe the QM framework that was adopted for the ACTION trial and the key tools that were used. In the protocol, particular attention was paid to explicit definition of tasks and responsibilities of all participants, and to unequivocal operational definitions of terms such as 'randomized', 'follow-up', etc. that could be applied by investigators, on-site monitors and during data processing at the coordinating centre. A comprehensive clinical trial and study management system based on simultaneous display of scanned documents and data base content had a central role. We describe in detail how compliance with good clinical practice was ensured, how the intention-to-treat principle was implemented, how compliance with study medication and completeness of follow-up was achieved, how double blinding was maintained throughout the study structure, and how patient safety was protected. The protocol ruled out participation in any other study at the same time by ACTION participants. Our experience showed that the reasons for this are not always understood by investigators. Unequivocal operational definitions of the procedural concepts that characterize randomized clinical trials should not only be the basis of QM, but also of reporting results.

  10. BLIND TRIALS EVALUATING IN VITRO INFECTIVITY OF CRYPTOSPORIDIUM PARVUM OOCYSTS USING CELL CULTURE IMMUNOFLUORESCENCE

    Science.gov (United States)

    An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...

  11. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  12. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    DEFF Research Database (Denmark)

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... in the acute sunburn reaction when applied 6 or 23 hours after UV exposure. Clinical Trial Registry: clinicaltrials. gov Identifier: NCT00206882 Udgivelsesdato: 2008/5...

  13. Accounting for Behavior in Treatment Effects: New Applications for Blind Trials.

    Directory of Open Access Journals (Sweden)

    Sylvain Chassang

    Full Text Available The double-blind randomized controlled trial (DBRCT is the gold standard of medical research. We show that DBRCTs fail to fully account for the efficacy of treatment if there are interactions between treatment and behavior, for example, if a treatment is more effective when patients change their exercise or diet. Since behavioral or placebo effects depend on patients' beliefs that they are receiving treatment, clinical trials with a single probability of treatment are poorly suited to estimate the additional treatment benefit that arises from such interactions. Here, we propose methods to identify interaction effects, and use those methods in a meta-analysis of data from blinded anti-depressant trials in which participant-level data was available. Out of six eligible studies, which included three for the selective serotonin re-uptake inhibitor paroxetine, and three for the tricyclic imipramine, three studies had a high (>65% probability of treatment. We found strong evidence that treatment probability affected the behavior of trial participants, specifically the decision to drop out of a trial. In the case of paroxetine, but not imipramine, there was an interaction between treatment and behavioral changes that enhanced the effectiveness of the drug. These data show that standard blind trials can fail to account for the full value added when there are interactions between a treatment and behavior. We therefore suggest that a new trial design, two-by-two blind trials, will better account for treatment efficacy when interaction effects may be important.

  14. Blinded sample size re-estimation in superiority and noninferiority trials: bias versus variance in variance estimation.

    Science.gov (United States)

    Friede, Tim; Kieser, Meinhard

    2013-01-01

    The internal pilot study design allows for modifying the sample size during an ongoing study based on a blinded estimate of the variance thus maintaining the trial integrity. Various blinded sample size re-estimation procedures have been proposed in the literature. We compare the blinded sample size re-estimation procedures based on the one-sample variance of the pooled data with a blinded procedure using the randomization block information with respect to bias and variance of the variance estimators, and the distribution of the resulting sample sizes, power, and actual type I error rate. For reference, sample size re-estimation based on the unblinded variance is also included in the comparison. It is shown that using an unbiased variance estimator (such as the one using the randomization block information) for sample size re-estimation does not guarantee that the desired power is achieved. Moreover, in situations that are common in clinical trials, the variance estimator that employs the randomization block length shows a higher variability than the simple one-sample estimator and in turn the sample size resulting from the related re-estimation procedure. This higher variability can lead to a lower power as was demonstrated in the setting of noninferiority trials. In summary, the one-sample estimator obtained from the pooled data is extremely simple to apply, shows good performance, and is therefore recommended for application. Copyright © 2013 John Wiley & Sons, Ltd.

  15. Prospective single blinded randomised controlled trial of two orally administered activated charcoal preparations.

    Science.gov (United States)

    Boyd, R; Hanson, J

    1999-01-01

    OBJECTIVES: To compare two activated charcoal preparations (Carbomix and Actidose-Aqua) in terms of amount ingested and incidence of vomiting after ingestion. METHODS: Single blinded prospective randomised controlled trial. RESULTS: The mean amount of charcoal ingested was Carbomix 26.5 g, Actidose-Aqua 19.5 g. The mean difference was 7 g (95% confidence interval (CI) 1.5 to 12.4 g). The incidence of vomiting was for the Carbomix 6% and the Actidose-Aqua 8%. The mean difference in vomiting was 2% (95% CI -0.8 to 4.8) CONCLUSIONS: Carbomix administration results in an increased amount of activated charcoal ingested after oral administration. Rates of vomiting after activated charcoal administration were low when compared with previously reported rates. PMID:9918281

  16. Blindness

    Science.gov (United States)

    ... doctors may do surgery to remove it. Is Learning Different? A baby who is blind can still ... do amazing things in many different fields, including music, the arts, and even sports. Serious vision problems ...

  17. FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) to placebo in patients with acute isovolemic anemia after gastrectomy - study protocol for a randomized controlled trial

    OpenAIRE

    Reim, Daniel; Kim, Young-Woo; Nam, Byung Ho; Kim, Mi-Jung; Yook, Jeong Hwan; Park, Young Kyu; Roh, Sung Hoon; Yu, Wan Sik; Bae, Jae Moon

    2014-01-01

    Background Isovolemic anemia (decrease in hemoglobin concentration with normal or even increased blood volume) after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g...

  18. Effectiveness of electric toothbrushing in patients with neuromuscular disability: A randomized observer-blind crossover trial.

    Science.gov (United States)

    Ikeda, Tokuhei; Yoshizawa, Kunio; Takahashi, Kazuya; Ishida, Chiho; Komai, Kiyonobu; Kobayashi, Kazuhiko; Sugiura, Shirou

    2016-01-01

    To evaluate the effectiveness of an electric toothbrush for oral care in patients with neuromuscular disability. In this randomized observer-blind crossover trial, 30 patients with neuromuscular disease performed either electric or manual toothbrushing each for 4 weeks. Plaque status (plaque control record), periodontal pocket depth, oral status (oral assessment guide), salivary bacterial count, and toothbrushing time were assessed after each period and compared between the two groups by Wilcoxon signed-rank test. Twenty-eight patients completed the study, including 18 communicative patients. Periodontal pockets were significantly shallower and toothbrushing time was significantly shorter with electric toothbrush use than with manual toothbrush use. No significant differences in oral status and salivary bacterial counts were noted between the approaches, but plaque status significantly improved after electric toothbrushing in communicative patients. Electric toothbrushing is beneficial for maintaining oral health in patients with neuromuscular disability and reducing the caregivers' oral care burden. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

  19. Subjective endpoints in clinical trials: the case for blinded independent central review

    Directory of Open Access Journals (Sweden)

    Walovitch R

    2013-09-01

    Full Text Available Richard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3 1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed. Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus panel

  20. Use of immobilized cryopreserved bovine semen in a blind artificial insemination trial.

    Science.gov (United States)

    Standerholen, Fride Berg; Waterhouse, Karin Elisabeth; Larsgard, Anne Guro; Garmo, Randi Therese; Myromslien, Frøydis Deinboll; Sunde, Jan; Ropstad, Erik; Klinkenberg, Geir; Kommisrud, Elisabeth

    2015-08-01

    To make timing of artificial insemination (AI) relative to ovulation less critical, methods for prolonging shelf life of spermatozoa in vivo after AI have been attempted to be developed. Encapsulation of sperm cells is a documented technology, and recently, a technology in which sperm cells are embedded in alginate gel has been introduced and commercialized. In this study, standard processed semen with the Biladyl extender (control) was compared with semen processed by sperm immobilization technology developed by SpermVital AS in a blind field trial. Moreover, in vitro acrosome and plasma membrane integrity was assessed and compared with AI fertility data for possible correlation. Semen from 16 Norwegian Red young bulls with unknown fertility was collected and processed after splitting the semen in two aliquots. These aliquots were processed with the standard Biladyl extender or the SpermVital extender to a final number of 12 × 10(6) and 25 × 10(6) spermatozoa/dose, respectively. In total, 2000 semen doses were produced from each bull, divided equally by treatment. Artificial insemination doses were set up to design a blinded AI regime; 5 + 5 straws from each extender within ejaculates in ten-straw goblets were distributed to AI technicians and veterinarians all over Norway. Outcomes of the inseminations were measured as 56-day nonreturn rate (NRR). Postthaw sperm quality was assessed by flow cytometry using propidium iodide and Alexa 488-conjugated peanut agglutinin to assess the proportion of plasma membrane and acrosome-intact sperm cells, respectively. In total, data from 14,125 first inseminations performed over a 12-month period, 7081 with Biladyl and 7044 with SpermVital semen, were used in the statistical analyses. There was no significant difference in 56-day NRR for the two semen categories, overall NRR being 72.5% and 72.7% for Biladyl and SpermVital, respectively. The flow cytometric results revealed a significant higher level of acrosome-intact live

  1. Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia

    DEFF Research Database (Denmark)

    MacDonald, T. M.; Ford, I.; Nuki, G.

    2014-01-01

    Introduction: Gout affects 2.5% of the UK's adult population and is now the most common type of inflammatory arthritis. The long-term management of gout requires reduction of serum urate levels and this is most often achieved with use of xanthine oxidase inhibitors, such as allopurinol. Febuxostat...... is the first new xanthine oxidase inhibitor since allopurinol and was licensed for use in 2008. The European Medicines Agency requested a postlicensing cardiovascular safety study of febuxostat versus allopurinol, which has been named the Febuxostat versus Allopurinol Streamlined trial (FAST). Methods...

  2. 20 CFR 404.1585 - Trial work period for persons age 55 or older who are blind.

    Science.gov (United States)

    2010-04-01

    ... who are blind. 404.1585 Section 404.1585 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL... § 404.1585 Trial work period for persons age 55 or older who are blind. If you become eligible for disability benefits even though you were doing substantial gainful activity because you are blind and age 55...

  3. Randomized, double-blind trial of mazindol in Duchenne dystrophy.

    Science.gov (United States)

    Griggs, R C; Moxley, R T; Mendell, J R; Fenichel, G M; Brooke, M H; Miller, P J; Mandel, S; Florence, J; Schierbecker, J; Kaiser, K K

    1990-12-01

    There is evidence that growth hormone may be related to the progression of weakness in Duchenne dystrophy. We conducted a 12-month controlled trial of mazindol, a putative growth hormone secretion inhibitor, in 83 boys with Duchenne dystrophy. Muscle strength, contractures, functional ability and pulmonary function were tested at baseline, and 6 and 12 months after treatment with mazindol (3 mg/d) or placebo. The study was designed to have a power of greater than 0.90 to detect a slowing to 25% of the expected rate of progression of weakness at P less than 0.05. Mazindol did not benefit strength at any point in the study. Side effects attributable to mazindol included decreased appetite (36%), dry mouth (10%), behavioral change (22%), and gastrointestinal symptoms (18%); mazindol dosage was reduced in 43% of patients. The effect of mazindol on GH secretion was estimated indirectly by comparing the postabsorptive IGF-I levels obtained following 3, 6, 9, and 12 months in the mazindol treated to those in the placebo groups. Although mazindol-treated patients gained less weight and height than placebo-treated patients, no significant effect on IGF-I levels was observed. Mazindol doses not slow the progression of weakness in Duchenne dystrophy.

  4. Comparing Whole Building Energy Implications of Sidelighting Systems with Alternate Manual Blind Control Algorithms

    Directory of Open Access Journals (Sweden)

    Christopher Dyke

    2015-05-01

    Full Text Available Currently, there is no manual blind control guideline used consistently throughout the energy modeling community. This paper identifies and compares five manual blind control algorithms with unique control patterns and reports blind occlusion, rate of change data, and annual building energy consumption. The blind control schemes detailed here represent five reasonable candidates for use in lighting and energy simulation based on difference driving factors. This study was performed on a medium-sized office building using EnergyPlus with the internal daylight harvesting engine. Results show that applying manual blind control algorithms affects the total annual consumption of the building by as much as 12.5% and 11.5% for interior and exterior blinds respectively, compared to the Always Retracted blinds algorithm. Peak demand was also compared showing blind algorithms affected zone load sizing by as much as 9.8%. The alternate algorithms were tested for their impact on American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE Guideline 14 calibration metrics and all models were found to differ from the original calibrated baseline by more than the recommended ±15% for coefficient of variance of the mean square error (CVRMSE and ±5% for normalized mean bias error (NMBE. The paper recommends that energy modelers use one or more manual blind control algorithms during design stages when making decisions about energy efficiency and other design alternatives.

  5. Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

    Science.gov (United States)

    Gökşen, Nurgül; Çaliş, Mustafa; Doğan, Serap; Çaliş, Havva T; Özgöçmen, Salih

    2016-08-01

    Therapeutic nuclear magnetic resonance therapy (MRT) works based on the electromagnetic fields. To investigate efficacy of MRT in knee osteoarthritis (OA). Prospective, randomized, double-blind, placebo controlled trial. Outpatient clinic, university hospital. Patients who had mild to moderate knee OA at a single knee joint and between 30-75-years-old were randomized by blinded chip cards (1:1). The treatment group received ten sessions of one hour daily MRT, controls received placebo MRT. All patients underwent clinical examination at baseline, after 2 weeks, and 12 weeks. Imaging included blindly assessed ultrasonography and magnetic resonance (MR) of the knee. Ninety-seven patients completed the study. Both groups improved significantly but the average change from baseline in outcome parameters was similar in MRT group (on VAS-pain,-2.6; WOMAC-pain, -2.09; WOMAC-stiffness, -1.81; WOMAC-physical, -1.96) compared to placebo after two weeks (VAS-pain,-1.6; WOMAC-pain, -1.91; WOMAC-stiffness, -1.27; WOMAC-physical, -1.54). Also changes were quite similar at the 12th week after the treatment. SF-36 components at 12th week improved but changes were not significant. Imaging arm also failed to show significant differences between groups in terms of cartilage thickness on US and MR scores. No adverse events were recorded. MRT is safe, but not superior to placebo in terms of improvement in clinical or imaging parameters after a 10-day course of treatment in mild to moderate knee OA. The present study does not promote use of a 10-day course of MRT in mild to moderate knee OA.

  6. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Bagnato, Gian Luca; Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-04-01

    This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of -0.73 (95% CI - 1.24 to - 0.19) was seen in VAS score, while the effect size was -0.34 (95% CI - 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  7. Acupuncture for Pain in Chronic Pancreatitis: A Single-Blinded Randomized Crossover Trial.

    Science.gov (United States)

    Juel, Jacob; Liguori, Stefano; Liguori, Aldo; Poulsen, Jakob L; Valeriani, Massimiliano; Graversen, Carina; Olesen, Søren S; Drewes, Asbjørn M

    2017-02-01

    Many patients with painful chronic pancreatitis (CP) have insufficient effect of treatment, and the prevalence of adverse effects is high. Consequently, alternatives to conventional management are needed. We aimed to study the effect of acupuncture in painful CP. This was a prospective, single-blinded, randomized crossover trial. Fifteen patients with CP were assigned to a session of acupuncture followed by sham stimulation or vice versa. Patients rated clinical pain scores daily on a 0 to 10 visual analogue scale (VAS) and completed the Patient Global Impression of Change. For mechanistic linkage, resting state electroencephalograms were recorded and quantified by spectral power analysis to explore effects on central pain processing. Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009). The effect, however, was short, and after 1-week follow-up, there was no difference in clinical pain scores between groups (P = 1.0) or the rating of Patient Global Impression of Change (P = 0.8). Electroencephalogram spectral power distributions between sham and acupuncture were comparable between groups (all P > 0.6). The study presents proof-of-concept for the analgesic effect of acupuncture in pancreatic pain. Although the effect was short lasting, the framework may be used to conceptualize future trials of acupuncture in visceral pain.

  8. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial.

    Science.gov (United States)

    Loeb, Mark; Russell, Margaret L; Manning, Vanessa; Fonseca, Kevin; Earn, David J D; Horsman, Gregory; Chokani, Khami; Vooght, Mark; Babiuk, Lorne; Schwartz, Lisa; Neupane, Binod; Singh, Pardeep; Walter, Stephen D; Pullenayegum, Eleanor

    2016-11-01

    Whether vaccinating children with intranasal live attenuated influenza vaccine (LAIV) is more effective than inactivated influenza vaccine (IIV) in providing both direct protection in vaccinated persons and herd protection in unvaccinated persons is uncertain. Hutterite colonies, where members live in close-knit, small rural communities in which influenza virus infection regularly occurs, offer an opportunity to address this question. To determine whether vaccinating children and adolescents with LAIV provides better community protection than IIV. A cluster randomized blinded trial conducted between October 2012 and May 2015 over 3 influenza seasons. (ClinicalTrials.gov: NCT01653015). 52 Hutterite colonies in Alberta and Saskatchewan, Canada. 1186 Canadian children and adolescents aged 36 months to 15 years who received the study vaccine and 3425 community members who did not. Children were randomly assigned according to community in a blinded manner to receive standard dosing of either trivalent LAIV or trivalent IIV. The primary outcome was reverse transcriptase polymerase chain reaction-confirmed influenza A or B virus in all participants (vaccinated children and persons who did not receive the study vaccine). Mean vaccine coverage among children in the LAIV group was 76.9% versus 72.3% in the IIV group. Influenza virus infection occurred at a rate of 5.3% (295 of 5560 person-years) in the LAIV group versus 5.2% (304 of 5810 person-years) in the IIV group. The hazard ratio comparing LAIV with IIV for influenza A or B virus was 1.03 (95% CI, 0.85 to 1.24). The study was conducted in Hutterite communities, which may limit generalizability. Immunizing children with LAIV does not provide better community protection against influenza than IIV. The Canadian Institutes for Health Research.

  9. FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) to placebo in patients with acute isovolemic anemia after gastrectomy - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Reim, Daniel; Kim, Young-Woo; Nam, Byung Ho; Kim, Mi-Jung; Yook, Jeong Hwan; Park, Young Kyu; Roh, Sung Hoon; Yu, Wan Sik; Bae, Jae Moon

    2014-04-05

    Isovolemic anemia (decrease in hemoglobin concentration with normal or even increased blood volume) after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g/dl at 12 weeks after randomization. Gastric cancer patients after oncologic resection and postoperative hemoglobin level ≥ 7 g/dl to hemoglobin level, hematology and quality of life assessment 3 and 12 weeks after randomization. Correction of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial. Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion. Further, improved quality of life for patients with quick recovery of hemoglobin levels is expected. NCT01725789 (international: http://www.clinicaltrials.gov) and NCCCTS-12-644 (NCC, Korea).

  10. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  11. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials.

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  12. A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA. Methods A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of

  13. Ultrasound therapy of subacromial bursitis. A double blind trial.

    Science.gov (United States)

    Downing, D S; Weinstein, A

    1986-02-01

    Ultrasound (US) is used widely to treat patients with supraspinatus tendinitis, subacromial bursitis, or adhesive capsulitis (SSA). No double blind studies of US in the treatment of SSA, however, have been conducted. This study was designed to determine whether the addition of US can further decrease pain and increase range of motion in those receiving the usual courses of ROM exercises and nonsteroidal anti-inflammatory drugs (NSAIDs) or ROM exercises in patients with SSA. Twenty patients with SSA were randomized to receive true or sham US three times a week for four weeks. All other aspects of treatment remained constant (ROM exercises and NSAIDs or ROM exercises). The physician, the physical therapist, and the patients were blinded throughout the study regarding the delivery of the true or sham US. Of the multiple variables analyzed (pain, ROM, and function), no significant difference was found between the sham or true US groups. Although the study group was small, the results suggest that US is of little or no benefit when combined with ROM exercises and NSAIDs or ROM exercises in the treatment of SSA.

  14. Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2017-01-01

    Objectives Randomized clinical trials often involve blinding as a methodological procedure to avoid bias. Unfortunately, blinding procedures may be unsuccessful, but the risk of unblinding is rarely reported in trial publications. Our primary aim was to assess the occurrence of unreported assessm...

  15. Effect of decaffeinated versus regular coffee on blood pressure: A 12-week, double-blind trial.

    NARCIS (Netherlands)

    Dusseldorp, van M.; Smits, P.; Thien, T.; Katan, M.B.

    1989-01-01

    The effect of decaffeinated versus regular coffee on blood pressure and heart rate was investigated. In a randomized double-blind, crossover trial, 45 healthy volunteers (23 women and 22 men, 25-45 years old) with a habitual intake of 4-6 cups coffee/day received 5 cups of regular coffee each day

  16. A double blind controlled trial of prednisolone-21-phosphate suppositories in the treatment of idiopathic proctitis

    Science.gov (United States)

    Lennard-Jones, J. E.; Baron, J. H.; Connell, A. M.; Jones, F. Avery

    1962-01-01

    A double blind trial of prednisolone suppositories in out-patients with idiopathic proctitis is reported. Significant improvement was noted. When prednisolone suppositories were given after the patient had already used suppositories of base alone for three weeks the active treatment was no longer so effective. PMID:13929632

  17. A double-blind placebo controlled trial of paroxetine in the ...

    African Journals Online (AJOL)

    A double-blind placebo controlled trial of paroxetine in the management of social phobia (social anxiety disorder) in South Africa. Dan J. Stein, Michael Berk, Charl Els, Robin A. Emsley, Leon Gittelson, Don Wilson, Rosemary Oakes, Brian Hunter ...

  18. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    A prospective, randomized, double-blind clinical trial of one nano-hybrid and one high-viscosity bulk-fill composite restorative systems in class II cavities: 12 ... composites (RCs) perform just as well as nano‑hybrid RCs with the 2 mm RC layering technique, therefore could be alternative to conventional nano‑hybrid RCs.

  19. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  20. The effect of neuromuscular blockade on canine laparoscopic ovariectomy: A double-blinded, prospective clinical trial

    NARCIS (Netherlands)

    van Goethem, B.; van Nimwegen, S.A.; Akkerdaas, L.C.; Murrell, J.C.; Kirpensteijn, J.

    2012-01-01

    The Effect of Neuromuscular Blockade on Canine Laparoscopic Ovariectomy: A Double-Blinded, Prospective Clinical Trial Bart Van Goethem, Diplomate ECVS, Sebastiaan Alexander van Nimwegen, PhD, Ies Akkerdaas, DVM, Joanna Claire Murrell, BVSc., PhD, Diplomate ECVAA, and Jolle Kirpensteijn, PhD,

  1. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial.

    Science.gov (United States)

    Enander, Jesper; Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alström, Katarina; Andersson, Gerhard; Ljótsson, Brjánn; Rück, Christian

    2016-02-02

    To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. A 12 week single blind parallel group randomised controlled trial. Academic medical centre. 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. CBT can be delivered safely via the internet to patients with body

  2. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

    Science.gov (United States)

    de Bont, Paul A J M; van den Berg, David P G; van der Vleugel, Berber M; de Roos, Carlijn; Mulder, Cornelis L; Becker, Eni S; de Jongh, Ad; van der Gaag, Mark; van Minnen, Agnes

    2013-05-23

    Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. The results from the post treatment measurement can be considered

  3. Double-blind placebo-controlled trial of dapsone in antihistamine refractory chronic idiopathic urticaria.

    Science.gov (United States)

    Morgan, Matt; Cooke, Andrew; Rogers, Laura; Adams-Huet, Beverley; Khan, David A

    2014-01-01

    Management of antihistamine refractory chronic idiopathic urticaria (CIU) has poorly defined therapeutic options. To evaluate the efficacy of dapsone (4,4'-diaminodiphenylsulfone) in antihistamine refractory CIU compared with placebo. Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14-week double-blind, placebo-controlled crossover trial. End points were measured from a daily diary that reflected the weekly hive score, the weekly itch score, and a visual analog scale (VAS) score. Secondary to a carryover effect, the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis. After 6 weeks, the patients in the dapsone arm showed mean improvement over baseline in VAS (2.3 [95% CI, 0.6-4.1], P = .01), urticaria score (-3.5 [95% CI, -6.2 to -0.9], P = .01), and itch score (-4.8 [95% CI, -7.6 to -2.1], P = .001), whereas the placebo arm showed no improvement over baseline for VAS, urticaria, or itch scores. Dapsone showed greater improvement compared with placebo for itch (P = .047) and VAS (P = .04). Of the 22 patients, 3 showed complete resolution of hives and itch with dapsone, whereas 31% and 41% had ≥ 50% resolution of hives and itch, respectively. No serious adverse effects were observed with dapsone. To our knowledge, this is the first double-blind, placebo controlled study of dapsone in CIU and indicates that dapsone has efficacy in patients with antihistamine refractory CIU. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  4. Comparing the effects of balance training with and without cognitive tasks on the quality of life and balance performance in community-dwelling older adults: a single-blind randomized clinical trial

    OpenAIRE

    Ehsan Sinaei; Fahimeh Kamali; Ahmadreza Nematollahi; Zahra Etminan

    2016-01-01

    Background: Aging process can deteriorate the ability to maintain balance, specifically under dual-task conditions. Thus far, different methods of exercises therapy have been applied to improve balance performance of older adults. The present study was designed to compare the effects of two protocols of balance training on the quality of life (QoL) and balance performance in older adults with mild balance impairments. Methods: Twenty-four older adults over 60 years old were ...

  5. A double-blind, randomized, controlled trial to compare the efficacy and tolerability of fixed doses of ropinirole, bupropion, and iron in treatment of restless legs syndrome (Willis–Ekbom disease)

    Science.gov (United States)

    Vishwakarma, Kirti; Kalra, Juhi; Gupta, Ravi; Sharma, Mukesh; Sharma, Taruna

    2016-01-01

    Background: We aimed to compare the efficacy of fixed doses of bupropion and ropinirole and iron alone for the treatment of restless legs syndrome (RLS) and to look for the tolerability of these medications. Materials and Methods: Patients diagnosed with RLS were randomly divided into three groups with thirty patients in each group (Group A: Bupropion [300 mg/day], Group B: Ropinirole [0.25–0.5 mg/day], and Group C: Oral iron [150 mg elemental iron] along with folic acid [500 μg]). Each participant was then assessed for severity of RLS, as well as RLS-related quality at the baseline, and thereafter, every 14th day till 6 weeks based on the International Restless Legs Scale (IRLS) severity rating scale and Restless Legs Syndrome Quality of Life (RLSQoL) Questionnaire, respectively. Results: IRLS scores differed significantly from baseline visit to last (F = 4.85; P = 0.01). The interaction between the time x treatment group was significant (F = 10.37; P < 0.001) showing an improvement with the therapy in all the groups. Pair-wise comparison depicted that ropinirole group differed from other two groups in IRLS score (F = 7.06; P = 0.001), which were comparable to each other. Regarding quality of life of these cases, within each group scores differed among all the four visits (F = 5.12; P = 0.002). Unlike IRLS, there was no significant difference among the RLSQOL scores between groups at any point of time (F = 1.2; P = 0.28). Conclusion: RLS severity decreased across time in all three groups; however, the ropinirole treatment was better than the bupropion and iron-folate therapy. Moreover, RLS-related quality of life although improved among all groups, it was comparable among three groups. PMID:27994356

  6. Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

    International Nuclear Information System (INIS)

    Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

    1996-01-01

    Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

  7. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial.

    Science.gov (United States)

    Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay

    2017-01-01

    To compare the anesthetic efficacy of 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, 4% articaine with 1:100,000 epinephrine, and 0.5% bupivacaine with 1:200,000 epinephrine on producing inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. A total of 91 adult patients who were actively experiencing mandibular molar pain were involved in this study. The patients were randomly divided into three groups on the basis of the anesthetic solution used. The first group received IANB with 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, the second group received IANB with 4% articaine with 1:100,000 epinephrine, and the third group received IANB with 0.5% bupivacaine with 1:200,000 epinephrine. After 15 minutes of IANB, conventional endodontic access preparation was started. The pain during the treatment was noted on a Heft-Parker visual analog scale (HP VAS). The primary outcome measure was anesthetic success, and anesthesia was considered successful if the patient reported no pain or weak/mild pain (HP VAS score .05). The 2% lidocaine solution used for IANB had similar success rates when compared with 4% articaine and 0.5% bupivacaine.

  8. Possible contribution of quantum-like correlations to the placebo effect: consequences on blind trials.

    Science.gov (United States)

    Beauvais, Francis

    2017-06-02

    Factors that participate in the biological changes associated with a placebo are not completely understood. Natural evolution, mean regression, concomitant procedures and other non specific effects are well-known factors that contribute to the "placebo effect". In this article, we suggest that quantum-like correlations predicted by a probabilistic modeling could also play a role. An elementary experiment in biology or medicine comparing the biological changes associated with two placebos is modeled. The originality of this modeling is that experimenters, biological system and their interactions are described together from the standpoint of a participant who is uninvolved in the measurement process. Moreover, the small random probability fluctuations of a "real" experiment are also taken into account. If both placebos are inert (with only different labels), common sense suggests that the biological changes associated with the two placebos should be comparable. However, the consequence of this modeling is the possibility for two placebos to be associated with different outcomes due to the emergence of quantum-like correlations. The association of two placebos with different outcomes is counterintuitive and this modeling could give a framework for some unexplained observations where mere placebos are compared (in some alternative medicines for example). This hypothesis can be tested in blind trials by comparing local vs. remote assessment of correlations.

  9. Objectifying Specific and Nonspecific Effects of Acupuncture: A Double-Blinded Randomised Trial in Osteoarthritis of the Knee

    Directory of Open Access Journals (Sweden)

    Max Karner

    2013-01-01

    Full Text Available Introduction. Acupuncture was recently shown to be effective in the treatment of knee osteoarthritis. However, controversy persists whether the observed effects are specific to acupuncture or merely nonspecific consequences of needling. Therefore, the objective of this study is to determine the efficacy of different acupuncture treatment modalities. Materials and Methods. We compared between three different forms of acupuncture in a prospective randomised trial with a novel double-blinded study design. One-hundred and sixteen patients aged from 35 to 82 with osteoarthritis of the knee were enrolled in three study centres. Interventions were individualised classical/ modern semistandardised acupuncture and non-specific needling. Blinded outcome assessment comprised knee flexibility and changes in pain according to the WOMAC score. Results and Discussion. Improvement in knee flexibility was significantly higher after classical Chinese acupuncture (10.3 degrees; 95% CI 8.9 to 11.7 as compared to modern acupuncture (4.7 degrees; 3.6 to 5.8. All methods achieved pain relief, with a patient response rate of 48 percent for non-specific needling, 64 percent for modern acupuncture, and 73 percent for classical acupuncture. Conclusion. This trial establishes a novel study design enabling double blinding in acupuncture studies. The data suggest a specific effect of acupuncture in knee mobility and both non-specific and specific effects of needling in pain relief.

  10. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique.

    Science.gov (United States)

    Lee, Hong-Jae; Lim, Kil-Byung; Kim, Dug-Young; Lee, Kyung-Tae

    2009-12-01

    Lee H-J, Lim K-B, Kim D-Y, Lee K-T. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. To evaluate the clinical effect of ultrasonography (US)-guided intra-articular injections compared with a blind (unguided) technique for the treatment of adhesive capsulitis. Randomized controlled trial. Outpatient rehabilitation clinic. Patients (N=43) diagnosed as having adhesive capsulitis after clinical examinations and radiologic and ultrasonographic study. Under either US-guided or a blind technique, patients received a 20-mg intra-articular injection of triamcinolone mixed with 1.5mL 2% lidocaine and 4mL normal saline in the first week followed by 5 weekly injections of sodium hyaluronate. A visual analog scale for pain intensity, range of motion (ROM) of the shoulder (flexion, abduction, external rotation, and internal rotation), and general shoulder function during daily activities at preinjection as a baseline and then every week after injection for 6 weeks for each patient. Twenty patients out of 22 in the blind injection group and 20 out of 21 in the US-guided group finished the entire 6-week study period. The improvement in pain intensity, ROM, and shoulder function score was significantly greater in the US-guided injection group than in the blind injection group by the second week postinjection (Padhesive capsulitis and may deliver clinical benefits during the first few weeks of treatment. This finding suggests that the improved targeting to the intra-articular space by using US can result in better treatment of adhesive capsulitis.

  11. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial.

    Science.gov (United States)

    Cetin, Nuri; Aytar, Aydan; Atalay, Ayce; Akman, Mahmut Nafiz

    2008-06-01

    To investigate the therapeutic effects of physical agents administered before isokinetic exercise in women with knee osteoarthritis. One hundred patients with bilateral knee osteoarthritis were randomized into five groups of 20 patients each: group 1 received short-wave diathermy + hot packs and isokinetic exercise; group 2 received transcutaneous electrical nerve stimulation + hot packs and isokinetic exercise; group 3 received ultrasound + hot packs and isokinetic exercise; group 4 received hot packs and isokinetic exercise; and group 5 served as controls and received only isokinetic exercise. Pain and disability index scores were significantly reduced in each group. Patients in the study groups had significantly greater reductions in their visual analog scale scores and scores on the Lequesne index than did patients in the control group (group 5). They also showed greater increases than did controls in muscular strength at all angular velocities. In most parameters, improvements were greatest in groups 1 and 2 compared with groups 3 and 4. Using physical agents before isokinetic exercises in women with knee osteoarthritis leads to augmented exercise performance, reduced pain, and improved function. Hot pack with a transcutaneous electrical nerve stimulator or short-wave diathermy has the best outcome.

  12. Topical ozonated oil versus hyaluronic gel for the treatment of partial- to full-thickness second-degree burns: A prospective, comparative, single-blind, non-randomised, controlled clinical trial.

    Science.gov (United States)

    Campanati, A; De Blasio, S; Giuliano, A; Ganzetti, G; Giuliodori, K; Pecora, T; Consales, V; Minnetti, I; Offidani, A

    2013-09-01

    Several studies have demonstrated that ozonated oil is effective on cutaneous wound healing. This in vivo study has been conducted to evaluate the clinical effect of the topical application of ozonated oil for 12 weeks on second-degree skin burns. A total of 30 patients suffering from second-degree skin burns in the phase of re-epithelisation were included in this study. Every skin burn was subdivided in two symmetrical parts. One part was treated with occlusive application of ozonated oil; the contralateral part of the lesion was treated with topical application of hyaluronic acid gel, once a day for 12 weeks. A clinical evaluation and an intra-vital video-capillaroscopy were performed on every patient at baseline, 6 and 12 weeks after. All treated lesions improved regardless of the treatment used. Ozonated oil was as effective as hyaluronic acid in improving erythema, tension, itching and burning sensation reported by patients, and it does not exert a specific anti-angiogenic effect compared to hyaluronic acid. However it seems more effective than hyaluronic acid in reducing post-lesional hyperpigmentation. Ozonated oil, topically applied for 12 weeks, seems to be as effective as hyaluronic acid in reducing symptoms related to skin burns, but it could be more effective in preventing the post-lesional hyperpigmentation. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  13. Comparing the effects of balance training with and without cognitive tasks on the quality of life and balance performance in community-dwelling older adults: a single-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ehsan Sinaei

    2016-12-01

    Full Text Available Background: Aging process can deteriorate the ability to maintain balance, specifically under dual-task conditions. Thus far, different methods of exercises therapy have been applied to improve balance performance of older adults. The present study was designed to compare the effects of two protocols of balance training on the quality of life (QoL and balance performance in older adults with mild balance impairments. Methods: Twenty-four older adults over 60 years old were allocated randomly into single-task (n=12 and dual-task (n=12 exercise groups. Single-task group received routine balance exercises, over a four-week period and dual-task group was treated by the same exercise program plus a cognitive task. QoL and balance status were assessed by the Short-Form Health Survey (SF-36 and Fullerton Advanced Balance scale (FAB questionnaires, before and after the interventions. Results: After four weeks of training, balance performance and some factors of QoL improved significantly in both groups (P<0.05. However, there were no significant differences in any of the variables between the two groups. Conclusion: Balance exercises, under both single- and dual-task conditions can improve the balance level and some aspects of QoL in older adults with mild balance impairments, with no priority of one group over another.

  14. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial.

    Science.gov (United States)

    Joo, Jayne; Custis, Trenton; Armstrong, April W; King, Thomas H; Omlin, Kenny; Kappel, Stefani T; Eisen, Daniel B

    2015-03-01

    Purse-string suture is a closure method that purportedly reduces the scar area compared with second intention healing. Randomized clinical trials comparing these 2 methods appear to be limited or absent. To determine if purse-string suture improves cosmetic outcome, healing time, and scar to defect area compared with second intention healing for circular defects on the trunk and extremities. Prospective, 2-arm, randomized, evaluator-blinded clinical trial in a single-center outpatient academic dermatology center. Patients were eligible if they were older than 18 years, able to give informed consent, and had circular or oval postoperative defects larger than 8 mm on the trunk or extremities. For the purse-string treatment arm, wounds were sewn in circumferential fashion using polydiaxanone suture. Patients in the other treatment arm were allowed to heal by second intent. The primary outcome measures were the mean total Patient and Observer Scar Assessment Scale (POSAS) scores ascertained from the patient and 2 blinded observers. Secondary outcomes included the ratio of scar to initial defect size, healing time, pain scores, and complication rates. Fifty-two patients were screened, and a total of 44 patients with 50 surgical sites were enrolled. Forty-two patients with 48 surgical sites completed the study. The mean total observer POSAS score was 18.38 for the purse-string group vs 19.91 for the secondary intention group, a nonsignificant difference (P = .41). Similarly, there were no significant differences for any of the following secondary outcome measures: mean total patient POSAS score (P = .96), mean scar-to-defect area (P = .61), and mean pain level at week 1 (P = .19). Statistical trends toward significance were seen in the mean healing time in favor of purse-string suture (P = .10) and scar relief, which favored second intention healing (P = .07). The purse-string suture results in similar cosmetic outcomes, scar sizes, and pain

  15. Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial.

    Science.gov (United States)

    Hofland, Jan; Ouattara, Alexandre; Fellahi, Jean-Luc; Gruenewald, Matthias; Hazebroucq, Jean; Ecoffey, Claude; Joseph, Pierre; Heringlake, Matthias; Steib, Annick; Coburn, Mark; Amour, Julien; Rozec, Bertrand; Liefde, Inge de; Meybohm, Patrick; Preckel, Benedikt; Hanouz, Jean-Luc; Tritapepe, Luigi; Tonner, Peter; Benhaoua, Hamina; Roesner, Jan Patrick; Bein, Berthold; Hanouz, Luc; Tenbrinck, Rob; Bogers, Ad J J C; Mik, Bert G; Coiffic, Alain; Renner, Jochen; Steinfath, Markus; Francksen, Helga; Broch, Ole; Haneya, Assad; Schaller, Manuella; Guinet, Patrick; Daviet, Lauren; Brianchon, Corinne; Rosier, Sebastien; Lehot, Jean-Jacques; Paarmann, Hauke; Schön, Julika; Hanke, Thorsten; Ettel, Joachym; Olsson, Silke; Klotz, Stefan; Samet, Amir; Laurinenas, Giedrius; Thibaud, Adrien; Cristinar, Mircea; Collanges, Olivier; Levy, François; Rossaint, Rolf; Stevanovic, Ana; Schaelte, Gereon; Stoppe, Christian; Hamou, Nora Ait; Hariri, Sarah; Quessard, Astrid; Carillion, Aude; Morin, Hélène; Silleran, Jacqueline; Robert, David; Crouzet, Anne-Sophie; Zacharowski, Kai; Reyher, Christian; Iken, Sonja; Weber, Nina C; Hollmann, Marcus; Eberl, Susanne; Carriero, Giovanni; Collacchi, Daria; Di Persio, Alessandra; Fourcade, Olivier; Bergt, Stefan; Alms, Angela

    2017-12-01

    Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24 h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15 ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09 ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous

  16. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Schache Anthony G

    2008-09-01

    Full Text Available Abstract Background The patellofemoral joint (PFJ is one compartment of the knee that is frequently affected by osteoarthritis (OA and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks. Physiotherapy treatment will consist of (i quadriceps muscle retraining; (ii quadriceps and hip muscle strengthening; (iii patellar taping; (iv manual PFJ and soft tissue mobilisation; and (v OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the

  17. Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.

    Science.gov (United States)

    Bolk, Nienke; Visser, Theo J; Nijman, Judy; Jongste, Ineke J; Tijssen, Jan G P; Berghout, Arie

    2010-12-13

    Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date, no large randomized trial investigating the best time of levothyroxine intake, including quality-of-life evaluation, has been performed. To ascertain if levothyroxine intake at bedtime instead of in the morning improves thyroid hormone levels, a randomized double-blind crossover trial was performed between April 1, 2007, and November 30, 2008, among 105 consecutive patients with primary hypothyroidism at Maasstad Hospital Rotterdam in the Netherlands. Patients were instructed during 6 months to take 1 capsule in the morning and 1 capsule at bedtime (one containing levothyroxine and the other a placebo), with a switch after 3 months. Primary outcome measures were thyroid hormone levels; secondary outcome measures were creatinine and lipid levels, body mass index, heart rate, and quality of life. Ninety patients completed the trial and were available for analysis. Compared with morning intake, direct treatment effects when levothyroxine was taken at bedtime were a decrease in thyrotropin level of 1.25 mIU/L (95% confidence interval [CI], 0.60-1.89 mIU/L; P levothyroxine. Levothyroxine taken at bedtime significantly improved thyroid hormone levels. Quality-of-life variables and plasma lipid levels showed no significant changes with bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime. isrctn.org Identifier: ISRCTN17436693 (NTR959).

  18. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Science.gov (United States)

    Crossley, Kay M; Vicenzino, Bill; Pandy, Marcus G; Schache, Anthony G; Hinman, Rana S

    2008-01-01

    Background The patellofemoral joint (PFJ) is one compartment of the knee that is frequently affected by osteoarthritis (OA) and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA) will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week) compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks). Physiotherapy treatment will consist of (i) quadriceps muscle retraining; (ii) quadriceps and hip muscle strengthening; (iii) patellar taping; (iv) manual PFJ and soft tissue mobilisation; and (v) OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the potential to reduce

  19. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation

    Directory of Open Access Journals (Sweden)

    Nilsson Robert

    2011-09-01

    Full Text Available Abstract Background Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81% expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ≥ 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits. Results At the week 24 visit, the proportion of participants who achieved the protocol definition of a ≥ 50% smoking reduction was similar in the two treatment groups. However, the proportion that reported more extreme reductions (≥ 75% was statistically significantly higher in the snus group than in the placebo group (p Conclusions Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco. Trial registration www.clinicaltrials.gov, identifier: NCT00601042

  20. Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Levin, Frances R; Mariani, John J; Brooks, Daniel J; Pavlicova, Martina; Cheng, Wendy; Nunes, Edward V

    2011-07-01

    Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow back method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P=.02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P=.02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  1. Prevention of acute mountain sickness by acetazolamide in Nepali porters: a double-blind controlled trial.

    Science.gov (United States)

    Hillenbrand, Peter; Pahari, Anil K; Soon, Yuen; Subedi, Deepak; Bajracharya, Rajan; Gurung, Puncho; Lal, Barun K; Marahatta, Ramesh; Pradhan, Santosh; Rai, Dilip; Sharma, Shailendra

    2006-01-01

    This study aimed to determine the efficacy, tolerability, and practicality of acetazolamide for the prevention of acute mountain sickness (AMS) in Nepali trekking porters early in the trekking season. This study was a randomized, double-blind controlled trial with 400 male Nepali porters in the Mount Everest region of Nepal, trekking from Namche Bazaar (3440 m) to Lobuche (4930 m), the study endpoint. Participants were randomized to receive 250 mg acetazolamide daily or placebo, and AMS symptom scores (Lake Louise) were compared in highlanders vs lowlanders. Only 109 (27.2%) of the 400 porters completed the trial (28 highlanders, 81 lowlanders). The rest either dropped out (275/400 porters, 68.8%) or were excluded (16/400 porters, 4%). Acute mountain sickness occurred in 13 (11.9%) of 109 porters; all were lowlanders; 7 were taking acetazolamide, 6 taking placebo. Birthplace, acclimatization in the week before the trial, ascent rate, and rest days were the most important variables affecting the incidence of AMS. No highlanders, but 13 (16.1%) of 81 lowlanders had AMS (P = .016). Acclimatization in the pretrial week reduced AMS incidence (P = .013), as did a slower ascent rate (P = .0126), but rest days were the most potent prophylactic variable (P = .0001). Side effects were more frequent in porters taking acetazolamide than in the placebo group (P = .0001), but there were no serious side effects. Acetazolamide was tolerable, but impractical for the routine prevention of AMS in Nepali porters. A good trekking schedule and adequate acclimatization remain the most effective preventive measures. This study identified lowland porters as a high-risk group for developing AMS.

  2. Double-Blind Comparative Trial of Parenteral Lorazepam and ...

    African Journals Online (AJOL)

    1974-04-27

    Apr 27, 1974 ... by deep injection into the triceps muscle. The patients were reassessed one hour later in the quiet environment ... 7 - 10 well sedated. Measurement of Forearm Blood Flow. In 10 patients (5 from each group) forearm blood flow was measured using a mercury-in-Silastic strain-gauge plethysmograph.

  3. Double-Blind Comparative Trial of Parenteral Lorazepam and ...

    African Journals Online (AJOL)

    1974-04-27

    OO1 . Papaveretum and hyoscine: There were significant de- creases in both heart rate (P<0,005) and systolic blood pressure (P<0,OO1) one hour after administration of papa- veretum and hyoscine. After challenge, heart rate.

  4. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  5. Different routes of misoprostol for cervical priming in first trimester surgical abortions: a randomized blind trial.

    Science.gov (United States)

    Ganer Herman, Hadas; Kerner, Ram; Gluck, Ohad; Feit, Hagit; Keidar, Ran; Bar, Jacob; Sagiv, Ron

    2017-04-01

    To compare effectiveness and patient satisfaction of different routes of misoprostol for short-term (same day) cervical priming in first trimester surgical abortions. In a blind randomized trial, patients undergoing surgical abortion at a gestational age of 6 + 0-14 + 6 were administered oral, vaginal, or sub-lingual 400 mcg misoprostol, 1.5 to 4 h prior to procedure. Surgeons blinded to patient allocation evaluated cervical priming. The primary outcome was initial cervical dilatation. Secondary outcomes were cervical consistency, ease of dilation, patient discomfort, and side effects. From July 2015 through May 2016, 120 patients were randomized as follows: 40 to oral, 40 to vaginal, and 40 to sublingual misoprostol administration. No differences were noted in patient age, gestational age, curettage indication (termination/delayed miscarriage), past vaginal delivery, and administration to procedure interval. Initial cervical dilatation was similar between the groups, as were cervical consistency and ease of dilation. Patients noted the greatest discomfort and side effects with sublingual administration. The followings were found to be independently associated with cervical dilatation in a linear regression analysis: sublingual administration, gestational age, missed abortion, and previous vaginal delivery. Side effects and administration to procedure interval were found non-significant. The same day cervical priming for first trimester surgical abortion is similarly achieved with all routes of misoprostol administration. In cases of termination of pregnancy with no prior vaginal delivery, sublingual administration may be considered, but entails a higher rate of side effects and patient discomfort.

  6. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

    Science.gov (United States)

    Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

    2015-09-24

    To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

  7. Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

    Science.gov (United States)

    Kok, Niels F M; Lind, May Y; Hansson, Birgitta M E; Pilzecker, Desiree; Mertens zur Borg, Ingrid R A M; Knipscheer, Ben C; Hazebroek, Eric J; Dooper, Ine M; Weimar, Willem; Hop, Wim C J; Adang, Eddy M M; van der Wilt, Gert Jan; Bonjer, Hendrik J; van der Vliet, Jordanus A; IJzermans, Jan N M

    2006-07-29

    To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Single blind, randomised controlled trial. Two university medical centres, the Netherlands. 100 living kidney donors. Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.

  8. Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial

    Science.gov (United States)

    Kron, Frederick W.; Fetters, Michael D.; Scerbo, Mark W.; White, Casey B.; Lypson, Monica L.; Padilla, Miguel A.; Gliva-McConvey, Gayle A.; Belfore, Lee A.; West, Temple; Wallace, Amelia M.; Guetterman, Timothy C.; Schleicher, Lauren S.; Kennedy, Rebecca A.; Mangrulkar, Rajesh S.; Cleary, James F.; Marsella, Stacy C.; Becker, Daniel M.

    2016-01-01

    Objectives To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group’s experiences and learning preferences. Methods A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR’s intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. Secondary outcomes: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. Results MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. Conclusions MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. Practice Implications MPathic-VR’s virtual human simulation offers an effective and engaging means of advanced communication training. PMID:27939846

  9. Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial.

    Science.gov (United States)

    Kron, Frederick W; Fetters, Michael D; Scerbo, Mark W; White, Casey B; Lypson, Monica L; Padilla, Miguel A; Gliva-McConvey, Gayle A; Belfore, Lee A; West, Temple; Wallace, Amelia M; Guetterman, Timothy C; Schleicher, Lauren S; Kennedy, Rebecca A; Mangrulkar, Rajesh S; Cleary, James F; Marsella, Stacy C; Becker, Daniel M

    2017-04-01

    To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group's experiences and learning preferences. A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR's intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. MPathic-VR's virtual human simulation offers an effective and engaging means of advanced communication training. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. The efficacy of azithromycin in pityriasis rosea: A randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Deepika Pandhi

    2014-01-01

    Full Text Available Background: Macrolides are prescribed in the treatment of pityriasis rosea despite conflicting results of the limited number of studies evaluating their role in its treatment. Aim: A randomized double-blind placebo-controlled trial was conducted to evaluate the effect of azithromycin on the clinical course of pityriasis rosea. Methods: Seventy patients of pityriasis rosea were given either azithromycin (n = 35 or placebo (n = 35 and were followed-up at 2, 4 and 6 weeks. Pruritus was assessed in both groups using the visual analogue scale (VAS . Change in the pityriasis rosea severity score (PRSS and in the VAS were recorded as outcome measures and were compared statistically. Results: The decrease in PRSS from baseline through 2, 4 and 6 weeks within both treatment (P < 0.001 and placebo (P < 0.001 arms was found to be statistically significant; however, this change was not significantly different in the two groups (P = 0.179. Similarly, the decrease in VAS was found to be statistically significant within both groups (P < 0.001; however, the change was comparable between the two groups (P < 0.937. Analysis by Fisher′s exact test did not find a significant difference between the two groups for PRSS and VAS. Conclusion: Azithromycin is not effective in pityriasis rosea and the use of macrolides for this disease should not be encouraged in clinical practice.

  11. Effect of aliskiren on proteinuria in non-diabetic chronic kidney disease: a double-blind, crossover, randomised, controlled trial

    OpenAIRE

    Lizakowski, Sławomir; Tylicki, Leszek; Renke, Marcin; Rutkowski, Przemysław; Heleniak, Zbigniew; Sławińska-Morawska, Maja; Aleksandrowicz, Ewa; Łysiak-Szydłowska, Wieslawa; Rutkowski, Bolesław

    2012-01-01

    Aim To evaluate the proteinuria-lowering effect of a renin inhibitor (aliskiren), compared to placebo and to an angiotensin-converting enzyme inhibitor (perindopril), in patients with non-diabetic chronic kidney disease. Methods A randomised, double-blind, crossover trial was performed in 14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93 ± 6.8 ml/min. The study consisted of five treatment perio...

  12. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial.

    Science.gov (United States)

    Grover, Samir C; Scaffidi, Michael A; Khan, Rishad; Garg, Ankit; Al-Mazroui, Ahmed; Alomani, Tareq; Yu, Jeffrey J; Plener, Ian S; Al-Awamy, Mohamed; Yong, Elaine L; Cino, Maria; Ravindran, Nikila C; Zasowski, Mark; Grantcharov, Teodor P; Walsh, Catharine M

    2017-11-01

    A structured comprehensive curriculum (SCC) that uses simulation-based training (SBT) can improve clinical colonoscopy performance. This curriculum may be enhanced through the application of progressive learning, a training strategy centered on incrementally challenging learners. We aimed to determine whether a progressive learning-based curriculum (PLC) would lead to superior clinical performance compared with an SCC. This was a single-blinded randomized controlled trial conducted at a single academic center. Thirty-seven novice endoscopists were recruited and randomized to either a PLC (n = 18) or to an SCC (n = 19). The PLC comprised 6 hours of SBT, which progressed in complexity and difficulty. The SCC included 6 hours of SBT, with cases of random order of difficulty. Both groups received expert feedback and 4 hours of didactic teaching. Participants were assessed at baseline, immediately after training, and 4 to 6 weeks after training. The primary outcome was participants' performance during their first 2 clinical colonoscopies, as assessed by using the Joint Advisory Group Direct Observation of Procedural Skills assessment tool (JAG DOPS). Secondary outcomes were differences in endoscopic knowledge, technical and communication skills, and global performance in the simulated setting. The PLC group outperformed the SCC group during first and second clinical colonoscopies, measured by JAG DOPS (P technical and communication skills and global performance in the simulated setting (P  .05). Our findings demonstrate the superiority of a PLC for endoscopic simulation, compared with an SCC. Challenging trainees progressively is a simple, theory-based approach to simulation whereby the performance of clinical colonoscopies can be improved. (Clinical trial registration number: NCT02000180.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  13. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial

    Directory of Open Access Journals (Sweden)

    Vonlanthen René

    2011-09-01

    Full Text Available Abstract Background Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES and single-port laparoscopic cholecystectomy (SPLC. Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated. Methods/Design The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10% resulted in a number of 55 randomized patients per arm. Discussion The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body

  14. Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial.

    Science.gov (United States)

    Mogollon, Jaime Andres; Boivin, Catherine; Lemieux, Simone; Blanchet, Claudine; Claveau, Joël; Dodin, Sylvie

    2014-06-27

    Solar ultraviolet (UV) radiation has deleterious effects on the skin, including sunburn, photoaging and cancer. Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage. We investigated the influence of 12-week high-flavanol chocolate (HFC) consumption on skin sensitivity to UV radiation, measured by minimal erythema dose (MED). We also evaluated skin elasticity and hydration. In this 2-group, parallel, double-blind, randomized controlled trial, 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City, for randomization to either HFC (n = 33) or low-flavanol chocolate (LFC) (n = 41). A blocked randomisation (4), considering date of entry, skin type and age as factors, generated a sequentially-numbered allocation list. Study participants and research assistants were blinded. Totally, 30 g of chocolate were consumed daily for 12 weeks, followed by a 3-week washout period. MED was assessed at baseline and at 6, 9, 12 and 15 weeks. Main outcome was changes in MED at week 12. 33 participants in the HFC group and 41 in the LFC group were analyzed with 15 weeks of follow-up. Both groups showed similarly-increased MED at 12 weeks (HFC: 0.0252 ± 0.1099 J/cm2 [mean ± standard deviation (SD)]; LFC: 0.0151 ± 0.1118; mean difference (MD): 0.0100 J/cm2; 95% confidence interval (CI): -0.0417 to 0.0618). However, after 3-week washout, the HFC group presented decreased MED (-0.0248 ± 0.1145) whereas no effect was seen in the LFC group (0.0168 ± 0.1698) (MD: -0.0417; 95% CI: -0.1106 to 0.0272). Net temple elasticity increased slightly but significantly by 0.09 ± 0.12 mm in the HFC group at 12 weeks compared to 0.02 ± 0.12 mm in the LFC group (MD: 0.06; 95% CI: 0.01 to 0.12 ). No significant adverse events were reported. Our study failed to demonstrate a statistically

  15. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    OpenAIRE

    Seyyedrasooli, Allehe; Valizadeh, Leila; Zamanzadeh, Vahid; Nasiri, Khadijeh; Kalantri, Hossein

    2013-01-01

    Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method). The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research wer...

  16. Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

    OpenAIRE

    Carbonell, Josep Lluis; Garcia, Ramon; Gonzalez, Adriana; Breto, Andres; Sanchez, Carlos

    2015-01-01

    Josep Lluis Carbonell,1 Ramon Garcia,2 Adriana Gonzalez,2 Andres Breto,2 Carlos Sanchez2 1Mediterranea Medica Clinic, Valencia, Spain; 2Eusebio Hernandez Gynecology and Obstetrics Teaching Hospital, Havana, Cuba Purpose: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. Methods: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women ...

  17. A double-blind clinical trial of griseofulvin in patients with Raynaud's phenomenon

    Science.gov (United States)

    Sabri, S.; Roberts, V. C.; Higgins, R. F.; Cotton, L. T.; Williams, D. I.; Wilson, L. C.

    1973-01-01

    Twenty-four patients with Raynaud's phenomenon were treated with griseofulvin and a placebo in a double-blind cross-over clinical trial. The results were assessed subjectively and plotted sequentially. The number of patients able to distinguish the active from the placebo treatment was statistically significant (P=0·05). There were indications that the response was dose dependent. Further studies are needed to establish whether griseofulvin offers useful clinical improvement in this condition. PMID:4596620

  18. External and internal validity of open label or double-blind trials in oral anticoagulation: better, worse or just different?

    Science.gov (United States)

    Beyer-Westendorf, J; Büller, H

    2011-11-01

    Currently, few topics in the field of anticoagulant therapy are as intensely discussed as the question: which is the best new oral anticoagulant? The most advanced substances in this field are the oral direct factor Xa-inhibitors rivaroxaban, apixaban and edoxaban and the oral direct thrombin inhibitor dabigatran. All of these substances are currently being tested in very similar phase III trials or are in the process of approval. In these trials, open-label or double-blind double-dummy designs are being used to evaluate the efficacy and safety in prevention and treatment of venous thromboembolism or stroke prevention in atrial fibrillation in several thousands of patients. As a consequence, an intense discussion of the advantages and disadvantages of open-label or double-blind trials is currently under way and interpretation of trial results is often focused on this matter. In general, a blinded trial is regarded as being less subject to bias than an open trial because it minimizes the impact of knowledge of treatment allocation on post-randomized treatment decisions and on reporting of outcomes. However, a blinded trial is not always feasible. Thus, in some respects, the two trial designs offer complementary strengths and weaknesses. This review addresses the risks of bias for internal and external validity of open-label and double-blind anticoagulation trials to help to objectify this debate. © 2011 International Society on Thrombosis and Haemostasis.

  19. Comparison of Ambu® AuraGain™ laryngeal mask and air-Q™ intubating laryngeal airway for blind tracheal intubation in adults: A randomized controlled trial

    OpenAIRE

    Sameer Sethi; Souvik Maitra; Vikas Saini; Tanvir Samara

    2017-01-01

    Background: This study has been designed to compare the performance of Ambu® AuraGain™ laryngeal mask with the air-Q™ as a conduit for blind tracheal intubation in adult patients. Methods: In this prospective randomized controlled trial blind endotracheal intubation success rates were compared between Ambu® AuraGain™ and air-Q™ intubating laryngeal airway in 90 adult patients. Patients were randomized in two equal groups: Group Ambu® AuraGain™ (n = 45) and Group air-Q™ (n = 45). Results...

  20. Distance education and diabetes empowerment: A single-blind randomized control trial.

    Science.gov (United States)

    Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

    2017-11-01

    Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (pdistance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  1. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

    Science.gov (United States)

    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  2. Dapsone Gel in the Treatment of Papulopustular Rosacea: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Faghihi, Gita; Khosravani, Parastoo; Nilforoushzadeh, Mohammad Ali; Hosseini, Sayyed Mohsen; Assaf, Fatemeh; Zeinali, Naser; Smiley, Abbas

    2015-06-01

    We aimed to evaluate the effects of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea. In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator's global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL). There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (PDapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.

  3. Acyclovir in pityriasis rosea: An observer-blind, randomized controlled trial of effectiveness, safety and tolerability

    Directory of Open Access Journals (Sweden)

    Anupam Das

    2015-01-01

    Full Text Available Background: Pityriasis rosea (PR is an acute inflammatory dermatosis. The association of human herpes virus 6 and 7 suggests the utility of use of antiviral agents in this disease. Aims and Objectives: To evaluate the effectiveness and safety of acyclovir in the treatment of PR. Methods: An observer-blind, randomized (1:1, parallel group, add-on trial was conducted on 24 adult patients with PR. Subjects of both Group A and B received the standard of care in the form of cetirizine 10 mg OD and calamine. Group A in addition received acyclovir 400 mg tablets thrice daily for 7 days. Both groups were followed up for four consecutive weeks for assessment of effectiveness and adverse events. Results: Group A complained of significantly fewer new lesions than Group B (P = 0.046. A complete response was obtained in all patients of Group A and 83% patients of Group B at the end of the follow up period. There was significant reduction in both lesional score and pruritus at second week follow-up in Group A and third week follow-up in Group B (P < 0.05. Minor adverse effects were observed in both treatment arms. Conclusion: Acyclovir offered rapid resolution of clinical severity of PR from second week onwards without significantly increased adverse events as compared to supportive therapy alone.

  4. Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

    Directory of Open Access Journals (Sweden)

    E. Tiralongo

    2012-01-01

    Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

  5. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

    Science.gov (United States)

    Bellad, M B; Tara, D; Ganachari, M S; Mallapur, M D; Goudar, S S; Kodkany, B S; Sloan, N L; Derman, R

    2012-07-01

    Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Double-blind randomised controlled trial. A teaching hospital: J N Medical College, Belgaum, India. A cohort of 652 consenting eligible pregnant women admitted to the labour room. Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  6. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial

    NARCIS (Netherlands)

    Buchbinder, R.; Hoving, J. L.; Green, S.; Hall, S.; Forbes, A.; Nash, P.

    2004-01-01

    OBJECTIVE: To determine whether a short course of prednisolone is superior to placebo for improving pain, function, and range of motion in adhesive capsulitis. DESIGN: Double blind, randomised, placebo controlled trial. SETTING: Community based rheumatology practice in Australia. PARTICIPANTS: 50

  7. Green banana reduces clinical severity of childhood shigellosis: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Rabbani, Golam H; Ahmed, Shamsir; Hossain, Iqbal; Islam, Rafiqul; Marni, Farzana; Akhtar, Mastura; Majid, Nashiha

    2009-05-01

    Mature green banana (GB) fruit is rich in amylase-resistant starch that stimulates colonic production of short-chain fatty acids (referred to as fatty acid) and is useful in treating diarrheal diseases. We studied therapeutic effects of GB in childhood shigellosis by determining colonic fatty acid production in a double-blind, randomized, controlled, clinical trial. Seventy-three children aged 6 to 60 months with severe bloody dysentery caused by Shigella infection were either given a rice-based diet (54 kcal/dL), with cooked GB (250 g/L) (n = 34) or without GB (n = 39) for 5 days; all given ciprofloxacin (15 mg/kg, q12 hours). Stool volume, frequency, excretion of blood/mucus, and relevant clinical and laboratory indices were determined. On day 5 (post-treatment), 59% children in GB group had no mucus compared with 36% in controls, fecal blood was completely cleared from 96% in GB group compared with 60% without GB (P < 0.05). GB treatment significantly reduced (P < 0.01) numbers of stools/day compared with controls (70% vs. 50%, P < 0.05). GB-specific reductions of mean fecal volumes (mL/kg) ranged from 25% to 40%; (P < 0.05) during the 5-day observations. Clinical success rates were 85% in GB group compared with 67% in controls (P < 0.05). GB significantly (P < 0.01) reduced fecal myeloperoxidase activity and increased fecal fatty acid concentrations (P < 0.01). GB diet improves clinical severity in childhood shigellosis and could be a simple and useful adjunct for dietary management of this illness.

  8. Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

    Directory of Open Access Journals (Sweden)

    Ito Mikako

    2011-10-01

    -treated MELAS patient, which subsided by reducing the insulin dose. Conclusions Hydrogen-enriched water improves mitochondrial dysfunction in MM and inflammatory processes in PM/DM. Less prominent effects with the double-blind trial compared to the open-label trial were likely due to a lower amount of administered hydrogen and a shorter observation period, which implies a threshold effect or a dose-response effect of hydrogen.

  9. A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial

    Directory of Open Access Journals (Sweden)

    Louise E. Kimball

    2016-12-01

    Conclusion: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP guidelines over a large geographic area.

  10. Trachyspermum ammi 10 % topical cream versus placebo on neuropathic pain, a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Petramfar, Peyman; Moein, Mahmoodreza; Samani, Soliman Mohammadi; Tabatabaei, Sayed Hamidreza; Zarshenas, Mohammad M

    2016-09-01

    A four-week, double-blind, randomized, placebo-controlled trial was conducted to assay the effectiveness of Ajwain 10 % (Trachyspermum ammi Sprague) topical cream on neuropathic pain. Intervention encompassed Ajwain 10 % and placebo creams. Ninety-two patients who specifically mentioned daily and nocturnal burning feet were randomly assigned to receive one of those interventions. Presence and decline in patients' numbness, tingling and allodynia were also evaluated. Major outcome measure was alteration in feet burning intensity (final week versus baseline week) regarding to a visual analog scale on a 0-10 cm scale (0 being "no pain", 10 being "worst pain"). Significant reduction in feet burning scores as well as numbness, tingling and allodynia were found in Ajwain group compared to placebo. This trial examining a cream of Ajwain essential oil versus placebo revealed the significance difference between two groups. This medicament can be a good candidate for the alleviation of feet burning, a neuropathic complication.

  11. Pentoxifylline as a rescue treatment for DMD: a randomized double-blind clinical trial.

    Science.gov (United States)

    Escolar, D M; Zimmerman, A; Bertorini, T; Clemens, P R; Connolly, A M; Mesa, L; Gorni, K; Kornberg, A; Kolski, H; Kuntz, N; Nevo, Y; Tesi-Rocha, C; Nagaraju, K; Rayavarapu, S; Hache, L P; Mayhew, J E; Florence, J; Hu, F; Arrieta, A; Henricson, E; Leshner, R T; Mah, J K

    2012-03-20

    To determine whether pentoxifylline (PTX) slows the decline of muscle strength and function in ambulatory boys with Duchenne muscular dystrophy (DMD). This was a multicenter, randomized, double-blinded, controlled trial comparing 12 months of daily treatment with PTX or placebo in corticosteroid-treated boys with DMD using a slow-release PTX formulation (~20 mg/kg/day). The primary outcome was the change in mean total quantitative muscle testing (QMT) score. Secondary outcomes included changes in QMT subscales, manual muscle strength, pulmonary function, and timed function tests. Outcomes were compared using Student t tests and a linear mixed-effects model. Adverse events (AEs) were compared using the Fisher exact test. A total of 64 boys with DMD with a mean age of 9.9 ± 2.9 years were randomly assigned to PTX or placebo in 11 participating Cooperative International Neuromuscular Research Group centers. There was no significant difference between PTX and the placebo group in total QMT scores (p = 0.14) or in most of the secondary outcomes after a 12-month treatment. The use of PTX was associated with mild to moderate gastrointestinal or hematologic AEs. The addition of PTX to corticosteroid-treated boys with DMD at a moderate to late ambulatory stage of disease did not improve or halt the deterioration of muscle strength and function over a 12-month study period. This study provides Class I evidence that treatment with PTX does not prevent deterioration in muscle function or strength in corticosteroid-treated boys with DMD.

  12. Double-Blind Placebo Controlled Trial of Dapsone in Antihistamine Refractory Chronic Idiopathic Urticaria

    Science.gov (United States)

    Morgan, Matt; Cooke, Andrew; Rogers, Laura; Adams-Huet, Beverley; Khan, David A.

    2014-01-01

    Background Management of antihistamine refractory CIU has poorly defined therapeutic options. Objective To evaluate the efficacy of dapsone in antihistamine refractory CIU compared to placebo. Methods Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14 week double-blind, placebo-controlled crossover trial. Endpoints were measured from a daily diary reflecting weekly hive score (WHS) and weekly itch score (WIS) and a visual analog score. Secondary to a carryover effect, the first period results were analyzed as a parallel design comparing placebo to dapsone directly using repeated measures analysis. Results After 6 weeks patients in the dapsone arm showed mean improvement over baseline in VAS (+2.3 [0.6,4.1], p=0.01), urticaria score (-3.5 [-6.2, -0.9], p=0.01), and itch score (-4.8 [-7.6, -2.1], p=0.001), whereas the placebo arm showed no improvement over baseline for VAS, urticaria or itch scores. Dapsone showed greater improvement compared to placebo for itch (p=0.047) and VAS (p=0.04). Of the 22 patients, 3 showed complete resolution of hives and itch with dapsone, while 31% and 41% had ≥ 50% resolution of hives and itch respectively. No serious adverse effects were observed from dapsone. Conclusion To our knowledge, this is the first DBPC study of dapsone in CIU and suggests dapsone has efficacy in antihistamine refractory CIU patients. PMID:25213055

  13. A comparative study of simple auditory reaction time in blind (congenitally) and sighted subjects.

    Science.gov (United States)

    Gandhi, Pritesh Hariprasad; Gokhale, Pradnya A; Mehta, H B; Shah, C J

    2013-07-01

    Reaction time is the time interval between the application of a stimulus and the appearance of appropriate voluntary response by a subject. It involves stimulus processing, decision making, and response programming. Reaction time study has been popular due to their implication in sports physiology. Reaction time has been widely studied as its practical implications may be of great consequence e.g., a slower than normal reaction time while driving can have grave results. To study simple auditory reaction time in congenitally blind subjects and in age sex matched sighted subjects. To compare the simple auditory reaction time between congenitally blind subjects and healthy control subjects. STUDY HAD BEEN CARRIED OUT IN TWO GROUPS: The 1(st) of 50 congenitally blind subjects and 2(nd) group comprises of 50 healthy controls. It was carried out on Multiple Choice Reaction Time Apparatus, Inco Ambala Ltd. (Accuracy±0.001 s) in a sitting position at Government Medical College and Hospital, Bhavnagar and at a Blind School, PNR campus, Bhavnagar, Gujarat, India. Simple auditory reaction time response with four different type of sound (horn, bell, ring, and whistle) was recorded in both groups. According to our study, there is no significant different in reaction time between congenital blind and normal healthy persons. Blind individuals commonly utilize tactual and auditory cues for information and orientation and they reliance on touch and audition, together with more practice in using these modalities to guide behavior, is often reflected in better performance of blind relative to sighted participants in tactile or auditory discrimination tasks, but there is not any difference in reaction time between congenitally blind and sighted people.

  14. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  15. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Whitlock, Richard P; Devereaux, P J; Teoh, Kevin H; Lamy, Andre; Vincent, Jessica; Pogue, Janice; Paparella, Domenico; Sessler, Daniel I; Karthikeyan, Ganesan; Villar, Juan Carlos; Zuo, Yunxia; Avezum, Álvaro; Quantz, Mackenzie; Tagarakis, Georgios I; Shah, Pallav J; Abbasi, Seyed Hesameddin; Zheng, Hong; Pettit, Shirley; Chrolavicius, Susan; Yusuf, Salim

    2015-09-26

    Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared

  16. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Maneeton B

    2013-07-01

    Full Text Available Benchalak Maneeton,1 Narong Maneeton,1 Manit Srisurapanont,1 Kaweesak Chittawatanarat2 1Department of Psychiatry, 2Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand Background: Atypical antipsychotic drugs may have low propensity to induce extrapyramidal side effects in delirious patients. This study aimed to compare the efficacy and tolerability between quetiapine and haloperidol in controlling delirious behavior. Methods: A 7-day prospective, double-blind, randomized controlled trial was conducted from June 2009 to April 2011 in medically ill patients with delirium. Measures used for daily assessment included the Delirium Rating Scale-revised-98 (DRS-R-98 and total sleep time. The Clinical Global Impression, Improvement (CGI–I and the Modified (nine-item Simpson–Angus Scale were applied daily. The primary outcome was the DRS-R-98 severity scores. The data were analyzed on an intention-to-treat basis. Results: Fifty-two subjects (35 males and 17 females were randomized to receive 25–100 mg/day of quetiapine (n = 24 or 0.5–2.0 mg/day of haloperidol (n = 28. Mean (standard deviation doses of quetiapine and haloperidol were 67.6 (9.7 and 0.8 (0.3 mg/day, respectively. Over the trial period, means (standard deviation of the DRS-R-98 severity scores were not significantly different between the quetiapine and haloperidol groups (-22.9 [6.9] versus -21.7 [6.7]; P = 0.59. The DRS-R-98 noncognitive and cognitive subscale scores were not significantly different. At end point, the response and remission rates, the total sleep time, and the Modified (nine-item Simpson–Angus scores were also not significantly different between groups. Hypersomnia was common in the quetiapine-treated patients (33.3%, but not significantly higher than that in the haloperidol-treated group (21.4%. Limitations: Patients were excluded if they were not able to take oral medications, and the sample size was small. Conclusion: Low

  17. Insufflation with Humidified and Heated Carbon Dioxide in Short-Term Laparoscopy: A Double-Blinded Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anja Herrmann

    2015-01-01

    Full Text Available Background. We tested the hypothesis that warm-humidified carbon dioxide (CO2 insufflation would reduce postoperative pain and morphine requirement compared to cold-dry CO2 insufflation. Methods. A double-blinded, randomized, controlled trial was conducted to compare warm, humidified CO2 and cold-dry CO2. Patients with benign uterine diseases were randomized to either treatment (n=48 or control (n=49 group during laparoscopically assisted vaginal hysterectomy. Primary endpoints of the study were rest pain, movement pain, shoulder-tip pain, and cough pain at 2, 4, 6, 24, and 48 hours postoperatively, measured by visual analogue scale. Secondary outcomes were morphine consumption, rejected boli, temperature change, recovery room stay, and length of hospital stay. Results. There were no significant differences in all baseline characteristics. Shoulder-tip pain at 6 h postoperatively was significantly reduced in the intervention group. Pain at rest, movement pain, and cough pain did not differ. Total morphine consumption and rejected boli at 24 h postoperatively were significantly higher in the control group. Temperature change, recovery room stay, and length of hospital were similar. Conclusions. Warm, humidified insufflation gas significantly reduces postoperative shoulder-tip pain as well as morphine demand. This trial is registered with Clinical Trial Registration Number  DRKS00003853 (German Clinical Trials Register (DRKS.

  18. A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

    Science.gov (United States)

    Whitley, Julie Anne; Rich, Bonnie L

    2008-12-01

    To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

  19. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups.

    Science.gov (United States)

    Haake, Michael; Müller, Hans-Helge; Schade-Brittinger, Carmen; Basler, Heinz D; Schäfer, Helmut; Maier, Christoph; Endres, Heinz G; Trampisch, Hans J; Molsberger, Albrecht

    2007-09-24

    To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain. A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement. At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

  20. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Peura, David A; Traxler, Barry; Kocun, Christopher; Lind, Tore

    2014-07-01

    To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider. Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries. The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole. A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

  1. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial.

    Science.gov (United States)

    Goudakos, John K; Markou, Konstantinos D; Psillas, George; Vital, Victor; Tsaligopoulos, Miltiadis

    2014-05-01

    IMPORTANCE The management of patients with unilateral acute vestibular neuritis (VN) has not been established to date. OBJECTIVE To compare the use of vestibular exercises vs corticosteroid therapy in the recovery of patients with acute VN. DESIGN, SETTING, AND PARTICIPANTS Prospective, single-blind, randomized clinical trial at a primary referral center. Among all patients with acute vertigo, those having VN were eligible for inclusion in the study. INTERVENTIONS Forty patients with acute VN were randomly assigned to perform vestibular exercises or to receive corticosteroid therapy. After a baseline examination, follow-up evaluations were performed at 1, 6, and 12 months. MAIN OUTCOMES AND MEASURES Efficacy outcomes included clinical, canal, and otolith recovery. Scores on the European Evaluation of Vertigo Scale and the Dizziness Handicap Inventory were used for the evaluation of clinical recovery. Findings of caloric irrigation and vestibular evoked myogenic potentials indicated canal and otolith improvement, respectively. RESULTS Comparing the 2 treatment groups, no statistically significant differences were found in clinical, canal, or otolith recovery. At the 6-month examination, the number of patients with complete disease resolution in the corticosteroids group was significantly higher than that in the vestibular exercises group. However, at the end of the follow-up period, 45%(9 of 20) of patients in the vestibular exercises group and 50% (10 of 20) of patients in the corticosteroids group had complete disease resolution (P > .05). CONCLUSIONS AND RELEVANCE Treating patients who have acute VN with vestibular exercises seems equivalently effective as treating them with corticosteroid therapy in clinical, caloric, and otolith recovery. Corticosteroid therapy seems to enhance earlier complete acute VN resolution, with no added benefit in the long-term prognosis.

  2. The effect of gabapentin on muscle cramps during hemodialysis: A double-blind clinical trial.

    Science.gov (United States)

    Beladi Mousavi, Seyed Seifollah; Zeraati, Abbasali; Moradi, Sajad; Mousavi, Marzieh Beladi

    2015-11-01

    Hemodialysis-associated muscle cramps (HAMC) are a common complication during hemodialysis (HD) sessions. A number of pharmacologic agents have been evaluated to prevent and or diminish HAMC; however, none of them has an established role. To the best of our knowledge, this is the first study to evaluate the possible effect of gabapentin on HAMC. In a double-blinded clinical trial, we compared the possible effect of gabapentin with a placebo in prevention and or diminishing episodes of HAMC in HD patients who had experienced frequent intradialytic muscle cramps. At first, placebo was given before each dialysis session for four weeks and then, after a two-week washout period, 300 mg of gabapentin was given before each dialysis session for four weeks to verify the effect of gabapentin on HAMC. Overall, 15 patients (seven men and eight women; mean age, 52.02 years) with frequent intradialytic muscle cramps were enrolled in the study. The incidence of symptomatic muscle cramp decreased in the gabapentin group compared with the placebo group, with a significant difference between them (P = 0.001). The intensity of muscle cramps also decreased in the gabapentin group (P = 0.001). There was no significant association between HAMC in male and female patients (P = 0. 397), mean age of HD patients (P = 0.226) and cause of end-stage renal disease (P = 0.551). According to the results of our study, gabapentin prescription before each HD session significantly reduced the frequency and the intensity of muscle cramps during HD without any major side-effects.

  3. The effect of gabapentin on muscle cramps during hemodialysis: A double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Seyed Seifollah Beladi Mousavi

    2015-01-01

    Full Text Available Hemodialysis‐associated muscle cramps (HAMC are a common complication during hemodialysis (HD sessions. A number of pharmacologic agents have been evaluated to prevent and or diminish HAMC; however, none of them has an established role. To the best of our knowledge, this is the first study to evaluate the possible effect of gabapentin on HAMC. In a double-blinded clinical trial, we compared the possible effect of gabapentin with a placebo in prevention and or diminishing episodes of HAMC in HD patients who had experienced frequent intradialytic muscle cramps. At first, placebo was given before each dialysis session for four weeks and then, after a two-week washout period, 300 mg of gabapentin was given before each dialysis session for four weeks to verify the effect of gabapentin on HAMC. Overall, 15 patients (seven men and eight women; mean age, 52.02 years with frequent intradialytic muscle cramps were enrolled in the study. The incidence of symptomatic muscle cramp decreased in the gabapentin group compared with the placebo group, with a significant difference between them (P = 0.001. The intensity of muscle cramps also decreased in the gabapentin group (P = 0.001. There was no significant association between HAMC in male and female patients (P = 0. 397, mean age of HD patients (P = 0.226 and cause of end-stage renal disease (P = 0.551. According to the results of our study, gabapentin prescription before each HD session significantly reduced the frequency and the intensity of muscle cramps during HD without any major side-effects.

  4. Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial.

    Science.gov (United States)

    Furyk, Jeremy S; Chu, Kevin; Banks, Colin; Greenslade, Jaimi; Keijzers, Gerben; Thom, Ogilvie; Torpie, Tom; Dux, Carl; Narula, Rajan

    2016-01-01

    We assess the efficacy and safety of tamsulosin compared with placebo as medical expulsive therapy in patients with distal ureteric stones less than or equal to 10 mm in diameter. This was a randomized, double-blind, placebo-controlled, multicenter trial of adult participants with calculus on computed tomography (CT). Patients were allocated to 0.4 mg of tamsulosin or placebo daily for 28 days. The primary outcomes were stone expulsion on CT at 28 days and time to stone expulsion. There were 403 patients randomized, 81.4% were men, and the median age was 46 years. The median stone size was 4.0 mm in the tamsulosin group and 3.7 mm in the placebo group. Of 316 patients who received CT at 28 days, stone passage occurred in 140 of 161 (87.0%) in the tamsulosin group and 127 of 155 (81.9%) with placebo, a difference of 5.0% (95% confidence interval -3.0% to 13.0%). In a prespecified subgroup analysis of large stones (5 to 10 mm), 30 of 36 (83.3%) tamsulosin participants had stone passage compared with 25 of 41 (61.0%) with placebo, a difference of 22.4% (95% confidence interval 3.1% to 41.6%) and number needed to treat of 4.5. There was no difference in urologic interventions, time to self-reported stone passage, pain, or analgesia requirements. Adverse events were generally mild and did not differ between groups. We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  5. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

    Directory of Open Access Journals (Sweden)

    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  6. Inattentional blindness on the full-attention trial: Are we throwing out the baby with the bathwater?

    Science.gov (United States)

    White, Rebekah C; Davies, Martin; Aimola Davies, Anne M

    2018-03-01

    When attention is otherwise engaged, observers may experience inattentional blindness, failing to notice objects or events that are presented in plain sight. In an inattentional blindness experiment, an unexpectedstimulus ispresented alongside primary-task stimuli, and its detection is probed. We evaluate a criterion that is commonly used to exclude observers from the data analysis. On the final experimental trial, observers do not perform the primary task, but instead look for anything new. Observers who fail to report the unexpected stimulus on thisfull-attention trialare excluded. On the basis of 4 hypothetical experiments and a review of 128 actual experiments from the literature, we demonstrate some potentially problematic consequences of implementing the full-attention-trial exclusion criterion. Excluded observers may cluster in experimental conditions and the exclusion criterion may lead researchers to understate the pervasiveness of inattentional blindness. It may even render usblindto inattentional blindness on the full-attention trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial.

    Science.gov (United States)

    Lemoel, Fabien; Contenti, Julie; Giolito, Didier; Boiffier, Mathieu; Rapp, Jocelyn; Istria, Jacques; Fournier, Marc; Ageron, François-Xavier; Levraut, Jacques

    2017-12-01

    The goal of our study was to compare the frequency and severity of recovery reactions between ketamine and ketamine-propofol 1:1 admixture ("ketofol"). We performed a multicentric, randomized, double-blind trial in which adult patients received emergency procedural sedations with ketamine or ketofol. Our primary outcome was the proportion of unpleasant recovery reactions. Other outcomes were frequency of interventions required by these recovery reactions, rates of respiratory or hemodynamic events, emesis, and satisfaction of patients as well as providers. A total of 152 patients completed the study, 76 in each arm. Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p ketamine. We found a significant reduction in recovery reactions and emesis frequencies among adult patients receiving emergency procedural sedations with ketofol, compared with ketamine. © 2017 by the Society for Academic Emergency Medicine.

  8. Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial.

    Science.gov (United States)

    Gillani, Syed Wasif; Sulaiman, Syed Azhar Syed; Abdul, Mohi Iqbal Mohammad; Baig, Mirza R

    2017-08-14

    We aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy. A 12-month single blinded multicenter randomized control trial was designed to investigate the measured variables [Glycated Hemoglobin (HbA1c), Renal function, Albumin Creatinine Ratio (ACR) etc.]. The trial was randomized into 2 experimental parallel arms (ascorbic acid vs acetylsalicylic acid) were blinded with study supplements in combination with metformin and findings were compared to control arm with metformin alone and blinded with placebo. Withdrawal criteria was defined to maintain the equity and balance in the participants in the whole trial. Patients with metformin and ascorbic acid (parallel arm I) was twice more likely to reduce HbA1c than metformin alone (control arm) in a year (OR 2.31 (95% CI 1.87-4.42) p ascorbic acid with metformin is more effective against reducing risks for diabetes related long-term complications (including ACR). TRIAL details Registration No: NTR-6100, Registry Name: Netherlands Trial Registry, URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6100 , Date of Registration: 20th October, 2016, Date of first Enrollment: 1 November, 2015.

  9. Effect of oral L-arginine supplementation on blood pressure: a meta-analysis of randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Dong, Jia-Yi; Qin, Li-Qiang; Zhang, Zengli; Zhao, Youyou; Wang, Junkuan; Arigoni, Fabrizio; Zhang, Weiguo

    2011-12-01

    Previous studies suggest that L-arginine, an amino acid and a substrate of nitric oxide synthase, may have blood pressure (BP)-lowering effect. Because some studies were performed with limited number of patients with hypertension and therefore limited statistical power with sometimes inconsistent results, we aimed to examine the effect of oral L-arginine supplementation on BP by conducting a meta-analysis of randomized, double-blind, placebo-controlled trials. PubMed, Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov databases were searched through June 2011 to identify randomized, double-blind, placebo-controlled trials of oral L-arginine supplementation on BP in humans. We also reviewed reference lists of obtained articles. Either a fixed-effects or, in the presence of heterogeneity, a random-effects model was used to calculate the combined treatment effect. We included 11 randomized, double-blind, placebo-controlled trials involving 387 participants with oral L-arginine intervention ranging from 4 to 24 g/d. Compared with placebo, L-arginine intervention significantly lowered systolic BP by 5.39 mm Hg (95% CI -8.54 to -2.25, P = .001) and diastolic BP by 2.66 mm Hg (95% CI -3.77 to -1.54, P L-arginine supplementation significantly lowers both systolic and diastolic BP. Copyright © 2011 Mosby, Inc. All rights reserved.

  10. Published and not fully published double-blind, randomised, controlled trials with oral naratriptan in the treatment of migraine

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer Carsten

    2011-01-01

    Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs...

  11. A Double Blind Study Comparing Virucare and Inter-feron as ...

    African Journals Online (AJOL)

    Objective: To present the results of a comparative double blind study between. Virucare and Interferon to evaluate their efficacy, safety and tolerability in treating Hepatitis C Virus and its complications. Keywords: Hepatitis C, polymerase chain reaction, interferon. Egypt. J. Hum. Genet Vol. 9 (1) 2008: pp. 71-84 ...

  12. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  13. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial

    Science.gov (United States)

    Hui, David; Kilgore, Kelly; Frisbee-Hume, Susan; Park, Minjeong; Tsao, Anne; Guay, Marvin Delgado; Lu, Charles; William, William; Pisters, Katherine; Eapen, George; Fossella, Frank; Amin, Sapna; Bruera, Eduardo

    2016-01-01

    Context Dexamethasone is often used to treat dyspnea in cancer patients but evidence is lacking. Objectives We determined the feasibility of conducting a randomized trial of dexamethasone in cancer patients, and estimated the efficacy of dexamethasone in the treatment of dyspnea. Methods In this double-blind, randomized, controlled trial, patients with dyspnea ≥4 were randomized to receive either dexamethasone 8 mg twice daily × four days then 4 mg twice daily × three days or placebo for seven days, followed by an open-label phase for seven days. We documented the changes in dyspnea (0-10 numeric rating scale [NRS]), spirometry measures, quality of life and toxicities. Results A total of 41 patients were randomized and 35 (85%) completed the blinded phase. Dexamethasone was associated with a significant reduction in dyspnea NRS of -1.9 (95% confidence interval [CI] -3.3 to -0.5, P=0.01) by day 4 and -1.8 (95% CI -3.2 to -0.3, P=0.02) by day 7. In contrast, placebo was associated with a reduction of -0.7 (95% CI -2.1 to 0.6, P=0.38) by day 4 and -1.3 (95% CI -2.4 to -0.2, P=0.03) by day 7. The between-arm difference was not statistically significant. Drowsiness improved with dexamethasone. Dexamethasone was well tolerated with no significant toxicities. Conclusion A double-blind, randomized, controlled trial of dexamethasone was feasible with a low attrition rate. Our preliminary data suggest that dexamethasone may be associated with rapid improvement in dyspnea and was well tolerated. Further studies are needed to confirm our findings. PMID:27330023

  14. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents.

    Science.gov (United States)

    Maahs, David; de Serna, Daniela Gonzalez; Kolotkin, Ronette L; Ralston, Shawn; Sandate, Jeffrey; Qualls, Clifford; Schade, David S

    2006-01-01

    To evaluate the efficacy of orlistat to enhance weight loss in obese adolescents. The study was a 6-month randomized, double-blind, placebo-controlled trial to compare the effects of orlistat (120 mg orally 3 times a day) and placebo on reduction of body mass index (BMI). Forty adolescents between 14 and 18 years of age with a mean BMI of 40 kg/m2 entered the protocol between December 2002 and February 2003. Study subjects stayed overnight in the General Clinical Research Center, during which dietary records were reviewed and lifestyle recommendations were given. The study participants received either orlistat (120 mg orally 3 times a day) or placebo and were assessed monthly for 6 months. At 0, 3, and 6 months, fasting laboratory tests were performed. The primary end point was the change in BMI from baseline to 6 months. Secondary outcomes included changes in weight, lean body mass, and results of blood chemistry studies. No statistically significant difference was noted between the 2 study groups for decrease in BMI from baseline to 6 months (P = 0.39). The decrease in BMI within the orlistat group (-1.3 +/- 1.6 kg/m2; P = 0.04) and within the placebo group (-0.8 +/- 3.0 kg/m2; P = 0.02), however, was statistically significant. Laboratory measurements did not differ between the 2 groups. In comparison with the placebo group, the orlistat group had increased adverse events, primarily gastrointestinal symptoms and findings. In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months.

  15. Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

    Science.gov (United States)

    Slovak, Martin; Chindo, Joseph; Nair, Krishnan Padmakumari Sivaraman; Reeves, Mark L; Heller, Ben; Barker, Anthony T

    2016-02-01

    To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity. © 2015 International Neuromodulation Society.

  16. Effect of Nepeta bracteata Benth. on allergic rhinitis symptoms: A randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Hajiheydari

    2017-01-01

    Full Text Available Background: Allergic rhinitis (AR is one of the health problems in the world. It is necessary to develop new treatment procedure for control of this disease. The aim of this study was to assess the effect of Zofa (Nepeta bracteata Benth on AR patients. Materials and Methods: In this double-blind randomized clinical trial study, 71 patients (37 patients in treatment and 34 in placebo group participated. In treatment group, N. bracteata syrup (NBS was used for 4 weeks as three times a day. The efficacy of the drug regarding AR symptoms (rhinorrhea, sneezing, nasal obstruction, itchy nose, and ocular symptoms were evaluated through a visual analog scale (VAS by 0–10 before administration and at the end of the whole treatment period. The collected information was entered in the SPSS software (version 18 and was analyzed using the Fisher's exact test, Chi-square test, independent sample t-test, and paired sample test. Results: The improvement of AR symptoms in the group receiving NBS was significantly higher compared to control group (4.73 ± 1.84 vs. 0.38 ± 2.06; P < 0.0001. Furthermore, the mean of total VAS before and after the treatment (in case group was 7.10 ± 1.92 and 2.37 ± 1.76, respectively (P < 0.001. Conclusion: The results of this study indicate that N. bracteata has significant effects on improving the symptoms of AR. Hence, it can be a good alternative to AR symptoms relief.

  17. Intravenous lidocaine for postmastectomy pain treatment: randomized, blind, placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Tania Cursino de Menezes Couceiro

    2015-06-01

    Full Text Available BACKGROUND AND OBJECTIVE: Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. METHODS: After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3 mg/kg infused over 1 h in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was. RESULTS: Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p = 0.50. Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p = 0.50; in the post-anesthetic recovery room in 14/22 and 12/22 (p = 0.37 of lidocaine and placebo groups, respectively. Pain evaluation 24 h after surgery showed that 2/22 and 3/22 patients (p = 0.50 of lidocaine and placebo groups, respectively, complained of pain. CONCLUSION: Intravenous lidocaine at a dose of 3 mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24 h, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients cannot be ruled out.

  18. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  19. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial

    Science.gov (United States)

    ABBASKHANIAN, Ali; EHTESHAMI, Sara; SAJJADI, Sadegh; REZAI, Mohammad Sadegh

    2012-01-01

    Objective Breath holding spells (BHS) are common paroxysmal non-epileptic events in the pediatric population which are very stressfull despite their harmless nature. There has been no specific treatment found for the spells yet. The aim of this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidine) on these children. Materials & Methods In this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August 2011 to July 2012. The patients were randomized into two equal groups. One received 40mg/kg/day piracetam and the other group received placebo, twice daily. Patients were followed monthly for three months. The number of attacks/month before and after treatment were documented. Results Of the enrolled patients, 86 were boys. The mean age of the patients was 17 months (range, 6 to 24 months). In the piracetam group, 1 month after treatment an 81% response to treatment was found. In the placebo group, none of the patients had complete remission and 7% of the cases had partial remission. Overall, control of breath-holding spells was observed in 91% of the patients in the group taking piracetam as compared with 16% in the group taking placebo at the end of the study. There was no significant difference detected between the groups regarding the prevalence of drug side effects. Conclusion A significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day) had a good effect on our patients. PMID:24665274

  20. Randomized, double-blind, placebo-controlled trial of Ficus carica paste for the management of functional constipation.

    Science.gov (United States)

    Baek, Hyang-Im; Ha, Ki-Chan; Kim, Hye-Mi; Choi, Eun-Kyung; Park, Eun-Ock; Park, Byung-Hyun; Yang, Hye Jeong; Kim, Min Jung; Kang, Hee Joo; Chae, Soo-Wan

    2016-01-01

    Constipation affects up to 20% of the world's population. The aim of this study was to investigate whether supplementation with Ficus carica paste could be used to treat constipation in Korean subjects with functional constipation. We conducted a randomized, double-blind, placebo-controlled trial. Subjects with functional constipation were orally supplemented with either F. carica paste (n=40) or placebo (n=40) for 8 weeks. We measured the efficacy and safety of F. carica paste. Primary outcomes (colon transit time) and secondary outcomes (questionnaire related to defecation) were compared before and after the 8-week intervention period. F. carica paste supplementation was associated with a significant reduction in colon transit time and a significant improvement in stool type and abdominal discomfort compared with the placebo. Blood parameters and clinical findings for organ toxicity remained within normal ranges. These results suggest that F. carica paste may have beneficial effects in subjects suffering from constipation.

  1. Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females.

    Science.gov (United States)

    Haskins-Coulter, Tao; Southern, Jo; Andrews, Nick; Miller, Elizabeth

    2017-06-03

    One hundred and ninety eight females aged 12-15 y were enrolled in an observer-blinded randomized trial to assess the immunogenicity and reactogenicity of the tetravalent HPV vaccine Gardasil® (group 2), in comparison to the bivalent HPV vaccine, Cervarix® (group 1), which was routinely offered in the national vaccination schedule at the time. Participants were blinded to treatment group until all 3 vaccinations had been given, while laboratory staff were masked during testing. For the majority of local and general reactions, recipients of both vaccines reported comparable frequencies. Local and systemic events were rarely of high severity, except for tenderness at the injection site which reached a severe level after at least one of the doses in 24% of the Cervarix® group and 7% of the Gardasil® group (p = 0.001 comparing groups). For most reactions, no dose response was recorded, except for swelling with higher reporting at dose 3 (17.7%) than dose 1 (3.1%) for Cervarix®. SAE reporting was low (n = 3) and considered unrelated to either vaccine. This paper supports the body of evidence that Gardasil® has an acceptable safety profile when compared with Cervarix® and other vaccines given in the national program.

  2. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

    Science.gov (United States)

    Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-01-01

    Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

  3. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive-behavioural therapy.

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-03-01

    There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

  4. Davunetide for Progressive Supranuclear Palsy: a multicenter, randomized, double-blind, placebo controlled trial

    Science.gov (United States)

    Boxer, Adam L.; Lang, Anthony E.; Grossman, Murray; Knopman, David S.; Miller, Bruce L.; Schneider, Lon S.; Doody, Rachelle S.; Lees, Andrew; Golbe, Lawrence I.; Williams, David R.; Corvol, Jean-Cristophe; Ludolph, Albert; Burn, David; Lorenzl, Stefan; Litvan, Irene; Roberson, Erik D.; Höglinger, Günter U.; Koestler, Mary; Jack, Clifford R.; Van Deerlin, Viviana; Randolph, Christopher; Lobach, Iryna V.; Heuer, Hilary W.; Gozes, Illana; Parker, Lesley; Whitaker, Steve; Hirman, Joe; Stewart, Alistair J.; Gold, Michael; Morimoto, Bruce H.

    2014-01-01

    Summary Background Davunetide (AL-108, NAP) is an eightamino acid peptide that promotes microtubule stability and decreases tau phosphorylation in pre-clinical studies. Since PSP is tightly linked to tau pathology, davunetide could be an effective treatment for PSP.The goals of this study were to evaluate the efficacy and safety of davunetide in PSP. Methods A phase 2/3 double-blind, parallel group, clinical trial of davunetide 30 mg or placebo (randomized 1:1) administered intranasally twice daily for 52 weeks was conducted at 48centers. Participants met modifiedNNIPPS criteria for possible or probable PSP. Co-primary endpointswere the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England ADL(SEADL) scale at up to 52 weeks. Data from all individuals who received at least one dose of medication and had a post-baseline efficacy assessment were compared using a rank-based method.Secondary outcomes included the Clinical Global Impression of Change (CGIC) and the change in regional brain volumeon MRI. Clinicaltrials.gov identifier: NCT01110720. Findings 360 participants were screened, 313 were randomized and 243 (77.6%) completed the study. There were no group differences in PSPRS (mean difference: 0.49 [95% CI: −1.5, 2.5], p = 0.72) or SEADL (1% [−2, 4%], p = 0.76) change from baseline (CFB) and mean 52 week CFB PSPRS scores were similar between the davunetide (11.3 [9.8,12.8]) and placebo groups (10.9 [9.1, 13.0]). There wereno differences in any of the secondary or exploratory endpoints. There were 11deaths in the davunetide group and tenin the placebo group. There were more nasal adverse events in the davunetide group. Interpretation Davunetide is well tolerated but is not an effective treatment for PSP. Clinical trials of disease modifying therapy are feasible in PSP and should be pursued with other promising tau-directed therapies. Funding Allon Therapeutics PMID:24873720

  5. Paracetamol as a prophylactic analgesic for hysterosalpingography: A double blind randomized controlled trial

    Energy Technology Data Exchange (ETDEWEB)

    Elson, E.M.; Ridley, N.T.F

    2000-09-01

    AIM: To evaluate the effectiveness of paracetamol as a prophylactic analgesic for hysterosalpingography (HSG). DESIGN: A prospective double blind randomized controlled trial comparing one 1 g of paracetamol (SmithKline Beecham, Brentford, U.K.) to placebo taken 30 min before HSG. One hundred consecutive out-patients were studied prospectively. The analgesic effectiveness during the procedure and at 24 h and 1 week post procedure was analysed by a postal pain score questionnaire. Additional data on the ethnicity of the patient, sex and level of experience of the radiologist performing the hysterosalpingogram, the parity of the patient, the ease of the procedure, and whether pathology was identified were also recorded. RESULTS: Eighty-eight patients (88%) replied, 39 (44%) received paracetamol and 49 placebo (56%). During the procedure 3/39 (7%) of women in the paracetamol group were pain-free compared to 9/49 (18%) in the placebo group, which was not significant (P = 0.11). At 24 h, 15/39 (38%) of women in the paracetamol group were pain-free compared to 20/49 (41%) in the placebo group, which was not significant (P = 0.82). At 1 week, 27/39 (69%) of women in the paracetamol group were pain-free compared to 29/49 (59%) in the placebo group, which was not significant (P = 0.33). No significant difference in mean pain scores was determined during the procedure (P 0.91), or at 24 h post procedure (P = 0.94). Similarly, no difference in mean pain scores was identified with regard to the ethnicity of the patient, the sex of the radiologist performing the procedure, the level of experience of the radiologist performing the procedure, or whether pathology was present or not. Difficult cannulations were associated with higher mean pain scores, however, there was no difference in mean pain scores between the paracetamol or placebo groups for both easy and difficult cannulations. CONCLUSION: Paracetamol is not effective as a prophylactic analgesic for HSG. If a prophylactic

  6. Poor reliability between Cochrane reviewers and blinded external reviewers when applying the Cochrane risk of bias tool in physical therapy trials.

    Science.gov (United States)

    Armijo-Olivo, Susan; Ospina, Maria; da Costa, Bruno R; Egger, Matthias; Saltaji, Humam; Fuentes, Jorge; Ha, Christine; Cummings, Greta G

    2014-01-01

    To test the inter-rater reliability of the RoB tool applied to Physical Therapy (PT) trials by comparing ratings from Cochrane review authors with those of blinded external reviewers. Randomized controlled trials (RCTs) in PT were identified by searching the Cochrane Database of Systematic Reviews for meta-analysis of PT interventions. RoB assessments were conducted independently by 2 reviewers blinded to the RoB ratings reported in the Cochrane reviews. Data on RoB assessments from Cochrane reviews and other characteristics of reviews and trials were extracted. Consensus assessments between the two reviewers were then compared with the RoB ratings from the Cochrane reviews. Agreement between Cochrane and blinded external reviewers was assessed using weighted kappa (κ). In total, 109 trials included in 17 Cochrane reviews were assessed. Inter-rater reliability on the overall RoB assessment between Cochrane review authors and blinded external reviewers was poor (κ  =  0.02, 95%CI: -0.06, 0.06]). Inter-rater reliability on individual domains of the RoB tool was poor (median κ  = 0.19), ranging from κ  =  -0.04 ("Other bias") to κ  =  0.62 ("Sequence generation"). There was also no agreement (κ  =  -0.29, 95%CI: -0.81, 0.35]) in the overall RoB assessment at the meta-analysis level. Risk of bias assessments of RCTs using the RoB tool are not consistent across different research groups. Poor agreement was not only demonstrated at the trial level but also at the meta-analysis level. Results have implications for decision making since different recommendations can be reached depending on the group analyzing the evidence. Improved guidelines to consistently apply the RoB tool and revisions to the tool for different health areas are needed.

  7. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    OpenAIRE

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi; Peñarrocha-Diago, Miguel

    2013-01-01

    Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were establish...

  8. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial.

    Science.gov (United States)

    Henshaw, Helen; Ferguson, Melanie A

    2013-12-05

    One in ten people aged between 55 to 74 years have a significant hearing impairment in their better hearing ear (as defined by audiometric hearing thresholds). However, it is becoming increasingly clear that the challenges faced by older listeners cannot be explained by the audiogram alone. The ability for people with hearing loss to use cognition to support speech perception allows for compensation of the degraded auditory input. This in turn offers promise for new cognitive-based rehabilitative interventions. Working memory is known to be highly associated with language comprehension and recent evidence has shown significant generalization of learning from trained working memory tasks to improvements in sentence-repetition skills of children with severe to profound hearing loss. This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations. This is a double-blind randomized active controlled trial aiming to assess whether a program of working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in adult hearing aid users aged (50 to 74 years) with mild-to-moderate hearing loss hearing aid users, compared with an active control group who receive a placebo version of the working memory training program. The present study aims to generate high-quality preliminary evidence for the efficacy of working memory training for adult hearing aid users with mild-to-moderate sensorineural hearing loss who are existing hearing aid users. This trial addresses a number of gaps in the published literature assessing training interventions for people with hearing loss, and in the general literature surrounding working memory training, such as the inclusion of an active control group, participant and tester blinding, and increased transparency in reporting. ClinicalTrials

  9. Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Koshak, Abdulrahman; Wei, Li; Koshak, Emad; Wali, Siraj; Alamoudi, Omer; Demerdash, Abdulrahman; Qutub, Majdy; Pushparaj, Peter Natesan; Heinrich, Michael

    2017-03-01

    Poor compliance with conventional asthma medications remains a major problem in achieving asthma control. Nigella sativa oil (NSO) is used traditionally for many inflammatory conditions such as asthma. We aimed to investigate the benefits of NSO supplementation on clinical and inflammatory parameters of asthma. NSO capsules 500 mg twice daily for 4 weeks were used as a supplementary treatment in a randomized, double-blind, placebo-controlled trial in asthmatics (clinicaltrials.gov: NCT02407262). The primary outcome was Asthma Control Test score. The secondary outcomes were pulmonary function test, blood eosinophils and total serum Immunoglobulin E. Between 1 June and 30 December 2015, 80 asthmatics were enrolled, with 40 patients in each treatment and placebo groups. After 4 weeks, ten patients had withdrawn from each group. Compared with placebo, NSO group showed a significant improvement in mean Asthma Control Test score 21.1 (standard deviation = 2.6) versus 19.6 (standard deviation = 3.7) (p = 0.044) and a significant reduction in blood eosinophils by -50 (-155 to -1) versus 15 (-60 to 87) cells/μL (p = 0.013). NSO improved forced expiratory volume in 1 second as percentage of predicted value by 4 (-1.25 to 8.75) versus 1 (-2 to 5) but non-significant (p = 0.170). This randomized, double-blind, placebo-controlled trial demonstrated that NSO supplementation improves asthma control with a trend in pulmonary function improvement. This was associated with a remarkable normalization of blood eosinophlia. Future studies should follow asthmatics for longer periods in a multicentre trial. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  10. Preoperative Use of Dexamethasone in Rhinoplasty: A Randomized, Double-blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Valente, Denis S; Steffen, Niveo; Carvalho, Lauro A; Borille, Giuliano B; Zanella, Rafaela K; Padoin, Alexandre V

    2015-01-01

    Postoperative edema and ecchymosis following rhinoplasty are a cause of anxiety for both patients and physicians and can affect the cosmetic results. Corticosteroids have been used to reduce these events. To determine whether preoperative use of dexamethasone sodium phosphate alters the occurrence of edema and ecchymosis following rhinoplasty. Randomized, double-blind, placebo-controlled clinical trial at an institutional referral center among a sample of individuals with rhinomegaly. Patients were randomized into 2 groups. In group 1, dexamethasone was intravenously injected before surgery. In group 2, normal saline solution was intravenously injected before surgery. When patients returned at 1 week after surgery, standardized photographs were obtained. The photographs were analyzed by 5 plastic surgeons who were blinded as to whether dexamethasone or normal saline solution had been injected. The plastic surgeons rated the degree of edema and ecchymosis. Forty-two patients participated in the study. Randomization by lottery resulted in 20 patients in group 1 and 22 patients in group 2. Group 1 showed lower rates of postoperative ecchymosis than group 2; the difference of 0.62 (P = .02) reflects less perceived ecchymosis when dexamethasone was administered. Group 1 also showed lower rates of postoperative edema than group 2; the difference of 0.68 (P = .01) reflects less perceived edema when dexamethasone was administered. Preoperative use of dexamethasone reduced edema and ecchymosis at 7 days after rhinoplasty. Rigorous methods in this trial demonstrate the beneficial effect of preoperative corticosteroid administration in this surgical procedure. 1.

  11. Industry sponsorship and selection of comparators in randomized clinical trials.

    Science.gov (United States)

    Lathyris, D N; Patsopoulos, N A; Salanti, G; Ioannidis, J P A

    2010-02-01

    Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.

  12. Temporary sympathectomy in chronic refractory angina: a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Denby, Christine; Groves, David G; Eleuteri, Antonio; Tsang, Hoo Kee; Leach, Austin; Hammond, Clare; Bridson, John D; Fisher, Michael; Elt, Matthew; Laflin, Robert; Fisher, Anthony C

    2015-08-01

    Temporary sympathectomy by injection of bupivacaine at the site of the left stellate ganglion is used in the management of refractory angina at several UK centres. Although patients frequently report significant reduction in symptoms, efficacy has not been established by double-blind, randomised placebo-controlled trial (RCT). To investigate the efficacy of the procedure for the first time by a double-blind RCT. Consecutive patients referred to the authors' National Health Service (NHS) angina centre who were candidates for temporary sympathectomy were invited to participate in a trial. A total of 65 patients were randomised to receive either bupivacaine or saline injections. Identical syringes were prepared remotely, blinding patients and staff from randomisation. Cardiac autonomic function was measured 3 hours pre- and post-injection using new heart rate variability (HRV) analyses. Angina episodes were recorded contemporaneously by patients in study diaries in the 7-day periods pre- and post-injection. In 51 patients suitable for analysis, no significant differences between the active and placebo groups were found in patient-recorded frequency or intensity of angina episodes pre- and post-injection. However, across both groups combined, a significant difference was found in the frequency of angina episodes pre- and post-injection. The reduction in frequency of angina episodes produced by this procedure may not be due to drug pharmacology. It may be a placebo response or due to the mechanical effects of the injection of fluid. There is a need for further work using a larger patient cohort considering both mechanical and psychological factors.

  13. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial.

    Science.gov (United States)

    Dauvilliers, Yves; Bassetti, Claudio; Lammers, Gert Jan; Arnulf, Isabelle; Mayer, Geert; Rodenbeck, Andrea; Lehert, Philippe; Ding, Claire-Li; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2013-11-01

    Narcolepsy is characterised by excessive daytime sleepiness (EDS) and cataplexy. Histamine neurons are crucial to maintain wakefulness. We assessed the safety and efficacy of pitolisant (previously called BF2.649), a selective histamine H3 receptor inverse agonist that activates these neurons, in patients with narcolepsy. For this double-blind, randomised, parallel-group controlled trial, we recruited patients with narcolepsy from 32 sleep disorder centres in five European countries. Patients were eligible if they were aged 18 years or older, had not taken psychostimulants for at least 14 days, and had EDS (defined as an Epworth Sleepiness Scale [ESS] score of at least 14). Using a computer-generated randomisation sequence, we randomly allocated patients to receive pitolisant, modafinil, or placebo (1:1:1). Treatment lasted 8 weeks: 3 weeks of flexible dosing according to investigator's judgment (10 mg, 20 mg, or 40 mg a day of pitolisant; 100 mg, 200 mg or 400 mg a day of modafinil) followed by 5 weeks of stable dosing. Patients took four tablets a day in a double-dummy design to ensure masking. For the primary analysis, assessed in the intention-to-treat population, we assessed the superiority of pitolisant versus placebo, and the non-inferiority of pitolisant versus modafinil. This trial is registered with ClinicalTrials.gov, number NCT01067222. Between May 26, 2009, and June 30, 2010, we screened 110 patients, 95 of whom were eligible and randomly assigned to treatment: 30 to placebo, 32 to pitolisant, and 33 to modafinil. Over the 8-week treatment period, mean ESS score reductions were -3·4 (SD 4·2) in the placebo group, -5·8 (6·2) in the pitolisant group, and -6·9 (6·2) in the modafinil group. Our primary analysis of between-group differences in mean ESS score at endpoint (adjusted for baseline) showed pitolisant to be superior to placebo (difference -3·0, 95% CI -5·6 to -0·4; p=0·024), but not non-inferior to modafinil (difference 0·12, 95% CI -2

  14. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S - Scandinavian Starch for Severe Sepsis/Septic Shock trial): Study protocol, design and rationale for a double-blinded, randomised clinical trial

    DEFF Research Database (Denmark)

    Perner, Anders; Haase, Nicolai; Wetterslev, Jørn

    2011-01-01

    ABSTRACT: BACKGROUND: By tradition colloid solutions have been used to obtain fast circulatory stabilisation in shock, but high molecular weight hydroxyethyl starch (HES) may cause acute kidney failure in patients with severe sepsis. Now lower molecular weight HES 130/0.4 is the preferred colloid...... in Scandinavian intensive care units (ICUs) and 1st choice fluid for patients with severe sepsis. However, HES 130/0.4 is largely unstudied in patients with severe sepsis. METHODS/DESIGN: The 6S trial will randomise 800 patients with severe sepsis in 30 Scandinavian ICUs to masked fluid resuscitation using either...... of HES 130/0.4 in patients with severe sepsis. The effects on mortality, dialysis-dependency, time on ventilator, bleeding and markers of resuscitation, metabolism, kidney failure, and coagulation will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00962156....

  15. Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation.

    Science.gov (United States)

    Kopp, Matthias Volkmar; Hennemuth, Isabell; Heinzmann, Andrea; Urbanek, Radvan

    2008-04-01

    The value of probiotics for primary prevention is controversial. Published trials vary considerably in study design and the applied probiotics, thereby limiting comparability of the results. The purpose of this trial was to study the preventive effect of the probiotic Lactobacillus GG on the development of atopic dermatitis. In a double-blind, placebo-controlled prospective trial, 105 pregnant women from families with > or = 1 member (mother, father, or child) with an atopic disease were randomly assigned to receive either the probiotic Lactobacillus GG (American Type Culture Collection 53103; 5 x 10(9) colony-forming units of Lactobacillus GG twice daily) or placebo. Ninety-four families (89.5%) completed the trial. The supplementation period started 4 to 6 weeks before expected delivery, followed by a postnatal period of 6 months. The primary end point was the occurrence of atopic dermatitis at the age of 2 years. Secondary outcomes were severity of atopic dermatitis, recurrent episodes of wheezing bronchitis, and allergic sensitization at the age of 2 years. Atopic dermatitis was diagnosed in 14 (28%) of 50 in the Lactobacillus GG group and in 12 (27.3%) of 44 in the placebo group. The risk of atopic dermatitis in children on probiotics relative to placebo was 0.96 (confidence interval 0.38-2.33). Severity of atopic dermatitis was comparable between the 2 groups. Notably, children with recurrent (> or = 5) episodes of wheezing bronchitis were more frequent in the Lactobacillus GG group (26%; n = 13), as compared with the placebo group (9.1%; n = 4). No difference was observed between both groups in total immunoglobulin E concentrations or numbers of specific sensitization to inhalant allergens. Supplementation with Lactobacillus GG during pregnancy and early infancy neither reduced the incidence of atopic dermatitis nor altered the severity of atopic dermatitis in affected children but was associated with an increased rate of recurrent episodes of wheezing

  16. Efficacy of L-arginine for preventing preeclampsia in high-risk pregnancies: A double-blind, randomized, clinical trial.

    Science.gov (United States)

    Camarena Pulido, E E; García Benavides, L; Panduro Barón, J G; Pascoe Gonzalez, S; Madrigal Saray, A J; García Padilla, F E; Totsuka Sutto, S E

    2016-05-01

    This study aimed to estimate the effectiveness of L-arginine for preventing preeclampsia in high-risk pregnancy. We performed a randomized, double-blind, placebo-controlled, clinical trial in patients with high-risk factors for preeclampsia. Fifty subjects received L-arginine, beginning from the 20th week of gestation. An additional 50 patients received homologated placebo. The placebo group had a higher number of cases of preeclampsia (11/47) compared with the L-arginine group (3/49, P = 0.01). Birth weight was higher in the L-arginine group and there was a smaller number of preterm births (P = 0.03). L-arginine is effective for preventing preeclampsia.

  17. Double blind clinical trial of mazindol on weight loss blood glucose, plasma insulin and serum lipids in overweight diabetic patients.

    Science.gov (United States)

    Slama, G; Selmi, A; Hautecouverture, M; Tchobroutsky, G

    1978-09-01

    Mazindol, a drug with tricyclic structure unrelated to amphetamine and other anorectic drugs, has been used as an anorectic agent in a double blind clinical trial at a dose of 2 mg/day for 12 week (mazindol v. s. placebo), associated with a 1000 calorie diet on 46 obese diabetic patients. Thirty seven patients completed the trial with no significant difference between the two groups in the drop-out population; mazindol was well tolerated. In the mazindol-treated group the mean weight loss was 13.5 kg (22.3%) which was significantly greater (p less than 0.001) than in the placebo treated group where the mean weight loss was 4.2 kg (9.8%). Comparing the two groups after the 12 week trial, decrease in fasting blood glucose, serum insulin and triglycerides was not significant. In the mazindol-treated group a significant decrease of serum cholesterol, triglycerides and of the mean area under the curve of insulinemia during the OGTT has been observed. In the placebo treated group only serum triglycerides decreased significantly. The variations of plasma insulin and serum cholesterol were found to be correlated to the magnitude of weight loss. In conclusion mazindol is an effective drug for weight loss on the whole well tolerated but without specific properties on metabolism.

  18. MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

    Science.gov (United States)

    Bivard, Andrew; Lillicrap, Thomas; Krishnamurthy, Venkatesh; Holliday, Elizabeth; Attia, John; Pagram, Heather; Nilsson, Michael; Parsons, Mark; Levi, Christopher R

    2017-05-01

    This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; P modafinil therapy during the study period ( P >0.05). Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527. © 2017 The Authors.

  19. Magnesium sulfate with lidocaine for preventing propofol injection pain: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Galgon, Richard E; Strube, Peter; Heier, Jake; Groth, Jeremy; Wang, Sijian; Schroeder, Kristopher M

    2015-04-01

    Propofol injection pain, despite various strategies, remains common and troublesome. This study aimed to test the hypothesis that pretreatment with the combination of intravenous lidocaine and magnesium would have an additive effect on reducing propofol injection pain. After institutional review board (IRB) approval and informed consent, we performed a prospective, double-blind, placebo-controlled, randomized trial. Subjects were randomly assigned to pretreatment with either lidocaine (50 mg), magnesium sulfate (0.25 mg), lidocaine (50 mg) plus magnesium sulfate (0.25 mg), or 0.9 % sodium chloride. Following pretreatment, propofol (50 mg) was administered, and subjects were questioned regarding injection site pain and observed for behavioral signs of pain. Two hundred subjects were enrolled and 158 subjects (39 placebo, 38 lidocaine, 44 magnesium sulfate, and 37 lidocaine plus magnesium sulfate) received their assigned pretreatment intervention. Intergroup baseline characteristics were similar. The proportion of subjects reporting propofol injection pain was highest in those pretreated with magnesium sulfate (57 %), followed by those pretreated with placebo (46 %), lidocaine plus magnesium sulfate (41 %), and then lidocaine (29 %; p = 0.011). When adjusted for age, gender, diabetes mellitus, chronic pain, tobacco use, and selective-serotonin reuptake inhibitor use, the pain response scale scores were significantly reduced by lidocaine pretreatment compared to magnesium sulfate and placebo (p = 0.031 and p = 0.0003, respectively). In this double-blind, placebo-controlled, randomized trial, the combination of intravenous magnesium sulfate and lidocaine offered no additional benefit for the relief of propofol injection pain compared to intravenous lidocaine alone. An improved, receptor-based understanding of the mechanism of propofol injection pain is still needed.

  20. Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.

    Science.gov (United States)

    Ghanizadeh, Ahmad; Haghighi, Alireza

    2014-10-01

    There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term.

  1. A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity.

    Directory of Open Access Journals (Sweden)

    Fábio Coelho Guarany

    Full Text Available Botulinum toxin type A (btxA is one of the main treatment choices for patients with spasticity. Prosigne® a new released botulinum toxin serotype A may have the same effectiveness as Botox® in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of Prosigne® with Botox® in the treatment of spasticity.We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after Prosigne® or Botox® administration. The main outcomes were changes in the patients' Modified Ashworth Scale (MAS, Functional Independence Measure (FIM and Pediatric Evaluation of Disability Inventory (PEDI scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the Prosigne® and Botox® treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups.Our results suggest that Prosigne® and Botox® are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.ClinicalTrials.gov NCT00819065.

  2. A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

    Science.gov (United States)

    Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

    2006-01-01

    Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

  3. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain.

    Science.gov (United States)

    Hamza, Maged; Doleys, Daniel M; Saleh, Islam A; Medvedovsky, Andrew; Verdolin, Michael H; Hamza, Monalyce

    2015-10-01

    The study aims to compare intrathecal (IT) boluses to continuous infusion trialing techniques prior to implantation of drug delivery systems (DDS) for the treatment of severe intractable chronic nonmalignant pain. This is a prospective, randomized, head-to-head long-term outcome study. Forty patients with comparable patient demographics were randomly assigned to two cohorts. Cohort A trialed with intermittent boluses; Cohort B trialed with continuous infusion. One patient failed trial in each group. Nineteen patients were implanted in each group. Follow-up was for 36 months with intervals at 6, 12, 18, 24, 36 months. The Brief Pain Inventory was used was used for assessment. We used the Brief Pain Inventory to measure pain (worst and average), physical function (walking, normal work, and general activity), behavioral function (mood, sleep, and relations with others), IT dose, and oral opioid use. We observed statistically significant reduction in pain and improvement of function in both cohorts following DDS implantation throughout the observation period. The IT dose remained virtually unchanged throughout as well, with overall limited dose escalation. Oral opioid use was significantly reduced. There was no statistically significant difference in prediction of trial success or long-term outcomes between the two cohorts. Low-dose IT opioids via DDS can provide significant and long-lasting reduction in pain, and improvement in function (physical and behavioral) for patients with chronic nonmalignant pain. The two trialing techniques tested, intermittent boluses, and continuous infusion delivered intrathecally showed no clinical significance difference in terms of predicting trial success or long-term outcomes. © 2015 International Neuromodulation Society.

  4. Symptoms after ingestion of pig whipworm Trichuris suis eggs in a randomized placebo-controlled double-blind clinical trial

    DEFF Research Database (Denmark)

    Bager, Peter; Kapel, Christian Moliin Outzen; Roepstorff, Allan Knud

    2011-01-01

    21 days for 168 days (total 8 doses) in a double-blind clinical trial. In a previous publication, we reported a lack of efficacy and a high prevalence of adverse gastrointestinal reactions. The aim of the present study was to present a detailed description of the adverse event data and post...... reactions lasting up to 14 days, whereas 4 months further treatment mainly provoked a subclinical stimulation. TRIAL REGISTRATION: University hospital Medical Information Network trial registry Reg. no. R000001298, Trial ID UMIN000001070....

  5. Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Legemate Dink A

    2009-07-01

    Full Text Available Abstract Background Intravenous (IV fluid administration is an essential part of postoperative care. Some studies suggest that a restricted post-operative fluid regime reduces complications and postoperative hospital stay after surgery. We investigated the effects of postoperative fluid restriction in surgical patients undergoing major abdominal surgery. Methods In a blinded randomized trial, 62 patients (ASA I-III undergoing elective major abdominal surgical procedures in a university hospital were allocated either to a restricted (1.5 L/24 h or a standard postoperative IV fluid regime (2.5 L/24 h. Primary endpoint was length of postoperative hospital stay (PHS. Secondary endpoints included postoperative complications and time to restore gastric functions. Results After a 1-year inclusion period, an unplanned interim analysis was made because of many protocol violations due to patient deterioration. In the group with the restricted regime we found a significantly increased PHS (12.3 vs. 8.3 days; p = 0.049 and significantly more major complications: 12 in 30 (40% vs. 5 in 32 (16% patients (Absolute Risk Increase: 0.24 [95%CI: 0.03 to 0.46], i.e. a number needed to harm of 4 [95%CI: 2–33]. Therefore, the trial was stopped prematurely. Intention to treat analysis showed no differences in time to restore gastric functions between the groups. Conclusion Restricted postoperative IV fluid management, as performed in this trial, in patients undergoing major abdominal surgery appears harmful as it is accompanied by an increased risk of major postoperative complications and a prolonged postoperative hospital stay. Trial registration Current Controlled Trials ISRCTN16719551

  6. Efficacy of Zinc Sulfate in Peptic Ulcer Disease: A Randomized Double-Blind Clinical Trial Study.

    Science.gov (United States)

    Yazdanpanah, Kambiz; Parhizkar, Baran; Sheikhesmaeili, Farshad; Roshani, Mohammad; Nayebi, Morteza; Gharibi, Fardin

    2016-08-01

    Peptic ulcer is a common disease that affects millions of people worldwide. Considering its global prevalence finding new approach for treating is important. The aim of this study was to investigate the effect of zinc sulfate on gastric and duodenal ulcer treatment. This double-blind clinical trial study was done on 90 patients who were admitted to the gastrointestinal endoscopy clinic of Tohid hospital in Sanandaj, Iran. All patients were diagnosed with gastric and duodenal ulcers. They were randomly divided into two-intervention and control groups, using block randomization with block sizes of 4. Patients and researcher were unaware of the grouping. To assess the level of zinc, blood samples were taken. In case of positive Rapid Urease Test (RUT), triple therapy regimen including amoxicillin, clarithromycin and omeprazole was administered for two weeks. For intervention group in addition to "triple therapy", an oral dose of Zinc Sulfate 220mg capsules were administered daily, while the control group received placebo capsules. A total of 54.5% and 57% of the patients in the intervention and control groups had gastric ulcer respectively. The Rapid Urease Test (RUT) result of 72.7% of intervention group and 83.3% of control group was positive (p = 0.24). Serum zinc level of 20.9% of intervention group and 35.7% of control group was lower than the normal level (p = 0.13). The mean of serum zinc level of intervention group and control group were 81.9 and 78.9 mg dL respectively (p = 0.4). After intervention, peptic ulcer in 81.8% of the intervention group and 83.3% of the control groups were improved (p= 0.85). Response to treatment were higher in patients with normal zinc levels compared to patients with abnormal levels (77.5% vs. 22.5%, p=0.019). A daily dose of 220mg zinc sulfate was not significantly effective on peptic ulcer. However, patients with normal zinc levels had better ulcer treatment.

  7. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Bertanha, Matheus; Jaldin, Rodrigo Gibin; Moura, Regina; Pimenta, Rafael Elias Farres; Mariúba, Jamil Victor de Oliveira; Lúcio Filho, Carlos Eduardo Pinheiro; Alcantara, Giovana Piteri; Padovani, Carlos Roberto; Yoshida, Winston Bonetti; Sobreira, Marcone Lima

    2017-12-01

    Reticular veins are subdermal veins located in the lower limbs and are mainly associated with aesthetic complaints. Although sclerotherapy is the treatment of choice for reticular veins in the lower limbs, no consensus has been reached regarding to the optimal sclerosant. To compare the efficacy and safety of 2 sclerosants used to treat reticular veins: 0.2% polidocanol diluted in 70% hypertonic glucose (HG) (group 1) vs 75% HG alone (group 2). Prospective, randomized, triple-blind, controlled, parallel-group clinical trial with patients randomly assigned in a 1:1 ratio between the 2 treatment groups from March through December 2014, with 2 months' follow-up. The study was conducted in a single academic medical center. Eligible participants were all women, aged 18 to 69 years, who had at least 1 reticular vein with a minimum length of 10 cm in 1 of their lower limbs. The patients underwent sclerotherapy in a single intervention with either 0.2% polidocanol plus 70% HG or 75% HG alone to eliminate reticular veins. The primary efficacy end point was the disappearance of the reticular veins within 60 days after treatment with sclerotherapy. The reticular veins were measured on images obtained before treatment and after treatment using ImageJ software. Safety outcomes were analyzed immediately after treatment and 7 days and 60 days after treatment and included serious adverse events (eg, deep vein thrombosis and systemic complications) and minor adverse events (eg, pigmentation, edema, telangiectatic matting, and hematomas). Ninety-three women completed the study, median (interquartile range) age 43.0 (24.0-61.0) years for group 1 and 41.0 (27.0-62.0) years for group 2. Sclerotherapy with 0.2% polidocanol plus 70% HG was significantly more effective than with 75% HG alone in eliminating reticular veins from the treated area (95.17% vs 85.40%; P vein pigmentation length for group 1 and 7.09% for group 2, with no significant difference between the groups (P = .09

  8. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial

    Directory of Open Access Journals (Sweden)

    Pickering G

    2015-07-01

    Full Text Available Gisèle Pickering,1–3 Adrian Kastler,4 Nicolas Macian,1,2 Bruno Pereira,5 Romain Valabrègue,6 Stéphane Lehericy,6 Louis Boyer,4,7 Claude Dubray,1–3 Betty Jean4 1CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Centre d’Investigation Clinique – Inserm 1405, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU Gabriel Montpied, Clermont-Ferrand, Service d’Imagerie Ostéo-articulaire thoracique et neurologique, 5CHU Clermont-Ferrand, Délégation Recherche Clinique et à l’Innovation, Clermont-Ferrand, France; 6Institut du Cerveau et de la Moelle epiniere – ICM, Centre de NeuroImagerie de Recherche CENIR, Inserm U1127, CNRS UMR 7225, Sorbonne Universités, UPMC University Paris, Paris, France, Department of Neuroradiology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France; 7UMR CNRS UdA 6284, Clemont-Ferrand, France Background: Paracetamol’s (APAP mechanism of action suggests the implication of supraspinal structures but no neuroimaging study has been performed in humans.Methods and results: This randomized, double-blind, crossover, placebo-controlled trial in 17 healthy volunteers (NCT01562704 aimed to evaluate how APAP modulates pain-evoked functional magnetic resonance imaging signals. We used behavioral measures and functional magnetic resonance imaging to investigate the response to experimental thermal stimuli with APAP or placebo administration. Region-of-interest analysis revealed that activity in response to noxious stimulation diminished with APAP compared to placebo in prefrontal cortices, insula, thalami, anterior cingulate cortex, and periaqueductal gray matter.Conclusion: These findings suggest an inhibitory effect of APAP on spinothalamic tracts leading to a decreased activation of higher structures, and a top-down influence on descending inhibition. Further binding and connectivity studies are needed to evaluate how APAP modulates pain, especially in the context of repeated

  9. Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial.

    Science.gov (United States)

    Macian, Nicolas; Pereira, Bruno; Shinjo, Coralie; Dubray, Claude; Pickering, Gisèle

    2015-04-03

    The prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain. Treatment is difficult and includes both drug and non-drug approaches. Milnacipran, an antidepressant, is used for fibromyalgia, with a possible beneficial effect on central pain modulation. Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls. A randomized, double blind, clinical trial (NCT01747044) with two parallel groups, in 48 women with fibromyalgia, is planned in the Clinical Pharmacology Center, University Hospital, Clermont-Ferrand, France. Conditioned pain modulation (estimated with thermal stimuli using a numeric pain rating scale), the primary endpoint measure, is evaluated before and one month after treatment with milnacipran or placebo. Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy, tolerance and cognitive function. Data analysis is performed using mixed models; the tests are two-sided, with a type I error set at alpha = 0.05. Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain. This method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem. ClinicalTrials.gov NCT01747044 .

  10. Hormone Replacement Therapy and Menopause: A Review of Randomized, Double-Blind, Placebo-Controlled Trials

    Directory of Open Access Journals (Sweden)

    Chueh Chang

    2003-06-01

    Full Text Available Hormone replacement therapy (HRT is frequently prescribed to healthy women to ameliorate menopausal symptoms. HRT is used long term (≥ 1 year to prevent chronic disease in older women. The objective of this study was to review the benefits and risks of HRT and studies of menopause or HRT in Taiwan via a MEDLINE search. Recommendations are provided for future HRT research in Taiwan. Randomized, double-blind, placebo-controlled clinical trials are considered the gold standard of scientific evidence. A MEDLINE literature search (January 1966-July 2002 identified 23 papers on trials (≥ 1 year that met the inclusion criteria. The results showed that various HRT regimens used for more than 1 year caused more harm than good in healthy menopausal women and that there was no benefit for women with coronary artery disease, Alzheimer's disease, hysterectomy, hysterosalpingooophorectomy, and ischemic stroke. None of this research was conducted in Taiwan. A MEDLINE search using the key words “estrogen replacement therapy and menopause in Taiwan” identified 16 studies. There was only one, short-term, HRT trial. No evidence suggested benefits from long-term HRT in menopausal women in Taiwan.

  11. A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.

    Science.gov (United States)

    Shearer, James; Darke, Shane; Rodgers, Craig; Slade, Tim; van Beek, Ingrid; Lewis, John; Brady, Donna; McKetin, Rebecca; Mattick, Richard P; Wodak, Alex

    2009-02-01

    To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome. Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post-treatment follow-up. Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22. Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects. Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials.

  12. Can homeopathically prepared mercury cause symptoms in healthy volunteers? A randomized, double-blind placebo-controlled trial.

    Science.gov (United States)

    Vickers, A J; van Haselen, R; Heger, M

    2001-04-01

    To pilot a method for determining whether homeopathically prepared mercury causes more symptoms (a "drug proving") in healthy volunteers than placebo. One hundred and eighteen (118) healthy volunteers ages 18 to 65 were recruited by local advertising. Subjects unfamiliar with homeopathy undertook a 1-week single-blind placebo run-in, a 1-week of double-blind, randomized treatment on either homeopathically prepared mercury 12C or placebo, and a third week of placebo run-out. Each day, symptoms were recorded on a checklist that included both true mercury symptoms and symptoms not expected to be caused by mercury (false symptoms). Additional symptoms were assessed by open reporting. Outcome was assessed by calculating a score for each day as the number of true symptoms minus the number of false symptoms. The mean score during placebo was then subtracted from the mean score for weeks two and three of the trial. Fourteen (14) subjects dropped out during placebo run-in. The remaining 104 completed the trial. Baseline comparability was good. Mean difference score was -0.125 (SD 3.47) for mercury and -0.221 (SD 3.01) for placebo (p > 0.2). No significant differences between groups were found for the number of subjects meeting predefined criteria for a drug-proving reaction. This pilot study failed to find evidence that mercury 12C causes significantly more symptoms in healthy volunteers than placebo. Questionnaires with a limited number of gross symptoms do not seem to be an appropriate methodological technique in drug proving research. If drug-proving phenomena exist, they appear to be rare.

  13. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.

    Science.gov (United States)

    Amsterdam, Jay D; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

    2009-08-01

    We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate generalized anxiety disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Sixty-one outpatients with mild to moderate GAD were enrolled, and 57 were randomized to either double-blind chamomile extract (n = 28) or placebo therapy (n = 29) for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory, Psychological Well Being, and Clinical Global Impression Severity scores and the proportion of patients with 50% reduction or more in baseline HAM-A score. We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (P = 0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or 3 adverse events or more was not significantly different between groups (P = 0.417). This is the first controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations.

  14. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL MATRICARIA RECUTITA (CHAMOMILE) EXTRACT THERAPY OF GENERALIZED ANXIETY DISORDER

    Science.gov (United States)

    Amsterdam, Jay D.; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

    2013-01-01

    Objective We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Materials & Methods 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. Results We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). Conclusion This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations. PMID:19593179

  15. Magnesium Sulfate in Acute Stroke: A Randomized Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    S A Mousavi

    2004-08-01

    Full Text Available Background: Administration of magnesium sulfate has neuroprotective effects and reduces infarct volume in animal models of stroke. Previous small clinical trials have reported beneficial effect of magnesium on the outcome in patients with stroke. This study was a randomized, placebo-controlled, double-blind study , investigated the benefit of magnesium sulfate the administration given intravenously as a neuroprotective. Methods: Patients who had cortical infarction in the middle cerebral artery territory (superior or inferior division with moderate neurologic deficits (Orgogozo scale score greater than 30 and less than 70 and onset less than 24 hours were included. The patients were treated with magnesium sulfate (4gr stat and 1gr/hr or placebo for 4 days and examined by a blind investigator. NIH Stroke Scale was obtained on admission and fifth day after stroke. Results: Eighteen patients were given treatment and nineteen patients were given placebo who demonstrated significant beneficial effects on the difference between NIH Stroke Scales on the day of admission and day 5 (3.16 ± 0.98 vs. 1.84 ± 1.06; p = 0.000 respectively. Conclusion: Intravenous magnesium sulfate had significant beneficial effect on acute phase of stroke patients and, as a result, may reduce duration of admission. Keywords: Stroke, Magnesium sulfate, Neuroprotective.

  16. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial

    DEFF Research Database (Denmark)

    Lassen, Michael Rud; Raskob, Gary E; Gallus, Alexander

    2010-01-01

    BACKGROUND: Low-molecular-weight heparins such as enoxaparin are preferred for prevention of venous thromboembolism after major joint replacement. Apixaban, an orally active factor Xa inhibitor, might be as effective, have lower bleeding risk, and be easier to use than is enoxaparin. We assessed...... efficacy and safety of these drugs after elective total knee replacement. METHODS: In ADVANCE-2, a multicentre, randomised, double-blind phase 3 study, patients undergoing elective unilateral or bilateral total knee replacement were randomly allocated through an interactive central telephone system...... of asymptomatic and symptomatic deep vein thrombosis, non-fatal pulmonary embolism, and all-cause death during treatment. The statistical plan required non-inferiority of apixaban before testing for superiority; analysis was by intention to treat for non-inferiority testing. The study is registered at ClinicalTrials...

  17. Static magnetic therapy does not decrease pain or opioid requirements: a randomized double-blind trial.

    Science.gov (United States)

    Cepeda, M Soledad; Carr, Daniel B; Sarquis, Tony; Miranda, Nelcy; Garcia, Ricardo J; Zarate, Camilo

    2007-02-01

    A growing multibillion dollar industry markets magnetic necklaces, bracelets, bands, insoles, back braces, mattresses, etc., for pain relief, although there is little evidence for their efficacy. We sought to evaluate the effect of magnetic therapy on pain intensity and opioid requirements in patients with postoperative pain. We designed a randomized, double-blind, controlled trial. One-hundred-sixty-five patients older than 12 yr of age were randomized to magnetic (n = 81) or sham therapy (n = 84) upon reporting moderate-to-severe pain in the postanesthesia care unit. Devices were placed over the surgical incision and left in place for 2 h. Patients rated their pain intensity on a 0-10 scale every 10 min and received incremental doses of morphine until pain intensity was Magnetic therapy lacks efficacy in controlling acute postoperative pain intensity levels or opioid requirements and should not be recommended for pain relief in this setting.

  18. Hyperkinesis and diet: a double-blind crossover trial with a tartrazine challenge.

    Science.gov (United States)

    Levy, F; Dumbrell, S; Hobbes, G; Ryan, M; Wilton, N; Woodhill, J M

    1978-01-28

    A pilot study was conducted on 22 children (19 boys and three girls) aged between four and eight years, who were selected as hyperactive on the basis of developmental history and clinical judgement. Conners' parent-teacher ratings, objective tests of attention, standard perceptualmotor tests and subtests from the Wechsler Intelligence Scale for Children (WISC), were used as response variables. The children were tested before and after four weeks on the elimination diet, after a tartrazine and placebo challenge, and, finally, after a four-week washout period on the diet. Results showed a statistically significant improvement in the mothers' ratings of the children's behaviour after the first four weeks of the diet. The improvement was maintained in a combined analysis of the initial four-week diet period and four-week washout period. This result was not substantiated by the statistical analysis of the results from objective tests. The rating scales and objective tests for the full sample did not show a statistically significant deterioration in the children's behaviour when they were challenged under double-blind test conditions with the Yellow Dye No. 5, tartrazine, and the tests were conducted the day after a two-week challenge period. A comparison of mother ratings of behaviour during challenge and placebo double-blind trial and in the 24 hours preceding tests, in a subgroup of the children who, while on the diet, showed a 25% reduction of symptoms on the Conner's rating scale, indicated a significant challenge effect (P less than 0.025), with mothers reporting more symptoms during the challenge period. Dietary infringements with suspected trigger substances occurred throughout the trial.

  19. Salivary Streptococcus mutans and Lactobacilli levels following probiotic cheese consumption in adults: A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Shiva Mortazavi

    2012-01-01

    Full Text Available Background: The beneficial effects of Lactobacillus species have been reported but the role of these species including Lactobacillus casei (L. casei on oral health is not well documented. The purpose of this study was to evaluate the ef-fects of conventional or probiotic cheese containing L.casei on salivary Streptococcus mutans (SM and Lactobacilli levels. Methods: In this double-blind controlled trial (IRCT201009144745N1, 60 adults were randomly allocated in 2 paral-lel blocks. SM and Lactobacilli count assessment were performed three times. Subjects consumed either cheese contain-ing L. casei (110[6] Cfu /g (probiotic block, n=29 or cheese without any probiotic (control block, n=31 twice daily for two weeks. Bacterial levels changes were compared using Wilcoxon and Mann-Whitney Tests. Logistic regression compared changes in number of subjects with lowest and highest SM or Lactobacilli levels. Results: Statistically significant (p = 0.001 reduction of salivary SM was found in probiotic group. SM levels reduc-tion was not significant between placebo and trial groups (p = 0.46, 62% in probiotic vs. 32% in placebo group. Lacto-bacilli count changes during trial were not statistically significant inter and intra blocks (p = 0.12. Probiotic interven-tion was significantly effective in high levels (> 10[5] cfu/ml of SM (Odds Ratio 11.6, 95% CI 1.56-86.17, p = 0.017. Conclusions: Probiotic cheese containing L. casei was not effective in salivary SM levels reduction comparing to conventional cheese. Adding L. casei to cheese could be useful in decreasing SM counts in adults 18-37 years old with highest level of SM.

  20. Efficacy of sodium butyrate adjunct therapy in shigellosis: a randomized, double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    2012-01-01

    Background Treatment of shigellosis in rabbits with butyrate reduces clinical severity and counteracts the downregulation of cathelicidin (CAP-18) in the large intestinal epithelia. Here, we aimed to evaluate whether butyrate can be used as an adjunct to antibiotics in the treatment of shigellosis in patients. Methods A randomized, double-blind, placebo-controlled, parallel-group designed clinical trial was conducted. Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40). The Intervention group was given an enema containing sodium butyrate (80 mM), twice daily for 3 days, while the Placebo group received the same dose of normal saline. The primary endpoint of the trial was to assess the efficacy of butyrate in improving clinical, endoscopic and histological features of shigellosis. The secondary endpoint was to study the effect of butyrate on the induction of antimicrobial peptides in the rectum. Clinical outcomes were assessed and concentrations of antimicrobial peptides (LL-37, human beta defensin1 [HBD-1] and human beta defensin 3 [HBD-3]) and pro-inflammatory cytokines (interleukin-1β [IL-1β] and interleukin-8 [IL-8]) were measured in the stool. Sigmoidoscopic and histopathological analyses, and immunostaining of LL-37 in the rectal mucosa were performed in a subgroup of patients. Results Compared with placebo, butyrate therapy led to the early reduction of macrophages, pus cells, IL-8 and IL-1β in the stool and improvement in rectal histopathology. Butyrate treatment induced LL-37 expression in the rectal epithelia. Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7. Conclusion Adjunct therapy with butyrate during shigellosis led to early reduction of inflammation and enhanced LL-37 expression in the rectal epithelia with prolonged release of LL-37 in the stool. Trial Registration ClinicalTrials

  1. Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

    Directory of Open Access Journals (Sweden)

    Krips Rover

    2009-07-01

    Full Text Available Abstract Background Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design A prospective, double-blind, randomized, placebo-controlled trial (RCT will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a the percentage of patients that resume and maintain sports, and (b the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society – Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D, and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration Netherlands Trial Register (NTR1636

  2. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Eric Verspyck

    Full Text Available To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding.PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54 or placebo (n = 55 until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis. Analysis was by intention to treat.Mean (SD prolongation of pregnancy was not different between the nifedipine (n = 54 and the placebo (n = 55 group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05-2.72. Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10-2.61. No maternal mortality or perinatal death occurred.Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes.ClinicalTrials.gov NCT00620724.

  3. a randomised trial comparing Foley catheter plus titrated oral ...

    African Journals Online (AJOL)

    Labour induction at term - a randomised trial comparing. Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. Baron B Matonhodze, G Justus Hofmeyr, Jonathan Levin. Objectives. To compare three methods of labour induction. Design. Randomised controlled trial.

  4. Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Gnant, Michael; Pfeiler, Georg; Dubsky, Peter C; Hubalek, Michael; Greil, Richard; Jakesz, Raimund; Wette, Viktor; Balic, Marija; Haslbauer, Ferdinand; Melbinger, Elisabeth; Bjelic-Radisic, Vesna; Artner-Matuschek, Silvia; Fitzal, Florian; Marth, Christian; Sevelda, Paul; Mlineritsch, Brigitte; Steger, Günther G; Manfreda, Diether; Exner, Ruth; Egle, Daniel; Bergh, Jonas; Kainberger, Franz; Talbot, Susan; Warner, Douglas; Fesl, Christian; Singer, Christian F

    2015-08-01

    Adjuvant endocrine therapy compromises bone health in patients with breast cancer, causing osteopenia, osteoporosis, and fractures. Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects. In this trial, we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal, aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer. In this prospective, double-blind, placebo-controlled, phase 3 trial, postmenopausal patients with early hormone receptor-positive breast cancer receiving treatment with aromatase inhibitors were randomly assigned in a 1:1 ratio to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months in 58 trial centres in Austria and Sweden. Patients were assigned by an interactive voice response system. The randomisation schedule used a randomly permuted block design with block sizes 2 and 4, stratified by type of hospital regarding Hologic device for DXA scans, previous aromatase inhibitor use, and baseline bone mineral density. Patients, treating physicians, investigators, data managers, and all study personnel were masked to treatment allocation. The primary endpoint was time from randomisation to first clinical fracture, analysed by intention to treat. As an additional sensitivity analysis, we also analysed the primary endpoint on the per-protocol population. Patients were treated until the prespecified number of 247 first clinical fractures was reached. This trial is ongoing (patients are in follow-up) and is registered with the European Clinical Trials Database, number 2005-005275-15, and with ClinicalTrials.gov, number NCT00556374. Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled into the trial, of whom 3420 were randomly assigned to receive denosumab 60 mg (n=1711) or placebo (n=1709) subcutaneously every 6 months. Compared with the placebo group, patients in the denosumab group had a

  5. Identification of sensitive and specific Avian influenza PCR methods through blind ring trials organized in the European Union

    NARCIS (Netherlands)

    Slomka, M.J.; Coward, V.J.; Banks, J.; Löndt, B.Z.; Brown, I.H.; Voermans, J.J.M.; Koch, G.; Handberg, K.J.; Jörgensen, P.H.; Cherbonnel-Pansart, M.; Jestin, V.; Cattoli, G.; Capua, I.; Ejdersund, A.; Thoren, P.; Czifra, G.

    2007-01-01

    Many different polymerase chain reaction (PCR) protocols have been used for detection and characterization of avian influenza (AI) virus isolates, mainly in research settings. Blind ring trials were conducted to determine the most sensitive and specific AI PCR protocols from a group of six European

  6. Lactotripeptides Show No Effect on Human Blood Pressure: Results from a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Engberink, M.F.; Schouten, E.G.; Kok, F.J.; Mierlo, van L.A.J.; Brouwer, I.A.; Geleijnse, J.M.

    2008-01-01

    Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and

  7. Cranberries vs antibiotics to prevent urinary tract infections: a randomized double-blind noninferiority trial in premenopausal women

    NARCIS (Netherlands)

    Beerepoot, Mariëlle A. J.; ter Riet, Gerben; Nys, Sita; van der Wal, Willem M.; de Borgie, Corianne A. J. M.; de Reijke, Theo M.; Prins, Jan M.; Koeijers, Jeanne; Verbon, Annelies; Stobberingh, Ellen; Geerlings, Suzanne E.

    2011-01-01

    The increasing prevalence of uropathogens resistant to antimicrobial agents has stimulated interest in cranberries to prevent recurrent urinary tract infections (UTIs). In a double-blind, double-dummy noninferiority trial, 221 premenopausal women with recurrent UTIs were randomized to 12-month

  8. Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlled trial

    NARCIS (Netherlands)

    Desmyter, J.; Colaert, J.; de Groote, G.; Reynders, M.; Reerink-Brongers, E. E.; Lelie, P. N.; Dees, P. J.; Reesink, H. W.

    1983-01-01

    The efficacy of a heat-inactivated hepatitis B vaccine, 3 micrograms of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in

  9. Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial

    NARCIS (Netherlands)

    Esan, Michael O.; van Hensbroek, Michael Boele; Nkhoma, Ernest; Musicha, Crispin; White, Sarah A.; ter Kuile, Feiko O.; Phiri, Kamija S.

    2013-01-01

    It is unknown whether iron supplementation in human immunodeficiency virus (HIV)-infected children living in regions with high infection pressure is safe or beneficial. A 2-arm, double-blind, randomized, controlled trial was conducted to examine the effects of iron supplementation on hemoglobin, HIV

  10. Lactotripeptides show no effect on human blood pressure : Results from a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Engberink, Mariëlle F; Schouten, Evert G.; Kok, Frans J; Van Mierlo, Linda A J; Brouwer, Ingeborg A.; Geleijnse, Johanna M

    Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and

  11. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C.M.; Raghoebar, Gerry M; Huddleston Slater, James J R; Meijer, Hendrikus; Winkel, Edwin G; van Winkelhoff, Arie Jan

    AIM: The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. MATERIAL & METHODS: Thirty patients (79 implants) with

  12. Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children : randomized double-blind controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Smulders, Sara; Hoes, Arno W; Hak, Eelko

    In a randomized double-blind controlled trial, the safety was assessed of simultaneous administration of influenza and pneumococcal conjugate vaccines in children with previous physician-diagnosed respiratory tract infections. In total, 579 children aged 18-72 months were assigned to receive

  13. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment : a randomized, double-blind, controlled trial

    NARCIS (Netherlands)

    de Waal, Y. C. M.; Raghoebar, G. M.; Meijer, H. J. A.; Winkel, E. G.; van Winkelhoff, A. J.

    ObjectiveThe objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine+0.05% cetylpyridinium chloride (CPC)

  14. Memantine for prophylaxis of chronic tension-type headache--a double-blind, randomized, crossover clinical trial

    DEFF Research Database (Denmark)

    Lindelof, K; Bendtsen, L; Lindelof, K

    2009-01-01

    Treatment for chronic tension-type headache (CTTH) is unsatisfactory. Our aim was to investigate the efficacy of the N-methyl D-aspartate (NMDA) antagonist memantine in the prophylactic treatment of CTTH. We included 40 patients in a randomized, double-blind, placebo-controlled, crossover trial...

  15. A Randomized, Double-Blind, Placebo-Controlled Trial of Niacinamide for Reduction of Phosphorus in Hemodialysis Patients

    OpenAIRE

    Cheng, Steven C.; Young, Daniel O.; Huang, Yihung; Delmez, James A.; Coyne, Daniel W.

    2008-01-01

    Background and objectives: Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies. A prospective, randomized, double-blind, placebo-controlled crossover trial was performed for assessment of the safety and efficacy of niacinamide.

  16. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...

  17. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  18. Treatment of dysferlinopathy with deflazacort: a double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    2013-01-01

    Background Dysferlinopathies are autosomal recessive disorders caused by mutations in the dysferlin (DYSF) gene encoding the dysferlin protein. DYSF mutations lead to a wide range of muscular phenotypes, with the most prominent being Miyoshi myopathy (MM) and limb girdle muscular dystrophy type 2B (LGMD2B). Methods We assessed the one-year-natural course of dysferlinopathy, and the safety and efficacy of deflazacort treatment in a double-blind, placebo-controlled cross-over trial. After one year of natural course without intervention, 25 patients with genetically defined dysferlinopathy were randomized to receive deflazacort and placebo for six months each (1 mg/kg/day in month one, 1 mg/kg every 2nd day during months two to six) in one of two treatment sequences. Results During one year of natural course, muscle strength declined about 2% as measured by CIDD (Clinical Investigation of Duchenne Dystrophy) score, and 76 Newton as measured by hand-held dynamometry. Deflazacort did not improve muscle strength. In contrast, there is a trend of worsening muscle strength under deflazacort treatment, which recovers after discontinuation of the study drug. During deflazacort treatment, patients showed a broad spectrum of steroid side effects. Conclusion Deflazacort is not an effective therapy for dysferlinopathies, and off-label use is not warranted. This is an important finding, since steroid treatment should not be administered in patients with dysferlinopathy, who may be often misdiagnosed as polymyositis. Trial registration This clinical trial was registered at http://www.ClincalTrials.gov, identifier: NCT00527228, and was always freely accessible to the public. PMID:23406536

  19. Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Wejse, Christian; Gomes, Victor F; Rabna, Paulo; Gustafson, Per; Aaby, Peter; Lisse, Ida M; Andersen, Paul L; Glerup, Henning; Sodemann, Morten

    2009-05-01

    Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).

  20. Botulinum toxin versus trihexyphenidyl in cervical dystoni - A prospective, randomized, double-blind controlled trial

    NARCIS (Netherlands)

    Brans, JWM; Lindeboom, R; Snoek, JW; Zwarts, MJ; vanWeerden, TW; Brunt, ERP; vanHilten, JJ; vanderKamp, W; Prins, MH; Speelman, J.D.

    Background: Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. Methods: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective,

  1. Rasagiline improves polysomnographic sleep parameters in patients with Parkinson's disease: a double-blind, baseline-controlled trial.

    Science.gov (United States)

    Schrempf, W; Fauser, M; Wienecke, M; Brown, S; Maaß, A; Ossig, C; Otto, K; Brandt, M D; Löhle, M; Schwanebeck, U; Graehlert, X; Reichmann, H; Storch, A

    2018-01-11

    The aim was to study the effects of rasagiline on sleep quality in patients with Parkinson's disease (PD) with sleep disturbances. Sleep disorders are common in PD. Rasagiline is widely used in patients with PD, but double-blind polysomnographic trials on its effects on sleep disturbances are missing. This was a single-center, double-blind, baseline-controlled investigator-initiated clinical trial of rasagiline (1 mg/day) over 8 weeks in patients with PD with sleep disturbances. Blinding was achieved by running a strategic matched placebo parallel group. Co-primary outcome measures were the changes between baseline and end of the treatment period in sleep maintenance/efficiency as assessed by polysomnography and the Parkinson's Disease Sleep Scale Version 2 (PDSS-2) score. A total of 20 of 30 patients were randomized to rasagiline (mean ± SD age, 69.9 ± 6.9 years; 10 male; Hoehn-Yahr stage, 1.9 ± 0.8). Compared with baseline, sleep maintenance was significantly increased at the end of the treatment period (relative change normalized to baseline, +16.3 ± 27.9%; P = 0.024, paired two-sided t-test) and a positive trend for sleep efficiency was detected (+12.1 ± 28.6%; P = 0.097). Treatment with rasagiline led to significantly decreased wake time after sleep onset, number of arousals, percentage of light sleep and improved daytime sleepiness as measured by the Epworth Sleepiness Scale. We did not observe changes in the co-primary endpoint PDSS-2 score, and no correlations of polysomnographic sleep parameters or PDSS-2 score with motor function (Unified Parkinson's Disease Rating Scale motor score). Rasagiline was well tolerated with no unexpected adverse events. In patients with PD with sleep disturbances, rasagiline showed beneficial effects on sleep quality as measured by polysomnography. These effects were probably not related to motor improvement or translated into improved overall sleep quality perception by patients. © 2018 EAN.

  2. The effect of low-level laser therapy on orthodontically induced root resorption: a pilot double blind randomized controlled trial.

    Science.gov (United States)

    Ng, Doreen; Chan, Ambrose K; Papadopoulou, Alexandra K; Dalci, Oyku; Petocz, Peter; Darendeliler, Mehmet Ali

    2017-09-07

    The effect of low-level laser therapy (LLLT) on accelerating orthodontic tooth movement has been extensively studied; however, there is limited knowledge on the use of LLLT on orthodontic root resorption. To investigate the effect of LLLT on orthodontically induced inflammatory root resorption (OIIRR) and to compare the difference between pulsed and continuous LLLT on OIIRR. Double-blind, single-centre 3-arm parallel split-mouth randomized controlled trial. Twenty adolescent patients who required bilateral maxillary first premolar (MFP) orthodontic extractions were recruited from the Sydney Dental Hospital between October 2014 and December 2014. All MFPs were tipped buccally for 28 days to induce OIIRR. The experimental premolars (n = 20) received LLLT and the control premolars (n = 20) received placebo-laser on days 0, 1, 2, 3, 7, 14, and 21. Ten experimental premolars received LLLT via continuous delivery and 10 received pulsed delivery. AlGaAs diode laser of 808 nm wavelength, 0.18 W power, 1.6 J per point, and duration of 9s for continuous mode and 4.5 s for pulsed mode. The difference in root resorption crater volume between LLLT and placebo-laser and continuous or pulsed laser delivery after 28 days. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered sealed envelopes. The participants and operator were blinded. Eighty-eight patients were screened and 20 patients were randomized. Forty premolars were analysed. LLLT resulted in 23 per cent less root resorption compared to the placebo (P = 0.026). Pulsed laser delivery resulted in 5 per cent less root resorption than continuous; however, this was not statistically significant (P = 0.823). No harm was observed. Teeth treated with LLLT had less total root resorption than placebo-laser. Furthermore, there was minimal difference between pulsed or continuous delivery of LLLT. Clinical Trials Registry (ACTRN12616000829415). The protocol was not published before trial

  3. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial

    Science.gov (United States)

    Montserrat-Bosch, Marta; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-01-01

    Objectives: To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). Study Design: A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. Results: A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Conclusions: Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries. Key words:Dental anesthesia, inferior alveolar nerve block, lidocaine, third molar, intravascular injection. PMID:24608204

  4. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

    Science.gov (United States)

    Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

    2016-09-01

    Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

  5. Palmitoylethanolamide as adjunctive therapy in major depressive disorder: A double-blind, randomized and placebo-controlled trial.

    Science.gov (United States)

    Ghazizadeh-Hashemi, Maryam; Ghajar, Alireza; Shalbafan, Mohammad-Reza; Ghazizadeh-Hashemi, Fatemeh; Afarideh, Mohsen; Malekpour, Farzaneh; Ghaleiha, Ali; Ardebili, Mehrdad Eftekhar; Akhondzadeh, Shahin

    2018-05-01

    Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models of depression. We aimed to evaluate the efficacy and tolerability of PEA add-on therapy in treatment of patients with major depressive disorder (MDD). In a randomized double-blind, and placebo-controlled study, 58 patients with MDD (DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 600 mg twice daily Palmitoylethanolamide or placebo in addition to citalopram for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6. Fifty-four individuals completed the trial. At week 2, patients in the PEA group demonstrated significantly greater reduction in HAM-D scores compared to the placebo group (8.30 ± 2.41 vs. 5.81 ± 3.57, P = .004). The PEA group also demonstrated significantly greater improvement in depressive symptoms [F (3, 156) = 3.35, P = .021] compared to the placebo group throughout the trial period. The patients in the PEA group experienced more response rate (≥ 50% reduction in the HAM-D score) than the placebo group (100% vs. 74% respectively, P = .01) at the end of the trial. Baseline parameters and frequency of side effects were not significantly different between the two groups. The population size in this study was small and the follow-up period was relatively short. Palmitoylethanolamide adjunctive therapy to citalopram can effectively improve symptoms of patients (predominantly male gender) with major depressive disorder. PEA showed rapid-onset antidepressant effects which need further investigation. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Hauser, Goran; Salkic, Nermin; Vukelic, Karina; JajacKnez, Alenka; Stimac, Davor

    2015-05-01

    The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.

  7. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

    Science.gov (United States)

    Smith, Stephen Ridley; Draganic, Brian; Pockney, Peter; Holz, Phillip; Holmes, Ryan; Mcmanus, Brendan; Carroll, Rosemary

    2015-09-01

    Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

  8. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

    Science.gov (United States)

    Fatheree, Nicole Y; Liu, Yuying; Taylor, Christopher M; Hoang, Thomas K; Cai, Chunyan; Rahbar, Mohammad H; Hessabi, Manouchehr; Ferris, Michael; McMurtry, Valarie; Wong, Christine; Vu, Ta; Dancsak, Theresa; Wang, Ting; Gleason, Wallace; Bandla, Vinay; Navarro, Fernando; Tran, Dat Q; Rhoads, J Marc

    2017-12-01

    To assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables. We performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 10 8 colony-forming units daily) or placebo for 42 days and followed for 134 days. Of 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (L reuteri strain DSM 17938 produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms. Daily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks. ClinicalTrials.gov: NCT01849991. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

    Directory of Open Access Journals (Sweden)

    Amy S Chappell

    2008-12-01

    Full Text Available Amy S Chappell1, Laurence A Bradley2, Curtis Wiltse1, Michael J Detke1,3,4, Deborah N D’Souza1, Michael Spaeth51Lilly Research Laboratories, Indianapolis, IN, USA; 2University of Alabama at Birmingham, Birmingham, Alabama, USA; 3Indiana University School of Medicine, Indianapolis, IN, USA; 4Harvard Medical School, Boston, MA, USA; 5Practice for Internal Medicine/Rheumatology, Graefelfing, GermanyObjective: Assess the efficacy of duloxetine 60/120 mg (N = 162 once daily compared with placebo (N = 168 in the treatment of patients with fibromyalgia, during six months of treatment.Methods: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine.Results: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI average pain severity from baseline to endpoint (P = 0.053 and the Patient’s Global Impressions of Improvement (PGI-I at endpoint (P = 0.073. Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups.Conclusions: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures.Keywords: fibromyalgia, duloxetine, placebo, double-blind, trial

  10. Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography: A multicenter, randomized, double-blind phase 3 trial

    Energy Technology Data Exchange (ETDEWEB)

    Park, Eun Ah; Lee, Whal [Dept. of Radiology, Seoul National University Hospital, Seoul (Korea, Republic of); Kang, Doo Kyoung [Dept. of Radiology, Ajou University School of Medicine, Suwon (Korea, Republic of); and others

    2016-06-15

    This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated. A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups: 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta: 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05). Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine.

  11. Three double-blind, randomized trials evaluating the safety and tolerance of different formulations of the saponin adjuvant QS-21.

    Science.gov (United States)

    Waite, D C; Jacobson, E W; Ennis, F A; Edelman, R; White, B; Kammer, R; Anderson, C; Kensil, C R

    2001-07-16

    The effects of the adjuvant QS-21 in various formulations on immediate pain on injection after intramuscular injection were evaluated in three Phase I clinical trials in healthy adults. Each trial was designed as a double-blind, randomized, four-way or five-way cross-over study with each subject acting as his/her own control. In the first trial, four formulations designed to evaluate the effect of QS-21 or pH (over a range of 6--7.2) were evaluated: phosphate-buffered saline at pH 6.0 or 7.2, and 50 microg of QS-21 in phosphate-buffered saline at pH 6.0 or 7.2. Thirty-three volunteers received each of the four intramuscular injections in random order separated by approximately 1 week. The volunteers assessed the immediate injection pain from 0 to 10 (none to most pain). The data indicate that the presence of QS-21, but not pH, is associated with transient injection site pain. The second trial, which utilized the same design as the first trial, evaluated formulations of QS-21 in various excipients. Fifteen volunteers received phosphate-buffered saline, QS-21/PBS, QS-21/aluminum hydroxide, and QS-21/4 mg/ml of polysorbate 80. Polysorbate 80, but not aluminum hydroxide, reduced the mean pain score compared to QS-21/PBS. The third trial evaluated formulations of QS-21 in additional excipients. Fifteen volunteers received aluminum hydroxide (without QS-21), QS-21/PBS, QS-21/0.72% benzyl alcohol, QS-21/30 mg/ml of hydroxypropyl-beta-cyclodextrin, and QS-21/8-mg/ml of polysorbate 80. Benzyl alcohol, cyclodextrin, and the higher concentration of polysorbate 80 reduced the pain scores associated with QS-21. Hence, QS-21 is associated with injection pain in simple buffer formulations, but it is possible to improve the acceptability of QS-21-containing formulations through reformulation with certain excipients.

  12. A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    2008-04-01

    Full Text Available BACKGROUND: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. METHODS AND FINDINGS: DESIGN: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. SETTING: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. PARTICIPANTS: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. INTERVENTIONS: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. OUTCOME MEASURES: Primary outcome was total Severe Impairment Battery (SIB score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI. RESULTS: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment, of whom 128 (78% commenced treatment (64 continue/64 placebo. Of those, 26 were lost to follow-up (13 per arm, resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo -0.4 (95% confidence interval [CI] -6.4 to 5.5, adjusted for baseline value (p = 0.9. For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment -2.4 (95% CI -8.2 to 3.5, adjusted for

  13. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.

    Science.gov (United States)

    Poulsen, Mai Bang; Damgaard, Bodil; Zerahn, Bo; Overgaard, Karsten; Rasmussen, Rune Skovgaard

    2015-12-01

    Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug modafinil. The trial was randomized, double-blinded, and placebo-controlled. Patients were treated with 400-mg modafinil or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the Stroke-specific quality of Life questionnaire. Adult patients with a recent stroke achieving a score of ≥12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe cognitive disabilities and contraindications for modafinil treatment. One thousand one hundred twenty-one patients with stroke were screened and 41 patients included, 21 received modafinil. The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. Patients in the modafinil group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the stroke-specific quality of life questionnaire (0.001trials. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800097. © 2015 American Heart Association, Inc.

  14. Randomized, double-blind, placebo-controlled trial of herbal therapy for children with asthma.

    Science.gov (United States)

    Wong, Eliza L Y; Sung, Rita Yn Tz; Leung, Ting Fan; Wong, Yeuk Oi; Li, Albert M C; Cheung, Kam Lau; Wong, Chun Kwok; Fok, Tai Fai; Leung, Ping Chung

    2009-10-01

    The purpose of this trial was to evaluate whether the herbal formula of CUF2 used as complementary therapy improves the clinical symptoms and biochemical markers in children with asthma using inhaled corticosteroids. In a double-blind, placebo-controlled prospective trial, 85 children with asthma aged 7-15 years were randomly assigned to receive either a daily oral herbal formula of 0.619-g CUF2 capsule of dried aqueous extract with an equal weight of five herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix stemonae, Bulbus fritillariae cirrhosae, and Radix scutellariae) or placebo for 6 months. The primary endpoint was the change in steroids dosage; the secondary outcomes included the disease severity score, lung function test, and biochemical markers in blood. Eighty-five (85) children (42 on active treatment and 43 on placebo) completed the 6-month clinical trial. Children randomized to the herbal formula of CUF2 and the placebo showed a similar improvement in clinical symptoms and biomedical markers. The comparison between the CUF2 group and the placebo group showed no significant difference on the dosage of steroids (-2.3 versus -3.1 mg, p = 0.915), disease severity score (-2.3 versus -3.1, p = 0.215), and lung function test of forced expiratory volume in 1 second/forced vital capacity percent (0.1 versus 0.6%, p = 0.809) and peak expiratory flow rate (-7.3 versus -0.6 l/minutes, p = 0.118). No significant difference was found between the two study groups in the biochemical outcomes measured. The intervention effect of CUF2 was smaller than the placebo effect. This study provides no evidence to support the use of the herbal formula of CUF2 in children with asthma. Parents are thus advised to discuss with health professionals before choosing an herbal formula in preference to conventional treatment modes.

  15. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery.

    Directory of Open Access Journals (Sweden)

    Dan Bagger-Sjöbäck

    Full Text Available Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies.We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight or matching placebo (1:1 ratio, starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo.One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model. Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting.N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy.ClinicalTrials.gov NCT00525551.

  16. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits. Copyright © 2016, American Association for the Advancement of Science.

  17. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Higurashi Takuma

    2012-03-01

    Full Text Available Abstract Background Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF. ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. Discussion This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with

  18. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    Chris Fox

    Full Text Available Agitation in Alzheimer's disease (AD is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI. Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI, Clinical Global Impression Change (CGI-C, Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p = 0.26; or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p = 0.012 and 12 (-9.6; -15.0 to -4.3 p = 0.0005. Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.ClinicalTrials.gov NCT00371059.International Standard Randomised Controlled Trial 24953404.

  19. Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial.

    Science.gov (United States)

    Marques, Duarte Nuno da Silva; da Mata, António Duarte Sola Pereira; Silveira, João Miguel Lourenço; Marques, Joana Rita Oliveira Faria; Amaral, João Pedro de Almeida Rato; Guilherme, Nuno Filipe Rito Parada Marques

    2012-02-01

    The objective of this study is to compare salivary hydrogen peroxide (HP) release kinetics and potential toxicity of systemic exposure of four different whitening products. A double-blind, randomized controlled trial was conducted in a Portuguese dental faculty clinic. Two hundred forty volunteers were randomized to eight intervention groups. Participants were randomly assigned to receive active or placebo applications of one of four different products: Opalescence 10% PF™ (OPL), Vivastyle® 10%™ (VS10%), Vivadent Paint On Plus™ (PO+), and Trés White Supreme™ (TWS). Saliva collection was obtained by established methods at different times. The HP salivary content was determined by a photometric method. Salivary HP variations, total amount of salivary HP, and counts of subjects above the safe daily HP dose were the main outcome measures. All whitening systems significantly released HP to the saliva when compared to placebo, and all showed different release kinetics. The adaptable tray system (TWS) presented a risk increase of 37% [20-54%, 95% confidence interval] when compared to the other systems. The use of an adaptable tray whitening system with higher concentration of HP increases the toxicity potential.

  20. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  1. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial.

    Science.gov (United States)

    Agyapong, Vincent I O; Ahern, Sinead; McLoughlin, Declan M; Farren, Conor K

    2012-12-10

    Mobile phone text message technology has the potential to improve outcomes for patients with depression and co-morbid Alcohol Use Disorder (AUD). To perform a randomised rater-blinded trial to explore the effects of supportive text messages on mood and abstinence outcomes for patients with depression and co-morbid AUD. Participants (n=54) with a DSM IV diagnosis of unipolar depression and AUD who completed an in-patient dual diagnosis treatment programme were randomised to receive twice daily supportive text messages (n=26) or a fortnightly thank you text message (n=28) for three months. Primary outcome measures were Beck's Depression Inventory (BDI-II) scores and Cumulative Abstinence Duration (CAD) in days at three months. NCT0137868. There was a statistically significant difference in three month BDI-II scores between the intervention and control groups; 8.5 (SD=8.0) vs. 16.7 (SD=10.3) respectively after adjusting for the baseline scores, F (1, 49)=9.54, p=0.003, η(p)(2)=0.17. The mean difference in change BDI-II scores was -7.9 (95% CI -13.06 to -2.76, Cohen'sd=0.85). There was a trend for a greater CAD in the text message group than the control group: 88.3 (SD=6.2) vs. 79.3 (SD=24.1), t=1.78, df=48, p=0.08. Limitations of the study include the small sample size, the potential for loss of rater blinding and the lack of long term follow-up to determine the longer term effects of the intervention. Supportive text messages have the potential to improve outcomes for patients with comorbid depression and alcohol dependency syndrome. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Risk factor management in survivors of stroke: a double-blind, cluster-randomized, controlled trial.

    Science.gov (United States)

    Thrift, Amanda G; Srikanth, Velandai K; Nelson, Mark R; Kim, Joosup; Fitzgerald, Sharyn M; Gerraty, Richard P; Bladin, Christopher F; Phan, Thanh G; Cadilhac, Dominique A

    2014-07-01

    Comprehensive community care has the potential to improve risk factor management of patients with stroke or transient ischaemic attack. The primary aim is to determine the effectiveness of an individualized management program on risk factor management for patients discharged from hospital after stroke. Multicentre, cluster-randomized, controlled trial, with clusters by general practice. Participants are randomized to receive intervention or control after a baseline assessment undertaken after discharge from hospital. The general practice they attend is marked as an intervention or control accordingly. All subsequent participants attending those practices are automatically assigned as intervention or control. Baseline and all outcome assessments, including an analysis of risk factors, are undertaken by assessors blinded to patient randomization. Based on the results of blinded assessments, the individualized management program group will receive targeted advice on how to manage their risk factors using a standardized, evidence-based template to communicate 'ideal' management with their general practitioner. In addition, patients randomized to the individualized management program group will receive counselling and education about stroke risk factor management by an intervention study nurse. Individualized management programs will be reviewed at three-months, six-months, 12 months, and 18 months after stroke, at which times they will be modified if appropriate. Stroke risk management will be evaluated using changes in the Framingham cardiovascular risk score. Analysis will be on an intention-to-treat basis using analysis of covariance or generalized linear model to adjust for baseline risk score and other relevant confounding factors. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  3. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...... stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative...

  4. Assessment of ganaxolone's anticonvulsant activity using a randomized, double-blind, presurgical trial design. Ganaxolone Presurgical Study Group.

    Science.gov (United States)

    Laxer, K; Blum, D; Abou-Khalil, B W; Morrell, M J; Lee, D A; Data, J L; Monaghan, E P

    2000-09-01

    A double-blind, randomized, placebo-controlled clinical trial to examine the safety, tolerability, and antiepileptic activity of ganaxolone in patients after withdrawal from other antiepileptic drugs during presurgical evaluations was performed. Fifty-two eligible patients were withdrawn from antiepileptic drugs and randomized to receive ganaxolone (24 patients) or placebo (28 patients) for up to 8 days. Ganaxolone was administered at a dose of 1500 mg/d on day 1 and 1875 mg/d on days 2 to 8. Dosing occurred three times per day: immediately after breakfast, lunch, and dinner. The primary measure of antiepileptic activity was duration of treatment before withdrawal from the trial. Kaplan-Meier curves depicted a clear separation between treatment groups, with 50% of the ganaxolone-treated patients completing the entire study, compared with 25% of patients treated with placebo. Intent-to-treat survival analyses revealed a trend toward efficacy with ganaxolone (p = 0.0795, log rank test). Covariate analyses revealed a significant treatment effect on survival time in men (p = 0.03). Post-hoc chi2 probe analyses focusing on patients who completed the entire study revealed a significant difference (p = 0.04) between treatment groups. The tolerability of ganaxolone was similar to that of placebo, with adverse events being reported by 79% of patients in the ganaxolone group and 68% of patients in the placebo group. Ganaxolone monotherapy was well tolerated for the duration of this clinical trial, and the results provide preliminary evidence that ganaxolone does have antiepileptic activity.

  5. Effects of synbiotics on treatment of children with failure to thrive: A triple blind placebo-controlled trial.

    Science.gov (United States)

    Famouri, Fatemeh; Khoshdel, Abolfazl; Golshani, Arghavan; Kheiri, Soleiman; Saneian, Hossein; Kelishadi, Roya

    2014-11-01

    Failure to thrive (FTT) is a common problem of children especially in underdeveloped countries. In addition to its short-term adverse health effects, it is associated with long-term behavioral and cognitive defects. One of the recommended treatment modalities for FTT is using synbiotics. Due to high prevalence of FTT with undefined organic causes and failure of most medications on treatment of this type of FTT, we decided to search the effect of synbiotics on these patients. A randomized, triple-blinded, placebo-controlled trial study was done from 2011 to 2012. A number of 84 patients were randomly assigned to intervention and control groups. The synbiotics sachets were administered to study group for 6 months. The growth indices were measured at the beginning of the trial after 3 and 6 months, and compared with control. Variance analysis of observations showed improvement of growth indices in both groups. The increase in weight was significantly higher in synbiotics group than in controls (P 0.05). At the beginning of the trial, the mean weights were 10.25 ± 0.20 kg and 10.750 ± 0.160 kg in intervention and control groups, respectively, Meanwhile, after 6 months, the mean weights of two groups became 12.280 ± 0.190 and 11.760 ± 0.17 kg in intervention and control groups, respectively. This result has confirmed that the effect of synbiotics is significant on weight gain of our patients. Our findings support beneficial effects of synbiotics in weight gain of children with FTT.

  6. Effects of synbiotics on treatment of children with failure to thrive: A triple blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Fatemeh Famouri

    2014-01-01

    Full Text Available Background: Failure to thrive (FTT is a common problem of children especially in underdeveloped countries. In addition to its short-term adverse health effects, it is associated with long-term behavioral and cognitive defects. One of the recommended treatment modalities for FTT is using synbiotics. Due to high prevalence of FTT with undefined organic causes and failure of most medications on treatment of this type of FTT, we decided to search the effect of synbiotics on these patients. Materials and Methods: A randomized, triple-blinded, placebo-controlled trial study was done from 2011 to 2012. A number of 84 patients were randomly assigned to intervention and control groups. The synbiotics sachets were administered to study group for 6 months. The growth indices were measured at the beginning of the trial after 3 and 6 months, and compared with control. Results: Variance analysis of observations showed improvement of growth indices in both groups. The increase in weight was significantly higher in synbiotics group than in controls (P 0.05. At the beginning of the trial, the mean weights were 10.25 ± 0.20 kg and 10.750 ± 0.160 kg in intervention and control groups, respectively, Meanwhile, after 6 months, the mean weights of two groups became 12.280 ± 0.190 and 11.760 ± 0.17 kg in intervention and control groups, respectively. This result has confirmed that the effect of synbiotics is significant on weight gain of our patients. Conclusion: Our findings support beneficial effects of synbiotics in weight gain of children with FTT.

  7. Sustained-release methylphenidate in methamphetamine dependence treatment: a double-blind and placebo-controlled trial.

    Science.gov (United States)

    Rezaei, Farzin; Emami, Maryam; Zahed, Shakiba; Morabbi, Mohammad-Javad; Farahzadi, Mohammadhadi; Akhondzadeh, Shahin

    2015-01-15

    The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy of sustained-release methylphenidate (MPH-SR) in treatment of methamphetamine dependence. Fifty-six individuals who met DSM-IV-TR criteria for methamphetamine dependence participated in this 10-week trial. The participants were randomly allocated into two groups and received 18 to 54 mg/day sustained-released methylphenidate or placebo for 10 weeks. Craving was evaluated by a visual analogue craving scale every week. Urinary screening test for methamphetamine was carried out each week. The Beck Depression Inventory-II (BDI-II) was used to monitor participant depressive symptoms at baseline and bi-weekly during the treatment period. At the end of the trial, the MPH-SR group was less methamphetamine positive compared to the placebo group and the difference was significant (p = 0.03). By the end of the study, MPH-SR group showed significantly less craving scores compared to the placebo group [MD (95% CI) = -10.28(0.88-19.18), t(54) = 2.19, p = 0.03]. There was greater improvement in the depressive symptoms scores in the intervention group compared to the placebo group [MD (95% CI) =2.03(0.31-3.75), t (54) =2.37, p = 0.02]. Sustained-released methylphenidate was safe and well tolerated among active methamphetamine users and significantly reduced methamphetamine use, craving and depressive symptoms. IRCT201202281556N38.

  8. Prospective double-blind randomized controlled trial of terazosin, finasteride and allylestrenol in the management of benign prostatic hyperplasia

    Directory of Open Access Journals (Sweden)

    Madhu S Agrawal

    2001-01-01

    Full Text Available Medical management is rapidly becoming a very im-portant part of the armamentarium of the urologist in-volved in the treatment of benign prostatic hyperplasia. The commonest options for medical management include alpha-blockers, 5-alpha reductase inhibitors, and pro-gestational anti-androgens. We present a double-blind randomized controlled trial evaluating the safety and efficacy of terazosin, finasteride and allylestrenol, the prototype drugs in each of these respective categories. A total of 140 patients who satisfied the inclusion and exclusion criteria were inducted into the trial after an informed consent. They were randomized into 4 groups, which received placebo, terazosin, finasteride and allylestrenol respectively for 6 months. Since 29 patients did not complete 6 months of therapy, there were 111 evaluable patients at the end of the study. We found that these 3 drugs produce comparable improvement in symp-tom score (-40%, flow rates (-60% and PVR (-50% which is significantly better than that in the placebo group. Both allylestrenol and finasteride bring about a comparable reduction in prostate volume (-23%, which is statistically significant as compared to the placebo and terazosin groups. Terazosin in doses of I and 2 mg/ day was, found to be effiective and well-tolerated in the vast majority of our cases. No adverse effects were seen in the placebo and finasteride groups, while 9.6% in the terazosin group had postural hypotension and 10.7% in the allylestrenol group had some loss of libido, prob-lems which were reversible upon cessation of therapy.

  9. Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Douglas Berger

    2015-08-01

    Full Text Available While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

  10. The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device.

    Science.gov (United States)

    Fargen, Kyle M; Mocco, J; Gobin, Y Pierre

    2016-01-01

    The use of retrievable stents for acute ischemic stroke (AIS) may result in the release of distal emboli in 12-22% of cases. The Lazarus Funnel is a novel CE-marked thrombectomy assist device designed to capture the stentriever and thrombus to minimize the likelihood of distal embolization. To study this technology, we performed a randomized blinded in vitro evaluation of this device. A cerebral flow model was used as an in vitro simulator for cerebral arterial thrombectomy procedures. Stratified block randomization was performed following embolus injection into one of three cohorts: Solitaire stentriever plus guide catheter (control); control plus proximal Funnel placement; or control plus distal Funnel placement. Time to embolectomy, recanalization, and incidence of distal emboli were determined by a blinded observer. Forty-five thrombectomy trials were performed (15 in each group). The average time required for thrombectomy in each group was 8 min 26 s, 11 min 0 s and 9 min 24 s, respectively (p=NS). Use of the Funnel was associated with significantly improved recanalization compared with stentriever alone (pFunnel resulted in a 25% increase in successful recanalization and a 20% reduction in distal emboli. Use of the distal Funnel resulted in a 200% increase in successful recanalization and a 60% reduction in emboli. In this AIS embolism flow model with Solitaire thrombectomy, the Lazarus Funnel resulted in a significant increase in recanalization and significant reduction in distal emboli without increase in time to recanalization. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. Aluminium foil for the prevention of post-amputation pain: a randomised, double-blinded, placebo-controlled, crossover trial.

    Science.gov (United States)

    Minnee, Robert C; Bosma, Jan; Lam, Kayan Y; Wisselink, Willem; Vahl, Anco C

    2013-05-01

    Phantom limb pain (PLP) is a painful sensation perceived in the missing limb after amputation. The underlying pathophysiology remains unclear. Until recently, only opioid analgesics have been proven to be effective in prospective studies. Anecdotally, patients with PLP employ self-help measures, sometimes including 'wrapping up' or rubbing their stump with aluminium foil for relief. Our hypothesis is that wrapping an amputation stump with aluminium foil perioperatively will prevent PLP in the postoperative period. From September 2007 to September 2009, 32 consecutive patients were included in a crossover, double-blinded, randomised clinical trial. Perioperative fitting of an aluminium stump bandage was compared with a placebo paper foil. Scores were noted daily in a variable diary. The observation period was 2 weeks: in the first week participants were double blinded, and in the second week there was a change of bandage from aluminium to placebo or vice versa. A visual analogue scale (VAS) score was used as primary research variable. Secondary variables were use of analgesics, VAS measures of wound pain and the incidence of wound infections. Statistical analysis was done by means of Student's t-test for non-paired observations. Baseline characteristics were similar between groups. A period effect (p= 0.84) and treatment-period interaction (p = 0.79) were not present. There was no significant difference (mean difference 0.42) between both treatments in PLP VAS scores (95% CI -2.56 to -1.81, p = 0.71). VAS measure of wound pain showed no significant difference between both groups (mean difference 0.34, 95% CI -2.32 to -1.66, p = 0.72). Also, the other secondary endpoints did not differ. Patients receiving an aluminium foil stump wrapping do not experience less phantom pain than with a placebo.

  12. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    Science.gov (United States)

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders. © 2013 The Authors Pain Practice © 2013 World Institute of Pain.

  13. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    International Nuclear Information System (INIS)

    Higurashi, Takuma; Fujisawa, Nobutaka; Uchiyama, Shiori; Ezuka, Akiko; Nagase, Hajime; Kessoku, Takaomi; Matsuhashi, Nobuyuki; Yamanaka, Shoji; Inayama, Yoshiaki; Morita, Satoshi; Nakajima, Atsushi; Takahashi, Hirokazu; Endo, Hiroki; Hosono, Kunihiro; Yamada, Eiji; Ohkubo, Hidenori; Sakai, Eiji; Uchiyama, Takashi; Hata, Yasuo

    2012-01-01

    Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF). ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR) pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with type 2 diabetes taking under treatment with metformin have been

  14. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial.

    Science.gov (United States)

    Rotenberg, Brian W; Zhang, Irene; Arra, Ian; Payton, Keith B

    2011-12-01

    Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS. Three-arm, randomized, double-blinded, controlled trial. Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made. Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P .05). There was no treatment effect noted. In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

  15. Double-blind randomized controlled trial of isoxicam vs piroxicam in elderly patients with osteoarthritis of the hip and knee

    Science.gov (United States)

    Bellamy, N.; Buchanan, W. W.; Grace, E.

    1986-01-01

    1 Fifty-seven elderly patients with primary osteoarthritis of the hip and knee were entered into a double-blind, randomized, controlled parallel group trial to compare the efficacy and tolerability of isoxicam (maximum = 200 mg day-1) and piroxicam (maximum = 20 mg day-1). 2 Clinical assessments were made following a 1 week NSAID-free washout period and at biweekly intervals during the next 6 weeks of active treatment. 3 The majority of patients in both groups experienced a clinically important and statistically significant therapeutic response. 4 No statistically significant between-group differences were noted with respect to drug efficacy. 5 One patient was withdrawn from the piroxicam group because of lack of effect, but there were no such withdrawals from the isoxicam group. 6 Five patients were withdrawn from the piroxicam group because of adverse reactions compared to only one withdrawal from the isoxicam group. 7 This study indicates that isoxicam is an efficacious and well-tolerated once-daily NSAID for elderly patients with osteoarthritis. PMID:3620274

  16. Minimally invasive video-assisted thyroidectomy versus conventional thyroidectomy: A single-blinded, randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    El-Labban Gouda

    2009-01-01

    Full Text Available We aimed to test the hypothesis that Minimally Invasive Video-assisted Thyroidectomy (MIVAT affords comparable safety and efficacy as to the open conventional surgery, when dealing with patients with unilateral thyroid nodules or follicular lesions, in terms of cosmetic results, intraoperative and postoperative complications, postoperative pain and hospital stay. Materials And Methods: This was a single-blinded randomised controlled trial comparing the MIVAT with conventional thyroidectomy. The primary endpoints of the study were measurement of postoperative pain after 24 and 48 hours from operation and self-rated patient satisfaction with cosmetic outcome three months postoperatively. The secondary outcome measures were operative time, incidence of temporary and permanent recurrent laryngeal nerve injury, postoperative haematoma formation, length of incision, and duration of hospital stay. Results: Operative time was significantly less with open thyroidectomy than with MIVAT, while MIVAT was associated with less pain 24 hours postoperatively. Blood loss did not reach significance between procedures. Comparisons between the two procedures with regard to pain scores after 24 and 48 hours, respectively, depicted statistically significant differences in favour of the MIVAT after 24 hours. MIVAT was associated with less scarring and more satisfactory cosmetic results. There were statistically no significant differences between both procedures for the presence of transient recurrent laryngeal nerve palsy and hypoparathyroidism. Conclusions: MIVAT is a safe procedure that produces outcomes, in view of short-term adverse events, similar to those of open thyroidectomy, and is superior in terms of immediate postoperative pain and cosmetic results.

  17. Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss.

    Science.gov (United States)

    Ragab, A; Shreef, E; Behiry, E; Zalat, S; Noaman, M

    2009-01-01

    To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss. Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial. Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates. Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p ozone-treated patients compared with placebo-treated patients (p Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

  18. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

    Directory of Open Access Journals (Sweden)

    C.-Y. Oliver Chen

    2017-02-01

    Full Text Available Orange pomace (OP, a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA, a low (35% OP (LOP, or a high (77% (HOP dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1 to the maximum concentration (Cmax1 of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA to 45 (HOP and 47 (LOP min (p = 0.055 and 0.013, respectively. OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05. HOP reduced the first 2-h insulin area under concentration time curve (AUC by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men.

  19. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  20. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy.

    Science.gov (United States)

    Ubhi, T; Bhakta, B B; Ives, H L; Allgar, V; Roussounis, S H

    2000-12-01

    Cerebral palsy is the commonest cause of severe physical disability in childhood. For many years treatment has centred on the use of physiotherapy and orthotics to overcome the problems of leg spasticity, which interferes with walking and can lead to limb deformity. Intramuscular botulinum toxin (BT-A) offers a targeted form of therapy to reduce spasticity in specific muscle groups. To determine whether intramuscular BT-A can improve walking in children with cerebral palsy. Randomised, double blind, placebo controlled trial. Forty patients with spastic diplegia or hemiplegia were enrolled. Twenty two received botulinum toxin and 18 received placebo. The primary outcome measure was video gait analysis and secondary outcome measures were gross motor function measure (GMFM), physiological cost index (PCI), and passive ankle dorsiflexion. Video gait analysis showed clinically and statistically significant improvement in initial foot contact following BT-A at six weeks and 12 weeks compared to placebo. Forty eight per cent of BT-A treated children showed clinical improvement in VGA compared to 17% of placebo treated children. The GMFM (walking dimension) showed a statistically significant improvement in favour of the botulinum toxin treated group. Changes in PCI and passive ankle dorsiflexion were not statistically significant. The study gives further support to the use of intramuscular botulinum toxin type A as an adjunct to conventional physiotherapy and orthoses to reduce spasticity and improve functional mobility in children with spastic diplegic or hemiplegic cerebral palsy.

  1. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Kwok, Timothy; Wong, Bel; Ip, Isaac; Chui, Kenny; Young, Daniel; Ho, Florence

    2013-01-01

    Many family caregivers of persons with dementia (PWD) are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann-Whitney U tests were used to compare the differences between the intervention and control groups. The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed.

  2. Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Yanyi Wang

    2015-01-01

    Full Text Available Objectives. This study aimed to evaluate the efficacy and safety of manual acupuncture as a prophylaxis for frequent migraine. Methods. Fifty frequent migraineurs were randomly allocated to receive 16 sessions of either real acupuncture (RA = 26 or sham acupuncture (SA = 24 during 20 weeks. The primary outcomes were days with migraine over four weeks, duration, and intensity of migraine and the number of responders with more than 50% reduction of migraine days. The secondary outcomes were the relief medication, quality of migraine, quality of life, and pressure pain thresholds. Results. The two groups were comparable at baseline. At the end of the treatment, when compared with the SA group, the RA group reported significant less migraine days (RA: 5.2 ± 5.0; SA: 10.1 ± 7.1; P=0.008, less severe migraine (RA: 2.18 ± 1.05; SA: 2.93 ± 0.61; P=0.004, more responders (RA: 19 versus SA: 7, and increased pressure pain thresholds. No other group difference was found. Group differences were maintained at the end of the three-month follow-up, but not at the one-year follow-up. No severe adverse event was reported. Blinding was successful. Discussion. Manual acupuncture was an effective and safe treatment for short-term relief of frequent migraine in adults. Larger trials are warranted.

  3. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

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    Vasanop Vachiramon

    2016-01-01

    Full Text Available Objective. Keratosis pilaris (KP is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2 laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians’ global assessment (p=0.02. Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  4. Investigator-reported efficacy of azelaic acid foam 15% in patients with papulopustular rosacea: secondary efficacy outcomes from a randomized, controlled, double-blind, phase 3 trial.

    Science.gov (United States)

    Solomon, James A; Tyring, Stephen; Staedtler, Gerald; Sand, Meike; Nkulikiyinka, Richard; Shakery, Kaweh

    2016-09-01

    Papulopustular rosacea (PPR) is characterized by centrofacial papules and pustules commonly associated with erythema. To compare investigator-reported efficacy outcomes for azelaic acid (AzA) foam 15% versus vehicle foam in PPR, a randomized, vehicle-controlled, double-blind phase 3 clinical trial was conducted at 48 US sites. Participants received AzA foam or vehicle foam for 12 weeks. Secondary efficacy outcomes included change in inflammatory lesion count (ILC), therapeutic response rate according to investigator global assessment (IGA), and change in erythema rating. This study was comprised of 961 participants with PPR. The results support the therapeutic superiority of AzA foam over vehicle foam.

  5. A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

    Science.gov (United States)

    Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.

    2011-01-01

    Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale–cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. PMID:21795660

  6. Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial.

    Science.gov (United States)

    Oluwalana, Claire; Camara, Bully; Bottomley, Christian; Goodier, Sean; Bojang, Abdoulie; Kampmann, Beate; Ceesay, Samba; D'Alessandro, Umberto; Roca, Anna

    2017-02-01

    We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections. This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery. From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034). Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted. Copyright © 2017 by the American Academy of Pediatrics.

  7. Mirror therapy in children with hemiparesis: a randomized observer-blinded trial.

    Science.gov (United States)

    Bruchez, Roselyn; Jequier Gygax, Marine; Roches, Sylvie; Fluss, Joel; Jacquier, David; Ballabeni, Pierluigi; Grunt, Sebastian; Newman, Christopher J

    2016-09-01

    To determine the efficacy of mirror therapy in children with hemiparesis. The design was an observer-blinded parallel-group randomized controlled trial (International Standard Randomised Controlled Trial Number 48748291). Randomization was computer-generated, 1:1 allocation to mirror therapy or comparison groups. The settings were home-based intervention and tertiary centre assessments. Participants were 90 children with hemiparesis aged 7 to 17 years. Intervention was 15 minutes per day of simultaneous arm training, 5 days a week, for 5 weeks. The mirror therapy group used a mirror; those in the comparison group looked at their paretic limb. Assessments comprised measures of upper limb strength, function (Melbourne Assessment 2), daily performance (ABILHAND-Kids), and sensory function at weeks 0 (T0 ), 5 (T1 ), and 10 (T2 ). There were no significant differences in outcomes and their progression over time between the mirror therapy and comparison groups. Post-hoc intention-to-treat analyses showed significant improvements in both groups for grasp strength (T0 -T1 +12.6%), pinch strength (T0 -T2 +9.1%), upper limb function in terms of accuracy (T0 -T2 +2.7%) and fluency (T0 -T2 +5.0%), as well as daily performance (T0 -T2 +16.6%). Per protocol analyses showed additional improvements in dexterity (T0 -T2 +4.0%). The use of the mirror illusion during therapy had no significant effect on treatment outcomes. However, 5 weeks of daily simultaneous arm training significantly improved paretic upper limb strength, function, and daily use. © 2016 Mac Keith Press.

  8. Efficacy of Plai Cream in Adult Patients with Muscle Strain: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Cheechareoan, Sukrom; Pathanawiriyasirikul, Thanate; Manmee, Charuwan; Janpol, Kanya

    2016-02-01

    Nonsteroidal anti-inflammatory drugs are a standard treatment option for muscle strain; however, side effects persist. This clinical trial was designed to compare the efficacy of Plai cream compared to placebos in adult patients with muscle strain. In this randomized, double-blind, placebo-controlled trial, 140 participants aged over 18 years with muscle strain were randomized to receive either Plai cream (n = 70 patients, treatment group) or placebos (n = 70 patients, control group) . Outcome assessments included the visual analog scale (VAS), quality of life (QoL), the amount of remaining cream, and the number of acetaminophen tablets used. After 2 weeks, the mean pain scores following treatment with both Plai cream and placebos in patients with muscle strain decreased from baseline to the end of the study at week 2. However, no significant difference for VA S score was found. The QoL of the two groups showed improvements in QoL as witnessed by increased mean QoL scores from baseline to week 2; however, these differences were not statistically significant. In general, mean QoL scores above 50 indicate good quality of life. The amount of Plai cream used reduced from baseline to week 2, but no significant difference in the amount of cream remaining was found between the two groups at each visit. Similarly, the number of acetaminophen tablets used was not statistically different between the treatment and control groups. There was no difference in pain reduction in the 2-week period between patients with muscle strain using Plai cream and those given placebos, but Plai cream tended to reduce pain in the long term. No side effects were found from Plai cream, so this non-invasive treatment may be offered to patients.

  9. Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial.

    Science.gov (United States)

    Myint, Ma Wai Wai; Wu, Jenny; Wong, Euann; Chan, Suk Ping; To, Tze Shing Jess; Chau, Mei Wa Rosanna; Ting, Kwai Hing; Fung, Pui Man; Au, Kit Sing Derrick

    2013-01-01

    malnutrition is an important risk factor for poor outcome in patients recovering after hip fracture surgery. This study aimed to investigate the clinical, nutritional and rehabilitation effects of an oral nutritional supplementation (ONS) in an inpatient rehabilitation setting. this was an observer-blinded randomised controlled trial of elderly post-surgical proximal femoral fracture patients. A ready-to-use oral liquid nutritional supplementation (18-24 g protein and 500 kcal per day) in addition to hospital diet was compared with hospital diet only. Both groups received usual rehabilitation therapy and oral calcium and vitamin D supplements. Outcomes were compared at discharge from rehabilitation and after 4 weeks of discharge. The primary outcome parameters were the serum albumin level, the body mass index (BMI), the functional independence measure (FIM) and the elderly mobility scale (EMS). Secondary outcome parameters were frequency of complications, inpatient length of stay, mortality and acute hospital use within 6 months after discharge. a total of 126 patients were recruited, 65 in the supplementation arm and 61 in the control arm. There was a significant difference in change in BMI with a decrease of 0.25 and 0.03 kg/m(2) in the ONS group and 0.72 and 0.49 kg/m(2) in the control group at hospital discharge and follow-up, respectively (P = 0.012). The length of stay in rehabilitation ward was shortened by 3.80 (SE = 1.81, P = 0.04) days favouring the ONS group. The total number of infection episodes was also reduced significantly. No difference was observed in the rate of change of the serum albumin level, the FIM and the EMS. clinical and nutritional benefits were seen in this trial but rehabilitation benefits could not be demonstrated.

  10. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    Science.gov (United States)

    Barnes, Thomas R E; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom K J; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-04-01

    Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. Adult psychiatric services, treating people with schizophrenia. Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There were no statistically significant differences between the two treatment arms over 48-week

  11. A randomized, double-blind, placebo-controlled trial of olanzapine in the treatment of trichotillomania.

    Science.gov (United States)

    Van Ameringen, Michael; Mancini, Catherine; Patterson, Beth; Bennett, Mark; Oakman, Jonathan

    2010-10-01

    Trichotillomania has been considered as part of the obsessive-compulsive disorder spectrum; however, trichotillomania treatment with obsessive-compulsive disorder medications has largely been unsuccessful. To determine whether a dopaminergic treatment as used in tics and Tourette's syndrome would be effective in trichotillomania. Twenty-five participants with DSM-IV trichotillomania participated in a 12-week, randomized, double-blind, placebo-controlled trial of flexible-dose olanzapine for trichotillomania. Recruitment occurred between August 2001 and December 2005, and follow-up was completed in February 2006. The primary outcome measure was the Clinical Global Impressions-Improvement (CGI-I) scale, and secondary measures of efficacy included the Yale-Brown Obsessive Compulsive Scale for Trichotillomania (TTM-YBOCS) and the Clinical Global Impressions-Severity of Illness (CGI-S) scale. Eleven of 13 participants (85%) in the olanzapine group and 2 of 12 (17%) in the placebo group were considered responders according to the CGI-I (P = .001). There was a significant change from baseline to end point in the TTM-YBOCS (P trichotillomania. clinicaltrials.gov Identifier: NCT00182507. © Copyright 2010 Physicians Postgraduate Press, Inc.

  12. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial.

    Science.gov (United States)

    Seyyedrasooli, Allehe; Valizadeh, Leila; Zamanzadeh, Vahid; Nasiri, Khadijeh; Kalantri, Hossein

    2013-12-01

    The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method). The purpose of this research was to examine footbath on sleep quality of the elderly. This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group) and another group did not have footbath (control group). The experimental group participants were asked to put their feet in warm water (41-42 ºC) for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention by individual interview. Data were analyzed by SPSS software. The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  13. Mexiletine for Muscle Cramps in ALS: A Randomized Double-Blind Crossover Trial.

    Science.gov (United States)

    Oskarsson, Björn; Moore, Dan; Mozaffar, Tahseen; Ravits, John; Wiedau-Pazos, Martina; Parziale, Nicholas; Joyce, Nanette C; Mandeville, Ross; Goyal, Namita; Cudkowicz, Merit E; Weiss, Michael; Miller, Robert G; McDonald, Craig M

    2018-03-06

    More than 90% of amyotrophic lateral sclerosis (ALS) patients have muscle cramps, and evidence-based treatments have not been available. A multicenter double-blind placebo-controlled crossover trial of mexiletine 150 mg twice daily was conducted of ALS patients requesting treatment of symptomatic muscle cramps. Muscle cramp frequency was reduced in 18 of 20 patients; 13 reductions were attributed to treatment (Pcramps per day (a reduction from 5.3 with placebo to 3.5 with mexiletine) based on t tests. The estimated reduction of cramp severity was 15 units on a 100-unit scale (P=.01), from a baseline average of 46. No effect on fasciculations was noted. One patient discontinued the study because of dizziness, and another patient discontinued the study to start open-label mexiletine therapy. No serious adverse event occurred. Mexiletine is well-tolerated and effective medication for controlling the symptom of muscle cramps in ALS. This article is protected by copyright. All rights reserved. © 2018 Wiley Periodicals, Inc.

  14. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Allehe Seyyedrasooli

    2013-11-01

    Full Text Available Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method. The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group and another group did not have footbath (control group. The experimental group participants were asked to put their feet in warm water (41-42 ºC for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI before and after the intervention by individual interview. Data were analyzed by SPSS software. Results: The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. Conclusion: According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  15. Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial.

    Science.gov (United States)

    Ramírez-Bosca, A; Zapater, P; Betlloch, I; Albero, F; Martínez, A; Díaz-Alperi, J; Horga, J F

    2012-09-01

    Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions. The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity. We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated. Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group. Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching. Copyright © 2011 Elsevier España, S.L. and AEDV. All rights reserved.

  16. Randomized double-blind trial of prednisone versus radiotherapy in Graves' ophthalmopathy

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    Prummel, M.F.; Mourits, M.; Blank, L.; Berghout, A.; Koornneef, L.; Wiersinga, W.M. (Univ. of Amsterdam (Netherlands))

    1993-10-16

    Corticosteriods are usually given for management of Graves' ophthalmopathy, but they have many and serious side-effects. By comparison, retrobulbar irradiation is well tolerated, although its efficacy has been evaluated only in uncontrolled studies. Therefore, the authors did a double-blind randomized trial, in which 28 patients with moderately severe Graves' ophthalmopathy were treated with a 3-month course of oral prednisone and sham irradiation, and 28 received retrobulbar irradiation (20 Gy) and placebo capsules. Therapeutic outcome, assessed twenty-four weeks after the start of treatment, was determined by the change in the highest NOSPECS class. A successful outcome was observed in 14 prednisone-treated and in 13 irradiated patients. Responders to treatment (but not nonresponders) in both groups showed improvements in total and subjective eye score and a decrease in eye-muscle volume. Response to either treatment was due largely to changes in soft-tissue involvement and eye-muscle motility. Radiotherapy and oral prednisone appear to be equally effective as initial treatment in patients with moderately severe Graves' ophthalmopathy. In view of its better tolerability, radiotherapy should be considered the treatment of first choice.

  17. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  18. Tap Water Versus Sterile Normal Saline in Wound Swabbing: A Double-Blind Randomized Controlled Trial.

    Science.gov (United States)

    Chan, Mun Che; Cheung, Kin; Leung, Polly

    2016-01-01

    The use of tap water as a wound-cleansing agent is becoming more common in clinical practice, especially in community settings. The aim of this study was to test whether there are differences in wound infection and wound healing rates when wounds are cleansed with tap water or sterile normal saline. Double-blinded randomized controlled trial. Subjects were recruited from the community nursing service of a local hospital in Hong Kong. The target sample included subjects who were aged 18 years or more, and receiving chronic or acute wound care treatment. Subjects were randomly assigned to wound cleansing with tap water (experimental group) or sterile normal saline (control group). Wound assessment was conducted at each home visit, and an assessment of wound size was conducted once a week. The main outcome measures, occurrence of a wound infection and wound healing, were assessed over a period of 6 weeks. Twenty-two subjects (11 subjects in each group) with 30 wounds participated in the study; 16 wounds were managed with tap water cleansing and 14 were randomly allocated to management with the sterile normal saline group. Analysis revealed no significant difference between the experimental and control groups in the proportions of wound infection and wound healing. Study findings indicate that tap water is a safe alternative to sterile normal saline for wound cleansing in a community setting.

  19. Tramadol relieves pain and allodynia in polyneuropathy: a randomised, double-blind, controlled trial.

    Science.gov (United States)

    Sindrup, S H; Andersen, G; Madsen, C; Smith, T; Brøsen, K; Jensen, T S

    1999-10-01

    It is generally believed that opioids relieve neuropathic pain less effectively than nociceptive pain and that they have no effect on some of the key characteristics of neuropathic pain such as touch-evoked pain (allodynia). Tramadol is an analgesic drug acting directly on opioid receptors and indirectly on monoaminergic receptor systems. The aim of this trial was to determine whether tramadol relieved painful polyneuropathy and reduced allodynia. The study design was randomised, double-blind, placebo-controlled and cross-over. After baseline observations, 45 patients were assigned to one of the two treatment sequences. The dose of tramadol slow-release tablets was titrated to at least 200 mg/day and at highest 400 mg/day. During the two treatment periods of 4 weeks duration, patients rated pain, paraesthesia and touch-evoked pain by use of 0-10 point numeric rating scales. Mechanical allodynia induced by stimulation with an electronic toothbrush was rated at the end of each treatment period with a similar scale. Thirty-four patients completed the study. Their ratings for pain (median 4 vs. 6, P=0.001), paraesthesia (4 vs. 6, P=0.001) and touch-evoked pain (3 vs. 5, P/=50% pain relief was 4.3 (95% confidence interval 2.4-20). It is concluded that tramadol appears to relieve both ongoing pain symptoms and the key neuropathic pain feature allodynia in polyneuropathy.

  20. Comparative characteristics of psychophysiological and physical performance in young and blind athletes-swimmers with the same level of preparedness

    Directory of Open Access Journals (Sweden)

    Ирина Владимировна Рябцева

    2016-04-01

    Full Text Available Studies of psychophysiological and physical characteristics of blind athletes-swimmers and young swimmers with the same level of preparedness on the basis of psychophysiological, physiological and pedagogical tests are conducted. A comparative analysis of dynamometry performance and opportunity of differentiation of the efforts, respond to sound and the ability to coordinate the movements of swimming on dry land for blind athletes-swimmers and young swimmers

  1. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Directory of Open Access Journals (Sweden)

    U. C. Adler

    2011-01-01

    Full Text Available Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1 in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654 and 8th weeks (P = .965 of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine were −3.04 (95% CI −6.95, 0.86 and −2.4 (95% CI −6.05, 0.77 at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of

  2. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Science.gov (United States)

    Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

    2011-01-01

    Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients

  3. Preoperative cesarean delivery intravenous acetaminophen treatment for postoperative pain control: a randomized double-blinded placebo control trial.

    Science.gov (United States)

    Towers, Craig V; Shelton, Sarah; van Nes, Jaclyn; Gregory, Emily; Liske, Emily; Smalley, Arion; Mobley, Edward; Faircloth, Barbara; Fortner, Kim B

    2018-03-01

    The United States currently has an opioid use disorder epidemic and research evaluating ways to minimize the use of opioids postsurgery are needed. One of these options is intravenous acetaminophen. If the use of preoperative intravenous acetaminophen was found to be effective for cesarean delivery, this would be beneficial for both the mother and breast-feeding neonate. The primary study objective was to see if maternal opioid use was significantly less in the postoperative period for the study group that received 1 g of intravenous acetaminophen preoperatively compared with a control group that received placebo. The secondary objectives were to evaluate maternal length of stay and pain scores postoperatively, and assess the acetaminophen level in cord blood at delivery. This study was a prospective double-blinded randomized placebo-controlled trial. All pregnant patients who entered labor and delivery for a scheduled cesarean from November 2015 through April 2017 were eligible. Once consented, the medication was supplied by the pharmacy department, which performed the blinded randomization. Both the study drug of 1000 mg (1 g) of acetaminophen and placebo of normal saline were distributed as unmarked 100-mL bags administered over 15 minutes just prior to incision. No study personnel from the obstetric or anesthesia departments had any access to the randomization. Based on a power analysis using the published surgical data results, the goal was to obtain a minimum of 100 patients (50 patients in each arm). Primary data collection included demographics, number of opioid doses and morphine milligram equivalents administered to the patient postoperatively, length of stay postdelivery, pain scores, and newborn cord blood acetaminophen levels. Exclusions were maternal acetaminophen allergy, receipt of acetaminophen in the prior 24 hours, opioid use disorder, and hepatitis/liver impairment. Statistics involved χ 2 , Fisher exact, and the Student t test where

  4. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture.

    Science.gov (United States)

    Cheon, Soyeon; Park, Hi-Joon; Chae, Younbyoung; Lee, Hyangsook

    2018-01-18

    While full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI) as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI -0.21 vs. -0.16; p = 0.38). In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference - 0.43 vs. -0.12; p = 0.03), probably due to enhanced expectations. How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we have few empirical findings on this issue, future studies are needed to

  5. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

    Directory of Open Access Journals (Sweden)

    Soyeon Cheon

    2018-01-01

    Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

  6. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial.

    Science.gov (United States)

    Rivera, Luis; Pedersen, Rasmus S; Peña, Lourdes; Olsen, Klaus J; Andreasen, Lars V; Kromann, Ingrid; Nielsen, Pernille I; Sørensen, Charlotte; Dietrich, Jes; Bandyopadhyay, Ananda S; Thierry-Carstensen, Birgit

    2017-07-01

    Cost and supply constraints are key challenges in the use of inactivated polio vaccine (IPV). Dose reduction through adsorption to aluminium hydroxide (Al) is a promising option, and establishing its effectiveness in the target population is a crucial milestone in developing IPV-Al. The aim of this clinical trial was to show the non-inferiority of three IPV-Al vaccines to standard IPV. In this phase 2, non-inferiority, observer-blinded, randomised, controlled, single-centre trial in the Dominican Republic, healthy infants aged 6 weeks, not previously polio vaccinated, were allocated after computer-generated randomisation by block-size of four, to receive one of four IPV formulations (three-times reduced dose [1/3 IPV-Al], five-times reduced dose [1/5 IPV-Al], ten-times reduced dose [1/10 IPV-Al], or IPV) intramuscularly in the thigh at 6, 10, and 14 weeks of age. The primary outcome was seroconversion for poliovirus types 1, 2, and 3 with titres more than or equal to four-fold higher than the estimated maternal antibody titre and more than or equal to 8 after three vaccinations. Non-inferiority was concluded if the lower two-sided 90% CI of the seroconversion rate difference between IPV-Al and IPV was greater than -10%. The safety analyses were based on the safety analysis set (randomly assigned participants who received at least one trial vaccination) and the immunogenicity analyses were based on the per-protocol population. This study is registered with ClinicalTrials.gov registration, number NCT02347423. Between Feb 2, 2015, and Sept 26, 2015, we recruited 824 infants. The per-protocol population included 820 infants; 205 were randomly assigned to receive 1/3 IPV-Al, 205 to receive 1/5 IPV-Al, 204 to receive 1/10 IPV-Al, and 206 to receive IPV. The proportion of individuals meeting the primary endpoint of seroconversion for poliovirus types 1, 2, and 3 was already high for the three IPV-Al vaccines after two vaccinations, but was higher after three vaccinations

  7. Psyllium Supplementation in Adolescents Improves Fat Distribution & Lipid Profile: A Randomized, Participant-Blinded, Placebo-Controlled, Crossover Trial

    OpenAIRE

    de Bock, Martin; Derraik, José G. B.; Brennan, Christine M.; Biggs, Janene B.; Smith, Greg C.; Cameron-Smith, David; Wall, Clare R.; Cutfield, Wayne S.

    2012-01-01

    AIMS: We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. METHODS: This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with...

  8. The Women's wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol.

    Science.gov (United States)

    Anderson, Debra; Seib, Charrlotte; Tjondronegoro, Dian; Turner, Jane; Monterosso, Leanne; McGuire, Amanda; Porter-Steele, Janine; Song, Wei; Yates, Patsy; King, Neil; Young, Leonie; White, Kate; Lee, Kathryn; Hall, Sonj; Krishnasamy, Mei; Wells, Kathy; Balaam, Sarah; McCarthy, Alexandra L

    2017-02-03

    Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women's Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers. A single-blinded, multi-centre randomized controlled trial recruited a total of 351 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura's social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All

  9. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2002-01-01

    cholecystectomy using two 10-mm and two 5-mm trocars (LC). Incisional pain at each port incision and overall pain were recorded for 1 week after the operation. Fatigue, nausea and vomiting, pulmonary function, and cosmetic results were also measured. RESULTS: Data from 52 patients were analyzed; eight patients......BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic.......01). In both groups, pain scores at the supraumbilical 10-mm port were significantly higher compared with other port sites (p

  10. Trial participants' understanding of randomization, double-blinding, and placebo use in low literacy populations: findings from a study conducted within a microbicide trial in Malawi.

    Science.gov (United States)

    Ndebele, Paul; Wassenaar, Douglas; Masiye, Francis; Munalula-Nkandu, Esther

    2014-07-01

    Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants' understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualitative methods, including structured questionnaire interviews with a random sample of 203 individual participants, four in-depth interviews with research nurses, and two focus group discussions with 18 study participants. Most respondents earned high scores on questions related to randomization (85%) and placebo use (72%), while a greater proportion of the same respondents obtained low scores on questions related to double-blinding (68%) and personal implications of the study procedures (63%). Overall, most respondents (61%; n = 124) obtained low scores on combined understanding of all the three concepts under study. © The Author(s) 2014.

  11. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial

    Science.gov (United States)

    Skinner, Elizabeth H; Browning, Laura; Reeve, Julie; Anderson, Lesley; Hill, Cat; Robertson, Iain K; Story, David; Denehy, Linda

    2018-01-01

    Abstract Objective To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. Design Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. Setting Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. Participants 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. Interventions Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. Main outcome measures The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. Results The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute

  12. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Dilek, Banu; Gözüm, Mehtap; Şahin, Ebru; Baydar, Meltem; Ergör, Gül; El, Ozlem; Bircan, Çigdem; Gülbahar, Selmin

    2013-04-01

    To evaluate the efficacy of paraffin bath therapy on pain, function, and muscle strength in patients with hand osteoarthritis. Prospective single-blinded randomized controlled trial. Department of physical medicine and rehabilitation in a university hospital. Patients with bilateral hand osteoarthritis (N=56). Patients were randomized into 2 groups with a random number table by using block randomization with 4 patients in a block. Group 1 (n=29) had paraffin bath therapy (5 times per week, for 3-week duration) for both hands. Group 2 (n=27) was the control group. All patients were informed about joint-protection techniques, and paracetamol intake was recorded. The primary outcome measures were pain (at last 48h) at rest and during activities of daily living (ADL), assessed with a visual analog scale (0-10cm) at 12 weeks. The secondary outcome measures were the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and the Dreiser Functional Index (DFI), used for subjective functional evaluation, loss of range of motion (ROM), grip and pinch strength, painful and tender joint counts, and paracetamol intake. A researcher blind to group allocation recorded the measures for both hands at baseline, 3 weeks, and 12 weeks at the hospital setting. At baseline, there were no significant differences between groups in any of the parameters (P>.05). After treatment, the paraffin group exhibited significant improvement in pain at rest and during ADL, ROM of the right hand, and pain and stiffness dimensions of the AUSCAN (P.05). The control group showed a significant deterioration in right hand grip and bilateral lateral pinch and right chuck pinch strength (Pparaffin group (Pparaffin group were significantly higher than the control group at 12 weeks (PParaffin bath therapy seemed to be effective both in reducing pain and tenderness and maintaining muscle strength in hand osteoarthritis. It may be regarded as a beneficial short-term therapy option, which is effective for a 12

  13. [Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies].

    Science.gov (United States)

    Gollnick, Harald P M; Graupe, Klaus; Zaumseil, Rolf-Peter

    2004-10-01

    Topical measures are still the mainstay in the therapy of mild-to-moderate acne vulgaris. Azelaic acid 20% in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non-alcoholic hydrogel formulation containing 15% azelaic acid was clinically tested against two standard drugs--5% benzoyl peroxide (BPO) and 1% clindamycin. In two independent, randomized, blinded comparative trials 15% azelaic acid gel was clinically tested against 5% benzoyl peroxide (BPO) gel in 351 patients and against 1% clindamycin gel in 229 patients. The drugs were applied b.i.d. for 4 months. Azelaic acid 15% gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70%, and 71% respectively. The azelaic acid gel was well-tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well-accepted by the majority of patients. Azelaic acid gel is an effective topical monotherapy for mild-to-moderate acne vulgaris; its new gel form is an enrichment of acne therapy.

  14. Phenobarbitone in Rh hemolytic disease of the newborn: a randomized double-blinded placebo-controlled trial.

    Science.gov (United States)

    Venkatnarayan, Kannan; Sankar, Mari Jeeva; Agarwal, Ramesh; Paul, Vinod K; Deorari, Ashok K

    2013-10-01

    To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn. In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy. Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04). PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.

  15. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.

    Science.gov (United States)

    Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

    2014-03-01

    Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population.

  16. Intracervical sodium nitroprusside versus vaginal misoprostol in first trimester surgical termination of pregnancy: a randomized double-blinded controlled trial.

    Science.gov (United States)

    Chan, C C W; Tang, O S; Ng, E H Y; Li, C F; Ho, P C

    2005-03-01

    Results from small-scale randomized studies on the effectiveness of different preparations of nitric oxide donors in cervical priming before first trimester termination of pregnancies are not consistent. We compared sodium nitroprusside gel to misoprostol, the standard agent for cervical priming in this randomized double-blinded controlled trial. Two hundred pregnant patients between 8 to 12 weeks admitted for surgical termination of pregnancy were recruited. They were randomized into either 400 microg vaginal misoprostol and intracervical placebo gel, or 10 mg intracervical sodium nitroprusside gel and placebo tablets 3 h before the procedure. The baseline cervical dilatation and cumulative force required to dilate the cervix from 4 to 9 mm were measured with a tonometer. Blood pressure was measured and side effects were assessed. The cumulative force to dilate the cervix from 4 to 9 mm was significantly higher in the sodium nitroprusside group, and the difference remained when a sub-group analysis was performed according to parity. Baseline cervical dilatation, duration of operation and operative blood loss were all in favour of misoprostol. Transient drop in blood pressure was observed after sodium nitroprusside treatment. Intracervical sodium nitroprusside is not as effective as misoprostol in cervical priming.

  17. Effect of aliskiren on proteinuria in non-diabetic chronic kidney disease: a double-blind, crossover, randomised, controlled trial.

    Science.gov (United States)

    Lizakowski, Sławomir; Tylicki, Leszek; Renke, Marcin; Rutkowski, Przemysław; Heleniak, Zbigniew; Sławińska-Morawska, Maja; Aleksandrowicz, Ewa; Łysiak-Szydłowska, Wieslawa; Rutkowski, Bolesław

    2012-12-01

    To evaluate the proteinuria-lowering effect of a renin inhibitor (aliskiren), compared to placebo and to an angiotensin-converting enzyme inhibitor (perindopril), in patients with non-diabetic chronic kidney disease. A randomised, double-blind, crossover trial was performed in 14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93±6.8 ml/min. The study consisted of five treatment periods. The patients were randomly assigned to receive aliskiren (150 mg), aliskiren (300 mg), perindopril (5 mg), perindopril (10 mg) or placebo. Aliskiren and perindopril reduced proteinuria. These effects were dose-dependent. Furthermore, 24-h proteinuria was reduced by 23% (mean 95% CI; 2–44) by treatment with aliskiren (150 mg), by 36% (95% CI, 17–55; Pproteinuria. The antiproteinuric effect is probably similar to that of perindopril, for equivalent hypotensive dosages. The renin inhibitor provides a promising alternative approach for the treatment of patients with chronic proteinuric non-diabetic kidney disease.

  18. Double-blind placebo-controlled randomized clinical trial on the use of paracetamol for performing mammography.

    Science.gov (United States)

    Freitas-Junior, Ruffo; Martins, Edesio; Metran-Nascente, Cristiane; Carvalho, Angela Assis; Silva, Marilceia Ferreira da; Soares, Leonardo Ribeiro; Ximenes, Carlos Alberto

    2018-03-01

    This study was conducted within the Goias Mastology Research Network. To verify the possibility of diminishing pain, and discomfort during the mammography using analgesic administration. Randomized, double-blinded, placebo controlled trial, testing paracetamol to diminish the pain, and discomfort during mammography. Three hundred patients who came for screening mammography were randomized for this study. A questionnaire with 2 parts was used: the first had questions that concerned the patient identification, and factors related to the pain during mammography; and the second asked about the scale of discomfort (no discomfort; uncomfortable; very uncomfortable; intolerable), and the pain (analogical linear scale) during the mammography. Each patient received 1000 mg of paracetamol, or placebo. Afterwards each patient filled out the second part of the questionnaire. Six patients were excluded from the analysis; this resulted in 149 in the paracetamol group, and 145 in the placebo group. The 2 groups were homogenous concerning the mean of the ages, weight, height, and breast size. The mean of the pain was 3.5 in the paracetamol, and 2.8 in the placebo group (P = .12). There were fewer women experiencing mild pain in the paracetamol group when compared with those in placebo group (relative risk [RR] 0.76, confidence interval [CI] 95% 0.52-0.98). There was no significant difference between the 2 groups, according to the degrees of discomfort (P =  .69). The use of paracetamol can reduces the mild pain for women undergoing mammography.

  19. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    Science.gov (United States)

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  20. Effects of Probiotic Supplementation on Oxidative Stress Indices in Women with Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial.

    Science.gov (United States)

    Vaghef-Mehrabany, Elnaz; Homayouni-Rad, Aziz; Alipour, Beitullah; Sharif, Sakineh-Khatoun; Vaghef-Mehrabany, Leila; Alipour-Ajiry, Serour

    2016-01-01

    Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that causes great pain and disability and increasing oxidative stress in patients. The objective of the present study was to evaluate the effects of probiotics-live microorganisms with many health benefits, including antioxidant properties-on oxidative stress indices of patients with RA. This study is a secondary analysis from a previously published study Methods: In a randomized double-blind placebo-controlled clinical trial, 46 patients with RA were assigned to one of two groups; patients in the probiotic group received a daily capsule containing 10(8) colony forming units (CFUs) of Lactobacillus casei 01 (L. casei 01), while those in the placebo group took identical capsules containing maltodextrin, for 8 weeks. In the baseline and at the end of the study, anxiety, physical activity levels, and dietary intakes were assessed. Anthropometric parameters, serum malondialdehyde (MDA), total antioxidant capacity (TAC), erythrocyte superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT) activities were measured. There was no significant difference between the two groups for demographic characteristics, anthropometric parameters, physical activity, anxiety levels, or dietary intakes, throughout the course of the study. No significant within- and between-group differences were observed for MDA, TAC, or CAT. SOD activity decreased only in the probiotic group and GPx activity decreased in both study groups (p 0.05). No significant effect of L. casei 01 supplementation was observed on the oxidative status of patients with RA, compared to placebo.

  1. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    Science.gov (United States)

    COELHO-DE-SOUZA, Fábio Herrmann; CAMARGO, Junara Cristina; BESKOW, Tiago; BALESTRIN, Matheus Dalmolin; KLEIN-JÚNIOR, Celso Afonso; DEMARCO, Flávio Fernando

    2012-01-01

    Objective This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. Material and Methods Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint) and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond) and composite resin (Filtek P60). A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa), according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p<0.05). Results Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05) than butt joint restorations. Conclusions It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities. PMID:22666833

  2. Lidocaine and tenoxicam effectiveness for pain relief during Pipelle: Non-randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Sargin, Mehmet Akif; Yassa, Murat; Celik, Ayhan; Ergun, Emrah; Tug, Niyazi

    2017-04-01

    To compare the effectiveness of intrauterine lidocaine infusion with lidocaine and intravenous tenoxicam for decreasing the pain levels associated with endometrial biopsy. This double-blind, placebo-controlled trial was conducted at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey, from May to November 2015, and comprised patients undergoing endometrial biopsy with Pipelle. Intrauterine lidocaine infusion, paracervical block with lidocaine, intravenous tenoxicam or 4ml intravenous normal saline administered prior to biopsy. The main outcome measure was pain intensity immediately afterwards and 30minutes after biopsy, determined by a visual analogue scale score. Number Cruncher Statistical System 2007 was used for statistical analyses. Of the 232 participants, intrauterine lidocaine infusion group had 59(25.4%) patients, 57(24.6%) were controls while paracervical block group and intravenous tenoxicam group each had 58(25%) patients. Both visual analogue scale 0 and 30 scores of the control group were significantly higher than the other three groups (p<0.05). Also, the scores of intravenous tenoxicam group were significantly higher than both intrauterine lidocaine infusion and paracervical block with lidocaine groups (p<0.05 each). Intravenous tenoxicam had a significantly lower effect than intrauterine lidocaine infusion and paracervical block with lidocaine during the early period after the procedure.

  3. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    Directory of Open Access Journals (Sweden)

    Fábio Herrmann Coelho-De-Souza

    2012-04-01

    Full Text Available OBJECTIVE: This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. MATERIAL AND METHODS: Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond and composite resin (Filtek P60. A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa, according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p <0.05. RESULTS: Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05 than butt joint restorations. CONCLUSIONS: It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities.

  4. CO(2) inhalation as a treatment for apnea of prematurity: a randomized double-blind controlled trial.

    Science.gov (United States)

    Alvaro, Ruben E; Khalil, Mohammad; Qurashi, Mansour; Al-Saif, Saif; Al-Matary, Abdulrahman; Chiu, Aaron; Minski, John; Manfreda, Juri; Kwiatkowski, Kim; Cates, Don; Rigatto, Henrique

    2012-02-01

    To compare the effect of prolonged inhalation of a low concentration of CO(2) with theophylline for the treatment of apnea of prematurity. Prospective, randomized, double-blind controlled trial of 87 preterm infants with apnea of prematurity (27-32 weeks' gestational age) assigned to either theophylline plus 0.5 L/min of room air via nasal prongs or placebo plus 0.5 L/min with CO(2) (about 1% inhaled) by nasal prongs for 3 days. Apnea time significantly decreased in the theophylline group from 189±33 s/h (control) to 57±11, 50±9, and 61±13 (days 1-3) (P=.0001) and in the CO(2) group from 183±44 (control) to 101±26, 105±29, and 94±26 s/h (days 1-3) (P=.03). Seven infants in the CO(2) group but none in the theophylline group failed to complete the study due to severe apneas (P=.003). Because theophylline was more effective in reducing the number and severity of apneas, inhalation of low concentration of CO(2), as used in the present study, cannot be considered as an alternative to theophylline in the treatment of apnea of prematurity. The less effectiveness of CO(2) treatment may have been related to the variability of the delivery of CO(2). Copyright © 2012 Mosby, Inc. All rights reserved.

  5. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Esmaeilzadeh, Hossein; Nabavi, Mohammad; Aryan, Zahra; Arshi, Saba; Bemanian, Mohammad Hassan; Fallahpour, Morteza; Mortazavi, Negar

    2015-10-01

    The effect of aspirin desensitization (AD) on immunologic profile of patients with AERD has been poorly understood. This study is aimed at investigating the effect of AD on clinical and immunological markers of patients with AERD. This randomized double-blind placebo-controlled trial comprised 34 adult patients (67.6% female) with chronic rhinosinusitis, nasal polyps, and aspirin-intolerant asthma. The active group underwent AD over a 2-day period with increasing doses of aspirin (60, 125, 325, and 625 mg), followed by receiving aspirin 625 mg twice daily for 6 months. Symptom scores and medication needs of patients with AERD who have undergone AD were significantly lower compared to the placebo group after 6 months (7.5 ± 3.5 vs. 10.6 ± 3.8 and 9.3 ± 2.0 vs. 11.0 ± 3.1, respectively, all p < 0.05). However, no significant difference was observed in serum concentration of IL-10, IFN-γ, and TGF-β between two groups neither at baseline nor at the end of study. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. The effect of counseling on anxiety after traumatic childbirth in nulliparous women; a single blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahnaz Azizi

    2010-09-01

    Full Text Available Background: Traumatic birthing mothers may expose more susceptible to experiences posttraumatic mental disorder such as anxiety. This study aimed to determine the effect of midwifery counseling intervention on the anxiety level after traumatic childbirth of primiparous women.Methods: In a randomized control trial 180 woman who had experienced traumatic childbirth based on DSM-IV criteria have been selected. The subjects were randomly divided into an intervention (n=90 and control (n=90 groups. The intervention group received midwifery counseling during two sessions and control group just received routin health care after childbirth. Both groups were followed up with partial – blind technique and compared 4-6 weeks and 3 months post partum. The data were analyzed using descriptive statistics by SPSS software. Results: Demographic characteristics, pregnancy complications and social support level were the same in both groups. In addition, there was no significant difference between two groups according to stress, depression and anxiety level before intervention (P>0.05. There was significant difference between two groups in anxiety level after 4-6 weeks and 3 months followup (P<0.001.Conclusion: Findings of this research shows that performing midwifery-counseling program may have significant effect on decreasing of anxiety level after traumatic childbirth.

  7. Double blind randomized trial of sucralfate vs. placebo during a course of radical radiotherapy for head and neck squamous carcinoma

    International Nuclear Information System (INIS)

    Carter, D.L.; Hebert, M.E.; Leopold, K.L.; Brizel, D.M.

    1997-01-01

    Purpose: To determine if sucralfate prophylaxis during a course of high dose radiation therapy (RT) for head and neck cancer decreases acute side effects including mucositis and weight loss. Methods: Ninety-eight patients receiving curative intent RT for advanced head and neck cancers participated in a single institution double blind randomized trial comparing sucralfate to placebo. Patients were stratified according to fractionation (QD or BID), use of concurrent chemotherapy (yes or no), Karnofsky performance status (KPS 5 % or > 10 % occurred more frequently in patients receiving chemotherapy (p<0.01 and p=0.05 respectively). Grade 3 mucositis was more common in patients receiving BID fractionation (p=0.04) or having a poor KPS status (continuous variable: p=0.01). Pain uncontrolled by narcotics was more common in patients who drank alcohol during therapy (p<0.01). No subset appeared to benefit from the use of sucralfate. Conclusions: Prophylactic treatment with sucralfate during high dose head and neck RT does not decrease acute treatment side effects. Other modalities should be investigated

  8. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    Science.gov (United States)

    Bowden, Deborah; Goddard, Lorna; Gruzelier, John

    2011-01-01

    This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood. PMID:21584234

  9. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    Directory of Open Access Journals (Sweden)

    Deborah Bowden

    2011-01-01

    Full Text Available This is a constructive replication of a previous trial conducted by Bowden et al. (2010, where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.

  10. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Danilo Maciel Carneiro

    2014-01-01

    Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.

  11. Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.

    Science.gov (United States)

    Lillicrap, Thomas; Krishnamurthy, Venkatesh; Attia, John; Nilsson, Michael; Levi, Christopher R; Parsons, Mark W; Bivard, Andrew

    2016-08-17

    Fatigue is a common symptom in stroke survivors for which there is currently no proven therapy. Modafinil is a wakefulness-promoting agent with established benefits in other disease models. We aim to test if modafinil will improve patient's self-reported fatigue scores when compared to placebo and if therapy results in increased quality of life. MIDAS is a phase II, single-centre, prospective, double-blinded, randomised, crossover trial of modafinil for the treatment of persistent fatigue in survivors of ischaemic stroke. The inclusion criteria will require an average score of 12 or more across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) and the diagnosis of a stroke more than 6 months prior. Patients will be randomised 1:1 to receive either modafinil 200 mg daily or placebo for a period of 6 weeks, after which a crossover will occur where patients who are on modafinil will begin taking placebo and vice versa. The primary outcome will be improvement in fatigue as measured by the MFI-20. Secondary outcomes will include changes in the Fatigue Severity Scale, improved cognition measured using the Montreal Cognitive Assessment, improvement in mood as determined by the Depression, Anxiety and Stress Scale and improvement in each patient's stroke-specific quality of life score. All participants will also undergo magnetic resonance imaging (MRI) at baseline, crossover and study conclusion to measure cerebral blood flow on arterial spin labelling and brain activity on resting state functional MRI. This study will comply with the CONSORT guidelines. The projected sample size requirement is 36 participants in a crossover trial giving a power of 80 % and a type-1 error rate of 0.05. MIDAS seeks to enhance the quality of life in stroke survivors by assisting or resolving stroke-associated fatigue. ACTRN12615000350527 , registered on the 17 April 2015. Protocol version 3, approved 16 June 2015.

  12. Effect of Transcutaneous Electric Nerve Stimulation on Pain after Total Knee Arthroplasty: A Blind Randomized Controlled Trial.

    Science.gov (United States)

    Beckwée, David; Bautmans, Ivan; Lefeber, Nina; Lievens, Pierre; Scheerlinck, Thierry; Vaes, Peter

    2018-02-01

    Transcutaneous electric nerve stimulation (TENS) has proven to be effective for postsurgical pain relief. However, there is a lack of well-constructed clinical trials investigating the effect of TENS after total knee arthroplasty (TKA). In addition, previous investigations reported that low- and high-frequency TENSs produced analgesic tolerance after 4 or 5 days of treatment. The aim of this study is to explore the effect of burst TENS on pain during hospitalization after TKA and to investigate whether burst TENS produces analgesic tolerance after 4 or 5 days of treatment. This stratified, triple blind, randomized controlled trial was approved by the University Hospital Brussels. Sixty-eight subjects were screened for eligibility before surgery; 54 were found eligible and 53 were included in the analyses. Patients were allocated to either a burst TENS or sham burst TENS group. TENS was applied daily during continuous passive mobilization. Knee pain intensity, knee range of motion, and analgesic consumption were assessed daily. Patients received burst TENS ( N  = 25) or sham burst TENS ( N  = 28). No significant differences in knee pain intensity were found between the groups ( p  > 0.05). Within the TENS and the sham TENS groups, the difference in knee pain before and after treatment did not evolve over time ( p  > 0.05). This study found no effects of burst TENS compared with sham burst TENS on pain during hospitalization after TKA. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  13. Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

    Science.gov (United States)

    Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

    2016-12-01

    Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring

  14. Topical lidocaine to improve oral intake in children with painful infectious mouth ulcers: a blinded, randomized, placebo-controlled trial.

    Science.gov (United States)

    Hopper, Sandy M; McCarthy, Michelle; Tancharoen, Chasari; Lee, Katherine J; Davidson, Andrew; Babl, Franz E

    2014-03-01

    We establish the efficacy of 2% viscous lidocaine in increasing oral intake in children with painful infectious mouth conditions compared with placebo. This was a randomized placebo-controlled trial of viscous lidocaine versus placebo at a single pediatric emergency department. Study staff, clinicians, nurses, caregivers, and participants were blinded to the group assignment. Children with acute infectious ulcerative mouth conditions (gingivostomatitis, ulcerative pharyngitis, or hand, foot, and mouth disease) and poor oral fluid intake were randomized to receive 0.15 mL/kg of either 2% viscous lidocaine or placebo with identical appearance and flavor. The primary outcome was the amount of fluid ingested in the 60 minutes after administration of the intervention, with a difference in intake of 4 mL/kg considered clinically important. Secondary outcomes were specific milliliter per kilogram fluid targets and incidence of adverse events. One hundred participants were recruited (50 per treatment group), all of whom completed the 60-minute fluid trial period. Oral intake 1 hour after drug administration was similar in both groups: lidocaine median 8.49 mL/kg (interquartile range 4.07, 13.84 mL/kg) versus placebo 9.31 mL/kg (interquartile range 3.06, 15.18 mL/kg); difference in medians 0.82 mL/kg (95% confidence interval -2.52 to 3.26); Mann-Whitney P=.90. Likewise, short-term secondary outcomes were similar between the groups and there were no adverse events in either group. Viscous lidocaine is not superior to a flavored gel placebo in improving oral intake in children with painful infectious mouth ulcers. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  15. Antioxidant supplement and long-term reduction of recurrent adenomas of the large bowel. A double-blind randomized trial.

    Science.gov (United States)

    Bonelli, Luigina; Puntoni, Matteo; Gatteschi, Beatrice; Massa, Paolo; Missale, Guido; Munizzi, Francesco; Turbino, Laura; Villanacci, Vincenzo; De Censi, Andrea; Bruzzi, Paolo

    2013-06-01

    Patients who undergo polypectomy are at increased risk of adenoma recurrence. The preventive potential of vitamins (A, C and E) and selenium supplementation represent an interesting opportunity for colorectal cancer prevention. To assess the efficacy of a combination of these micronutrients in reducing the incidence of recurrent adenomas in subjects on post-polypectomy endoscopic follow-up, a double-blind placebo-controlled randomized trial was started in Italy in 1988. A total of 411 patients were randomized to receive either an active compound (200 μg selenium, 30 mg zinc, 2 mg vitamin A, 180 mg vitamin C, 30 mg vitamin E) or a placebo daily for 5 years. Of them, 330 had follow-up colonoscopy (164 in the intervention and 166 in the placebo group). After a median follow-up of 4 years (range 1-15 years), 100 patients had recurrence: 38 in the intervention and 62 in the placebo arm. The 15-year cumulative incidence of recurrence was 48.3% in the intervention and 64.5% in the placebo arm (HR = 0.59; log-rank P = 0.009). A 39% reduction of the risk of recurrence was observed in the intervention compared to the placebo group (adjusted HR = 0.61; 95% CI 0.41-0.92): the risk reduction was similar for small tubular (adjusted HR = 0.61; 95% CI 0.37-0.99) and advanced adenomas (adjusted HR = 0.50; 95% CI 0.24-1.01). Our study showed a statistically significant effect of antioxidant supplementation on adenoma recurrence. Further clinical trials are needed to address the role of antioxidants in subgroups of subjects at increased risk for colorectal cancer.

  16. Perturbation During Treadmill Training Improves Dynamic Balance and Gait in Parkinson's Disease: A Single-Blind Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Steib, Simon; Klamroth, Sarah; Gaßner, Heiko; Pasluosta, Cristian; Eskofier, Björn; Winkler, Jürgen; Klucken, Jochen; Pfeifer, Klaus

    2017-08-01

    Gait and balance dysfunction are major symptoms in Parkinson's disease (PD). Treadmill training improves gait characteristics in this population but does not reflect the dynamic nature of controlling balance during ambulation in everyday life contexts. To evaluate whether postural perturbations during treadmill walking lead to superior effects on gait and balance performance compared with standard treadmill training. In this single-blind randomized controlled trial, 43 PD patients (Hoehn & Yahr stage 1-3.5) were assigned to either an 8-week perturbed treadmill intervention (n = 21) or a control group (n = 22) training on the identical treadmill without perturbations. Patients were assessed at baseline, postintervention, and at 3 months' follow-up. Primary endpoints were overground gait speed and balance (Mini-BESTest). Secondary outcomes included fast gait speed, walking capacity (2-Minute Walk Test), dynamic balance (Timed Up-and-Go), static balance (postural sway), and balance confidence (Activities-Specific Balance Confidence [ABC] scale). There were no significant between-group differences in change over time for the primary outcomes. At postintervention, both groups demonstrated similar improvements in overground gait speed ( P = .009), and no changes in the Mini-BESTest ( P = .641). A significant group-by-time interaction ( P = .048) existed for the Timed Up-and-Go, with improved performance only in the perturbation group. In addition, the perturbation but not the control group significantly increased walking capacity ( P = .038). Intervention effects were not sustained at follow-up. Our primary findings suggest no superior effect of perturbation training on gait and balance in PD patients. However, some favorable trends existed for secondary gait and dynamic balance parameters, which should be investigated in future trials.

  17. Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

    Directory of Open Access Journals (Sweden)

    Audicana Maria T

    2011-08-01

    Full Text Available Abstract Background Natural rubber latex allergy is a common and unsolved health problem. Since the avoidance of exposure is very difficult, immunotherapy is strongly recommended, but before its use in patients, it is essential to prove the efficacy and safety of extracts. The aim of the present randomised, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of latex sublingual immunotherapy in adult patients undergoing permanent latex avoidance. Methods Twenty-eight adult latex-allergic patients (5 males and 23 females, with mean age of 39 years (range 24-57 were randomized to receive a commercial latex-sublingual immunotherapy or placebo during one year, followed by another year of open, active therapy. The following outcomes were measured at baseline and at the end of first and second year of follow-up: skin prick test, gloves-use score, conjunctival challenge test, total and specific IgE, basophil activation test, and adverse reactions monitoring. Results No significant difference in any of the efficacy in vivo variables was observed between active and placebo groups at the end of the placebo-controlled phase, nor when each group was compared with their baseline values at the end of the two year-study. An improvement in the average percentage of basophils activated was observed. During the induction phase, 4 reactions in the active group and 5 in the placebo group were recorded. During the maintenance phase, two patients dropped out due to pruritus and to acute dermatitis respectively. Conclusion Further studies are needed to evaluate latex-sublingual immunotherapy, since efficacy could not be demonstrated in adult patients with avoidance of the allergen. Trial registration number ACTRN12611000543987

  18. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen

    NARCIS (Netherlands)

    Vranken, J. H.; Dijkgraaf, M. G. W.; Kruis, M. R.; van der Vegt, M. H.; Hollmann, M. W.; Heesen, M.

    2008-01-01

    The effective treatment of patients suffering from central neuropathic pain remains a clinical challenge, despite a standard pharmacological approach in combination with anticonvulsants and antidepressants. A randomized, double-blinded, placebo-controlled trial evaluated the effects of pregabalin on

  19. Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vranken, J. H.; Hollmann, M. W.; van der Vegt, M. H.; Kruis, M. R.; Heesen, M.; Vos, K.; Pijl, A. J.; Dijkgraaf, M. G. W.

    2011-01-01

    The mechanisms underlying central neuropathic pain are poorly understood. Pain inhibitory mechanisms including sertononergic and norepinephrine systems may be dysfunctional. In this randomized, double-blinded, placebo-controlled trial we evaluated the effects of duloxetine on pain relief

  20. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

    Directory of Open Access Journals (Sweden)

    Jamshidi Amir-Hossein

    2004-09-01

    Full Text Available Abstract Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS (Group 1 and capsule of imipramine 100 mg/day (TDS (Group 2 for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09. In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted.

  1. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

    Science.gov (United States)

    Akhondzadeh, Shahin; Fallah-Pour, Hasan; Afkham, Khosro; Jamshidi, Amir-Hossein; Khalighi-Cigaroudi, Farahnaz

    2004-01-01

    Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted. PMID:15341662

  2. Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

    Science.gov (United States)

    Hölzel, Lars P; Ries, Zivile; Kriston, Levente; Dirmaier, Jörg; Zill, Jördis M; Rummel-Kluge, Christine; Niebling, Wilhelm; Bermejo, Isaac; Härter, Martin

    2016-11-23

    To evaluate the usefulness of culture-sensitive patient information material compared with standard translated material. Multicentre, double-blind randomised controlled trial. 37 primary care practices. 435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin. Intervention group: provision of culture-sensitive adapted material. provision of standard translated material. Primary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points. Usefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005). Cultural adaptation of patient information material provides benefits over high quality

  3. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial.

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2014-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective:  The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants:  We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure:  The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L-arginine supplementation. at the beginning and end of the study. Results:  In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion : The use of L-arginine significantly improved outcomes compared to placebo.

  4. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2017-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective: The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants: We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure: The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L–arginine supplementation. at the beginning and end of the study. Results: In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion: The use of L-arginine significantly improved outcomes compared to placebo

  5. Nortriptyline versus fluoxetine in the treatment of major depressive disorder: a six-month, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Hashemi SN

    2012-01-01

    Full Text Available SN Hashemi1, HR Ghafarian Shirazi2,3, A Mohamadi4, GH Zadeh-Bagheri5, KH Noorian5, M Malekzadeh21Department of Psychiatry, Faculty of Medicine, 2Research Center of Social Factors Affecting Health, Yasuj University of Medical Sciences, Yasuj, 3School of Public Health, Tehran University of Medical Sciences, Tehran, 4Department of Psychiatry, 5School of Medicine, Yasuj University of Medical Sciences, Yasuj, IranBackground: Depression is a common psychiatric disorder worldwide, including in Iran, and is estimated to affect 10%–15% of the population. Antidepressant drugs can have multiple side effects, so a good choice of drug is important for successful treatment. This study compared the efficacy of nortriptyline with that of fluoxetine in the treatment of patients with major depressive disorder and assessed related factors, including age, gender, and level of education.Methods: The study was a double-blind, randomized clinical trial with a six-month follow-up period. Participants were 120 patients aged 15–60 years with a diagnosis of major depressive disorder based on a psychiatry interview and the Beck depression rating scale, which were performed at the beginning, middle, and end of the study. The patients were treated with nortriptyline or fluoxetine. The paired t-test, independent t-test, and the k chi-square test were used to analyze the data.Results: Twenty-three patients dropped out and 97 remained in the trial. Before intervention, the mean depression score was 32.85 ± 6.23 in the nortriptyline group and 33.12 ± 6.50 in the fluoxetine group. The results of the independent t-test showed a significant difference between depression score means before and after treatment in both groups. Changes at the end of the trial compared with baseline scores were 13.4 ± 4.68 and 16.96 ± 4.96 for nortriptyline and fluoxetine, respectively. Paired t-testing showed a significant difference in the mean depression score for both the nortriptyline and

  6. Rationale and design of a randomized, double-blind, event-driven, multicentre study comparing the efficacy and safety of oral rivaroxaban with placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an exacerbation of heart failure: the COMMANDER HF trial.

    Science.gov (United States)

    Zannad, Faiez; Greenberg, Barry; Cleland, John G F; Gheorghiade, Mihai; van Veldhuisen, Dirk J; Mehra, Mandeep R; Anker, Stefan D; Byra, William M; Fu, Min; Mills, Roger M

    2015-07-01

    Thrombin is a critical element of crosstalk between pathways contributing to worsening of established heart failure (HF). The aim of this study is to explore the efficacy and safety of rivaroxaban 2.5 mg bid compared with placebo (with standard care) after an exacerbation of HF in patients with reduced ejection fraction (HF-rEF) and documented coronary artery disease. This is an international prospective, multicentre, randomized, double-blind, placebo-controlled, event-driven study of approximately 5000 patients for a targeted 984 events. Patients must have a recent symptomatic exacerbation of HF, increased plasma concentrations of natriuretic peptides (B-type natriuretic peptide ≥200 pg/mL or N-terminal pro-B-type natriuretic peptide ≥800 pg/mL), with left ventricular ejection fraction ≤40% and coronary artery disease. Patients requiring anticoagulation for atrial fibrillation or other conditions will be excluded. After an index event (overnight hospitalization, emergency department or observation unit admission, or unscheduled outpatient parenteral treatment for worsening HF), patients will be randomized 1:1 to rivaroxaban or placebo (with standard of care). The primary efficacy outcome event is a composite of all-cause mortality, myocardial infarction or stroke. The principal safety outcome events are the composite of fatal bleeding or bleeding into a critical space with potential permanent disability, bleeding events requiring hospitalization and major bleeding events according to International Society on Thrombosis and Haemostasis bleeding criteria. COMMANDER HF is the first prospective study of a target-specific oral antithrombotic agent in HF. It will provide important information regarding rivaroxaban use following an HF event in an HF-rEF patient population with coronary artery disease. © 2015 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

  7. A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

    DEFF Research Database (Denmark)

    Agren, Magnus S; Ostenfeld, Ulla; Kallehave, Finn

    2006-01-01

    The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile...... abnormalities by histopathological examination of wound biopsies, or other harmful effects. Larger clinical trials will be required to show definitive effects of topical zinc oxide on wound healing and infection....

  8. Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Carbonell JL

    2015-01-01

    Full Text Available Josep Lluis Carbonell,1 Ramon Garcia,2 Adriana Gonzalez,2 Andres Breto,2 Carlos Sanchez2 1Mediterranea Medica Clinic, Valencia, Spain; 2Eusebio Hernandez Gynecology and Obstetrics Teaching Hospital, Havana, Cuba Purpose: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. Methods: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba. A total of 2,418 women who requested emergency contraception after unprotected coitus received either 5 mg or 10 mg mifepristone. The variables for assessing efficacy were the pregnancies that occurred and the fraction of pregnancies that were prevented. Other variables assessed were the side effects of mifepristone, vaginal bleeding, and changes in the date of the following menstruation. Results: There were 15/1,206 (1.2% and 9/1,212 (0.7% pregnancies in the 5 mg and 10 mg group, respectively (P=0.107. There were 88% and 93% prevented pregnancies in the 5 mg and 10 mg group, respectively. The side effect profiles were similar in both groups. Delayed menstruation ≥7 days was experienced by 4.9% and 11.0% of subjects in the 5 mg and 10 mg group, respectively (P=0.001. There was a significant high failure rate for women weighing >75 kg in the 5 mg group. Conclusion: It would be advisable to use the 10 mg dose of mifepristone for emergency contraception as there was a trend suggesting that the failure rate of the larger dose was lower. Keywords: mifepristone, emergency contraception

  9. Tetrahydrocannabinol (THC) for cramps in amyotrophic lateral sclerosis: a randomised, double-blind crossover trial.

    Science.gov (United States)

    Weber, M; Goldman, B; Truniger, S

    2010-10-01

    Many patients with amyotrophic lateral sclerosis (ALS) experience cramps during the course of the disease but so far, none of the medications used has been of proven benefit. The objective was to determine the effect of orally administered tetrahydrocannabinol (THC) on cramps in ALS patients. The authors conducted a randomised, double-blind, placebo-controlled crossover trial in 27 ALS patients suffering from moderate to severe (visual analogue scale (VAS); VAS≥4) daily cramps. There were 7 women and 20 men with a mean age of 57 years and a mean functional ALS score (ALSFRS-R) of 38.4. Patients were randomly assigned to receive 5 mg THC twice daily followed by placebo or vice versa. Each treatment period lasted for 2 weeks and was preceded by a 2-week drug-free observation period (run-in, wash-out period respectively). The primary outcome measure was change in cramp intensity as assessed by a VAS. Secondary outcome measures included the number of cramps per day, number of cramps during daytime and bedtime, intensity of fasciculations (VAS) as well as validated measures of quality of life (ALSAQ-40), quality of sleep (SDQ), appetite (FAACT) and depression (HADS). Complete data were available from 22 patients. THC was well tolerated. There was no evidence for a treatment effect on cramp intensity, number of cramps, fasciculation intensity or any of the other secondary outcome measures. This interventional study with orally administered THC 5 mg twice daily did not demonstrate subjective improvement of cramp intensity in ALS patients.

  10. A double-blind trial of mazindol using a very low calorie formula diet.

    Science.gov (United States)

    Baird, I M; Howard, A N

    1977-01-01

    Thirty-eight obese patients, resistant to conventional diet therapy, agreed to consume a 1.09 MJ (260 kcal)/day semi-synthetic diet consisting of 25 g egg albumin, 40 g oligosaccharides, vitamins and minerals, and were seen weekly as outpatients for eight weeks. At the beginning, the semi-synthetic diet was given with either the anorectic drug, mazindol (2 mg/day) or a placebo for four weeks and then changed over for the remaining four weeks; the study being conducted on a double-blind basis. The final treatment was a 4.2 MJ (1000 KCAL) conventional diet for a further four weeks without drug or placebo. Twenty-five patients completed the first eight weeks and 21 patients the final four weeks of the trial. The total mean weight losses were as follows: week 4, 9.3 kg; week 8, 13.7 kg; week 12, 12.2 kg. There was no significant difference in weight loss between mazindol treatment and placebo but the former group reported feeling less hungry. The chief side-effects observed were dizziness, nausea, dry mouth, insomnia and depression which were more frequent with mazindol. Six patients had to stop mazindol because of side-effects, but were able to continue the diet alone. It is concluded that a semi-synthetic diet containing 1.09 MJ (260 kcal) daily can be successfully employed in the treatment of obese outpatients, and is a practical therapeutic alternative to admission to hospital. There is no clinical advantage to be gained by the additional use of the anorectic drug, mazindol.

  11. Double-Blind, Placebo-Controlled, Randomized Trial of Selenium in Graves Hyperthyroidism.

    Science.gov (United States)

    Kahaly, George J; Riedl, Michaela; König, Jochem; Diana, Tanja; Schomburg, Lutz

    2017-11-01

    Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Evaluate efficacy of add-on Se on medical treatment in GD. Double-blind, placebo-controlled, randomized supplementation trial. Academic endocrine outpatient clinic. Seventy untreated hyperthyroid patients with GD. Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Response rate (week 24), recurrence rate (week 36), and safety. A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) at week 24 [odds ratio (OR) 0.93; 95% confidence interval (CI), 0.26 to 3.25; P = 0.904] in the Se (+MMI) and placebo (+MMI) groups, respectively. During a 12-week follow-up, 11 of 23 (48%) and 12 of 27 (44%) relapsed (OR 1.13; 95% CI, 0.29 to 2.66; P = 0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates. At week 36, 12 of 29 (41%) and 15 of 33 (45%) were responders and still in remission in the Se and placebo groups, respectively (OR 0.85; 95% CI, 0.31 to 2.32; P = 0.80). Serum levels of free triiodothyronine/free tetraiodothyronine, thyroid-stimulating hormone receptor antibody, prevalence of moderate to severe Graves orbitopathy, thyroid volume, and MMI starting dose were significantly lower in responders than in nonresponders. A total of 56 and 63 adverse events occurred in the Se and placebo groups, respectively (P = 0.164), whereas only one drug-related side effect (2.9%) was noted in 35 patients on placebo + MMI. Supplemental Se did not affect response or recurrence rates in GD. Copyright © 2017 Endocrine Society

  12. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial].

    Science.gov (United States)

    Sánchez Bayle, M; Martín Martín, R; Cano Fernández, J; Martínez Sánchez, G; Gómez Martín, J; Yep Chullen, G; García García, M C

    2012-07-01

    [corrected] To study the utility of chest physiotherapy by increased exhalation technique with assisted cough in the acute bronchiolite of the hospitalized new-born babys. Double-blind clinical trial accomplished on 236 patients of age lower than 7 months and hospitalizad with diagnosis of acute bronchiolitis, first episode, in a pediatric department in Madrid.The patients were randomized in two groups: those who have received maneuvers of chest physiotherapy and those who have received maneuvers placebo. Only physiotherapist were aware of the allocation group of the infants. The days of hospitalization and the hours of oxygentherapy were used like result measurement. From the totality of the studied children 57,6% received maneuvers of chest physiotherapy and 42,4% remaining received maneuvers placebo. In the group that received chest physiotherapy the average stay in the hospital was 4,56 days (95% confidence interval [CI] 4,36-6,06) and the average time of oxygentherapy was 49,98 (95% CI 43,64-67,13) hours opposite to 4,54 days (95%CI 3,81-5,73) and 53,53 hours (95% CI 48,03-81,40) respectively in the group that did not receive chest physiotherapy. In the patients with analytical print for VRS and that received chest physiotherapy less hours of oxygen therapy were needed 48,80 hours (95% CI 42,94-55,29) opposite to 56,68 hours (95% CI 55,46-65,52) respectively, being the only one turned out as per statistics significantly (P=.042). Results show that chest physiotherapy has not been effective in reducing hospital stay or length of oxygentherapy in patients with acute bronchiolitis, but in the positive study of children with respiratory syncytial virus in nasopharyngeal aspirate showed a reduced need hours of oxygen. hours (P=.042). Copyright © 2011 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  13. Clinical Trial Adaptation by Matching Evidence in Complementary Patient Sub-groups of Auxiliary Blinding Questionnaire Responses.

    Directory of Open Access Journals (Sweden)

    Ognjen Arandjelović

    Full Text Available Clinical trial adaptation refers to any adjustment of the trial protocol after the onset of the trial. Such adjustment may take on various forms, including the change in the dose of administered medicines, the frequency of administering an intervention, the number of trial participants, or the duration of the trial, to name just some possibilities. The main goal is to make the process of introducing new medical interventions to patients more efficient, either by reducing the cost or the time associated with evaluating their safety and efficacy. The principal challenge, which is an outstanding research problem, is to be found in the question of how adaptation should be performed so as to minimize the chance of distorting the outcome of the trial. In this paper we propose a novel method for achieving this. Unlike most of the previously published work, our approach focuses on trial adaptation by sample size adjustment i.e. by reducing the number of trial participants in a statistically informed manner. We adopt a stratification framework recently proposed for the analysis of trial outcomes in the presence of imperfect blinding and based on the administration of a generic auxiliary questionnaire that allows the participants to express their belief concerning the assigned intervention (treatment or control. We show that this data, together with the primary measured variables, can be used to make the probabilistically optimal choice of the particular sub-group a participant should be removed from if trial size reduction is desired. Extensive experiments on a series of simulated trials are used to illustrate the effectiveness of our method.

  14. Trunk Exercises Improve Gait Symmetry in Parkinson Disease: A Blind Phase II Randomized Controlled Trial.

    Science.gov (United States)

    Hubble, Ryan P; Naughton, Geraldine; Silburn, Peter A; Cole, Michael H

    2018-03-01

    Deficits in step-to-step symmetry and trunk muscle activations have been linked to falls in Parkinson disease. Given such symptoms are poorly managed with anti-parkinsonian medications, alternate therapies are needed. This blind phase II randomized controlled trial sought to establish whether exercise can improve step-to-step symmetry in Parkinson disease. Twenty-four Parkinson disease patients with a falls history completed baseline assessments of symptom severity, balance confidence, mobility, and quality of life. Step-to-step symmetry was assessed by deriving harmonic ratios from three-dimensional accelerations collected for the head and trunk. Patients were randomly assigned to either 12 wks of exercise and falls prevention education or falls prevention education only. Both groups repeated the baseline tests 12 and 24 wks after the initial assessment. The Australian and New Zealand Clinical Trials Registry number is ACTRN12613001175763. At 12 wks, the exercise group had statistically significant and clinically relevant improvements in anterior-posterior step-to-step trunk symmetry. In contrast, the education group recorded statistically significant and clinically meaningful reductions in medial-lateral and vertical step-to-step trunk symmetry at 12 wks. Given that step-to-step symmetry improved for the exercise group and declined for the education group after intervention, active interventions seem more suited to increasing independence and quality of life for people with Parkinson disease. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Upon completion of this article, the reader should be able to do the following: (1) Describe the effect deficits in trunk muscle function have on gait in individuals with Parkinson disease; (2) Identify the benefits of targeted trunk exercises on step-to-step symmetry; and (3) Discuss the benefits of improving step-to-step symmetry in individuals with Parkinson

  15. A Comparative Study of the Manneristic Behaviour of Blind and Sighted Children. Research Series No. 1.

    Science.gov (United States)

    Indian National Inst. for the Visually Handicapped, Dehra Dun.

    Examination of the manneristic behavior (stereotyped or repetitive movement) of 542 blind and 365 sighted children was undertaken. Seventeen types of manneristic behavior were investigated, including head movement, eye poking and rubbing, body rocking, kicking, and posture distortion. Comparison of the behaviors observed in sighted and blind Ss…

  16. The effect of calf stretching box on stretching calf muscle compliance: a prospective, randomized single-blinded controlled trial.

    Science.gov (United States)

    Chadchavalpanichaya, Navaporn; Srisawasdi, Gulapar; Suwannakin, Atchara

    2010-12-01

    To study the effect of calf stretching box usage in increasing the compliance of performing calf stretching exercise as compared to the conventional exercise method. To study the effect of calf stretching box usage in decreasing the calf muscle tightness and complications as compared to the conventional exercise method. Eighty patients older than 45 years old with calf muscles tightness were enrolled in a prospective, randomized single-blinded controlled trial at the out-patient Rehabilitation medicine clinic, Siriraj Hospital, Bangkok Thailand between April and August 2009. Patients were randomized into two groups, the study group (stretching by using calf stretching box) and the control group (stretching by the conventional exercise method). Patients in both groups were asked to hold the stretch for at least 1 minute and to perform the stretching program at least two times per day, every day for two weeks. Furthermore, they were asked to record the real frequency and duration of their exercise and complications in a logbook every day. Thirty-eight patients in each group completed the study. The baseline characteristics of the patients in both groups were similar. The study group had higher frequency and longer duration of performing calf stretching exercise than the control group. They also reported more decrease of calf muscle tightness with less pain complication (shoulder pain, knee pain, low back pain, and calf muscle pain) than the control group (p calf muscle and degree of ankle range of motion between the two groups. Stretching calf muscle with calf stretching box can increase compliance, decrease calf muscle tightness and decrease complications when compared with the conventional exercise method.

  17. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Morice, Alyn H; McGarvey, Lorcan; Pavord, Ian D; Higgins, Bernard; Chung, Kian Fan; Birring, Surinder S

    2017-07-01

    To investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity. This was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests. At baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P<0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (-12.2±23.28 in BC1036 group and -11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups. This study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity. ClinicalTrials.gov: NCT01656668.

  18. Selenium supplementation improves the nutritional status of hemodialysis patients: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Salehi, Moosa; Sohrabi, Zahra; Ekramzadeh, Maryam; Fallahzadeh, Mohammad Kazem; Ayatollahi, Maryam; Geramizadeh, Bita; Hassanzadeh, Jafar; Sagheb, Mohammad Mahdi

    2013-03-01

    Malnutrition is highly prevalent in hemodialysis (HD) patients. These patients have high levels of oxidative stress and inflammation which can subsequently induce malnutrition. Selenium levels have been found to be decreased in HD patients. As selenium deficiency leads to oxidative stress and inflammatory response, the aim of this study was to evaluate the effects of selenium supplementation on oxidative and inflammatory markers and the nutritional status of HD patients. In this randomized double-blind placebo-controlled trial, 80 patients on stable HD for at least 3 months without any acute illness or active infections were randomly allocated to two equal groups to receive one selenium (200 µg) or placebo capsule daily for 12 weeks. Serum levels of lipoproteins, malondialdehyde (MDA), interleukin-6 (IL-6), high-sensitivity C-reactive protein (HSCRP), homocysteine, ferritin and transferrin as well as the subjective global assessment (SGA) score, malnutrition-inflammation score (MIS) and hemoglobin (Hb) levels were measured at the baseline and at the end of the treatment phase. The primary outcome was a change in the nutritional status measured by the SGA score from the baseline towards the end of the treatment phase of the study. The SGA score and MIS decreased significantly in the selenium group compared to the placebo group (P < 0.001 for both). Moreover, serum levels of MDA decreased significantly in the selenium group compared with increasing levels in the placebo group (P < 0.001). Selenium supplementation also hindered an increase in IL-6 levels compared with the placebo group (P = 0.016). There were no significant differences between the selenium and placebo groups in terms of changes in serum levels of lipoproteins, HSCRP, homocysteine, ferritin and transferrin or Hb levels. This study shows that selenium may be an effective complementary supplement for reducing the severity of malnutrition in HD patients through alleviating oxidative stress and

  19. Lactobacillus GG (LGG) and smectite versus LGG alone for acute gastroenteritis: a double-blind, randomized controlled trial.

    Science.gov (United States)

    Pieścik-Lech, Małgorzata; Urbańska, Magdalena; Szajewska, Hania

    2013-02-01

    Diarrhea treatment with either Lactobacillus GG (LGG) or smectite as an adjuvant to standard rehydration therapy has proven efficacy. In countries where both LGG and smectite are available, concomitant use is frequently practiced. We investigated whether LGG plus smectite is superior to LGG alone in the management of children with acute gastroenteritis (AGE). A double-blind, placebo-controlled, randomized trial was performed. Children aged 4 to 60 months with AGE received LGG 6 × 10(9) colony forming units/day plus randomly either smectite (3 g) or placebo as an adjuvant to the standard rehydration therapy. Of the 88 children randomized, 81 (92 %) were available for intention-to-treat analysis. The duration of diarrhea in the LGG/smectite group (n = 44) compared with the LGG/placebo group (n = 37) was similar (P = 0.43). There were no significant differences between the study groups for the secondary outcomes, with three exceptions. On day 4, in the LGG/placebo group compared to the LGG/smectite group, there was significantly reduced stool frequency (P = 0.03). While there was a significant (P = 0.05) difference in stool consistency on the Bristol Stool Form Scale on day 4, it was not of clinical relevance. Finally, in the LGG/smectite group compared to the LGG/placebo group, there was a significantly shorter duration of intravenous therapy after randomization (P = 0.02). No adverse events were observed in the study groups. LGG plus smectite and LGG alone are equally effective for treating young children with AGE. Combined use of the two interventions is not justified.

  20. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

    Science.gov (United States)

    Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark; Livant, Edward; Palanee-Phillips, Thesla; Hendrix, Craig W; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Soto-Torres, Lydia E; Schwartz, Katie; Hillier, Sharon L; Baeten, Jared M

    2017-11-01

    Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. An upward trend in adherence was observed (P 95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.

  1. Antifatigue Effects of Panax ginseng C.A. Meyer: A Randomised, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Yoo, Sa-Ra; Lee, Jin-Seok; Han, Jong-Min; Lee, Nam-Hun; Ahn, Yo-Chan; Son, Chang-Gue

    2013-01-01

    The present study investigated the antifatigue effects of Panax ginseng C.A. Meyer in 90 subjects (21 men and 69 women) with idiopathic chronic fatigue (ICF) in a randomised, double-blind, placebo-controlled and parallel designed trial. A bespoke 20% ethanol extract of P. ginseng (1 g or 2 g day–1) or a placebo was administered to each group for 4 weeks, and then fatigue severity was monitored using a self-rating numeric scale (NRS) and a visual analogue scale (VAS) as a primary endpoint. Serum levels of reactive oxygen species (ROS), malondialdehyde (MDA), total glutathione (GSH) contents and glutathione reductase (GSH-Rd) activity were determined. After 4-week, P. ginseng administration decreased the total NRS score, but they were not statistically significant compared with placebo (P>0.05). Mental NRS score was significantly improved by P. ginseng administrations as 20.4±5.0 to 15.1±6.5 [95% CI 2.3∼8.2] for 1 g and 20.7±6.3 to 13.8±6.2 [95% CI −0.1∼4.2] for 2 g compared with placebo 20.9±4.5 to 18.8±2.9 [95% CI 4.1∼9.9, Pginseng significantly reduced the VAS score from 7.3±1.3 to 4.4±1.8 [95% CI 0.7∼1.8] compared with the placebo 7.1±1.0 to 5.8±1.3 [95% CI 2.2 ∼3.7, Pginseng compared to placebo. P. ginseng 1 g increased GSH concentration and GSH-Rd activity. Our results provide the first evidence of the antifatigue effects of P. ginseng in patients with ICF, and we submit that these changes in antioxidant properties contribute in part to its mechanism. Trial Registration Clinical Research Information Service (CRIS) KCT0000048 PMID:23613825

  2. Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Anzić, S A; Turkalj, M; Župan, A; Labor, M; Plavec, D; Baudoin, T

    2018-04-01

    Gastroesophageal reflux recommended treatment (dose and duration) with proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms of laryngopharyngeal reflux (LPR) and comorbid chronic rhinosinusitis (CRS). Double-blind randomised placebo-controlled trial. Eight weeks of treatment with omeprazole 20 mg once daily (OD). Sixty patients (28 women, aged 19-87 years) with diagnosed LPR and comorbid CRS. Significant reduction in signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) of LPR after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo. Secondary objectives were significant reduction in signs and symptoms of comorbid CRS after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo and the association of the severity of signs and symptoms of LPR with the ones of CRS. RSI and RFS decreased significantly more in the active treatment group after 8 weeks compared to placebo (P < .001 for both). CRS and endoscopy scoring decreased both significantly more in the active group after 8 weeks compared to placebo (P < .001 for both). CRS scoring significantly correlated with RSI (R = 0.312, P = .015) but not with RFS (R = 0.199, P = .127). The results of our trial suggest that omeprazole 20 mg OD for 8 weeks was effective in reducing signs and symptoms of both LPR and CRS, although in most patients still present at the end of the trial. © 2017 John Wiley & Sons Ltd.

  3. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Meredith, Ruby; Salter, Merle; Kim, Robert; Spencer, Sharon; Weppelmann, Burkhard; Rodu, Brad; Smith, Judy; Lee, Jeanette

    1997-01-01

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of antacid, diphenhydramine, and viscous lidocaine alone. Methods and Materials: A double-blind study was conducted in which nurses and pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of antacid, diphenhydramine, and viscous lidocaine vs. the same solution plus sucralfate. Eligible patients were those receiving >40 Gy at 1.8 Gy/fraction, one fraction/day, five fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. The observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective nonstudy agents was not allowed. The ability to eat various consistency of foods was graded 0-5, with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + SD for food and soreness scores, paired t-test, and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 111 patients were entered. Because some withdrew and others did not require medication, results are presented for evaluable patients in each category. Mild adverse effects from the medication solution (usually mouth discomfort) were reported by <10% of patients in each treatment group among 106 patients evaluable for toxicity. There was a comparable incidence of mild-moderate mucositis for the two treatment groups. Severe mucositis was noted in two patients of the standard medication group and none among patients receiving sucralfate. The groups were comparable

  4. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial.

    Science.gov (United States)

    Boden, Ianthe; Skinner, Elizabeth H; Browning, Laura; Reeve, Julie; Anderson, Lesley; Hill, Cat; Robertson, Iain K; Story, David; Denehy, Linda

    2018-01-24

    To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7

  5. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial.

    Science.gov (United States)

    Potter, John F; Robinson, Thompson G; Ford, Gary A; Mistri, Amit; James, Martin; Chernova, Julia; Jagger, Carol

    2009-01-01

    Raised blood pressure is common after acute stroke and is associated with an adverse prognosis. We sought to assess the feasibility, safety, and effects of two regimens for lowering blood pressure in patients who have had a stroke. Patients who had cerebral infarction or cerebral haemorrhage and were hypertensive (systolic blood pressure [SBP] >160 mm Hg) were randomly assigned by secure internet central randomisation to receive oral labetalol, lisinopril, or placebo if they were non-dysphagic, or intravenous labetalol, sublingual lisinopril, or placebo if they had dysphagia, within 36 h of symptom onset in this double-blind pilot trial. The doses were titrated up if target blood pressure was not reached. Analysis was by intention to treat. This trial is registered with the National Research Register, number N0484128008. 179 patients (mean age 74 [SD 11] years; SBP 181 [SD 16] mm Hg; diastolic blood pressure [DBP] 95 [SD 13] mm Hg; median National Institutes of Health stroke scale [NIHSS] score 9 [IQR 5-16] points) were randomly assigned to receive labetolol (n=58), lisinopril (n=58), or placebo (n=63) between January, 2005, and December, 2007. The primary outcome--death or dependency at 2 weeks--occurred in 61% (69) of the active and 59% (35) of the placebo group (relative risk [RR] 1.03, 95% CI 0.80-1.33; p=0.82). There was no evidence of early neurological deterioration with active treatment (RR 1.22, 0.33-4.54; p=0.76) despite the significantly greater fall in SBP within the first 24 h in this group compared with placebo (21 [17-25] mm Hg vs 11 [5-17] mm Hg; p=0.004). No increase in serious adverse events was reported with active treatment (RR 0.91, 0.69-1.12; p=0.50) but 3-month mortality was halved (9.7%vs 20.3%, hazard ratio [HR] 0.40, 95% CI 0.2-1.0; p=0.05). Labetalol and lisinopril are effective antihypertensive drugs in acute stroke that do not increase serious adverse events. Early lowering of blood pressure with lisinopril and labetalol after acute

  6. Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial.

    Science.gov (United States)

    Stephenson, Kevin B; Agapova, Sophia E; Divala, Oscar; Kaimila, Yankho; Maleta, Kenneth M; Thakwalakwa, Chrissie; Ordiz, M Isabel; Trehan, Indi; Manary, Mark J

    2017-12-01

    Background: Growth faltering is common in rural African children and is attributed to inadequate dietary intake and environmental enteric dysfunction (EED). Objective: We tested the hypothesis that complementary feeding with cowpea or common bean flour would reduce growth faltering and EED in 6-mo-old rural Malawians compared with the control group receiving a corn-soy blend. Design: A prospective, double-blind, randomized controlled clinical trial was conducted in which children received daily feeding for 6 mo (200 kcal/d when 6-9 mo old and 300 kcal/d when 10-12 mo old). The primary outcomes were change in length-for-age z score (LAZ) and improvements in EED, as measured by percentage of lactulose excretion (%L). %L group and the control group with Student's t test. Results: Of the 355 infants enrolled, 291 infants completed the trial, and 288 were breastfed throughout the duration of the study. Cowpea and common bean added 4.6-5.2 g protein/d and 4-5 g indigestible carbohydrate/d to the diet. LAZ and weight-for-height z score were reduced in all 3 groups from 6 to 12 mo of age. The changes in LAZ [mean (95% CI)] for the cowpea, common bean, and control groups from 6 to 9 mo were -0.14 (-0.24, -0.04), -0.27 (-0.38, -0.16), and -0.27 (-0.35, -0.19), respectively. LAZ was reduced less in infants receiving cowpea than in those receiving control food from 6 to 9 mo ( P = 0.048). The absolute value of %L did not differ between the dietary groups at 9 mo of age (mean ± SD: 0.30 ± 0.43, 0.23 ± 0.21, and 0.26 ± 0.31 for cowpea, common bean, and control, respectively), nor did the change in %L from 6 to 9 mo. Conclusion: Addition of cowpea to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT02472262. © 2017 American Society for Nutrition.

  7. Comparing the accuracy and efficacy of ultrasound-guided versus blind injections of steroid in the glenohumeral joint in patients with shoulder adhesive capsulitis.

    Science.gov (United States)

    Raeissadat, Seyed Ahmad; Rayegani, Seyed Mansoor; Langroudi, Taraneh Faghihi; Khoiniha, Maryam

    2017-04-01

    Shoulder adhesive capsulitis is a condition mainly characterized by a decreased range of motion (ROM), with a lifelong prevalence of 2-5 %. Intra-articular steroid injection is an important treatment in this disease. It has been suggested that ultrasound-guided (US-guided) intra-articular injections are more accurate and effective than blind injections. This randomized clinical trial was designed to compare efficacy and accuracy of US-guided injections versus blind injections of steroid in the glenohumeral joint. Forty-one patients diagnosed with shoulder adhesive capsulitis were included. Patients randomly underwent intra-articular injection either blind or under guidance of ultrasound by a specialist. Immediately after injection, radiograms were obtained to assess the accuracy of injection. Demographic characteristics, their functional status, the severity of pain, and the ROM were gathered and compared between the two groups. Twenty patients in the US-guided group and 21 in the blind group finished the 4-week period of the study. Improvements in pain, ROM, and functional score after 1 and 4 weeks were more prominent in the US-guided group, but the differences were not statistically significant, except for the changes in extension where the improvements were significantly higher in the US-guided group (p = 0.01). The accuracy of injections was also higher in the US-guided group (90 % vs. 76.19 %), but the differences were not found to be significant (p = 0.24). US-guided injections can be more accurate and yield better improvements in pain, ROM, and function of the patients, but they cost more and are time-consuming.

  8. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial.

    Science.gov (United States)

    Buigues, Cristina; Fernández-Garrido, Julio; Pruimboom, Leo; Hoogland, Aldert J; Navarro-Martínez, Rut; Martínez-Martínez, Mary; Verdejo, Yolanda; Mascarós, Mari Carmen; Peris, Carlos; Cauli, Omar

    2016-06-14

    Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre(®) (Bonusan Besloten Vennootschap (BV), Numansdorp, The Netherlands) to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin). Participants were randomized to a parallel group intervention of 13 weeks' duration with a daily intake of Darmocare Pre(®) or placebo. Either prebiotic or placebo were administered after breakfast (between 9-10 a.m.) dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis). The overall rate of frailty was not significantly modified by Darmocare Pre(®) administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p sleep quality. The use of novel therapeutic approaches influencing the gut microbiota-muscle-brain axis could be considered for treatment of the frailty syndrome.

  9. Blinded by the White: A Comparative Analysis of Jury Challenges on Racial Grounds

    Directory of Open Access Journals (Sweden)

    Thalia Anthony

    2017-08-01

    Full Text Available Indigenous peoples in Australia, the United States and Canada are significantly overrepresented as defendants in criminal trials and yet vastly underrepresented on juries in criminal trials. This means that all-white juries mostly determine the guilt of Indigenous defendants or white defendants responsible for harming Indigenous victims. In this article, we explore cases in which Indigenous defendants have perceived that an all-white jury’s prejudice against Indigenous people would prevent them receiving a fair trial. It focuses on Indigenous defendants (often facing charges in relation to protesting against white racism challenging the array of all-white juries. Across these cases, Australian courts rely on formal notions of fairness in jury selection to dismiss the Indigenous defendant’s perception of bias and foreclose an inquiry into the potential prejudices of white jurors. We compare the Australian judicial ‘colour-blindness’ towards all-white juries with that of the United States and Canada. We argue that the tendency for courts in the United States and Canada to question jurors on their biases provides useful lessons for Australian judiciaries, including in relation to the impending trials of Indigenous defendants in Kalgoorlie, Western Australia, accused of committing crimes in response to white racist violence. Nonetheless, across all jurisdictions where there is a challenge to the array based on racial composition, courts consistently uphold all-white juries. We suggest that the judicial view of the racial neutrality of white jury selection misapprehends the substantive biases in jury selection and the injustice perceived by defendants in having a white jury adjudicate an alleged crime that is committed in circumstances involving protest against white prejudice.

  10. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kwok T

    2013-09-01

    Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

  11. Effect of home visit training program on growth and development of preterm infants: a double blind randomized controlled trial.

    Science.gov (United States)

    Edraki, Mitra; Moravej, Hossian; Rambod, Masoume

    2015-01-01

    Home visit program can be effective in infants' growth and development. The present study aimed to investigate the effect of home visit program on preterm infants' growth and development within 6 months. It was a double-blind clinical trial study. The study was conducted in Hafez, Hazrat-e-Zeinab, and Namazee Hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran from 2010 to 2011. Preterm infants were divided into intervention (n=30) and control groups (n=30) through blocked randomization. The intervention group received home visit training program for 6 months, while the control group only received the hospital's routine care. Then, the infants' growth indexes, including weight, height, and head circumference, and development criteria were compared on the first day of admission in Neonatal Intensive Care Unit, and then first, second, third, and sixth months. The data were analyzed using Chi-square, independent t-test, and repeated measures ANCOVA. The mean weight of the intervention and control group infants was 7207.3±1129.74 and 6366.7±922.26 gr in the sixth month. Besides, the intervention group infants' mean weight was higher compared to the control group after six months (t=-3.05, P=0.03). Also, a significant difference was found between the two groups regarding development indexes, such as following moving objects with the head, keeping the head stable when changing the position from lying to sitting,  producing "Agha" sound, and taking objects by hand (Ppreterm infants' weight gain and some development indexes at the sixth month. Considering the importance of infants' growth and development, healthcare staff is recommended to incorporate home visit training into their programs, so that steps can be taken towards improvement of preterm infants' health. IRCT2014082013690N3 

  12. Chlorhexidine alcohol base mouthrinse versus Chlorhexidine formaldehyde base mouthrinse efficacy on plaque control: Double blind, randomized clinical trials

    Science.gov (United States)

    Lakhdar, Leila; Bouziane, Amal; Bensouda, Yahia; Abouqal, Redouane

    2013-01-01

    Background: Chlorhexidine is well known for its antiplaque effect. However, the mouthrinse based chlorhexidine antiplaque efficiency may vary according to the formulation of the final product. The aim of the present study was to compare anti-plaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). Material and Methods: the study was a seven day randomized, double-blind, placebo-controlled trial including 30 volunteers. At the start, all participants received a dental prophylaxis. Over 7 days experimental non-brushing period, during which subjects abstained from all forms of mechanical oral hygiene, one group test rinsed twice daily with 15ml of an alcohol base 0.12% Chlorhexidine mouthrinse. The second group test used 15ml of alcohol free 0.1% Chlorhexidine mouthrinse base 0.1% formaldehyde twice daily. The negative control group used a placebo. Plaque indexes were recorded in all volunteers prior to treatment at Day 0, 1 and 7. Results: After 7 days, the mean plaque index for the first group was 0.76±0.38 compared with a mean plaque index of 1.43±0.56 for the second group. The difference in plaque scores between the groups was statistically significant. Conclusion: the results of this study showed that rinsing with an alcohol base 0.12% Chlorhexidine mouthrinse is significantly different from rinsing with an alcohol free 0.1% Chlorhexidine mouthrinse on plaque inhibition. Key words:Chlorhexidine, dental plaque, mouthrinse, alcohol, formaldehyde. PMID:23229237

  13. The influence of ginger (Zingiber officinale on human sperm quality and DNA fragmentation: A double-blind randomized clinical trial

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    Jalil Hosseini

    2016-08-01

    Full Text Available Background: Although the effectiveness of ginger as an antioxidant agent has been exploited, little human research has been conducted on its activity on male reproductive functions. Objective: This study was designed to investigate the effects of ginger (Zingiber officinale on sperm DNA fragmentation (SDF in infertile men. Materials and Methods: This randomized double-blind, placebo-controlled trial with a 1:1 allocation was performed on 100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran. Patients were randomly assigned to receive one of two treatments: ginger and placebo. Patients were given a 3-month oral treatment (members received capsules containing 250 mg of ginger powder twice a day in ginger and a placebo in other group. Before and after treatment, standardized semen samples were obtained to determine sperm concentration, motility, and SDF according to World Health Organization. Results: There was no significant difference between two groups regarding SDF at baseline (53.48. 95%CI: 37.95-69.02 in cases and (56.75, 95%CI: 40.01-73.5 in controls. The average positive percentage of SDF in patients receiving ginger (17.77, 95%CI: 6.16-29.39 was lower compared with placebo (40.54, 95%CI: 23.94-57.13 after three month of treatment (p=0.02. In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009. There were no significant differences between two groups regarding to semen parameters. Conclusion: The present study has demonstrated that ginger in a controlled study of efficacy was effective in decreasing SDF in infertile men.

  14. Chlorhexidine alcohol base mouthrinse versus Chlorhexidine formaldehyde base mouthrinse efficacy on plaque control: double blind, randomized clinical trials.

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    Ennibi, Oumkeltoum; Lakhdar, Leila; Bouziane, Amal; Bensouda, Yahia; Abouqal, Redouane

    2013-01-01

    Chlorhexidine is well known for its antiplaque effect. However, the mouthrinse based chlorhexidine antiplaque efficiency may vary according to the formulation of the final product. The aim of the present study was to compare anti-plaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). the study was a seven day randomized, double-blind, placebo-controlled trial including 30 volunteers. At the start, all participants received a dental prophylaxis. Over 7 days experimental non-brushing period, during which subjects abstained from all forms of mechanical oral hygiene, one group test rinsed twice daily with 15 ml of an alcohol base 0.12% Chlorhexidine mouthrinse. The second group test used 15 ml of alcohol free 0.1% Chlorhexidine mouthrinse base 0.1% formaldehyde twice daily. The negative control group used a placebo. Plaque indexes were recorded in all volunteers prior to treatment at Day 0, 1 and 7. After 7 days, the mean plaque index for the first group was 0.76 ± 0.38 compared with a mean plaque index of 1.43 ± 0.56 for the second group. The difference in plaque scores between the groups was statistically significant. the results of this study showed that rinsing with an alcohol base 0.12% Chlorhexidine mouthrinse is significantly different from rinsing with an alcohol free 0.1% Chlorhexidine mouthrinse on plaque inhibition.

  15. Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial

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    Arun Shyam

    2014-01-01

    Full Text Available Introduction: Over the years chlorhexidine (CHX, triclosan and sodium fluoride (NaF mouth rinses are used alone or combined in the prevention of dental diseases. However, at present little is known about the combined effects of NaF + triclosan and CHX + NaF + triclosan mouth rinses on reducing dental plaque and gingivitis. Aim: The aim was to determine the efficacy of mouth rinses used as adjuncts to regular oral hygiene measures on reducing dental plaque and gingivitis. Materials and Methods: A randomized, placebo-controlled, double-blind, parallel-group study was conducted for 6-month, among 12-15 years old school children in Nellore, India. Eligible subjects (n = 210 with consent were randomly allocated to four groups and were provided with a mouth rinse (Group A = 0.2% CHX; Group B = 0.05% sodium fluoride + 0.03% triclosan; Group C = 0.2% CHX + 0.05% sodium fluoride + 0.03% triclosan; Group D = Placebo. All subjects used 10 ml of mouth rinse, once daily for 60 s. The clinical parameters evaluated were plaque index (PlI and gingival Index (GI. Statistical significance within and between four groups was tested using one-way analysis of variance (ANOVA, repeated measures ANOVA with post-hoc and paired t-test. Results: At the end of clinical trial, the three test groups showed statistically significant (P < 0.001 reduction in PlI and GI scores compared with placebo group. Conclusion: The active agents demonstrated highly potent antiplaque and antigingivitis properties when compared to placebo.

  16. Effects of Prenatal Micronutrient Supplementation on Spontaneous Preterm Birth: A Double-Blind Randomized Controlled Trial in China.

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    Li, Zhiwen; Mei, Zuguo; Zhang, Le; Li, Hongtian; Zhang, Yali; Li, Nan; Ye, Rongwei; Ren, Aiguo; Liu, Jian-Meng; Serdula, Mary K

    2017-08-01

    In this secondary analysis of data from a double-blind randomized controlled trial carried out in northern China, we aimed to assess the effect of prenatal supplementation with multiple micronutrients (MMN) or iron + folic acid (IFA), versus folic acid (FA) alone, on risk of spontaneous preterm birth (SPB) and the impact of supplementation timing on SPB. A total of 18,775 nulliparous pregnant women enrolled between 2006 and 2009 were randomly assigned to receive daily FA, IFA, or MMN from the period before 20 weeks' gestation to delivery. The incidences of SPB for women consuming FA, IFA, and MMN were 5.7%, 5.6% and 5.1%, respectively. Compared with women given FA, the relative risks of SPB for those using MMN and IFA were 0.99 (95% confidence interval: 0.85, 1.16) and 0.89 (95% confidence interval: 0.79, 1.05), respectively. SPB incidence in women who started consuming FA, IFA, and MMN before the 12th week of gestation (4.6%, 4.2%, and 3.9%, respectively) was significantly reduced compared with starting supplement use on or after the 12th gestational week (6.9%, 7.2%, and 6.4%, respectively). Starting use of FA, IFA, or MMN supplements before the 12th week of gestation produced a 41%-45% reduction in risk of SPB. Early prenatal enrollment and micronutrient use during the first trimester of pregnancy appeared to be of particular importance for prevention of SPB, regardless of supplement group. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  17. Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

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    Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

    2014-01-01

    Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstin