Brouwers, F.M.; Werf, S.P. van der; Bleijenberg, G.; Zee, L. van der; Meer, J.W.M. van der
BACKGROUND:The efficacy of dietary supplements in chronic fatigue syndrome (CFS) is uncertain, with conflicting evidence. Aim: To assess the effect of a polynutrient supplement on fatigue and physical activity of patients with CFS. DESIGN:Prospective randomized placebo-controlled, double-blind
Schroeder, C.; Heusser, K.; Zoerner, A.A.; Grosshennig, A.; Wenzel, D.; May, M.; Sweep, F.C.; Mehling, H.; Luft, F.C.; Tank, J.; Jordan, J.
Hyperpolarization-activated, cyclic nucleotide-gated 4 (HCN4) channels comprise the final pathway for autonomic heart rate (HR) regulation. We hypothesized that HCN4 inhibition could reverse autonomic imbalance in a human model of cardiac sympathetic activation. Nineteen healthy men ingested oral me
Rigo, Flavia Karine; Trevisan, Gabriela; Godoy, Maria C; Rossato, Mateus Fortes; Dalmolin, Gerusa D; Silva, Mariane A; Menezes, Mirian S; Caumo, Wolnei; Ferreira, Juliano
Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain. Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain. We conducted a randomized, double blind, active-controlled parallel-group clinical trial. Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period. During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia. Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms. This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.
Vives, Roser; Pontes, Caridad; Sarasa, Maria; Millier, Aurelie
UR-1505 is a new small molecule with immune modulator properties intended for the topical treatment of inflammatory skin diseases that has shown anti-inflammatory effects in models of skin inflammation. We compared the activity of UR-1505 ointment against its vehicle in the treatment of atopic dermatitis. Secondary objectives included exploring dose response, safety, and local tolerability of UR-1505. Patients with AD lesions on 2 symmetrical topographic areas (arms, leg, or trunk) were included in this unicenter randomized, double-blind, within-patient, controlled Phase II exploratory trial and received simultaneously 2 different treatments (0.5%, 1%, or 2% UR-1505 and vehicle or 0.1% tacrolimus ointment) once daily during 28 days. The primary efficacy end point was the change from baseline in the Investigator Global Assessment score at Day 28. Secondary end points were percentage of area clearance, local Eczema Area Severity Index (local EASI), and local tolerability. A linear mixed model was used, fitting treatment, body side, and group (treatment at the contralateral side) as fixed factors and the patient as a random effect. Twenty-eight patients were randomized and 25 patients were included in the per protocol analysis, with 50 evaluable lesions (n = 13 for vehicle, n = 8 for UR-1505 0.5%, n = 9 for 1% UR-1505, n=8 for 2% UR-1505, and n=12 for tacrolimus). The mean Investigator Global Assessment score change from baseline at Day 28 was -1.7 for vehicle, -1.0, -1.2, and -1.5 for 0.5%, 1%, and 2% UR-1505, respectively, and -2.6% for tacrolimus (P = 0.002). No serious nor causal adverse reactions were reported in this study, but patients reported numerous local symptoms after product applications, especially itching, tingling, tightness, and heat/burning sensations at frequencies that were similar for vehicle, 1% UR-1505, and 2% UR-1505; more frequent with 0.5% UR-1505; and lowest for tacrolimus. This study found that UR-1505 may not be a suitable option for the
Full Text Available Background: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. Methods: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and post-operative hemorrhage were gathered and compared between two groups containing 47 patients in each group. Results: We found statistically significant differences in operation time (p 0.5 was not significantly different between two groups. Conclusions: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method.
den Heijer, P; Vermeer, F; Ambrosioni, E; Sadowski, Z; Lopez-Sendon, JL; von Essen, R; Beaufils, P; Thadani, U; Adgey, J; Pierard, L; Brinker, J; Davies, RF; Smalling, RW; Wallentin, L; Caspi, A; Pangerl, A; Trickett, L; Hauck, C; Henry, D; Chew, P
Background-Lanoteplase (nPA) is a rationally designed variant of tissue plasminogen activator with greater fibrinolytic potency and slower plasma clearance than alteplase. Methods and Results-InTIME (Intravenous nPA for Treatment of Infarcting Myocardium Early), a multicenter, double-blind, randomiz
Raschke, Silvia U; Orendurff, Michael S; Mattie, Johanne L; Kenyon, David E A; Jones, O Yvette; Moe, David; Winder, Lorne; Wong, Angie S; Moreno-Hernández, Ana; Highsmith, M Jason; J Sanderson, David; Kobayashi, Toshiki
Providing appropriate prosthetic feet to those with limb loss is a complex and subjective process influenced by professional judgment and payer guidelines. This study used a small load cell (Europa™) at the base of the socket to measure the sagittal moments during walking with three objective categories of prosthetic feet in eleven individuals with transtibial limb loss with MFCL K2, K3 and K4 functional levels. Forefoot stiffness and hysteresis characteristics defined the three foot categories: Stiff, Intermediate, and Compliant. Prosthetic feet were randomly assigned and blinded from participants and investigators. After laboratory testing, participants completed one week community wear tests followed by a modified prosthetics evaluation questionnaire to determine if a specific category of prosthetic feet was preferred. The Compliant category of prosthetic feet was preferred by the participants (P=0.025) over the Stiff and Intermediate prosthetic feet, and the Compliant and Intermediate feet had 15% lower maximum sagittal moments during walking in the laboratory (P=0.0011) compared to the Stiff feet. The activity level of the participants did not change significantly with any of the wear tests in the community, suggesting that each foot was evaluated over a similar number of steps, but did not inherently increase activity. This is the first randomized double blind study in which prosthetic users have expressed a preference for a specific biomechanical characteristic of prosthetic feet: those with lower peak sagittal moments were preferred, and specifically preferred on slopes, stairs, uneven terrain, and during turns and maneuvering during real world use.
Gerstgrasser, Alexandra; Röchter, Sigrid; Dressler, Dirk; Schön, Christiane; Reule, Claudia; Buchwald-Werner, Sybille
Mangifera indica fruit preparation (Careless™) activates the evolutionary conserved metabolic sensors sirtuin 1 and adenosine monophosphate-activated protein kinase, which have been identified as playing a key role in microcirculation and endothelial function. Here, an acute effect of a single dose of 100 mg or 300 mg Careless™ on microcirculation was investigated in a randomized, double-blind, crossover pilot study in ten healthy women to determine the effective dosage. Microcirculation and endothelial function were assessed by the Oxygen-to-see system and pulse amplitude tonometry (EndoPAT™), respectively. Cutaneous blood flow was increased over time by 100 mg (54% over pre-values, p = 0.0157) and 300 mg (35% over pre-value, p = 0.209) Careless™. The EndoPAT™ reactive hyperemia response was slightly improved 3 h after intake compared to pretesting with 300 mg Careless™. Furthermore, activation of endothelial nitric oxide synthase, as an important regulator for endothelial function, was tested in vitro in primary human umbilical vein endothelial cells. Careless™, after simulation of digestion, increased the activated form of endothelial nitric oxide synthase dose-dependently by 23% (300 µg/mL), 42% (1500 µg/mL), and 60% (3000 µg/mL) compared to the untreated control. In conclusion, the study suggests moderate beneficial effects of Careless™ on microcirculation, which is at least partly mediated by endothelial nitric oxide synthase activation.
Júdice, Pedro B; Magalhães, João P; Santos, Diana A; Matias, Catarina N; Carita, Ana Isabel; Armada-Da-Silva, Paulo A S; Sardinha, Luís B; Silva, Analiza M
Research on the effect of caffeine on energy expenditure (EE), physical activity (PA), and total sleep time (TST) during free-living conditions using objective measures is scarce. We aimed to determine the impact of a moderate dose of caffeine on TST, resting EE (REE), physical activity EE (PAEE), total EE (TEE), and daily time spent in sedentary, light, moderate, and vigorous intensity activities in a 4-day period and the acute effects on heart rate (HR) and EE in physically active males. Using a double-blind crossover trial (ClinicalTrials.gov ID: NCT01477294) with two conditions (4 days each with 3-day washout) randomly ordered as caffeine (5 mg/kg of body mass/day) and placebo (maltodextrin) administered twice per day (2.5 mg/kg), 30 nonsmoker males, low-caffeine users (caffeine intake, while no differences were found between conditions for REE, PAEE, TEE, and PA patterns. Also, no acute effects on HR and EE were found between conditions. Though a large individual variability was observed, our findings revealed no acute or long-term effects of caffeine on EE and PA but decreased TST during free-living conditions in healthy males.
Timms, M S; Temple, R H
Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.
Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna
The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.
Kim, Ji Young; Park, Ju Yeon; Kang, Hee Jung; Kim, Oh Yoen; Lee, Jong Ho
The reported health benefits of Korean red ginseng (KRG) include antioxidant, antitumor, antimutagenic, and immunomodulatory activities; however, the effects on oxidative stress have not yet been evaluated. Therefore, we assessed the effect of KRG on antioxidant enzymes and oxidative stress markers in humans. We conducted a randomized, double-blind, placebo-controlled study with three groups, including placebo, low-dose (3 g/day), and high-dose (6 g/day), which were randomly assigned to healthy subjects aged 20-65 years. Lymphocyte DNA damage, antioxidative enzyme activity, and lipid peroxidation were assessed before and after the 8-week supplementation. Fifty-seven subjects completed the protocol. Plasma superoxide dismutase (SOD) activity after the 8-week KRG supplementation was significantly higher in the low-and high-dose groups compared to baseline. Plasma glutathione peroxidase (GPx) and catalase activities were also increased after the high-dose supplementation. Furthermore, the DNA tail length and tail moment were significantly reduced after the supplementation (low-dose and high-dose), and plasma oxidized low-density lipoprotein (LDL) levels were reduced in low-dose and high-dose groups, but increased in the placebo group. The net changes in oxidized LDL after the supplementation differed significantly between both KRG supplementation groups and the placebo group. Net changes in GPx, SOD and catalase activities, and DNA tail length and tail moment were significantly different between the high-dose group and the placebo group. Additionally, the net changes in urinary 8-epi-PGF(2α) were significantly different between the KRG supplementation groups and the placebo group. KRG supplementation may attenuate lymphocyte DNA damage and LDL oxidation by upregulating antioxidant enzyme activity.
Tanaka, Yoshiya; Emoto, Kahaku; Cai, Zhihong; Aoki, Takehiro; Schlichting, Douglas; Rooney, Terence; Macias, William
To evaluate efficacy and safety, baricitinib [Janus kinase (JAK) 1/JAK2 inhibitor] was compared with placebo in Japanese patients with active rheumatoid arthritis (RA) despite background treatment with methotrexate (MTX). This was a phase IIB, double-blind, randomized, placebo-controlled study (clinicaltrials.gov: NCT01469013). Patients had moderate to severe active adult-onset RA despite stable treatment with MTX. Patients (n = 145) were randomized in a 2:1:1:1:1 ratio to placebo or 1 mg, 2 mg, 4 mg, or 8 mg oral baricitinib daily for 12 weeks. The primary analysis compared the combined 4/8-mg dose groups with placebo for the American College of Rheumatology (ACR) 20 response rate at 12 weeks. Other outcomes included additional measures of disease activity, physical function, laboratory abnormalities, and adverse events. A significantly higher proportion of patients in the combined 4/8-mg baricitinib group (37/48, 77%) compared with the placebo group (15/49, 31%) had at least an ACR20 response after 12 weeks of treatment (p physical function were observed as early as Week 2 of treatment with baricitinib, particularly with daily doses of ≥ 4 mg. Only 1 patient receiving baricitinib discontinued because of an adverse event. Adverse event rates with baricitinib doses ≤ 4 mg daily were similar to placebo, but there was a higher incidence of adverse events and laboratory abnormalities in the 8-mg group. In this phase II study, baricitinib was well tolerated and rapidly improved the signs, symptoms, and physical function of Japanese patients with active RA, supporting continued development of baricitinib (clinicaltrials.gov NCT01469013).
Full Text Available Background: About 468 million non-pregnant women are estimated to suffer from iron-deficiency anemia (IDA worldwide. The highest prevalence of IDA occurs in the Taiwanese population. Objective: To evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA. Design: Phase III double-blind, randomized, active-controlled, and parallel comparative study enrolled 124 patients with IDA and consisted of a 2-week run-in period, randomization, 12 weeks of supplementation, and 4 weeks of follow-up. The treatment group received Herbiron drink 50 mL p.o., b.i.d., before meals (daily iron intake: 21 mg/day plus placebo tablets. The control group received a ferrous sulfate tablet, t.i.d., plus placebo 50-mL drink before meals (daily iron intake: 195 mg/day. Results: Both treatments significantly improved hemoglobin and all secondary efficacy endpoints. Most IDA patients treated with Herbiron or ferrous sulfate finished the study in the normal range. Ferrous sulfate treatment induced a rapid rate of hemoglobin synthesis, which plateaued by week 8, whereas Herbiron treatment increased the rate of hemoglobin synthesis more slowly, likely due to its nine-fold lower iron content. Gastrointestinal adverse events (diarrhea, abdominal pain, dyspepsia, and nausea but not infectious adverse events were significantly more common in the ferrous sulfate group (n=11, 18.3% than those in the Herbiron group (n=1, 1.6% (p=0.004. Conclusion: Twelve weeks of Herbiron treatment delivering 21mg of iron or ferrous sulfate treatment delivering 195 mg of iron induced normal hemoglobin levels in 62 or 91% of non-pregnant women with IDA in Taiwan, respectively, suggesting dose-dependent and bioavailability effects.
Wang, Jie; Li, Yong; Tang, Yan-Li; Lin, Hong-Sheng; Wu, Xin-Fang; Liu, Jie
To observe the Immune No. 2 (2) on the immune reconstitution in patients with human immunodeficiency virus or acquired immune deficiency syndrome (HIV/AIDS) after highly active antiretroviral therapy (HAART). A randomized, double-blind, placebo-controlled clinical trial was designed. 233 patients failing immune reconstitution after HAART were randomly divided into treatment group (116 cases) and control group (117 cases), respectively using Immune No. 2 plus HAART and placebo combined with HAART for 6 months. CD4, CD45RA, CD45RO cell numbers, as well as the symptoms, signs and integral improvement rates were observed in order to evaluate the immune reconstitution efficiency. after the intervention for 1 month, the effective rate of the treatment group (18.97%, 22/116) was significantly higher than that of the control group (9.40%, 11/117) (P=0.02); 3 months after treatment, the effective rate of the treatment group (27.59%, 32/116) was no difference from that of the control group (22.22%, 26/117) (P=0.31); 6 months after treatment, the effective rate of the treatment group (34.48%, 40/116) was significantly superior to the control group (21.37%, 25/117) (P=0.02). CD4, CD45RA, CD45RO count of the treatment group was significantly higher than that of the control group (P<0.05). The total score of symptoms and signs in the treatment group was significantly lowered compared with the control group (P=0.02), and the improvement of fatigue, muscle and joint pain, pruritus and shortness of breath in the treatment group was better than the control group (P<0.05). Immune No. 2 can effectively improve the numbers of CD4 cells and its subgroups, as well as the main clinical symptoms and signs of patients after HAART, thereby promoting the immune reconstitution.
Leffler, Daniel A; Kelly, C P; Abdallah, H Z; Colatrella, A M; Harris, L A; Leon, F; Arterburn, L A; Paterson, B M; Lan, Z H; Murray, J A
OBJECTIVES: In patients with celiac disease, enteropathy is caused by the entry of gluten peptides into the lamina propria of the intestine, in which their immunogenicity is potentiated by tissue transglutaminase (tTG) and T-helper type 1–mediated immune responses are triggered. Tight junction disassembly and paracellular permeability are believed to have an important role in the transport of gluten peptides to the lamina propria. Larazotide acetate is a tight-junction regulator peptide that, in vitro, prevents the opening of intestinal epithelial tight junctions. The aim of this study was to evaluate the efficacy and tolerability of larazotide acetate in protecting against gluten-induced intestinal permeability and gastrointestinal symptom severity in patients with celiac disease. METHODS: In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days. The primary efficacy outcome was the urinary lactulose/mannitol (LAMA) fractional excretion ratio. Secondary endpoints included gastrointestinal symptom severity, quality-of-life measures, and antibodies to tTG. RESULTS: LAMA measurements were highly variable in the outpatient setting. The increase in LAMA ratio associated with the gluten challenge was not statistically significantly greater than the increase in the gluten-free control. Among patients receiving the gluten challenge, the difference in the LAMA ratios for the larazotide acetate and placebo groups was not statistically significant. However, larazotide acetate appeared to limit gluten-induced worsening of gastrointestinal symptom severity as measured by the Gastrointestinal Symptom Rating Scale at some lower doses but not at the higher dose. Symptoms worsened significantly in the gluten challenge–placebo arm compared with the placebo–placebo arm
Gilinsky, N H; Bright-Asare, P; Cobert, B L; Fitch, D D; Lanza, F L; Kerr, R M; Savitsky, J P
This multicenter randomized, double-blind, 4-wk study compared the new H2-receptor antagonistic roxatidine (R) to placebo (P) for treatment of endoscopically diagnosed active duodenal ulcer disease. Subjects were evaluated after 2 and 4 wk of treatment. Those whose ulcer was unhealed at 2 wk received 2 more weeks of treatment before final evaluation. Ulcer healing (endoscopically determined) with roxatidine was more effective than placebo at both wk 0-2 (R = 33.9%, P = 21.9%, p = 0.018) and wk 2-4 (R = 68.2%, P = 29.7%, p less than 0.001), with an overall 4-wk effectiveness of 78.9% compared to 44.8% (p less than 0.001). At the end of treatment, average maximum ulcer diameter diminished 83% in R and 50% in P (p less than 0.001). Roxatidine was also more effective than placebo in decreasing abdominal pain (p less than 0.001), decreasing the number of antacid tablets taken for pain relief (p less than 0.001), improving dyspeptic symptoms (p less than 0.001), and permitting return to a normal routine for subjects with previous illness-imposed restrictions on work and/or other daily activities. The profile of laboratory values and adverse experiences demonstrated roxatidine to be safe and well-tolerated. The efficacy of roxatidine as evaluated by the healing rate of duodenal ulcer and reduction in abdominal pain emphasize its value as an addition to the family of H2-receptor antagonists.
Naito, Yuji; Yamaguchi, Shinnichi; Mori, Yasuhiro; Nakajima, Kouji; Hashimoto, Sanshiro; Tomaru, Masakazu; Satoh, Yoshihiko; Hitomi, Yuji; Karita, Masakazu; Hiwatashi, Tomoaki; Kawahito, Yutaka; Yoshikawa, Toshikazu
Static electric field therapy by high voltage alternating current (EF-HVAC) is a traditional complementary Japanese medicine used for headache, shoulder stiffness, chronic constipation and insomnia. Open-label studies and clinical experience in Japan have suggested that this electric field therapy is safe and effective in treating chronic arthritis. We evaluated the efficacy of EF-HVAC therapy in a randomized, double-blinded, sham-controlled trial in patients with active rheumatoid arthritis (RA) in community-based general physician centers. Thirty patients fulfilling American College of Rheumatology (ACR) criteria for RA were treated with EF-HVAC therapy with the LEGACIS PLUS System (COCOROCA Corp., Tokyo, Japan) or sham therapy for 12 weeks and followed for 4 weeks without treatment. The disease activity score 28 (DAS28-CRP), visual analogue scale for pain (VAS), modified health assessment questionnaire (MHAQ), and inflammatory parameters were used as the outcome variable. Twenty four patients (n = 12 in each group) were analyzed by a per protocol analysis. Although a significant reduction in DAS28-CRP was observed in EF-HVAC group at 8 and 12 weeks compared to before treatment, there were no significant differences in DAS28-CRP scores during treatment between two groups. The scale of VAS was also significantly decreased by the treatment with EF-HVAC compared to before treatment, in addition, the scale of VAS in EF-HVAC group was significantly lower than sham group at 8 and 12 weeks. Changes in another parameters including MHAQ were not significant between before and after treatment, or by all comparative study between two groups. There were no adverse events related the treatment. In conclusion, the EF-HVAC therapy has a beneficial effect on the improvement to subjective pain of RA.
L(U) Liang-jing; TENG Jia-lin; BAO Chun-de; HAN Xing-hai; SUN Ling-yun; XU Jiang-hua; LI Xing-fu; WU Hua-xiang
Background A novel anti-rheumatic drug,T-614,has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis(RA).To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients.Methods In a multicenter,randomized,double blind,placebo controlled study,280 patients were randomly assigned to receive placebo(n=95)or T-614 at 50 mg(n=93)or 25 mg(n=92)daily.Active disease was defined by 4 of the following 5 criteria:≥5 tender joints,≥3 swollen joints,morning stiffness lasting for≥60 minutes,and Westergren erythrocyte sedimentation rate(ESR)≥28 mm/h,the assessment of pain at the rest by patient as moderate or severe.Clinical and laboratory parameters were analyzed at baseline,2,4,6,12,18 and 24 weeks.The primary efficacy variable at week 24 was the American College of Rheumatology(ACR)response rate using the intent-to-treat population.Results The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment.After 24 weeks,the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%,61.29% and 24-21% in ACR20 and 23.91%,31.18%and 7.37% in ACR50,respectively.A time-response in ACR response was observed,with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo(P＜0.0001),and the 50 mg/d dose compared to the 25 mg/d dose(P＜0.05)when using the ACR response analyses after 24 weeks.ESR and c-reactive protein(CRP)were significantly different in the treatment groups after 24 weeks.The incidence of adverse events(Aes)was not significantly higher with T-614 than with placebo,but upper abdominal discomfort,leucopenia,elevated serum alanine aminotransferase(sALT),skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups.Conclusion T-614,a new slow-acting drug,is effective in treatment
Sampalis John S
Full Text Available Abstract Background Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs for pain and osteoarthritis (OA have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial. Method A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75 with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15; Group A0 (Placebo, CMC capsule, Group A1 (UP446 250 mg/day, Group A2 (UP446 500 mg/day and Group A3 (Celecoxib, 200 mg/day. MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT, fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety. Results Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006, at 60 days (p = 0.016 and p = 0.002 and at 90 days (p = 0.018 and p = 0.002, these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies
Aoki, Nobuo; Matsuda, Tamotsu; Saito, Hidehiko; Takatsuki, Kiyoshi; Okajima, Kenji; Takahashi, Hoyu; Takamatsu, Junki; Asakura, Hidesaku; Ogawa, Nobuya
A randomized prospective double-blind trial was performed to compare the safety and efficacy of human activated protein C (APC) and unfractionated heparin for the treatment of disseminated intravascular coagulation (DIC). One hundred thirty-two patients with DIC were enrolled in this study: 63 patients received APC (12.5 U [2.5 microg]/kg body wt per hour) and 69 patients received heparin (8 U/kg body wt per hour) by intravenous infusion for 6 days. Forty-nine APC-treated patients and 55 heparin-treated patients were evaluated for efficacy, and 52 APC-treated patients and 55 heparin-treated patients were evaluated for safety. The 2 groups were similar with respect to sex, age, body weight, underlying diseases, and coagulation/fibrinolysis parameters before treatment. Aggravation of bleeding was seen after treatment in 8 patients receiving heparin, but in none of the patients receiving APC. The number of patients who showed alleviation of bleeding was significantly higher in the APC group than the heparin group (P = .009). The effects on DIC-related organ dysfunction were not significantly different between the 2 groups. Fibrinogen-fibrin degradation products, D-dimer, thrombin-antithrombin complex (TAT), and plasmin-plasmin inhibitor complex (PIC) were all significantly decreased by treatment in both groups. Fibrinogen, protein C, and antithrombin were significantly increased in the APC group, whereas only protein C was significantly increased in the heparin group. Platelet count in the nonleukemic group was significantly increased in those patients receiving APC but not increased in those patients receiving heparin. Improvement of coagulation/fibrinolysis was assessed by scoring 4 parameters (soluble fibrin monomers, D-dimer, TAT, and PIC), and the results indicated that the APC group showed significantly greater improvement than the heparin group (P = .046). There was, however, no significant difference in the rate of complete recovery from DIC between the 2
Notay, Karambir; Incognito, Anthony V; Millar, Philip J
Acute dietary nitrate ([Formula: see text]) supplementation reduces resting blood pressure in healthy normotensives. This response has been attributed to increased nitric oxide bioavailability and peripheral vasodilation, although nitric oxide also tonically inhibits central sympathetic outflow. We hypothesized that acute dietary [Formula: see text] supplementation using beetroot (BR) juice would reduce blood pressure and muscle sympathetic nerve activity (MSNA) at rest and during exercise. Fourteen participants (7 men and 7 women, age: 25 ± 10 yr) underwent blood pressure and MSNA measurements before and after (165-180 min) ingestion of 70ml high-[Formula: see text] (~6.4 mmol [Formula: see text]) BR or [Formula: see text]-depleted BR placebo (PL; ~0.0055 mmol [Formula: see text]) in a double-blind, randomized, crossover design. Blood pressure and MSNA were also collected during 2 min of static handgrip (30% maximal voluntary contraction). The changes in resting MSNA burst frequency (-3 ± 5 vs. 3 ± 4 bursts/min, P = 0.001) and burst incidence (-4 ± 7 vs. 4 ± 5 bursts/100 heart beats, P = 0.002) were lower after BR versus PL, whereas systolic blood pressure (-1 ± 5 vs. 2 ± 5 mmHg, P = 0.30) and diastolic blood pressure (4 ± 5 vs. 5 ± 7 mmHg, P = 0.68) as well as spontaneous arterial sympathetic baroreflex sensitivity (P = 0.95) were not different. During static handgrip, the change in MSNA burst incidence (1 ± 8 vs. 8 ± 9 bursts/100 heart beats, P = 0.04) was lower after BR versus PL, whereas MSNA burst frequency (6 ± 6 vs. 11 ± 10 bursts/min, P = 0.11) as well as systolic blood pressure (11 ± 7 vs. 12 ± 8 mmHg, P = 0.94) and diastolic blood pressure (11 ± 4 vs. 11 ± 4 mmHg, P = 0.60) were not different. Collectively, these data provide proof of principle that acute BR supplementation can decrease central sympathetic outflow at rest and during exercise. Dietary [Formula: see text] supplementation may represent a novel intervention to target
Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC
Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula
Rainer, Timothy Hudson; Cheng, Chi Hung; Janssens, Hein J E M; Man, Chi Yin; Tam, Lai Shan; Choi, Yu Fai; Yau, Wah Hon; Lee, Ka Hing; Graham, Colin Alexander
Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. To compare the effectiveness and safety of oral prednisolone versus oral indomethacin in patients presenting to emergency departments (EDs) with acute gout. Multicenter, double-blind, randomized equivalence trial. Patients were randomly assigned (1:1 ratio) to receive either indomethacin or prednisolone. (ISRCTN registry number: ISRCTN45724113). Four EDs in Hong Kong. 416 patients aged 18 years or older. Analgesic effectiveness was defined as changes in pain (at rest or with activity) greater than 13 mm on a 100-mm visual analogue scale. Outcomes were measured during the first 2 hours in the ED and from days 1 to 14. 376 patients completed the study. Equivalent and clinically significant within-group reductions in mean pain score were observed with indomethacin and prednisolone in the ED (approximately 10 mm [rest] and 20 mm [activity]) and from days 1 to 14 (approximately 25 mm [rest] and 45 mm [activity]). No major adverse events occurred during the study. During the ED phase, patients in the indomethacin group had more minor adverse events than those in the prednisolone group (19% vs. 6%; P gout was usually based on clinical criteria rather than examination of joint fluid. Oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout. Prednisolone is a safe, effective first-line option for treatment of acute gout. Health and Health Services Research Grant Committee of the Hong Kong Government.
Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie
The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (Pback pain can be concluded.
Nourbakhsh, Mohammad Reza; Fearon, Frank J.
Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and Stat
Heijneman, Karin M.; de Kleine, Emile; van Dijk, Pim
Objective. The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. Study Design. A double-blind crossover randomized controlled trial. Setting. This study was conducted at the Univer
Rainer, T.H.; Cheng, C.H.; Janssens, H.J.; Man, C.Y.; Tam, L.S.; Choi, Y.F.; Yau, W.H.; Lee, K.H.; Graham, C.A.
BACKGROUND: Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. OBJECTIVE: To compare
Arya, A; Donne, A J; Nigam, A
This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.
Simons, AHM; Roelofs, HJM; Schmoutziguer, APE; Roozenburg, BJ; van't Hof-van den Brink, EP; Schoonderwoerd, SA
Objective: To compare the efficacy of two early cessation protocols of triptorelin treatment in controlled ovarian hyperstimulation with the conventional long protocol in in vitro ferfilization/intracytoplasmic sperm injection. Design: A double-blind, randomized, multicenter study. Setting: Three Du
Bisgaard, T; Klarskov, B; Trap, R;
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...
Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.
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…
Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.
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…
H.J. Bueving (Herman); R.M.D. Bernsen (Roos); J.C. de Jongste (Johan); L.W.A. van Suijlekom-Smit (Lisette); G.F. Rimmelzwaan (Guus); A.D.M.E. Osterhaus (Albert); M.P.M.H. Rutten-van Mölken (Maureen); S. Thomas (Siep); J.C. van der Wouden (Hans)
textabstractThere is little evidence that influenza vaccination reduces asthma exacerbations. We determined whether influenza vaccination is more effective than placebo in 6-18-year-old children with asthma. We performed a randomized, double-blind, placebo-controlled trial. Parenteral vaccination
Branco, Jaime C; Zachrisson, Olof; Perrot, Serge
This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....
Clinical Safety of a High Dose of Phycocyanin-Enriched Aqueous Extract from Arthrospira (Spirulina) platensis: Results from a Randomized, Double-Blind, Placebo-Controlled Study with a Focus on Anticoagulant Activity and Platelet Activation.
Jensen, Gitte S; Drapeau, Cassandra; Lenninger, Miki; Benson, Kathleen F
The goal for this study was to evaluate safety regarding anticoagulant activity and platelet activation during daily consumption of an aqueous cyanophyta extract (ACE), containing a high dose of phycocyanin. Using a randomized, double-blind, placebo-controlled study design, 24 men and women were enrolled after informed consent, and consumed either ACE (2.3 g/day) or placebo daily for 2 weeks. The ACE dose was equivalent to ∼1 g phycocyanin per day, chosen based on the highest dose Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration. Consuming ACE did not alter markers for platelet activation (P-selectin expression) or serum P-selectin levels. No changes were seen for activated partial thromboplastin time, thrombin clotting time, or fibrinogen activity. Serum levels of aspartate transaminase (AST) showed a significant reduction after 2 weeks of ACE consumption (P < .001), in contrast to placebo where no changes were seen; the difference in AST levels between the two groups was significant at 2 weeks (P < .02). Reduced levels of alanine transaminase (ALT) were also seen in the group consuming ACE (P < .08). Previous studies showed reduction of chronic pain when consuming 1 g ACE per day. The higher dose of 2.3 g/day in this study was associated with significant reduction of chronic pain at rest and when physically active (P < .05). Consumption of ACE showed safety regarding markers pertaining to anticoagulant activity and platelet activation status, in conjunction with rapid and robust relief of chronic pain. Reduction in AST and ALT suggested improvement in liver function and metabolism.
Watz, Henrik; Krippner, Felix; Kirsten, Anne; Magnussen, Helgo; Vogelmeier, Claus
Indacaterol is a long-acting beta-2 agonist for once-daily treatment of COPD. We evaluated the effects of indacaterol 150 μg on lung hyperinflation compared with placebo and open-label tiotropium 18 μg. We measured physical activity during treatment with indacaterol 150 μg and matched placebo. We performed a randomized, three-period, cross-over study (21 days of treatment separated by two wash-out periods of 13 days) with indacaterol 150 μg or matching placebo and tiotropium 18 μg. Lung function was assessed by body plethysmography and spirometry. Physical activity was measured for one week by a multisensory armband at the end of both treatment periods with indacaterol/matched placebo. The primary endpoint was peak inspiratory capacity at the end of each treatment period. 129 patients (mean age, 61 years; mean post-bronchodilator FEV1, 64%), were randomized and 110 patients completed the study. Peak inspiratory capacity was 0.22 L greater with Indacaterol at day 21 compared to placebo (p indacaterol versus placebo. Indacaterol 150 μg improved lung hyperinflation in patients with moderate COPD, which was associated with an increase of physical activity. ClinicalTrials.gov registration number: NCT01012765.
Petrovic, Snjezana; Arsic, Aleksandra; Glibetic, Marija; Cikiriz, Nikola; Jakovljevic, Vladimir; Vucic, Vesna
The effect of polyphenol-rich chokeberry juice consumption on plasma phospholipid fatty acid profiles of 32 active male and female handball players was examined. This randomized, double-blind, placebo-controlled study was conducted during the preparatory training in a closed campus, where 18 players (8 males, 10 females) consumed 100 mL of chokeberry juice, while 14 players (7 males, 7 females) consumed placebo. Lipid status, glucose, thiobarbituric acid reactive substances (TBARS), and percentages of fatty acids were assessed at baseline and at the end of the study. Consumption of chokeberry juice induced decreases of C18:1n-9 and C18:3n-3 in men, but no changes in female players. However, placebo-controlled groups had reduced proportions of mono- (C16:1n-7, C18:1n-7) and polyunsaturated fatty acids (PUFAs: C18:3n-3, C20:5n-3, and C22:4n-6) in males, as well as n-6 PUFAs and total PUFAs in females after consumption. These results indicate that chokeberry juice had a weak impact on attenuating the effect of intensive training in active handball players.
Full Text Available The effect of resistance exercise with the ingestion of supplementary protein on the activation of the mTOR cascade, in human skeletal muscle has not been fully elucidated. In this study, the impact of a single bout of resistance exercise, immediately followed by a single dose of whey protein isolate (WPI or placebo supplement, on the activation of mTOR signalling was analyzed. Young untrained men completed a maximal single-legged knee extension exercise bout and were randomized to ingest either WPI supplement (n = 7 or the placebo (n = 7. Muscle biopsies were taken from the vastus lateralis before, and 2, 4 and 24 hr post-exercise. WPI or placebo ingestion consumed immediately post-exercise had no impact on the phosphorylation of Akt (Ser473. However, WPI significantly enhanced phosphorylation of mTOR (Ser2448, 4E-BP1 (Thr37/46 and p70S6K (Thr389 at 2 hr post-exercise. This study demonstrates that a single dose of WPI, when consumed in modest quantities, taken immediately after resistance exercise elicits an acute and transient activation of translation initiation within the exercised skeletal muscle.
Tintner, R; Gross, R; Winzer, U F; Smalky, K A; Jankovic, J
To compare autonomic effects of botulinum toxin (BTX), we randomized patients with cervical dystonia to receive either BTX-A or BTX-B in a double-blind manner. Efficacy and physiologic questionnaire measures of autonomic function were assessed at baseline and 2 weeks after injection. Patients treated with BTX-B had less saliva production (p BTX-A, but did not differ in other tests of autonomic functions.
Raja, Indu M.; Asha Basavareddy; Deepali Mukherjee; Bikash Ranjan Meher
Objective: To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. Patients and Methods: This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come...
Lee, Yeon Joo; Paik, Doo-Jin; Kwon, Dae Young; Yang, Hye Jeong
BACKGROUND/OBJECTIVES The present study investigated the hypothesis that a highly pure linear β-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of 4,000-8,000 cells/µL were participated and randomly assigned to take two capsules per day containing either 350 mg β-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-γ, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-α were measured. RESULTS NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the β-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of β-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of β-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration β-1,3-glucan did not significantly modulate the levels of IFN-γ, IL-2, IL-4, IL-6, IL-12, TNF-α and IgG compared with the placebo. CONCLUSION The results showed that supplementation with bacterial β-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of β-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.
Oneda, Bruna; Cardoso, Crivaldo G; Forjaz, Cláudia L M; Araújo, Tatiana G; Bernardo, Fernanda R; de Gusmão, Josiane Lima; Pinto, Luiz Gustavo; Labes, Eliana; Abrahão, Sandra B; Mion, Décio; Fonseca, Angela M; Tinucci, Taís
The aim of this study was to evaluate the isolated and associated effects of aerobic training and estrogen therapy on sympathetic nerve activity and hemodynamics in healthy postmenopausal women. Forty-five postmenopausal women (mean [SD] age, 51  y) were randomly divided into four groups: sedentary-placebo (SED-PLA; n = 11), sedentary-estrogen therapy (SED-ET; n = 14), aerobic training-placebo (AT-PLA; n = 12), and aerobic training-estrogen therapy (AT-ET; n = 8). The ET groups received oral estradiol valerate (1 mg/d), whereas the PLA groups received placebo. The AT groups performed aerobic exercise three times a week on a cycle ergometer for 50 minutes, whereas the SED groups remained sedentary. All participants were evaluated before and after 6 months. Muscle sympathetic nerve activity (MSNA; microneurography), forearm blood flow (plethysmography), blood pressure (oscillometry), and heart rate (HR) were measured at rest for 10 minutes. Data were analyzed by three-way analysis of variance. Estrogen administration itself did not change any of the studied parameters. AT improved forearm blood flow (AT-PLA, 2.02 [0.85] vs 2.92 [1.65] mL min(-1) 100 mL(-1), P = 0.03; AT-ET, 1.68 [1.11] vs 2.27 [0.76] mL min(-1) 100 mL(-1), P = 0.03), reduced MSNA in the AT-PLA group (39  vs 34  bursts/min(-1), P = 0.01), and decreased HR in the AT-ET group (65  vs 62  beats/min, P = 0.01). AT reduces sympathetic nerve activity and improves muscle blood flow in healthy hysterectomized postmenopausal women. Moreover, AT decreases HR when combined with ET. However, ET abolishes the reducing effect of AT on MSNA.
Xiao-Yan Liang; Qing Gao; Neng-Ping Gong; Li-Ping Tang; Pi-Long Wang; Xiao-Hong Tao
AIM: To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers.METHODS: A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules (40 mg) or esomeprazole magnesium (40 mg), once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed.RESULTS: Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively (P = 0.8410), and reached 100% at the end of wk 4 in both groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group (P = 0.5406); at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively (P = 0.5786). Adverse events occurred in 16.7% of the esomeprazole enteric-coated capsules group and 14.8% of the esomeprazole magnesium group (P = 1.0000).CONCLUSION: The efficacies of esomeprazole enteric-coated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of both drugs were comparable.
Effects of Intravenous and Catheter Directed Thrombolytic Therapy with Recombinant Tissue Plasminogen Activator (Alteplase in Non-Traumatic Acute Limb Ischemia; A Randomized Double-Blind Clinical Trial
Full Text Available Objective: To evaluate the efficacy and safety of intravenous and catheter directed thrombolysis by recombinant tissue plasminogen activator (Alteplase in the patients with non-traumatic acute limb ischemia (ALI. Methods: This was a randomized clinical trial being performed between 2009 and 2011 in Mashhad University of Medical Sciences. We included those patients who were<75 years, with symptoms of less than 14 days duration, ALI of grade IIa and IIb (according to Rutherford classification and absence of distal run off. Baseline assessment of peripheral circulation performed in all the patients. Patients were randomly assigned to undergo intravenous (n=18 or catheter directed thrombolysis (n=20 with Alteplase. The primary endpoint of the study was improvement of clinical status measured by Rutherford classification, ankle brachial index (ABI, visual analogue scale (VAS score measured at 1, 3 and 6 months. The secondary endpoint of the study was complete or near complete recanalization of the occluded artery. Results: A total number of 38 patients with mean age of 54.13±13.5 years were included in the study. There were 23 (60.5% men and 15 (39.5% women among the patients. Overall 3 (7.9% patients had upper and 35 (92.1% lower extremity ischemia. There was no significant difference between two study groups. None of the patients experienced major therapeutic side effects. Both ABI and VAS score improved in patients who have received first dose of t-PA within 24-hourof ALI. There was no significant difference between two study groups regarding the 6-month clinical grade ( p=0.088, VAS score ( p=0.316 and ABI ( p=0.360. The angiographic improvement was significantly higher in CDT group ( p<0.001. Conclusion: Intravenous and catheter directed thrombolysis with t-PA is a safe and effective method in treatment of acute arteriolar ischemia of extremities. However there both intravenous thrombolysis and CDT are comparable regarding the clinical outcome
Full Text Available Objective: Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics. All efforts to develop nonsteroidal anti-inflammatory drugs (NSAIDs which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough. Hence we evaluated the analgesic activity of an ayurvedic drug, Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose (125 mg, 2 capsules of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects. Materials and Methods: After taking written informed consent, twelve healthy subjects were randomized (1:1 to receive single oral dose of Boswellia serrata (Shallaki® 125 mg, 2 capsules or identical placebo in a crossover design. Mechanical pain was assessed using Ugo basile analgesymeter (by Randall Selitto test at baseline and at 1 hr, 2 hrs and 3 hrs after test drug administration. Pain Threshold force and time and Pain Tolerance force and time were evaluated. Statistical analysis was done by paired t-test. Results : Twelve healthy volunteers have completed the study. Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased [Force: 9.7 ± 11.0 vs 2.9 ± 3.4 (P = 0.05 and time: 9.7 ± 10.7 vs 2.8 ± 3.4 (P = 0.04] at third hr. Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly (P ≤ 0.01 increased at 1 hr, 2 hrs and 3 hrs. Conclusion : In the present study, Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo. Both study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug.
Full Text Available Abstract Background We report the safety findings from a 3-year phase 3 study (NCT00205777 of bazedoxifene, a novel selective estrogen receptor modulator under development for the prevention and treatment of postmenopausal osteoporosis. Methods Healthy postmenopausal osteoporotic women (N = 7,492; mean age, 66.4 years were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. Safety and tolerability were assessed by adverse event (AE reporting and routine physical, gynecologic, and breast examination. Results Overall, the incidence of AEs, serious AEs, and discontinuations due to AEs in the bazedoxifene groups was not different from that seen in the placebo group. The incidence of hot flushes and leg cramps was higher with bazedoxifene or raloxifene compared with placebo. The rates of cardiac disorders and cerebrovascular events were low and evenly distributed among groups. Venous thromboembolic events, primarily deep vein thromboses, were more frequently reported in the active treatment groups compared with the placebo group; rates were similar with bazedoxifene and raloxifene. Bazedoxifene showed a neutral effect on the breast and an excellent endometrial safety profile. The incidence of fibrocystic breast disease was lower with bazedoxifene 20 and 40 mg versus raloxifene or placebo. Reductions in total and low-density lipoprotein levels and increases in high-density lipoprotein levels were seen with bazedoxifene versus placebo; similar results were seen with raloxifene. Triglyceride levels were similar among groups. Conclusion Bazedoxifene showed a favorable safety and tolerability profile in women with postmenopausal osteoporosis. Trial Registration Trial registration number: NCT00205777; Trial registration date: September 16, 2005
Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; van Luijk, Peter; Stokman, Monique A.; Vissink, Arjan
Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with
Lavretsky, Helen; Reinlieb, Michelle; St. Cyr, Natalie; Siddarth, Prabha; Ercoli, Linda M; Senturk, Damla
... patients.Method:The authors conducted a 16-week randomized double-blind placebo-controlled trial for geriatric depression in 143 older outpatients diagnosed with major depression comparing treatment response in three treatment groups...
Mooney, V. (Univ. of California, Irvine (USA))
A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.
Functional Brain Activity Changes after 4 Weeks Supplementation with a Multi-Vitamin/Mineral Combination: A Randomized, Double-Blind, Placebo-Controlled Trial Exploring Functional Magnetic Resonance Imaging and Steady-State Visual Evoked Potentials during Working Memory.
White, David J; Cox, Katherine H M; Hughes, Matthew E; Pipingas, Andrew; Peters, Riccarda; Scholey, Andrew B
This study explored the neurocognitive effects of 4 weeks daily supplementation with a multi-vitamin and -mineral combination (MVM) in healthy adults (aged 18-40 years). Using a randomized, double-blind, placebo-controlled design, participants underwent assessments of brain activity using functional Magnetic Resonance Imaging (fMRI; n = 32, 16 females) and Steady-State Visual Evoked Potential recordings (SSVEP; n = 39, 20 females) during working memory and continuous performance tasks at baseline and following 4 weeks of active MVM treatment or placebo. There were several treatment-related effects suggestive of changes in functional brain activity associated with MVM administration. SSVEP data showed latency reductions across centro-parietal regions during the encoding period of a spatial working memory task following 4 weeks of active MVM treatment. Complementary results were observed with the fMRI data, in which a subset of those completing fMRI assessment after SSVEP assessment (n = 16) demonstrated increased BOLD response during completion of the Rapid Visual Information Processing task (RVIP) within regions of interest including bilateral parietal lobes. No treatment-related changes in fMRI data were observed in those who had not first undergone SSVEP assessment, suggesting these results may be most evident under conditions of fatigue. Performance on the working memory and continuous performance tasks did not significantly differ between treatment groups at follow-up. In addition, within the fatigued fMRI sample, increased RVIP BOLD response was correlated with the change in number of target detections as part of the RVIP task. This study provides preliminary evidence of changes in functional brain activity during working memory associated with 4 weeks of daily treatment with a multi-vitamin and -mineral combination in healthy adults, using two distinct but complementary measures of functional brain activity.
amrutesh, sunita; Malini, J; Tandur, Prakash S; Pralhad S. Patki
Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hyg...
Sattar, Fouzia A; Ahmed, Fayaz; Ahmed, Nadeem; Sattar, Samina A; Malghani, Muhammad A K; Choudhary, Muhammad I
A controlled study was conducted to determine the efficiency of a topical ointment prepared from the stem extract of Morinda citrifolia against cutaneous leishmaniasis. Similarly, the in vitro antileishmanial activity of morindicone and morinthone isolated from the extract were investigated against Leishmania major. These compounds displayed good activity. Out of 40 patients, 50% showed an excellent response and 30% exhibited good improvement.
Conclusions: Mizolastine has good antihistaminic activity than loratadine. Neither drug causes any psychomotor impairment or has anti-cholinergic action. [Int J Basic Clin Pharmacol 2016; 5(3.000: 661-675
Kaur, S; Greaves, M; Eftekhari, N
The HI-antihistamine chlorpheniramine and the H2-antihistamine cimetidine, given alone and in combination, have been compared with placebo in twenty patients with factitious urticaria (dermographism), in a double-blind, randomized cross-over trial. Of these regimes, the combination was the only treatment which significantly reduced weal size, flare size and duration of weal, compared with placebo, although other treatments approached statistical significance. Continuation of the most effective of the four treatments in nineteen of the patients for a further 3 months without breaking the randomization code provided further evidence of the great effectivness of combined cimetidine and chlorpheniramine. No significant side effects were note.
Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. De...
Bisgaard, T; Klarskov, B; Trap, R;
BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy......: The study was discontinued after inclusion of 26 patients because five of the 13 patients (38%) randomized to micro-LC were converted to LC. In the remaining 21 patients, overall pain and incisional pain intensity during the first 3 h postoperatively increased in the LC group (n = 13) compared...
Ogata, Haruhiko; Aoyama, Nobuo; Mizushima, Seiichi; Hagino, Atsushi; Hibi, Toshifumi
This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine. In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period. The change in the UC-DAI (mean±standard deviation) in the per-protocol set was -2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and -1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was -0.7 (two-sided 95% confidence interval, -1.3 to -0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups. Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.
A randomized, double-blind, placebo-controlled clinical study to assess safety and clinical activity of OTO-104 given as a single intratympanic injection in patients with unilateral Ménière's disease.
Lambert, Paul R; Nguyen, Shaun; Maxwell, Kenneth S; Tucci, Debara L; Lustig, Lawrence R; Fletcher, Malcolm; Bear, Moraye; Lebel, Carl
To evaluate the safety, tolerability, and clinical activity of a single intratympanic injection of OTO-104, sustained-release dexamethasone formulation, in patients with unilateral Ménière's disease. Prospective, double-blind, randomized, placebo-controlled, dose-escalation study of 16 weeks' (4-wk lead-in before dosing; 12-wk follow-up after dosing) duration for each patient. Fifteen centers (physician offices and academic or tertiary referral centers). Forty-four patients aged 22 to 75 years. Single intratympanic injection of OTO-104 (3 or 12 mg) or placebo. Safety and tolerability were assessed via adverse event reports, otoscopy, audiometry, and tympanometry. Clinical activity was assessed primarily as changes in vertigo frequency. OTO-104 was well tolerated, with no impact on hearing function. Plasma levels were observed in a few patients and were barely quantifiable. The most frequently reported adverse event considered related to investigational product was tympanic membrane perforation; no clinical sequelae were associated with these perforations and all were graded mild or moderate. At Month 3, the observed mean ± standard deviation (SD) change from baseline in vertigo frequency was -0.124 ± 0.153, -0.147 ± 0.166, and -0.211 ± 0.153 for the placebo, 3-mg OTO-104, and 12-mg OTO-104 groups, respectively; corresponding to 42%, 56% and 73% reductions in vertigo frequency, respectively. Similar results were observed for tinnitus, measured by the Tinnitus Handicap Inventory (THI-25). OTO-104 was safe and well tolerated. Although the sample size was small, the data suggest 12 mg of OTO-104 was associated with a clinically meaningful reduction in vertigo frequency compared to placebo 3 months after treatment.
Full Text Available BACKGROUND: SRT2104 has been developed as a selective small molecule activator of SIRT1, a NAD(+-dependent deacetylase involved in the regulation of energy homeostasis and the modulation of various metabolic pathways, including glucose metabolism, oxidative stress and lipid metabolism. SIRT1 has been suggested as putative therapeutic target in multiple age-related diseases including type 2 diabetes and dyslipidemias. We report the first clinical trial of SRT2104 in elderly volunteers. METHODS: Oral doses of 0.5 or 2.0 g SRT2104 or matching placebo were administered once daily for 28 days. Pharmacokinetic samples were collected through 24 hours post-dose on days 1 and 28. Multiple pharmacodynamic endpoints were explored with oral glucose tolerance tests (OGTT, serum lipid profiles, magnetic resonance imaging (MRI for assessment of whole body visceral and subcutaneous fat, maximal aerobic capacity test and muscle 31P magnetic resonance spectroscopy (MRS for estimation of mitochondrial oxidative capacity. RESULTS: SRT2104 was generally safe and well tolerated. Pharmacokinetic exposure increased less than dose-proportionally. Mean Tmax was 2-4 hours with elimination half-life of 15-20 hours. Serum cholesterol, LDL levels and triglycerides decreased with treatment. No significant changes in OGTT responses were observed. 31P MRS showed trends for more rapid calculated adenosine diphosphate (ADP and phosphocreatine (PCr recoveries after exercise, consistent with increased mitochondrial oxidative phosphorylation. CONCLUSIONS: SRT2104 can be safely administered in elderly individuals and has biological effects in humans that are consistent with SIRT1 activation. The results of this study support further development of SRT2104 and may be useful in dose selection for future clinical trials in patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00964340.
Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker;
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...
Yingli Zhang; Huan Yang; Shichang Yang; Wei Liang; Ping Dai; Changhong Wang; Yalin Zhang
OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepres-sants in the treatment of bipolar disorder. DATA SOURCES:A literature search of randomized, double-blind, control ed trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Control ed Trials databases. The keywords“bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed mania and depression, rapid cycling and bipolar disorder”, AND “antidepressant agent, antidepressive agents second-generation, antidepressive agents tricyclic, monoamine oxidase inhibitor, noradrenaline uptake in-hibitor, serotonin uptake inhibitor, and tricyclic antidepressant agent” were used. The studies that were listed in the reference list of the published papers but were not retrieved in the above-mentioned databases were supplemented. STUDY SELECTION: Studies selected were double-blind randomized control ed trials assessing the efficacy and safety of antidepressants in patients with bipolar disorder. Al participants were aged 18 years or older, and were diagnosed as having primary bipolar disorder. Antidepressants or antidepressants combined with mood stabilizers were used in experimental interventions. Placebos, mood stabilizers, antipsychotics and other antide pressants were used in the control interventions. Studies that were quasi-randomized studies, or used antidepressants in combination with antipsy-chotics in the experimental group were excluded. Al analyses were conducted using Review Man-ager 5.1 provided by the Cochrane Col aboration. MAIN OUTCOME MEASURES:The primary outcome was the response and switching to mania. The secondary outcomes included remission, discontinuation rate, and suicidality. RESULTS: Among 5 001 treatment studies published, 14 double-blind randomized control ed trials involving 1 244 patients were included in the meta
Full Text Available "nObjective:Premenstrual syndromes (PMS affecting 20-40% of women of reproductive age. The aim of this double blind and placebo controlled trial was to investigate whether femicofort a supplement contains Vitamin B6, Vitamin E and evening primrose oil could relieve symptoms of PMS. "nMethod: This was a randomized and double blind clinical trial. The trial was conducted between November 2009 and April March 2010. Women aged 20 to 45 years with regular menstrual cycles and experience of PMS symptoms (According to the current diagnostic criteria proposed by the American College of Obstetrics and Gynecology for at least 6 months were eligible for the study. Patients were randomized to receive femicomfort or placebo in a 1: ratio using a computer-generated code. The assignments were kept in sealed, opaque envelopes until the point of analysis of data. In this double-blind, patients were randomly assigned to receive capsule of femicomfort (Group A or capsule placebo for two menstrual cycles (cycles 3 and 4. The primary outcome measure was the Daily Symptom Report, a checklist of 17 premenstrual symptoms rated from 0 to 4 according to their severity throughout the menstrual cycle. Secondary outcome measure was Hamilton Depression Rating Scale (17-item. "nResults:Femicomfort at this dose was found to be effective in relieving symptoms of PMS. The difference between the femicomfort and placebo in the frequency of side effects was not significant. Conclusion: The results of this study indicate the efficacy of femicomfort in the treatment of PMS.
Trevisani Virgínia FM
Full Text Available Abstract Background Systemic sclerosis (scleroderma; SSc is an orphan disease with the highest case-specific mortality of any connective-tissue disease. Excessive collagen deposit in affected tissues is a key for the disease's pathogenesis and comprises most of the clinical manifestations. Lidocaine seems to be an alternative treatment for scleroderma considering that: a the patient's having excessive collagen deposits in tissues affected by scleroderma; b the patient's demonstrating increased activity of the enzyme prolyl hydroxylase, an essential enzyme for the biosynthesis of collagen; and c lidocaine's reducing the activity of prolyl hydroxylase. The aim of this study was to evaluate the efficacy and safety of lidocaine in treating scleroderma. Methods A randomized double-blind clinical trial included 24 patients with scleroderma randomized to receive lidocaine or placebo intravenously in three cycles of ten days each, with a one-month interval between them. Outcomes: cutaneous (modified Rodnan skin score, oesophageal (manometry and microvascular improvement (nailfold capillaroscopy; improvement in subjective self-assessment and in quality of life (HAQ. Results There was no statistically significant difference between the groups for any outcome after the treatment and after 6-months follow-up. Improvement in modified Rodnan skin score occurred in 66.7% and 50% of placebo and lidocaine group, respectively (p = 0.408. Both groups showed an improvement in subjective self-assessment, with no difference between them. Conclusions Despite the findings of a previous cohort study favouring the use of lidocaine, this study demonstrated that lidocaine at this dosage and means of administration showed a lack of efficacy for treating scleroderma despite the absence of significant adverse effects. However, further similar clinical trials are needed to evaluate the efficacy of lidocaine when administered in different dosages and by other means.
Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott
Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.
Likar, R; Molnar, M; Pipam, W; Koppert, W; Quantschnigg, B; Disselhoff, B; Sittl, R
The aim of this study was to determine whether 3 days of TENS therapy postoperatively after shoulder operations would result in better pain relief and/or reduced analgesic intake when compared to placebo. The study was carried out randomized, double-blind and placebo controlled. Thirty patients were randomized to two groups. The verum group received TENS SM1AKS 80 Hz 6 mA and the placebo group received TENS SM1AKS 80 Hz 0 mA. The pain was assessed pre-operatively using the Hamburg Pain Adjective List. Premedication and Anaesthesia were standardized. TENS was applied to the patients immediately postoperatively for 8 hours and then on the following days 5 times daily for 45 minutes. The effectiveness was evaluated postoperatively using a visual analogue scale (rest, activity), the Hamburg Pain Adjective List and postoperative analgesic consumption. The visual analogue scale at rest and on activity showed no significant difference between the groups. Postoperative analgesic consumption of morphine hydrochloride in the first 24 hours was at time 8 hours postoperative significantly and at all other time points markedly less in the verum group compared to the placebo group. The sensory secondary scale score of the "Hamburg Pain Adjective List" was significantly lower postoperatively compared to preoperatively in the verum group. We were able to show in this study that TENS applied postoperatively after shoulder surgery clearly reduced analgesic consumption in the first 72 hours. Furthermore there was a significant difference in the pain scores using the "Hamburg Pain Adjective List" in favour of the verum group. TENS applied postoperatively is a effective, simple modality with few side-effects.
Hauser, Robert A; Schapira, Anthony H V; Rascol, Olivier; Barone, Paolo; Mizuno, Yoshikuni; Salin, Laurence; Haaksma, Monika; Juhel, Nolwenn; Poewe, Werner
The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well-tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double-blind, placebo and active comparator-controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty-nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post-levodopa rescue evaluations, was -5.1 (1.3) in the placebo group, -8.1 (1.1) in the pramipexole ER group (P = 0.0282), and -8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post-levodopa rescue data, was -2.7 (1.3) in the placebo group, -7.4 (1.1) in the pramipexole ER group (P = 0.0010), and -7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID.
How to cite this article:Abbaskhanian A, Ehteshami S, Sajjadi S, Rezai MS. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial. Iran J Child Neurol Autumn 2012; 6(4): 9-15. Abstarct:Objective Breath holding spells (BHS) are common paroxysmal non-epileptic eventsin the pediatric population which are very stressfull despite their harmlessnature. There has been no specific treatment found for the spells yet. The aimof this study was to evaluate the...
Luca; Gianotti; Lorenzo; Morelli; Francesca; Galbiati; Simona; Rocchetti; Sara; Coppola; Aldo; Beneduce; Cristina; Gilardini; Daniela; Zonenschain; Angelo; Nespoli; Marco; Braga
AIM:To investigate whether probiotic bacteria,given perioperatively,might adhere to the colonic mucosa, reduce concentration of pathogens in stools,and modulate the local immune function. METHODS:A randomized,double-blind clinical trial was carried out in 31 subjects undergoing elective colorectal resection for cancer.Patients were allocated to receive either a placebo(group A,n=10),or a dose of 10 7 of a mixture of Bifidobacterium longum(BB536) and Lactobacillus johnsonii(La1)(group B,n=11),or the same mix...
Padmanabhan, Anantha; Frangopoulos, Christoforos; Shaffer, Lynn E T
Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points. This study was a double-blind, randomized, parallel-group controlled clinical trial (NCT 02937506). This study was conducted at a single ambulatory surgery center at an urban teaching community health system. Patients were scheduled for outpatient colonoscopy. Those with high-risk cardiac or pulmonary disease were excluded. Anesthesia personnel administered either fentanyl/midazolam (n = 300) or propofol (n = 300) for sedation during outpatient colonoscopy. A single, highly experienced endoscopist performed all colonoscopies. The primary outcomes measured were patient satisfaction (5-point Likert scale) and procedure complications. Data were collected on the day of endoscopy by the nursing staff of the postanesthesia care unit. A subinvestigator blinded to the randomization called patients 24 to 72 hours after discharge to obtain data on postprocedure problems and status of resumption of normal activities. Analysis was intention-to-treat. Fewer patients who received propofol remembered being awake during the procedure (2% vs 17% for fentanyl, p propofol (p propofol group (2.7% vs 11.7%, p propofol over a combination of fentanyl/midazolam as their anesthetic for outpatient colonoscopies. From a patient and provider perspective, propofol appears to be superior to fentanyl/midazolam for outpatient colonoscopy. See Video Abstract at http://links.lww.com/DCR/A445.
Full Text Available 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 < 0.01 and p < 0.05, respectively. No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota–muscle–brain axis could be considered for treatment of the frailty syndrome.
Full Text Available "nAs the most common male sexual disorder premature ejaculation (PE, also referred to as early ejaculation (EE or rapid ejaculation (RE, affects 30%-40% of sexually active men. Despite the limited number of available studies comparing the efficacy of selective serotonin re-uptake inhibitors (SSRI they have been thought to have beneficial effects for the treatment of patients with PE. In the present study, we assessed the efficacy of on-demand use of citalopram, in the treatment of premature ejaculation. A randomized double blind study of fixed dose on-demand use of citalopram was performed in Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample was consisted of 80 married patients diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders. The patients were randomly assigned to two groups: group 1 consisting of 42 patients received 20mg citalopram, and group 2 consisting of 38 patients received placebo four hours before intercourse for a 4-week treatment course. The effects of drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of treatment course. The mean IELT increased from 66.78±36.94 to 80.85±43.05 seconds in group 1 and from 63.44±33.16 to 65.71±34.26 seconds in group 2 (P = 0.000. Mean CIPE score increased 1.14±1.04 and 0.52±0.50 in group 1 and 2 respectively (P = 0.002. The patients treated with on demand citalopram showed significantly greater improvement in IELT and CIPE score compared to the patients receiving placebo. It seems that citalopram may be an effective treatment of premature ejaculation with on-demand usage. However further studies are warranted.
R TALA KOUB
Full Text Available Introduction. Extradural anesthesia is a successfull procedure in many operations.This is also a suitable and elective anesthetic procedure in many operations have particular hemodynamic conditions. Hence the onset time on this of anesthesia is slow and the degree of sensory and motor block is relatively variable in many cases, this procedure is not accepted by anesthesiologists and surgeons. So, inspite of its priority in many cases, it is less used. Thegoal of this study is to achieve a practical and effective solution to shorten the onset of analgesia and increasing analgesic duration which studies adding ketamin to bupivacain in extradural anesthesia. Methods. This study is a double blinded randomized clinical trial. Forty adult patients in class 1 and 2 of ASA who have been candidate for elective lower limb or lower abdominal surgery in Al-zahra and Kashani medical center in 1998 were selected. Without receiving any premedications, all of the patients received 500 CC ringer lactated solution before onset of anesthesia and they were divided into 2 groups. Group 1 received 20 cc of 0.5 percent bupivacain+0.5cc of 0.9 percent normal saline. Group 2 (interventional received 20 cc of 0.5 percent bupivacain + 0.5 cc of Ketamin (25mg. The onset of sensory block and the duration of sensory and motor block were measured and compared in both groups. Results. The onset of sensory block in interventional group was shorter than in controlled group. The duration of sensory block in interventional group was longer than in controlled group. The duration of the motor block was longer in controlled group than interventional group (P < 0.05. Discussion. Adding ketamin to bupivacain results in earlier onset and longer duration of analgesia in extradural anesthesia. This effect may be due to the inhibitory effect of the ketamin on posterior nerve root activity in spinal cord which can be an effective mechanism of ketamin in making analgesia.
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
Randomized, double-blind, placebo-controlled and active-controlled study to assess the relative abuse potential of oxycodone HCl-niacin tablets compared with oxycodone alone in nondependent, recreational opioid users
Full Text Available Lynn R Webster,1 Robert L Rolleri,2,3 Glenn C Pixton,3 Kenneth W Sommerville31Lifetree Clinical Research, Salt Lake City, UT, USA; 2Salix Pharmaceuticals, Inc., Raleigh, NC, USA; 3Pfizer Inc, Cary, NC, USABackground: Abuse-deterrent formulations attempt to address public health and societal concerns regarding opioid abuse. Oxycodone HCl-niacin tablets combine oxycodone HCl with niacin and functional inactive excipients to create potential barriers to oral, intranasal, and intravenous abuse. This study compared the relative abuse potential of oral immediate-release oxycodone HCl-niacin with that of oral immediate-release oxycodone HCl and placebo in nondependent, recreational opioid users.Methods: Forty-nine participants received oxycodone HCl-niacin 40/240 mg and 80/480 mg, oxycodone 40 mg and 80 mg, and placebo in a randomized, double-blind, placebo-controlled and active-controlled, five-way crossover study. Primary endpoints based on a bipolar 100 mm visual analog scale for drug liking were area under effect curve (AUE0–1h, AUE0–2h, AUE0–3h, peak disliking, and effect at 0.5 hours post-dose (E0.5h. Other endpoints included take drug again assessment, overall drug liking, and pupillometry.Results: There were statistically significant differences between oxycodone HCl-niacin and oxycodone HCl doses for all primary endpoints (P < 0.0001, all comparisons, suggesting reduced abuse potential with oxycodone HCl-niacin. Take drug again and overall drug liking showed greater liking of oxycodone alone. Oxycodone HCl-niacin 80/480 mg had consistently lower liking assessments than oxycodone HCl-niacin 40/240 mg, suggesting a dose-response to the aversive effects of niacin. Opioid-related adverse events were similar for equivalent oxycodone doses. The treatment-emergent adverse events most specifically associated with oxycodone HCl-niacin (ie, skin-burning sensation, warmth, and flushing were consistent with the expected vasocutaneous effects of
Double-blind, randomized, multicentre, and active comparator controlled investigation of the effect of Pioglitazone, Metformin, and the combination of both on cardiovascular risk in patients with type 2 diabetes receiving stable basal insulin therapy: the PIOCOMB study
Full Text Available Abstract Background We analyzed specific effects of an add-on therapy with pioglitazone compared to metformin and their combination in patients with basal insulin treatment on biomarkers of CV risk. Methods In this double-blind, randomized, multicentre, active comparator controlled trial, 121 patients with type 2 diabetes were enrolled. Inclusions: treatment with basal insulin, HbA1C 6.5% - 8.5%, age 30 - 75 years. After glargine therapy over 2 weeks for titration towards FBG ≤ 7.8 mmol/L, patients received either (A bid 850 mg metformin (n = 42, (B bid 15 mg pioglitazone (n = 40, or (C 30 mg pioglitazone plus 1.7 g metformin (n = 39 over 6 months. Matrix Metal Proteinase 9 (MMP-9 was primary objective, together with biomarkers of CV risk. Results Pioglitazone (B reduced MMP-9 versus baseline by 54.1 + 187.1 ng/mL, with metformin (A it was increased by 49.6 + 336.2 ng/mL (p = 0.0345; B vs. A, and with the combination of both (C it was decreased by 67.8 + 231.4 ng/mL (A vs. C: p = 0.0416; B vs. C: p = 0.8695. After logarithmic transformation due to high variances the exploratory results showed significance for A vs. B (p = 0.0043 and for A vs. C (p = 0.0289. Insulin dosage was reduced by 7.3 units in group B (p 1C was only significantly decreased in the combination group. No significant effects were observed for NFkB and PGFα. peripheral edema were seen in 11.9% vs. 40.0% vs. 20.5%, and weight change was -0.7 kg vs. +4.3 kg vs. +2.7 kg (A vs. B vs. C. Conclusions Addition of pioglitazone but not of metformin reduces MMP-9, hs-CRP and increased insulin sensitivity and adiponectin in this study. The combination of both had no additional effect on inflammation. Pioglitazone is suggested to be a rational add-on therapy to basal insulin in patients with high CV risk.
Vege, Santhi Swaroop; Atwal, Tegpal; Bi, Yan; Chari, Suresh T; Clemens, Magdalen A; Enders, Felicity T
In acute pancreatitis (AP) tumor necrosis factor-α mediates multi-organ failure; in animal models its blockade with pentoxifylline ameliorates AP. The efficacy of pentoxifylline in predicted severe AP (pSAP) was tested in a double-blinded, randomized, control trial. Twenty-eight patients with pSAP were randomized within 72 hours of diagnosis to pentoxifylline or placebo. Baseline characteristics were similar in both groups. The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days (all P < .05). Patients receiving pentoxifylline had no adverse effects. Pentoxifylline within 72 hours of pSAP is safe; a larger study of pentoxifylline in AP is needed to confirm efficacy. ClinicalTrials.gov number: NCT01292005. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.
Valero, Gonzalo; González, E U Roxana
A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.
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
Objective: To assess the efficacy and safety of cerivastatin in Chinese with primary hypercholesterolemia. Methods: The multicentre, randomized, double-blind, placebo-controlled, parallel group trial was conducted in 3 hospitals. After a 5-week single-blind run-in period (period A), 470 patients were randomized to receive cerivastatin 0.1mg (n=119), 0.2mg (n=
Full Text Available Mucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9% in COPD.A randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50 were screened, 21 were treated and 19 patients completed the study per protocol.A comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3 compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3. The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8 during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000, only 27 adverse events (20 during the Tyloxapol and seven during saline were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.Our study
Abhishek, K N; Supreetha, S; Sam, George; Khan, S Nubesh; Chaithanya, K H; Abdul, Nishad
The present study was designed to assess the effect of toothpaste containing neem on plaque and gingivitis. Randomized, double blind clinical trial was designed. Thirty first year dental students volunteered to participate in the study. Neem containing tooth paste was used as an intervention. Clinical examination was carried out using Silness and Loe plaque index (PI) and Loe and Silness gingival index (GI). Independent t-test and paired t-test was used for the intergroup and the intragroup comparison. Out of 30 participants, 22 (73.3%) were females and eight (26.7%) were males. A statistically significant difference was found between the test and control group after intervention with respect to the PI and GI. Neem containing toothpaste can be used as an adjunct for maintenance of oral hygiene. Regular brushing with neem toothpaste might act as an adjunct to maintenance of good oral hygiene, and thus improve oral health.
Faurschou, A.; Wulf, Hans Chr.
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...... minimally) through III (sun-sensitive skin, sometimes burns, slowly tans to light brown). Intervention: Seven 34-cm(2) areas were marked on the upper aspect of the back of each participant. An untreated area was tested to determine UV sensitivity. Two areas were treated with excess amounts (2 mg/cm(2......) was determined by the following equation: SIF=MED(minimal erythema dose) on treated skin/MED on nontreated skin. An SIF greater than 1 indicated an effect of topical corticosteroids in sunburn relief. Results: The SIFs in the areas treated with either topical corticosteroid 30 minutes before UV-B exposure...
In a randomized double-blind study, treatment with either metoprolol, nifedipine, or their combination was compared for effects on ischemic variables and heart rate obtained during ambulatory monitoring in 42 patients with chronic stable angina. All patients had severe chronic stable angina...... of at least 6 months' duration despite medical treatment, and exhibited coronary artery stenosis of 75% in one or more coronary arteries. Metoprolol reduced the frequency of total (p less than 0.01) and asymptomatic ischemic episodes (p less than 0.05), the duration of ischemia (p less than 0.......05), and the ischemic burden (p less than 0.05), which contrasted to the lack of any similar significant effect during nifedipine monotherapy. During combination therapy, there was a tendency to further improvement, which did not reach statistical significance compared with metoprolol monotherapy. Heart rate...
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
Schölmerich, Jürgen; Fellermann, Klaus; Seibold, Frank W
BACKGROUND & AIMS: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis (TSO) versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease (CD). METHODS: Adults with active CD (n=252......) randomly received six fortnightly doses of 250, 2500 or 7500 TSO/15 ml suspension/day (TSO 250, TSO 2500, TSO 7500), or 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up. Primary endpoint was the rate of clinical remission (Crohn's disease activity index [CDAI
Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas
This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain.
Thamsborg, G; Florescu, A; Oturai, P
OBJECTIVE: The investigation aimed at determining the effectiveness of pulsed electromagnetic fields (PEMF) in the treatment of osteoarthritis (OA) of the knee by conducting a randomized, double-blind, placebo-controlled clinical trial. DESIGN: The trial consisted of 2h daily treatment 5 days per...
Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker;
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 stimula...
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 simulta
Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; van Luijk, Peter; Stokman, Monique A.; Vissink, Arjan
Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with HN
Hoving, Marjanke A.; van Raak, Elisabeth P. M.; Spincemaille, Geert H. J. J.; Palmans, Liesbeth J.; Sleypen, Frans A. M.; Vles, Johan S. H.
Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB…
de Waal, Yvonne C. M.; Raghoebar, Gerry M.; Huddleston Slater, James J. R.; Meijer, Henny J. A.; 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 peri-impla
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 peri-imp
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
Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.
Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…
Jacobsen, D.E.; Samson, M.M.; Emmelot-Vonk, M.H.; Verhaar, H.J.
OBJECTIVE: To compare the effects of raloxifene and placebo on body composition and muscle strength. DESIGN: Randomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, T
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
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)
de Waal, Yvonne C. M.; Raghoebar, Gerry M.; Huddleston Slater, James J. R.; Meijer, Henny J. A.; 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
Laan, Wijnand; Grobbee, Diederick E.; Selten, Jean-Paul; Heijnen, Cobi J.; Kahn, Rene S.; Burger, Huibert
Objective: Inflammatory processes may play a role in the pathophysiology of schizophrenia. The aim of this study was to determine the efficacy of adjuvant treatment with aspirin (acetylsalicylic acid) in schizophrenia spectrum disorders. Method: This randomized, double-blind, placebo-controlled
Szivak Tunde K
Full Text Available Abstract Background While exercise acts to combat inflammation and aging, the ability to exercise may itself be compromised by inflammation and inflammation's impact on muscle recovery and joint inflammation. A number of nutritional supplements have been shown to reduce inflammation and improve recovery. The purpose of the current investigation was to examine the effect of a multi-nutrient supplement containing branched chain amino acids, taurine, anti-inflammatory plant extracts, and B vitamins on inflammatory status, endothelial function, physical function, and mood in middle-aged individuals. Methods Thirty-one healthy and active men (N = 16, mean age 56 ± 6.0 yrs and women (N = 15, mean age = 52 ± 7.5 yrs participated in this investigation. Subjects completed one 28 day cycle of placebo supplementation and one 28 day cycle of multi-nutrient supplementation (separated by a one week washout period in a balanced, randomized, double-blind, cross-over design. Subjects completed weekly perceptual logs (PROMIS-57, KOOS and pre- and post- testing around the supplementation period. Testing consisted of brachial artery flow mediated dilation (FMD, blood measures, and physical performance on vertical jump, handgrip strength, and balance (dispersion from center of pressure. Significance for the investigation was p ≤ 0.05. Results IL-6 significantly decreased in both men (from 1.2 ± 0.2 to 0.7 ± 0.4 pg·mL-1 and women (from 1.16 ± 0.04 to 0.7 ± 0.4 pg·mL-1. Perceived energy also improved for both men (placebo: 1.8 ± 0.7; supplement: 3.7 ± 0.8 AUC and women (placebo: 1.2 ± 0.7; supplement: 2.8 ± 0.8 AUC. Alpha-1-antichymotrypsin (from 108.9 ± 38.6 to 55.5 ± 22.2 ug·mL-1, Creatine Kinase (from 96 ± 34 to 67 ± 23 IU·L-1, general pain, and joint pain decreased in men only, while anxiety and balance (from 0.52 ± 0.13 to 0.45 ± 0.12 cm improved in women only. Men showed increased performance in vertical jump power (from 2642 ± 244 to 3134
Dunn-Lewis, Courtenay; Kraemer, William J; Kupchak, Brian R; Kelly, Neil A; Creighton, Brent A; Luk, Hui-Ying; Ballard, Kevin D; Comstock, Brett A; Szivak, Tunde K; Hooper, David R; Denegar, Craig R; Volek, Jeff S
While exercise acts to combat inflammation and aging, the ability to exercise may itself be compromised by inflammation and inflammation's impact on muscle recovery and joint inflammation. A number of nutritional supplements have been shown to reduce inflammation and improve recovery. The purpose of the current investigation was to examine the effect of a multi-nutrient supplement containing branched chain amino acids, taurine, anti-inflammatory plant extracts, and B vitamins on inflammatory status, endothelial function, physical function, and mood in middle-aged individuals. Thirty-one healthy and active men (N = 16, mean age 56 ± 6.0 yrs) and women (N = 15, mean age = 52 ± 7.5 yrs) participated in this investigation. Subjects completed one 28 day cycle of placebo supplementation and one 28 day cycle of multi-nutrient supplementation (separated by a one week washout period) in a balanced, randomized, double-blind, cross-over design. Subjects completed weekly perceptual logs (PROMIS-57, KOOS) and pre- and post- testing around the supplementation period. Testing consisted of brachial artery flow mediated dilation (FMD), blood measures, and physical performance on vertical jump, handgrip strength, and balance (dispersion from center of pressure). Significance for the investigation was p ≤ 0.05. IL-6 significantly decreased in both men (from 1.2 ± 0.2 to 0.7 ± 0.4 pg·mL(-1)) and women (from 1.16 ± 0.04 to 0.7 ± 0.4 pg·mL(-1)). Perceived energy also improved for both men (placebo: 1.8 ± 0.7; supplement: 3.7 ± 0.8 AUC) and women (placebo: 1.2 ± 0.7; supplement: 2.8 ± 0.8 AUC). Alpha-1-antichymotrypsin (from 108.9 ± 38.6 to 55.5 ± 22.2 ug·mL(-1)), Creatine Kinase (from 96 ± 34 to 67 ± 23 IU·L(-1)), general pain, and joint pain decreased in men only, while anxiety and balance (from 0.52 ± 0.13 to 0.45 ± 0.12 cm) improved in women only. Men showed increased performance in vertical jump power (from 2642 ± 244 to 3134 ± 282 W) and grip strength (from
Full Text Available Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.
Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.
Ajori, Ladan; Nazari, Leila; Eliaspour, Dariush
This double-blind randomized controlled trial was conducted to evaluate whether use of acupuncture could initiate labor at term and thus reduce post-term induction. Between 2010 and 2011, a total of 80 women at 38 weeks of gestation or greater were randomized to acupuncture and sham acupuncture groups. Acupuncture points LI4, SP6 and BL67 were needled bilaterally. The primary outcome was initiation of labor. The time from acupuncture to delivery, mode of delivery, fetal and maternal outcome and Apgar scores were recorded. The trial is registered at irct.ir, number IRCT201111218151N1. Eighty women were randomized and 75 women completed the study procedure. Age, BMI, parity and gestational age were similar in both groups. Spontaneous labor was initiated in 94.7 % of acupuncture group and 89.2 % of sham acupuncture group (p = 0.430). There were no statistically significant difference between groups for time from enrollment to delivery (p = 0.06). According to this study, it seems that acupuncture was not effective in labor initiation compared to sham acupuncture.
Karel Rauš; Stephan Pleschka; Peter Klein, MSc; Roland Schoop, MSc; Peter Fisher
Background: Echinacea has antiviral activity against influenza viruses in vitro and has traditionally been used for treatment of colds and flu. Objectives: This randomized, double-blind, double-dummy, multicenter, controlled clinical trial compared a new echinacea formulation with the neuraminidase inhibitor oseltamivir, the gold standard treatment for influenza. Methods: Following informed consent, 473 patients with early influenza symptoms (≤48 hours) were recruited in primary care in...
Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective w...
Karel Rauš; Stephan Pleschka; Peter Klein, MSc; Roland Schoop, MSc; Peter Fisher
Background: Echinacea has antiviral activity against influenza viruses in vitro and has traditionally been used for treatment of colds and flu. Objectives: This randomized, double-blind, double-dummy, multicenter, controlled clinical trial compared a new echinacea formulation with the neuraminidase inhibitor oseltamivir, the gold standard treatment for influenza. Methods: Following informed consent, 473 patients with early influenza symptoms (≤48 hours) were recruited in primary care in...
Full Text Available Background: The transverse abdominis plane (TAP block, a regional block provides effective analgesia after lower abdominal surgeries if used as part of multimodal analgesia. In this prospective, randomized double-blind study, we determined the efficacy of TAP block in patients undergoing cesarean section. Materials and Methods: Totally, 62 parturients undergoing cesarean section were randomized in a double-blind manner to receive either bilateral TAP block at the end of surgery with 20 ml of 0.25% bupivacaine or no TAP block, in addition to standard analgesic comprising 75 mg diclofenac 8 hourly and intravenous patient-controlled analgesia (PCA tramadol. Each patient was assessed at 0, 4, 8, 12, 24, 36, and 48 h after surgery by an independent observer for pain at rest and on movement using numeric rating scale of 0-10, time of 1 st demand for tramadol, total consumption of PCA tramadol, satisfaction with pain management and side effects. Results: Use of tramadol was reduced in patients given TAP block by 50% compared to patients given no block during 48 h after surgery (P < 0.001. Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001, time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group. Conclusion: Transverse abdominis plane block was effective in providing analgesia with a substantial reduction in tramadol use during 48 h after cesarean section when used as adjunctive to standard analgesia.
Full Text Available Objective : "nWe conducted a double-blind, placebo-controlled study todetermine the efficacy of an herbal sexual supplement (vigRX on premature ejaculation (PE. Method: "nA randomized double blind study was conducted on a fixed dose of herbal vigRX at Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample consisted of 85 married patients diagnosed withprimary PE according to Diagnostic and Statistical Manual of Mental Disorders. Each patient underwent diagnostic evaluation by one trained psychiatrist, using Structured Clinical Interview for DSM-IV-TR. Each patient was evaluated by researchers to exclude the organic sexual dysfunctions. The patients were randomly assigned in to two groups: group 1 consisting of 42 patients receiving placebo, and group 2 consisting of 43 patients receiving 540 mg herbal vigRX for a 4-week treatment course. The effects of the drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of the treatment course. Statistical analysis was performed using SPSS software (15th version. Results: "nThe mean IELT increased 22.4 and 32.0 seconds in the placebo and the vigRX group respectively after the treatment course. The mean IELT differences between the two groups was not significant. The mean CIPE score increased 2.40 and 4.37 in the placebo and the vigRX group respectively .The mean CIPE score differences between the two groups was not significant.No side effect was reported by the subjects in neither groups during the treatment course. "nConclusion: Although the improvement in IELT and CIPE scores in the herbal vigRX group was more than the placebo group, this difference was not statistically significant. The increasing of IELT and CIPE score in the placebo group may be due to the placebo effects. Further studies with higher vigRX doses, greater sample size
Full Text Available Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21, were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm and 24% oxygen ("treatment group", n = 33 or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29. Outcome measures included Clinical Global Impression (CGI scale, Aberrant Behavior Checklist (ABC, and Autism Treatment Evaluation Checklist (ATEC. Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008, receptive language (p Conclusion Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. Trial Registration clinicaltrials.gov NCT00335790
Velayudha S Reddy
Full Text Available Background : Control of post spinal shivering is essential for optimal perioperative care, which can be achieved either by oral or parental medications. The present study is designed to evaluate the efficacy and safety of intravenous low-dose clonidine and tramadol in the treatment of post spinal shivering. Materials and Methods : In this prospective, a double blind, randomized study, 90 ASA grade I or II, parturients aged 18 - 35 years, undergoing caesarean section under spinal anaesthesia, who subsequently developed shivering grade 3 or 4, were randomized into two groups, to receive either clonidine or tramadol. The efficacy and response rate of the study drugs were evaluated and recorded. Side effects like, nausea, vomiting, hypotension, bradycardia, dry mouth, sedation, skin rash and headache, if present, were recorded. All data were analyzed by using the Chi square test and the Z-test. Results : There were significant differences in the response rate between the drugs (P < 0.05. Time taken from the starting of treatment to cessation of shivering was significantly less with the tramadol group (P < 0.05, however, the frequency of nausea, vomiting, sedation and headache were also significantly more in the tramadol group Conclusion : In our study we concluded that both clonidine and tramadol control shivering. However, the response rate was higher and time taken to control shivering was lesser with tramadol, but the response rate and the side effects were lesser with clonidine.
Sadeghi, Mostafa; Atefyekta, Reza; Azimaraghi, Omid; Marashi, Seyed Mojtaba; Aghajani, Yasaman; Ghadimi, Fatemeh; Spahn, Donat R; Movafegh, Ali
Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0±1.4 in fibrinogen group, and 1.3±1.1 in control group). Less postoperative bleeding was observed in the fibrinogen group (477±143 versus 703±179, p=0.0001). Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p=0.094). No thrombotic event was observed through 72 h after surgery. Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.
Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison
Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.
Park, Soo-Hyun; Huh, Tae-Lin; Kim, Sun-Young; Oh, Mi-Ra; Tirupathi Pichiah, P B; Chae, Soo-Wan; Cha, Youn-Soo
The effects of actiponin was investigated, a heat-processed Gynostemma pentaphyllum extract, on body weight, fat loss, and metabolic markers of Korean participants in a 12-week, randomized, double-blind, placebo-controlled clinical trial. Obese participants (BMI ≥ 25 kg m(-2) and WHR ≥ 0.90 for male or WHR ≥ 0.85 for female) who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 80 subjects were randomly divided into actiponin (n = 40, 450 mg day(-1) ) and placebo (n = 40) groups. Outcomes included measurement of efficacy (abdominal fat distribution, anthropometric parameters, and blood lipid profiles) and safety (adverse events, laboratory test results, electrocardiogram data, and vital signs). During 12-week of actiponin supplementation, total abdominal fat area, body weight, body fat mass, percent body fat, and BMI were significantly decreased (P = 0.044, P < 0.05, P < 0.0001, P < 0.0001, and P < 0.05, respectively) in the actiponin group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that actiponin is a potent antiobesity reagent that does not produce any significant adverse effects. These results suggest that actiponin supplementation may be effective for treating obese individuals. Copyright © 2013 The Obesity Society.
Full Text Available Introduction: There is some evidence that omega-3 fatty acids are associated with depression. The aim of this study was to compare the effects of eicosapentaenoic acid(EPA and placebo on mild to moderate depression. Methods: This double-blind randomized clinical trial was conducted on 54 outpatients with mild to moderate depression. Patients were randomly assigned to two groups: receiving EPA supplement or placebo. EPA and placebo groups received two identical capsules per day for 12 weeks. Each capsule contained 500 mg EPA or coconut oil. Hamilton Rating Scale for Depression(HRSD was used to determine the severity of depression at baseline, sixth and twelfth weeks after intervention. Results: Forty two patients(77.8% completed the 12-week intervention. A statistically significant difference was observed in mean scores of HRSD between EPA and placebo groups at the end of the study (P=0.001. Mean scores of HRSD decreased over time in both groups so that the analysis of variance for repeated measurements showed a statistically significant time effect(F=50.55, df=1.32, P<0.0001. Also, a statistically significant treatment effect of EPA compared to placebo was observed over time (treatment*time interaction, F=12.67, df=1.32, P=0.0001. Conclusion: The results of this study showed the efficacy of EPA in treatment of depression, so its use is recommended as an add-on to antidepressant medications in treatment of mild to moderate depression.
M KAR AHMADI
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.
Wilkie, M E; Beer, J C; Evans, S J; Raftery, M J; Lord, R H; Moore, R; Marsh, F P
A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function when added to a triple therapy immunosuppression regime comprising low-dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cadaveric renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria included recent calcium antagonist treatment. At 3 months after transplantation mean GFR adjusted for graft loss was significantly higher in group NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P nifedipine commenced preoperatively and continued for 3 months following transplantation has beneficial effects on early renal allograft function when incorporated as part of an immunotherapy regimen based on cyclosporin.
Full Text Available BACKGROUND: T-cell vaccination (TCV for multiple sclerosis (MS refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. AIM: To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. METHODOLOGY: Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7. T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180 and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo were eligible for per-protocol analysis. RESULTS: At one year following the inclusion, an increase in the EDSS (+0.50 and an increase in 10-meter walking time (+0.18 sec, were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01 and in the 10-meter walking time (0.84 sec; p<0.005. Sixteen of the 17 patients (94.1% in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment. The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. CONCLUSIONS: This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT01448252.
Ramesh R Rai; Manisha Dwivedi; Nirmal Kumar
Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo tre...
Mittal, N; Goyal, A; Gauba, K; Kapur, A; Jain, K
To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients. This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5 mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25 mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75 microg/kg/min titrated to a predefined Worse level as per Houpt's sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose. Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups. Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.
Barak, Shlomo; Katz, Joseph
Halitosis (bad breath) is a common condition that is socially crippling for vast parts of the population and results from malodorous volatile sulfur compounds, which are by-products of oral bacteria. In this doubled-blind, randomized study, 75 subjects with halitosis were evaluated. The participants were treated with or without abrasive microcapsules (candy) containing zinc gluconate 0.5%, propolis 2%, and a combination of both (zinc 0.25% and propolis 1%). The halitosis was assessed by a Halimeter, a portable instrument that measures the emission of volatile sulfur compounds at different time exposures to the treatments. Breezy candy (which is sugar-free) was found effective in the treatment of halitosis for up to 4 hours. While treatment with regular candy (group 1, traditional candy without abrasive particles) showed reduction in malodor of 10%, Breezy candy showed reduction of up to 60% in malodor (P halitosis. The combined effect of abrasion by microcapsules with zinc supplement represents a novel and successful approach for the treatment of halitosis.
Goy, J A; Maynard, J H; McNaughton, W M; O'Shea, A
A study was carried out to assess the effectiveness of ranitidine in the short-term treatment of reflux oesophagitis. In a double-blind randomized trial of 37 outpatients with symptomatic, endoscopically proven, moderate or severe reflux oesophagitis, 18 patients received ranitidine (150 mg twice a day) and 19 patients received identical-looking placebo tablets for a period of six weeks. Clinical, laboratory, and endoscopic assessments were made initially, and at the end of six weeks. Two patients withdrew during the trial. Endoscopic evidence of improvement was found in 15 of 17 ranitidine-treated and in five of 18 placebo-treated patients. This difference was significant (P less than 0.01). Antacid consumption was significantly lower in the ranitidine-treated group (P less than 0.01). Improvement in histological findings, and the relief of retrosternal pain, regurgitation, dysphagia, and epigastric pain did not achieve levels of statistical significance. No adverse clinical or laboratory changes occurred in patients in either group. It is concluded that, as judged by endoscopic evidence, ranitidine is an effective drug for the short-term treatment of reflux oesophagitis.
Maruani, Annabel; Vierron, Emilie; Machet, Laurent; Giraudeau, Bruno; Halimi, Jean-Michel; Boucaud, Alain
Sonophoresis [low-frequency ultrasound (US)] has been used in animals and in vitro to investigate enhanced percutaneous absorption of drugs. No study focused on its clinical human tolerance has been published as yet. We aimed to assess the bioeffects of low-frequency US in vivo on human skin in a double-blind randomized-controlled study. We applied pulse-mode US at 36 kHz for 5 min in a step procedure of increasing dosage, from 1.57 to 3.50 W/cm(2), and placebo. The primary outcome was toxic effects of the procedure, defined as a pain score >40 on a 0-100 mm visual analogue scale or necrosis. Erythema (scored from 0 to 3 in severity) was also evaluated. The secondary outcomes were measurements of skin thickness by high-resolution skin imaging, of skin capacitance and temperature. We included 34 healthy volunteers. We found no pain score >38 and no skin necrosis with either US or placebo. Erythema was systematically observed immediately after US application, but after 1 day, we observed three cases in the knee group. The most frequent adverse effect was tinnitus. We observed no marked increase in temperature or cutaneous thickness after US or placebo. Cutaneous capacitance increased immediately after both applications. Such data demonstrating good tolerance of sonophoresis can be useful before the initiation of a clinical trial of the therapeutic use of low-frequency sonophoresis in humans. © 2011 John Wiley & Sons A/S.
Niharika Ranjan Lal
Full Text Available Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty-eight patients with cutaneous warts (male: female = 32:16 were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293. Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88 than in the control group (10.04 ± 5.80 from 8 weeks onwards (P = 0.010. Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases, keloid formation (3 and hypopigmentation (3. Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.
Roohi-Azizi, Mahtab; Arabzadeh, Somaye; Amidfar, Meysam; Salimi, Samrand; Zarindast, Mohammad Reza; Talaei, Ali; Akhondzadeh, Shahin
Residual symptoms of major depressive disorder are a source of long-term morbidity. New therapeutic strategies are required to alleviate this morbidity and enhance patient quality of life. Citicoline has been used for vascular accidents and has been effective in cognitive rehabilitation. It has been used successfully to reduce craving in patients with substance abuse disorder and for mood management of bipolar disorder. Here, we test citicoline effectiveness as an adjuvant therapy in major depression. A double-blind randomized trial was designed on 50 patients with major depressive disorder who were under treatment with citalopram. Patients were allocated to 2 groups and received citicoline (100 mg twice a day) or placebo as an adjuvant treatment for 6 weeks. Depressive symptoms were assessed by the Hamilton Depression Rating Scale (HDRS) at baseline and at weeks 2, 4, and 6. Significantly greater improvement was observed in the HDRS scores of the citicoline group compared with the placebo group from baseline to weeks 2, 4, and 6 (Ps = 0.030, 0.032, and 0.021, respectively). Repeated-measures general linear model demonstrated a significant effect for time × treatment interaction on the HDRS score (F2.10,101.22 = 3.12, P = 0.04). Remission rate was significantly higher in the citicoline group compared with the placebo group (P = 0.045). Citicoline was an effective adjuvant to citalopram in the therapy of major depressive disorder.
Kappelle L Jaap
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
Balaskas, Elias; Szepietowski, Jacek C.; Bessis, Didier; Ioannides, Dimitrios; Ponticelli, Claudio; Ghienne, Corinne; Taberly, Alain
Summary Background and objectives Uremic xerosis is a bothersome condition that is poorly responsive to moisturizing and emollient therapy. Design, setting, participants, & measurements A randomized, double-blind, intraindividual (left versus right comparison), multicentric clinical study was performed on 100 patients with moderate to severe uremic xerosis for 7 days, during which the patients applied twice daily an emulsion combining glycerol and paraffin (test product) on one allocated lower leg, and the emulsion alone (comparator) on the other lower leg. This was followed by an open-labeled use of the test product on all of the xerotic areas for 49 days. The main efficacy parameter was treatment response on each lower leg, as defined by a reduction from baseline of at least two grades in a five-point clinical score on day 7. Results Among the 99 patients analyzed, the test product was highly effective with a treatment response in 72 patients (73%), whereas 44 patients (44%) responded to the comparator (P emollient therapy is used. PMID:21258039
Spanemberg, Lucas; Massuda, Raffael; Lovato, Lucas; Paim, Leonardo; Vares, Edgar Arrua; Sica da Rocha, Neusa; Ceresér, Keila Maria Mendes
Randomized clinical trial (RCT) is the best study design for treatment-related issues, yet these studies may present a number of biases and limitations. The objective of this study is to carry out a qualitative analysis of RCT methodology in the treatment of bipolar depression (BD). A systematic review covering the last 20 years was performed on PubMed selecting double-blind RCTs for BD. The identification items of the articles, their design, methodology, outcome and grant-related issues were all analyzed. Thirty articles were included, all of which had been published in journals with an impact factor >3. While almost half studies (46.7%) used less than 50 patients as a sample, 70% did not describe or did not perform sample size calculation. The Last Observation Carried Forward (LOCF) method was used in 2/3 of the articles and 53.4% of the studies had high sample losses (>20%). Almost half the items were sponsored by the pharmaceutical industry and 33.3% were sponsored by institutions or research foundations. Articles on the pharmacological treatment of BD have several limitations which hinder the extrapolation of the data to clinical practice. Methodological errors and biases are common and statistical simplifications compromise the consistency of the findings.
Prummel, M.F.; Mourits, M.; Blank, L.; Berghout, A.; Koornneef, L.; Wiersinga, W.M. (Univ. of Amsterdam (Netherlands))
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.
Trampitsch, E; Pipam, W; Moertl, M; Sadjak, A; Dorn, C; Sittl, R; Likar, R
Lornoxicam is a non opioid analgesic belonging to the oxicam group. The aim of this study was to determine whether lornoxicam has a preemptive analgesic effect. This study was carried out in a randomized, double-blind fashion with 66 patients divided into three groups undergoing gynecological operations. Group I was administered 8 mg of lornoxicam i.v. preoperatively followed by an 8-mg bolus every 8 h for a total dose of 24 mg in the first 24 h. Group II was administered 8 mg of lornoxicam i.v. bolus before the end of the operation followed by 8 mg every 8 h for a total dose of 24 mg in the first 24 h. Group III was administered placebo before and after the operation and for the first 24 h. The effectiveness was assessed postoperatively using the visual analogue scale (at rest, on exertion) and by calculating the total analgesic consumption of morphine hydrochloride in the first 24 h following operation. Vital signs and side effects were documented. Groups I and II demonstrated significantly reduced pain scores compared to group III at various points in time. Group I also demonstrated a weakly significant reduction in analgesic consumption of morphine hydrochloride postoperatively compared to groups II and III. Lornoxicam administered preemptively appears to improve the quality of postoperative analgesia and lead to reduced consumption of opioid analgesics postoperatively in patients undergoing gynecological operations.
Full Text Available Attention-Deficit/Hyperactivity Disorder is one of the most common mental disorders in childhood, and it continues to adulthood without proper treatment. Stimulants have been used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD for many years, and the efficacy of methylphenidate in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies. However, there are some concerns about stimulants. Finding other effective medications for the treatment of adult ADHD seems necessary. We hypothesized bupropion could be effective in the treatment of adult ADHD because some theoretical and experimental evidence exists to support efficacy of this medication. Forty-two patients with a diagnosis of ADHD, according to the revised fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, were randomized to receive 150 mg/day bupropion or placebo for a 6-week double-blind, placebo-controlled clinical trial. Each patient filled the Conners' Adult ADHD Rating Scales-Self-Report-Screening version (CAARS before starting to take medication and in weeks 3 and 6 of the study. The mean score of the two groups receiving bupropion or placebo decreased over the 6 weeks. There was a significant difference between the two groups in CAARS score after 6 weeks. Bupropion is more effective than placebo in the treatment of adults with ADHD. Bupropion can be an alternative medication for the treatment of Adults with ADHD as its clinical efficacy was proven by other studies.
Amir M. Ziaee
Full Text Available INTRODUCTION: The exact mechanism of chronic nonbacterial prostatitis has not been yet elucidated and the outcome with the current management is dismal. In this trial, we studied the effect of allopurinol in the treatment of this disease. MATERIALS AND METHODS: In this randomized double blind controlled trial, a calculated sample size of 56 were grouped into "intervention group" who received allopurinol (100 mg tds for 3 months with ofloxacin (200 mg tds for 3 weeks (n = 29 and "control group" who received placebo tablets with ofloxacin (n = 27. Patients’ scores based on the National Institute of Health Chronic Prostatitis Symptom Score were recorded before therapy and then every month during the study. A four-glass study was performed before intervention and after 3 months. RESULTS: The 2 groups were similar regarding outcome variables. In the first month of study, a significant but similar improvement in symptom scores was observed in both groups. Microscopic examination of prostate massage and post-massage samples were also similar in both groups. No side effects due to allopurinol were observed in patients. CONCLUSION: We did not find any advantage for allopurinol in the management of chronic prostatitis versus placebo in patients receiving routine antibacterial treatment.
Riche, Daniel M; Riche, Krista D; Blackshear, Chad T; McEwen, Corey L; Sherman, Justin J; Wofford, Marion R; Griswold, Michael E
Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL ≥ 100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6-8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P = 0.001) which was not seen with GE combination (P = 0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (-7.8 mmHg; P < 0.01) and diastolic blood pressure (-7.3 mmHg; P < 0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n = 51) exhibited minor weight loss with pterostilbene (-0.62 kg/m(2); P = 0.012). Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.
Daniel M. Riche
Full Text Available Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL≥100 mg/dL. Subjects were divided into four groups: (1 pterostilbene 125 mg twice daily; (2 pterostilbene 50 mg twice daily; (3 pterostilbene 50 mg + grape extract (GE 100 mg twice daily; (4 matching placebo twice daily for 6–8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P=0.001 which was not seen with GE combination (P=0.47. Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (−7.8 mmHg; P<0.01 and diastolic blood pressure (−7.3 mmHg; P<0.001 were reduced with high dose pterostilbene. Patients not on cholesterol medication (n=51 exhibited minor weight loss with pterostilbene (−0.62 kg/m2; P=0.012. Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.
Full Text Available Objectives: To compare the anti platelet effects of locally manufactured clopidogrel with the anti platelet effect of clopidogrel manufactured by multinational pharmaceutical abroad. Methodology: A total of 118 subjects were enrolled, 18 to 65 years of age, who presented with suspected ischemic heart disease and were randomly assigned to receive either drug A (Pidogrel or drug B (Plavix in a double blind manner for 7 days. Platelet aggregation was measured in both the groups at baseline and at final visit. Results: Base line platelet aggregability in both drug groups was not significantly different (p=0.317 Mean reduction in platelet aggregation by drug-A was 8.47+/- 0.45 ohms (p<0.001 and mean reduction in platelet aggregation by drug-B was 8.62+/- 0.46 (p<0.001. The difference in platelet aggregability at day 7(follow up between the two groups was not statistically significant i.e., was the same. Conclusion: Locally manufactured clopidogrel is equally effective as that manufactured by the multinational company abroad giving us the added advantage of cost effectiveness
Waldinger, M D; Zwinderman, A H; Olivier, B
Selective serotonin reuptake inhibitors (SSRIs) are known to induce delayed orgasm and ejaculation. However, different SSRIs may differentially delay ejaculation. A double-blind, fixed-dose study in healthy men with lifelong rapid ejaculation was performed to evaluate potential differences between clinically relevant doses of two selective serotonin reuptake inhibitors, paroxetine and citalopram, in their effects on ejaculation. Thirty men with an intravaginal ejaculation latency time (IELT) less than 1 minute were randomly assigned to receive paroxetine (20 mg/day) and citalopram (20 mg/day) for 5 weeks, after taking half the dosage in the first week. During the 1-month baseline and 6-week treatment period, IELTs were measured at home by using a stopwatch procedure. The trial was completed by 23 men. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.0004); the IELT after paroxetine and citalopram gradually increased from 18 and 21 seconds to approximately 170 and 44 seconds, respectively. Paroxetine 20 mg/day exerted a strong delay (8.9-fold increase), whereas citalopram 20 mg/day mildly delayed ejaculation (1.8-fold increase). These results indicate that paroxetine leads to a significant delay in orgasm and ejaculation, whereas citalopram seems to have less of an effect on it.
Batool Hossein Rashidi
Full Text Available To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG, in sub fertile couples.This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg and hMG (75 IU in preparation for the IUI cycle. Study group (n = 127 received luteal phase support in the form of vaginal progesterone (400 mg twice a day, and control group (n = 126 received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups.The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3. The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45.It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.
Raja, Indu M; Basavareddy, Asha; Mukherjee, Deepali; Meher, Bikash Ranjan
To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1(st) week and 4(th) week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test. A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4(th) week (P = 0.0013), but not at 1(st) week (P = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole. Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile.
Nader, T A; Smith, D E; Dillbeck, M C; Schanbacher, V; Dillbeck, S L; Gallois, P; Beall-Rougerie, S; Schneider, R H; Nidich, S I; Kaplan, G P; Belok, S
To explore ancient Vedic medical techniques, one hundred and seventy-six subjects with arthritis participated in a controlled study through the non-pharmacologic approach known as the Maharishi Vedic Vibration Technology (MVVT). Using a double-blinded and randomized experimental design, the findings showed significant reductions of pain and stiffness, and improvement in range of motion in the study sample. One hundred percent relief of symptoms was the most commonly reported category of improvement due to treatment. For the group as a whole, differences in mean response of treatment and control conditions with respect to relief of pain, limitation of motion, and reduction in stiffness were highly significant: t values ranged from a low of 5.609 in stiffness to a high of 20.950 in pain, p = 0.000009 to <10-49 respectively. Analysis by sub-categories of peripheral arthritis, painful conditions of the spine, and rheumatoid arthritis likewise produced significant results. Mechanisms of action were proposed, drawing on Maharishi Vedic Science, developments in quantum field theory, and specifically the theories of chaos and self-organizing systems as they relate to physiological functioning. The instantaneous relief of pain and improvement in function in such a high proportion of subjects with chronic arthritis is unparalleled in modern medical science
Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.
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
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.
Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.
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
Full Text Available Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba and Streptase (Aventis Behring GmbH, Marburg, Germany. Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK or Streptase (STP, in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis. Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2% to HBK (n=119 and STP (n=102 groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]. Angiography was done for 158 (71.5 % patients in the first 24 hours (9% and in the first 72 hours (38.8% after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]. The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]. The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.
Full Text Available Objectives: The purpose of this study was to determine analgesic efficacy of dexmedetomidine used as a continuous infusion without loading dose in postcardiac surgery patients. Settings and Design: A prospective, randomized, double-blind clinical study in a single tertiary care hospital on patients posted for elective cardiac surgery under cardiopulmonary bypass. Interventions: Sixty-four patients who underwent elective cardiac surgery under general anesthesia were shifted to intensive care unit (ICU and randomly divided into two groups. Group A (n = 32 received a 12 h infusion of normal saline and group B (n = 32 received a 12 h infusion of dexmedetomidine 0.4 μg/kg/h. Postoperative pain was managed with bolus intravenous fentanyl. Total fentanyl consumption, hemodynamic monitoring, Visual Analogue Scale (VAS pain ratings, Ramsay Sedation Scale were charted every 6 th hourly for 24 h postoperatively and followed-up till recovery from ICU. Student′s t-test, Chi-square/Fisher′s exact test has been used to find the significance of study parameters between the groups. Results: Dexmedetomidine treated patients had significantly less VAS score at each level (P < 0.001. Total fentanyl consumption in dexmedetomidine group was 128.13 ± 35.78 μg versus 201.56 ± 36.99 μg in saline group (P < 0.001. A statistically significant but clinically unimportant sedation was noted at 6 and 12 h (P < 0.001, and P = 0.046 respectively. Incidence of delirium was less in dexmedetomidine group (P = 0.086+. Hemodynamic parameters were statistically insignificant. Conclusions: Dexmedetomidine infusion even without loading dose provides safe, effective adjunct analgesia, reduces narcotic consumption, and showed a reduced trend of delirium incidence without undesirable hemodynamic effects in the cardiac surgery patients.
Mohammad Sadegh REZAI
Full Text Available ObjectiveBreath holding spells (BHS are common paroxysmal non-epileptic events in the pediatric population which are very stressful 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-pyrrolidineon these children.Materials & MethodsIn 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 nosignificant difference detected between the groups regarding the prevalence of drug side effects.ConclusionA significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day had a good effect on our patients.
S Ashraffodin Ghoshegir
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.
Zhang, Puhong; Wang, Hongyi; Sun, Lei; Zhang, Jing; Xi, Yang; Wu, Yangfeng; Yan, Lijing L; Li, Xian; Sun, Ningling
To compare the blood pressure (BP)-lowering effects of telmisartan 40 mg/day and hydrochlorothiazide (HCTZ) 25 mg/day in high sodium intake patients with mild-to-moderate hypertension in China. In this randomized, double-blind trial, eligible patients were randomly divided into telmisartan and HCTZ groups with three follow-ups scheduled on days 15, 30, and 60 after enrollment to compare BP decrease, hypokalemia, and other adverse events after intervention. A total of 1333 mild-to-moderate hypertensive patients with average sodium intake of 5909 mg/day were enrolled from 14 county hospitals in China. Baseline characteristics were well balanced. At 15, 30, and 60 days of follow-up, average SBP/DBP reduction in telmisartan and HCTZ group was 12.5/8.0, 14.3/9.1, 12.8/7.2, 11.0/5.8, 13.6/7.1, and 11.5/5.3 mmHg, respectively. Telmisartan showed greater BP response than HCTZ at three visits, with statistical significance for DBP (P telmisartan (P = 0.0238 for group × PP). Compared with telmisartan, HCTZ showed more hypokalemia (0.4 vs. 4.5%, P telmisartan and HCTZ were effective for the treatment of hypertensive patients with high sodium intake. Telmisartan showed better DBP-lowering effect and less hypokalemia than HCTZ among high sodium intake patients. Further studies are needed to evaluate the plausible superiority effect of hydrochlorothiazide among patients with large PP.
Rakesh, Singh; Anand, T S; Payal, Garg; Pranjal, Kulshreshtha
This randomized double blind study was conducted prospectively to determine whether coblation tonsillectomy fared better than the conventional dissection method in terms of postoperative pain, bleeding, and rapidity of healing in adult Indian patients undergoing tonsillectomy. Sixty adult patients undergoing tonsillectomy for benign indications were randomized to have one tonsil removed by subcapsular radiofrequency ablation method and the other by conventional dissection method. The operative time and blood loss was noted for each side. Patients were evaluated at 6, 12, 24, 48, 72 h and then on 7th and 20th postoperative day for postoperative pain (by visual analog scale), bleeding, and tonsillar fossa healing. Statistical comparison was done using appropriate tests. The two groups were demographically matched. It took longer to perform the coblation procedure (15 vs 11 min) (P > 0.05). The operative blood loss on the radiofrequency side was 11 ml, vs 34 ml on the conventional side (P = 0.009). 77% patients said that the coblation side was less painful for the overall 20-day recovery period. There were significant differences seen at 6, 12, 24, 48, and 72 h in terms of postoperative pain scores. Beyond that, the pain was consistently less on the coblation side, but the difference was not significant. There was no case of reactionary or secondary hemorrhage in either arm. The healing took longer on the radiofrequency side. Coblation tonsillectomy is an easy to learn technique with significantly reduced operative blood loss and postoperative pain. Longer operative times maybe further reduced with experience.
Ghoshegir, S. Ashraffodin; Mazaheri, Mohammad; Ghannadi, Alireza; Feizi, Awat; Babaeian, Mahmoud; Tanhaee, Maryam; Karimi, Mehrdad; Adibi, Peyman
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. PMID:25767516
ABBASKHANIAN, Ali; EHTESHAMI, Sara; SAJJADI, Sadegh; REZAI, Mohammad Sadegh
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
Maria Laura Menezes Bonow
Full Text Available The aim of this double-blind randomized clinical trial was to evaluate the efficacy of 1.23% APF gel application on the arrest of active incipient carious lesions in children. Sixty 7- to 12-year-old children, with active incipient lesions were included in the study. Children were divided randomly into 2 groups: 1.23% APF gel and placebo gel applications. Each group received 8 weekly applications of treatment. The lesions were re-evaluated at the 4th and 8th appointments. Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions. Groups showed similar results (PR = 1.67; CI 95% 0.69–3.98. The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline (PR = 2.67; CI 95% 1.19–6.03, but not with sugar intake (PR = 1.06; CI 95% 0.56–2.86 and previous exposure to fluoride dentifrice (PR = 1.26; CI 95% 0.49–2.29. The trial demonstrates the equivalence of the treatments. The use of the APF gel showed no additional benefits in this sample of children exposed to fluoridated water and dentifrice. The professional dental plaque removal in both groups may also account for the resulting equivalence of the treatments.
Randomized, double-blind, active-controlled study evaluating the safety and immunogenicity of three vaccination schedules and two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults.
Hopkins, Robert J; Kalsi, Gurdyal; Montalvo-Lugo, Victor M; Sharma, Mona; Wu, Yukun; Muse, Derek D; Sheldon, Eric A; Hampel, Frank C; Lemiale, Laurence
AV7909 vaccine being developed for post-exposure prophylaxis of anthrax disease may require fewer vaccinations and reduced amount of antigen to achieve an accelerated immune response over BioThrax(®) (Anthrax Vaccine Adsorbed). A phase 2, randomized, double-blind, BioThrax vacccine-controlled study was conducted to evaluate the safety and immunogenicity of three intramuscular vaccination schedules and two dose levels of AV7909 in 168 healthy adults. Subjects were randomized at a 4:3:2:4:2 ratio to 5 groups: (1) AV7909 on Days 0/14; (2) AV7909 on Days 0/28; (3) AV7909 on Days 0/14/28; (4) half dose AV7909 on Days 0/14/28; and (5) BioThrax vaccine on Days 0/14/28. Vaccinations in all groups were well tolerated. The incidences of adverse events (AEs) were 79% for AV7909 subjects and 65% for BioThrax subjects; 92% of AV7909 subjects and 87% of BioThrax subjects having AEs reported Grade 1-2 AEs. No serious AEs were assessed as potentially vaccine-related, and no AEs of potential autoimmune etiology were reported. There was no discernible pattern indicative of a safety concern across groups in the incidence or severity of reactogenicity events. Groups 2-4 achieved success for the primary endpoint, demonstrated by a lower 95% confidence limit of the percentage of subjects with protective toxin neutralizing antibody NF50 values (≥0.56) to be ≥40% at Day 63. Group 1 marginally missed the criterion (lower bound 95% confidence limit of 39.5%). Immune responses were above this threshold for Groups 1, 3 and 4 at Day 28 and all groups at Day 42. Further study of an AV7909 two-dose schedule given 2 weeks apart is warranted in light of the favorable tolerability profile and immunogenicity response relative to three doses of BioThrax vaccine, as well as preliminary data from nonclinical studies indicating similar immune responses correlate with higher survival for AV7909 than BioThrax vaccine.
International audience; Background Novel treatments against for tinea capitis are needed, and the natural aminosterol squal-amine is a potential topical antidermatophyte drug candidate. Objectives This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Patients Males aged 6–15 years presenting with tinea capitis were treated with either topical squal-amine o...
Promthep, Kreeta; Eungpinichpong, Wichai; Sripanidkulchai, Bungorn; Chatchawan, Uraiwan
Background Physical fitness is a fundamental prerequisite for soccer players. Kaempferia parviflora is an herbal plant that has been used in some Asian athletes with the belief that it might prevent fatigue and improve physical fitness. This study aimed to determine the effects of Kaempferia parviflora on the physical fitness of soccer players. Material/Methods Sixty soccer players who routinely trained at a sports school participated in a double-blind placebo-controlled trial and were random...
Hu, Miao; Zeng, Weiwei; Tomlinson, Brian
Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (-9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by -3.9% in the active treatment group, but the change was not significantly different from that with placebo (-1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.
Full Text Available Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily, Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c, and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C levels between placebo and active treatment (−9% was significantly (P<0.05 better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1% (P=0.098. There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.
Zeng, Weiwei; Tomlinson, Brian
Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096
Sha, S; Polidori, D; Farrell, K; Ghosh, A; Natarajan, J; Vaccaro, N; Pinheiro, J; Rothenberg, P; Plum-Mörschel, L
To compare the pharmacodynamic effects of the highest approved doses of the sodium glucose co-transporter 2 (SGLT2) inhibitors canagliflozin and dapagliflozin on urinary glucose excretion (UGE), renal threshold for glucose excretion (RTG ) and postprandial plasma glucose (PPG) excursion in healthy participants in a randomized, double-blind, two-period crossover study. In each treatment period, participants (n = 54) received canagliflozin 300 mg or dapagliflozin 10 mg for 4 days (20 min before breakfast). A mixed-meal tolerance test (600 kcal; 75 g glucose) was performed at baseline and on day 4 of each treatment period to assess changes in incremental PPG (PPGΔAUC0-2 h ). We measured 24-h UGE and plasma glucose on day 4 to determine 24-h mean RTG . Canagliflozin 300 mg and dapagliflozin 10 mg had similar effects on UGE and RTG for 4 h after dosing, but canagliflozin was associated with higher UGE and greater RTG reductions for the remainder of the day. Mean 24-h UGE was ∼25% higher with canagliflozin than with dapagliflozin (51.4 vs. 40.8 g), and 24-h mean RTG was ∼0.4 mmol/l (7 mg/dl) lower with canagliflozin than with dapagliflozin (3.79 vs. 4.17 mmol/l; p canagliflozin delayed and reduced PPG excursion (between-treatment difference in PPGΔAUC0-2 h from baseline expressed as a percentage of baseline mean, -10.2%; p = 0.0122). Canagliflozin and dapagliflozin were generally well tolerated. In healthy participants, canagliflozin 300 mg provided greater 24-h UGE, a lower RTG and smaller PPG excursions than dapagliflozin 10 mg. © 2014 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.
Ingalls, Nichole K; Horton, Zachary A; Bettendorf, Matthew; Frye, Ira; Rodriguez, Carlos
The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy. Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%. The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.
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.
Full Text Available Abstract Background Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea. Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks, the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study. Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p Mentha longifolia L. syrup. Conclusion In conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea.
F. H. Comhaire; Y. El Garem; A. Mahmoud; F. Eertmans; F. Schoonjans
Aim: To evaluate the treatment of male infertility with a strong natural antioxidant, in addition to conventional treatment.Methods: Using a double blind, randomized trial design, 30 men with infertility of ≥12 months and female partners with no demonstrable cause of infertility received conventional treatment according to the guidelines of the World Health Organization (WHO), and either a strong antioxidant Astaxanthin 16 mg/day (AstaCarox(R), AstaReal AB,Gustavsberg, Sweden) or placebo for 3 months. The effects of treatment on semen parameters, reactive oxygen species (ROS), zona-free hamster oocyte test, serum hormones including testosterone, luteinizing hormone (LH),follicle stimulating hormone (FSH) and Inhibin B, and spontaneous or intrauterine insemination (IUI)-induced pregnancies were evaluated. Results: ROS and Inhibin B decreased significantly and sperm linear velocity increased in the Astaxanthin group (n = 11), but not in the placebo group (n = 19). The results of the zona-free hamster oocyte test tended to improve in the Astaxanthin group in contrast with the placebo group, though not reaching statistical significance.The total and per cycle pregnancy rates among the placebo cases (10.5 % and 3.6 %) were lower compared with 54.5 % and 23.1% respectively in the Astaxanthin group (P = 0.028; P = 0.036). Conclusion: Although the present study suggests a positive effect of Astaxanthin on sperm parameters and fertility, the results need to be confirmed in a larger trial before recommending Astaxanthin for the complementary treatment of infertile men.
Pickering, Gisèle; Macian, Nicolas; Dubray, Claude; Pereira, Bruno
Background Acetaminophen (APAP, paracetamol) mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467) was carried out from May 30, 2011 to July 12, 2011. Methods Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature), and a battery of cognitive tests were recorded before and after oral APAP (2 g) or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05). Spatial planning and working memory initial thinking time were decreased (P=0.04). All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01) and body temperature did not change. Conclusion This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance and antinociception are independent of APAP effect on thermogenesis. We suggest that cognitive performance mirrors the analgesic rather than thermic cascade of events, with possibly a central role for serotonergic and cannabinoid systems that need to be explored further in the context of pain and cognition. PMID:27980393
Riou, Bruno; Plaisance, Patrick; Lecomte, François; Soulat, Louis; Orcel, Philippe; Mazoit, Jean-Xavier
The aim of our study was to compare the efficacy and safety of two doses of ketoprofen (200 mg vs. 300 mg/day) in ambulatory emergency patients with pain related to traumatic and nontraumatic bone and joint diseases. We tested the hypothesis that the efficacy of the lower dose was not lower than that of the higher dose in a double-blind, randomized, noninferiority trial. Patients included in the study were aged 18-65 years with closed benign trauma of the motor system or acute noninfectious rheumatologic conditions, with a resting pain intensity ≥3/10 on a numeric pain scale (NPS), requiring ketoprofen for 5 days. The main end-point was based on two efficacy co-criteria: (i) mean change from baseline of resting pain intensity at the end of the day over 5 days and (ii) total intake of concomitant analgesics. We included 409 patients: 200 in the 200-mg group and 209 in the 300-mg group. The mean change in pain intensity at rest (difference between groups: 0.0, 95% CI -0.4 to 0.4; P = 1.00) and in analgesic consumption (difference between groups: -0.6, 95% CI -1.9 to 0.6; P = 0.33) was not significantly different between the two groups, and the differences were lower than the predefined inferiority margins (0.5 and 1.5, respectively), thus demonstrating noninferiority. No significant difference was noted in the incidence of adverse events (21% vs. 20%, P = 0.71). The efficacy of the 200-mg daily dose of ketoprofen in relieving pain in emergency cases was not inferior to that of the 300-mg dose.
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
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.
Dupont, Eric; Journet, Michel; Oula, Marie-Laure; Gomez, Juan; Léveillé, Claude; Loing, Estelle; Bilodeau, Diane
Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. To assess the clinical efficacy of a complex integral anti-cellulite gel. This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25-55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined). At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (Pcellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (Pcellulite and reshape the silhouette.
MONSÓ, A.; RIUDEUBAS, J.; BARBAL, F.; LAPORTE, J-R.; ARNAU, J. M.
1Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2A randomized, double-blind, placebo-controlled clinical trial was performed, including 104 adult patients who presented with post-anaesthetic shivering during the recovery from general anaesthesia. They were randomized to receive placebo (n=32), metamizol 25 mg kg−1 (n=37), or pethidine 0.4 mg kg−1 (n=35). The response to treatment was assessed 5, 15 and 45 min after drug administration, and the main outcome variable was complete suppression of shivering. 3The efficacy at 5, 15 and 45 min was as follows: placebo 6%, 16% and 37%; metamizol 13.5%, 32% and 76%, and pethidine 89%, 91% and 89%. With both active drugs the efficacy at all three time intervals was significantly higher than that with placebo (Pmetamizol were statistically significant (Pmetamizol produces a better post-anaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response. PMID:8877020
Na, Lixin; Zhang, Qiao; Jiang, Shuo; Du, Shanshan; Zhang, Wei; Li, Ying; Sun, Changhao; Niu, Yucun
Our previous studies have shown that mangiferin decreased serum triglycerides and free fatty acids (FFAs) by increasing FFAs oxidation in both animal and cell experiments. This study sought to evaluate the effects of mangiferin on serum lipid profiles in overweight patients with hyperlipidemia. Overweight patients with hyperlipidemia (serum triglyceride ≥ 1.70 mmol/L, and total cholesterol ≥ 5.2 mmol/L) were included in this double-blind randomized controlled trial. Participants were randomly allocated to groups, either receiving mangiferin (150 mg/day) or identical placebo for 12 weeks. The lipid profile and serum levels of mangiferin, glucose, L-carnitine, β-hydroxybutyrate, and acetoacetate were determined at baseline and 12 weeks. A total of 97 participants completed the trial. Compared with the placebo control, mangiferin supplementation significantly decreased the serum levels of triglycerides and FFAs, and insulin resistance index. Mangiferin supplementation also significantly increased the serum levels of mangiferin, high-density lipoprotein cholesterol, L-carnitine, β-hydroxybutyrate, and acetoacetate, and increased lipoprotein lipase activity. However, there were no differences in the serum levels of total cholesterol, low-density lipoprotein cholesterol, serum glucose, and insulin between groups. Mangiferin supplementation could improve serum lipid profiles by reducing serum triglycerides and FFAs in overweight patients with hyperlipidemia, partly due to the promotion of FFAs oxidation.
Lin, Hsin-Fu; Tung, Kang; Chou, Chun-Chung; Lin, Ching-Che; Lin, Jaung-Geng; Tanaka, Hirofumi
Muscle damage induced by unaccustomed or eccentric exercise results in delayed onset vascular stiffening. We tested the hypothesis that a 7-day supplementation of panax ginseng and salvia miltiorrhiza prior to an acute eccentric exercise could attenuate arterial stiffening. By using a double-blind study placebo-controlled randomized design, subjects were randomly assigned to either the Chinese herb (N = 12) or the placebo group (N = 11) and performed a downhill running (eccentric exercise) trial and a control (seated rest) trial. Muscle soreness increased 1-2 days after exercise similarly in both groups, whereas the herb group demonstrated a faster recovery on active range of motion. Plasma creatine kinase concentration increased significantly at 24 h in both groups but the magnitude of increase was attenuated in the herb group. Arterial stiffness as measured by carotid-femoral pulse wave velocity increased significantly at 24 h in the placebo group but such increase was absent in the herb group. Flow-mediated dilation did not change in either group. Plasma concentrations of CRP and IL-6 increased in the placebo group but no such increases were observed in the herb group. Changes in arterial stiffness induced by eccentric exercise were associated with the corresponding changes in IL-6 (r = 0.46, P exercise. ClinicalTrials.gov: NCT02007304. Registered Dec. 5, 2013).
Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A
To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total
U. C. Adler
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
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
Louise E. Kimball
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.
.... In this study, we conducted a randomized, double-blind, placebo-controlled clinical trial to evaluate the immunopotentiation and fatigue-alleviation effects of Lactobacillus gasseri OLL2809 (LG2809) and α-lactalbumin (αLA...
Rest, van de O.; Geleijnse, J.M.; Kok, F.J.; Staveren, van W.A.; OldeRikkert, M.G.M.; Beekman, A.T.F.; Groot, de C.P.G.M.
OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:
Rest, O. van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Olde Rikkert, M.G.M.; Beekman, A.T.; Groot, L.C. de
OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:
Rest, van de O.; Geleijnse, J.M.; Kok, F.; Staveren, van W.A.; Olderikkert, M.G.M.; Beekman, A.T.F.; Groot, de L.C.P.G.M.
OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:
Background 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. Methods 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. Results 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. Conclusion Our study failed to
Elgebaly, Ahmed Said; Eldabaa, Ahmed Ali
Background: A double-blinded, prospective, and randomized study was designed to determine the efficacy and tolerability of intravenous (IV) magnesium sulfate (MgSO4) to facilitate fiberoptic bronchoscopic (FOB) nasotracheal intubations. Patients and Methods: A total of 120 patients scheduled to undergo elective awake fiberoptic nasotracheal intubation, while they were anesthetized for elective surgery were randomly allocated to one of three groups: The control Group S (n = 40) received 100 ml (50 ml 0.9% saline + 50 ml paracetamol) was infused in 10 min and direct IV 5 ml 0.9% normal saline, Group MD (n = 40): Received midazolam IV in a dose of 0.07 mg/kg in 5 ml 0.9% normal saline and 100 ml 0.9% was infused in 10 min and Group MS (n = 40): IV 45 mg/kg MgSO4 10 min in 100 ml of 0.9% normal saline through 10 min and direct IV 5 ml 0.9% normal saline. Results: Time required for nasotracheal intubation was significantly less in group Groups MD and MS, as compared with the control group, but not significant between the two groups. (Group MD: 9.05 + 1.95 min, Group MS 3.75 + 0.75 min and Group S 16.85 + 1.7 min). However, the number of fiberoptic intubation was significantly more in the MD and MS groups, as compared with the control group. Easy intubation (control group: 0, Group MD: 25 and Group MS: 35), moderate difficulty (control group: 5, Group MD: 12 and Group MS: 4) and difficult (control group: 35, Group MD: 3 and Group MS: 1). Procedure adverse events were significantly lower in Group MS. None of the patients in Group MS had procedure hypoxia, but it occurred in 10 patients of Group MD and 20 patients in Group S. Six patients in Group S and two in Group MD had procedure apnea whereas, none of the patients in the MS group experienced this. After medication and just before intubation heart rate and mean arterial pressure were significantly less in Groups MD and MS, as compared to the control group (Group MD: 77 + 7.7 beat/min, Group MS: 70 + 5.6 beat/min and
Full Text Available Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea.Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks, the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study.Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p < 0.001. The regularity of bleeding throughout the study was markedly better in the drug group compared with those given placebo (33.3% vs. 3.3%; p < 0.001. No notable complication or side effect was reported in relation to Mentha longifolia L. syrup.ConclusionIn conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea.
Background Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea. Methods A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day) for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks), the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no) of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study. Results The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p < 0.001). The regularity of bleeding throughout the study was markedly better in the drug group compared with those given placebo (33.3% vs. 3.3%; p < 0.001). No notable complication or side effect was reported in relation to Mentha longifolia L. syrup. Conclusion In conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea. PMID
Full Text Available Gisèle Pickering,1–3 Nicolas Macian,1,2 Claude Dubray,1–3 Bruno Pereira4 1University Hospital, CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Inserm, CIC 1405, UMR Neurodol 1107, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU de Clermont-Ferrand, Délégation Recherche Clinique Innovation, Clermont-Ferrand, France Background: Acetaminophen (APAP, paracetamol mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467 was carried out from May 30, 2011 to July 12, 2011. Methods: Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature, and a battery of cognitive tests were recorded before and after oral APAP (2 g or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results: APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05. Spatial planning and working memory initial thinking time were decreased (P=0.04. All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01 and body temperature did not change. Conclusion: This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance
Elson, E.M.; Ridley, N.T.F
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
Esmaeilzadeh, Hossein; Nabavi, Mohammad; Aryan, Zahra; Arshi, Saba; Bemanian, Mohammad Hassan; Fallahpour, Morteza; Mortazavi, Negar
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.
Kashanian, Maryam; Fekrat, Mohsen; Zarrin, Zahra; Ansari, Narges S
The comparison between the effect of oxytocin alone or in combination with propranolol on labor. A double blind randomized controlled trial was performed on 150 nulliparas with a gestational age of 39-41 weeks of pregnancy and a Bishop score of oxytocin group = 75), oxytocin alone was used for induction of labor. In the second group (propranolol group = 75 cases), before the beginning of oxytocin, 2 mg propranolol was slowly injected intravenously then the oxytocin was initiated. The number of patients who delivered in the first day showed no difference between the two groups. The mean duration for obtaining good contractions was shorter in the propranolol group in both the first and second day of induction The mean interval between the beginning of induction until the beginning of active phase at the first day of induction was shorter in the propranolol group. The mean interval between the beginning of induction until delivery at the first day of induction was shorter in the propranolol group. The amount of necessary oxytocin for the first day of induction was less in the propranolol group. Propranolol may shorten the induction duration and labor and reduce the amount of necessary oxytocin.
Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D.; Zava, Dario; Pinessi, Lorenzo
The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment pe...
Full Text Available How to cite this article:Abbaskhanian A, Ehteshami S, Sajjadi S, Rezai MS. Effects of Piracetam on Pediatric Breath Holding Spells: A Randomized Double Blind Controlled Trial. Iran J Child Neurol Autumn 2012; 6(4: 9-15. Abstarct:Objective Breath holding spells (BHS are common paroxysmal non-epileptic eventsin the pediatric population which are very stressfull despite their harmlessnature. There has been no specific treatment found for the spells yet. The aimof this study was to evaluate the efficacy of piracetam (2-oxo-l-pyrrolidineon these children.Materials & MethodsIn this randomized double blind clinical trial study, 150 children with severe BHS referred to our pediatric outpatient service were enrolled from August2011 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 numberof attacks/month before and after treatment were documented.ResultsOf the enrolled patients, 86 were boys. The mean age of the patients was17 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 partialremission. 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 wasd nosignificant difference detected between the groups regarding the prevalenceof drug side effects.ConclusionA significant difference was detected between piracetam and placebo in prevention and controlling BHS. Piracetam (40mg/kg/day had a good effecton our patients. ReferencesDi Mario FJ Jr. Prospective study of children with cyanotic and pallid breath-holding spells. Pediatrics. 2001 Feb;107(2:265-9.Kotagal P, Costa M, Wyllie E, Wolgamuth B. Paroxysmal non epileptic
Taverner, Murray; Loughnan, Terence
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.
Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco
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
Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco
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
Huang, Hui; Dai, Hua Ping; Kang, Jian; Chen, Bao Yuan; Sun, Tie Ying; Xu, Zuo Jun
Idiopathic pulmonary fibrosis (IPF) lacks effective treatment. Pirfenidone has been used to treat IPF patients. N-acetylcysteine (NAC) exerts antioxidant and antifibrotic effects on IPF cases.This study is a double-blind, modified placebo-controlled, randomized phase II trial of pirfenidone in Chinese IPF patients. We randomly assigned the enrolled Chinese IPF patients with mild to moderate impairment of pulmonary function to receive either oral pirfenidone (1800 mg per day) and NAC (1800 mg per day) or placebo and NAC (1800 mg per day) for 48 weeks. The primary endpoints were the changes in forced vital capacity (FVC) and walking distance and the lowest SPO2 during the 6-minute walk test (6MWT) at week 48. The key secondary endpoint was the progression-free survival time. This study is registered in ClinicalTrials.gov as number NCT01504334.Eighty-six patients were screened, and 76 cases were enrolled (pirfenidone + NAC: 38; placebo + NAC: 38). The effect of pirfenidone treatment was significant at the 24th week, but this effect did not persist to the 48th week. At the 24th week, the mean decline in both FVC and ΔSPO2 (%) during the 6MWT in the pirfenidone group was lower than that in the control group (-0.08 ± 0.20 L vs -0.22 ± 0.29 L, P = 0.02 and -3.44% ± 4.51% vs -6.29% ± 6.06%, P = 0.03, respectively). However, there was no significant difference between these 2 groups at the 48th week (-0.15 ± 0.25 L vs -0.25 ± 0.28 L, P = 0.11 and -4.25% ± 7.27% vs -5.31% ± 5.49%, P = 0.51, respectively). The pirfenidone treatment group did not achieve the maximal distance difference on the 6MWT at either the 24th or the 48th week. But pirfenidone treatment prolonged the progression-free survival time in the IPF patients (hazard ratio = 1.88, 95% confidence interval: 1.092-3.242, P = 0.02). In the pirfenidone group, the adverse event (AE) rate (52.63%) was higher than that in the control group (26.3%, P = 0.03). Rash was more common in the pirfenidone group (39
Sköldenberg, Olof; Rysinska, Agata; Eisler, Thomas; Salemyr, Mats; Bodén, Henrik; Muren, Olle
Wear-induced osteolysis is the main factor in reducing the longevity of total hip arthroplasty (THA). The transmembrane Receptor Activator of Nuclear Factor κ B (RANK) and its corresponding ligand RANKL is an important regulator of osteoclast activity and bone resorption and is associated with osteolysis around implant. Inhibiting RANKL with denosumab is effective in vivo in preventing osteoporosis-related fractures. In vitro, osteoclasts can be blocked in animal models of osteolysis. We hypothesize that denosumab is effective in reducing wear-induced osteolysis around uncemented acetabular implants in THA. A randomized, double-blind, placebo-controlled trial will be conducted. We will include 110 patients, 40-85 years of age, with a known osteolytic lesion around an uncemented acetabular component ≥7 years after the primary operation. The patients will be randomized in a 1:1 ratio to subcutaneous injections of 60 mg denosumab or placebo for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion at 3 years measured with three-dimensional computed tomography (3D-CT). Secondary endpoints include functional outcome scores, change in bone mineral density of the lumbar spine, serological markers of bone turnover and adverse events. In vitro results of both bisphosphonates and RANKL inhibitors have been promising, showing reduced osteolysis with treatment. This is, to our knowledge, the first clinical trial testing the efficacy of denosumab in reducing wear-induced osteolysis. The study is an academic, phase II trial from an independent center and is designed to demonstrate efficacy in reducing volume of osteolytic lesions around a total hip arthroplasty. ClinicalTrials.gov (NCT02299817) 2014-11-20.
Zanwar, Vinay G.; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S.; Surude, Ravindra G.; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M.
Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who f...
Vejtorp, M; Bollerup, A C; Vejtorp, L
In a double-blind randomized controlled trial we assessed the effect of metronidazole treatment of the male partner on the recurrence rate of bacterial vaginosis. Women who fulfilled the diagnostic criteria for bacterial vaginosis were treated with metronidazole given in single doses of 2 g on days...... for bacterial vaginosis. At assessment 5 weeks after the treatment, 75% reported that they were cured or improved and the diagnostic criteria were not present in 73%. Treatment of the male partner did not affect subjective symptoms, clinical signs and isolation rates of Gardnerella vaginalis at 1 and 5 weeks...
Full Text Available Erratum:Affiliation of authors of the article "Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial. Ir J neurol 2012; 11(3: 106-110' was changed as:Hooshang Gerami 1, Alia Saberi2, Shadman Nemati1, Ehsan Kazemnejad1, Mohammad Aghajanpour1.1.Department of Otolaryngology , Nose and Sinus Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.2. Department of Neurology, Guilan University of Medical Sciences, Rasht, Iran
Garfinkel, Doron; Zorin, Mariana; Wainstein, Julio; Matas, Zipora; Laudon, Moshe; Zisapel, Nava
Background: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46–77 years). Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1) with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for anot...
Audicana Maria T
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
Borges, Natália A; Carmo, Flávia L; Stockler-Pinto, Milena B; de Brito, Jessyca S; Dolenga, Carla J; Ferreira, Dennis C; Nakao, Lia S; Rosado, Alexandre; Fouque, Denis; Mafra, Denise
The objective of the study was to evaluate the effects of probiotic supplementation on the gut microbiota profile and inflammatory markers in chronic kidney disease patients undergoing maintenance hemodialysis (HD). This was a randomized, double-blind, placebo-controlled study. Forty-six HD patients were assigned to receive 1 of 2 treatments: probiotic (n = 23; Streptococcus thermophilus, Lactobacillus acidophilus e Bifidobacterialongum, 90 billion colony-forming units per day) or placebo (n = 23) daily for 3 months. Blood and feces were collected at baseline and after intervention. The inflammatory markers (C-reactive protein and interleukin-6) were analyzed by immunoenzymatic assay (enzyme-linked immunosorbent assay). Uremic toxins plasma levels (indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid) were obtained by Reversed-Phase High-Performance Liquid Chromatography. Routine laboratory parameters were measured by standard techniques. Fecal pH was measured by the colorimetric method, and the gut microbiota profile was assessed by Denaturing Gradient Gel Electrophoresis analysis. Sixteen patients remained in the probiotic group (11 men, 53.6 ± 11.0 year old, 25.3 ± 4.6 kg/m(2)) and 17 in the placebo group (10 men, 50.3 ± 8.5 year old, 25.2 ± 5.7 kg/m(2)). After probiotic supplementation there was a significant increase in serum urea (from 149.6 ± 34.2 mg/dL to 172.6 ± 45.0 mg/dL, P = .02), potassium (from 4.4 ± 0.4 mmol/L to 4.8 ± 0.4 mmol/L, P = .02), and indoxyl sulfate (from 31.2 ± 15.9 to 36.5 ± 15.0 mg/dL, P = .02). The fecal pH was reduced from 7.2 ± 0.8 to 6.5 ± 0.5 (P = .01). These parameters did not change significantly in placebo group. Changes in the percentage delta (Δ) between groups were exhibited with no statistical differences observed. The inflammatory markers and gut profile were not altered by supplementation. Aprobiotic supplementation failed to reduce uremic toxins and
Becky L Rivoire
Full Text Available New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials.A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.. Healthy non-exposed subjects (n = 10 received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg of MLSA-LAM (n = 5 or MLCwA (n = 5 and control antigens [Rees MLSA (1.0 µg and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal, but involved only the 1.0 µg (high dose and 0.1 µg (low dose of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose, each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT leprosy patients, 20 household contacts of leprosy patients (HC, and 20 tuberculosis (TB patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration.In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50 showed induration against the high dose of each antigen, and 4% (2 of 50 reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60
Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.
Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens
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.
Hosseini, Jalil; Mardi Mamaghani, Azar; Hosseinifar, Hani; Sadighi Gilani, Mohammad Ali; Dadkhah, Farid; Sepidarkish, Mahdi
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. PMID:27679829
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.
Heiss, Wolf-Dieter; Brainin, Michael; Bornstein, Natan M; Tuomilehto, Jaakko; Hong, Zhen
Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke. Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily). The patients were followed up to 90 days. The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale. Adverse events were documented to assess safety. A total of 1070 patients were enrolled in this study. Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo. The confirmatory end point showed no significant difference between the treatment groups. When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97; modified Rankin Scale: OR, 1.27; CI lower bound, 0.90). In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013). In this study, the confirmatory end point showed neutral results between the treatment groups. However, a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin. This observation should be confirmed by a further clinical trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00868283.
Kalliomäki, Jarkko; Attal, Nadine; Jonzon, Bror; Bach, Flemming W; Huizar, Karin; Ratcliffe, Stuart; Eriksson, Britta; Janecki, Marcin; Danilov, Andrei; Bouhassira, Didier
We evaluated the analgesic efficacy, safety and tolerability of a novel chemokine receptor 2 (CCR2) antagonist, AZD2423, in posttraumatic neuralgia. This was a double-blind, randomized, parallel-group, multicentre study. One hundred thirty-three patients with posttraumatic neuralgia were equally randomized to 28days' oral administration of 20mg AZD2423, 150mg AZD2423 or placebo. The primary efficacy variable was the change of average pain score from 5days at baseline to the last 5days of treatment, measured by a numerical rating scale (NRS, 0-10). The secondary efficacy measures included NRS worst pain score, patient global impression of change, pain interference on sleep and activity, and Neuropathic Pain Symptom Inventory (NPSI). The change of the NRS average pain score was not significantly different between treatment groups (AZD2423 20mg -1.54; AZD2423 150mg -1.53; placebo -1.44). There were trends towards larger reduction of NPSI total score and NPSI subscores for paroxysmal pain and paresthesia/dysesthesia by AZD2423 150mg compared to placebo. No other secondary efficacy variables differed between treatment groups. The frequency and type of adverse events for AZD2423 were similar to placebo. Increased plasma levels of chemokine ligand 2 and reduced mean levels of monocytes (-30% by AZD2423 150mg) suggested that the administrated doses of AZD2423 had interacted with the CCR2 target. The CCR2 antagonist AZD2423 demonstrated no efficacy on NRS average pain scores and most of the secondary pain variables. The NPSI data suggested possible effects on certain sensory components of pain. There were no major safety or tolerability concerns. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
Ana C. R. Pitangui
Full Text Available Objective: To evaluate the effectiveness of low-frequency TENS (LFT and high-frequency TENS (HFT in post-episiotomy pain relief. Method: A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs, LFT (5 Hz; 100 µs, and placebo (PT. Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. Results: In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05. In the HFT and LFT, a significant difference was observed in all activities (P<0.001. In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001. In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008. No significant difference was verified among the groups in ambulation (P<0.20. Conclusions: LFT and HFT are an effective resource that may be included in the routine of maternity wards.
Full Text Available Introduction. L-Acetylcarnitine (LAC, the acetyl ester of carnitine naturally present in the central nervous system and involved in several neural pathways, has been demonstrated to be active in various animal experimental models resembling some features of human depression. The aim of the study is to verify whether LAC can have an antidepressant action in a population of elderly patients with dysthymic disorder in comparison with a traditional antidepressant such as fluoxetine.Methods. Multicentric, double-blind, double-dummy, controlled, randomized study based on a observation period of 7 weeks. 80 patients with DSM-IV diagnosis of dysthymic disorder were enrolled in the study and subdivided into 2 groups. Group A patients received LAC plus placebo; group B patients received fluoxetine 20 mg/die plus placebo. Clinical assessment was performed through several psychometric scales at 6 different moments.Results. Group A patients showed a statistically significant improvement in the following scales: HAM-D, HAM-A, BDI and Touluse–Pieron Test. Comparison between the two groups, A and B, generally showed very similar clinical progression.Discussion. The results obtained with LAC and fluoxetine were equivalent. As the subjects in this study were of senile age, it is possible to hypothesize that the LAC positive effect on mood could be associated with improvement in subjective cognitive symptomatology. The difference in the latency time of clinical response (1 week of LAC treatment, compared with the 2 weeks' latency time with fluoxetine suggests the existence of different mechanisms of action possibly in relation to the activation of rapid support processes of neuronal activity.
Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio
An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.
Stamenova, P; Koytchev, R; Kuhn, K; Hanasen, C; Horvath, F; Ramm, S; Pongratz, D
To study the efficacy and safety of tolperisone--a centrally acting muscle relaxant with membrane stabilizing activity--in the treatment of stroke-related spasticity. This was a randomized, double-blind, placebo-controlled, multicenter study with parallel groups. Treatment lasted 12 weeks and was started with a titration period of variable length (dose range 300-900 mg tolperisone daily). The degree of spasticity determined on the Ashworth Scale in the most severely affected joint area was denned as primary target parameter. Hundred and twenty patients (43 females, 77 males) in a mean age of 63,3 +/- 10,6 years were recruited and received treatment. In the majority of patients both limbs of each side were affected by the spasticity which on average had been present for 3,3 +/- 4,4 years. A 62% of the patients were treated with a daily dose >600 mg tolperisone. Tolperisone reduced the mean Ashworth Score by a mean of 1,03 +/- 0,71 compared with a mean reduction of 0,47 +/- 0,54 in the placebo group (ptolperisone versus 45% of the placebo patients experienced a reduction by at least 1 point on the Ashworth Scale (ptolperisone. Adverse events occurred less often on active treatment (n=19) than on placebo (n=26) and were mostly of mild-to-moderate intensity. No withdrawals caused by adverse events were reported in the tolperisone group. The findings of the present study demonstrate the efficacy and excellent tolerance of tolperisone in the treatment of spastic hypertonia following cerebral stroke. Study data further suggest that an individual dose titration which may exceed the recommended maximum dose of 450 mg daily results in optimized therapeutic benefit.
Terry L Noah
Full Text Available Smokers have increased susceptibility and altered innate host defense responses to influenza virus infection. Broccoli sprouts are a source of the Nrf2 activating agentsulforaphane, and short term ingestion of broccoli sprout homogenates (BSH has been shown to reduce nasal inflammatory responses to oxidant pollutants.Assess the effects of BSH on nasal cytokines, virus replication, and Nrf2-dependent enzyme expression in smokers and nonsmokers.We conducted a randomized, double-blind, placebo-controlled trial comparing the effects of BSH on serially sampled nasal lavage fluid (NLF cytokines, viral sequence quantity, and Nrf2-dependent enzyme expression in NLF cells and biopsied epithelium. Healthy young adult smokers and nonsmokers ingested BSH or placebo (alfalfa sprout homogenate for 4 days, designated Days -1, 0, 1, 2. On Day 0 they received standard vaccine dose of live attenuated influenza virus (LAIV intranasally. Nasal lavage fluids and nasal biopsies were collected serially to assess response to LAIV.In area under curve analyses, post-LAIV IL-6 responses (P = 0.03 and influenza sequences (P = 0.01 were significantly reduced in NLF from BSH-treated smokers, whilequinoneoxidoreductasein NLF cells was significantly increased. In nonsmokers, a similar trend for reduction in virus quantity with BSH did not reach statistical significance.In smokers, short term ingestion of broccoli sprout homogenates appears to significantly reduce some virus-induced markers of inflammation, as well as reducing virus quantity. Nutritional antioxidant interventions have promise as a safe, low-cost strategy for reducing influenza risk among smokers and other at risk populations.ClinicalTrials.gov NCT01269723.
Biesiekierski, Jessica R; Newnham, Evan D; Irving, Peter M; Barrett, Jacqueline S; Haines, Melissa; Doecke, James D; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R
Despite increased prescription of a gluten-free diet for gastrointestinal symptoms in individuals who do not have celiac disease, there is minimal evidence that suggests that gluten is a trigger. The aims of this study were to determine whether gluten ingestion can induce symptoms in non-celiac individuals and to examine the mechanism. A double-blind, randomized, placebo-controlled rechallenge trial was undertaken in patients with irritable bowel syndrome in whom celiac disease was excluded and who were symptomatically controlled on a gluten-free diet. Participants received either gluten or placebo in the form of two bread slices plus one muffin per day with a gluten-free diet for up to 6 weeks. Symptoms were evaluated using a visual analog scale and markers of intestinal inflammation, injury, and immune activation were monitored. A total of 34 patients (aged 29-59 years, 4 men) completed the study as per protocol. Overall, 56% had human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8. Adherence to diet and supplements was very high. Of 19 patients (68%) in the gluten group, 13 reported that symptoms were not adequately controlled compared with 6 of 15 (40%) on placebo (P=0.0001; generalized estimating equation). On a visual analog scale, patients were significantly worse with gluten within 1 week for overall symptoms (P=0.047), pain (P=0.016), bloating (P=0.031), satisfaction with stool consistency (P=0.024), and tiredness (P=0.001). Anti-gliadin antibodies were not induced. There were no significant changes in fecal lactoferrin, levels of celiac antibodies, highly sensitive C-reactive protein, or intestinal permeability. There were no differences in any end point in individuals with or without DQ2/DQ8. "Non-celiac gluten intolerance" may exist, but no clues to the mechanism were elucidated.
Spellberg, Brad; Ibrahim, Ashraf S.; Chin-Hong, Peter V.; Kontoyiannis, Dimitrios P.; Morris, Michele I.; Perfect, John R.; Fredricks, David; Brass, Eric P.
Objectives Host iron availability is fundamental to mucormycosis pathogenesis. The combination of liposomal amphotericin B (LAmB) and deferasirox iron chelation therapy synergistically improved survival in diabetic mice with mucormycosis. To determine the safety of combination deferasirox plus LAmB therapy for mucormycosis, a multicentred, placebo-controlled, double-blinded clinical trial was conducted. Methods Twenty patients with proven or probable mucormycosis were randomized to receive treatment with LAmB plus deferasirox (20 mg/kg/day for 14 days) or LAmB plus placebo (NCT00419770, clinicaltrials.gov). The primary analyses were for safety and exploratory efficacy. Results Patients in the deferasirox arm (n = 11) were more likely than those in the placebo arm (n = 9) to have active malignancy, neutropenia and corticosteroid therapy, and were less likely to receive concurrent non-study antifungal therapy. Reported adverse events and serious adverse events were similar between the groups. However, death was more frequent in the deferasirox than in the placebo arm at 30 days (45% versus 11%, P = 0.1) and 90 days (82% versus 22%, P = 0.01). Global success (alive, clinically stable, radiographically improved) for the deferasirox arm versus the placebo arm at 30 and 90 days, respectively, was 18% (2/11) versus 67% (6/9) (P = 0.06) and 18% (2/11) versus 56% (5/9) (P = 0.2). Conclusions Patients with mucormycosis treated with deferasirox had a higher mortality rate at 90 days. Population imbalances in this small Phase II study make generalizable conclusions difficult. Nevertheless, these data do not support a role for initial, adjunctive deferasirox therapy for mucormycosis. PMID:21937481
Li-Ying Feng; Xi-Xian Yao; Shu-Lin Jiang
AIM: To study the therapeutic efficacy of a Chinese and Western integrated regimen, killing Helicobacter pylori quadruple therapy on H pylori-associated peptic ulcers(PU).METHODS: With prospective and double-blind controlled method, seventy-five active PU patients with H pylori infection were randomized to receive one of the following three regimens: (1) new triple therapy (group A:lansoprazole 30 mg qd, plus clarithromycin 250 mg bid,plus amoxycillin 500 mg tid, each for 10 d); (2) killing Hp quadruple therapy(group B: the three above drugs plus killing H pylori capsule 6 capsules bid for 4 wk) and (3)placebo(group C: gastropine 3 tablets bid for 4 wk).H pylori eradication and ulcer healing quality were evaluated under an endoscope 4 wk after treatment. The patients were followed up for 5 years.RESULTS: Both the healing rate of PU and H pylori eradication rate in group B were significantly higher than those in group C (100% and 96.4% vs 20% and 0%,respectively, P＜0.005), but there was no significant difference compared to those in group A (88% and92%, P＞0.05). The healing quality of ulcer in group B was superior to that in groups C and A (P＜0.05). The recurrence rate of PU in group B (4%) was lower than that in group A (10%) and group C (100%, P＜0.01).CONCLUSION: Killing Helicobacter pylori quadruple therapy can not only promote the eradication of H pylori and healing quality of ulcer but also reduce recurrence rate of ulcer.
Lee, Belinda T.; Gabardi, Steven; Grafals, Monica; Hofmann, R. Michael; Akalin, Enver; Aljanabi, Aws; Mandelbrot, Didier A.; Adey, Deborah B.; Heher, Eliot; Fan, Pang-Yen; Conte, Sarah; Dyer-Ward, Christine
Background and objectives BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia. Design, setting, participants, & measurements Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months. Results At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period. Conclusions A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression. PMID:24482066
Mohammadi, Mohammad-Reza; Hafezi, Poopak; Galeiha, Ali; Hajiaghaee, Reza; Akhondzadeh, Shahin
A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD) and -15.60±7.81 (mean±SD) for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD) and -22.40±9.90 (mean±SD) for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of buspirone was
Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of
Full Text Available Abstract Background Colorectal cancer (CRC is one of the most commonly occurring neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Eicosapentaenoic acid (EPA, the omega-3 polyunsaturated fatty acid that is widely used in the treatment of hyperlipidemia and prevention of cardiovascular disease, has recently been suggested to have a suppressive effect on tumorigenesis and cancer cell growth. In CRC chemoprevention trials, in general, the incidence of polyps or of the cancer itself is set as the study endpoint. Although the incidence rate of CRC would be the most reliable endpoint, use of this endpoint would be unsuitable for chemoprevention trials, because of the relatively low occurrence rate of CRC in the general population and the long-term observation period that it would necessitate. Moreover, there is an ethical problem in conducting long-term trials to determine whether a test drug might be effective or harmful. Aberrant crypt foci (ACF, defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are considered as a reliable surrogate biomarker of CRC. Thus, we devised a prospective randomized controlled trial as a preliminary study prior to a CRC chemoprevention trial to evaluate the chemopreventive effect of EPA against colorectal ACF formation and the safety of this drug, in patients scheduled for polypectomy. Methods This study is a multicenter, double-blind, placebo-controlled, randomized controlled trial to be conducted in patients with both colorectal ACF and colorectal polyps scheduled for polypectomy. Eligible patients shall be recruited for the study and the number of ACF in the rectum counted at the baseline colonoscopy. Then, the participants shall be allocated randomly to either one of two groups, the EPA group and the placebo group. Patients in the EPA group shall receive oral
Hsieh, Ru-Lan; Lee, Wen-Chung
We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function
Nielsen, R E; Levander, S; Nielsen, Jimmi
Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Objective: To assess the cognitive effects of sertindole augmentation in clozapine-treated patients diagnosed with schizophrenia. Cognition is secondary outcome of the trial....... Method: A 12-week, double-blinded, randomized, placebo-controlled, augmentation study of patients treated with clozapine. Participants were randomized 1:1 to receive 16 mg of sertindole or placebo as adjunctive treatment to clozapine. Results: Participants displayed substantial cognitive deficits...... changes in cognitive test performance, and found no significant correlations. Conclusion: The clozapine-treated patients displayed marked cognitive deficits at baseline. Adding sertindole did not improve or worsen cognitive functioning, which is in line with previous negative studies of the effect...
Nielsen, I.L.F.; Chee, W.S.S.; Bredsdorff, Lea
to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n = 16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice...... with natural hesperidin ("low dose"), orange juice treated with hesperidinase enzyme to yield hesperetin-7-glucoside, and orange juice fortified to obtain 3 times more hesperidin than naturally present ("high dose"). The area under the curve (AUC) for total plasma hesperetin of subjects consuming hesperetin-7......Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group...
Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh
Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.
Petramfar, Peyman; Moein, Mahmoodreza; Samani, Soliman Mohammadi; Tabatabaei, Sayed Hamidreza; Zarshenas, Mohammad M
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.
Vejtorp, M; Bollerup, A C; Vejtorp, L
In a double-blind randomized controlled trial we assessed the effect of metronidazole treatment of the male partner on the recurrence rate of bacterial vaginosis. Women who fulfilled the diagnostic criteria for bacterial vaginosis were treated with metronidazole given in single doses of 2 g on days...... for bacterial vaginosis. At assessment 5 weeks after the treatment, 75% reported that they were cured or improved and the diagnostic criteria were not present in 73%. Treatment of the male partner did not affect subjective symptoms, clinical signs and isolation rates of Gardnerella vaginalis at 1 and 5 weeks...... 1 and 3. The sexual partners were randomized to receive either the same dosage of metronidazole or a placebo. A total of 107 pairs completed the study. One week after the start of treatment 89% of the women considered themselves improved or cured and 93% no longer had the diagnostic criteria...
A phase 2, randomized, double-blind, placebo-controlled trial of clinical activity and safety of subcutaneous Å6 in women with asymptomatic CA125 progression after first-line chemotherapy of epithelial ovarian cancer
Ghamande, Sharad A.; Silverman, Michael H.; Huh, Warner
OBJECTIVES: A6 is a novel peptide that interferes with single-chain urokinase plasminogen activator activity and has shown anti-angiogenic, anti-migratory, and anti-invasive properties. We evaluated clinical efficacy and safety of subcutaneously administered A6 in women with epithelial ovarian...... cancer. METHODS: Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer in clinical remission after first-line chemotherapy with 2 consecutive increases of CA125 values above normal but with no disease on physical examination or imaging studies were randomly assigned to receive daily...
O'Donnell, Colin P; Allott, Kelly A; Murphy, Brendan P; Yuen, Hok Pan; Proffitt, Tina-Marie; Papas, Alicia; Moral, Jennifer; Pham, Tee; O'Regan, Michaela K; Phassouliotis, Christina; Simpson, Raelene; McGorry, Patrick D
Taurine is an inhibitory neuromodulatory amino acid in the central nervous system that activates the GABA- and glycine-insensitive chloride channel and inhibits the N-methyl-D-aspartate receptor. It also functions as a neuroprotective agent and has a role in neural development and neurogenesis. The aim of this study was to determine the efficacy of adjunctive taurine in improving symptomatology and cognition among patients with a DSM-IV first-episode psychotic disorder. 121 patients with first-episode psychosis, aged 18-25 years, attending early intervention services consented to participate in this randomized, double-blind, placebo-controlled trial conducted from January 2007 to May 2009. Patients taking low-dose antipsychotic medication were randomly assigned to receive once-daily taurine 4 g or placebo for 12 weeks. The coprimary outcomes were change in symptomatology (measured by the Brief Psychiatric Rating Scale [BPRS] total score) and change in cognition (measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS] Consensus Cognitive Battery composite score) at 12 weeks. Secondary outcomes included tolerability and safety and additional clinical and functioning measures. 86 participants (n = 47 taurine; n = 39 placebo) were included in the final analysis. Taurine significantly improved symptomatology measured by the BPRS total score (95% CI, 1.8-8.5; P = .004) and psychotic subscale (95% CI, 0.1-1.5; P = .026) compared to placebo. Additionally, improvements were observed in the Calgary Depression Scale for Schizophrenia (95% CI, 0.1-3.0; P = .047) and Global Assessment of Functioning (95% CI, 0.3-8.8; P = .04) scores. There was no group difference in composite cognitive score (95% CI, -1.7 to 1.0; P = .582). A significant group difference was found on one safety and tolerability item (psychic item 2, asthenia/lassitude/increased fatigability) of the Udvalg for Kliniske Undersogelser, with the taurine group showing a
Louie, Thomas; Nord, Carl Erik; Talbot, George H; Wilcox, Mark; Gerding, Dale N; Buitrago, Martha; Kracker, Hilke; Charef, Pascal; Cornely, Oliver A
Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 ± 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence), and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20, and 22 received 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [CI], 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5), and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for cadazolid and vancomycin. Cadazolid was well tolerated, with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.).
Full Text Available Eric Dupont,1 Michel Journet,2 Marie-Laure Oula,3 Juan Gomez,1 Claude Léveillé,4 Estelle Loing,5 Diane Bilodeau6 1Immanence IDC Inc, Québec, QC, Canada; 2Clinique de Dermatologie St-Joseph, Montréal, QC, Canada; 3Evalulab Inc, Mont-Royal, QC, Canada; 4Clinique de Chirurgie Esthétique du Québec Métropolitain, Lévis, QC, Canada; 5Lucas Meyer Cosmetics, Québec, QC, Canada; 6CosmeConsult, Québec, QC, Canada Background: Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. Objective: To assess the clinical efficacy of a complex integral anti-cellulite gel. Methods: This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25–55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. Results: At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined. At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (P<0.05 over placebo, on all studied areas. Skin tonicity improved on average by +41% for buttocks, +35% for hips, and +31% for thighs. Orange peel appearance was reduced on average by -25% for buttocks, -22% for hips, and -22% for thighs. Stubborn cellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (P<0.05 over placebo
Smith, Robert C; Amiaz, Revital; Si, Tian-Mei; Maayan, Lawrence; Jin, Hua; Boules, Sylvia; Sershen, Henry; Li, Chunbo; Ren, Juanjuan; Liu, Yanhong; Youseff, Mary; Lajtha, Abel; Guidotti, Alessandro; Weiser, Mark; Davis, John M
Schizophrenic patients have a high rate of smoking and cognitive deficits which may be related to a decreased number or responsiveness of nicotinic receptors in their brains. Varenicline is a partial nicotinic agonist which is effective as an antismoking drug in cigarette smokers, although concerns have been raised about potential psychiatric side-effects. We conducted a double-blind placebo controlled study in 87 schizophrenic smokers to evaluate the effects of varenicline (2 mg/day) on measures of smoking, cognition, psychiatric symptoms, and side-effects in schizophrenic patients who were cigarette smokers. Varenicline significantly decreased cotinine levels (Psmoking (P smoking urges scale (P = .02), more than placebo. Varenicline did not improve scores on a cognitive battery designed to test the effect of drugs on cognitive performance in schizophrenia (the MATRICS battery), either in overall MATRICS battery Composite or individual Domain scores, more than placebo. There were no significant differences between varenicline vs. placebo effects on total symptom scores on psychiatric rating scales, PANSS, SANS, or Calgary Depression scales, and there were no significant drug effects in any of these scales sub-scores when we used Benjamin-Hochberg corrected significance levels (α = .05). Varenicline patients did not show greater side-effects than placebo treated patients at any time point when controlled for baseline side-effect scores. Our study supports the use of varenicline as a safe drug for smoking reduction in schizophrenia but not as a cognitive enhancer. ClinicalTrials.gov 00802919.
Full Text Available Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults. Background: Citrus sudachi Hort. ex Shirai (Rutaceae, called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of
Chen, Chun-Chung; Wei, Sung-Tai; Tsaia, Shiu-Chiu; Chen, Xian-Xiu; Cho, Der-Yang
In adults, mild traumatic brain injury (MTBI) frequently results in impairments of cognitive functions which would lead to psychological consequences in the future. Cerebrolysin is a nootropic drug, and can significantly improve cognitive function in patients with Alzheimer's disease and stroke. The purpose of this study was to investigate how Cerebrolysin therapy enhances cognitive recovery for mild traumatic brain injury patients using a double-blinded, placebo-controlled, randomized phase II pilot study. Patients having head injury within 24 h sent to our hospital were screened and recruited if patients were alert and conscious, and had intracranial contusion haemorrhage. From July 2009 to June 2010, totally, thirty-two patients were recruited in the double-blinded, placebo-controlled, and randomized study. Patients were randomized to receive Cerebrolysin (Group A, once daily intravenous infusion of 30 mL Cerebrolysin over a 60-min period for 5 days) or placebo (Group B, same dosage and administration of normal saline as Group A). The primary outcome measures were differences of cognitive function including Mini-Mental Status Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI) scores between baseline and week 1, between baseline and week 4, and between baseline and week 12. Thirty-two patients completed the trial. For Group A, the CASI score difference between baseline and week 12 was 21.0 ± 20.4, a significantly greater change than that of Group B (7.6 ± 12.1) (p = 0.0461). Besides, drawing function (one of the domains of CASI; p = 0.0066) on week 4 and both drawing function (p = 0.0472) and long-term memory (one of the domains of CASI; p = 0.0256) on week 12 were also found to be significantly improved in the patients receiving Cerebrolysin treatment. Our results suggest that Cerebrolysin improves the cognitive function of the MTBI in patients at 3rd month after injury, especially for long-term memory and drawing function.
Full Text Available AbstractBackground and purpose: Symptoms of chronic rhinisinositis (CRS are cumbersome and refractory to most systemic medications and even after surgical intervention, the recurrence of symptoms are frequent. In order to study the beneficial effects of Origanum vulgar inhaler in relaxing the symptoms, this study was conducted in Boo Ali Sina Hospital, Sari, Iran.Materials and Methods: The study was a randomized double blind placebo controlled clinical trial carried out from April to December 2005. The diagnosis of CRS was made by an ENT specialist upon clinical and CT scan findings and or signs during functional endoscopy sinuses surgery (FESS. Patients younger than 15 years old, with a history of allergic eye disease and symptoms of infections were excluded. Patients were randomized in case and control groups (32 in each according to age, sex and disease chronicity. After verbal explanation of the trial, an informed consent form was signed by each patient. The study was approved by the medical ethics committee of the Mazandaran University of Medical Sciences, Iran. Origanum vulgar was gathered from local mountains (Kojor area, Nour, Mazandaran, Iran, and identified by an experienced botanist. The airial organs of the herb were dried, macerated followed by 75% hydroalcoholic extraction and standardized by Emerson method. The active ingredient and placebo in the same bottles were administered to the patients and they were asked to add 5 ml of the liquid to boiling water and inhale it for 15 minutes, three times a day for two weeks. A telephone contact was made to the patients, to increase the compliance to treatment. A questionnaire was filled in for each patient before and after the intervention by a doctor blind to groups. Chi square test was used for comparing the differences in symptoms and P< 0.05 was considered statistically significant.Results: Sixty four patients were recruited and allocated equally in case and control groups matched for
Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk
This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... = 0.0001). Caffeine also reduced the rating of perceived exertion after 5 min of cycling by 11% (95% CI: 5–17; P = 0.002) and postural stability with eyes open by 25% (95% CI: 2–53; P = 0.03). Caffeine ingestion did not affect muscle strength, walking speed, reaction, and movement times. At the end...... consumption. Further studies are required to investigate whether caffeine can be utilized to improve the physical performance of elderly citizens....
Hunter, J O; Walker, R J; Crowe, J; Gillies, R R; Gillies, K R; Gough, K R; Lorber, S
The efficacy of ranitidine 150 mg twice daily and Maalox TC three tablets four times daily were compared in patients with endoscopically confirmed duodenal ulcer. Seventy-nine patients were randomly allocated to double-blind, double-dummy treatment, stratified for smokers. Endoscopy was repeated after four weeks. Those unhealed continued treatment for a further two weeks before final endoscopy. Per protocol analysis in 53 patients showed ulcer healing rates at week 4 and at weeks 4 and 6 combined of 78 and 89% on Maalox TC, and of 81 and 91% on ranitidine, respectively. The same analysis gave overall healing rates of 81% in smokers and 100% in nonsmokers, irrespective of treatment. Both treatments provided early ulcer pain relief. Diarrhea was a commoner side effect in patients on Maalox TC. The study showed Maalox TC and ranitidine were equally effective in healing duodenal ulceration.
Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco
Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.
Full Text Available OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27 and experimental (24. RESULTS There is statistically significant evidence (p-value = 0.0120 that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402. CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.
Johnson, Morgan; Hassinger, Lauren; Davis, Joshua; Devor, Steven T; DiSilvestro, Robert A
Spirulina may increase people's ability to resist mental and physical fatigue. This study tested that hypothesis in a randomized, double blinded, placebo controlled study in men. After 1 week, a 3 g/day dose of spirulina produced a small, but statistically significant increase in exercise output (Kcals consumed in 30 min exercise on a cross trainer machine). A mathematical based mental fatigue test showed improved performance 4 h after the first time of supplementation as well as 8 weeks later. Similarly, a subjective survey for a sense of physical and mental fatigue showed improvement within 4 h of the first supplementation as well as 8 weeks later. These results show that spirulina intake can affect fatigue in men.
WANGJiejun; ZOUJianjun; GAOYong; XUQing; CAOChuanwu; QIANJianxin; XUDefeng; PANHuijun
Objective: To compare the effects and adverse reactions of dihydrocodeine tartrate and codeine phosphate in treating moderate cancer pain. Methods: Sixty-nine cases of cancer patients with moderate pain were treated with dihydrocodeine tartrate or codeine phosphate respectively by double-blind,controlled randomized methods and the effects and adverse reactions were observed. Results: After administration of dihydrocodeine tartrate or codeine phosphate, in treatment group or control group, the total effective rate was 86.6% and 93.6%, and common adverse symptoms included constipation (31.3%/12.9%),nausea (18.8%/19.7%), gastric trouble (18.8%/19.7%), skin pruritus (12.5%/10%), vomit (9.3% and 6.5%) with the difference being not significant. Conclusion: The effects of dihydrocodeine tartrate in treating moderate cancer pain are similar to codeine phosphate. Both them can be used to treat moderate cancer pain.
Kashani, L; Eslatmanesh, S; Saedi, N; Niroomand, N; Ebrahimi, M; Hosseinian, M; Foroughifar, T; Salimi, S; Akhondzadeh, S
Introduction: Postpartum depression is a common mental health problem that is associated with maternal suffering. The aim of this double-blind clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression. Methods: This was a 6-week, double-blind, randomized clinical trial. Subjects were women aged 18-45 years with mild to moderate postpartum depression who had Hamilton Depression Rating Scale (HDRS 17-item) score≤18. Eligible participants were randomized to receive either a capsule of saffron (15 mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks. The primary outcome measure was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms (HDRS score). Results: There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50)=1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups. Discussion: The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression. Nevertheless, it should be mentioned that the trial is not well powered and should be considered a preliminary study. Therefore, large clinical trials with longer treatment periods and comparison with placebo group would be appropriate for future studies.
Jagdeesh N Kulkarni
Full Text Available Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an-drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44 and flutamide (42 group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem-onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites and low volume disease (LVD< 5 sites. The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30% required decoding, reasons for decod-ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas-tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura-tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben-efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.
Likar, R; Krumpholz, R; Mathiaschitz, K; Pipam, W; Burtscher, M; Ozegovic, G; Breschan, C; Bernatzky, G; Sittl, R
Ketoprofen exerts its clinical effect by inhibition of prostaglandin synthesis, but also acts as an NMDA-receptor antagonist by means of the kynurenic acid. Based on ketoprofen's supposed central mechanism of analgesia, we expected a preemptive effect, which was assessed by the present study. In a prospective, randomised, double-blind investigation of 48 patients undergoing gynaecological procedures (laparotomy, pelvioscopy), the first group received ketoprofen 2 mg/kg body weight i.v. 20 min before the beginning of surgery and placebo i.v. at the end of surgery. In the second group, placebo was administered first and ketoprofen at the end of surgery. Premedication and anaesthesia were standardised by protocol. The postoperative analgesic patient-controlled analgesia consumption by was also standardised (piritramide). Efficacy was assessed by visual analogue scale (VAS) and total requirement of analgesics within the first 24 postoperative hours. The time to the first request for postoperative analgesics was also recorded. Safety was assessed by continuous monitoring of vital parameters such as respiratory rate, heart rate, blood pressure, and oxygen saturation. The incidence and severity of adverse events was documented. There were no significant differences between the groups in demographic data or type or duration of surgery. The time to the first request for analgesic, VAS pain intensity, and analgesic consumption in the first 24 h post-surgery were not significantly different between the groups (t-test). Ketoprofen is an effective post-operative analgesic in combination with an opioid, but has no preemptive effect according to the results of this study.
Leitner, Lorenz; Sybesma, Wilbert; Chanishvili, Nina; Goderdzishvili, Marina; Chkhotua, Archil; Ujmajuridze, Aleksandre; Schneider, Marc P; Sartori, Andrea; Mehnert, Ulrich; Bachmann, Lucas M; Kessler, Thomas M
Urinary tract infections (UTI) are among the most prevalent microbial diseases and their financial burden on society is substantial. The continuing increase of antibiotic resistance worldwide is alarming. Thus, well-tolerated, highly effective therapeutic alternatives are urgently needed. Although there is evidence indicating that bacteriophage therapy may be effective and safe for treating UTIs, the number of investigated patients is low and there is a lack of randomized controlled trials. This study is the first randomized, placebo-controlled, double-blind trial investigating bacteriophages in UTI treatment. Patients planned for transurethral resection of the prostate are screened for UTIs and enrolled if in urine culture eligible microorganisms ≥10(4) colony forming units/mL are found. Patients are randomized in a double-blind fashion to the 3 study treatment arms in a 1:1:1 ratio to receive either: a) bacteriophage (i.e. commercially available Pyo bacteriophage) solution, b) placebo solution, or c) antibiotic treatment according to the antibiotic sensitivity pattern. All treatments are intended for 7 days. No antibiotic prophylaxes will be given to the double-blinded treatment arms a) and b). As common practice, the Pyo bacteriophage cocktail is subjected to periodic adaptation cycles during the study. Urinalysis, urine culture, bladder and pain diary, and IPSS questionnaire will be completed prior to and at the end of treatment (i.e. after 7 days) or at withdrawal/drop out from the study. Patients with persistent UTIs will undergo antibiotic treatment according to antibiotic sensitivity pattern. Based on the high lytic activity and the potential of resistance optimization by direct adaptation of bacteriophages, and considering the continuing increase of antibiotic resistance worldwide, bacteriophage therapy is a very promising treatment option for UTIs. Thus, our randomized controlled trial investigating bacteriophages for treating UTIs will provide
Mahmoud Reza ASHRAFI
Full Text Available How to Cite This Article: Ashrafi MR, Najafi Z, Shafiei M, Heidari K, Togha M. Cinnarizinev ersus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial. Iran J Child Neurol. 2014 Autumn;8(4: 18-27. AbstractObjectiveMigraines, a common health problem in children and adolescents, still do not have an FDA approved preventive treatment for patients under the age of 18 years. This study compares and contrasts the efficacy and safety of cinnarizine and topiramate in preventing pediatric migraines.Materials & MethodsIn this randomized, double-blind clinical trial 44 migrainous (from 4–15 years of age were equally allocated to receive cinnarizine or topiramate. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate. Efficacy measures were recorded at the baseline and at 4, 8, and 12 weeks of treatment.ResultsDuring the double-blind phase of the study, monthly migraine frequency and intensity were significantly decreased in both the cinnarizine and topiramate groups when compared to the baseline. However, at the end of the study, the cinnarizine group exhibits a significant decrease from the baseline in the mean monthly migraine intensity when compared to the topiramate group (4.7 vs. 3, respectively; 95% CI = -0.8 to -3.2.ConclusionNo significant difference between cinnarizine and topiramate was found for the prevention of pediatric migraines. Both treatments were well tolerated.ReferencesHershey AD, Winner PK. Pediatric Migraine: Recognition and Treatment. J Am Osteopath Assoc. 2005;105:2S-8.Lewis DW, Yonker M, Winner P, Sowell M. The treatment of pediatric migraine. Pediatric Annals. 2005;34:448-460.Abu-Arefeh I, Russell G. Prevalence of headache and migraine in schoolchildren. BMJ. 1994;309:765-769.Linet MS, Stewart WF, Celentano DD, Ziegler D, Sprecher M. An Epidemiologic Study of Headache among
A post hoc analysis of negative symptoms and psychosocial function in patients with schizophrenia: a 40-week randomized, double-blind study of ziprasidone versus haloperidol followed by a 3-year double-blind extension trial.
Stahl, Stephen M; Malla, Ashok; Newcomer, John W; Potkin, Steven G; Weiden, Peter J; Harvey, Philip D; Loebel, Antony; Watsky, Eric; Siu, Cynthia O; Romano, Steve
Schizophrenia is a persistent, lifelong illness such that enduring functional improvements may only occur over the course of years [corrected].This post hoc analysis in stable outpatients with schizophrenia investigated the negative symptom efficacy and treatment outcomes of ziprasidone (80-160 mg/d given twice a day, mean modal dose of 112 mg/d; and 80-120 mg/d given every day, mean modal dose of 96 mg/d) versus haloperidol (5-20 mg/d, mean modal dose of 12 mg/d) in a randomized, 40-week, double-blind study, followed by a double-blind continuation trial that extended up to 156 additional weeks. Symptomatic and functional recovery criteria were met when subjects attained both negative symptom remission and adequate psychosocial functioning based on the 4 Quality-of-Life subscales (instrumental role, interpersonal relations, participation in community, and intrapsychic foundations). Negative symptom remission (P = 0.005), as well as sustained adequate functioning (6 months) in instrumental role (P = 0.04) and participation in community (P = 0.02), was associated with significantly shorter time to remission in the ziprasidone 80 to 160 mg group than in the haloperidol group, as was the combination of symptomatic and functional recovery during the 196-week double-blind study period. A similar pattern was observed for the ziprasidone 80 to 120 mg group, which showed significant differences versus haloperidol in negative symptom remission and instrumental role functioning (but not other Quality-of-Life subscale measures). The clinically relevant outcome differences detected in this post hoc exploratory analysis support the potential for both enhanced remission in negative symptoms and psychosocial recovery during long-term treatment with an atypical agent and add to our understanding regarding the degree to which negative symptom remission can be attained in the maintenance phase.
LI Ting; CHEN Shun-le; DAI Qing; HAN Xing-hai; LI Zhan-guo; WU Dong-hai; ZHANG Xiao
Background Acute gout is an intensely painful,inflammatory arthritis.Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition,the efficacy is based on only a few studies,particularly in China.We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.Methods A randomized,double-blind,active comparator study was conducted at 10 sites in China.Patients (n=178； ≥18 years of age) with acute gouty attack (＜48 hours) were treated for 5 days with etoricoxib (120 mg/d； n=89) or indometacin (75 mg twice daily； n=89).The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2-5.Secondary end points included investigator assessments of tenderness and swelling,patient/ investigator global assessments of response to therapy,and patients discontinuing treatment.Safety was assessed by adverse events (AEs).Results Etoricoxib and indometacin had comparable primary and secondary end points.Mean change difference from baseline from days 2-5 was 0.03 (95％ confidence interval (Cl)-0.19 to 0.25； P=0.6364),which fell within the prespecified comparative bounds of-0.5 to 0.5.No severe AEs were associated with etoricoxib use.Non-severe AEs were mainly digestive and general,and most (73.7％) were mild,although they caused withdrawal of two subjects in the etoricoxib group,due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related).Overall,AEs were similar,although the absolute number of AEs in the etoricoxib group (n=31) was less than the indometacin group (n=34).Conclusions Etoricoxib (120 mg once daily) is effective in treating acute gout,is generally safe and well-tolerated,and is comparable in efficacy to indometacin (75 mg twice daily).
Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of Valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So
Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So
Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials.
Buono, Jessica L; Tourkodimitris, Stavros; Sarocco, Phil; Johnston, Jeffrey M; Carson, Robyn T
Irritable bowel syndrome with constipation (IBS-C), a chronic functional gastrointestinal disorder, has been shown to negatively affect work productivity and impair daily activity, resulting in a substantial burden for patients and employers. Linaclotide is a first-in-class guanylate cyclase-C agonist approved for the treatment of adults with IBS-C and chronic idiopathic constipation in the United States. To analyze the impact of treatment with linaclotide on work productivity and daily activity impairment in adults with IBS-C and estimate the indirect costs associated with this condition. This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C. The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2. An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure. Indirect costs were calculated by converting overall work productivity losses into monetary values using the human capital cost approach. Of the 1602 patients with IBS-C who were randomized in the 2 clinical trials, 1555 (97.1%) completed a baseline and at least 1 postbaseline WPAI:IBS-C assessment and were included in the analysis cohort; 1148 (71.7%) of these patients were employed. Once-daily treatment with linaclotide significantly reduced overall work productivity loss and daily activity impairment among patients with IBS-C at all study weeks. From baseline to week 12, compared with placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work productivity loss by 6.1%, and daily activity impairment by 4.7% (all P employee with IBS-C. The results of this
A phase 3, randomized, double-blinded, active-controlled, unblinded standard of care study assessing the efficacy and safety of intramyocardial autologous CD34+ cell administration in patients with refractory angina: design of the RENEW study.
Povsic, Thomas J; Junge, Candice; Nada, Adel; Schatz, Richard A; Harrington, Robert A; Davidson, Charles J; Fortuin, F David; Kereiakes, Dean J; Mendelsohn, Farrell O; Sherman, Warren; Schaer, Gary L; White, Christopher J; Stewart, Duncan; Story, Kenneth; Losordo, Douglas W; Henry, Timothy D
Preclinical trials indicate that CD34+ cells represent an effective angiogenic stem cell component. Early-phase clinical trials suggest that intramyocardial administration of autologous CD34+ cells may improve functional capacity and symptoms of angina. RENEW is a pivotal phase 3 trial designed to determine the efficacy of granulocyte colony-stimulating factor (G-CSF)-mobilized CD34+ stem cells for the treatment for patients with refractory angina and chronic myocardial ischemia. Patients (n = 444) receiving maximally tolerated antianginal therapies and lacking conventional revascularization options with Canadian Cardiovascular Society class III or IV angina and ischemia on stress testing will be randomized 2:1:1 to cell therapy (G-CSF-mediated stem cell mobilization, apheresis, and intramyocardial injection of 1 × 10(5) autologous CD34(+) cells/kg), active control (G-CSF-mediated stem cell mobilization, apheresis, and intramyocardial placebo injection), or open-label standard of care. The primary efficacy end point is change in exercise treadmill time in the treated vs active control patients, with 90% power to detect a 60-second difference in exercise time between cell-treated (n = 200) and active control (n = 100) patients. Key secondary end points include total number of anginal episodes per week and the incidence of independently adjudicated major adverse cardiac events and serious adverse events. RENEW will be the first adequately powered study aimed at definitively determining the efficacy of a cell therapy (intramyocardially delivered autologous CD34+ cells) for improvement of functional capacity in patients with refractory angina.
Amy S Chappell
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
Vialet, Cécile; Hwang, Eunhee; Tourian, Karen A.
Objective: To examine long-term (11-month) antidepressant efficacy of desvenlafaxine 50 mg/d across a broad range of clinical and functional outcomes in patients with major depressive disorder. Method: Adult outpatients (≥ 18 years) with major depressive disorder (DSM-IV criteria) and a 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 at screening and baseline who responded to 8 weeks of open-label desvenlafaxine 50 mg/d and had a continuing stable response through week 20 were randomly assigned to receive placebo or desvenlafaxine 50 mg/d in a 6-month, double-blind, randomized withdrawal period. Depressive symptoms were evaluated using the HDRS-17, 6-item HDRS, and Clinical Global Impressions–Severity of Ilness and –Improvement (CGI-S, CGI-I). Health outcomes included the Work Productivity and Activity Impairment (WPAI) questionnaire and the World Health Organization 5-Item Well-Being Index (WHO-5). The trial was conducted from June 2009 to March 2011 at 87 study sites in 14 countries worldwide. Results: Of 874 patients enrolled in open-label treatment, 548 patients were randomly assigned to receive double-blind placebo (n = 276) or desvenlafaxine 50 mg/d (n = 272). At the end of the 6-month double-blind treatment, improvements in depressive symptoms were better maintained among the desvenlafaxine- than placebo-treated patients on all efficacy endpoints (all P ≤ .001); in the desvenlafaxine group, 21.8% (vs 42.9% in the placebo group) had CGI-I ratings of 5, 6, and 7 (minimally worse/much worse/very much worse), and 74.4% met criteria for remission (placebo: 54.2%). WPAI and WHO-5 scores indicated significantly better productivity and well-being with continued desvenlafaxine (vs placebo, P ≤ .001). Conclusions: Long-term treatment with desvenlafaxine 50 mg/d maintained improvements in major depressive disorder among adult outpatients who exhibited a stable therapeutic response. Trial Registration: ClinicalTrials.gov identifier: NCT
Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.
Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind
Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud
The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice...
Wolffenbuttel, B H; Landgraf, R
OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type
Thornton, Steven; Goodwin, Thomas M; Greisen, Gorm;
OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 second...
van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J
OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.
Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.
Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or…
Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher
Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…
Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.
Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…
van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J
OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study. SETT
Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick
Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized
Maison-Blanche, Pierre; Vermorken, Jan B; Goksel, Tuncay;
: The effect of repeated doses of aflibercept on ventricular repolarization in cancer patients was evaluated in an intensive electrocardiogram trial. This randomized, placebo-controlled, double-blind trial was conducted in 87 treated solid tumor patients. Treatment was with 6 mg/kg aflibercept, 1...
Kristoferitsch, W; Seeldrayers, P; Kyriallis, K; Brochet, B; Confavreux, C; Clanet, M; Cesaro, P; Defer, G; Edan, G; Lyon-Caen, O; Pelletier, J; Rumbach, L; Roullet, E; Vermersch, P; Dengler, R; Zschenderlein, R; Storch-Hagenlocher, B; Sailer, M; Hohlfeld, R; Kunze, KP; Heesen, C; Bamborschke, P; Grunwald, F; Hartung, HP; Rieckmann, P; DeKeyser, J; Montalban, [No Value; Fernandez, U; Arbizu, T; Sandberg, M; Kappos, L; Bates, D; Campbell, MJ; Capildeo, R; Compston, A; McLellan, DL; Wroe, S; Young, C; Clanet, M; Hartung, HP; Hohlfeld, R; Kappos, L; Radue, EW; Rieckmann, P; Sandberg, M; Polman, C; Kesselring, J; Thompson, A; Wekerle, H; Whitehead, J; Bains, H; Butler, E; Kooijmans-Coutinho, M; McAllister, A; Simonian, N; White, K; Anderson, D; Liddiard, S; Keane, R
We describe the rationale and design of a double-blind, randomized multicenter, dose-comparison study of interferon-beta-Ia (IFN-beta -Ia: AVONEX(R) in the treatment of relapsing multiple sclerosis (MS). The study is expected to provide quantitative insights on the dose range for optimal clinical be
Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick
Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized stu
Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick
Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized stu
Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children : a randomized, double-blind, placebo-controlled trial
Jansen, Angelique G S C; Sanders, Elisabeth A M; Hoes, Arno W; van Loon, Anton M; Hak, Eelko
OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with
Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig;
INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed...
Ponikowski, Piotr; Mitrovic, Veselin; Ruda, Mikhail; Fernandez, Alberto; Voors, Adriaan A.; Vishnevsky, Alexander; Cotter, Gad; Milo, Olga; Laessing, Ute; Zhang, Yiming; Dahlke, Marion; Zymlinski, Robert; Metra, Marco
The aim of this study was to evaluate the haemodynamic effects of serelaxin (30 g/kg/day 20-h infusion and 4-h post-infusion period) in patients with acute heart failure (AHF). This double-blind, multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure (PCWP) 18 mmHg,
Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher
Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…
Mockenhaupt, F.P.; Ehrhardt, S.; Dzisi, S.Y.; Bousema, T.; Wassilew, N.; Schreiber, J.; Anemana, S.D.; Cramer, J.P.; Otchwemah, R.N.; Sauerwein, R.W.; Eggelte, T.A.; Bienzle, U.
The therapeutic efficacy of sulfadoxine-pyrimethamine (SP) alone, SP plus amodiaquine (AQ), and SP plus artesunate (AS) was assessed in a randomized, placebo-controlled, and double-blind trial among 438 children with uncomplicated Plasmodium falciparum malaria in northern Ghana. Clinical and parasit
Biewenga, Jeike; Keung, Chi; Solanki, Bhavna; Natarajan, Jaya; Leitz, Gerhard; Deleu, Sofie; Soons, P.
Domperidone effects on QTc duration were assessed in a single-center, double-blind, four-way crossover study of 44 healthy participants randomized to one of four treatment sequences consisting of four treatment periods separated by 4–9 days washout. On Day 1 of each 4-day period, participants began
Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children : a randomized, double-blind, placebo-controlled trial
Jansen, Angelique G S C; Sanders, Elisabeth A M; Hoes, Arno W; van Loon, Anton M; Hak, Eelko
OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with
Patient-Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Kavanaugh, Arthur; McInnes, Iain B; Krueger, Gerald G; Gladman, Dafna; Beutler, Anna; Gathany, Tim; Mack, Michael; Tandon, Neeta; Han, Chenglong; Mease, Philip
Objective To evaluate the effect of golimumab on physical function, health-related quality of life (HRQOL), and productivity in psoriatic arthritis (PsA). Methods GO-REVEAL was a multicenter, randomized, placebo-controlled study. Adult patients with active PsA (n = 405) received golimumab (50 or 100 mg) or placebo every 4 weeks, with early escape at week 16 (placebo → 50 mg, 50 → 100 mg) or placebo crossover to golimumab 50 mg at week 24. Patient-reported outcomes included physical function (Health Assessment Questionnaire [HAQ] disability index [DI] score), HRQOL (36-item Short Form health survey [SF-36] mental component summary [MCS] and physical component summary [PCS] scores), and productivity (home/school/work). Clinical response was assessed using the 28-joint Disease Activity Score using the C-reactive protein level (DAS28-CRP) and the Psoriasis Area and Severity Index (PASI) score for arthritis and skin symptoms, respectively. Results At week 24, golimumab-treated patients had significant mean improvements in HAQ DI (0.36), SF-36 (PCS 7.83, MCS 3.84), and productivity (2.24) scores compared with placebo (−0.01, 0.67, −0.60, and 0.08, respectively; P <0.001 for all). Also, greater proportions of golimumab- than placebo-treated patients had clinically meaningful improvements in HAQ DI (≥0.30) and SF-36 PCS and MCS (≥5) scores at week 24 (P <0.05). Also at week 24, improvements in DAS28-CRP scores were significantly but moderately correlated with improvements in HAQ DI, SF-36 PCS, and productivity scores. Correlations between these patient-reported outcomes and improvements in PASI, enthesitis, and dactylitis scores were very weak. Improvements in HAQ DI, SF-36, and productivity scores were similar among all groups by week 52 and week 104 when including placebo → golimumab crossover patients. Conclusion Golimumab-treated patients had significant improvements in physical function, HRQOL, and productivity through week 24; these improvements
Bai, Y M; Lin, C C; Chen, J Y; Liu, W C
The objective of this study was to investigate the efficacy of pirenzepine in the treatment of clozapine-induced hypersalivation. Pirenzepine is reported to counteract hypersalivation by its selective antagonistic activity on the M4-muscarinic receptor, which is stimulated by clozapine. Twenty patients with clozapine-induced hypersalivation underwent a random-order, double-blind, placebo-controlled, cross-over trial which lasted 8 weeks each for the pirenzepine and placebo investigations, with a 4-week washout period in between. The severity of hypersalivation was assessed using an objective measure: saliva production monitored through the diameter of wetted surface on tissue paper placed over the patient's pillow. Our study showed that pirenzepine had no significant therapeutic effect on hypersalivation compared with placebo, suggesting that hypersalivation induced by clozapine might have a neurobiological basis other than the M4-muscarinic receptor.
A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single enantiomer (+)-mefloquine compared with racemic mefloquine in healthy persons.
Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg
Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (-) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (-)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted.
Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F;
OBJECTIVE: To investigate if IV immunoglobulin (IVIG) treatment in the acute phase of optic neuritis (ON) could improve visual outcome and reduce MRI disease activity 6 months after onset of ON. METHODS: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty...... during follow-up. CONCLUSIONS: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neuritis, nor was there an effect of IVIG treatment in reducing latency on visual evoked potentials and thus preserving function of axons of the optic nerve...
History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release
Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.
Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,
History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release
Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.
Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placeb
FUKUDA, TAKUYA; FUKUI, MICHIAKI; TANAKA, MUHEI; SENMARU, TAKAFUMI; IWASE, HIROYA; YAMAZAKI, MASAHIRO; AOI, WATARU; INUI, TOSHIO; NAKAMURA, NAOTO; MARUNAKA, YOSHINORI
Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR. PMID:26137235
Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation
Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G
The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional
Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang
Background:In China,no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now.This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women.Methods:This was a double-blinded,prospective randomized controlled study including nulliparous women from 6 university hospitals across China.Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2.Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction.Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h.Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes.Results:A total of 173 women for misoprostol group and 49 women for placebo were analyzed.The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2％ vs.22.5％,relative risk [RR]:2.9,95％ confidence interval [CI]:1.4-6.0).The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0％ vs.18.4％,RR:2.6,95％ CI:1.2-5.7);and the induction-onset of labor interval was significantly shorter in the misoprostol group (P =0.0003).However,there were no significant differences in the median process time of vaginal labor (6.4 vs.6.8 h;P =0.695),incidence (39.3％ vs.49.0％,RR:0.8,95％ CI:0.4-1.5) and indications (P =0.683) of cesarean section deliveries,and frequencies of maternal,fetal/neonatal adverse events between the groups.Conclusion:Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.
Sachinis, Nikolaos Platon; Boutsiadis, Achilleas; Papagiannopoulos, Sotirios; Ditsios, Konstantinos; Christodoulou, Anastasios; Papadopoulos, Pericles
It has been indicated that rotator cuff tears, especially large or massive ones, can cause suprascapular neuropathy. When such a diagnosis has been established, it is still unknown whether an arthroscopic release of the superior transverse scapular ligament during cuff repair can change the course of this neuropathy. This is a single-center, double-blinded randomized controlled trial for which 42 patients with large or massive repairable rotator cuff tears and suprascapular neuropathy will be recruited and followed up at 6 and 12 months. Nerve function will be measured by nerve conduction and electromyography studies preoperatively and at the selected follow-up periods. Patients will be randomly divided into equally numbered groups, the first one being the control group. Patients of this group will undergo arthroscopic repair of the rotator cuff without combined arthroscopic release of the superior transverse scapular ligament; in the second group the ligament will be released. The primary objective is to test the null hypothesis that arthroscopic repair of large/massive rotator cuff tears in patients with combined suprascapular neuropathy provides equivalent outcomes to one-stage arthroscopic cuff repair where the superior suprascapular ligament is additionally released. The secondary objective is to search for a relation between rotator cuff tear size and degree of suprascapular nerve recovery. The tertiary objective is to demonstrate any relation between rotator cuff muscle fatty infiltration grade and degree of suprascapular nerve function. Patients, clinicians during follow-up clinics and the neurologist will be blinded to the type of surgery performed. To the best of our knowledge, we are unaware of any prospective, randomized double-blinded studies with similar objectives. So far, the evidence suggests a positive correlation between massive rotator cuff tears and suprascapular neuropathy. However, there is mixed evidence suggesting that neuropathy can be
Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen
Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739
Full Text Available Abstract Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD, four patients with polymyositis/dermatomyositis (PM/DM, and five patients with mitochondrial myopathies (MM, and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3 in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin
YANG Quan-yong; XUE Fu-shan; LIAO Xu; LIU He-ping; LUO Mao-ping; XU Ya-chao; LIU Yi; ZHANG Yan-ming
Background The authors found no study to compare the efficacy of bolus dose fentanyl and remifentanil blunting the cardiovascular intubation response in children, so they designed this randomized, double-blind clinical study to assess the effects of remifentanil 2 ug/kg and fentanyl 2 ug/kg by bolus injection on the cardiovascular intubation response in healthy children.Methods One hundred and two children, the American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for elective plastic surgery under general anesthesia, were randomly divided into one of two groups to receive the following treatments in a double blind manner: remifentanil 2 ug/kg (Group R) and fentanyl 2 ug/kg (Group F) when anesthesia was induced with propofol and vecuronium. The orotracheal intubation was performed using a direct laryngoscope. Blood pressure (BP) and heart rate (HR) were recorded before anesthesia induction (baseline values), immediately before intubation, at intubation and every minute for 5 minutes after intubation. The percent changes of systolic blood pressure (SBP) and HR relative to baseline values and the rate pressure product (RPP) at every observing point were calculated. The incidences of SBP and HR percent changes >30% of baseline values and RPP >22 000 during the observation were recorded. Results There were no significant differences between groups in the demographic data, baseline values of BP and HR and the intubation time. As compared to baseline values, BP, HR and RPP at intubation and their maximum values during observation increased significantly in Group F, but they all decreased significantly in Group R. BP, HR and RPP at all observed points, and their maximum values during the observation, were significantly different between groups. There were also significant differences between groups in the percent change of SBP and HR relative to baseline values at all observed points and their maximum percent changes during the observation. The
Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P
Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m(2) and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.
Full Text Available A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract of Glycyrrhiza glabra in the management of Helicobacter pylori (H. pylori gastric load. Participants diagnosed with H. pylori infection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55 or placebo (n=52 once daily for 60 days. H. pylori infection was assessed using 13C-urea breath test (13C-UBT at days 0, 30, and 60. Stool Antigen test (HpSA was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA, chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00 and significant difference in mean Delta Over Baseline (DOB values between GutGard (n=50 and placebo (n=50 treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56% in GutGard treated group whereas in placebo treated group only 2 subjects (4% showed negative response; the difference between the groups was statistically significant. On day 60, the results of 13C-UBT were negative in 24 (48% in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management of H. pylori.
Xian, Shao-xiang; Yang, Zhong-qi; Ren, Pei-hua; Ye, Xiao-han; Ye, Sui-lin; Wang, Qing-hai; Wang, Zhao-hui; Shen, Shu-jing; Huang, Xi-wen
To investigate the safety and efficacy of yangxinkang tablets in patients with chronic heart failure (CHF) and syndrome of qi and yin deficiency, blood stasis, and water retention. In a double-blinded, randomized, placebo-controlled, multicenter clinical trail, 228 patients with CHF New York Heart Association (NYHA) class II or III in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus yangxinkang tablets for 4 weeks. The outcome measure were effect of cardiac function, Chinese medicine (CM) syndromes, scores of symptoms, signs, and quality of life measured by Minnesota Living with heart failure questionnaire (MLHFQ) before and after the treatment. Totally 112 patients were analyzed in the treatment group and 109 in the control group. They were comparable in NYHA functional class, basic parameters and primary diseases before treatment. Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment. Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group (Pgasp, cough with phlegm, pulmonary rales and jugular vein engorgement between the two groups (P0.05). There was no obvious adverse reaction in either group noted during the study. Yangxinkang tablets were safe and efficacious in improving cardiac function, CM syndromes, symptoms, signs, and quality of life in patients with CHF class II or III in stage C on the base of conventional treatment.
Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A
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.
Zanwar, Vinay G; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M
The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (Pgluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (Pgluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions.
Ghaleiha, Ali; Ghyasvand, Mohammad; Mohammadi, Mohammad-Reza; Farokhnia, Mehdi; Yadegari, Noorollah; Tabrizi, Mina; Hajiaghaee, Reza; Yekehtaz, Habibeh; Akhondzadeh, Shahin
The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4-12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms.
Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.
Pawlik, Michael T; Hansen, Ernil; Waldhauser, Daniela; Selig, Christoph; Kuehnel, Thomas S
Patients with sleep apnea often present with cardiac diseases and breathing difficulties, with a high risk of postoperative respiratory depression. We conducted a randomized, double-blind, prospective study in 30 adult patients with obstructive sleep apnea, undergoing elective ear-nose-throat surgery. The patients were randomly assigned to receive placebo or clonidine (2 microg/kg oral) the night before and the next morning 2 h before surgery. Spo2, heart rate, mean arterial blood pressure, snoring, and oronasal airflow were monitored for 36 h. A standard anesthesia was used consisting of propofol and remifentanil. Anesthetic drug consumption, postoperative analgesics, and pain score were recorded. In the clonidine group, mean arterial blood pressures were significantly lower during induction, operation, and emergence from anesthesia. Both propofol dose required for induction (190 +/- 32.2 mg) and anesthesia (6.3 +/- 1.3 mg . kg(-1).h(-1)) during surgery were significantly reduced in the clonidine group compared with the placebo group (induction 218 +/- 32.4, anesthesia 7.70 +/- 1.5; P clonidine group. Apnea and desaturation index were not different between the groups, whereas the minimal postoperative oxygen saturation on the day of surgery was significantly lower in the placebo than in the clonidine group (76.7% +/- 8.0% versus 82.4% +/- 5.8%; P clonidine premedication stabilizes hemodynamic variables during induction, maintenance, and emergence from anesthesia and reduces the amount of intraoperative anesthetics and postoperative opioids without deterioration of ventilation.
Marco Antonio Botelho
Full Text Available Several different plant extracts have been evaluated with respect to their antimicrobial effects against oral pathogens and for reduction of gingivitis. Given that a large number of these substances have been associated with significant side effects that contraindicate their long-term use, new compounds need to be tested. The aim of this study was to assess the short-term safety and efficacy of a Lippia sidoides ("alecrim pimenta"-based essential oil mouthrinse on gingival inflammation and bacterial plaque. Fifty-five patients were enrolled into a pilot, double-blinded, randomized, parallel-armed study. Patients were randomly assigned to undergo a 7-day treatment regimen with either the L. sidoides-based mouthrinse or 0.12% chlorhexidine mouthrinse. The results demonstrated decreased plaque index, gingival index and gingival bleeding index scores at 7 days, as compared to baseline. There was no statistically significance difference (p>0.05 between test and control groups for any of the clinical parameters assessed throughout the study. Adverse events were mild and transient. The findings of this study demonstrated that the L. sidoides-based mouthrinse was safe and efficacious in reducing bacterial plaque and gingival inflammation.
Full Text Available Acute gastroenteritis is one of the most common infectious diseases of childhood. Its symptoms are vomiting, diarrhea, and dehydration. In the emergency ward, intravenous rather than oral rehydration is usually preferred because of the high likelihood of emesis. Treatments to reduce emesis are of value in improving the rehydration procedure. Our study is a double-blind randomized trial and proposes the use of ondansetron as an anti-emetic drug to treat children with acute gastroenteritis. Seventy-four in-patients, aged 3 months to 15 years, were enrolled and randomly assigned to an ondansetron or placebo group. Inclusion criteria were the diagnosis of acute gastroenteritis and the absence of other diseases or allergies to drugs. A single bolus (0.15 mg/kg of ondansetron was injected intravenously; normal 0.9% saline solution was used as a placebo. This treatment induced vomiting cessation in the ondansetron group significantly in comparison to the placebo group. The length of the hospital stay and the oral rehydration fluid volume were similar in the two groups and no adverse effects were noticed. Thus, safety, low cost, and overall benefit of ondansetron treatment suggests that this drug can be administered successfully to children with acute gastroenteritis.
Frizziero, Antonio; Causero, Araldo; Bernasconi, Stefano; Papalia, Rocco; Longo, Mario; Sessa, Vincenzo; Sadile, Francesco; Greco, Pasquale; Tarantino, Umberto; Masiero, Stefano; Rovati, Stefano; Frangione, Valeria
to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, -39.35±27.69 mm for BMV12-h and -36.91±32.50 mm for BMV24-h, than with placebo, -20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated.
Objectives To assess weight loss efficacy ,safety and tolerability of sibutramine in simple obese subjects.Methods Randomized, double-blind, placebo-controlled clinical trial. Four hospital outpatient clinics in Shanghai, Chongqing, Shandong and Tianjin, respectively. Participants: 233 men and women, 18-65 years old, with body mass index (BMI) ranging from 27 to 40*!kg/m2 were randomly divided into an intervened group and a placebo control group. Sibutramine 10 mg or placebo once a day. Main outcome measures: Body weight, routine laboratory and clinical safety monitoring.Results Of 233 eligible patients, 120 received sibutramine and 113 received placebo. Weight reduction was significantly greater in the intervened group (6.8±3.1) kg than the placebo control group (0.48±2.6) kg from week 4 onwards to week 24 (P<0.001). Some minor side effects were noticed in the subjects who took sibutramine. But the symptoms were light and short term. Sibutramine was will tolerated.Conclusions Sibutramine 10*!mg once a day is an effective an safe therapy for weight reduction in simple over-weighted and obese subjects.
Faghihi, Gita; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh
Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment ( 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion. PMID:27689135
Shin, Jae-Young; Ku, Boncho; Kim, Jaeuk U; Lee, Yu Jung; Kang, Jae Hui; Heo, Hyun; Choi, Hyo-Joon; Lee, Jun-Hwan
Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n = 28) or the sham laser acupuncture group (n = 28). Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version) were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.
A double blind, prospective and randomized study was carried out in forty patients with clinical diagnosis of vernal conjunctivitis and eosinophilia in conjunctival scrapings. They were divided in two randomized groups of 20 patients each. One of the groups received levocabastine ophthalmic solution and the other saline solution drops. The mean age of the study group was 9.1 years old with a vernal conjunctivitis history of 44 months. The control group mean age was 10.1 years old and a history of vernal conjunctivitis of 48 months prior the enter of the study. One group received levocabastine 0.5 mgrs/ml while the other balanced saline solution, one drop every 12 hours per seven days. The patients evaluated their symptoms through a visual analogic scale (every day). Data collected was analyzed, for the first, third and seventh day, through U-Mann Whitney statistical analysis. Epiphora and photophobia showed a significant improvement. Itching, edema and foreign body sensation showed improvement in the levocabastine group but without statistical significance. Hyperthermia remained the same in both groups studied.
Ghanizadeh, Ahmad; Haghighi, Alireza
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.
Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching
The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.
Simona Cionac Florescu
Full Text Available Objective. This randomized double-blind study compared the analgesic efficacy and tolerability of etoricoxib versus ketoprofen in 165 patients with elective total primary knee arthroplasty. Methods. After ethical committee approval, 165 patients were randomized in 3 groups: the etoricoxib group (E receiving etoricoxib 120 mg/day, at the end of surgery and in the first postoperative day; the ketoprofen group (K receiving ketoprofen 2 pills of 100 mg/day, the first at the end of surgery and then 1 pill every 12 hours in the surgery day and the first postoperative day; the placebo group (P. All groups received postoperatively the same analgesia protocol when NRS is over 3 with IV Perfalgan and morphine. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose, the total amount of morphine administered in the surgery day and the first postoperative day, and the frequency of patients with side effects and necessary amount of adjuvant medication. Results. The baseline demographic characteristics were similar among the 3 groups. In both study days etoricoxib provided an analgesic effect superior to placebo and to ketoprofen, the total administered morphine being significantly lower in etoricoxib group. There were no statistically significant differences between groups regarding the side effects.
Pityriasis rosea is an acute self-limiting skin disorder of unknown aetiology. Recently human herpes virus 6 and 7 has been hypothesized to be the cause of pityriasis rosea. To determine the efficacy of acyclovir, an anti-viral drug, in the treatment of pityriasis rosea. A randomized, double-blind, placebo-controlled study of efficacy of oral acyclovir in the treatment of pityriasis rosea was conducted on 73 patients. Thirty eight randomly selected patients were started on oral acyclovir. Thirty-five patients were prescribed placebo. The patients as well as the chief investigator were unaware of the therapeutic group to which patients belonged (acyclovir or placebo). Patients in both the groups were evaluated clinically after 7 and 14 days following the first visit and the data were analysed. Follow up data of 60 patients was available and these were included in the statistical analysis. 53.33% and 86.66% of the patients belonging to the acyclovir group showed complete resolution on the 7(th) day and 14(th) day respectively following the first visit compared to 10% and 33.33% of patients from the placebo group. The findings were statistically significant. The study showed that high dose acyclovir is effective in the treatment of pityriasis rosea.
Fujiwara, Takashi; Nishida, Naoya; Nota, Jumpei; Kitani, Takashi; Aoishi, Kunihide; Takahashi, Hirotaka; Sugahara, Takuya; Hato, Naohito
Chlorophyll c2 extracted from Sargassum horneri improved allergic symptoms in an animal model of allergic rhinitis. In the present study, we explored the efficacy of chlorophyll c2 in patients with seasonal allergic rhinitis. This was a single-center, randomized, double-blind placebo-controlled trial. Sixty-six patients aged 20-43 years, each with a 2-year history of seasonal allergic rhinitis, were randomly assigned to receive either a single daily dose (0.7 mg) of chlorophyll c2 or placebo for 12 weeks. The use of medications including H1-antihistamines and topical nasal steroids was recorded by rescue medication scores (RMSs) noted after 4, 8, and 12 weeks of treatment. Disease-specific quality of life was measured using the Japan Rhinitis Quality of Life Questionnaire (JRQLQ) both before and after 4, 8, and 12 weeks of treatment. The RMS at 8 weeks was significantly better in the chlorophyll c2 than the placebo group (mean RMS difference = -3.09; 95 % confidence interval = -5.96 to -0.22); the mean RMS at 4 weeks was only slightly better in the chlorophyll c2 group. The JRQLQ scores did not differ significantly between the two groups. Chlorophyll c2 would have a potential to be an alternative treatment for allergic rhinitis.
Full Text Available BACKGROUND: Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. METHODS: In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30 or vehicle (normal saline; n = 30 injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS, Visual Analogue Scale (VAS and photographic plus ultrasound measurements of scar widths. RESULTS: 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. CONCLUSION: Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. TRIAL REGISTRATION: ClinicalTrials.gov NCT01429402.
Full Text Available Objective: The study assessed the efficacy of low dose ketoconazole in addition to clomiphene citrate (CC and hMG on ovulation induction.Materials and methods:A double blind, randomized, clinical trial was performed on fifty infertile patients with PCOS who had failed to respond to a daily dose of hMG and 100 mg CC for controlled ovarian hyperstimulation in Vali-e-Asr Reproductive Health Research Center.These patients were randomly divided into two equal groups receiving ketoconazole or placebo.All patients received CC and hMG for controlled ovarian hyperstimulation.Number of mature follicles, estradiol and progesterone levels at the time of hCG adminstration, endometrial thickness, ovarian hyperstimulation syndrome(OHSS, pregnancy rate, abortion, multiple pregnancies were measured. SPSS 11 software was used for statistical analysis. Statistical significance was defined as P < 0.05.Results: No significant statistical differences existed in the number of mature follicles, estradiol and progesterone levels prior to hCG administration ,endometrial thickness, OHSS and pregnancy rate between two groups. Estradiol level was lower among those receiving ketoconazole. No abortion and multiple pregnancy were found.Conclusion: Ketoconazole may suppress steroid production in resistant PCOS patients undergoing CC and hMG induction. But it has no effects on follicular maturation and OHSS prevention.
Full Text Available Background: Permethrin, a pyrethroid insecticide, is not yet available in Iran and may be a useful substitute for the control of scabies in Iran. Aim: To compare the efficacy of topical lindane with topical permethrin in the treatment of scabies in a population in Iran. Methods: In a double-blind, randomized study, all consecutive patients with scabies were randomized into two groups. One group and their family contacts received 1% lindane cream, and the other group and their family contacts were treated with topical 5% permethrin cream. Subsequently, patients were followed up at 2- and 4-week post-treatment. Results: Of the 99 patients enrolled in the study, 47 patients received 1% lindane cream, and 52 patients were treated topically with 5% permethrin cream. Permethrin provided an improvement rate of 84.6% after two weeks, whereas lindane was effective only in 48.9% of patients. Conclusion: Permethrin (5% cream was found to be significantly more effective in the treatment of scabies in comparison with lindane in this study, and it seems that it could be an alternative treatment.
Koyuncu, Onur; Leung, Steve; You, Jing; Oksar, Menekse; Turhanoglu, Selim; Akkurt, Cagla; Dolapcioglu, Kenan; Sahin, Hanifi; Sessler, Daniel I; Turan, Alparslan
To determine that perioperative ondansetron reduces the analgesic efficacy of acetaminophen. Randomized, double-blinded study. 120 patients ASA I-II who underwent abdominal hysterectomy. All the patients were given 1g acetaminophen at skin closure. Patients were divided into two groups; ondansetron HCl (8mg, 2ml IV) (Group I, N=60) and saline (2ml IV) (Group II, N=60) at the skin closure. Postoperative pain scores (VAS) while resting in bed and sitting, total opioid consumption were noted. Patients randomized to ondansetron had significantly worse pain scores upon arrival to the recovery unit [by 1.7 (99.7% CI: 0.75, 2.59) cm] and at 1h [by 1.3 (0.5, 2.1) cm] while resting in bed. Pain scores while sitting were also significantly greater in ondansetron group at arrival in PACU by 0.6 (99.7% CI: 0.1, 1.0) cm. Thereafter, pain scores did not differ significantly. Median total opioid (tramadol) consumption was 441 [Q1, Q3: 280, 578] mg in the ondansetron group and 412 [309, 574] mg in the placebo group, P=0.95. Ondansetron significantly decreased the analgesic effect of acetaminophen during the initial postoperative period. Our results thus confirm that acetaminophen analgesia is partially mediated by serotonin receptors. However, the reduction was of marginal clinical importance and short-lived. Copyright © 2017 Elsevier Inc. All rights reserved.
Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo
The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting rizatriptan (3.2±1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (prizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p=NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.
Jena, Bhagya Ranjan; Paswan, Anil; Singh, Yashpal; Loha, Sandeep; Singh, Anil Prasad; Rastogi, Virendra
Background: Radiofrequency (RF) is a minimally invasive target-selective technique that has been used with success for many years in the treatment of different pathologies, such as low back pain, trigeminal neuralgia, and others. Aim: The aim of this study is to compare different mode of RF - continuous RF (CRF) versus pulsed RF (PRF) along with steroid in the management of low back pain of discogenic origin. Setting and Design: Prospective, randomized, double-blind trial. Materials and Methods: Forty patients with chronic discogenic low back pain were randomized to receive CRF plus intradiscal triamcinolone 40 mg (Group 1) or to receive PRF plus intradiscal triamcinolone 40 mg (Group 2). Outcome measured includes immediate as well as long-term pain relief using visual analog scale, the Oswestry Disability Index and straight leg raising test. Statistical Analysis: The continuous variables were compared by one-way analysis of variance test. Discrete variables were compared by Fisher's exact test/Chi-square test/Student's t-test, whichever appropriate. The value of P PRF was insignificant. Conclusion: CRF with steroid seems to be better for treatment of chronic discogenic low back pain than PRF with steroid. PMID:27746559
Takenori, A; Ikuhiro, M; Shogo, U; Hiroe, K; Junji, S; Yasutaka, T; Hiroya, K; Miki, N
To determine the immediate pain relief effect of low-level laser therapy on sports injuries in athletes and degree of pain relief by the therapy. Double-blind, randomized, comparative clinical study. Participants were 32 college athletes with motion pain at a defined site. Participants were randomized into two groups in which the tested or placebo laser therapy was administered to determine pain intensity from painful action before and after laser irradiation, using the Modified Numerical Rating Scale. The post-therapeutic Modified Numerical Rating Scale score was subtracted from the pre-therapeutic Modified Numerical Rating Scale score to determine pain intensity difference, and the rate of pain intensity difference to pre-therapeutic Modified Numerical Rating Scale was calculated as pain relief rate. Low-level laser therapy was effective in 75% of the laser group, whereas it was not effective in the placebo group, indicating a significant difference in favor of the laser group (prelief rate was significantly higher in the laser group than in the placebo group (36.94% vs. 8.20%, respectively, prelief rate being 28.74%. Low-level laser therapy provided an immediate pain relief effect, reducing pain by 28.74%. It was effective for pain relief in 75% of participants. Copyright Â© 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Safety and Efficacy of an Oral Inhibitor of the Purinergic Receptor P2X7 in Adult Patients with Moderately to Severely Active Crohn's Disease: A Randomized Placebo-controlled, Double-blind, Phase IIa Study
Eser, Alexander; Colombel, Jean-Frederic; Rutgeerts, Paul; Vermeire, Severine; Vogelsang, Harald; Braddock, Martin; Persson, Tore; Reinisch, Walter
AZD9056 is a selective orally active inhibitor of the purinergic receptor P2X7, which is a key player in the generation and secretion of several proinflammatory cytokines involved in the pathogenesis of Crohn's disease (CD...
Nicholson, Michael L; Pattenden, Clare J.; Barlow, Adam D.; Hunter, James P.; Lee, Gwyn; Hosgood, Sarah A.
Abstract Ischemic conditioning involves the delivery of short cycles of reversible ischemic injury in order to induce protection against subsequent more prolonged ischemia. This randomized controlled trial was designed to determine the safety and efficacy of remote ischemic conditioning (RC) in live donor kidney transplantation. This prospective randomized clinical trial, 80 patients undergoing live donor kidney transplantation were randomly assigned in a 1:1 ratio to either RC or to a contro...
Srinivasan Maheswari G
Full Text Available Abstract Background Pneumonia is a leading cause of children's deaths in developing countries and hinders achievement of the fourth Millennium Development Goal. This goal aims to reduce the under-five mortality rate, by two thirds, between 1990 and 2015. Few studies have examined the impact of zinc adjunct therapy on the outcome of childhood pneumonia. We determined the effect of zinc as adjunct therapy on time to normalization of respiratory rate, temperature and oxygen saturation. We also studied the effect of zinc adjunct therapy on case fatality of severe childhood pneumonia (as a secondary outcome in Mulago Hospital, Uganda. Methods In this double blind, randomized, placebo-controlled clinical trial, 352 children aged 6 to 59 months, with severe pneumonia were randomized to zinc (20 mg for children ≥12 months, and 10 mg for those Results Time to normalization of the respiratory rate, temperature and oxygen saturation was not significantly different between the two arms. Case fatality was 7/176 (4.0% in the zinc group and 21/176 (11.9% in the placebo group: Relative Risk 0.33 (95% CI 0.15 to 0.76. Relative Risk Reduction was 0.67 (95% CI 0.24 to 0.85, while the number needed to treat was 13. Among HIV infected children, case fatality was higher in the placebo (7/27 than in the zinc (0/28 group; RR 0.1 (95% CI 0.0, 1.0. Among 127 HIV uninfected children receiving the placebo, case fatality was 7/127 (5.5%; versus 5/129 (3.9% among HIV uninfected group receiving zinc: RR 0.7 (95% CI 0.2, 2.2. The excess risk of death attributable to the placebo arm (Absolute Risk Reduction or ARR was 8/100 (95% CI: 2/100, 14/100 children. This excess risk was substantially greater among HIV positive children than in HIV negative children (ARR: 26 (95% CI: 9, 42 per 100 versus 2 (95% CI: -4, 7 per 100; P-value for homogeneity of risk differences = 0.006. Conclusion Zinc adjunct therapy for severe pneumonia had no significant effect on time to normalization of
Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus
Full Text Available Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15 and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P<0.001. No significant difference was found when compared with acarbose group (P=0.652. Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P<0.05, without any significant differences compared with acarbose group (P=0.748 and 0.558, resp.. The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76% and 5 of 15 patients in acarbose group (33.33% suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes.
Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension.
Jin, S-M; Park, C-Y; Cho, Y M; Ku, B J; Ahn, C W; Cha, B-S; Min, K W; Sung, Y A; Baik, S H; Lee, K W; Yoon, K-H; Lee, M-K; Park, S W
We aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add-ons to metformin in patients with type 2 diabetes. Patients who were inadequately controlled by metformin were randomized and treated once daily with either lobeglitazone (0.5 mg, n = 128) or pioglitazone (15 mg, n = 125) for 24 weeks, with a 28-week extension trial of lobeglitazone treatment in patients who consented. The primary endpoint was the change in glycated haemoglobin (HbA1c) concentration from baseline to week 24. At week 24, the mean change from baseline in HbA1c was -0.74% for the lobeglitazone group and -0.74% for the pioglitazone group, with a mean difference of 0.01% [95% confidence interval (CI) of difference, -0.16 to 0.18]. The effects of lobeglitazone on lipid variables and the adverse events associated with lobeglitazone were similar to those observed with pioglitazone. Lobeglitazone was not inferior to pioglitazone as an add-on to metformin in terms of their efficacy and safety.
Full Text Available Introduction: Remifentanil, with its rapid activity onset and short duration of action, may be more effective than other opioids for providing hemodynamic stability during obstetric anesthesia. However, there is some evidence of adverse effects on neonatal respiratory function. We investigated maternal and fetal effects of remifentanil during cesarean section surgery. Methods: Eighteen women with singleton term pregnancies, and physical class status of I or II as defined by the American Society of Anesthesia (ASA, who were undergoing general anesthesia for semi-elective cesarean section were randomized into two groups (40 in each group that received either and intravenous bolus of 0.5 µg/kg remifentanil or the same dose of saline as a placebo. Maternal hemodynamic variables and neonatal umbilical artery pH and Apgar score at first and fifth min were evaluated in both groups. Results: Systolic and diastolic blood pressure were significantly lower after tracheal intubation and skin incision in the remifentanil group as compared with the control group (p<0.05. There were no significant differences regarding heart rate between groups at any time (p>0.05. Apgar scores at first and fifth min were not significantly different among groups (p>0.05. No neonate required assisted ventilation or naloxan administration. Conclusion: Remifentanil may be a safe and effective drug for the induction of general anesthesia and surgical stimulation without subsequent neonatal depression.
Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F;
-four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential...
Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial
ZHU Ding-liang; GAO Ping-jin; LIU Shao-wen; Myung Ho Jeong; Michaela Mattheus; Birgit Voelker
Background Hypertension is an important issue in Asia,responsible for up to 66％ of cardiovascular disease cases.This randomized controlled trial subgroup analysis compared telmisartan 80 mg (T80)/hydrochlorothiazide 25 mg (H25) singlepill combination with T80 monotherapy,specifically in Chinese and Korean patients.Methods Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg (T40)/hydrochlorothiazide 12.5 mg (H12.5) combination or T40 monotherapy for one week,before uptitrating the dose to T80/H25 or T80,respectively,for the remaining 6 weeks.The primary endpoint was systolic blood pressure (SBP) mean change from baseline.Secondary endpoints included mean diastolic blood pressure (DBP) change from baseline,and blood pressure (BP) goal achievement.Adverse events were recorded.Results Of a total 888 patients who were treated,efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80.At week 7,mean SBP reductions from baseline were -37.5 mmHg (1 mmHg=0.133 kPa) and-26.9 mmHg in the T80/H25 and T80 groups (adjusted mean difference,-10.6 mmHg; 95％ confidence interval (CO,-15.6 to-5.7).Mean DBP reductions were-19.0 and-14.1 mmHg in the T80/H25 and T80 groups (adjusted mean difference,-4.9 mmHg; 95％ CI,-8.0 to-1.8).In total,56.7％ of patients receiving T80/H25 achieved BP goal (＜140/90 mmHg) compared with 35.2％ receiving T80.SBP goal attainment (＜140 mmHg) and DBP goal attainment (＜90 mmHg) were also higher in the T80/H25 group compared with the T80 group (SBP:69.3％ vs.48.1％; DBP:62.2％ vs.46.3％).A small number of treatment-related adverse events were observed in both T80/H25 (nine patients,6.9％) and T80 monotherapy (two patients,3.6％) groups.Conclusions In Chinese and Korean patients with moderate-to-severe hypertension,treatment with T80/H25 provided large reductions in mean SBP and DBP,and high BP goal attainment rates.This once-daily combination is
BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington disease and baseline cognitive impairment (Mini-Mental State Examination score, 10-26). INTERVENTION Latrepirdine (20 mg) vs matching placebo administered orally 3 times daily for 26 weeks. MAIN OUTCOME MEASURES The co-primary outcome measures were cognition as measured by the change in Mini-Mental State Examination score from baseline to week 26 and global function at week 26 as measured by the Clinician Interview-Based Impression of Change, plus carer interview, which ranges from 1 (marked improvement) to 7 (marked worsening). Secondary efficacy outcome measures included behavior, daily function, motor function, and safety. RESULTS The mean change in Mini-Mental State Examination score among participants randomized to latrepirdine (1.5-point improvement) did not differ significantly from that among participants randomized to placebo (1.3-point improvement) (P=.39). Similarly, the distribution of the Clinician Interview-Based Impression of Change, plus carer interview did not differ significantly among those randomized to latrepirdine compared with placebo (P=.84). No significant treatment effects were detected on the secondary efficacy outcome measures. The incidence of adverse events was similar between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with
Andrew J. Butler
Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.
Butler, Andrew J.; Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.
Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287
Sugimine, S; Saito, S; Araki, T; Yamamoto, K; Obata, H
Conditioned pain modulation (CPM) is widely used to measure endogenous analgesia, and a recent study indicated that drugs that act on endogenous analgesia are more effective in individuals with lower CPM. Recent animal studies have indicated that pregabalin activates endogenous analgesia by stimulating the descending pain inhibitory system. The present study examined whether the analgesic effect of pregabalin is greater in individuals with lower original endogenous analgesia using CPM. Fifty-nine healthy subjects were randomly assigned to either a pregabalin group or a placebo group, and 50 of them completed the study. CPM was measured before and after pregabalin or placebo administration. The correlation of initial CPM to change in CPM was compared between the pregabalin and placebo groups. Initial CPM was significantly correlated with the change in CPM in the pregabalin group (r = -0.73, p < 0.0001) but not in the placebo group (p = 0.56) (difference in correlation coefficients between groups; p = 0.004). Furthermore, the initial CPM significantly affected the change in CPM in the pregabalin group but not in the placebo group (pregabalin group: adj R(2) = 0.51, p < 0.001, y = -0.54x + 2.98; placebo group: p = 0.56, significant difference in regression slopes; p = 0.015). These results indicate that pregabalin has a higher endogenous analgesic effect in individuals with lower original endogenous analgesia. The analgesic effect of pregabalin depends on the original endogenous analgesia status. Its effect on conditioned pain modulation (CPM) was stronger for subjects with lower original endogenous analgesia, suggesting that the mechanism of pregabalin involves the improvement of endogenous analgesia. © 2017 European Pain Federation - EFIC®.
Roos, A; Linn-Rasker, SP; van Domburg, RT; Tijssen, JP; Berghout, A
Background: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. Methods: We conducted a prospective, randomized, double-bl
Smita M Gaikwad; Kanchan R. Rupwate; Bharati A Tendolkar
Background: Postoperative sore throat (POST) is an undesirable outcome of general anesthesia. The aim of the study was to evaluate the effectiveness of benzydamine preoperative gargles in reducing the incidence and severity of POST. Methods: A randomized double blind prospective study involving 200 adult male and female patients was performed to assess the incidence of sore throat, cough and hoarseness of voice following tracheal intubation. The patients were randomly divided into two gro...
McClung, M; Clemmesen, B; Daifotis, A
BACKGROUND: Preventing bone loss associated with menopause and aging and maintaining the normal micro-architecture of bone provide important opportunities for the prevention of osteoporosis and fractures. OBJECTIVE: To determine the safety and efficacy of alendronate, an aminobisphosphonate......, for preventing postmenopausal bone loss. DESIGN: 3-year double-blind, randomized, placebo-controlled trial. SETTING: 15 osteoporosis centers throughout the world. PARTICIPANTS: 447 women who had recently experienced menopause (6 to 36 months before study entry). INTERVENTION: Participants were randomly assigned...
Full Text Available BACKGROUND: Pioglitazone, an oral anti-diabetic that stimulates the PPAR-gamma transcription factor, increased survival of mice with amyotrophic lateral sclerosis (ALS. METHODS/PRINCIPAL FINDINGS: We performed a phase II, double blind, multicentre, placebo controlled trial of pioglitazone in ALS patients under riluzole. 219 patients were randomly assigned to receive 45 mg/day of pioglitazone or placebo (one: one allocation ratio. The primary endpoint was survival. Secondary endpoints included incidence of non-invasive ventilation and tracheotomy, and slopes of ALS-FRS, slow vital capacity, and quality of life as assessed using EUROQoL EQ-5D. The study was conducted under a two-stage group sequential test, allowing to stop for futility or superiority after interim analysis. Shortly after interim analysis, 30 patients under pioglitazone and 24 patients under placebo had died. The trial was stopped for futility; the hazard ratio for primary endpoint was 1.21 (95% CI: 0.71-2.07, p = 0.48. Secondary endpoints were not modified by pioglitazone treatment. Pioglitazone was well tolerated. CONCLUSION/SIGNIFICANCE: Pioglitazone has no beneficial effects on the survival of ALS patients as add-on therapy to riluzole. TRIAL REGISTRATION: Clinicaltrials.gov NCT00690118.
Adachi, Yushi U; Makita, Koshi
Background Droperidol (DHB) reportedly reduces the dose of propofol needed to achieve hypnosis when anesthesia is induced and decreases the bispectral index (BIS) in propofol-sedated patients during spinal anesthesia. We reported previously that supplemental DHB decreased the BIS after the administration of sevoflurane and remifentanil. This study investigated the effect of DHB on desflurane (DES) consumption in a clinical setting. Methods We conducted a prospective, randomized double-blinded study of 35 women with American Society of Anesthesiologist physical status I or II who underwent a mastectomy. Either DHB (20 µg/kg) or a saline placebo was administered to patients 30 min after the induction of anesthesia. A blinded anesthesiologist maintained a BIS value of 50 during anesthesia by modulating inhaled DES concentrations that changed 0.5% at 2.5 min intervals and maintained analgesia via the constant administration of remifentanil by referring to vital signs. The primary endpoint was the effect of DHB on DES consumption. The secondary endpoints included blood circulatory parameters, the time from the end of surgery to extubation, and discharge time between the groups. Results The characteristics of the patients did not differ between the groups. The DHB group used a mean of 27.2 ± 6.0 ml of DES compared with 41.4 ± 9.5 ml by the placebo group (P effects.
Full Text Available Background: The benefit of prophylactic combination therapy using crystalloid and colloid preload with ephedrine has not been cleared to prevent maternal hypotension after spinal anesthesia at cesarean delivery. This study evaluated the efficacy of three combinational methods to prevent hypotension following spinal anesthesia. Materials and Methods: In this prospective double blind trial, 150 candidates of elective cesarean delivery under spinal anesthesia were randomly allocated to three treatment groups; 1---Ringer′s Lactate (RL solution (15 ml/kg plus Hemaxel (7 ml/kg preload, 2---RL solution (15 ml/kg preload plus ephedrine (15 mg, IV, bolus, 3---Hemaxel (7 ml/kg preload plus ephedrine (15 mg, IV, bolus. Maternal hemodynamic changes during 60 min after spinal injection, nausea/vomiting, and neonatal condition were compared among the groups. Results: The cumulative incidence of hypotension was 44%, 40%, and 46% in groups 1 to 3, respectively. There were not significant differences in supplementary ephedrine requirement among groups which received or among groups which did not receive prophylactic ephedrine. Groups were not different in the incidence of hypertension and nausea or vomiting. There were no significant differences among groups in Apgar scores at 1 or 5 min and umbilical artery PH. Conclusion: Combination of preventive methods decreased the occurrence of hypotension following spinal anesthesia to an acceptable level. Overall, the most effective method was a combination of crystalloid preload with ephedrine.
Full Text Available The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS, which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology.Double-blind randomized clinical trial of gluten vs placebo rechallenge.>18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day and 7 placebo. Clinical symptoms, quality of life (GIQLI, and presence of gamma/delta+ cells and transglutaminase deposits were evaluated.91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01. Clinical scores and GIQLI worsened after gluten but not after placebo (p<0.01. The presence of coeliac tissue markers at baseline biopsy on a gluten-free diet allowed classifying 9 out of the 18 (50% patients as having probable 'coeliac lite' disease.This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet.ClinicalTrials.gov NCT02472704.
Schloerb, P R; Amare, M
In a paper by Ziegler et al (Ann Intern Med 116: 821-828, 1992), total parenteral nutrition supplemented with L-glutamine (TPN/GLN) was reported beneficial in patients receiving bone marrow transplantation (BMT) for hematologic malignancies. By using a similar protocol, we studied 29 patients with both hematologic malignancies and solid tumors, and with both allogeneic and autologous BMTs. In a double-blind, randomized approach, patients were given isocaloric, isonitrogenous TPN after BMT until they consumed 50% of their required diet orally. Total body water and extracellular water were measured before and after TPN in 10 patients. Total body water increased in patients receiving standard TPN and decreased significantly in patients receiving TPN/GLN. Length of hospital stay after BMT was significantly (5.8 days) less in patients receiving TPN/GLN. Incidence of positive bacterial cultures, clinical infections, and mortality did not differ significantly between the two groups. When the groups were subdivided into patients with hematologic malignancies and those with solid tumors, there were no significant differences in the above variables associated with TPN/GLN. In 17 of 30 additional hospitalized patients receiving standard TPN, substitution of TPN/GLN did not have discernible clinical or laboratory effects but appeared to be safe. Inclusion of patients with solid tumors and a higher mortality in our patients may have obscured beneficial effects of TPN/GLN observed by others.
Ahmadi-Abhari Seyed Ali
Full Text Available Abstract Background Results of preclinical studies suggest that the GABAB receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence. Methods A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. Secondary outcome measures included opioids and alcohol use according to urinalysis and self-report ratings, intensity of opioid craving assessed with a visual analogue scale, opioid withdrawal symptoms as measured by the Short Opiate Withdrawal Scale and depression scores on the Hamilton inventory. Results Treatment retention was significantly higher in the baclofen group. Baclofen also showed a significant superiority over placebo in terms of opiate withdrawal syndrome and depressive symptoms. Non-significant, but generally favorable responses were seen in the baclofen group with other outcome measures including intensity of opioid craving and self-reported opioid and alcohol use. However, no significant difference was seen in the rates of opioid-positive urine tests. Additionally, the drug side effects of the two groups were not significantly different. Conclusion The results support further study of baclofen in the maintenance treatment of opioid dependence.
Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif
The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.
Dmochowski, Roger R; Peters, Kenneth M; Morrow, Jon D; Guan, Zhonghong; Gong, Jason; Sun, Franklin; Siami, Paul; Staskin, David R
To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB). In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo). Subjects completed 3-day bladder diaries, Patient Perception of Bladder Condition, and Urgency Perception Scale at baseline and weeks 2, 6, and 12 as well as OAB Questionnaire at baseline and week 12. Of 883 subjects, 63% and 73% of the fesoterodine (n = 438) and placebo (n = 445) groups, respectively, opted for dose escalation. Week 12 improvements from baseline in total micturitions, urgency episodes, urgency urinary incontinence episodes, frequency-urgency sum, and all OAB Questionnaire scales and domains, but not nocturnal micturitions or nocturnal urgency episodes, were significantly greater with fesoterodine than placebo (all P fesoterodine had improved Patient Perception of Bladder Condition and Urgency Perception Scale scores at weeks 2, 6, and 12 (P fesoterodine, 26%; placebo, 8%) and constipation (fesoterodine, 11%; placebo, 6%) were the most common adverse events. In both groups, 87% of the subjects completed the trial; 8% and 5% of the fesoterodine and placebo groups, respectively, discontinued because of an adverse event. Flexible-dose fesoterodine was efficacious and generally well tolerated for treatment of OAB symptoms. 2010 Elsevier Inc. All rights reserved.
C.-Y. Oliver Chen
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.
Kreisler, M B; Haj, H Al; Noroozi, N; Willershausen, B d'Hoedt
The aim of the study was to evaluate the effect of low level laser application on postoperative pain after endodontic surgery in a double blind, randomized clinical study. Fifty-two healthy adults undergoing endodontic surgery were included into the study. Subsequently to suturing, 26 patients had the operation site treated with an 809 nm-GaAlAs-laser (oralaser voxx, Oralia GmbH, Konstanz, Germany) at a power output of 50 mW and an irradiation time of 150 s. Laser treatment was simulated in further 26 patients. Patients were instructed to evaluate their postoperative pain on 7 days after surgery by means of a visual analogue scale (VAS). The results revealed that the pain level in the laser group was lower than in the placebo group throughout the 7 day follow-up period. The differences, however, were significant only on the first postoperative day (Mann-Whitney U-test, p<0.05). Low level laser therapy can be beneficial for the reduction of postoperative pain. Its clinical efficiency and applicability with regard to endodontic surgery, however require further investigation. This is in particular true for the optimal energy dosage and the number of laser treatments needed after surgery.
Scholey, Andrew; Benson, Sarah; Gibbs, Amy; Perry, Naomi; Sarris, Jerome; Murray, Greg
Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality. PMID:28218661
Balighi, K; Ghodsi, S Z; Daneshpazhooh, M; Ghale-Baghi, S; Nasimi, M; Azizpour, A
Seborrheic dermatitis (SD) is a chronic dermatitis with periods of remission and relapse that requires long-term treatment. We compared the efficacy and safety of treatment with sertaconazole with standard corticosteroid medications in adults with facial SD. In this double-blind, randomized controlled trial, 60 patients with a diagnosis of SD were enrolled. Patients were instructed to apply either sertaconazole 2% cream (30 patients) or hydrocortisone 1% cream (30 patients) twice daily to the affected area of the face. The severity of facial SD was assessed at 0, 2, and 4 weeks of treatment. Secondary efficacy measures included patient assessment of seborrhea, adverse events, and improvement percentage (IP). SD lesions cleared significantly (p .05). Both treatments resulted in significant improvement of SD lesions and the rate of adverse events was similar in both groups. The IP was higher for treatment with hydrocortisone in Week 2 and similar in both groups at the end of the study. Limitations include the small number of patients who were recruited for this study and the lack of evaluation of time to relapse. Treatment with topical sertaconazole may be regarded as a substitute for topical corticosteroid medications due to the fewer adverse events and similar efficacy.
Lal, Niharika Ranjan; Sil, Amrita; Gayen, Tirthankar; Bandyopadhyay, Debabrata; Das, Nilay Kanti
In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Forty-eight patients with cutaneous warts (male: female=32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P=0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50±13.88) than in the control group (10.04±5.80) from 8 weeks onwards (P=0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.
Chen, C.-Y. Oliver; Rasmussen, Helen; Kamil, Alison; Du, Peng; Blumberg, Jeffrey B.
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. PMID:28208806
Full Text Available The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14–65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001. The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.
de Oliveira, Gilvandro Lins; Serralheiro, Fernando Cesar; Fonseca, Fernando Luiz Affonso; Ribeiro, Onésimo Duarte; Adami, Fernando; Christofolini, Denise Maria; Bianco, Bianca; Barbosa, Caio Parente
ABSTRACT Objective: 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. Methods: 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. Results: 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; p<0.001), and lower mean of hemodynamic parameters in the MRPB Group (p<0.05). Conclusion: Anesthesia with fentanyl and propofol as well as with midazolam, remifentanil, and paracervical block offered satisfactory anesthetic conditions when performing assisted reproduction procedures, providing comfort for the patient and physician. PMID:27759816
Caremans, Jeroen; Hamans, Evert; Muylle, Ludo; Van de Heyning, Paul; Van Rompaey, Vincent
Allograft tympano-ossicular systems (ATOS) have proven their use over many decades in tympanoplasty and reconstruction after resection of cholesteatoma. The transcranial bone plug technique has been used in the past 50 years to procure en bloc ATOS (tympanic membrane with malleus, incus and stapes attached). Recently, our group reported the feasibility of the endoscopic procurement technique. The aim of this study was to assess whether clinical outcome is equivalent in ATOS acquired by using the endoscopic procurement technique compared to ATOS acquired by using the transcranial technique. A double-blind randomized controlled audit was performed in a tertiary referral center in patients that underwent allograft tympanoplasty because of chronic otitis media with and without cholesteatoma. Allograft epithelialisation was evaluated at the short-term postoperative visit by microscopic examination. Failures were reported if reperforation was observed. Fifty patients underwent allograft tympanoplasty: 34 received endoscopically procured ATOS and 16 received transcranially procured ATOS. One failed case was observed, in the endoscopic procurement group. We did not observe a statistically significant difference between the two groups in failure rate. This study demonstrates equivalence of the clinical outcome of allograft tympanoplasty using either endoscopic or transcranial procured ATOS and therefore indicates that the endoscopic technique can be considered the new standard procurement technique. Especially because the endoscopic procurement technique has several advantages compared to the former transcranial procurement technique: it avoids risk of prion transmission and it is faster while lacking any noticeable incision.
Lopez Jornet, P; Aznar-Cayuela, C
The purpose of this study was to compare the clinical therapeutic efficacy of topical applications of chamomile vs. a placebo for treating oral lichen planus (OLP). This double-blind study, randomly divided 60 patients with OLP into two groups, 30 treated with 2% Chamaemelum nobile gel (0.5 mL/3 times a day) and 30 treated with a placebo (Trial Registration NCT02421770). A visual analogue scale was used to rate pain, itching and burning sensation, and Thongprasom Index, the Oral Health Impact Profile 14 (OHIP-14) and the Hospital Anxiety-Depression Scale. Patients were evaluated at baseline and after 4 weeks of treatment. Patients treated with chamomile showed significant improvements after 4 weeks for pain (P < 0.001), burning sensation (P < 0.001), itching (P = 0.011), OHIP-14 (P < 0.001) and Thongprasom index (P = 0.001); 92% of patients treated with chamomile showed a partial or total response, while only five subjects (17%) in the placebo group showed any improvement. The topical application of 2% chamomile gel is an effective treatment for OLP. © 2016 European Academy of Dermatology and Venereology.
Alessandra S. Braz
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.
Villada, G; Zetlaoui, J; Revuz, J
EMLA cream is a topical formulation based upon the eutectic mixture of lidocaine and prilocaine and is used in clinical settings to produce local analgesia after application under occlusive dressing. A blanching reaction has been reported to occur locally after application, but it is not clear whether this reaction is caused by the anesthetic mixture, by the vehicle or the occlusion. We studied this blanching reaction in 50 healthy volunteers in a double-blind randomized assay: EMLA versus placebo, under occlusive dressing for 1 h, each subject being his own control. We found 33 cases (66%) of blanching after application of EMLA cream versus 3 cases (6%) after placebo, this difference being highly significant. Blanching was observed without delay, after removal of the dressing, and was very transient, disappearing in less than 3 h in all cases. We thus conclude that the blanching reaction is (1) frequent but very transient, and (2) determined by the anesthetic mixture included in EMLA cream and not by the vehicle alone, nor by the occlusion, since it is not found with the placebo. The precise mechanism of this reaction is unknown.
Quintana Hernández, Domingo Jesús; Miró Barrachina, María Teresa; Ibáñez Fernández, Ignacio; del Pino, Angelo Santana; García Rodríguez, Javie r; Hernández, Jaime Rojas
The purpose of this research was to assess effects of a mindfulness based neuropsychological intervention on the clinical course of Alzheimer's disease. A two year randomized and double blind clinical trial was conducted on 127 probable Alzheimer's disease patients, according to NINCDS-ADRDA scale. Patients were grouped into three experimental groups (cognitive stimulation, progressive muscular relaxation, and mindfulness) plus a control group. All participants were receiving donepezil. Cognitive skills were assessed with CAMCOG and MMSE, functional area with RDRS-2, and NPI was used for psychopathology screening. Three treatment sessions per week were carried out for two years, and follow up measurements were taken every six months. The global cognitive function, functionality and behavioral disorders measurements indicated that patients from the experimental group based on mindfulness were stable during the two years, while patients from the control group, as well as the other experimental groups, showed a mild but significant worsening of their mental capacities. The mindfulness based neuropsychological program showed better cognitive and functional stability, as well as significant improvement in the psychopathological condition of mild to moderate Alzheimer' patients. These results support the idea that a mindfulness based intervention can produce a clinically relevant improvement in the treatment of dementia. More research is needed to confirm these data. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.
Fock, K M; Kang, J Y; Ng, H S; Ng, T M; Gwee, K A; Lim, C C
Roxatidine acetate, a new H2 receptor antagonist, was compared with ranitidine in the treatment of duodenal ulcers in a double-blind multicentre study. Eighty-four patients with endoscopically proven duodenal ulcer were randomized to receive 150 mg roxatidine acetate or 300 mg ranitidine at bedtime. Repeat endoscopy was performed after 4 weeks (25-33 days) and if the ulcer had not healed, another endoscopy was performed after a further 4 weeks of treatment. Using per protocol analysis 73.6% of ulcers treated with roxatidine healed at 4 weeks compared to 72.2% of ulcers treated with ranitidine (P = NS). The healing rates at 8 weeks were 92% with roxatidine and 83.3% with ranitidine (P = NS). Using equivalence tests, the healing rate of roxatidine was found to be equivalent to that of ranitidine within a 20% region. Roxatidine users took significantly less antacids than ranitidine users (P roxatidine or ranitidine. Roxatidine is a safe effective drug in the treatment of duodenal ulcers with a healing rate comparable to that of ranitidine.
van Nierop, Lotte E; Slottje, Pauline; Kingma, Herman; Kromhout, Hans
We assessed postural body sway performance after exposure to movement induced time-varying magnetic fields in the static magnetic stray field in front of a 7 Tesla (T) magnetic resonance imaging scanner. Using a double blind randomized crossover design, 30 healthy volunteers performed two balance tasks (i.e., standing with eyes closed and feet in parallel and then in tandem position) after standardized head movements in a sham, low exposure (on average 0.24 T static magnetic stray field and 0.49 T·s(-1) time-varying magnetic field) and high exposure condition (0.37 T and 0.70 T·s(-1)). Personal exposure to static magnetic stray fields and time-varying magnetic fields was measured with a personal dosimeter. Postural body sway was expressed in sway path, area, and velocity. Mixed-effects model regression analysis showed that postural body sway in the parallel task was negatively affected (P static magnetic stray field and time-varying magnetic field exposure. In addition, practical safety implications of these findings, e.g., for surgeons and others working near magnetic resonance imaging scanners need to be investigated.
Full Text Available Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6, in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171 were randomized (1:1 to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.
Melka, A; Tekle-Haimanot, R; Lambien, F
The efficacy and safety of oral Tolperisone HCL was evaluated in double blind, placebo-controlled, randomized trial in 72 patients with neurolathyrism in stages I, II, and III of the disease at Kolla Duba Health Centre of Dembia District of North Gondar between January and April 1995. Taken orally daily for 12 weeks, tolperisone HCL (Mydocalm) in a dose of 150 milligrams (mgs) twice daily significantly improved subjective complaints such as muscle cramps, heaviness of the legs, startle attacks, flexor spasms and repeated falls. An overall subjective improvement was observed in 75% of the patients on tolperisone HCL and 39% of the placebo group (P = 0.002). When objectively assessed spastic muscle tone in the abductors, stiffness of Achilles and spontaneous ankle clonus were significantly reduced in tolperisone HCL group (P values = 0.001, 0.04, and 0.0001, respectively). Walking ability and speed of walking was also significantly improved. The drug is most effective in relieving symptoms of stage I and stage II disease. Some adverse effects like muscle pain, generalized body weakness and dizziness were recorded in patients taking the drug but all were minor and self limited, none requiring discontinuation of treatment. It is concluded that tolperisone is a well tolerated and efficacious drug for symptomatic treatment of neurolathyrism.
Olguin-García, María Guadalupe; Jurado-Santa Cruz, Fermín; Peralta-Pedrero, María Luisa; Morales-Sánchez, Martha Alejandra
Abstract Background: Recalcitrant facial flat warts are caused by human papillomavirus and may persist for years despite treatment. Isotretinoin has demonstrated benefits in the treatment of recalcitrant, genital and common warts, but placebo-controlled trials have not been performed. To determine whether isotretinoin is safe and effective for recalcitrant facial flat warts. Isotretinoin 30 mg/day or placebo was administered to 16 and 15 patients, respectively, in double-blind, randomized fashion for 12 weeks. Cutaneous lesions were assessed and adverse events including serologic and ophthalmologic changes were recorded. It is considered that warts were recalcitrant if the patient was treated for at least 3 years with at least three of the following options: retinoids, 5-fluorouracil, imiquimod and cryotherapy using liquid nitrogen. Each patient in the istotretinoin group showed complete clearance of all flat warts, while none of the patients in the placebo group showed any improvement (p=0.0001). The most frequent adverse event was cheilitis. There were no statistically significant changes in the laboratory findings. The study design does not permit complete blinding of the dermatologist who can easily recognize the adverse effects of isotretinoin. The clinical findings, however, were so dramatic that this would not have impacted the findings. Another limitation of the study is a lack of follow-up to assess for recurrence after the drug was discontinued. Isotretinoin is an effective treatment for recalcitrant flat facial warts with a well-known, manageable safety profile.
Tang, Yu-Ping; Li, Peng-Gao; Kondo, Miwako; Ji, Hong-Ping; Kou, Yan; Ou, Boxin
The effect of a mangosteen product containing multivitamins and essential minerals was tested on immune function and well-being in healthy adults. A randomized, double blinded, placebo-controlled study was conducted in 59 healthy human subjects (40-60 years old). Changes from baseline immune function were measured after a 30-day consumption of the mangosteen product and the placebo. The subjects' self-appraisal of their health status was also surveyed. A xanthone-rich mangosteen product intake increased mean values for peripheral T-helper cell frequency (P = .020) and reduced the serum C-reactive protein concentration (P = .014). Increases in peripheral CD4/CD8 double-positive (DP) T-cell frequency and serum complement C3, C4, and interleukin (IL)-1alpha concentrations were significantly higher in the experimental group than in the placebo group (DP, P = .038; C3, P = .017; C4, P = .031; IL-1alpha, P = .006). At the end of study, serum IL-1alpha and IL-1beta concentrations in the study group were significantly higher than that in the placebo group (IL-1alpha, P = .033; IL-1beta, P = .04). Furthermore, more participants in the experimental group reported greatly improved overall health status compared with participants receiving placebo (P = .001). The results indicated that the intake of an antioxidant-rich product significantly enhanced immune responses and improved the subject's self-appraisal on his or her overall health status.
Waldinger, M D; Zwinderman, A H; Olivier, B
Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors--paroxetine and sertraline--and the 5-HT2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p < 0.001 and p = 0.024, respectively) from placebo, but the nefazodone group did not (p = 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone.
Smith, David; Cheek, Hugh; Denson, Brenda; Pruitt, Christopher M
Intranasal (IN) midazolam is a commonly prescribed medication for pediatric sedation and anxiolysis. One of its most frequently encountered adverse effects is discomfort with administration. While it has been proposed that premedicating with lidocaine reduces this undesirable consequence, this combination has not been thoroughly researched. The objective of our study was to assess whether topical lidocaine lessens the discomfort associated with IN midazolam administration. This was a double-blind, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department. Children 6-12 years of age who were receiving IN midazolam for procedural sedation received either 4% lidocaine or 0.9% saline (placebo) via mucosal atomizer. Subjects were subsequently given IN midazolam in a similar fashion and then rated their discomfort using the Wong-Baker FACES Pain Rating Scale (WBS). The primary endpoint of WBS score was analyzed with a two-tailed Mann-Whitney U-test, with p midazolam administration (median WBS = 3, interquartile range [IQR] = 0-6) than those who received placebo (median WBS = 8, IQR = 2-9; p = 0.006). Premedication with topical lidocaine reduces the discomfort associated with administration of IN midazolam (ClinicalTrials.gov, NCT02396537). © 2016 by the Society for Academic Emergency Medicine.
Odabaş, Mesut Enes; Cınar, Cagdas; Deveci, Ceren; Alaçam, Alev
The purpose of this study was to evaluate and compare the reaction to pain during local injection and duration of numbness of soft tissue with 4% articaine or 3% mepivacaine in children. A randomized, double-blind, split-mouth study was used with a sample of 50 7- to 13-year-old children (25 boys and 25 girls; mean age=11.3 years old) that had similar operative procedure needs in symmetric primary teeth. The modified behavioral pain scale was used for objective evaluation of the children. The sensation after injection and treatment was evaluated using the Wong-Baker FACES pain rating scale. Parents were instructed to ask the child and to record the time when feeling of numbness disappeared. The duration of soft tissue was longer for articaine (140.69 ± 49.76 minutes) than for mepivacaine (117.52 ± 42.99 minutes). No difference regarding efficacy of the anesthesia was observed. No statistically significant difference was found in blood pressure, heart rate, or oxygen saturation in all evaluation periods for both solutions. The feeling after treatment was similar for the 2 solutions. Four percent articaine with 1:200,000 and 3% mepivacaine presented the same efficacy, and children displayed the same behavior during injection.
Colombini, Bella L; Modena, Karin C S; Calvo, Adriana M; Sakai, Vivien T; Giglio, Fernando P M; Dionísio, Thiago J; Trindade, Alceu S; Lauris, José R P; Santos, Carlos F
Comparison of the clinical efficacy of 4% articaine in relation to 2% mepivacaine, both with 1:100,000 epinephrine, in the prevention of postoperative pain after lower third molar removal. Twenty patients underwent removal of bilateral lower third molars under local anesthesia (articaine or mepivacaine) in 2 separate appointments, in a double-blind, randomized, and crossed manner. Objective and subjective parameters were recorded for paired comparison of postoperative courses. Duration of analgesia provided by articaine and mepivacaine was 198.00 +/- 25.86, and 125.40 +/- 13.96 min, respectively (P = .02), whereas the duration of anesthesia was 273.80 +/- 15.94 and 216.85 +/- 20.15 min, respectively (P = .06). Both solutions exerted no important effects upon arterial pressure, heart rate, or oxygen saturation (P > .05). Articaine provides a longer period of analgesic effect and a tendency for a longer period of anesthesia as compared to mepivacaine. The presence of a vasoconstrictor agent in local anesthetic solutions does not seem to influence hemodynamic parameters during lower third molar removal in healthy subjects.
Hersh, Elliot V; Lindemeyer, Rochelle; Berg, Joel H; Casamassimo, Paul S; Chin, Judith; Marberger, Adam; Lin, Brent P; Hutcheson, Matthew C; Moore, Paul A; Group, Pediatric Soft Tissue Anesthesia Recovery
The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of phentolamine mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only. One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period. There were no significant differences in adverse events between the phentolamine and sham injections. Compared to sham, phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (Pfive-year-olds; in four- to five-year-olds, a statistically significant more rapid recovery of lip sensation compared to sham injections was determined.
Jun Haeng Lee; Soo Teik Lee; Eun Hyun Lee; Jong Chul Rhee; Jae J Kim; Ki-Baik Hahm; Dong Ho Lee; Nayoung Kim; Sung Kook Kim; Jong Jae Park; Seok Reyol Choi; Jong Hun Lee
AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia.METHODS: We performed a multi-center, prospective,randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-Ⅱ criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients),400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3,14, and 28 d after initiating the treatment.RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment,the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P ＞ 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups.There was no clinically significant adverse event in both groups.CONCLUSION: In patients with functional dyspepsia,ecabet sodium has similar clinical efficacy with cimetidine.
Beaulieu, Karen; Beland, Patricia; Pinard, Marilee; Handfield, Guilène; Handfield, Nicole; Goffaux, Philippe; Corriveau, Hélène; Léonard, Guillaume
Previous studies suggested that pulsed electromagnetic field (PEMF) therapy can decrease pain. To date, however, it remains difficult to determine whether the analgesic effect observed in patients are attributable to a direct effect of PEMF on pain or to an indirect effect of PEMF on inflammation and healing. In the present study, we used an experimental pain paradigm to evaluate the direct effect of PEMF on pain intensity, pain unpleasantness, and temporal summation of pain. Twenty-four healthy subjects (mean age 22 ± 2 years; 9 males) participated in the experiment. Both real and sham PEMF were administered to every participant using a randomized, double-blind, cross-over design. For each visit, PEMF was applied for 10 minutes on the right forearm using a portable device. Experimental pain was evoked before (baseline) and after PEMF with a 9 cm(2) Pelletier-type thermode, applied on the right forearm (120 s stimulation; temperature individually adjusted to produce moderate baseline pain). Pain intensity and unpleasantness were evaluated using a 0-100 numerical pain rating scale. Temporal summation was evaluated by comparing pain intensity ratings obtained at the end of tonic nociceptive stimulation (120 s) with pain intensity ratings obtained after 60 s of stimulation. When compared to baseline, there was no change in pain intensity and unpleasantness following the application of real or sham PEMF. PEMF did not affect temporal summation. The present observations suggest that PEMF does not directly influence heat pain perception in healthy individuals.
Combination therapy for erectile dysfunction: a randomized, double blind, unblinded active-controlled, cross-over study of the pharmacodynamics and safety of combined oral formulations of apomorphine hydrochloride, phentolamine mesylate and papaverine hydrochloride in men with moderate to severe erectile dysfunction.
Lammers, P I; Rubio-Aurioles, E; Castell, R; Castaneda, J; Ponce de Leon, R; Hurley, D; Lipezker, M; Loehr, L A; Lowrey, F
Oral therapy has become first line treatment for patients with mild to moderate erectile dysfunction (ED). Studies have shown that sildenafil may not be effective in all patients, and has been associated with a variety of adverse effects and an adverse interaction with nitrates and inhibitors of cytochrome P450 enzymes. The objective was to compare the efficacy and safety of three different oral combinations with the highest dose of sildenafil in men with moderate to severe ED. Randomized, double blind, unblinded active-controlled, Phase II study was carried out at three sites in Mexico. After a 4-week placebo run-in period, patients received all four of the following treatments using a 4-way cross-over design: 40 mg phentolamine (PM) +6 mg apomorphine (Apo); 40 mg PM +150 mg papaverine (Pap); 40 mg PM +6 mg Apo +150 mg Pap (Tricombo); 100 mg sildenafil (SC). With the exception of sildenafil tablets, all study medication was blinded. Moderate to severe ED was defined as a less than 50% vaginal penetration success rate during the placebo run-in period. A total of 44 patients were enrolled, of whom 36 completed all four treatment periods. All treatments produced a significant effect in primary efficacy variable (Sexual Encounter Profile) compared to baseline, however, no statistically significant differences were found between treatments. A significant period effect was observed. Also, the four treatments were found not to differ significantly in five out of six secondary efficacy variables. The lowest incidence of treatment-related adverse events (AE) occurred in the 40 mg PM +6 mg Apo group (9.8%), followed by 100 mg SC (15%), and the other two combinations (16.7 and 17.5%, respectively). Nasocongestion and headache were the most frequently reported AE. An oral combination of vasoactive agents may provide an alternative approach to sildenafil. Based on these results a combination of phentolamine and apomorphine warrants further clinical investigation.
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, randomize
DHA-enriched fish oil upregulates cyclin-dependent kinase inhibitor 2A (P16(INK)) expression and downregulates telomerase activity without modulating effects of PPARγ Pro12Ala polymorphism in type 2 diabetic patients: A randomized, double-blind, placebo-controlled clinical trial.
Toupchian, Omid; Sotoudeh, Gity; Mansoori, Anahita; Abdollahi, Shima; Ali Keshavarz, Seyyed; Djalali, Mahmoud; Nasli-Esfahani, Ensieh; Alvandi, Ehsan; Chahardoli, Reza; Koohdani, Fariba
The present study investigated the effects of docosahexaenoic acid (DHA)-enriched fish oil supplement on telomerase activity, mRNA expression of P16(INK), IL-6, and TNF-α considering Pro12Ala polymorphism in the PPARγ gene. In this double-blind randomized controlled trial, 72 PPARγ Pro12Ala polymorphism genotyped type 2 diabetic patients aged 30-70 years were randomly assigned to receive 2.4 gr of DHA-enriched fish oil or a placebo for 8 weeks. Genotyping of the Pro12Ala polymorphism in the PPARγ gene was assessed using polymerase chain reaction-restriction length polymorphism (PCR-RFLP), telomerase activity in the peripheral blood mononuclear cell (PBMC) was measured using PCR-ELISA based on the telomeric repeat amplification protocol (TRAP), and changes in the mRNA expression of P16, IL-6, and TNF-α were measured using real-time quantitative reverse transcription-polymerase chain reaction (RT-PCR). In the DHA group, telomerase activity was decreased (p = 0.001) during the intervention. In addition, between-group comparisons showed significant differences in the changes in telomerase activity (p = 0.003) and P16 mRNA expression (p = 0.028) and non-significant differences in TNF-α and IL-6 mRNA expression. The gene*DHA interaction could not affect changes in P16, IL-6, or TNF-α mRNA expression or in telomerase activity in PBMC. Short-time DHA-enriched fish oil supplementation caused increased levels of P16 expression and a decline in telomerase activity compared with the control group without modulating the effects of Pro12Ala polymorphism on the PPARγ gene. Because of the positive correlation between P16 activity and cellular senescence, the possibility of senescence stimulation by DHA is proposed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Nicholson, Michael L; Pattenden, Clare J; Barlow, Adam D; Hunter, James P; Lee, Gwyn; Hosgood, Sarah A
Ischemic conditioning involves the delivery of short cycles of reversible ischemic injury in order to induce protection against subsequent more prolonged ischemia. This randomized controlled trial was designed to determine the safety and efficacy of remote ischemic conditioning (RC) in live donor kidney transplantation.This prospective randomized clinical trial, 80 patients undergoing live donor kidney transplantation were randomly assigned in a 1:1 ratio to either RC or to a control group. RC consisted of cycles of lower limb ischemia induced by an arterial tourniquet cuff placed around the patient's thigh. In the RC treatment group, the cuff was inflated to 200 mm Hg or systolic pressure +25 mm Hg for 4 cycles of 5 min ischemia followed by 5 min reperfusion. In the control group, the blood pressure cuff was inflated to 25 mm Hg. Patients and medical staff were blinded to treatment allocation. The primary end-point was renal function measured by estimated glomerular filtration rate (eGFR) at 1 and 3 months posttransplant.Donor and recipient demographics were similar in both groups (P protocol described here, did not improve renal function after live donor kidney transplantation.
Dettenkofer, M; Wilson, C; Gratwohl, A; Schmoor, C; Bertz, H; Frei, R; Heim, D; Luft, D; Schulz, S; Widmer, A F
To compare the efficacy of two commercially available, alcohol-based antiseptic solutions for preparation and care of central venous catheter (CVC) insertion sites, with and without octenidine dihydrochloride, a double-blind, randomized, controlled trial was undertaken in the haematology units and in one surgical unit of two university hospitals. Adult patients with a non-tunnelled CVC were randomly assigned to two different skin disinfection regimens at the insertion site: 0.1% octenidine with 30% 1-propanol and 45% 2-propanol, and as control 74% ethanol with 10% 2-propanol. Endpoints were (i) skin colonization at the insertion site; (ii) positive culture from the catheter tip (> or = 15 CFU); and (iii) occurrence of CVC-associated bloodstream infection (defined according to criteria set by the CDC). Four hundred patients with inserted CVC were enrolled from May 2002 through April 2005. Both groups were similar in respect of patient characteristics and co-morbidities. Skin colonization at the CVC insertion site during the first 10 days was significantly reduced by octenidine treatment (relative difference octenidine vs. control: 0.21; 95%CI: 0.11-0.39, p octenidine group (7.9%) than in the control group (17.8%): OR = 0.39 (95%CI: 0.20-0.80, p 0.009). Patients treated with octenidine had a non-significant reduction in catheter-associated bloodstream infections (4.1% vs. 8.3%; OR = 0.44; 95%CI: 0.18-1.08, p 0.081). Side effects were similar in both groups. This randomized controlled trial supports the results of two observational studies demonstrating octenidine in alcoholic solution to be a better option than alcohol alone for the prevention of CVC-associated infections.
Full Text Available Sutherlandia frutescens (L. R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant's safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL.In Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm.S. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant was greater in the S. frutescens arm: mean (SD 5.0 (5.5 vs. 9.0 (12.7 days (p = 0.045, attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT.A possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified.ClinicalTrials.gov NCT00549523.
Full Text Available Many patients experience pain and discomfort after colonoscopy. Carbon dioxide (CO2 can reduce periprocedural pain although air insufflation remained the standard procedure. The objective of this double-blinded, randomized controlled trial was to evaluate whether CO2 insufflation does decrease pain and bloating during and after colonoscopy compared to room air. Methods. 219 consecutive patients undergoing colonoscopy were randomized to either CO2 or air insufflation. Propofol was used in all patients for sedation. Transcutaneous CO2 was continuously measured with a capnograph as a safety parameter. Pain, bloating, and overall satisfaction were assessed at regular intervals before and after the procedure. Results(data are mean ±SD. 110 patients were randomized to CO2 and 109 to room air. The baseline characteristics were similar in both groups. The mean propofol dose was not different between the treatments, as were the time to reach the ileum and the withdrawal time. pCO2 at the end of the procedure was 35.2±4.3 mmHg (CO2 group versus 35.6±6.0 mmHg in the room air group (>.05. No relevant complication occurred in either group. There was significantly less bloating for the CO2 group during the postprocedural recovery period (<.001 and over the 24-hour period (<.001. Also, patients with CO2 insufflation experienced significantly less pain (=.014. Finally, a higher overall satisfaction (=.04 was found in the CO2 group. Conclusions. This trial provides compelling evidence that CO2 insufflation significantly reduces bloating and pain after routine colonoscopy in propofol-sedated patients. The procedure is safe with no significant differences in CO2 between the two groups.
Cheng, Steven C; Young, Daniel O; Huang, Yihung; Delmez, James A; Coyne, Daniel W
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. Hemodialysis patients with phosphorus levels > or =5.0 mg/dl were randomly assigned to 8 wk of niacinamide or placebo, titrated from 500 to 1500 mg/d. After a 2-wk washout period, patients switched to 8 wk of the alternative therapy. Vitamin D analogs and calcimimetics were held constant; phosphorus binders were not changed unless safety criteria were met. Thirty-three patients successfully completed the trial. Serum phosphorus fell significantly from 6.26 to 5.47 mg/dl with niacinamide but not with placebo (5.85 to 5.98 mg/dl). A concurrent fall in calcium-phosphorus product was seen with niacinamide, whereas serum calcium, intact parathyroid hormone, uric acid, platelet, triglyceride, LDL, and total cholesterol levels remained stable in both arms. Serum HDL levels rose with niacinamide (50 to 61 mg/dl but not with placebo. Adverse effects were similar between both groups. Among patients who were > or =80% compliant, results were similar, although the decrease in serum phosphorus with niacinamide was more pronounced (6.45 to 5.28 mg/dl) and the increase in HDL approached significance (49 to 58 mg/dl). In hemodialysis patients, niacinamide effectively reduces serum phosphorus when co-administered with binders and results in a potentially advantageous increase in HDL cholesterol. Further study in larger randomized trials and other chronic kidney disease populations is indicated.
Liebowitz, Michael R; Yeung, Paul P; Entsuah, Richard
This study evaluated the efficacy and tolerability of desvenlafaxine succinate (desvenlafaxine) in the treatment of major depressive disorder (MDD). In this 8-week, multicenter, randomized, double-blind, placebo-controlled trial, adult outpatients (aged 18-75 years) with a primary diagnosis of MDD (DSM-IV criteria) were randomly assigned to treatment with desvenlafaxine (100-200 mg/day) or placebo. The primary outcome measure was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)) score at final on-therapy evaluation. The Clinical Global Impressions-Improvement scale (CGI-I) was the key secondary measure. Other secondary measures included the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity of Illness scale, Visual Analog Scale-Pain Intensity (VAS-PI) overall and subcomponent scores, and HAM-D(17) response and remission rates. The study was conducted from June 2003 to May 2004. Of the 247 patients randomly assigned to treatment, 234 comprised the intent-to-treat population. Following titration, mean daily desvenlafaxine doses ranged from 179 to 195 mg/day. At endpoint, there were no significant differences in scores between the desvenlafaxine (N = 120) and placebo (N = 114) groups on the HAM-D(17) or CGI-I. However, the desvenlafaxine group had significantly greater improvement in MADRS scores (p = .047) and in VAS-PI overall pain (p = .008), back pain (p = .006), and arm, leg, or joint pain (p Desvenlafaxine was generally safe and well tolerated. In this study, it did not show significantly greater efficacy than placebo on the primary or key secondary efficacy endpoints, but it did demonstrate efficacy on an alternate depression scale and pain measure associated with MDD. ClinicalTrials.gov identifier NCT00063206.
Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh
Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for
Full Text Available Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED 95 ; Group 75: Received atracurium at 75% dose of ED 95 ; Group 100: Received atracurium of 100% dose of ED 95 . Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001. Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001 with the least satisfaction in Group 0. The laryngeal mask airway (LMA insertion score was statistically significant in the four groups (P - 0.001. However, number of attempts for LMA placement was comparable among the four groups (P - 0.766. Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better
Full Text Available Abstract Background and objectives: There are many studies conducted on reducing the frequency and severity of fentayl-induced cough during anesthesia induction. We propose that pheniramine maleate, an antihistaminic, may suppress this cough. We aim to observe the effect of pheniramine on fentanyl-induced cough during anesthesia induction. Methods: This is a double-blinded, prospective, three-arm parallel, randomized clinical trial of 120 patients with ASA (American Society of Anesthesiologists physical status III and IV who aged ≥18 and scheduled for elective open heart surgery during general anesthesia. Patients were randomly assigned to three groups of 40 patients, using computer-generated random numbers: placebo group, pheniramine group, and lidocaine group. Results: Cough incidence differed significantly between groups. In the placebo group, 37.5% of patients had cough, whereas the frequency was significantly decreased in pheniramine group (5% and lidocaine group (15% (Fischer exact test, p = 0.0007 and p = 0.0188, respectively. There was no significant change in cough incidence between pheniramine group (5% and lidocaine group (15% (Fischer exact test, p = 0.4325. Cough severity did also change between groups. Post Hoc tests with Bonferroni showed that mean cough severity in placebo differed significantly than that of pheniramine group and lidocaine group (p < 0.0001 and p = 0.009, respectively. There was no significant change in cough severity between pheniramine group and lidocaine group (p = 0.856. Conclusion: Intravenous pheniramine is as effective as lidocaine in preventing fentayl-induced cough. Our results emphasize that pheniramine is a convenient drug to decrease this cough.
Kwok, Yuen H; Swift, James E; Gazerani, Parisa; Rolan, Paul
Background Chronic migraine (CM) is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily) or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion Using the current regimen, ibudilast does not improve migraine with CM participants. PMID:27826212
Full Text Available Yuen H Kwok,1 James E Swift,1 Parisa Gazerani,2 Paul Rolan1 1Discipline of Pharmacology, University of Adelaide, Level 5 Medical School North, South Australia, Australia; 2Department of Health Science & Technology, Aalborg University, Aalborg, Denmark Background: Chronic migraine (CM is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods: The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results: A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion: Using the current regimen, ibudilast does not improve migraine with CM participants. Keywords: chronic migraine, glia, ibudilast, headache, immune system
Faris, P L; Kim, S W; Meller, W H; Goodale, R L; Oakman, S A; Hofbauer, R D; Marshall, A M; Daughters, R S; Banerjee-Stevens, D; Eckert, E D; Hartman, B K
Several lines of evidence have led us to postulate that afferent vagal hyperactivity could be an important factor in the pathophysiology of the eating disorder bulimia nervosa. Ondansetron is a peripherally active antagonist of the serotonin receptor 5-HT3, and is marketed for prevention of vagally-mediated emesis caused by cancer chemotherapeutic agents. We investigated the effects of ondansetron on bulimic behaviours in patients with severe and chronic bulimia nervosa in a randomised, double-blind, placebo-controlled study. We enrolled patients with severe bulimia nervosa (at least seven coupled binge/vomit episodes per week). The patients were otherwise healthy, their weight was normal, and they were not receiving medical or psychiatric treatment. During the first week of the study, patients recorded all eating-behaviour events to establish a baseline. In the second week, all patients received placebo, but were told that they were receiving either placebo or active drug. At the end of this single-blind phase, patients were randomly assigned placebo or ondansetron (24 mg daily) for a further 4 weeks. The primary outcome measure was the number of binge/vomit episodes per week. Data were analysed by intention to treat. 29 patients met the inclusion criteria, of whom 28 completed the baseline study, and 26 completed the single-blind placebo week. 12 patients were assigned placebo, and 14 ondansetron; one patient in the ondansetron group dropped out owing to accidental injury. During the 4th week of double-blind treatment, mean binge/vomit frequencies were 13.2 per week (SD 11.6) in the placebo group, versus 6.5 per week (3.9) in the ondansetron group (estimated difference 6.8 [95% CI 4.0-9.5]; ptime spent engaging in bulimic behaviours was decreased on average by 7.6 h per week in the ondansetron group, compared with 2.3 h in the placebo group (estimated difference 5.1 [0.6-9.7]). Similarly, the number of normal meals and snacks increased on average by 4.3 normal
Amer-Cuenca, J J; Goicoechea, C; Girona-López, A; Andreu-Plaza, J L; Palao-Román, R; Martínez-Santa, G; Lisón, J F
Transcutaneous electrical nerve stimulation (TENS) is a noninvasive alternative to traditional pain treatments. TENS has been studied in the past as a pain reduction modality in colonoscopy with limited success. Reviews and meta-analysis have shown that the inconclusive results of TENS may be due to the lack of randomized controlled trials and the difficulty in defining precise output parameters. The objective of this double-blind randomized placebo-controlled trial was to investigate the pain-relieving effect of a new application of TENS in unsedated screening colonoscopy. Ninety patients undergoing unsedated screening colonoscopy were randomly allocated to one of three groups: a control group (n=30), a group to receive active TENS (n=30), or a group to receive placebo TENS (n=30). A visual analogue scale (VAS) and a five-point Likert scale were used to assess pain 5 min into the procedure and at the end of the procedure. The patient's bloating sensation during colonoscopy and the effect on the duration of the procedure were also evaluated. Throughout the procedure, the active TENS group experienced a VAS pain score reduction ≥50% compared to the placebo TENS group (PTENS group compared to the placebo TENS and control groups (P=0.009). No significant differences were found between the study groups as to the bloating sensation and the duration of the procedure. We conclude that TENS can be used as a pain relief therapy in unsedated screening colonoscopy.
Gebuhr, Peter Henrik; Sletgård, J; Dalsgård, J;
147 patients due to have a cemented total hip arthroplasty were randomized to 4 groups. They received either tenoxicam 20 mg or 40 mg, or placebo, for 5 days or morphine on the day of operation and placebo for 4 days. During the first 5 days 14 patients were excluded. The patients were followed...... for 1 year, during which another 10 patients were excluded. At follow-up, significantly fewer patients had heterotopic ossifications in the tenoxicam groups than in the placebo and morphine groups. There was no significant difference between the 2 tenoxicam-treated groups, and we therefore conclude...... that tenoxicam 20 mg for 5 days postoperatively can reduce heterotopic ossification after cemented total hip arthroplasty....
Full Text Available Background: Oral aphthous is one of the most common oral mucosal inflammatory disorders which are very painful. There is no definite medical strategy up to now for aphthous treatment. Recently, some researchers have focused on immunomodulatory drugs such as tacrolimus and pimecrolimus in preventing aphthus recurrences. The aim of this study is to assess the effect of pimecrolimus cream against placebo in management of oral minor aphthous.Methods: The study is a randomized clinical trial, was done in “Shariati” hospital and Isfahan Skin Research Center. 62 patients with minor aphthuos were included and divided randomly to two groups (31 in each. In experimental group, pimecrolimus cream was applied for two weeks and cold cream for the same duration in control group. Patients were followed for 3 and one week; results were assessed in recovery after drug administration. Compared variables between two groups were including: the size of lesions, the time to recovery and pain intensity.Results: Results showed that mean size lesion in experimental and placebo group after complete recovery reduced (23.6 ±15.3 and 24.8 ±15 mm respectively but it was not significant (P: 0.1. Mean time for recovery in both groups was 8±2.2 and 9.5±2.5 respectively which was significant in pimecrolimus treated patients (P: 0.014. Also mean degree for pain intensity measured by pain scale method was reduced significantly in test group (6 ± 1.2 before treatment and 5.3 ± 1.1 after treatment, P<0.001.Conclusion: This study stated that pimecrolimus cream has an appropriate effect in reduction of recovery time and pain in minor aphthous compared to placebo but more clinical studies are needed to better conclusion.
Haghdoost, Mehdi; Taghizadeh, Sepehr; Montazer, Majid; Poorshahverdi, Parinaz; Ramouz, Ali; Fakour, Sanam
A decreased rate of successful helicobacter pylori (H.pylori) infection treatment has revealed serious demand for more effective regimens to eradicate infection. Therefore, probiotics have recently been considered to increase the rate of antibiotic regimens efficacy in H. pylori infections. In current randomized controlled trial, we evaluated the effect of double strain probiotic combination with standard triple therapy (STT), in the eradication rate of H. pylori infection. In current randomized placebo-control study, all patients (176 subjects) underwent the STT for 10 days. However, the study group received triple therapy for the eradication of H. pylori with supplement of Lactobacillus probiotic for 4 weeks and placebo was administered to control group, as well. Adverse effects of the antibiotic regimen were recorded for all patients. Six weeks after the cessation of probiotic intake, all patients underwent H. Pylori with fecal antigen of test, followed by a recurrence evaluation six months later. There was no significant difference in demographic data and presenting symptoms between the study groups. The eradication rate of H. pylori infection was significantly higher in probiotic group (78.4%), compared to that of placebo group (64.8%) (P=0.033). In addition, adverse events were significantly less prevalent in patients that received probiotic (P=0.047). Nonetheless, there was no significant difference in terms of infection recurrence during a 6-month follow-up (P=0.07). Double strain probiotic in combination with STT increased the eradication rate of H. pylori infection, while the adverse events due to antibiotic therapy decreased.
Modanlou Juibari, Hamed; Eftekharian, Hamid Reza; Arabion, Hamid Reza
The preoperative or intraoperative administration of intravenous magnesium sulfate has been approved as an accepted medication for stabilizing hemodynamic indices during surgeries. Intraoperative blood loss during orthognathic surgery is frequently abundant and sometimes requires blood transfusion. The present trial addressed the efficacy of intravenous magnesium sulfate on deliberating hypotension and bleeding reduction in patients undergoing bimaxillary orthognathic surgery. This randomized double-blinded placebo controlled trial was conducted on 52 consecutive patients who underwent orthognathic surgery. The participants were randomly assigned to two groups receiving intravenous magnesium sulfate 30 mg/kg body weight bolus for 15 minutes immediately before anesthesia induction, followed by 10 mg/kg/hr dissolved in saline via pump infusion (n=26) and the second group received placebo as same bolus volume of normal saline in a 15-minute intravenous infusion which was continued until the end of operation (n=26). Both systolic and diastolic blood pressures were measured before anesthesia induction at baseline, during surgery, and at the end of the surgery. Intraoperative blood loss was also determined. Systolic and diastolic blood pressures did not differ between the two groups at baseline. Although a downward trend of both systolic and diastolic blood pressures was seen during the operation in both groups, the decrease in blood pressures occurred with greater gradient in the group administered magnesium sulfate. Assessing difference in the trend of the changes in systolic and diastolic blood pressures between the two study groups (adjusted for gender, age, mean body mass index, and time of surgery) showed different trends in the changes of blood pressures. No differences were observed in blood loss or blood product requirement between the two groups. The administration of intravenous magnesium sulfate can attenuate both systolic and diastolic blood pressures during
Sun, Qianqian; Wang, Bin; Li, Yingsha; Sun, Fang; Li, Peng; Xia, Weijie; Zhou, Xunmei; Li, Qiang; Wang, Xiaojing; Chen, Jing; Zeng, Xiangru; Zhao, Zhigang; He, Hongbo; Liu, Daoyan; Zhu, Zhiming
Taurine, the most abundant, semiessential, sulfur-containing amino acid, is well known to lower blood pressure (BP) in hypertensive animal models. However, no rigorous clinical trial has validated whether this beneficial effect of taurine occurs in human hypertension or prehypertension, a key stage in the development of hypertension. In this randomized, double-blind, placebo-controlled study, we assessed the effects of taurine intervention on BP and vascular function in prehypertension. We randomly assigned 120 eligible prehypertensive individuals to receive either taurine supplementation (1.6 g per day) or a placebo for 12 weeks. Taurine supplementation significantly decreased the clinic and 24-hour ambulatory BPs, especially in those with high-normal BP. Mean clinic systolic BP reduction for taurine/placebo was 7.2/2.6 mm Hg, and diastolic BP was 4.7/1.3 mm Hg. Mean ambulatory systolic BP reduction for taurine/placebo was 3.8/0.3 mm Hg, and diastolic BP was 3.5/0.6 mm Hg. In addition, taurine supplementation significantly improved endothelium-dependent and endothelium-independent vasodilation and increased plasma H2S and taurine concentrations. Furthermore, changes in BP were negatively correlated with both the plasma H2S and taurine levels in taurine-treated prehypertensive individuals. To further elucidate the hypotensive mechanism, experimental studies were performed both in vivo and in vitro. The results showed that taurine treatment upregulated the expression of hydrogen sulfide-synthesizing enzymes and reduced agonist-induced vascular reactivity through the inhibition of transient receptor potential channel subtype 3-mediated calcium influx in human and mouse mesenteric arteries. In conclusion, the antihypertensive effect of chronic taurine supplementation shows promise in the treatment of prehypertension through improvement of vascular function. © 2016 American Heart Association, Inc.
Chaparro, Luis E; Lezcano, Wilson; Alvarez, Hernan D; Joaqui, William
The efficacy of non-narcotic analgesics is mostly supported by randomized, placebo-controlled trials with no comparison with ordinary practice. Additionally, systematic reviews of these placebo-controlled trials have failed to determine clinically meaningful dose-response effect. In this double-blind, randomized trial, patients undergoing elective inguinal, umbilical or epigastric herniorrhaphy under general anesthesia were assigned to receive 15 mg/kg (D15 group) vs. 40 mg/kg (D40 group) of dipyrone intravenously during surgery. The primary outcome was the incidence of moderate to severe pain with movement during the recovery room phase. The secondary outcomes were morphine consumption, incidence of vomiting, and Ramsay score (sedation scale). One hundred sixty-two patients were enrolled and analyzed for the primary and secondary outcomes. Relative to the D15 group, the D40 group showed a lower incidence of moderate to severe pain in the first 30 minutes (61% and 40%; P value < 0.05); lower cumulative morphine consumption during the recovery period (3.85 vs. 2.55 mg, P value < 0.006) as well as a lower incidence of vomiting (15.8% vs. 2.5%, P value < 0.005). In addition, more cases of sedation were recorded in the D15 group than in the D40 group (17 vs. 10 cases). There were no serious adverse effects attributed to dipyrone in either group. This trial shows a dose-response effect of 40 mg/kg over 15 mg/kg of intravenous dipyrone based on better movement-induced pain control, lower morphine consumption and fewer opioid-related side effects. © 2011 The Authors. Pain Practice © 2011 World Institute of Pain.
Salehi, Mehrdad; Zargar, Ali; Ramezani, Mohammad Arash
BACKGROUND: Dextromethorphan (DM) is an N-methyl-D-aspartate (NMDA) receptor antagonist that may be useful during opiate addiction process, especially in reducing methadone consumption in methadone maintenance therapy (MMT). The goal of the current study was to evaluate the effects of oral administration of DM on reducing methadone dose in MMT used to treat illicit opioid drug abuse. METHODS: A double-blinded randomized clinical trial was designed. Seventy two opiate abusers undergoing MMT were randomly divided into two groups. Participants in the intervention group were medicated by DM while those in the control group received placebo. After a 6-week follow-up, methadone consumption dosage, quality of life (QOL) and withdrawal symptoms were assessed and compared between the two groups by repeated measure ANOVA statistical test. RESULTS: The mean of methadone consumption in the DM and control groups were 62.7 mg/day (52.7-72.7) and 70.4 mg/day (60.4-80.4), respectively. No statistically significant difference was found between the two groups among the four evaluations made (F = 1.192, P = 0.279). There were not any significant differences in withdrawal symptoms between the two groups (P > 0.05). Total mean scores of QOL in the intervention and control groups were 84.8 (78.7-90.8) and 77.8 (71.8-83.7) (P > 0.05), respectively. CONCLUSIONS: Although DM might be useful for opioid dependence treatment, results of the current study did not reveal any statistically significant differences. Therefore, further studies exploring this possibility are needed. PMID:22973331
Alijaniha, Fatemeh; Naseri, Mohsen; Afsharypuor, Suleiman; Fallahi, Faramarz; Noorbala, Ahmadali; Mosaddegh, Mahmood; Faghihzadeh, Soghrat; Sadrai, Sima
In Traditional Iranian Medicine (TIM), Melissa officinalis L. is commonly regarded as an effective therapy for heart palpitations. Heart palpitation is a common complaint that is often benign and associated with a marked distress that makes the condition difficult to treat. Herbal medicines provide an alternative to conventional drugs for treating various kinds of diseases. This study was done as a double blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of the dried extract of M. officinalis on adults suffering from benign palpitations. Eligible volunteers were randomly assigned as outpatients to a 14 day treatment with 500 mg twice a day of lyophilized aqueous extract of M. officinalis leaves (or placebo). Participants in the tests, physicians and researchers were blind to group assignments. Both primary and secondary outcomes were patient-reported. Primary outcomes were obtained from two measures: mean frequency of palpitation episodes per week, derived from patients׳ diaries, and mean intensity of palpitation estimated through Visual Analogue Scale (VAS) in a self-report questionnaire. Psychiatric symptoms (somatization, anxiety and insomnia, social dysfunction and severe depression) were evaluated as secondary outcomes by General Health Questionnaire-28 (GHQ-28), before and after intervention. Fifty-five volunteers out of 71 recruited study subjects completed the trial. Results showed that 14-day of treatment with lyophilized aqueous extract of M. officinalis leaves reduced frequency of palpitation episodes and significantly reduced the number of anxious patients in comparison to the placebo (P=0.0001, P=0.004 resp.). Also, M. officinalis extract showed no indication of any serious side effects. Lyophilized aqueous extract of M. officinalis leaves may be a proper and safe herbal drug for the treatment of benign palpitations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Brautigam, M R; Blommaert, F A; Verleye, G; Castermans, J; Jansen Steur, E N; Kleijnen, J
A growing number of people is subject to age-related cognitive impairment due to the proportional increase of the ageing population. Therefore, there is a growing interest in cognition-enhancing substances. The efficacy of an alcohol/water extract of Ginkgo biloba in elderly individuals with memory- and/or concentration complaints was tested in a randomized, double-blind, placebo-controlled study by using both subjective and objective parameters. After a wash-out period of 4 weeks 241 non-institutionalised patients in the age range 55-86 years were randomly allocated to receive either Ginkgo biloba alcohol/water extract in a high dose (HD), a low dose (LD) or a placebo (PL) for 24 weeks. Patients were assessed using a psychometric testbattery in the following order: Expended Mental Control Test (EMCT) measuring attention and concentration, Benton Test of Visual Retention-Revised (measures short term visual memory), Rey Test part 1 (measures short term memory and learning curve), Beck Depressive Inventory (BDI) measuring the presence and severeness of a depression in order to exclude depressive patients and Rey Test part 2 (measures long term memory: recognition). Furthermore, subjective perception of memory and concentration was measured. 197 patients completed the study (mean MMSE score: 26.29). In the subjective test, the EMCT, the Rey 1 and Rey 2 no significant differences in improvement in time between the groups were observed. In the Benton test increases of 18%, 26% and 11% (expressed as percentage of baseline scores) were observed in the HD, LD and PL respectively (MANOVA; p = 0.0076). No substantial correlation was observed between subjective perception of the severeness of memory complaints and the objective test results. No differences in the number of (gastrointestinal) side effects were observed between placebo and verum groups. These results indicate that the use of Ginkgo extracts in elderly individuals with cognitive impairment might be promising
Fleur van der Valk
Full Text Available BACKGROUND AND AIMS: Obesity and its associated cardiometabolic co-morbidities are increasing worldwide. Since thyroid hormone mimetics are capable of uncoupling the beneficial metabolic effects of thyroid hormones from their deleterious effects on heart, bone and muscle, this class of drug is considered as adjacent therapeutics to weight-lowering strategies. This study investigated the safety and efficacy of TRC150094, a thyroid hormone mimetic. MATERIALS AND METHODS: This 4-week, randomized, placebo-controlled, double-blind trial was conducted in India and The Netherlands. Forty subjects were randomized at a 1:1 ratio to receive either TRC150094 dosed at 50 mg or placebo once daily for 4 weeks. Hyperinsulinemic euglycemic clamp and (1H-Magnetic Resonance Spectroscopy (MRS were performed before and after treatment. RESULTS: At baseline, subjects were characterized by markedly impaired hepatic and peripheral insulin sensitivity. TRC150094 dosed 50 mg once daily was safe and well tolerated. Hepatic nor peripheral insulin sensitivity improved after TRC150094 treatment, expressed as the suppression of Endogenous Glucose Production from 59.5 to 62.1%; p = 0.477, and the rate of glucose disappearance from 28.8 to 26.4 µmol kg(-1min(-1, p = 0.185. TRC150094 administration did not result in differences in fasting plasma free fatty acids from 0.51 to 0.51 mmol/L, p = 0.887 or in insulin-mediated suppression of lipolysis from 57 to 54%, p = 0.102. Also, intrahepatic triglyceride content was unaltered. CONCLUSION: Collectively, these data show that, in contrast to the potent metabolic effects in experimental models, TRC150094 at a dose of 50 mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk. Further studies are needed to evaluate whether TRC150094 has beneficial effects in patients with more severe metabolic derangement, such as overt diabetes mellitus and hypertriglyceridemia. TRIAL REGISTRATION
Matov, V; Metchkov, G; Krastev, Z; Tchernev, K; Mitova, R; Márquez, M; Torres, J; Herrero, E; Fillat, O; Ortiz, J A
A total of 478 patients with endoscopically confirmed duodenal ulcer entered this randomized, parallel, double-blind trial. Patients were randomly assigned to receive ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfona mid e, CAS 100981-43-9, FI-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. Endoscopy, clinical examination and symptom assessment were performed at baseline and at weeks 4 and 8. Safety evaluations including laboratory tests, treatment compliance and antacid consumption checks were conducted at the beginning and/or at the 4 and 8 week visits. Patients whose ulcer showed endoscopic healing at the 4-week control left the study. Both groups were matched in all parameters studied. The healing rates at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine respectively, while at 8 weeks the final rates were 95% and 91.8% respectively. Accompanying symptoms disappeared rapidly and the patients returned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the healing rates among patients treated with ebrotidine were similar regardless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebrotidine (94%) proved to be more effective than ranitidine (86%) in smokers with higher healing rates (p < 0.05). Alcohol intake showed no significant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.
Dietlind L. Wahner-Roedler
Full Text Available Most patients with fibromyalgia use complementary and alternative medicine (CAM. Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ and the Center for Epidemiologic Studies Depression Scale (CES-D at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = .02 and by 18% in the placebo group (P < .001. The difference in change in scores between the groups was not significant (P = .16. With the same analysis, CES-D scores decreased in the soy group by 16% (P = .004 and in the placebo group by 15% (P = .05. The change in scores was similar in the groups (P = .83. Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated.
Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L
The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.
Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai
Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg(-1), Group C getting clonidine 1mcg.kg(-1) and Group D patients receiving dexmedetomidine 0.5mcg.kg(-1). The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.
Full Text Available Background: Green and black teas have known anti-oxidant and anti-inflammatory properties. The current study was a prospective randomized, double-blind, placebo controlled study of 3 doses of a water-extracted green and black tea agent (AssuriTEA® [AT]. Methods: Subjects who met inclusion criteria were randomized to one of four groups: 1000, 500, or 250 mg AT or placebo for 28 days. At baseline (BL and day 28, serum antioxidant capacity, quality of life and safety were assessed. Results: Of the 55 subjects screened, 43 were considered evaluable. Age was 56.77 ± 2.83 years (mean ± SEM. Evaluable subjects demonstrated improved antioxidant status, as measured by ferric iron reducing antioxidant power at all doses over the placebo (p < 0.05. There was significant improvement in cellular antioxidant protection in the 1000 mg AT group versus the placebo (p=0.032. Glucose levels were higher in the placebo group versus the 250 mg AT group (p=0.023 and there was a significant improvement in systolic blood pressure in the 250 mg AT group at day 28 versus BL (p=0.048. In the 1000 mg AT group, there was a significant decrease in systolic blood pressure at day 28 versus BL (p=0.017. There was a significant improvement in the vitality category in the 1000 mg AT group (p=0.029. Overall, AT was safe and well tolerated with no differences in adverse events or serum chemistries between groups. Conclusions: Results demonstrate that the administration of AT resulted in improvement of serum antioxidant status, vitality level, blood glucose, and systolic blood pressure in test subjects.
Full Text Available Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS. Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS and intention-to-treat (ITT. However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: −0.23±0.08; placebo: −0.03±0.08, P<0.018, tension (TJ-54: −0.42±0.09; placebo: −0.18±0.09, P<0.045, and poor impulse control (TJ-54: −0.39±0.10; placebo: −0.07±0.10, P<0.037. Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.
Velayudha Sidda Reddy
Full Text Available Background: Alpha 2 -adrenergic agonists have synergistic action with local anesthetics and may prolong the duration of sensory, motor blockade and postoperative analgesia obtained with spinal anesthesia. Aim: The objectives of this study are to compare and evaluate the efficacy of intravenous dexmedetomidine premedication with clonidine and placebo on spinal blockade duration, postoperative analgesia and sedation in patients undergoing surgery under bupivacaine intrathecal block. Materials and Methods: In this prospective, randomized, double-blind placebo-controlled study, 75 patients of the American Society of Anesthesiologists status I or II, scheduled for orthopedic lower limb surgery under spinal anesthesia, were randomly allocated into three groups of 25 each. Group DE received dexmedetomidine 0.5 μgkg−1 , group CL received clonidine 1.0 μgkg−1 and placebo group PL received 10 ml of normal saline intravenously before subarachnoid anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Onset time and regression times of sensory and motor blockade, the maximum upper level of sensory blockade were recorded. Duration of postoperative analgesia and sedation scores along with side effects were also recorded. Data was analyzed using analysis of variance or Chi-square test, and the value of P < 0.05 was considered statistically significant. Results: The sensory block level was higher with dexmedetomidine (T4 ± 1 than clonidine (T6 ± 1 or placebo (T6 ± 2. Dexmedetomidine also increased the time (243.35 ± 56.82 min to first postoperative analgesic request compared with clonidine (190.93 ± 42.38 min, P < 0.0001 and placebo (140.75 ± 28.52 min, P < 0.0001. The maximum Ramsay sedation score was greater in the dexmedetomidine group than other two groups (P < 0.0001. Conclusion: Premedication with intravenous dexmedetomidine is better than intravenous clonidine to provide intraoperative sedation and postoperative analgesia during bupivacaine
Full Text Available This was a randomized double-blinded study; in which 60 ASAI-II adult patients scheduled for major abdominal surgeries (colostomy, radical cystectomy, major gynecological surgery, and abdominal vascular surgery were received standard general anesthesia. Twenty minutes before the anticipated end of surgery, patients were randomized into two equal groups: dexmedetomidine group (group D and morphine group (group M. Group D received dexmedetomidine IV infusion 4µg/kg/h for 15 minutes (1µg/Kg followed by 0.4µg/kg/h for 3h. Group M received morphine sulfate IV (0.07mg/kg. All patients were given a morphine patient controlled analgesia (PCA pump in the post anesthesia care unit (PACU, delivering IV morphine 2mg with a lockout time of 5 minutes if pain score assessed through visual analog scale (VAS was more than 5 at any given 5-min assessment. During the PACU recovery period, morphine consumption; pain and sedation scores; hemodynamic variables (heart rate, mean arterial blood pressure, oxygen saturation and respiratory rate; and postoperative nausea, retching and vomiting (PONV were recorded every 30 min for 3h (study period by a member of staff blinded to the treatment. The study demonstrated that the use of dexmedetomidine led to significant decrease in the total amount of morphine consumed throughout the entire PACU recovery period (P0.05; significant decrease in mean arterial pressure (P0.05; without any significant changes in oxygen saturation (P<0.05 or respiratory rate (P<0.05. In conclusion, dexmedetomidine exhibited both analgesic and sedative properties. The associated cardiovascular protective pharmacological profile and the lack of respiratory depression made it potentially extremely interesting for postoperative analgesia after major abdominal surgeries.
BACKGROUND: Tramadol has been administered peripherally to prolong analgesia after brachial plexus and neuraxial blocks. Our aim was to evaluate the systemic and perineural effects of tramadol as an analgesic adjunct to psoas compartment block (PCB) with levobupivacaine. METHODS: In a randomized, prospective, double-blinded trial, 60 patients (ASA I-III), aged 49-88 yr, undergoing primary total hip or knee arthroplasty underwent PCB and subsequent bupivacaine spinal anaesthesia. Patients were randomized into three groups. Each patient received PCB with levobupivacaine 0.5%, 0.4 ml kg(-1). The control group (group L, n=21) received i.v. saline, the systemic tramadol group (group IT, n=19) received i.v. tramadol 1.5 mg kg(-1) and the perineural tramadol group (group T, n=20) received i.v. saline and PCB with tramadol 1.5 mg kg(-1). Postoperatively patients received regular paracetamol 6-hourly and diclofenac sodium 12-hourly. Time to first morphine analgesia, 24-hour morphine consumption, sensory block, pain and sedation scores and haemodynamic parameters were recorded. RESULTS: Time (h) to first morphine analgesia was similar in the three groups [mean (SD)]: group L, 11.2 (6.6); group T, 14.5 (8.0); group IT, 14.6 (6.8); P=0.35. Twenty-four-hour cumulative morphine (mg) consumption was also similar in the three groups [group L, 21.9 (10.1); group T, 19.8 (6.7), group IT, 16.5 (9.5)], as were durations of sensory and motor block. There were no differences in the incidence of adverse effects except that patients in group IT were more sedated at 14 h than group L (P=0.02). CONCLUSION: We conclude that our data do not support a clinically important local anaesthetic or peripheral analgesic effect of tramadol as adjunct to PCB with levobupivacaine 0.5%.
Holscher, Hannah D; Czerkies, Laura A; Cekola, Pamela; Litov, Richard; Benbow, Marshall; Santema, Sheryl; Alexander, Dominik D; Perez, Vanessa; Sun, Shumei; Saavedra, José M; Tappenden, Kelly A
Addition of probiotics to infant formula may positively affect immune function in nonexclusively breastfed infants. This study aimed to investigate the effect of infant starter formula containing the probiotic Bifidobacterium animalis subspecies lactis (Bb12) on intestinal immunity and inflammation. Six-week-old healthy, full-term infants (n = 172) were enrolled in a prospective, randomized, double-blind, controlled clinical trial with 2 groups studied in parallel to a breastfed comparison group. Formula-fed (FF) infants were randomized to partially hydrolyzed whey formula (CON) or the same formula containing 10(6) colony-forming units (CFU) Bb12/g (PRO) for 6 weeks. Fecal secretory IgA (sIgA), calprotectin, lactate, and stool pH were assessed at baseline, 2 weeks, and 6 weeks. Anti-poliovirus-specific IgA and anti-rotavirus-specific IgA were assessed at 2 and 6 weeks. Among vaginally delivered FF infants, PRO consumption increased (P IgA concentration increased (P IgA tended to increase (P = .056) with PRO consumption in cesarean-delivered infants. Anthropometrics and tolerance did not differ significantly between FF infants. Infants consuming formula with Bb12 produced feces with detectable presence of Bb12 and augmented sIgA concentration. Furthermore, cesarean-delivered infants consuming Bb12 had heightened immune response, as evidenced by increased anti-rotavirus- and anti-poliovirus-specific IgA following immunization. These results demonstrate that negative immune-related effects of not breastfeeding and cesarean delivery can be mitigated by including Bb12 in infant formula, thereby providing infants a safe, dietary, immune-modulating bacterial introduction.
S Ashraffodin Ghoshegir
Full Text Available Background: We aimed to assess the effects of anise on quality of life (QOL of patients with functional dyspepsia (FD in a double-blind randomized clinical trial. Materials and Methods: Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch, 3 g after each meal (3 times/day for 4 weeks. The QOL was assessed by short-form (SF-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. Results: The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1. At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001. Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1. At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001. Conclusion: The current study revealed the effectiveness of anise in improvement of QOL in patients with FD.
Full Text Available Current standardized treatments for cognitive impairment in attention-deficit/hyperactivity disorder remain limited and their efficacy restricted. Transcranial direct current stimulation (tDCS is a promising tool for enhancing cognitive performance in several neuropsychiatric disorders. Nevertheless, the effects of tDCS in reducing cognitive impairment in patients with attention-deficit/hyperactivity disorder (ADHD have not yet been investigated.A parallel, randomized, double-blind, sham-controlled trial was conducted to examine the efficacy of tDCS on the modulation of inhibitory control in adults with ADHD. Thirty patients were randomly allocated to each group and performed a go/no-go task before and after a single session of either anodal stimulation (1 mA over the left dorsolateral prefrontal cortex or sham stimulation.A nonparametric two-sample Wilcoxon rank-sum (Mann-Whitney test revealed no significant differences between the two groups of individuals with ADHD (tDCS vs. sham in regard to behavioral performance in the go/no go tasks. Furthermore, the effect sizes of group differences after treatment for the primary outcome measures-correct responses, impulsivity and omission errors--were small. No adverse events resulting from stimulation were reported.According to these findings, there is no evidence in support of the use of anodal stimulation over the left dorsolateral prefrontal cortex as an approach for improving inhibitory control in ADHD patients. To the best of our knowledge, this is the first clinical study to assess the cognitive effects of tDCS in individuals with ADHD. Further research is needed to assess the clinical efficacy of tDCS in this population.ClinicalTrials.gov NCT01968512.
Cheechareoan, Sukrom; Pathanawiriyasirikul, Thanate; Manmee, Charuwan; Janpol, Kanya
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.
Full Text Available Menopause is one of the most critical periods of woman's life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms.The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012. The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg's general health questionnaire (GHQ, Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention.We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001. In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001. No significant difference was found regarding side effects between the two groups (P= 0.135.The study findings showed that using melatonin improved the climacteric symptoms.
Kwang-Min Kim; Moon-Jong Kim; Sang-Wook Song; Doo-Yeoun Cho; Kyung-Chae Park; Sung-Won Yang; Young-Sang Kim
Background:Fatigue is a common symptom both in diseases status and in healthy subjects.Various supplements and nutraceuticals for relieving of fatigue have been used.However,there are a few studies to evaluate the efficacy and the safety of the drug for fatigue alleviation,we conducted using URSA Complex to evaluate the efficacy on physical fatigue via score changes in the checklist individual strength (CIS).Methods:The study was designed as a multicenter,randomized,double-blind,placebo-controlled trial,with subjects randomized to one of the two arms,receiving either placebo or URSA Complex administered as identical capsules.The primary efficacy endpoints of this clinical trials are the ratio of improving CIS scores ＜ 76 points in patients at the end (4 weeks).Secondary efficacy variables are as follows one is an improvement of fatigue and the other is an improvement of the liver enzyme.Results:The fatigue recovery rate in who had improved CIS scores of＜ 76 points were 70.0％,50.9％ in the therapy group and placebo group,respectively (P =0.019).The fatigue recovery rate in CIS score was higher in URSA Complex therapy group than placebo group.The difference between therapy group and placebo group was statistically significant at 4 weeks later,but not 2 weeks.Conclusions:Our results provided that the URSA Complex was effective in alleviating physical fatigue.The adverse event frequency in the therapy groups was similar to that in the placebo group.
Clarence S Ivie
Full Text Available Background : The addition of clonidine to lidocaine intravenous regional anesthesia (IVRA has been previously reported to improve postoperative analgesia in patients undergoing upper extremity surgery. Our objective was to perform a dose ranging study in order to determine the optimal dose of clonidine used with lidocaine in IVRA. Design & Setting : We performed a double-blinded randomized placebo-controlled study with 60 patients scheduled for elective endoscopic carpal tunnel release under IVRA with 50 ml lidocaine 0.5%. University-affiliated outpatient surgery center. Data collected in operating rooms, recovery room, and by telephone after discharge from surgery center. Materials & Methods : Sixty adult ASA I or II patients undergoing outpatient endoscopic carpal tunnel release under intravenous regional anesthesia.Patients were randomized into five study groups receiving different doses of clonidine in addition to 50 ml 0.5% lidocaine in their IVRA. Group A received 0 mcg/kg, group B 0.25 mcg/kg, group C 0.5 mcg/kg, group D 1.0 mcg/kg and group E 1.5 mcg/kg of clonidine.Intraoperative fentanyl, recovery room pain scores, time to first postsurgical analgesic, total number of acetaminophen/codeine tablets consumed postsurgery, incidence of sedation, hypotension and bradycardia. Results & Conclusions : There was no benefit from any dose of clonidine compared to placebo. There were no clonidine-related side effects seen within the dose range studied. In short duration minor hand surgery, the addition of clonidine to lidocaine-based intravenous regional anesthesia provides no measurable benefit.
Full Text Available BACKGROUND: Remote ischemic preconditioning (RIPC has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD in patients undergoing complex cardiac surgery. METHODS: We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5-7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion or if the combined Z score was 1.96 or greater (Z score criterion. RESULTS: According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5-7 days after surgery (p = 0.753. The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30 compared to the RIPC group (1.14±4.02; p = 0.228. Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19-1.94 µg/L vs. 0.48 (0.07-1.84 µg/L] and 24 hours after surgery [0.36 (0.14-1.89 µg/L vs. 0.26 (0.07-0.90 µg/L]. CONCLUSIONS: We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00877305.
Full Text Available Background : Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK. Aim: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK and natural streptokinase (Streptase, n-SK. Settings and Design: Double blind, randomized, non-inferiority, multicentric, parallel study. Materials and Methods: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V1- V6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > 50% ST segment were used to assess reperfusion. Statistical analysis: Difference in the groups was assessed by chi-square or paired t test as required. Probability value Results: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58 and 69.4% (34 patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%, hypotension in 3 (3.6%, nausea in 2 (2.4% patients. Minor bleeding were seen in 4 (4.8% of patients. Conclusion: Indigenous recombinant Streptokinase (r-SK is as efficacious as natural streptokinase (n-SK in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile..
Chen, Renjie; Zhao, Ang; Chen, Honglei; Zhao, Zhuohui; Cai, Jing; Wang, Cuicui; Yang, Changyuan; Li, Huichu; Xu, Xiaohui; Ha, Sandie; Li, Tiantian; Kan, Haidong
Background Indoor exposure to fine particulate matter (PM2.5) from outdoor sources is a major health concern, especially in highly polluted developing countries, such as China. Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas. Objectives To evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health. Methods We conducted a randomized double-blind crossover trial among 35 healthy college students in Shanghai, China in 2014. These students lived in dormitories that were randomized into 2 groups and alternated the use of true or sham air purifiers for 48 h with a 2-week washout interval. We measured 14 circulating biomarkers of inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and fractional exhaled nitric oxide (FeNO). We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables. Results On average, air purification resulted in a 57% reduction in PM2.5 concentration from 96.2 to 41.3 μg/m3 within hours of operation. Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers, including 17.5% in monocyte chemoattractant protein-1, 68.1% in interleukin-1β, 32.8% in myeloperoxidase and 64.9% in soluble CD40 ligand. Further, systolic BP, diastolic BP, and FeNO were significantly decreased by 2.7%, 4.8%, and 17.0% in geometric mean, respectively. The impacts on lung function and vasoconstriction biomarkers were beneficial, but not statistically significant. Conclusion This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young, healthy adults in a Chinese city with severe ambient particulate air pollution. (Intervention Study on the Health Impact of Air Filters in Chinese Adults; NCT02239744) PMID:26022815
Full Text Available Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat.” Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste or treatment group (group B with Crest Herbal Crystal Toothpaste with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of “clearing internal heat” for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage. Results. The rating scale on efficacy of “clearing internal heat” for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT analysis and 67-case per-protocol (PP analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P<0.05. The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT and 62.50%, 60.64% (PP. The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste. Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat” was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of “clearing internal heat.”
Full Text Available "n Background and the purpose of the Study: Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease. "n Methods: This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness and the secondary outcomes were alteration in plaque index (Sillness & Loe, bleeding index (Cowell and probing pocket depth (WHO probe. All indices were measured in the 0, 7th and 14th days of the study. "n Results: Seventy five patients ranged of 15-18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (p< 0.05, except for the bleeding index in the group without SRP and drug therapy (p=0.111. More precise analysis of data revealed that SRP in association with Frankincense application (either extract or powder can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p<0.001. In addition, no significant difference was observed between powder or extract therapy (p >0.05 and between patients received either SRP or treatment alone (p=0.169. "n Conclusion: Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy.
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
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.
Seyede Hajar Sharami
Full Text Available Background: Patients with arrested preterm labor (PTL are at increased risk for recurrence ofpreterm birth (PTB. Maintenance tocolysis after arrest of acute PTL is of questionable value. Theobjective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order toprevent PTB in women with episodes of threatened PTL.Materials and Methods: This is a randomized double blind clinical trial study.Women with singletonpregnancies between 28-36 weeks of gestation, who were hospitalized for PTL were included. Atotal of 173 pregnant patients were randomly allocated to receive 200 mg vaginal progesteronesuppositories (n=86 or placebo (n=87 daily until the 36th gestational week. The two groups werecompared relative to demographic characteristics, incidence of PTB before 34 and 37 weeks, andmaternal and neonatal complications. Data were analyzed by chi-square and Fisher’s exact tests.Results: Mean latency until delivery in the cases was longer than the control group (23.88 ± 18.01vs. 16.67 ± 12.9; p=0.004.Treatment with progesterone was not associated with a reduction inthe rate of PTB before 34 weeks [cases: 9 (10.8% vs. controls: 8 (10%] and 37 weeks [cases: 45(54.2% vs. controls: 33 (41.2%]. Log rank analysis revealed a significant difference for mean timeto delivery between the two groups (p=0.028. There were no significant differences for neonataland maternal complications in the two groups.Conclusion: Prophylactic administration of 200 mg vaginal progesterone suppositories aftersuccessful tocolysis in patients with threatened idiopathic PTL is associated with a longer latencyto delivery, but failed to reduce the rate of PTB (Registeration Number: IRCT138706051096N1.
Full Text Available Background: Oxidative stress is a complicated process, which was defined as an increase in prooxidants and decrease in antioxidants caused by various mechanisms, including inflammation and surgical trauma. The association between acute appendicitis and oxidative stress has been showed in previous studies. However, comparison of oxidative stress in laparoscopic or open appendectomy (OA has not been established. Patients and Methods: Patients who were diagnosed as acute appendicitis between October 2012 and January 2013 were randomized to open (OA, n = 50 and laparoscopic appendectomy (LA, n = 50. Blood samples for oxidative stress markers (total oxidant status [TOS] and total antioxidant status [TAS], C-reactive protein (CRP and white blood cells (WBC's were collected just before the surgery and 24 h after surgery. Results: There were no differences in preoperative values of WBC and CRP between LA and OA groups (P = 0.523 and 0.424, however, in postoperative 24th h, CRP was reduced in LA group (P = 0.031. There were no differences in preoperative levels of TOS, TAS, and oxidative stress index (OSI between LA and OA groups. In the postoperative 24th h, TOS and OSI were found to be significantly higher in OA group when compared to LA group (P = 0.017 and 0.002 whereas no difference was detected in TAS level in the postoperative 24th h (P = 0.172. Conclusions: This double-blind, randomized clinical trial provides evidence that LA for uncomplicated appendicitis is associated with significantly lower oxidative stress compared with OA. Some of the advantages of LA may be attributed to the significant reduction of oxidative stress in these patients.
Bun Teoh, Anthony Yuen; Ning Chong, Charing Ching; Wa Leung, Wing; Cheong Chan, Simon Kin; Kit Tse, Yee; Wai Ng, Enders Kwok; San Lai, Paul Bo; Yuen Wu, Justin Che; Wong Lau, James Yun
The role of electroacupuncture (EA) in reducing sedative and analgesic requirements during EUS is uncertain. The aim of the current study is to investigate the efficacy of EA in reducing procedure-related pain and discomfort during EUS. This was a double-blinded randomized controlled study conducted between March 2014 and July 2016. Consecutive patients who were scheduled for diagnostic EUS were recruited and randomized to receive electroacupuncture (EA) or sham-electroacupuncture (SA). The primary outcome was the dosage of propofol used. Other outcome measurements included pain scores, anxiety scores, satisfaction scores, patients' willingness to repeat the procedure, total procedure time, and adverse events. One hundred twenty-eight patients were recruited to the study. The patients that received EA had significantly fewer PCA requirements. The median (IQR range) number of demands for PCA (2 [1 - 5] vs 16.5 [8.5 - 33.8], P<0.001), the number of successful demands (2 [1 - 4] vs 9 [5.3 - 13], P<0.001), the total dose of propofol (0.15 [0.08 - 0.34] vs 0.77 [0.38 - 1.09], P<0.001) and alfentanil (0.38 [0.20 - 0.86] vs 1.92 [0.94 - 2.72], P<0.001) were all significantly less. Patients that received EA also had significantly less procedural pain scores and anxiety scores (P<0.001), higher satisfaction scores (P<0.001), and they are more willing to repeat the procedure (P<0.001). Both being in the SA group and the procedural time were significant predictors to increased PCA demands (P < 0.001 and P = 0.009 respectively). In conclusion, the use of EA reduced sedative and analgesic demands, improved patient experience, and was associated with low risk of adverse events during diagnostic EUS. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Ghoshegir, S. Ashraffodin; Mazaheri, Mohammad; Ghannadi, Alireza; Feizi, Awat; Babaeian, Mahmoud; Tanhaee, Maryam; Karimi, Mehrdad; Adibi, Peyman
Background: We aimed to assess the effects of anise on quality of life (QOL) of patients with functional dyspepsia (FD) in a double-blind randomized clinical trial. Materials and Methods: Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day) for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch), 3 g after each meal (3 times/day) for 4 weeks. The QOL was assessed by short-form (SF)-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. Results: The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1). At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001). Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1). At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001). Conclusion: The current study revealed the effectiveness of anise in improvement of QOL in patients with FD. PMID:25709650
Ramesh R Rai
Full Text Available Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS. Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups. Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration. Subject Global Assessment of Relief (SGA of IBS symptoms was assessed at the end of the study. Appropriate statistical analysis was done using SPSS software. Statistical Analysis Used: Mann-Whitney U-test (two-tailed, Wilcoxon signed ranks test, and McNemar tests. Results: Pain frequency decreased significantly (P < 0.01 in 22 (25.9%, 51 (60%, and 66 (77.7% patients in the drotaverine group, at the end of 2 nd , 3 rd , and 4 th weeks, respectively, as compared with 8 (9.4%, 18 (21.2%, and 26 (30.6% in the placebo group. Pain severity scores also decreased significantly in the drotaverine group 66 (77.7% as compared with placebo 26 (30.6% after 4 weeks. Drotaverine HCl was shown to provide significant improvement (P < 0.01 in global relief in abdominal pain as perceived by the patient (85.9% vs 39.5% and the clinician (82.4% vs 36.5% in the drotaverine group as compared with placebo. There is significant (P < 0.01 improvement in stool frequency in drotaverine HCl treatment group as compared with placebo. The drug is well tolerated without any major side effects. Conclusions: A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS.
Amr H Yehia; Magdy H Koleib; Ibrahim A Abdelazim; Ahmed Atik
Objective:To evaluate the efficacy of tranexamic acid in reduction of blood loss during and after cesarean section.Methods:Women included in the current double blinded, randomized, controlled trial were recruited from women attending for elective cesarean section and randomized into two groups; study group: received tranexamic acid with induction of anesthesia plus10IU of oxytocin injection after delivery of the baby.Control group: received only oxytocin 10IU injection after delivery of the baby.Results:Twenty four hours post-operative hemoglobin level was significantly higher in study group(11.2±1.5 mg/dL) compared to control(9.6±1.2 mg/dL), also24 hours post-operative hematocrit was significantly higher in study group(30.2±6.6) compared to control(29.2±2.8).Calculated total blood loss from placental delivery till end of cesarean section was significantly less in study group compared to control(369.5±198.0 versus606.8±193.0 mL; respectively), also, calculated vaginal bleeding during first6 hours post-operative was significantly less in study group compared to control(85.0±30.7 mL versus130.8±49.3 mL, respectively).The incidence of post-partum hemorrhage was significantly less in study group compared to control(31.1% versus63.2%; respectively), also the need for iron replacement therapy was significantly less frequent in study group compared to control(0.9% versus6.6%, respectively). Conclusions:Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.
Simón-Talero, Macarena; García-Martínez, Rita; Torrens, Maria; Augustin, Salvador; Gómez, Susana; Pereira, Gustavo; Guevara, Mónica; Ginés, Pere; Soriano, Germán; Román, Eva; Sánchez-Delgado, Jordi; Ferrer, Roser; Nieto, Juan C; Sunyé, Pilar; Fuentes, Inma; Esteban, Rafael; Córdoba, Juan
Episodic hepatic encephalopathy is frequently precipitated by factors that induce circulatory dysfunction, cause oxidative stress-mediated damage or enhance astrocyte swelling. The administration of albumin could modify these factors and improve the outcome of hepatic encephalopathy. The aim of this study is to assess the efficacy of albumin in a multicenter, prospective, double-blind, controlled trial (ClinicalTrials.gov number, NCT00886925). Cirrhotic patients with an acute episode of hepatic encephalopathy (grade II-IV) were randomized to receive albumin (1.5g/kg on day 1 and 1.0g/kg on day 3) or isotonic saline, in addition to the usual treatment (laxatives, rifaximin 1200mg per day). The primary end point was the proportion of patients in which encephalopathy was resolved on day 4. The secondary end points included survival, length of hospital stay, and biochemical parameters. Fifty-six patients were randomly assigned to albumin (n=26) or saline (n=30) stratified by the severity of HE. Both groups were comparable regarding to demographic data, liver function, and precipitating factors. The percentage of patients without hepatic encephalopathy at day 4 did not differ between both groups (albumin: 57.7% vs. saline: 53.3%; p>0.05). However, significant differences in survival were found at day 90 (albumin: 69.2% vs. saline: 40.0%; p=0.02). Albumin does not improve the resolution of hepatic encephalopathy during hospitalization. However, differences in survival after hospitalization suggest that the development of encephalopathy may identify a subgroup of patients with advanced cirrhosis that may benefit from the administration of albumin. Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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
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.
Rani, P.; Hemanth Kumar, V. R.; Ravishankar, M.; Sivashanmugam, T.; Sripriya, R.; Trilogasundary, M.
Background: Fentanyl and dexmedetomidine have been tried to attenuate airway and circulatory reflexes during emergence and extubation individually but have not been compared with respect to the level of sedation to evolve a reliable technique for rapid and smooth extubation. Aim: To compare the effects of fentanyl and dexmedetomidine in attenuating airway and circulatory reflexes during emergence and extubation of the endotracheal tube. Setting and Design: This double-blind, randomized, controlled study was done in patients undergoing surgery under general anesthesia belonging to the American Society of Anesthesiologists physical status 1 or 2. Methodology: All patients received a standardized anesthetic protocol. Patients were randomized to receive either fentanyl 1 μg/kg or dexmedetomidine 0.75 μg/kg. Fifteen minutes before expected last surgical suture, isoflurane was cutoff and equal amount of test solution was given when train-of-four ratio was 0.3. The degree of sedation, airway, and circulatory responses at the time of suction and extubation were analyzed. Statistical Analysis Used: Chi-square test for nonparametric data and t-test for parametric data. Results: Heart rate (HR) was comparable in both the groups until endotracheal extubation. Later, there was rise in HR in fentanyl group. There was stastisticaly significant drop in blood pressure at 5 min after test drug administration in both the groups. Airway response for suctioning and extubation was better in dexmedetomidine group and it was associated with better sedation score than fentanyl group. Conclusion: Single dose of 0.75 μg/kg dexmedetomidine given 15 min before extubation provides smooth extubation when compared to fentanyl. PMID:27746558
Madhu S Agrawal
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.
Jafarbegloo, Esmat; Ahmari Tehran, Hoda; Dadkhah Tehrani, Tahmineh
Some pregnant women discontinue iron supplements consumption due to Gastrointestinal (GI) complications, whereas pregnancy induces the same complications physiologically. The aim of the present study was to assess GI complications of ferrous sulfate in pregnant women. This randomized, double-blind, placebo-controlled clinical trial was performed on 176 pregnant women referred to prenatal care clinic of Maryam Hospital from April 2011 to February 2012. Pregnant women with Hb ≥ 13.2 gr/dL at 13(th) - 18(th) weeks of gestation were selected based on the inclusion criteria and were randomly assigned to the ferrous sulfate and placebo groups. The ferrous sulfate group (n = 90) received a 50-mg ferrous sulfate tablet daily from the 20(th) week to the end of pregnancy and the placebo group (n = 89) received one placebo tablet in the same way. All participants were visited twice at 24(th) - 28(th) and 32(nd) - 36(th) weeks to assess the GI complications as well as Hb level to determine the Hb changes in two groups. Chi-square test, t-test and Kolmogorov-Smirnov test were used to analyze the data. P value of ferrous sulfate and placebo groups at 24(th) - 28(th) and 32(nd) - 36(th) weeks. Hemoglobin drop lower than 10.5 gr/dL at 24(th) - 28(th) weeks or lower than 11 g/dL at 32(nd) - 36(th) weeks was not observed in any cases. It can be concluded that GI complications in pregnant women using ferrous sulfate are mostly caused by physiologic changes of pregnancy rather than ferrous sulfate; therefore, it is not reasonable to stop using ferrous sulfate due to GI complications.
Zhao, Wangmiao; Ge, Chunyan; Zhang, Wanzeng; Sun, Zhaosheng; Li, Xiaowei
To investigate whether positioning the body in a lateral decubitus position will facilitate nasogastric tube insertion in unconscious patients. Inserting a nasogastric tube into unconscious patients can be challenging because these patients cannot cooperate with the operator. The piriform sinus and arytenoid cartilage are the most commonly reported impaction sites. However, we found that the first impaction site was the backward displaced tongue when inserting a nasogastric tube in unconscious patients who often exhibited glossoptosis. Performing an intubation in the lateral decubitus position could make this procedure easy. This prospective, double-blind, parallel, randomized controlled trial was conducted in Hengshui City, Hebei Province, China. 110 cases of unconscious patients were enrolled. The patients were randomly assigned to a conventional group (group C) or a lateral decubitus position group (group L). In group C, the nasogastric tube was inserted while the patients were in a supine position using the conventional technique, and in group L, the tube was inserted in a lateral decubitus position or further tilting the body to a prone decubitus position 20-30 degrees. We discussed reasonable intubation methods in unconscious patients by comparing the success rate on first insertion, the overall success rate, the intubation time and the complication rates between the two groups. Group L had a higher success rate on first insertion and overall success rate than group C (Ppassage. Nasogastric tube insertions in the lateral decubitus position are recommended in unconscious patients because of the higher success rate, reduced intubation time and lower complication rate. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
Full Text Available Objective: This study investigated the efficacy of bupivacaine wound infusion for pain control and opioid sparing effect after cesarean delivery.Materials and methods: We conducted a randomized double blind, placebo controlled clinical trial on 60 parturients undergoing cesarean section at a university hospital in Tehran. Patients were randomized to receive a pump infusion system that was filled with either 0.25% bupivacaine or equal volume of distilled water. A catheter was placed above the fascia and connected to electronic pump for 24 hours. Postoperative analog pain scores and morphine consumption were assessed at 6, 12 and 24 hours. Also time interval to first ambulation, length of hospitalization, complications and patient satisfaction were recorded. Data were analyzed using the SPSS software and P < 0.05 was considered statistically significant. Mann-Whitney u-test, student t-test and chi-square were used. Results: There were no differences in patient demographics and length of hospitalization and patient-generated resting pain scores between the two groups. Pain scores after coughing and leg raise during the first 6 postoperative hours were significantly less in the Bupivacaine group (P<0.001. The total dose of morphine consumption during the 24 hours study period was 2.5 ± 2.5 mg vs. 7.3 ± 2.7 mg for the bupivacaine and control groups, respectively (P<0.001. Compared with the control group, time to first ambulation was shorter in the bupivacaine group (11± 5h vs. 16 ± 4h (P< 0.01. Conclusion: Bupivacaine wound infusion was a simple and safe technique that provides effective analgesia and reduces morphine requirements after cesarean delivery.
Han, Kyungsun; Wang, Jinghwa; Seo, Jae-Gu; Kim, Hojun
The purpose of this study was to elucidate the effects of a dual-coated probiotic supplement (Duolac Care) on symptoms of diarrhea-predominant irritable bowel syndrome in a randomized double-blind clinical trial. Fifty subjects with diarrhea-predominant irritable bowel syndrome were randomly assigned to either the non-coating group or the dual-coating group in order to receive two capsules per day of multi-species probiotics containing 5 billion bacteria per capsule for 4 weeks. Data from an adequate relief questionnaire were used in assessment of primary outcome. Daily records of stool frequencies and the Bristol stool scale, a weekly symptom diary using 100-mm visual analog scale, and Beck depression inventories were collected. Blood tests including blood cell counts, interleukin-10, tumor necrosis factor-alpha and inducible nitric oxide synthase, and regulatory T cells-CD4 + CD25(high) T cells, CD4 + LAP + T cells and CD25(high) + LAP + T cells-were analyzed before and after the study. The shift of gut microbiota was investigated using a quantitative real-time polymerase chain reaction assay. Responses to the adequate relief questionnaire indicated significant improvement in overall discomfort in the dual-coating group and the ratio of normal stools to hard or watery stools had a better effect from dual-coated probiotics compared to non-coated probiotics. This may be due to a shift of intestinal microbiota, as our correlation analysis showed significant negative correlation between Bifidobacterium and urgency of defecation. Our result implies that dual-coating layers of probiotic supplement can be a candidate for treatment of diarrhea-predominant irritable bowel syndrome.
Felismino, Amanda Soares; Costa, Eduardo Caldas; Aoki, Marcelo Saldanha; Ferraresi, Cleber; de Araújo Moura Lemos, Telma Maria; de Brito Vieira, Wouber Hérickson
The aim of this randomized double-blind placebo-controlled study was to investigate the effect of low-level laser therapy (LLLT) on markers of muscle damage (creatine kinase (CK) and strength performance) in the biceps brachii. Twenty-two physically active men were randomized into two groups: placebo and laser. All volunteers were submitted to an exercise-induced muscle damage protocol for biceps brachii (biceps curl, 10 sets of 10 repetitions with load of 50% of one-repetition maximum test (1RM)). Active LLLT (808 nm; 100 mW; 35.7 W/cm(2), 357.14 J/cm(2) per point, energy of 1 J per point applied for 10 s on four points of the biceps brachii belly of each arm) or placebo was applied between the sets of the biceps curl exercise. CK activity and maximum strength performance (1RM) were measured before, immediately after, 24, 48, and 72 h after the exercise-induced muscle damage protocol. There was an increase in CK activity after the muscle damage protocol in both groups; however, this increase was attenuated in the laser group compared to the placebo group at 72 h (placebo = 841 vs. laser = 357%; p effect on the recovery of strength performance.
Makvandi, Somayeh; Tadayon, Mitra; Abbaspour, Mohammadreza
Aim To determine the effects of hyoscine-N-butyl bromide (HBB) rectal suppository on labor progress in primigravid women. Methods A randomized double-blind placebo-controlled clinical trial was carried out on 130 primigravid women admitted for spontaneous labor. The women were recruited based on the inclusion and exclusion criteria and randomized into the experimental (n = 65) and control group (n = 65). In the beginning of the active phase of labor, 20 mg of HBB rectal suppository was administered to the experimental group, while a placebo suppository was administered to the control group. Cervical dilatation and duration of active phase and second stage of labor were recorded. Results The rate of cervical dilatation was 2.6 cm/h in the experimental and 1.5 cm/h in the control group (P suppository in the active management of labor can shorten both the active phase and second stage of labor without significant side-effects. Registration No IRCT138804282204N1. PMID:21495198
Gottrup, F.; Jorgensen, B.; Karlsmark, T.
Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator...... without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly...
Full Text Available Background: Tranexamic acid has been used to reduce bleeding and the subsequent need for blood transfusion in many surgeries. Because orthognathic surgery can be associated with significant bleeding, this study evaluated the efficacy of prophylactic intravenous (IV tranexamic acid on blood loss during bimaxillary osteotomy. Methods: Thirty-two consecutive patients, scheduled for elective bimaxillary osteotomy, were included in the study and 16 were randomly assigned to each group. They received tranexamic acid (20 mg/kg or equal volume of placebo (normal saline intravenously just before induction of anesthesia. Intraoperative blood loss, pre and post operative hemoglobin (Hb and hematocrit (Hct concentration, duration of surgery, hospital stay time, and rate of blood transfusion were recorded for each patient. Results: Intraoperative blood loss in the tranexamic group and control group were 585.9 and 790 mL respectively (P=0.008. Postoperative Hb concentration at the 6 th hour was greater in the tranexamic group (P=0.008. There was no significant difference in the Hct concentration between the study groups. There was no significant difference in blood transfusion rate, hospital stay time and duration of surgery between the study groups. Conclusion: Preoperative IV administration of tranexamic acid reduces the amount of blood loss during bimaxillary osteotomy.
Full Text Available Background and objectives: Success rate of catheter applications is low in supraclavicular block. Thus, bupivacaine and levobupivacaine become important with their long effect time in single injection practices. In this study, we aimed to compare the effectiveness, side effects and complications of bupivacaine and levobupivacaine in supraclavicular block. Methods: Sixty patients aged between 20 and 65, with body weight between 50 and 100 kg, in the ASA I-II-III group who were scheduled for hand, forearm and arm surgery using supraclavicular block were randomized into two groups of 30. The patients received 30 ml 0.5% bupivacaine (Group B or 30 ml 0.5% levobupivacaine (Group L. Motor and sensory blocks were evaluated. Motor and sensory block onset times, total block durations, postoperative pain, amount of postoperative analgesic used and patient satisfaction were recorded. Results: Demographic data, distribution of surgical area and hemodynamic data were similar between the two groups. Surgery, motor and sensory block durations of Group B and L patients did not vary statistically significantly. However, motor and sensory block onset times in Group B were significantly shorter than Group L (p 0.05. Conclusion: 30 ml 0.5% bupivacaine and levobupivacaine provide similar block characteristics for supraclavicular block. Bupivacaine leads to faster motor and sensory block onset compared to levobupivacaine however similar duration of postoperative analgesia.
Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.
Full Text Available Background. Inconsistent data exist about the role of probiotics in the treatment of constipated children. The aim of this study was to investigate the effectiveness of probiotics in childhood constipation. Materials and Methods. In this placebo controlled trial, fifty-six children aged 4–12 years with constipation received randomly lactulose plus Protexin or lactulose plus placebo daily for four weeks. Stool frequency and consistency, abdominal pain, fecal incontinence, and weight gain were studied at the beginning, after the first week, and at the end of the 4th week in both groups. Results. Forty-eight patients completed the study. At the end of the fourth week, the frequency and consistency of defecation improved significantly (P=0.042 and P=0.049, resp.. At the end of the first week, fecal incontinence and abdominal pain improved significantly in intervention group (P=0.030 and P=0.017, resp. but, at the end of the fourth week, this difference was not significant (P=0.125 and P=0.161, resp.. A significant weight gain was observed at the end of the 1st week in the treatment group. Conclusion. This study showed that probiotics had a positive role in increasing the frequency and improving the consistency at the end of 4th week.
Walter F Schlech
Full Text Available Fifty renal transplant patients were randomized to receive either 800 mg acyclovir by mouth four times daily or identical placebo tablets for prophylaxis of herpes simplex infection. Patients were followed weekly to assess reactivation of herpes simplex, varicella zoster virus, Epstein-Barr virus or cytomegalovirus (CMV infections. The patients received standard immunosuppressive regimens including cyclosporine A. Acyclovir suppressed secretion of herpes simplex virus in treated patients (P=0.001. Three episodes of mucocutaneous herpes simplex virus occurred in placebo recipients and one in a noncompliant acyclovir recipient. A clinically important difference in graft survival was demonstrated, but because of sample size failed to reach statistical significance (P=0.11. No reactivation of varicella zoster virus, Epstein-Barr virus or CMV infection was detected in either group. Toxicity was limited to central nervous irritability. The authors conclude that high dose oral acyclovir provides effective prophylaxis for prevention of herpes simplex virus infections in renal transplantation and may be associated with increased graft survival, perhaps from suppression of CMV infection.
Full Text Available "nVarious studies suggest that selective serotonin reuptake inhibitors (SSRIs may be useful in treating pathological skin picking (PSP. This study sought to assess effectiveness of citalopram in comparison with placebo in treating PSP. Forty five individuals with PSP were recruited in a four-week, randomized clinical trial of citalopram (20 mg/day in comparison with placebo. Study measures assessing skin picking severity, mental health status, obsessive compulsive disorder and quality of life were given at baseline, weeks 2 and 4. PSP severity, general health status, obsession-compulsion severity and quality of life level were similar between two groups at baseline (P > 0.05. Treatment analyses revealed significant improvements in quality of life, general health status and obsession-compulsion severity in citalopram group compared to placebo group (P < 0.05. Mean PSP severity reduction in citalopram group was more than placebo group but this difference was not significant. Citalopram can improve general health status and quality of life in individuals with PSP but its effect on skin picking behavior doesn't differ significantly with placebo. Other trials with longer time are needed to determine the exact efficacy of citalopram on PSP
Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial.
Bingham, Clifton O; Mendelsohn, Alan M; Kim, Lilianne; Xu, Zhenhua; Leu, Jocelyn; Han, Chenglong; Lo, Kim Hung; Westhovens, Rene; Weinblatt, Michael E
To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab plus methotrexate (MTX) in an open-label extension of a phase III trial of patients with active rheumatoid arthritis (RA) despite MTX therapy. In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, 592 patients with active RA were randomized (2:1) to intravenous golimumab 2 mg/kg plus MTX (Group 1) or placebo plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter; placebo patients crossed over to golimumab at week 16 (early escape) or week 24 (crossover). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) response criteria, 28-joint count disease activity score using the C-reactive protein level (DAS28-CRP), physical function and quality of life measures, and changes in the modified Sharp/van der Heijde scores (SHS). Safety was monitored through week 112. In total, 486 patients (82.1%) continued treatment through week 100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at week 100. Clinical response and improvements in physical function and quality of life were generally maintained from week 24 through 2 years. Mean change from baseline to week 100 in SHS score was 0.74 in Group 1 and 2.10 in Group 2 (P = 0.005); progression from week 52 to week 100 was clinically insignificant in both groups. A total of 481 patients completed the safety followup through week 112; 79.1% had an adverse event, and 18.2% had a serious adverse event. Clinical response to IV golimumab plus MTX was maintained through week 100. Radiographic progression following golimumab treatment was clinically insignificant between week 52 and week 100. No unexpected adverse events occurred through week 112, and the safety profile was consistent with anti-tumor necrosis factor therapy. © 2015 The
Taslimi, Shervin; Vahidi, Hamed; Pourvaziri, Ali; Modabbernia, Amirhossein; Fallah, Arezoo Yeke; Yazdani, Nasrin; Taslimi, Negin; Hosseini, Mostafa; Zarandi, Masoud Motesadi
The aim of this study was to assess the effect of ondansetron on symptoms of patients with subjective tinnitus accompanied by sensorineural hearing loss or normal hearing. Sixty patients with a chief complaint of tinnitus (with duration of more than 3 months) were equally randomized to ondansetron or placebo for 4 weeks. The dose of ondansetron was gradually increased from 4 mg/day (one tablet) to 16 mg/day (4 tablets) during 12 days and then continued up to 4 weeks. The exact number of tablets was prescribed in the placebo group. Patients underwent audiologic examinations and filled questionnaires at baseline and after 4 weeks of treatment. Our primary outcomes were changes in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Severity Index (TSI) and visual analog scale (VAS) scores. Our secondary outcomes were the changes in depression and anxiety based on Hospital Anxiety and Depression (HADS) questionnaire, side effects, tinnitus loudness matching, tinnitus pitch matching, pure tone audiometry and speech recognition threshold (SRT). In the ondansetron and placebo groups, 27 and 26 patients completed the study, respectively. The changes in VAS (P = 0.934), THI (P = 0.776), anxiety (P = 0.313) and depression (P = 0.163) scores were not different between the groups. TSI score decreased significantly in the ondansetron compared with the placebo group (P = 0.004). Changes in tinnitus loudness matching (P = 0.75) and pitch matching (P = 0.56) did not differ between the two groups. Ondansetron, but not placebo, decreased the SRT threshold (right, P tinnitus hypothetically through cochlear amplification.
Full Text Available Introduction: Acceleration of wounf healing is intrested because of decreasing the risk of wound complication and infections as well as reducing the cost of treatment. In animal models, it has been proved that estrogen can accelerate wound healing. It has been also suggested that topical estrogen can eliminate effect of aging on wound healing and can increase the speed of wound healing in old people. Methods: We selected 16 young healthy people who developed symmetrical and ulcers (regarding size and depths after dermabrasion, shave and electrocoagulouzon and CO2 laser. Primary lesions of patients were benign and noninfective. Identical and symmetrical lesions of each patient were randomly divided into two groups (A and B. Topical estrogen with concentration of 0.625 mg/g in the base of silver sulfadiazine cream was applied to A ulcers and silver sulfadiazine cream alone was applied on B ulcers. Ulcers were dressed by Telfa gauzes. The A ulcers of each patients were compared to counterpart B ulcers in regard of redness, size, depth, general appearance of ulcers and wound healing duration at three days intervals by a physician. Results: Average time of healing was 10.8 days and 8.5 days for B (n=29 and A (n=29 ulcers, respectively (P < 0.001. In 78 percent of cases, the A ulcers were judged better than B ulcers by physician (P < 0.01. Discussion: It seems that estrogen not only accelerate healing of acute ulcers but also it is efficient in young healthy people who don"t have any hormonal or wound healing problems.
Full Text Available : OBJECTIVE: Controlled hypotension is commonly used to achieve a bloodless operative field which is needed for successful FESS. This study was carried out to assess the hypotensive effect of dexmedetomidine (DEX during FESS. METHODS: Fifty ASA grades I and II patients of either sex aged 20–50 years undergoing FESS were randomly divided into two groups of 25 each. Group D received 10–15 min prior to induction of anesthesia 1 μg/kg IV bolus DEX diluted in 10 ml of normal saline over 10 min. Immediately thereafter an infusion of 0.4 μg/kg/hr of DEX commenced. Group C received placebo bolus and infusion of saline at a rate similar to DEX in Group D. Standard anesthetic technique was used. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR; emergence time and total recovery from anesthesia (Aldrete score ≥9 were recorded. RESULT: Group D reached the desired MAP (55-65 mmHg. In group D patients the average MAP was 55.9±5.3 mm of Hg, where as in group C it was 86.2±11.4 mm of Hg. Patients in group D had a better surgical field, and the duration of surgery was significantly reduced(78.34±16.7mins in group D vs 103.2±113.1 mins in group C The mean awakening time was significantly reduced in patients of Group D (9.1±2.7 mins in group D vs12.8±2.2 mins in group C when compared to patients of Group C. CONCLUSION: This study demonstrated that dexmedetomidine is a safe agent for controlled hypotension and is effective in providing ideal surgical field during FESS.
Kishi, Taro; Matsuda, Yuki; Nakamura, Hiroshi; Iwata, Nakao
There is uncertainty about the efficacy and tolerability of blonanserin in schizophrenia. PubMed, the Cochrane Library databases, PsycINFO, and Google Scholar were searched up to September 2012. A systematic review and meta-analysis of individual patient data from randomized, controlled trials comparing blonanserin with other antipsychotics were conducted. The risk ratio (RR), 95% confidence intervals (CI), numbers-needed-to-harm (NNH), and weighted mean difference (WMD) were calculated. Four studies (total n = 1080) were identified (vs. risperidone studies [n = 508], vs. haloperidol studies [n = 572]). Comparing blonanserin with other pooled antipsychotics, there were no significant differences in the Positive and Negative Syndrome Scale (PANSS) total score (p = 0.75), PANSS positive (p = 0.41), PANSS negative (p = 0.09), and PANSS general psychopathology subscale scores (p = 0.96), and response rate (p = 0.72). However, blonanserin showed greater efficacy in PANSS negative subscale scores compared with haloperidol (WMD = -1.29, CI = -2.29 to -0.30, p = 0.01, I(2) = 0%). No significant differences were found in discontinuation rates between blonanserin and other pooled antipsychotics (due to any cause: p = 0.29, inefficacy: p = 0.32, adverse events: p = 0.56). Blonanserin had a 0.31 lower risk of hyperprolactinemia than the other pooled antipsychotics (CI = 0.20-0.49, NNH = not significant). While dizziness (RR = 0.47, CI = 0.23-0.93, NNH = not significant) and akathisia (RR = 0.54, CI = 0.32-0.90, NNH = 7) occurred significantly less often with blonanserin than with haloperidol, blonanserin had a 1.62 higher risk of akathisia than risperidone (CI = 1.18-2.22, NNH = 8) [corrected]. Our results suggest that although blonanserin has a more beneficial effect on negative symptoms than haloperidol, there was a significant difference in the adverse events profile between blonanserin and other antipsychotics. Copyright © 2012 Elsevier Ltd. All rights reserved.
Honey, R John D'A; Ghiculete, Daniela; Ray, A Andrew; Pace, Kenneth T
The optimal method of pain control after percutaneous nephrolithotomy (PCNL) remains controversial. We sought to determine whether intercostal nerve block with bupivicaine provided superior pain control, when compared with placebo, with a lower need for narcotics and improved health-related quality of life (HRQL) in the immediate postoperative period. Sixty-three patients were randomized to receive intercostal blockade with either 20 mL of 0.5% bupivacaine with epinephrine or 20 mL physiologic saline. All patients received intravenous narcotic patient-controlled analgesia (PCA) postoperatively. Data were collected on stone parameters, demographics, analgesic usage, length of stay, and HRQL as assessed by the Postoperative Recovery Scale. The mean age was 47.7±1.2 years; mean body mass index was 28.0±5.0 kg/m(2); mean stone diameter was 29.2±15.8 mm. Within the first 3 to 6 hours after surgery, there was a significant reduction in narcotic use for the group receiving intercostal nerve blockade with bupivacaine compared with placebo. At 3 hours, narcotic use was 2.4±3.1 mg vs 4.3±3.8 mg morphine equivalents (P=0.034), and within 6 hours of surgery, narcotic use was 5.9±6.1 mg vs 8.8±7.4 mg (P=0.096). Durable improvement in HRQL was also observed in patients receiving intercostal nerve blockade with bupivacaine compared with placebo (P=0.034). No complications were attributable to the intercostal nerve blocks in either group. Intercostal blockade with bupivacaine significantly improves both pain control and HRQL in the early postoperative period. The effectiveness of bupivacaine disappears within 6 hours of surgery, after which narcotic use becomes indistinguishable. Intercostal nerve blockade is an easy, safe, and inexpensive method that can be used to optimize pain control after PCNL.
Gupta, Pawan K; Chullikana, Anoop; Parakh, Rajiv; Desai, Sanjay; Das, Anjan; Gottipamula, Sanjay; Krishnamurthy, Sagar; Anthony, Naveen; Pherwani, Arun; Majumdar, Anish S
Background Peripheral vascular disease of the lower extremities comprises a clinical spectrum that extends from no symptoms to presentation with critical limb ischemia (CLI). Bone marrow derived Mesenchymal Stem Cells (BM- MSCs) may ameliorate the consequences of CLI due to their combinatorial potential for inducing angiogenesis and immunomodulatory environment in situ. The primary objective was to determine the safety of BM- MSCs in patients with CLI. Methods Prospective, double blind random...
Yi Poravuth; Duong Socheat; Ronnatrai Rueangweerayut; Chirapong Uthaisin; Aung Pyae Phyo; Neena Valecha; B. H. Krishnamoorthy Rao; Emiliana Tjitra; Asep Purnama; Isabelle Borghini-Fuhrer; Stephan Duparc; Chang-Sik Shin; Lawrence Fleckenstein
BACKGROUND: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND FINDINGS: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years) with microscopically confirmed P. vivax mono-infection ...
Kimihiro Okubo; Minoru Gotoh; Mikiya Asako; Yasuyuki Nomura; Michinori Togawa; Akihiro Saito; Takayuki Honda; Yoshihiro Ohashi
Background: Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). Methods: This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexo...
Yuan-Yu Chan; Yi-Hung Chen; Szu-Nian Yang; Wan-Yu Lo; Jaung-Geng Lin
Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed ...
Background Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave® Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chro...
Giath Gazal; Abdullah Muteb Alharbi; Khalid HidayatAllah Al-Samadani; Mohammad Dib Kanaa
Aims: A crossover double-blind, randomized study was designed to explore the efficacy of 2% mepivacaine with 1:100,000 adrenaline buccal infiltration and 4% articaine with 1:100,000 adrenaline buccal infiltration following 2% mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB) for testing pulp anesthesia of mandibular first molar teeth in adult volunteers. Materials and Methods: A total of 23 healthy adult volunteers received two regimens with at least 1-week apart; one...
Full Text Available Background: Quercetin, a phenolic compound, exhibits various functional effectsthat includeanti-oxidant, anti-dyslipidemic, and anti-dysglycemic activities, in addition tobeneficial effects on cognitive function. We evaluated the effects of a powder made from quercetin-rich onions (‘Quergold’ and ‘Sarasara-gold’ on cognitive function.Methods:In this randomized, double-blind, placebo-controlled study, we randomized 50 adults (25 males and 25 females, aged 65–84 years and made them consume products made from quercetin-rich (active test food group or quercetin-free(placebo food group onions. Cognitive function,hematological, and biological examinations were performed at the beginning (week 0 of the study and at weeks 12 and 24 after the start of the study. Results:There were no differences in the Mini-Mental State Examination (MMSE and cognitive impairment rating scale scores between the two groups. However, in younger subjects, the MMSE scores were significantly higher in the active test food group than in the placebo food group at week 24 (p = 0.019. Conclusion: These results suggest that the ingestion of quercetin-rich onions improves cognitive function and reduce cognitive declinein elderly people.
Javidnia, K; Dastgheib, L; Mohammadi Samani, S; Nasiri, A
Idiopathic hirsutism is defined as the occurrence of excessive male pattern hair growth in women who have a normal ovulatory menstrual cycle and normal levels of serum androgens. It may be a disorder of peripheral androgen metabolism. In this study we evaluated the clinical response of idiopathic hirsutism to topical Fennel extract. Fennel, Foeniculum vulgare, is a plant, which has been used as an estrogenic agent. The ethanolic extract of Fennel was obtained by using a soxhlete apparatus. In a double blind study, 38 patients were treated with creams containing 1%, 2% of Fennel extract and placebo. Hair diameter was measured and rate of growth was considered. The efficacy of treatment with the cream containing 2% Fennel is better than the cream containing 1% Fennel and these two were more potent than placebo. The mean values of hair diameter reduction was 7.8%, 18.3% and -0.5% for patients receiving the creams containing 1%, 2% and 0% (placebo) respectively.
Barrack, R L; Wolfe, M W; Waldman, D A; Milicic, M; Bertot, A J; Myers, L
During a two-year period, eighty-nine patients who were scheduled to have a total knee arthroplasty for the treatment of degenerative osteoarthrosis were randomly assigned to one of two groups: resurfacing of the patella or retention of the patella. All patients received the same posterior cruciate-sparing prosthesis, and all operations were performed by, or under the direct supervision of, one of us. Three patients died in the early postoperative period. The remaining eighty-six patients (118 knees; fifty-eight that had had resurfacing of the patella and sixty that had not) formed the study group. They were followed for a mean of thirty months (range, twenty-four to forty-four months). Evaluation was performed with use of the clinical scoring system of The Knee Society, a patient-satisfaction questionnaire, specific questions regarding patellofemoral symptoms and function, and radiographs. All clinical evaluations were performed by the same research nurse, without the involvement of a physician, in a blinded manner (neither the nurse nor the patient had knowledge of whether the patella had been resurfaced). Preoperatively, the mean Knee Society score, on a scale ranging from 0 to 200 points, was 89.7 points (range, 33 to 132 points); postoperatively, this score improved to a mean of 172.7 points (range, 98 to 200 points). With the numbers available for study, we could detect no significant difference between the knees that had had patellar resurfacing and those that had not with regard to the over-all score (p = 0.63), the subscore for pain (p = 0.56), or the subscore for function (p = 0.77). We also could detect no difference between the treatment groups, with the numbers available, with regard to patient satisfaction or the responses to questions involving the function of the patellofemoral joint, including the ability to exit from an automobile, to rise from a chair, and to climb stairs. Thirty-two patients had bilateral total knee replacement with resurfacing
Full Text Available Abstract Background The extent to which mental and physical exercise may slow cognitive decline in adults with early signs of cognitive impairment is unknown. This article provides the rationale and methodology of the first trial to investigate the isolated and combined effects of cognitive training (CT and progressive resistance training (PRT on general cognitive function and functional independence in older adults with early cognitive impairment: Study of Mental and Regular Training (SMART. Our secondary aim is to quantify the differential adaptations to these interventions in terms of brain morphology and function, cardiovascular and metabolic function, exercise capacity, psychological state and body composition, to identify the potential mechanisms of benefit and broader health status effects. Methods SMART is a double-blind randomized, double sham-controlled trial. One hundred and thirty-two community-dwelling volunteers will be recruited. Primary inclusion criteria are: at risk for cognitive decline as defined by neuropsychology assessment, low physical activity levels, stable disease, and age over 55 years. The two active interventions are computerized CT and whole body, high intensity PRT. The two sham interventions are educational videos and seated calisthenics. Participants are randomized into 1 of 4 supervised training groups (2 d/wk × 6 mo in a fully factorial design. Primary outcomes measured at baseline, 6, and 18 months are the Alzheimer's Disease Assessment Scale (ADAS-Cog, neuropsychological test scores, and Bayer Informant Instrumental Activities of Daily Living (B-IADLs. Secondary outcomes are psychological well-being, quality of life, cardiovascular and musculoskeletal function, body composition, insulin resistance, systemic inflammation and anabolic/neurotrophic hormones, and brain morphology and function via Magnetic Resonance Imaging (MRI and Spectroscopy (fMRS. Discussion SMART will provide a novel evaluation of the
Full Text Available Objective: The study was done to compare propofol and ketofol for sedation of pediatric patients scheduled for elective pulmonary valve implantation in a catheterization laboratory. Design: This was a double-blind randomized study. Setting: This study was conducted in Prince Sultan Cardiac Centre, Saudi Arabia. Patients and Methods: The study included 60 pediatric patients with pulmonary regurge undergoing pulmonary valve implantation. Intervention: The study included sixty patients, classified into two groups (n = 30. Group A: Propofol was administered as a bolus dose (1–2 mg/kg and then a continuous infusion of 50–100 μg/kg/min titrated as needed. Group B: Ketofol was administered 1–2 mg/kg and then infusion of 20–60 μg/kg/min. The medication was prepared by the nursing staff and given to anesthetist blindly. Measurements: The monitors included heart rate, mean arterial blood pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, fentanyl dose, antiemetic medications, and Aldrete score. Main Results: The comparison of heart rate, mean arterial pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, and Aldrete score were insignificant (P > 0.05. The total fentanyl increased in Group A more than Group B (P = 0.045. The required antiemetic drugs increased in Group A patients more than Group B (P = 0.020. The durations of full recovery and in the postanesthesia care unit were longer in Group A than Group B (P = 0.013, P < 0.001, respectively. Conclusion: The use of propofol and ketofol is safe and effective for sedation of pediatric patients undergoing pulmonary valve implantation in a catheterization laboratory. However, ketofol has many advantages more than the propofol. Ketofol has a rapid onset of sedation, a rapid recovery time, decreased incidence of nausea and vomiting and leads to rapid discharge of patients from the postanesthesia care unit.
Miriam Bellini Gazi
Full Text Available CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to assess the efficacy of intra-articular morphine and bupivacaine on the joint flexion and extension angles of patients with knee osteoarthritis. DESIGN AND SETTING: A randomized double-blind study was performed at a pain clinic of Universidade Federal de São Paulo. METHODS: Thirty-nine patients with pain for more than three months, of intensity greater than three on a numerical scale (zero to 10, were included. G1 patients received 1 mg (1 ml of morphine diluted in 9 ml of saline, intra-articularly, and G2 patients received 25 mg (10 ml of 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic supplementation using 500 mg doses of paracetamol was also determined. RESULTS: No significant difference in pain intensity was observed between G1 and G2. Significant decreases in pain at rest and during movement and significant increases in mean flexion and extension angles were observed in both groups, with no significant difference between the two groups. The mean total amount of paracetamol used over a seven-day period was 3578 mg in G1 and 5333 mg in G2 (P = 0.2355; Mann-Whitney test. CONCLUSION: The analgesic effects of 1 mg of morphine and 25 mg of 0.25% bupivacaine were similar among patients with osteoarthritis of the knee.
Full Text Available Objective: "n "nAttention-Deficit/Hyperactivity Disorder (ADHD is one of the most common mental disorders in childhood and it continues to adulthood without proper treatment. Stimulants have been used in treatment of ADHD for many years and the efficacy of methylphenidate (MPH in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies. However, there are some concerns about stimulants. Finding other effective medications for the treatment of adult ADHD seems necessary. We tried a monoamine oxidase inhibitor, Selegiline, as there are some theoretical and experimental evidences for the efficacy of this medication . "nMethod: Forty patients were randomized to receive Selegiline or methylphenidate in an equal ratio for an 8-week double-blind clinical trial. Each patient filled the CAARS self report screening form before starting to take the medication and in weeks 2-4-6 and 8. Patients were also assessed by a psychiatrist at the baseline and on each 14 days up to the 8 weeks period. "nResults: The mean score of the two groups- receiving Selegiline or methylphenidate- decreased over the 8 weeks. There was not a significant difference between the two groups. The most prevalent side-effect of methylphenidate was decrease of appetite and for Selegiline change in sleep pattern . "nConclusion: Selegiline is as effective as methylphenidate in the treatment of adults with Attention-Deficit/Hyperactivity Disorder. Selegiline can be an alternative medication for the treatment of adult ADHD If its clinical efficacy is proven by other larger studies .
Silverman, Ann; Samuels, Qiana; Gikas, Helen; Nawras, Ali
Chronic pain related to postoperative abdominal adhesions is a common problem with no standard analgesic regimen currently established. In a double-blind, placebo-controlled trial, we examined the effects of pregabalin on pain modulation in patients with prior abdominal surgery and documented adhesion. The primary outcome measure was pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption. A total of 18 women were randomized to receive either the drug (n = 11) or placebo (n = 7). Thirteen patients (eight pregabalin, five placebo) completed the blinded phase and 10 patients (seven pregabalin, three placebo) completed the open-label phase. Statistical analysis was performed in two settings: 1) Week 0 (as the baseline) through the end of Week 7 of the blinded fixed-dose phase; and 2) Week 7 (as the baseline) along With weeks 8 through 11 of the open-label phase. The pain score result from the blinded phase setting indicated that the amount of decrease was significantly greater in the drug group (P = 0.024), whereas the pain score result from the open-label setting indicated that the amount of decrease was significantly greater in the placebo group (P = 0.043). Only the sleep score result in the open-label setting was significantly greater in the placebo group (P = 0.024). We conclude that pregabalin significantly reduced patient-documented pain scores compared with placebo in our small cohort of patients with abdominal adhesion pain.
Full Text Available OBJECTIVE A genuine attempt was made to find ideal drug for premedication in paediatric surgical patients. Dexmedetomidine a newer, highly selective alpha-2 agonist was compared to midazolam via intramuscular route. Setting: Institute-Department of Anaesthesiology, Krishna Institute of Medical Sciences. METHODS Dexmedetomidine group (Group D with the conventional Midazolam group (Group M was compared for premedication in cases of paediatric surgical patients. A total of sixty patients, scheduled for elective surgery of duration 15 to 90 minutes, were enrolled and randomly assigned in a double blind manner to Group D and Group M. Intramuscular Dexmedetomidine (1.5 mcg/kg in Group D or midazolam (0.05 mg/kg in Group M, as a premedication in preoperative room was given and sedation score with Ramsay sedation scale and parent separation anxiety score were recorded. After 45 mins, patient was shifted in the operation room and a standard technique of anaesthesia was applied to all patients. Mask acceptance score, wake up score, demand of post-op analgesia, time for first analgesia requirement were recorded. RESULTS Our study comparing dexmedetomidine with midazolam premedication found a stable heart rate and blood pressure with comparable sedative effects, (90% vs 56%, P value 0.0074 concluded that dexmedetomidine group had better sedative effect. Parent separation anxiety score was better with dexmedetomidine group compared to midazolam group with p value 0.0419 (93% vs 70%. Mask acceptance was better with dexmedetomidine group compared to midazolam group with p value 0.0153 (90% vs 60%. Wake up score were compared and dexmedetomidine was better than midazolam with p value 0.0001 (93% vs 46%. CONCLUSION Premedication with low-dose intramuscular dexmedetomidine resulted in better sedation, lower anxiety levels during parent separation, better mask acceptance and wake up behaviour as compared with low-dose intramuscular midazolam.
Dalli, E; Colomer, E; Tormos, M C; Cosín-Sales, J; Milara, J; Esteban, E; Sáez, G
Crataegus laevigata is a medicinal plant most commonly used for the treatment of heart failure and psychosomatic disorders. Based on previous experimental findings, this double-blind placebo-controlled study was aimed at finding beneficial effects of C. laevigata on biomarkers of coronary heart disease (CHD). The study included 49 diabetic subjects with chronic CHD who were randomly assigned to the treatment for 6 months with either a micronized flower and leaf preparation of C. laevigata (400 mg three times a day) or a matching placebo. Blood cell count, lipid profile, C-reactive protein, neutrophil elastase (NE) and malondialdehyde were analyzed in plasma at baseline, at one month and six months. The main results were that NE decreased in the C. laevigata group compared to the placebo group. In the C. laevigata group, baseline figures (median and interquartile range) were 35.8 (4.5) and in the placebo group 31 (5.9). At the end of the study, values were 33.2 (4.7) ng/ml and 36.7 (2.2) ng/ml, respectively; plaevigata, added to statins, decreased LDL cholesterol (LDL-C) (mean±SD) from 105±28.5 mg/dl at baseline to 92.7±25.1 mg/dl at 6 months (p=0.03), and non-HDL cholesterol from 131±37.5 mg/dl to 119.6±33 mg/dl (plaevigata decreased NE and showed a trend to lower LDL-C compared to placebo as add-on-treatment for diabetic subjects with chronic CHD. Copyright © 2010 Elsevier GmbH. All rights reserved.
Nimmerichter, Alfred; Holdhaus, Johann; Mehnen, Lars; Vidotto, Claudia; Loidl, Markus; Barker, Alan R.
Limited research has suggested that acute exposure to negatively charged ions may enhance cardio-respiratory function, aerobic metabolism and recovery following exercise. To test the physiological effects of negatively charged air ions, 14 trained males (age: 32 ± 7 years; : 57 ± 7 mL min-1 kg-1) were exposed for 20 min to either a high-concentration of air ions (ION: 220 ± 30 × 103 ions cm-3) or normal room conditions (PLA: 0.1 ± 0.06 × 103 ions cm-3) in an ionization chamber in a double-blinded, randomized order, prior to performing: (1) a bout of severe-intensity cycling exercise for determining the time constant of the phase II response ( τ) and the magnitude of the slow component (SC); and (2) a 30-s Wingate test that was preceded by three 30-s Wingate tests to measure plasma [adrenaline] (ADR), [nor-adrenaline] (N-ADR) and blood [lactate] (BLac) over 20 min during recovery in the ionization chamber. There was no difference between ION and PLA for the phase II τ (32 ± 14 s vs. 32 ± 14 s; P = 0.7) or SC (404 ± 214 mL vs 482 ± 217 mL; P = 0.17). No differences between ION and PLA were observed at any time-point for ADR, N-ADR and BLac as well as on peak and mean power output during the Wingate tests (all P > 0.05). A high-concentration of negatively charged air ions had no effect on aerobic metabolism during severe-intensity exercise or on performance or the recovery of the adrenergic and metabolic responses after repeated-sprint exercise in trained athletes.
Full Text Available Gregory J Dale,1 Stephanie Phillips,2 Gregory L Falk3 1Westmead Hospital Clinical School, The University of Sydney, 2Sydney Adventist Hospital Clinical School, The University of Sydney, 3Concord Clinical School, The University of Sydney, Sydney, Australia Abstract: This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286 or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487. Three adverse events occurred in the lidocaine group (25% of patients. Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested. Keywords: analgesia, local anesthetics, intravenous infusions, pharmacokinetics
Yongsiri, Somchai; Thammakumpee, Jiranuch; Prongnamchai, Suriya; Tengpraettanakorn, Pechngam; Chueansuwan, Rachaneeporn; Tangjaturonrasme, Siriporn; Dinchuthai, Pakaphan
The incidence of hypokalemia in continuous ambulatory peritoneal dialysis (CAPD) patients is about 15-60%, leading to significant complications. There is no standard treatment other than potassium supplement in this setting. The aim of this study was to evaluate effect of spironolactone 25 mg/day in CAPD patients who have a history of hypokalemia. This is a randomized, double-blind, placebo-controlled, cross-over study in CAPD patients who had a history of hypokalemia. Study intervention is 4 weeks of oral spironolactone 25 mg/day or placebo, cross-over after a 2-week wash-out period. The primary outcome was the difference of serum potassium before and after 4 weeks of spironolactone treatment. Serum potassium was measured every 2 weeks, serum magnesium, urine and peritoneal fluid potassium measured before and after each treatment period. We enrolled 24 patients, and 20 completed the cross-over study. Ten patients were anuric. The total doses of potassium supplement were the same during the study period. Serum potassium levels before and after study intervention were not significantly different in both groups (4.23 ± 0.64 vs. 3.90 ± 0.59 mEq/L for spironolactone P = 0.077 and 3.84 ± 0.62 vs. 3.91 ± 0.52 for placebo P = 0.551). Total 24-h potassium, magnesium, sodium excretion, urine volume and ultrafiltration volume were not affected by spironolactone or placebo. There was one episode of hyperkalemia (5.6 mEq/L) during the spironolactone treatment period. Spironolactone 25 mg/day does not have a significant effect on serum potassium or urine and peritoneal excretion rate in CAPD patients who have a history of hypokalemia.
Roberio Dias LEITE
Full Text Available Context Glutamine is the main source of energy of the enterocyte and diarrhea and weight loss are frequent in HIV infected patients. Objective To determine the effect of alanyl-glutamine supplementation on intestinal permeability and absorption in these patients. Methods Randomized double-blinded, placebo-controlled study using isonitrogenous doses of alanyl-glutamine (24 g/day and placebo (glycine, 25 g/day during 10 days. Before and after this nutritional supplementation lactulose and mannitol urinary excretion were determined by high performance liquid chromatography. Results Forty six patients with HIV/AIDS, 36 of whom were male, with 37.28 ± 3 (mean ± standard error years were enrolled. Twenty two and 24 subjects were treated with alanyl-glutamine and with glycine respectively. In nine patients among all in the study protocol that reported diarrhea in the 14 days preceding the beginning of the study, mannitol urinary excretion was significantly lower than patients who did not report this symptom [median (range: 10.51 (3.01–19.75 vs. 15.37 (3.93–46.73; P = 0.0281] and lactulose/mannitol ratio was significantly higher [median (range: 0.04 (0.00–2.89 vs. 0.02 (0.00–0.19; P = 0.0317]. There was also a significant increase in mannitol urinary excretion in the group treated with alanyl-glutamine [median (range: 14.38 (8.25–23.98 before vs 21.24 (6.27–32.99 after treatment; n = 14, P = 0.0382]. Conclusion Our results suggest that the integrity and intestinal absorption are more intensely affected in patients with HIV/AIDS who recently have had diarrhea. Additionally, nutritional supplementation with alanyl-glutamine was associated with an improvement in intestinal absorption.
Brambilla, Michela; Cotelli, Maria; Manenti, Rosa; Dagani, Jessica; Sisti, Davide; Rocchi, Marco; Balestrieri, Matteo; Pini, Stefano; Raimondi, Sara; Saviotti, Francesco Maria; Scocco, Paolo; de Girolamo, Giovanni
Deficits in social cognition, including emotional processing, are hallmarks of schizophrenia and antipsychotic agents seem to be ineffectual to improve these symptoms. However, oxytocin does seem to have beneficial effects on social cognition. The aim of this study was to examine the effects of four months of treatment with intranasal oxytocin, in 31 patients with schizophrenia, on distinct aspects of social cognition. This was assessed using standardized and experimental tests in a randomized, double-blind, placebo-controlled, cross-over trial. All patients underwent clinical and experimental assessment before treatment, four months after treatment and at the end of treatment. Social cognition abilities were assessed with the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Reading the Mind in the Eyes task (RMET). Furthermore, an Emotional Priming Paradigm (EPP) was developed to examine the effects of oxytocin on implicit perceptual sensitivity to affective information and explicit facial affect recognition. We found that oxytocin improved performance on MSCEIT compared to placebo in Branch 3-Understanding Emotion (p-value=0.004; Cohen׳s d=1.12). In the EPP task, we observed a significant reduction of reaction times for facial affect recognition (p-value=0.021; Cohen׳s d=0.88). No effects were found for implicit priming or for theory of mind abilities. Further study is required in order to highlight the potential for possible integration of oxytocin with antipsychotic agents as well as to evaluate psycho-social treatment as a multi-dimensional approach to increase explicit emotional processing abilities and compensate social cognition deficits related to schizophrenia.
Hamazaki, Kei; Itomura, Miho; Hamazaki, Tomohito; Sawazaki, Shigeki
One-third of the total population seems to develop minor recurrent aphthous stomatitis (RAS) during their lifetime. However, well-controlled dietary intervention studies to prevent minor RAS are very rare. The objective of the present study was to investigate whether the prevalence of RAS decreased with perilla oil (rich in alpha-linolenic acid). Thirty subjects (8 men and 22 women) who had minor RAS at least once a month were randomly allocated to a soybean oil group or a perilla oil group in a double-blind manner (experimental phase) after a run-in phase of 4 mo during which subjects used a reference oil, the most popular cooking oil in Japan, or a 50/50 mixture of soybean oil and rapeseed oil. During the experimental phase, subjects were asked to use soybean oil or perilla oil as the sole cooking oil for 8 mo. Blood samples were collected at the start and end of the experimental phase for fatty acid analysis of total plasma phospholipid fraction. Occurrence and needed days for healing of minor RAS were recorded during the two phases and compared. alpha-Linolenic acid concentrations in the plasma phospholipid fraction increased significantly in both groups during the experimental phase to a similar extent. The prevalence of minor RAS in the experimental phase decreased significantly in both groups compared with the run-in phase to a similar extent, without intergroup differences. Perilla oil, which is rich in alpha-linolenic acid, was not superior to soybean oil in preventing minor RAS. There was a possibility that avoiding rapeseed oil might be beneficial for prevention of minor RAS.
Soliman, Rabie; Mofeed, Mohammed; Momenah, Tarek
The study was done to compare propofol and ketofol for sedation of pediatric patients scheduled for elective pulmonary valve implantation in a catheterization laboratory. This was a double-blind randomized study. This study was conducted in Prince Sultan Cardiac Centre, Saudi Arabia. The study included 60 pediatric patients with pulmonary regurge undergoing pulmonary valve implantation. The study included sixty patients, classified into two groups (n = 30). Group A: Propofol was administered as a bolus dose (1-2 mg/kg) and then a continuous infusion of 50-100 μg/kg/min titrated as needed. Group B: Ketofol was administered 1-2 mg/kg and then infusion of 20-60 μg/kg/min. The medication was prepared by the nursing staff and given to anesthetist blindly. The monitors included heart rate, mean arterial blood pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, fentanyl dose, antiemetic medications, and Aldrete score. The comparison of heart rate, mean arterial pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, and Aldrete score were insignificant (P > 0.05). The total fentanyl increased in Group A more than Group B (P = 0.045). The required antiemetic drugs increased in Group A patients more than Group B (P = 0.020). The durations of full recovery and in the postanesthesia care unit were longer in Group A than Group B (P = 0.013, P < 0.001, respectively). The use of propofol and ketofol is safe and effective for sedation of pediatric patients undergoing pulmonary valve implantation in a catheterization laboratory. However, ketofol has many advantages more than the propofol. Ketofol has a rapid onset of sedation, a rapid recovery time, decreased incidence of nausea and vomiting and leads to rapid discharge of patients from the postanesthesia care unit.
Thomas Mc Graw
AIM:to evaluate the efficacy and safety of polyethylene glycol(PEG)3350 in subjects with self-reported occasional constipation.METHODS:Eligible subjects≥17 years of age were randomized to receive either placebo or PEG 335017 g once daily in this multicenter,double-blind trial.Evaluations were conducted before(baseline)and after a 7-d treatment period.The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools.Secondary efficacy variables assessed the severity of the subjects’daily bowel movement(BM)symptoms,and preference of laxatives based on diary entries,visual analog scale scores,and questionnaires.RESULTS:Of the 203 subjects enrolled in the study,11had major protocol violations.Complete resolution was noted by 36/98(36.7%)subjects in the PEG 3350 group and 23/94(24.5%)in the placebo group(P=0.0595).The number of com