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Sample records for randomized treatment trial

  1. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  2. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  3. Assertive community treatment in the Netherlands : a randomized controlled trial

    NARCIS (Netherlands)

    Sytema, S.; Wunderink, L.; Bloemers, W.; Roorda, L.; Wiersma, D.

    Objective: Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for

  4. Assertive community treatment in the Netherlands: a randomized controlled trial.

    Science.gov (United States)

    Sytema, S; Wunderink, L; Bloemers, W; Roorda, L; Wiersma, D

    2007-08-01

    Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for other European countries with modern mental health services. Open randomized controlled trial of long-term severely mentally ill patients [Health of the Nation Outcome Scales (HoNOS) total score >or=15], assigned to assertive community treatment (n = 59) or to standard community mental health care (n = 59). sustained contact; housing stability and admission days. This trial is registered as an International Standard Randomized Clinical Trial, number ISRCTN 11281756. Assertive community treatment was significantly better in sustaining contact with patients, but not in reducing admission days. No differences in housing stability, psychopathology, social functioning or quality of life were found. The results are in agreement with UK studies. However, the sustained contact potential of assertive community treatment is important, as too many patients are lost in standard care.

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

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

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

  6. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  7. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  8. Randomized trial of aromatherapy. Successful treatment for alopecia areata.

    Science.gov (United States)

    Hay, I C; Jamieson, M; Ormerod, A D

    1998-11-01

    To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.

  9. Aromatherapy as treatment for postoperative nausea: a randomized trial.

    Science.gov (United States)

    Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George

    2013-09-01

    Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.

  10. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial

  11. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  12. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    The increasing emergence of predictive markers for different treatments in the same patient population allows us to define stratified treatment strategies. We consider randomized clinical trials that compare a standard treatment with a new stratified treatment strategy that divides the study...... population into subgroups receiving different treatments. Because the new strategy may not be beneficial in all subgroups, we consider in this paper an intermediate approach that establishes a treatment effect in a subset of patients built by joining several subgroups. The approach is based on the simple...

  13. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

    Science.gov (United States)

    Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael

    2016-04-01

    Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  15. Antiplatelet treatments: recent evidence from randomized controlled trials.

    Science.gov (United States)

    Vogel, Birgit; Baber, Usman

    2017-07-01

    To provide an overview of selected randomized studies reported over the last 2 years evaluating antiplatelet therapies in patients with either acute or stable manifestations of atherosclerosis. From large outcome trials included evidence for reduced risk of ischemic events associated with use of ticagrelor and aspirin versus aspirin alone, albeit with an increased bleeding risk in patients with stable coronary artery disease and history of myocardial infarction. No benefit regarding ischemic outcomes could be demonstrated for ticagrelor monotherapy compared with aspirin or clopidogrel in patients with stroke or peripheral vascular disease, respectively. Results from pharmacokinetic/pharmacodynamic studies suggest that switching from prasugrel to ticagrelor is safe, regardless of the use of a loading dose, and that loading with prasugrel or ticagrelor compared with clopidogrel leads to more prompt and potent platelet inhibition in patients undergoing ad hoc percoutaneous coronary intervention. No evidence could be demonstrated for the prognostic value of routine platelet function monitoring to adjust antiplatelet therapy. Large outcome trials demonstrated various effects of antithrombotic strategies including ticagrelor on clinical outcomes across patient populations. Pharmacokinetic/pharmacodynamic studies confirmed a more prompt and potent platelet inhibition after loading with the new P2Y12 inhibitors versus clopidogrel, and suggested the safety of switching from prasugrel to ticagrelor.

  16. Caffeine for treatment of Parkinson disease: a randomized controlled trial.

    Science.gov (United States)

    Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit

    2012-08-14

    Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime

  17. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial.

    Science.gov (United States)

    Titov, Nickolai; Andrews, Gavin; Johnston, Luke; Robinson, Emma; Spence, Jay

    2010-09-01

    Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen's d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic

  18. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days)

    OpenAIRE

    Kuijper Ed J; Ablij Hans C; Delfos Nathalie M; Wattel-Louis G Hanke; Koster Ted; Leyten Eliane MS; Elzevier Henk W; Assendelft Willem JJ; van't Wout Jan W; van Nieuwkoop Cees; Pander Jan; Blom Jeanet W; Spelt Ida C; van Dissel Jaap T

    2009-01-01

    Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febri...

  19. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    OpenAIRE

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-01-01

    Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred ...

  20. Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

    DEFF Research Database (Denmark)

    Tulstrup, Morten; Larsen, Hanne Bækgaard; Castor, Anders

    2015-01-01

    BACKGROUND: When offered participation in clinical trials, families of children with cancer face a delicate balance between cure and toxicity. Since parents and children may perceive this balance differently, this paper explores whether adolescent patients have different enrollment patterns...... compared to younger children in trials with different toxicity profiles. PROCEDURE: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx....../VCR) trial tested treatment intensifications to improve cure, and the back-to-back ALL2008 6-mercaptopurine (6MP) and ALL2008 PEG-asparaginase (ASP) trials tested treatment intensifications (6MP) and toxicity reduction without compromising survival (ASP). Patient randomization and toxicity data were...

  1. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    Science.gov (United States)

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  2. Randomized clinical trial of ascorbic acid in the treatment of pressure ulcers

    NARCIS (Netherlands)

    ter Riet, G.; Kessels, A. G.; Knipschild, P. G.

    1995-01-01

    The objective of this study was to assess the effects of ascorbic acid supplementation, 500 mg twice daily in the treatment of pressure ulcers as an adjunct to standardized treatment. The design consisted of a multicenter blinded randomized trial. The control group received 10 mg of ascorbic acid

  3. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    Science.gov (United States)

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  4. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial.

    Science.gov (United States)

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-03-30

    The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity) and secondary outcome was: general satisfaction with treatment. 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%). The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. CCMO; NL23471.098.08.

  5. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  6. Treatment of Co-Occurring Substance Abuse and Suicidality among Adolescents: A Randomized Trial

    Science.gov (United States)

    Esposito-Smythers, Christianne; Spirito, Anthony; Kahler, Christopher W.; Hunt, Jeffrey; Monti, Peter

    2011-01-01

    Objective: This study tested a cognitive-behavioral treatment protocol for adolescents with a co-occurring alcohol or other drug use disorder (AOD) and suicidality in a randomized clinical trial. Method: Forty adolescents (M[subscript age] = 15 years; 68% female, 89% White) and their families recruited from an inpatient psychiatric hospital were…

  7. The Effectiveness of Two Grammar Treatment Procedures for Children with SLI: A Randomized Clinical Trial

    Science.gov (United States)

    Smith-Lock, Karen M.; Leitão, Suze; Prior, Polly; Nickels, Lyndsey

    2015-01-01

    Purpose: This study compared the effectiveness of two grammar treatment procedures for children with specific language impairment. Method: A double-blind superiority trial with cluster randomization was used to compare a cueing procedure, designed to elicit a correct production following an initial error, to a recasting procedure, which required…

  8. Mindfulness-Based Stress Reduction for the Treatment of Adolescent Psychiatric Outpatients: A Randomized Clinical Trial

    Science.gov (United States)

    Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.

    2009-01-01

    Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…

  9. Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

    Science.gov (United States)

    Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

    2016-01-01

    Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

  10. Power for Detecting Treatment by Moderator Effects in Two- and Three-Level Cluster Randomized Trials

    Science.gov (United States)

    Spybrook, Jessaca; Kelcey, Benjamin; Dong, Nianbo

    2016-01-01

    Recently, there has been an increase in the number of cluster randomized trials (CRTs) to evaluate the impact of educational programs and interventions. These studies are often powered for the main effect of treatment to address the "what works" question. However, program effects may vary by individual characteristics or by context,…

  11. Childhood Resiliency Effects from Schoolwide Treatment: A Cluster Randomized Trial

    Science.gov (United States)

    Hinerman, Krystal M.; Hull, Darrell M.; Hayes, DeMarquis; Powell, Marvin G.; Ferguson, Sarah; Naslund-Hadley, Emma I.

    2014-01-01

    The purpose of the Childhood Resiliency Effects from Schoolwide Treatment (CREST) Pilot was to implement a comprehensive school wide social and character development program aimed at decreasing violence among students and assisting students exposed to violence in Belize City. This one-year pilot program implemented portions of the Positive Action…

  12. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids : 10-year outcomes from the randomized EMMY trial

    NARCIS (Netherlands)

    de Bruijn, Annefleur M.; Ankum, Willem M.; Reekers, Jim A.; Birnie, Erwin; van der Kooij, Sanne M.; Volkers, Nicole A.; Hehenkamp, Wouter J. K.

    2016-01-01

    BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled

  13. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial

    Directory of Open Access Journals (Sweden)

    van Heukelem Henk A

    2008-08-01

    Full Text Available Abstract Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab

  14. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

    Science.gov (United States)

    Eshuis, Emma J; Bemelman, Willem A; van Bodegraven, Ad A; Sprangers, Mirjam AG; Bossuyt, Patrick MM; de Wit, AW Marc van Milligen; Crolla, Rogier MPH; Cahen, Djuna L; Oostenbrug, Liekele E; Sosef, Meindert N; Voorburg, Annet MCJ; Davids, Paul HP; van der Woude, C Janneke; Lange, Johan; Mallant, Rosalie C; Boom, Maarten J; Lieverse, Rob J; van der Zaag, Edwin S; Houben, Martin HMG; Vecht, Juda; Pierik, Robert EGJM; van Ditzhuijsen, Theo JM; Prins, Hubert A; Marsman, Willem A; Stockmann, Henricus B; Brink, Menno A; Consten, Esther CJ; van der Werf, Sjoerd DJ; Marinelli, Andreas WKS; Jansen, Jeroen M; Gerhards, Michael F; Bolwerk, Clemens JM; Stassen, Laurents PS; Spanier, BW Marcel; Bilgen, Ernst Jan Spillenaar; van Berkel, Anne-Marie; Cense, Huib A; van Heukelem, Henk A; van de Laar, Arnold; Slot, Warner Bruins; Eijsbouts, Quirijn A; van Ooteghem, Nancy AM; van Wagensveld, Bart; van den Brande, Jan MH; van Geloven, Anna AW; Bruin, Karien F; Maring, John K; Oldenburg, Bas; van Hillegersberg, Richard; de Jong, Dirk J; Bleichrodt, Robert; van der Peet, Donald L; Dekkers, Pascal EP; Goei, T Hauwy; Stokkers, Pieter CF

    2008-01-01

    Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the

  15. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  16. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Moen Maarten

    2012-03-01

    Full Text Available Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity and secondary outcome was: general satisfaction with treatment. Results 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%. The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. Conclusion This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. Trial registration CCMO; NL23471.098.08

  17. Internet Treatment Addressing either Insomnia or Depression, for Patients with both Diagnoses: A Randomized Trial

    Science.gov (United States)

    Blom, Kerstin; Jernelöv, Susanna; Kraepelien, Martin; Bergdahl, Malin Olséni; Jungmarker, Kristina; Ankartjärn, Linda; Lindefors, Nils; Kaldo, Viktor

    2015-01-01

    Study Objectives: To compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression. Design: A 9-w randomized controlled trial with 6- and 12-mo follow-up. Setting: Internet Psychiatry Clinic, Stockholm, Sweden. Participants: Forty-three adults in whom comorbid insomnia and depression were diagnosed, recruited via media and assessed by psychiatrists. Interventions: Guided Internet-delivered cognitive behavior therapy (ICBT) for either insomnia or depression. Measurements and Results: Primary outcome measures were symptom self-rating scales (Insomnia Severity Index [ISI] and the Montgomery Åsberg Depression Rating Scale [MADRS-S]), assessed before and after treatment with follow-up after 6 and 12 mo. The participants' use of sleep medication and need for further treatment after completion of ICBT was also investigated. The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment (P = 0.05), and equally effective in reducing depression severity. Group differences in insomnia severity were maintained during the 12-mo follow-up period. Post treatment, participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment (P Internet-delivered treatment with cognitive behavior therapy (ICBT) for insomnia was more effective than ICBT for depression for patients with both diagnoses. This indicates, in line with previous research, that insomnia when comorbid with depression is not merely a symptom of depression, but needs specific treatment. Trial Registration: The trial was registered at Clinicaltrials.gov, registration ID: NCT01256099. Citation: Blom K, Jernelöv S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjärn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. SLEEP 2015;38(2):267–277. PMID:25337948

  18. Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors

    Directory of Open Access Journals (Sweden)

    Menning Hans

    2006-07-01

    Full Text Available Abstract Background We translated, modified, and extended a cognitive behavioral treatment (CBT protocol by Blanchard and Hickling (2003 for the purpose of treating survivors of MVA with full or subsyndromal posttraumatic stress disorder (PTSD whose native language is German. The treatment manual included some additional elements, e. g. cognitive procedures, imaginal reliving, and facilitating of posttraumatic growth. The current study was conducted in order to test the efficacy of the modified manual by administering randomized controlled trial in which a CBT was compared to a wait-list control condition. Methods Forty-two motor vehicle accident survivors with chronic or severe subsyndromal posttraumatic stress disorder (PTSD completed the treatment trial with two or three detailed assessments (pre, post, and 3-month follow-up. Results CAPS-scores showed significantly greater improvement in the CBT condition as compared to the wait list condition (group × time interaction effect size d = 1.61. Intent-to-treat analysis supported the outcome (d = 1.34. Categorical diagnostic data indicated clinical recovery of 67% (post-treatment and 76% (3 months FU in the treatment group. Additionally, patients of the CBT condition showed significantly greater reductions in co-morbid major depression than the control condition. At follow-up the improvements were stable in the active treatment condition. Conclusion The degree of improvement in our treatment group was comparable to that in previously reported treatment trials of PTSD with cognitive behavioral therapy. Trial registration ISRCTN66456536

  19. Traditional Chinese Medicine for Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Cao, Huijuan; Lewith, George T.

    2010-01-01

    Abstract Background Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety. Objective To review systematically the beneficial and harmful effects of TCM therapies for FM. Methods We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI). Results Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, –3.21; 95% CI –4.23 to –2.11; p effect, with a random-effect model, compared with sham acupuncture (MD, –0.55; 95% CI, –1.35–0.24; p = 0.17; I2 = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, –1.66; 95% CI, –2.14 to –1.19; p effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials. Conclusions TCM therapies appear to be effective for treating FM. However, further large, rigorously designed trials are warranted because of insufficient methodological rigor in the included trials. PMID:20423209

  20. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2006-10-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or

  1. A randomized controlled trial of Minnesota day clinic treatment of alcoholics

    DEFF Research Database (Denmark)

    Grønbaek, Morten; Nielsen, Bent

    2007-01-01

    dependence were included in a 1-year clinical trial. MEASUREMENTS: Self-reported drinking pattern and the seven composite scores from the addiction severity index (ASI). FINDINGS: A total of 42 (57%) and 45 (61%) patients (P > 0.05) completed the Minnesota treatment and public treatment, respectively......AIM: To compare the Minnesota day clinic treatment with the traditional public psychosocial treatment. DESIGN: Randomized controlled trial. SETTING: Public out-patient alcohol clinic and privately funded Minnesota day clinic in Denmark. PARTICIPANTS: A total of 148 individuals with alcohol......% of the patients treated according to the Minnesota model were abstainers, while this was the case for 43% of the patients treated in the public out-patient alcohol clinic (P = 0.249). There were insignificant differences in the seven ASI scores. CONCLUSIONS: Twelve months after onset of treatment, the Minnesota...

  2. Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Salsbury, Stacie A; DeVocht, James W; Hondras, Maria

    2014-01-01

    and study participants regarding treatment group assignment. METHODS: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed...... the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non......-parametric statistics were calculated. RESULTS: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs...

  3. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tulbure Bogdan Tudor

    2012-10-01

    Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

  4. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

    OpenAIRE

    Stegenga Boudewijn; Dommerholt Jan; de Gast Arthur; Bron Carel; Wensing Michel; Oostendorp Rob AB

    2011-01-01

    Abstract Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group receiv...

  5. Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review.

    Science.gov (United States)

    Gerbens, L A A; Chalmers, J R; Rogers, N K; Nankervis, H; Spuls, P I

    2016-10-01

    'Symptoms' is a core outcome domain for atopic eczema (AE) trials, agreed by consensus as part of the Harmonising Outcome Measures for Eczema (HOME) initiative. To standardize and validate the core domain symptoms and symptom instruments for AE trials the HOME roadmap is followed. Its first step is to establish if and how symptoms have been measured in published AE treatment trials. Therefore the Global Resource for Eczema Trials database was used to collect all randomized controlled trials (RCTs) of treatments for AE between January 2000 and April 2014. Study selection and data extraction were performed by three reviewers independently. We identified the use of symptoms in 295 of 378 trials (78%). Symptoms as a primary end point were applied by 147 RCTs (50%). Seventeen different symptoms were measured, but mostly itch and sleep loss. Symptoms were assessed by only 37% of trials by a stand-alone symptom measurement. Overall 63% of RCTs used a composite instrument, and 30 different instruments were identified. The Scoring Atopic Dermatitis (SCORAD) index was the most commonly applied, but only 23% of RCTs reported the SCORAD symptom score separately. This systematic review demonstrates that symptoms, most frequently itch and sleep loss, are commonly reported in AE treatment trials, but are measured using many different instruments. Often symptoms are evaluated as part of a composite instrument, and currently it is not possible to extract symptoms-only data from most published studies. Future trials should report symptom scores to permit meta-analysis of the core outcomes. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  6. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    Science.gov (United States)

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998 PMID:26155004

  7. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial.

    Science.gov (United States)

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998.

  8. A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

    Directory of Open Access Journals (Sweden)

    Pei He

    2015-10-01

    Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

  9. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  10. A randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment entry.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E; Vocci, Frank J

    2014-09-01

    Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pPrison buprenorphine Treatment Condition (47.5% vs. 33.7%). Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. A Randomized Controlled Trial of Prison-Initiated Buprenorphine: Prison Outcomes and Community Treatment Entry

    Science.gov (United States)

    Gordon, Michael S.; Kinlock, Timothy W.; Schwartz, Robert P.; Fitzgerald, Terrence; O’Grady, Kevin E.; Vocci, Frank J.

    2014-01-01

    Background Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. Methods This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3–9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. Results There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pbuprenorphine Treatment Condition (47.5% vs. 33.7%). Conclusions Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. PMID:24962326

  12. Randomized trial within a trial of yellow 'post-it notes' did not improve questionnaire response rates among participants in a trial of treatments for neck pain.

    Science.gov (United States)

    Tilbrook, Helen E; Becque, Taeko; Buckley, Hannah; MacPherson, Hugh; Bailey, Mathew; Torgerson, David J

    2015-04-01

    Attrition is a threat to the validity of randomized trials. Few randomized studies have been conducted within randomized trials to test methods of reducing attrition. To test whether using yellow post-it notes on follow-up questionnaires in the ATLAS treatment trial for neck pain reduces attrition. Nested trial within a trial. ATLAS participants were randomized to have their 6-month follow-up questionnaire have a 3' yellow post-it note with a handwritten message encouraging return of questionnaire. 499 participants were independently randomized using simple allocation to receive the post-it notes or not. Two hundred fifteen of the 256 (84.0%) participants in the intervention group returned their questionnaire compared with 205 of the 243 (84.4%) in the control group. There was no difference in time to response. Yellow post-it notes do not enhance questionnaire return rates for participants in a randomized trial of neck pain. © 2014 John Wiley & Sons, Ltd.

  13. Treatment duration of febrile urinary tract infection (FUTIRST trial: a randomized placebo-controlled multicenter trial comparing short (7 days antibiotic treatment with conventional treatment (14 days

    Directory of Open Access Journals (Sweden)

    Kuijper Ed J

    2009-08-01

    Full Text Available Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febrile urinary tract infection will be randomly allocated to a short treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded placebo or standard treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded ciprofloxacin. The study is performed in the Leiden region in which one university hospital, 6 general hospitals and 32 primary health care centers are clustered. Patients eligible for randomization are competent patients aged 18 years or above with a presumptive diagnosis of acute pyelonephritis as defined by the combination of fever, one or more symptoms of urinary tract infection and a positive urine nitrate test and/or the presence of leucocyturia. Exclusion criteria are known allergy to fluoroquinolones, female patients who are pregnant or lactating, polycystic kidney disease, permanent renal replacement therapy, kidney transplantation, isolation of ciprofloxacin-resistant causal uropathogen, renal abscess, underlying chronic bacterial prostatitis, metastatic infectious foci and inability to obtain follow-up. The primary endpoint is the clinical cure rate through the 10- to 18-day post-treatment visit. Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the

  14. Functional treatment versus plaster for simple elbow dislocations (FuncSiE: a randomized trial

    Directory of Open Access Journals (Sweden)

    Verleisdonk Egbert JMM

    2010-11-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation, health-related quality of life (Short-Form 36 and EuroQol-5D, radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications, costs, and cost-effectiveness. Discussion The successful

  15. A pilot randomized controlled trial of pioglitazone for the treatment of poorly controlled asthma in obesity.

    Science.gov (United States)

    Dixon, Anne E; Subramanian, Meenakumari; DeSarno, Michael; Black, Kendall; Lane, Lisa; Holguin, Fernando

    2015-11-26

    Obese asthmatics tend to have poorly controlled asthma, and resistance to standard asthma controller medications. The purpose of this study was to determine the efficacy of pioglitazone, an anti-diabetic medication which can alter circulating adipokines and have direct effects on asthmatic inflammation, in the treatment of asthma in obesity. A two-center, 12-week, randomized, placebo-controlled, double-blinded trial. Treatments were randomly assigned with concealment of allocation. The primary outcome was difference in change in airway reactivity between participants assigned to pioglitazone versus placebo at 12 weeks. Twenty-three participants were randomized to treatment, 19 completed the study. Median airway reactivity, measured by PC20 to methacholine was 1.99 (IQR 3.08) and 1.60 (5.91) mg/ml in placebo and pioglitazone group at baseline, and 2.37 (15.22) and 5.08 (7.42) mg/ml after 12 weeks, p = 0.38. There was no difference in exhaled nitric oxide, asthma control or lung function between treatment groups over the 12 week trial. Participants assigned to pioglitazone gained a significant amount more weight than those assigned to placebo (pioglitazone group mean weight 113.6, CI 94.5-132.7 kg at randomization and 115.9, CI 96.9-135.1 at 12 weeks; placebo mean weight 127.5, CI 108.4 - 146.6 kg at randomization and 124.5, CI 105.4 - 143.6 kg at 12 weeks; p = 0.04). This pilot study suggests limited efficacy for pioglitazone in the treatment of poorly controlled asthma in obesity, and also the potential for harm, given the weight gain in those assigned to active treatment, and the association between increased weight and worse outcomes in asthma. Clinicaltrials.gov (NCT00634036).

  16. Neurodynamic treatment for patients with nerve-related leg pain: Protocol for a randomized controlled trial.

    Science.gov (United States)

    Ferreira, Giovanni E; Stieven, Fábio F; Araújo, Francisco X; Wiebusch, Matheus; Rosa, Carolina G; Plentz, Rodrigo Della Méa; Silva, Marcelo F

    2016-10-01

    To investigate if neurodynamic treatment is more effective than advice to remain active in patients with nerve-related leg pain. Parallel-group randomized controlled trial blinded to the outcome assessor conducted in Porto Alegre, Brazil. Sixty patients recruited from the community and private practices. Patients will be randomly assigned to receive four sessions of neurodynamic treatment over two weeks comprising passive lumbar foramen opening and neurodynamic sliders plus home exercises or advice to remain active. Leg pain intensity, disability, low back pain intensity, functional ability, symptoms distribution and global impression of recovery will be assessed at two and four weeks after randomization. A linear mixed model will be employed for each outcome following intention to treat principles. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010

    Directory of Open Access Journals (Sweden)

    Williams Hywel C

    2011-05-01

    Full Text Available Abstract Background Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011 covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each

  18. Matching of treatment-resistant heroin-dependent patients to medical prescription of heroin or oral methadone treatment: results from two randomized controlled trials

    NARCIS (Netherlands)

    Blanken, Peter; Hendriks, Vincent M.; Koeter, Maarten W. J.; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    AIMS: To investigate which baseline patient characteristics of treatment-resistant heroin addicts differentially predicted treatment response to medical heroin prescription compared to standard methadone maintenance treatment. DESIGN: Two open-label randomized controlled trials; pooled data.

  19. Depression beliefs, treatment preference, and outcomes in a randomized trial for major depressive disorder.

    Science.gov (United States)

    Dunlop, Boadie W; Kelley, Mary E; Mletzko, Tanja C; Velasquez, Cristina M; Craighead, W Edward; Mayberg, Helen S

    2012-03-01

    Previous studies suggest that individual preferences for medication- or psychotherapy-based treatments for depression may affect outcomes in clinical trials that compare these two forms of treatment. We assessed patients' beliefs about the causes of their depression, their preferred treatment, and strength of that preference in 80 patients participating in a 12-week clinical trial evaluating neuroimaging predictors of response to cognitive behavior therapy (CBT) or escitalopram. Forty-five patients expressed a preference for one of the 2 treatments, but being matched to preference did not influence remission or completion rates. Medication-preferring patients were more likely to terminate the trial early, regardless of treatment received. CBT-preferring patients rarely endorsed unknown causes for their depression, and medication-preferring patients were highly unlikely to identify pessimistic attitudes as a source of their depression. Among patients willing to be randomized to treatment, preference does not appear to strongly influence outcome. Specific preferences for CBT or medication may reflect differing conceptualizations about depressive illness, knowledge of which may enhance treatment retention and efficacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

  20. Sequential causal inference: application to randomized trials of adaptive treatment strategies.

    Science.gov (United States)

    Dawson, Ree; Lavori, Philip W

    2008-05-10

    Clinical trials that randomize subjects to decision algorithms, which adapt treatments over time according to individual response, have gained considerable interest as investigators seek designs that directly inform clinical decision making. We consider designs in which subjects are randomized sequentially at decision points, among adaptive treatment options under evaluation. We present a sequential method to estimate the comparative effects of the randomized adaptive treatments, which are formalized as adaptive treatment strategies. Our causal estimators are derived using Bayesian predictive inference. We use analytical and empirical calculations to compare the predictive estimators to (i) the 'standard' approach that allocates the sequentially obtained data to separate strategy-specific groups as would arise from randomizing subjects at baseline; (ii) the semi-parametric approach of marginal mean models that, under appropriate experimental conditions, provides the same sequential estimator of causal differences as the proposed approach. Simulation studies demonstrate that sequential causal inference offers substantial efficiency gains over the standard approach to comparing treatments, because the predictive estimators can take advantage of the monotone structure of shared data among adaptive strategies. We further demonstrate that the semi-parametric asymptotic variances, which are marginal 'one-step' estimators, may exhibit significant bias, in contrast to the predictive variances. We show that the conditions under which the sequential method is attractive relative to the other two approaches are those most likely to occur in real studies.

  1. Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials.

    Science.gov (United States)

    Kasper, Siegfried

    2015-06-01

    Based on subgroup analyses of randomized, controlled clinical trials, we review the efficacy of three phytopharmaceutical drugs, respectively of the corresponding active substances silexan® (WS® 1265, lavender oil) in anxiety disorders, WS® 5570 (Hypericum extract) in major depression, and EGb 761® (Ginkgo biloba extract) in Alzheimer, vascular, or mixed type dementia, in elderly patients aged ≥ 60 years. Four trials were eligible in each indication. Meta-analyses and analyses based on pooled raw data showed that the three drugs were significantly superior to placebo in the elderly subset, and that their treatment effects reflected in the main outcome measures (Hamilton Anxiety scale, Hamilton Depression scale, Neuropsychiatric Inventory) were comparable with those observed in the original trials without age restrictions. The results confirm the efficacy of the three herbal active substances in elderly patients of ≥ 60 years of age. In anxiety, depression, and dementia, they thus represent efficacious and well-tolerated alternatives to synthetic drugs.

  2. Cumulative Hazard Ratio Estimation for Treatment Regimes in Sequentially Randomized Clinical Trials.

    Science.gov (United States)

    Tang, Xinyu; Wahed, Abdus S

    2015-05-01

    The proportional hazards model is widely used in survival analysis to allow adjustment for baseline covariates. The proportional hazard assumption may not be valid for treatment regimes that depend on intermediate responses to prior treatments received, and it is not clear how such a model can be adapted to clinical trials employing more than one randomization. Besides, since treatment is modified post-baseline, the hazards are unlikely to be proportional across treatment regimes. Although Lokhnygina and Helterbrand (Biometrics 63: 422-428, 2007) introduced the Cox regression method for two-stage randomization designs, their method can only be applied to test the equality of two treatment regimes that share the same maintenance therapy. Moreover, their method does not allow auxiliary variables to be included in the model nor does it account for treatment effects that are not constant over time. In this article, we propose a model that assumes proportionality across covariates within each treatment regime but not across treatment regimes. Comparisons among treatment regimes are performed by testing the log ratio of the estimated cumulative hazards. The ratio of the cumulative hazard across treatment regimes is estimated using a weighted Breslow-type statistic. A simulation study was conducted to evaluate the performance of the estimators and proposed tests.

  3. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial.

    Science.gov (United States)

    Herrin, Kinsey; Geil, Mark

    2016-04-01

    Orthotic treatment of idiopathic toe walking is complicated by the lack of a known etiology. This study compared control of toe walking using an articulated ankle-foot orthosis versus a rigid carbon fiber footplate attached to a foot orthosis. Ascertain differences between two orthoses in the control of idiopathic toe walking. Randomized controlled trial. A total of 18 children with idiopathic toe walking were randomized to either the ankle-foot orthosis or foot orthosis treatment group in a Parallel Randomized Controlled Trial with no blinding. Prior to and after 6 weeks of treatment, participants completed three-dimensional gait assessment and the L-test of Functional Mobility. Parents completed a satisfaction survey and a subset of the Orthotic and Prosthetic User Survey after treatment. Nine participants were analyzed in each group. Both groups showed significant improvement in kinematics versus baseline with orthoses; however, when the orthoses were removed, the ankle-foot orthosis group did not immediately sustain this improvement, while the foot orthosis group did. Parents preferred the foot orthosis for donning and appearance. The ankle-foot orthosis controls idiopathic toe walking, but subjects may revert to earlier patterns following treatment. The foot orthosis does not control idiopathic toe walking as well but is less restrictive and more accepted by children and their parents, with similar out-of-brace effects. This study suggests that sequential orthotic treatment for children with idiopathic toe walking (ITW) may be beneficial. Initial treatment could include a less restrictive orthosis like a foot orthosis (FO); if this is unsuccessful within a set time frame, then the patient may require a more restrictive form of treatment such as an ankle-foot orthosis (AFO). © The International Society for Prosthetics and Orthotics 2015.

  4. Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    Science.gov (United States)

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

    2011-01-01

    Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

  5. Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

    Science.gov (United States)

    Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

    2015-01-01

    To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

  6. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  7. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    National Research Council Canada - National Science Library

    Seo, Byung-Kwan; Lee, Jun-Hwan; Kim, Pil-Kun; Baek, Yong-Hyeon; Jo, Dae-Jean; Lee, Sanghun

    2014-01-01

    ... in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA...

  8. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation

    National Research Council Canada - National Science Library

    Gil, Alberto Luiz; Azevedo, Mirela Jobim de; Tomasetto, Giovani Generali; Muniz, Carlos Henrique Gervini; Lavinsky, Jacó

    2011-01-01

    .... The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients...

  9. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial.

    Science.gov (United States)

    Yin, Xuan; Gou, Minghui; Xu, Jian; Dong, Bo; Yin, Ping; Masquelin, Fernand; Wu, Junyi; Lao, Lixing; Xu, Shifen

    2017-09-01

    The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primary insomnia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventy-two patients with primary insomnia were randomly assigned into two groups - the acupuncture group, who received acupuncture treatment, and the control group, who received sham acupuncture treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Compared with pretreatment baseline, patients in both groups had varying degrees of improvements in their sleep conditions. Paired t-test showed that there was a significant difference in all indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks post-treatment (F = 11.3, p = 0.001), four weeks post-treatment (F = 33.6, p acupuncture treatment group after the two-week and four-week follow-ups. Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients' sleep quality and improving their psychological health. Chinese Clinical Trial Registry: Chi CTR-TRC-14004859. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  10. Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schepers, Nicolien J; Bakker, Olaf J; Besselink, Marc G H; Bollen, Thomas L; Dijkgraaf, Marcel G W; van Eijck, Casper H J; Fockens, Paul; van Geenen, Erwin J M; van Grinsven, Janneke; Hallensleben, Nora D L; Hansen, Bettina E; van Santvoort, Hjalmar C; Timmer, Robin; Anten, Marie-Paule G F; Bolwerk, Clemens J M; van Delft, Foke; van Dullemen, Hendrik M; Erkelens, G Willemien; van Hooft, Jeanin E; Laheij, Robert; van der Hulst, René W M; Jansen, Jeroen M; Kubben, Frank J G M; Kuiken, Sjoerd D; Perk, Lars E; de Ridder, Rogier J J; Rijk, Marno C M; Römkens, Tessa E H; Schoon, Erik J; Schwartz, Matthijs P; Spanier, B W Marcel; Tan, Adriaan C I T L; Thijs, Willem J; Venneman, Niels G; Vleggaar, Frank P; van de Vrie, Wim; Witteman, Ben J; Gooszen, Hein G; Bruno, Marco J

    2016-01-05

    Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients. The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation. The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications. Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012).

  11. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    Science.gov (United States)

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  12. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Emma Robinson

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for generalized anxiety disorder (GAD has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ and the Generalized Anxiety Disorder-7 Item (GAD-7. Completion rates were high, and both treatment groups reduced scores on the PSWQ (p<0.001 and GAD-7 (p<0.001 compared to the delayed treatment group, but did not differ from each other. Within group effect sizes on the PSWQ were 1.16 and 1.07 for the clinician- and technician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment

  13. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Nickolai Titov

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for depression is effective when guided by a clinician, less so if unguided. QUESTION: Would guidance from a technician be as effective as guidance from a clinician? METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II and the Patient Health QUESTIONnaire-9 Item (PHQ-9. Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001 and PHQ-9 (p<0.001 compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large

  14. Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

    2015-07-15

    Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

  15. Lactobacillus GG for treatment of acute childhood diarrhoea: an open labelled, randomized controlled trial.

    Science.gov (United States)

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-03-01

    Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; PLactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; PLactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.

  16. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days).

    Science.gov (United States)

    van Nieuwkoop, Cees; van't Wout, Jan W; Assendelft, Willem J J; Elzevier, Henk W; Leyten, Eliane M S; Koster, Ted; Wattel-Louis, G Hanke; Delfos, Nathalie M; Ablij, Hans C; Kuijper, Ed J; Pander, Jan; Blom, Jeanet W; Spelt, Ida C; van Dissel, Jaap T

    2009-08-19

    Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febrile urinary tract infection will be randomly allocated to a short treatment arm (7 days of ciprofloxacin or 7 days of empirical beta-lactams +/- gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded placebo) or standard treatment arm (7 days of ciprofloxacin or 7 days of empirical beta-lactams +/- gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded ciprofloxacin). The study is performed in the Leiden region in which one university hospital, 6 general hospitals and 32 primary health care centers are clustered. Patients eligible for randomization are competent patients aged 18 years or above with a presumptive diagnosis of acute pyelonephritis as defined by the combination of fever, one or more symptoms of urinary tract infection and a positive urine nitrate test and/or the presence of leucocyturia. Exclusion criteria are known allergy to fluoroquinolones, female patients who are pregnant or lactating, polycystic kidney disease, permanent renal replacement therapy, kidney transplantation, isolation of ciprofloxacin-resistant causal uropathogen, renal abscess, underlying chronic bacterial prostatitis, metastatic infectious foci and inability to obtain follow-up. The primary endpoint is the clinical cure rate through the 10- to 18-day post-treatment visit. Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the clinical cure rate 70- to 84-day post-treatment

  17. A Randomized Controlled Trial of Intensive Sleep Retraining (ISR): A Brief Conditioning Treatment for Chronic Insomnia

    Science.gov (United States)

    Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

    2012-01-01

    Study Objective: To investigate the effectiveness of intensive sleep retraining in comparison and combination with traditional behavioral intervention for chronic primary insomnia. Participants: Seventy-nine volunteers with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomly assigned either to intensive sleep retraining (ISR), stimulus control therapy (SCT), ISR plus SCT, or the control (sleep hygiene) treatment condition. Intervention: ISR treatment consisted of 50 sleep onset trials over a 25-h sleep deprivation period. Measurements and Results: Treatment response was assessed with sleep diary, activity monitoring, and questionnaire measures. The active treatment groups (ISR, SCT, ISR+SCT) all resulted in significant improvements in sleep onset latency and sleep efficiency, with moderate to large effect sizes from pre- to post-treatment. Wake time after sleep onset decreased significantly in the SCT and ISR+SCT groups. Total sleep time increased significantly in the ISR and ISR+SCT treatment groups. Participants receiving ISR (ISR, ISR+SCT) experienced rapidly improved SOL and TST during treatment, suggesting an advantage of rapid improvements in sleep in response to ISR. Although there were few statistically significant differences between groups on individual variables, ISR+SCT resulted in consistently larger effect sizes of change than other treatments, including questionnaire measures of sleep quality, sleep self-efficacy, and daytime functioning. The combination treatment group (ISR+SCT) showed trends to outperform other active treatment groups with fewer treatment dropouts, and a greater proportion of treatment responders with 61% reaching “good sleeper” status. Treatment gains achieved at post-treatment in the active treatment groups were largely maintained throughout follow-up periods to 6 months. Conclusion: This 25-hour intensive conditioning treatment for chronic insomnia can produce rapid improvements in

  18. Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Caroline Maltepe

    2013-01-01

    Full Text Available Objectives. To determine whether the initiation of treatment (preemptive treatment before the symptoms of nausea and vomiting of pregnancy (NVP versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047. In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13% in the first 3 weeks of NVP (P=0.05. In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50% (P<0.002. Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

  19. Vitamin D for treatment and prevention of infectious diseases: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Yamshchikov, Alexandra V; Desai, Nirali S; Blumberg, Henry M; Ziegler, Thomas R; Tangpricha, Vin

    2009-01-01

    To review the existing human controlled intervention studies of vitamin D as adjunctive therapy in settings of infection and provide recommendations for design and implementation of future studies in this field on the basis of the evidence reviewed. We conducted a systematic review of randomized controlled clinical trials that studied vitamin D for treatment or prevention of infectious diseases in humans. Studies from 1948 through 2009 were identified through search terms in PubMed and Ovid MEDLINE. Thirteen published controlled trials were identified by our search criteria. Ten trials were placebo controlled, and 9 of the 10 were conducted in a rigorous double-blind design. The selected clinical trials demonstrated substantial heterogeneity in baseline patient demographics, sample size, and vitamin D intervention strategies. Serious adverse events attributable to vitamin D supplementation were rare across all studies. On the basis of studies reviewed to date, the strongest evidence supports further research into adjunctive vitamin D therapy for tuberculosis, influenza, and viral upper respiratory tract illnesses. In the selected studies, certain aspects of study design are highlighted to help guide future clinical research in the field. More rigorously designed clinical trials are needed for further evaluation of the relationship between vitamin D status and the immune response to infection as well as for delineation of necessary changes in clinical practice and medical care of patients with vitamin D deficiency in infectious disease settings.

  20. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism.

    Science.gov (United States)

    Hardan, Antonio Y; Gengoux, Grace W; Berquist, Kari L; Libove, Robin A; Ardel, Christina M; Phillips, Jennifer; Frazier, Thomas W; Minjarez, Mendy B

    2015-08-01

    With rates of autism diagnosis continuing to rise, there is an urgent need for effective and efficient service delivery models. Pivotal Response Treatment (PRT) is considered an established treatment for autism spectrum disorder (ASD); however, there have been few well-controlled studies with adequate sample size. The aim of this study was to conduct a randomized controlled trial to evaluate PRT parent training group (PRTG) for targeting language deficits in young children with ASD. Fifty-three children with autism and significant language delay between 2 and 6 years old were randomized to PRTG (N = 27) or psychoeducation group (PEG; N = 26) for 12 weeks. The PRTG taught parents behavioral techniques to facilitate language development. The PEG taught general information about ASD (clinical trial NCT01881750; http://www.clinicaltrials.gov). Analysis of child utterances during the structured laboratory observation (primary outcome) indicated that, compared with children in the PEG, children in the PRTG demonstrated greater improvement in frequency of utterances (F(2, 43) = 3.53, p = .038, d = 0.42). Results indicated that parents were able to learn PRT in a group format, as the majority of parents in the PRTG (84%) met fidelity of implementation criteria after 12 weeks. Children also demonstrated greater improvement in adaptive communication skills (Vineland-II) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG. This is the first randomized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date. The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children, especially in functional and adaptive communication skills. Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms. © 2014 Association for Child and Adolescent Mental Health.

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

    Science.gov (United States)

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

    2011-07-01

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

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

    DEFF Research Database (Denmark)

    Wejse, Christian; Gomes, Victor F; Rabna, Paulo

    2009-01-01

    RATIONALE: Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. OBJECTIVES: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. METHODS: We conducted a randomized, double-blind......, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months...

  3. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morielli, Andria R; Usmani, Nawaid; Boulé, Normand G; Severin, Diane; Tankel, Keith; Nijjar, Tirath; Joseph, Kurian; Fairchild, Alysa; Courneya, Kerry S

    2018-01-12

    Standard treatment for locally advanced rectal cancer includes 5-6 weeks of neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision 6-8 weeks later. NACRT improves local disease control and surgical outcomes but also causes side effects including fatigue, diarrhea, hand-foot syndrome, and physical deconditioning that may impede quality of life (QoL), treatment completion, treatment response, and long-term prognosis. Interventions to improve treatment outcomes and manage side effects that are safe, tolerable and low-cost are highly desirable. Exercise has been shown to improve some of these outcomes in other cancer patient groups but no study to date has examined the potential benefits (and harms) of exercise training during and after NACRT for rectal cancer. The Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT) trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO 2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness assessed by the Senior's Fitness Test, QoL assessed by the European

  4. Effects of short-term treatment with atorvastatin in smokers with asthma - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lloyd Suzanne M

    2011-04-01

    Full Text Available Abstract Background The immune modulating properties of statins may benefit smokers with asthma. We tested the hypothesis that short-term treatment with atorvastatin improves lung function or indices of asthma control in smokers with asthma. Methods Seventy one smokers with mild to moderate asthma were recruited to a randomized double-blind parallel group trial comparing treatment with atorvastatin (40 mg per day versus placebo for 4 weeks. After 4 weeks treatment inhaled beclometasone (400 μg per day was added to both treatment arms for a further 4 weeks. The primary outcome was morning peak expiratory flow after 4 weeks treatment. Secondary outcome measures included indices of asthma control and airway inflammation. Results At 4 weeks, there was no improvement in the atorvastatin group compared to the placebo group in morning peak expiratory flow [-10.67 L/min, 95% CI -38.70 to 17.37, p = 0.449], but there was an improvement with atorvastatin in asthma quality of life score [0.52, 95% CI 0.17 to 0.87 p = 0.005]. There was no significant improvement with atorvastatin and inhaled beclometasone compared to inhaled beclometasone alone in outcome measures at 8 weeks. Conclusions Short-term treatment with atorvastatin does not alter lung function but may improve asthma quality of life in smokers with mild to moderate asthma. Trial Registration Clinicaltrials.gov identifier: NCT00463827

  5. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

    Directory of Open Access Journals (Sweden)

    Francesco Cerritelli

    Full Text Available Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group or osteopathic manipulative treatment (study group. The primary outcome was the mean difference in length of hospital stay between groups.A total of 695 newborns were randomly assigned to either the study group (n= 352 or the control group (n=343. A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31. Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001. Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001 but not in daily weight gain. There were no complications associated to the intervention.Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

  6. Anxiety Treatment of Opioid Dependent Patients with Buprenorphine: A Randomized, Double-blind, Clinical Trial.

    Science.gov (United States)

    Ahmadi, Jamshid; Jahromi, Mina Sefidfard

    2017-01-01

    The objective of this study is to examine the impact of vary doses of buprenorphine on anxiety symptoms in opioid-dependent inpatients over a 7 days period, using a randomized controlled trial design. Patients were randomized to three groups. Fourteen men who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for both opioid use disorder and generalized anxiety disorder and were seeking for treatment. Patients obtain dosages of 32 mg or 64 mg or 96 mg of buprenorphine as a single dose only and were treated in a psychiatric inpatient unit. Of 14 subjects; 5 (35.7%) obtained 32 mg, 4 (28.6%) obtained 64 mg, and 5 (35.7%) obtained 96 mg of buprenorphine. Administering daily Hamilton Anxiety Rating Scale and interview. All the patients ended the 7-day treatment time. The results showed a significant reduction in anxiety symptoms within each of the three groups (P = 0.00), but no difference in outcome between the groups (P = 0.605). The outcome suggests a single high dose of buprenorphine can supply a speedy, safe, simple, and suitable means of anxiety treatment. The single high dose of buprenorphine could be a novel mechanism medication that provides a rapid and sustained improvement for generalized anxiety disorder in opioid dependent patients. Placebo-controlled trials of longer duration are needed to evaluate ability, safety, and psychological and physiological influence of extended exposure to this medication.

  7. Open-label placebo treatment in chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J; Kirsch, Irving

    2016-12-01

    This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

  8. A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia.

    Science.gov (United States)

    Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

    2012-01-01

    To investigate the effectiveness of intensive sleep retraining in comparison and combination with traditional behavioral intervention for chronic primary insomnia. Seventy-nine volunteers with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomly assigned either to intensive sleep retraining (ISR), stimulus control therapy (SCT), ISR plus SCT, or the control (sleep hygiene) treatment condition. ISR treatment consisted of 50 sleep onset trials over a 25-h sleep deprivation period. Treatment response was assessed with sleep diary, activity monitoring, and questionnaire measures. The active treatment groups (ISR, SCT, ISR+SCT) all resulted in significant improvements in sleep onset latency and sleep efficiency, with moderate to large effect sizes from pre- to post-treatment. Wake time after sleep onset decreased significantly in the SCT and ISR+SCT groups. Total sleep time increased significantly in the ISR and ISR+SCT treatment groups. Participants receiving ISR (ISR, ISR+SCT) experienced rapidly improved SOL and TST during treatment, suggesting an advantage of rapid improvements in sleep in response to ISR. Although there were few statistically significant differences between groups on individual variables, ISR+SCT resulted in consistently larger effect sizes of change than other treatments, including questionnaire measures of sleep quality, sleep self-efficacy, and daytime functioning. The combination treatment group (ISR+SCT) showed trends to outperform other active treatment groups with fewer treatment dropouts, and a greater proportion of treatment responders with 61% reaching "good sleeper" status. Treatment gains achieved at post-treatment in the active treatment groups were largely maintained throughout follow-up periods to 6 months. This 25-hour intensive conditioning treatment for chronic insomnia can produce rapid improvements in sleep, daytime functioning, and psychological variables. Adding ISR to traditional

  9. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study A Randomized Controlled Trial

    Science.gov (United States)

    HENSEL, Kendi L.; BUCHANAN, Steve; BROWN, Sarah K.; RODRIGUEZ, Mayra; CRUSER, des Anges

    2014-01-01

    Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (P<.001 for both), with outcomes for the OMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester. PMID:25068560

  10. Hyperbaric oxygen therapy for treatment of children with autism: a systematic review of randomized trials

    Directory of Open Access Journals (Sweden)

    Ghanizadeh Ahmad

    2012-05-01

    Full Text Available Abstract There is a controversy about the efficacy of hyperbaric oxygen (HBO therapy for the treatment of autism. This study systematically reviews the current evidences for treating of autism with HBO therapy. According to PRISMA guidelines for a systematic review, the databases of MEDLINE/Pubmed, Google Scholar, and Randomised Controlled Trials in Hyperbaric Medicine were electronically searched. In addition, medical subject heading terms and text words for hyperbaric oxygen therapy and autism were used. The main inclusion criteria were published studies which reported the original data from the trials conducted on the patients with autism and assessed outcomes with a valid and reliable instrument. A quality assessment was also conducted. The electronically search resulted in 18 title of publications. Two studies were randomized, double-blind, controlled-clinical trials. While some uncontrolled and controlled studies suggested that HBO therapy is effective for the treatment of autism, these promising effects are not replicated. Therefore, sham-controlled studies with rigorous methodology are required to be conducted in order to provide scientific evidence-based HBO therapy for autism treatment.

  11. Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials

    Science.gov (United States)

    Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

    2011-01-01

    Background Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with western medication. Methods We included randomized controlled trials on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials quality independently. RevMan 5.0.18 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Results 8 RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medications regarding the number of cured patients (RR 2.49, 95%CI 1.91 to 3.24, pcupping plus medications was significantly better than medications alone on number of cured patients (RR 1.93, 95%CI 1.23 to 3.04, p=0.005), but no difference in symptom improvement (RR 1.00, 95%CI 0.92 to 1.08, p=0.98). There were no serious adverse effects with related to wet cupping therapy in the included trials. Conclusions Wet cupping appears to be effective in treatment of herpes zoster. However, further large, rigorous designed trials are warranted. PMID:21280462

  12. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial.

    Science.gov (United States)

    Boettcher, Johanna; Aström, Viktor; Påhlsson, Daniel; Schenström, Ola; Andersson, Gerhard; Carlbring, Per

    2014-03-01

    Mindfulness-based interventions have proven effective for the transdiagnostic treatment of heterogeneous anxiety disorders. So far, no study has investigated the potential of mindfulness-based treatments when delivered remotely via the Internet. The current trial aims at evaluating the efficacy of a stand-alone, unguided, Internet-based mindfulness treatment program for anxiety. Ninety-one participants diagnosed with social anxiety disorder, generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified were randomly assigned to a mindfulness treatment group (MTG) or to an online discussion forum control group (CG). Mindfulness treatment consisted of 96 audio files with instructions for various mindfulness meditation exercises. Primary and secondary outcome measures were assessed at pre-, posttreatment, and at 6-months follow-up. Participants of the MTG showed a larger decrease of symptoms of anxiety, depression, and insomnia from pre- to postassessment than participants of the CG (Cohen's d(between)=0.36-0.99). Within effect sizes were large in the MTG (d=0.82-1.58) and small to moderate in the CG (d=0.45-0.76). In contrast to participants of the CG, participants of the MTG also achieved a moderate improvement in their quality of life. The study provided encouraging results for an Internet-based mindfulness protocol in the treatment of primary anxiety disorders. Future replications of these results will show whether Web-based mindfulness meditation can constitute a valid alternative to existing, evidence-based cognitive-behavioural Internet treatments. The trial was registered at ClinicalTrials.gov (NCT01577290). Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial.

    Science.gov (United States)

    Prates, Fernanda V de O; Dourado, Mayra E F; Silva, Silvana C; Schriefer, Albert; Guimarães, Luiz H; Brito, Maria das Graças O; Almeida, Juliana; Carvalho, Edgar M; Machado, Paulo R L

    2017-01-01

     The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb v ) is associated with a high rate of failure, up to 45% of cases. In addition, Sb v can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.  A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sb v protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.  A total of 53 subjects were included in the trial; 26 were treated with Sb v , and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sb v group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sb v and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2).  Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  14. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.

    Science.gov (United States)

    Malmivaara, Antti; Slätis, Pär; Heliövaara, Markku; Sainio, Päivi; Kinnunen, Heikki; Kankare, Jyrki; Dalin-Hirvonen, Nina; Seitsalo, Seppo; Herno, Arto; Kortekangas, Pirkko; Niinimäki, Timo; Rönty, Hannu; Tallroth, Kaj; Turunen, Veli; Knekt, Paul; Härkänen, Tommi; Hurri, Heikki

    2007-01-01

    A randomized controlled trial. To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these

  15. Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

    Science.gov (United States)

    Nagao, Mizuho; Ikeda, Masanori; Fukuda, Norimasa; Habukawa, Chizu; Kitamura, Tetsuro; Katsunuma, Toshio; Fujisawa, Takao

    2017-05-16

    While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β2-agonists in this population, we conducted a randomized controlled trial. Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β2-agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219. From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033). Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  16. A randomized controlled trial to influence client language in substance use disorder treatment.

    Science.gov (United States)

    Moyers, Theresa B; Houck, Jon; Glynn, Lisa H; Hallgren, Kevin A; Manuel, Jennifer K

    2017-03-01

    Client language is hypothesized to be a mechanism of action in motivational interviewing (MI). Despite the association of change and sustain talk with substance treatment outcomes, it not known whether providers can intentionally influence this language as hypothesized. This is a randomized controlled trial to investigate whether substance use providers can be trained to influence client language. Treatment providers specializing in substance use disorders (n=190) were randomly assigned to standard training in MI (MI-AU) or training emphasizing an influence of client language (MI-LEAF). Treatment sessions with actual clients were evaluated 3, 6 and 12 months after training by masked raters. Frequencies of client change and sustain talk were the outcome variables. Sustain talk, but not change talk, was significantly lower in clients whose providers had received the specialized training (b=-0.175, SE=0.087, p=0.046, CI[-0.348 to 0.002], d=-0.325). Mediation analyses supported a causal chain between a) training, b) providers' attempts to minimize sustain talk in treatment sessions via directive reflective listening and c) client sustain talk in the treatment session (κ 2 =0.0833, bootstrap SE=0.0394, 95% CI [0.0148, 0.1691]). With specialized training, providers can reduce the amount of opposition language their clients offer when considering a change in their substance use. Demonstrating that client language is under partial control of the provider supports the feasibility of clinical trials to investigate the impact of shaping client language on treatment outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

    Science.gov (United States)

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

    2015-01-01

    Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, ptreatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; pOsteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

  18. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

    2015-06-01

    Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

  19. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    Science.gov (United States)

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  20. Patterns of Enrollment in Randomized and Preference Trials of Behavioral Treatments for Insomnia

    Directory of Open Access Journals (Sweden)

    Souraya Sidani

    2011-05-01

    Full Text Available Participants’ preferences for treatment may deter enrollment in a randomized clinical trial (RCT. The Partially randomized clinical trial (PRCT is proposed as an alternative design to increase enrollment rate and enhance representativeness of the sample. There is limited evidence supporting the advantages of the PRCT. This study aimed to examine enrollment and refusal rates, reasons for refusal, and clinical profile of persons who declined participation and those who enrolled, in the context of a RCT and a PRCT. Persons with chronic insomnia completed a questionnaire to determine if they met the eligibility criteria regarding type, frequency, and duration of insomnia. Those who declined participation indicated reasons for refusal. Enrollment rate was computed as the percentage of individuals who took part in the study out of those found eligible. Independent sample t-test was used to compare enrollees and non-enrollees on characteristics of insomnia. The results showed a higher enrollment rate in the RCT than PRCT. Reasons for refusal were similar under the RCT and PRCT. Significant differences between enrollees and non-enrollees were found on fewer characteristics in the RCT than PRCT. The results do not support the advantages of the PRCT in enhancing enrollment of participants in studies evaluating the effectiveness of behavioral treatments of chronic insomnia. DOI: 10.2458/azu_jmmss.v1i2.100

  1. Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Caroline de Sonneville-Koedoot

    Full Text Available Stuttering is a common childhood disorder. There is limited high quality evidence regarding options for best treatment. The aim of the study was to compare the effectiveness of direct treatment with indirect treatment in preschool children who stutter.In this multicenter randomized controlled trial with an 18 month follow-up, preschool children who stutter who were referred for treatment were randomized to direct treatment (Lidcombe Program; n = 99 or indirect treatment (RESTART-DCM treatment; n = 100. Main inclusion criteria were age 3-6 years, ≥3% syllables stuttered (%SS, and time since onset ≥6 months. The primary outcome was the percentage of non-stuttering children at 18 months. Secondary outcomes included stuttering frequency (%SS, stuttering severity ratings by the parents and therapist, severity rating by the child, health-related quality of life, emotional and behavioral problems, and speech attitude.Percentage of non-stuttering children for direct treatment was 76.5% (65/85 versus 71.4% (65/91 for indirect treatment (Odds Ratio (OR, 0.6; 95% CI, 0.1-2.4, p = .42. At 3 months, children treated by direct treatment showed a greater decline in %SS (significant interaction time x therapy: β = -1.89; t(282.82 = -2.807, p = .005. At 18 months, stuttering frequency was 1.2% (SD 2.1 for direct treatment and 1.5% (SD 2.1 for indirect treatment. Direct treatment had slightly better scores on most other secondary outcome measures, but no differences between treatment approaches were significant.Direct treatment decreased stuttering more quickly during the first three months of treatment. At 18 months, however, clinical outcomes for direct and indirect treatment were comparable. These results imply that at 18 months post treatment onset, both treatments are roughly equal in treating developmental stuttering in ways that surpass expectations of natural recovery. Follow-up data are needed to confirm these findings in the longer term

  2. Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial.

    Science.gov (United States)

    van Vulpen, Jonna K; Siersema, Peter D; van Hillegersberg, Richard; Nieuwenhuijzen, Grard A P; Kouwenhoven, Ewout A; Groenendijk, Richard P R; van der Peet, Donald L; Hazebroek, Eric J; Rosman, Camiel; Schippers, Carlo C G; Steenhagen, Elles; Peeters, Petra H M; May, Anne M

    2017-08-18

    Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery. The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed

  3. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain

    DEFF Research Database (Denmark)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner

    2012-01-01

    We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12...

  4. Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Licciardone, John C; Buchanan, Steve; Hensel, Kendi L; King, Hollis H; Fulda, Kimberly G; Stoll, Scott T

    2010-01-01

    To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy. A randomized, placebo-controlled trial was conducted to compare usual obstetric care and osteopathic manipulative treatment, usual obstetric care and sham ultrasound treatment, and usual obstetric care only. Outcomes included average pain levels and the Roland-Morris Disability Questionnaire to assess back-specific functioning. Intention-to-treat analyses included 144 subjects. The Roland-Morris Disability Questionnaire scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the usual obstetric care and osteopathic manipulative treatment group (effect size, 0.72; 95% confidence interval, 0.31-1.14; P = .001 vs usual obstetric care only; and effect size, 0.35; 95% confidence interval, -0.06 to 0.76; P = .09 vs usual obstetric care and sham ultrasound treatment). During pregnancy, back pain decreased in the usual obstetric care and osteopathic manipulative treatment group, remained unchanged in the usual obstetric care and sham ultrasound treatment group, and increased in the usual obstetric care only group, although no between-group difference achieved statistical significance. Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy. 2010 Mosby, Inc.

  5. Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

    Science.gov (United States)

    Rose, Annika; Vinogradov, Sophia; Fisher, Melissa; Green, Michael F; Ventura, Joseph; Hooker, Christine; Merzenich, Michael; Nahum, Mor

    2015-07-03

    Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits. Despite the functional significance of the social cognition deficits affecting many aspects of daily living, such as social relationships, occupational status, and independent living, there is still no effective treatment option for these deficits, which is applied as standard of care. To address this need, we developed a novel, internet-based training program that targets social cognition deficits in schizophrenia (SocialVille). Preliminary studies demonstrate the feasibility and initial efficacy of Socialville in schizophrenia patients (Nahum et al., 2014). The purpose of the current trial (referred to as the TReatment of Social cognition in Schizophrenia Trial or TRuSST) is to compare SocialVille to an active control training condition, include a larger sample of patients, and assess both social cognitive functioning, and functional outcomes. We will employ a multi-site, longitudinal, blinded, randomized controlled trial (RCT) design with a target sample of 128 patients with schizophrenia. Patients will perform, at their home or in clinic, 40 sessions of either the SocialVille training program or an active control computer game condition. Each session will last for 40-45 minutes/day, performed 3-5 days a week, over 10-12 weeks, totaling to 30 hours of training. Patients will be assessed on a battery of social cognitive, social functioning and functional outcomes immediately before training, mid-way through training (after 20 training sessions) and at the completion of the 40 training sessions. The strengths of this protocol are that it tests an innovative, internet-based treatment that targets fundamental social cognitive deficits in schizophrenia, employs a highly sensitive and extensive battery of functional outcome measures, and incorporates a large sample size in an RCT design. ClinicalTrials.gov NCT

  6. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.

    Science.gov (United States)

    Rush, A John; Marangell, Lauren B; Sackeim, Harold A; George, Mark S; Brannan, Stephen K; Davis, Sonia M; Howland, Robert; Kling, Mitchel A; Rittberg, Barry R; Burke, William J; Rapaport, Mark H; Zajecka, John; Nierenberg, Andrew A; Husain, Mustafa M; Ginsberg, David; Cooke, Robert G

    2005-09-01

    Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n = 210) or nonpsychotic, depressed phase, bipolar disorder (n = 25). In the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sham VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (>/=50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD(24)]). At 10-weeks, HRSD(24) response rates were 15.2% for the active (n = 112) and 10.0% for the sham (n = 110) groups (p = .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology - Self-Report (IDS-SR(30)), were 17.0% (active) and 7.3% (sham) (p = .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression.

  7. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ana Luiza Soares Rodrigues

    2015-06-01

    Full Text Available OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients.METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel.RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed.CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998

  8. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials.

    Science.gov (United States)

    Lynch, Mary E; Campbell, Fiona

    2011-11-01

    Effective therapeutic options for patients living with chronic pain are limited. The pain relieving effect of cannabinoids remains unclear. A systematic review of randomized controlled trials (RCTs) examining cannabinoids in the treatment of chronic non-cancer pain was conducted according to the PRISMA statement update on the QUORUM guidelines for reporting systematic reviews that evaluate health care interventions. Cannabinoids studied included smoked cannabis, oromucosal extracts of cannabis based medicine, nabilone, dronabinol and a novel THC analogue. Chronic non-cancer pain conditions included neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain. Overall the quality of trials was excellent. Fifteen of the eighteen trials that met the inclusion criteria demonstrated a significant analgesic effect of cannabinoid as compared with placebo and several reported significant improvements in sleep. There were no serious adverse effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases. Overall there is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis. The context of the need for additional treatments for chronic pain is reviewed. Further large studies of longer duration examining specific cannabinoids in homogeneous populations are required. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

  9. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Thomas L. Sevier

    2015-05-01

    Full Text Available Introduction. Patients with chronic lateral elbow (LE tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1 to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE for patients with chronic LE tendinopathy, and (2 to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment.Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities.Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows or EE treatment (56 elbows. Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments.Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047 and in maximum grip strength (p = 0.008 than EE subjects. Astym therapy also resolved 20/21 (95.7% of the EE non-responders, who showed improvements in DASH scores (p < 0.005, pain with activity (p = 0.002, and function (p = 0.004 following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported.Conclusion. This study

  10. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  11. Treatment comparison in randomized clinical trials with nonignorable missingness: A reverse regression approach.

    Science.gov (United States)

    Zhang, Zhiwei; Cheon, Kyeongmi

    2017-04-01

    A common problem in randomized clinical trials is nonignorable missingness, namely that the clinical outcome(s) of interest can be missing in a way that is not fully explained by the observed quantities. This happens when the continued participation of patients depends on the current outcome after adjusting for the observed history. Standard methods for handling nonignorable missingness typically require specification of the response mechanism, which can be difficult in practice. This article proposes a reverse regression approach that does not require a model for the response mechanism. Instead, the proposed approach relies on the assumption that missingness is independent of treatment assignment upon conditioning on the relevant outcome(s). This conditional independence assumption is motivated by the observation that, when patients are effectively masked to the assigned treatment, their decision to either stay in the trial or drop out cannot depend on the assigned treatment directly. Under this assumption, one can estimate parameters in the reverse regression model, test for the presence of a treatment effect, and in some cases estimate the outcome distributions. The methodology can be extended to longitudinal outcomes under natural conditions. The proposed approach is illustrated with real data from a cardiovascular study.

  12. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial.

    Science.gov (United States)

    Hoffman, Jessica; Frerichs, Leah; Story, Mary; Jones, Jason; Gaskin, Kiah; Apple, Annie; Skinner, Asheley; Armstrong, Sarah

    2018-01-01

    Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity (P = .010) and quality of life (P = .008). An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment. Copyright © 2018 by the American Academy of Pediatrics.

  13. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Pérez-Palomares, Sara; Oliván-Blázquez, Bárbara; Pérez-Palomares, Ana; Gaspar-Calvo, Elena; Pérez-Benito, Marina; López-Lapeña, Elena; de la Torre-Beldarraín, Maria Luisa; Magallón-Botaya, Rosa

    2017-01-01

    Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.

  14. Randomized Trial of MST and ARC in a Two-Level Evidence-Based Treatment Implementation Strategy

    Science.gov (United States)

    Glisson, Charles; Schoenwald, Sonja K.; Hemmelgarn, Anthony; Green, Philip; Dukes, Denzel; Armstrong, Kevin S.; Chapman, Jason E.

    2010-01-01

    Objective: A randomized trial assessed the effectiveness of a 2-level strategy for implementing evidence-based mental health treatments for delinquent youth. Method: A 2 x 2 design encompassing 14 rural Appalachian counties included 2 factors: (a) the random assignment of delinquent youth within each county to a multisystemic therapy (MST) program…

  15. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment.

    Science.gov (United States)

    Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette

    2017-07-01

    Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect

  16. Comparing treatments for children with ADHD and word reading difficulties: A randomized clinical trial.

    Science.gov (United States)

    Tamm, Leanne; Denton, Carolyn A; Epstein, Jeffery N; Schatschneider, Christopher; Taylor, Heather; Arnold, L Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C; Maltinsky, Jan; Brinson, Patricia; Loren, Richard E A; Prasad, Mary R; Ewing-Cobbs, Linda; Vaughn, Aaron

    2017-05-01

    This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  17. Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

    2010-01-01

    Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication. We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials. Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed

  18. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Cambron, Jerrilyn A; Dexheimer, Jennifer M; Duarte, Manuel; Freels, Sally

    2017-09-01

    To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. Randomized controlled trial. Integrative medicine teaching clinic at a university. Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (Ppain (P=.3431). Group differences at 12 weeks and later were not significant. Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. A randomized pilot trial of a full subsidy vs. a partial subsidy for obesity treatment.

    Science.gov (United States)

    Tsai, Adam G; Felton, Sue; Hill, James O; Atherly, Adam J

    2012-09-01

    Intensive obesity treatment is mandated by federal health care reform but is costly. A partial subsidy for obesity treatment could lower the cost of treatment, without reducing its efficacy. This study sought to test whether a partial subsidy for obesity treatment would be feasible, as compared to a fully subsidized intervention. The study was a pilot randomized trial. Participants (n = 50) were primary care patients with obesity and at least one comorbid condition (diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). Each participant received eight weight loss counseling visits as well as portion-controlled foods for weight loss. Participants were randomized to full subsidy or partial subsidy (2 vs. 1 meal per day provided). The primary outcome was weight change after 4 months. Secondary outcomes included changes in blood pressure, waist circumference, and health-related quality of life. Participants in the full and partial subsidy groups lost 5.9 and 5.3 kg, equivalent to 5.3% and 5.1% of initial weight, respectively (P = 0.71). Changes in secondary outcomes were similar in the two groups. A partial subsidy was feasible and induced a clinically similar amount of weight loss, compared to a full subsidy. Large-scale testing of economic incentives for weight control is merited given the federal mandate to offer weight loss counseling to obese patients.

  20. A randomized placebo-controlled clinical trial of phonophoresis for the treatment of chronic neck pain.

    Science.gov (United States)

    Durmus, Dilek; Alayli, Gamze; Tufekci, Tugce; Kuru, Omer

    2014-05-01

    The aim of this trial was to investigate and compare the effects of phonophoresis (PP), placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with chronic neck pain (CNP). This is a randomized, single-blind, placebo-controlled study. A total of 61 patients with definite CNP were included in this study. The patients were randomized into three groups. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale), disability (the neck pain disability index), depression (Beck Depression Inventory scores), and sleep quality (Pittsburgh Sleep Quality Index) of all participants were evaluated. Measurements were taken before and after treatment. All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression. While there was no difference between groups regarding depression and sleep quality, intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2. We observed that PP treatment was effective in the treatment for patients with CNP. A combination of PP with exercises can be used to obtain optimal clinical results.

  1. A randomized clinical trial to determine optimal infertility treatment in older couples: the Forty and Over Treatment Trial (FORT-T).

    Science.gov (United States)

    Goldman, Marlene B; Thornton, Kim L; Ryley, David; Alper, Michael M; Fung, June L; Hornstein, Mark D; Reindollar, Richard H

    2014-06-01

    To determine the optimal infertility therapy for women at the end of their reproductive potential. Randomized clinical trial. Academic medical centers and private infertility center in a state with mandated insurance coverage. Couples with ≥ 6 months of unexplained infertility; female partner aged 38-42 years. Randomized to treatment with two cycles of clomiphene citrate (CC) and intrauterine insemination (IUI), follicle stimulating hormone (FSH)/IUI, or immediate IVF, followed by IVF if not pregnant. Proportion with a clinically recognized pregnancy, number of treatment cycles, and time to conception after two treatment cycles and at the end of treatment. We randomized 154 couples to receive CC/IUI (N = 51), FSH/IUI (N = 52), or immediate IVF (N = 51); 140 (90.9%) couples initiated treatment. The cumulative clinical pregnancy rates per couple after the first two cycles of CC/IUI, FSH/IUI, or immediate IVF were 21.6%, 17.3%, and 49.0%, respectively. After all treatments, 110 (71.4%) of 154 couples had conceived a clinically recognized pregnancy, and 46.1% had delivered at least one live-born baby; 84.2% of all live-born infants resulting from treatment were achieved via IVF. There were 36% fewer treatment cycles in the IVF arm compared with either COH/IUI arm, and the couples conceived a pregnancy leading to a live birth after fewer treatment cycles. A randomized controlled trial in older women with unexplained infertility to compare treatment initiated with two cycles of controlled ovarian hyperstimulation/IUI versus immediate IVF demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group. NCT00246506. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  2. Bath thermal waters in the treatment of knee osteoarthritis: a randomized controlled clinical trial.

    Science.gov (United States)

    Branco, Marcelo; Rêgo, Neiva N; Silva, Paulo H; Archanjo, Ingrid E; Ribeiro, Mirian C; Trevisani, Virgínia F

    2016-08-01

    Osteoarthritis is a degenerative disease associated with pain, reduced range of motion, and impaired function. Balneotherapy or bathing in thermal or mineral waters is used as a non-invasive treatment for various rheumatic diseases. To evaluate the effectiveness of hot sulfurous and non-sulfurous waters in the treatment of knee osteoarthritis. A randomized, assessor-blind, controlled trial. A spa resort. One hundred and forty patients of both genders, mean age of 64.8±8.9 years, with knee osteoarthritis and chronic knee pain. Patients were randomized into three groups: the sulfurous water (SW) group (N.=47), non-sulfurous water (NSW) group (N.=50), or control group (N.=43) who received no treatment. Patients were not blinded to treatment allocation. Treatment groups received 30 individual thermal baths (three 20-minute baths a week for 10 weeks) at 37-39 °C. The outcome measures were pain (visual analog scale, VAS), physical function (Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC; Lequesne Algofunctional Index, LAFI; Stanford Health Assessment Questionnaire, HAQ), and use of pain medication. Patients were assessed before treatment (T1), at treatment endpoint (T2), and two months post-intervention (T3). Intra- and intergroup comparisons were performed at a significance level of 0.05 (Ptreatment groups (Ptreatment groups at T2 and T3 (Ptreatment groups at T2, but patients in the SW group reported less pain and better functional status than those in the NSW group at T3, showing a lasting effect of sulfurous water baths. Both therapeutic methods were effective in the treatment of knee osteoarthritis; however, sulfurous baths yielded longer-lasting effects than non-sulfurous water baths. Baths in thermal waters, especially those in sulfurous waters, are effective in reducing pain and improving physical function in patients with knee osteoarthritis.

  3. Multicenter Randomized Clinical Trial of Nonoperative Versus Operative Treatment of Acute Acromio-Clavicular Joint Dislocation.

    Science.gov (United States)

    2015-11-01

    To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. Prospective, randomized. Multicenter. Eight-three patients with acute (dislocations of the AC joint. Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate

  4. Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sunny Aggarwal

    2014-01-01

    Full Text Available Background & objectives : 0 Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting 0 outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. 0 Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results : 0 Median (inter quartile range duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72 h vs. 78 (72-90 h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36 h vs. 42 (36-48 h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001 compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions : 0 Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.

  5. Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial.

    Science.gov (United States)

    Elkins, Gary R; Fisher, William I; Johnson, Aimee K; Carpenter, Janet S; Keith, Timothy Z

    2013-03-01

    The use of estrogen and progesterone to manage vasomotor symptoms (ie, hot flashes and night sweats) has declined because of concerns about their risks, and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized controlled trial of clinical hypnosis for treating vasomotor symptoms among postmenopausal women. This is a randomized, single-blind, controlled, clinical trial involving 187 postmenopausal women reporting a minimum of seven hot flashes per day (or at least 50 hot flashes a week) at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries on weeks 2 to 6 and week 12. Secondary outcomes included measures of hot flash-related daily interference, sleep quality, and treatment satisfaction. In a modified intent-to-treat analysis that included all randomized participants who provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 (74.16%) hot flashes for the clinical hypnosis intervention versus a mean reduction of 12.89 (17.13%) hot flashes for controls (P hypnosis intervention as compared with 3.53 (15.38%) for controls (P hypnosis and 0.88 (9.94%) for controls (P hypnosis results in significant reductions in self-reported and physiologically measured hot flashes and hot flash scores in postmenopausal women.

  6. Treatment of panic disorder with agoraphobia: randomized placebo-controlled trial of four psychosocial treatments combined with imipramine or placebo.

    Science.gov (United States)

    Marchand, Andre; Coutu, Marie-France; Dupuis, Gilles; Fleet, Richard; Borgeat, Francois; Todorov, Christo; Mainguy, Nicole

    2008-01-01

    Few randomized controlled trials have included panic disorder patients with moderate to severe agoraphobia. Therefore, this population was studied using pharmacotherapy as well as psychotherapy. At the time of the study, imipramine was widely used as a pharmacological treatment. Also, current practice guidelines for patients with panic disorder find selective serotonin reuptake inhibitors and tricyclic antidepressants roughly comparable in terms of efficacy. Therefore, the main objective of this study is to compare four psychosocial treatments-cognitive and graded in vivo exposure treatments, graded in vivo exposure, cognitive treatment, and supportive therapy-to evaluate the benefits of combining cognitive therapy with exposure in vivo. These treatments were combined with imipramine or placebo for a total of eight experimental conditions. Participants presented moderate to severe agoraphobia. The method involved a randomized, double-blind, placebo-controlled trial with 137 participants who completed a 14-session protocol involving the treatments just mentioned. Measures were taken at baseline and posttreatment and at 3-, 6-, and 12-month follow-up. All treatment conditions were statistically and clinically effective in reducing self-reported panic-agoraphobia symptoms over the 1-year follow-up. No statistical differences were observed between imipramine and placebo conditions. This study found that all treatment modalities helped reduce panic and agoraphobic symptomatology over a 1-year follow-up period. These surprising results support the need to document the relations among the various components of an intervention. This would make it possible to assess the relative efficacy of the treatment components rather than of the intervention as a whole.

  7. Scapular-focused treatment in patients with shoulder impingement syndrome: a randomized clinical trial.

    Science.gov (United States)

    Struyf, F; Nijs, J; Mollekens, S; Jeurissen, I; Truijen, S; Mottram, S; Meeusen, R

    2013-01-01

    The purpose of this clinical trial is to compare the effectiveness of a scapular-focused treatment with a control therapy in patients with shoulder impingement syndrome. Therefore, a randomized clinical trial with a blinded assessor was used in 22 patients with shoulder impingement syndrome. The primary outcome measures included self-reported shoulder disability and pain. Next, patients were evaluated regarding scapular positioning and shoulder muscle strength. The scapular-focused treatment included stretching and scapular motor control training. The control therapy included stretching, muscle friction, and eccentric rotator cuff training. Main outcome measures were the shoulder disability questionnaire, diagnostic tests for shoulder impingement syndrome, clinical tests for scapular positioning, shoulder pain (visual analog scale; VAS), and muscle strength. A large clinically important treatment effect in favor of scapular motor control training was found in self-reported disability (Cohen's d = 0.93, p = 0.025), and a moderate to large clinically important improvement in pain during the Neer test, Hawkins test, and empty can test (Cohen's d 0.76, 1.04, and 0.92, respectively). In addition, the experimental group demonstrated a moderate (Cohen's d = 0.67) improvement in self-experienced pain at rest (VAS), whereas the control group did not change. The effects were maintained at three months follow-up.

  8. Hyperbaric oxygen brain injury treatment (HOBIT) trial: a multifactor design with response adaptive randomization and longitudinal modeling.

    Science.gov (United States)

    Gajewski, Byron J; Berry, Scott M; Barsan, William G; Silbergleit, Robert; Meurer, William J; Martin, Renee; Rockswold, Gaylan L

    2016-09-01

    The goals of phase II clinical trials are to gain important information about the performance of novel treatments and decide whether to conduct a larger phase III trial. This can be complicated in cases when the phase II trial objective is to identify a novel treatment having several factors. Such multifactor treatment scenarios can be explored using fixed sample size trials. However, the alternative design could be response adaptive randomization with interim analyses and additionally, longitudinal modeling whereby more data could be used in the estimation process. This combined approach allows a quicker and more responsive adaptation to early estimates of later endpoints. Such alternative clinical trial designs are potentially more powerful, faster, and smaller than fixed randomized designs. Such designs are particularly challenging, however, because phase II trials tend to be smaller than subsequent confirmatory phase III trials. The phase II trial may need to explore a large number of treatment variations to ensure that the efficacy of optimal clinical conditions is not overlooked. Adaptive trial designs need to be carefully evaluated to understand how they will perform and to take full advantage of their potential benefits. This manuscript discusses a Bayesian response adaptive randomization design with a longitudinal model that uses a multifactor approach for predicting phase III study success via the phase II data. The approach is based on an actual clinical trial design for the hyperbaric oxygen brain injury treatment trial. Specific details of the thought process and the models informing the trial design are provided. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  9. Acceptability, efficacy and safety of two treatment protocols for dental fluorosis: a randomized clinical trial.

    Science.gov (United States)

    Castro, Kaline Silva; Ferreira, Ana Cláudia de Araújo; Duarte, Rosângela Marques; Sampaio, Fábio Correia; Meireles, Sônia Saeger

    2014-08-01

    This parallel randomized clinical trial evaluated the efficacy of two treatments for removing fluorosis stains. Seventy individuals living in an area endemic for fluorosis, with at least four maxillary anterior teeth presenting fluorosis with a Thylstrup and Fejerskov index from 1 to 7, were randomized into two treatment groups (n=35): GI - enamel microabrasion or GII - microabrasion associated with at-home bleaching. Microabrasion was performed using 37% phosphoric acid and pumice and, at-home tooth bleaching was performed with 10% carbamide peroxide. Areas of enamel opacities were recorded by digital camera at baseline and 1-month (1M) after treatment. Two blinded examiners evaluated the reduction in the area (mm(2)) of opacity using software. Two visual analogue scales were used: one for recording tooth sensitivity and/or gingival irritation ranging from 1 (none) to 5 (severe) and the other to evaluate participant satisfaction with the treatment used ranging from 1 (no improvement) to 7 (exceptional improvement). 1M after treatment, both groups showed a significant reduction in the area of enamel opacity (p=0.0001) and there was no difference between groups (p=0.1). Most of the participants from both treatment groups reported no or mild tooth sensitivity and gingival irritation (p>0.05). Participants reported that they were happy with the improvement in dental appearance, however, individuals from GII reported that they were happier than those from GI (p=0.004). Both treatment protocols were effective in reducing fluoride stains, however, when home bleaching was associated to enamel microabrasion, patients reported a major satisfaction with dental appearance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Block urn design - a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation

    Science.gov (United States)

    Zhao, Wenle; Weng, Yanqiu

    2011-01-01

    Permuted block design is the most popular randomization method used in clinical trials, especially for trials with more than two treatments and unbalanced allocation, because of its consistent imbalance control and simplicity in implementation. However, the risk of selection biases caused by high proportion of deterministic assignments is a cause of concern. Efron’s biased coin design and Wei’s urn design provide better allocation randomness without deterministic assignments, but they do not consistently control treatment imbalances. Alternative randomization designs with improved performances have been proposed over the past few decades, including Soares and Wu’s big stick design, which has high allocation randomness, but is limited to two-treatment balanced allocation scenarios only, and Berger’s maximal procedure design which has a high allocation randomness and a potential for more general trial scenarios, but lacks the explicit function for the conditional allocation probability and is more complex to implement than most other designs. The block urn design proposed in this paper combines the advantages of existing randomization designs while overcoming their limitations. Statistical properties of the new algorithm are assessed and compared to currently available designs via analytical and computer simulation approaches. The results suggest that the block urn design simultaneously provides consistent imbalance control and high allocation randomness. It can be easily implemented for sequential clinical trials with two or more treatments and balanced or unbalanced allocation. PMID:21893215

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

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

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

  12. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial.

    Science.gov (United States)

    Maldonado, José R; Nguyen, Long H; Schader, E Merritt; Brooks, John O

    2012-01-01

    The objectives were to compare the efficacy of a benzodiazepine loading versus a symptom-triggered protocol in the management of alcohol withdrawal. We conducted a prospective, randomized, controlled trial including 47 consecutive patients admitted to one of two tertiary care medical centers who developed alcohol withdrawal syndrome. Patients were randomly assigned to either a benzodiazepine loading protocol or a symptom-triggered treatment protocol. The Clinical Institute Withdrawal Assessment for Alcohol-Revised scale (CIWA-Ar) was recorded throughout the length of stay, along with measures of autonomic system functioning. The average rate of change of CIWA-Ar scores was -1.5 ± 1.3 for the symptom-triggered group and -2.3 ± 2.5 for the loading group. Average rate of change for systolic blood pressure was -2.7 ± 5.3 for the symptom-triggered group and -2.3 ± 6.4 for the loading group. There was no significant difference between the rates of change for either group on either measure. Similarly, there was no significant difference in total benzodiazepine use between groups. Within 72 h of treatment, 69.6% of patients in the loading group were free of withdrawal symptoms versus 41.7% in the symptom-triggered group, a difference not reaching statistical significance. This study did not reveal clear evidence of a clinical advantage for choosing either treatment method. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. A Randomized Trial of Chinese Diaoshi Jifa on Treatment of Dizziness in Meniere’s Disease

    Directory of Open Access Journals (Sweden)

    Yong-Xin Sun

    2014-01-01

    Full Text Available Background. Meniere’s disease is characterized by refractory dizziness and hearing disturbance. We aimed to investigate the efficacy and tolerance of Diaoshi Jifa, a Chinese hand skill for treating dizziness in Meniere’s disease. Methods. An open-labeled, randomized, controlled intervention trial was conducted. Twenty-seven patients diagnosed with Meniere’s disease were randomly allocated to control group or experimental group. Both groups were assessed by DHI (dizziness handicap inventory (DHI questionnaire score before and within 24 hours of receiving treatment, respectively. Results. Twenty-six participants completed the study, and no adverse event was reported due to Diaoshi Jifa treatment. The difference in the DHI scores between baseline and posttreatment reached significant difference in both groups (63.88±19.94 versus 10.25±9.77 and 54.36±17.97 versus 49.6±20.50. Significant difference in DHI scores was observed between the two groups after treatment (10.25±9.77 versus 49.6±20.50. Further investigation of DHI subscales in the experimental group revealed significant improvement posttreatment in the physical domain, functional domain, and emotional domain. Although higher rate of improvement in the emotional domain compared to physical or functional domains was found, the difference was not statistically significant. Conclusions. Diaoshi Jifa might be a fast, effective, and well-tolerated method for alleviating dizziness in Meniere’s disease.

  14. Albendazole versus metronidazole in the treatment of adult giardiasis: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Cañete, Roberto; Rodríguez, Pablo; Mesa, Lumey; Brito, Katia; Prior, Ada; Guilhem, Dirce; Novaes, M R C G

    2012-01-01

    Albendazole (ABZ) is a benzimidazole carbamate compound currently in use for human medical practice against enterobiasis and soil-transmitted helminthiasis (STH); However, its spectrum of activity is broad and goes beyond these infections. This study compares the efficacy and safety of ABZ versus metronidazole (MTZ) in human giardiasis. A randomized, double-blind, clinical trial was carried out at the Centre of Hygiene, Epidemiology and Microbiology in Matanzas City, Cuba. Adult patients with confirmed symptomatic G. duodenalis mono-infection were randomly assigned to receive either ABZ [400 mg daily (n = 75)] or MTZ [250 mg t.i.d. (n = 75)], both for 5 days. Follow-up fecal samples were obtained at 3, 5, 7 days after treatment end. The efficacy was similar for both treatment groups: ABZ (82.6%) and MTZ (85.3%); p > 0.05. Side-effects including bitter taste, headache, vomiting and dizziness were significantly higher in the MTZ group. Abdominal pain was significantly higher in ABZ group. ABZ was found as effective as MTZ in the treatment of G. duodenalis infections in adult patients from Cuba and could be a useful drug in areas where co-infection with STH infections is common.

  15. Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

    Directory of Open Access Journals (Sweden)

    Minjie Gao

    Full Text Available Whether patients with smoldering multiple myeloma (SMM needed to receive early interventional treatment remains controversial. Herein, we conducted a meta-analysis comparing the efficacy and safety of early treatment over deferred treatment for patients with SMM.MEDLINE and Cochrane Library were searched to May 2014 for randomized controlled trials (RCTs that assessed the effect of early treatment over deferred treatment. Primary outcome measure was mortality, and secondary outcome measures were progression, response rate, and adverse events.Overall, 5 trials including 449 patients were identified. There was a markedly reduced risk of disease progression with early treatment (Odds Ratio [OR] = 0.13, 95% confidence interval [CI] = 0.07 to 0.24. There were no significant differences in mortality and response rate (OR = 0.85, 95% CI = 0.45 to 1.60, and OR = 0.63, 95% CI = 0.32 to 1.23, respectively. More patients in the early treatment arm experienced gastrointestinal toxicities (OR = 10.02, 95%CI = 4.32 to 23.23, constipation (OR = 8.58, 95%CI = 3.20 to 23.00 and fatigue or asthenia (OR = 2.72, 95%CI = 1.30 to 5.67. No significant differences were seen with the development of acute leukemia (OR = 2.80, 95%CI = 0.42 to 18.81, hematologic cancer (OR = 2.07, 95%CI = 0.43 to 10.01, second primary tumors (OR = 3.45, 95%CI = 0.81 to 14.68, nor vertebral compression (OR = 0.18, 95%CI = 0.02 to 1.59.Early treatment delayed disease progression but increased the risk of gastrointestinal toxicities, constipation and fatigue or asthenia. The differences on vertebral compression, acute leukemia, hematological cancer and second primary tumors were not statistically significant. Based on the current evidence, early treatment didn't significantly affect mortality and response rate. However, further much larger trials were needed to provide more evidence.

  16. Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

    Science.gov (United States)

    Gao, Minjie; Yang, Guang; Tompkins, Van S; Gao, Lu; Wu, Xiaosong; Tao, Yi; Hu, Xiaojing; Hou, Jun; Han, Ying; Xu, Hongwei; Zhan, Fenghuang; Shi, Jumei

    2014-01-01

    Whether patients with smoldering multiple myeloma (SMM) needed to receive early interventional treatment remains controversial. Herein, we conducted a meta-analysis comparing the efficacy and safety of early treatment over deferred treatment for patients with SMM. MEDLINE and Cochrane Library were searched to May 2014 for randomized controlled trials (RCTs) that assessed the effect of early treatment over deferred treatment. Primary outcome measure was mortality, and secondary outcome measures were progression, response rate, and adverse events. Overall, 5 trials including 449 patients were identified. There was a markedly reduced risk of disease progression with early treatment (Odds Ratio [OR] = 0.13, 95% confidence interval [CI] = 0.07 to 0.24). There were no significant differences in mortality and response rate (OR = 0.85, 95% CI = 0.45 to 1.60, and OR = 0.63, 95% CI = 0.32 to 1.23, respectively). More patients in the early treatment arm experienced gastrointestinal toxicities (OR = 10.02, 95%CI = 4.32 to 23.23), constipation (OR = 8.58, 95%CI = 3.20 to 23.00) and fatigue or asthenia (OR = 2.72, 95%CI = 1.30 to 5.67). No significant differences were seen with the development of acute leukemia (OR = 2.80, 95%CI = 0.42 to 18.81), hematologic cancer (OR = 2.07, 95%CI = 0.43 to 10.01), second primary tumors (OR = 3.45, 95%CI = 0.81 to 14.68), nor vertebral compression (OR = 0.18, 95%CI = 0.02 to 1.59). Early treatment delayed disease progression but increased the risk of gastrointestinal toxicities, constipation and fatigue or asthenia. The differences on vertebral compression, acute leukemia, hematological cancer and second primary tumors were not statistically significant. Based on the current evidence, early treatment didn't significantly affect mortality and response rate. However, further much larger trials were needed to provide more evidence.

  17. Etifoxine versus alprazolam for the treatment of adjustment disorder with anxiety: a randomized controlled trial.

    Science.gov (United States)

    Stein, Dan J

    2015-01-01

    Adjustment disorder with anxiety (ADWA) is a highly prevalent condition, particularly in primary care practice. There are relatively few systematic treatment trials in the area of ADWA, and there are few data on predictors of treatment response. Etifoxine is a promising agent insofar as it is not associated with dependence, but in primary care settings benzodiazepines continue to be frequently prescribed for psychiatric symptoms. A randomized controlled trial of etifoxine versus alprazolam for ADWA was undertaken, focusing on efficacy and safety measures, and including an investigation of predictors of clinical response. This was a comparative, multicenter, double-blind, randomized trial in two parallel groups of outpatients with ADWA. One group was treated with 150 mg/day for etifoxine, and the other with 1.5 mg/day for alprazolam for 28 days. Patients were followed for 4 weeks of treatment, and for an additional week after treatment discontinuation. The primary outcome measure was the Hamilton Anxiety Rating Scale (HAM-A), while secondary outcome measures included the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Change Scale (CGI-C), and the Self-Report for the Assessment of Adjustment Disorders. Non-inferiority analysis was used to assess the primary outcome measure, and a multivariate logistic regression was employed to investigate predictors of response. Two hundred and two adult outpatients with ADWA were enrolled at 17 primary care sites. One hundred and seventy seven patients completed the study (n = 87 in the etifoxine group; n = 90 in the alprazolam group). Etifoxine and alprazolam were accompanied by decreases in the HAM-A at day 28, with a difference between treatment groups in HAM-A score of 1.78 [90% CI; 0.23, 3.33] in favor of alprazolam. However, after medication discontinuation, HAM-A scores continued to improve in the etifoxine group, but increased in the alprazolam group; the difference between groups in mean change between day

  18. Effect of Oral Voriconazole on Fungal Keratitis in the Mycotic Ulcer Treatment Trial II (MUTT II): A Randomized Clinical Trial.

    Science.gov (United States)

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Rajaraman, Revathi; Patel, Sushila; Srinivasan, Muthiah; Das, Manoranjan; Ray, Kathryn J; O'Brien, Kieran S; Oldenburg, Catherine E; McLeod, Stephen D; Zegans, Michael E; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

    2016-12-01

    To compare oral voriconazole with placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis. The Mycotic Ulcer Treatment Trial II (MUTT II), a multicenter, double-masked, placebo-controlled, randomized clinical trial, was conducted in India and Nepal, with 2133 individuals screened for inclusion. Patients with smear-positive filamentous fungal ulcers and visual acuity of 20/400 (logMAR 1.3) or worse were randomized to receive oral voriconazole vs oral placebo; all participants received topical antifungal eyedrops. The study was conducted from May 24, 2010, to November 23, 2015. All trial end points were analyzed on an intent-to-treat basis. Study participants were randomized to receive oral voriconazole vs oral placebo; a voriconazole loading dose of 400 mg was administered twice daily for 24 hours, followed by a maintenance dose of 200 mg twice daily for 20 days, with dosing altered to weight based during the trial. All participants received topical voriconazole, 1%, and natamycin, 5%. The primary outcome of the trial was rate of corneal perforation or the need for therapeutic penetrating keratoplasty (TPK) within 3 months. Secondary outcomes included microbiologic cure at 6 days, rate of re-epithelialization, best-corrected visual acuity and infiltrate and/or scar size at 3 weeks and 3 months, and complication rates associated with voriconazole use. A total of 2133 patients in India and Nepal with smear-positive ulcers were screened; of the 787 who were eligible, 240 (30.5%) were enrolled. Of the 119 patients (49.6%) in the oral voriconazole treatment group, 65 were male (54.6%), and the median age was 54 years (interquartile range, 42-62 years). Overall, no difference in the rate of corneal perforation or the need for TPK was determined for oral voriconazole vs placebo (hazard ratio, 0.82; 95% CI, 0.57-1.18; P = .29). In prespecified subgroup analyses comparing treatment effects among organism subgroups, there was some

  19. Open-label placebo treatment in chronic low back pain: a randomized controlled trial

    Science.gov (United States)

    Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J.; Kirsch, Irving

    2016-01-01

    Abstract This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland–Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (−1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain. PMID:27755279

  20. A randomized trial of aripiprazole vs blonanserin for the treatment of acute schizophrenia and related disorders

    Directory of Open Access Journals (Sweden)

    Kishi T

    2016-11-01

    Full Text Available Taro Kishi,1 Yuki Matsuda,1 Shinji Matsunaga,1 Tomohiko Mukai,1,2 Masatsugu Moriwaki,1,2 Hideaki Tabuse,3 Kiyoshi Fujita,2 Nakao Iwata1 1Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 2Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, 3Department of Psychiatry, Holy Cross Hospital, Toki, Gifu, Japan Objective: There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d vs blonanserin (4-24 mg/d in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194.Methods: The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS total score at week 24. Secondary outcomes were PANSS subscale scores, 21-item Hamilton Rating Scale for Depression (HAMD-21 score, response rate, discontinuation rate, and individual adverse events.Results: Forty-four patients were recruited. The discontinuation rate was 86.4% in the aripiprazole group and 68.2% in the blonanserin treatment group. There was no significant difference in mean time to discontinuation between the groups. Although both treatment groups showed significant reductions in the PANSS total score, PANSS subscale scores, and HAMD-21 scores at week 24, the magnitudes of the changes did not differ between the groups. There were no significant differences in the incidences of adverse events including somnolence, extrapyramidal symptoms, prolactin-related adverse events, and weight change between the groups.Conclusion: Our results suggest similar efficacy and safety profiles of aripiprazole and blonanserin in the patients with schizophrenia. Double-blind controlled studies are needed to further explore the efficacy and safety of aripiprazole and blonanserin in schizophrenia. Keywords: aripiprazole, blonanserin, schizophrenia

  1. Treatment of ADHD in children with tics: a randomized controlled trial.

    Science.gov (United States)

    2002-02-26

    The treatment of children with attention deficit hyperactivity disorder (ADHD) and Tourette syndrome (TS) has been problematic because methylphenidate (MPH)--the most commonly used drug to treat ADHD--has been reported to worsen tics and because clonidine (CLON)--the most commonly prescribed alternative--has unproven efficacy. The authors conducted a multicenter, randomized, double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were randomly administered CLON alone, MPH alone, combined CLON + MPH, or placebo (2 x 2 factorial design). Each subject participated for 16 weeks (weeks 1-4 CLON/placebo dose titration, weeks 5-8 added MPH/placebo dose titration, weeks 9-16 maintenance therapy). Thirty-seven children were administered MPH alone, 34 were administered CLON alone, 33 were administered CLON + MPH, and 32 were administered placebo. For our primary outcome measure of ADHD (Conners Abbreviated Symptom Questionnaire--Teacher), significant improvement occurred for subjects assigned to CLON (p tics as an adverse effect was no higher in those treated with MPH (20%) than those being administered CLON alone (26%) or placebo (22%). Compared with placebo, measured tic severity lessened in all active treatment groups in the following order: CLON + MPH, CLON alone, MPH alone. Sedation was common with CLON treatment (28% reported moderate or severe sedation), but otherwise the drugs were tolerated well, including absence of any evident cardiac toxicity. Methylphenidate and clonidine (particularly in combination) are effective for ADHD in children with comorbid tics. Prior recommendations to avoid methylphenidate in these children because of concerns of worsening tics are unsupported by this trial.

  2. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures.

    Science.gov (United States)

    Lantto, Iikka; Heikkinen, Juuso; Flinkkila, Tapio; Ohtonen, Pasi; Siira, Pertti; Laine, Vesa; Leppilahti, Juhana

    2016-09-01

    The optimal treatment of acute Achilles tendon ruptures for active patients is under debate. To compare clinical outcomes and calf muscle strength recovery after the nonsurgical treatment and open surgical repair of acute Achilles tendon ruptures with identical accelerated rehabilitation programs. Randomized controlled trial; Level of evidence, 1. From 2009 to 2013, a total of 60 patients with an acute Achilles tendon rupture were randomized to surgery or nonsurgical treatment. Nonsurgical treatment included first a week of cast immobilization, followed by a functional orthosis for 6 weeks, allowing full weightbearing after week 1 and active plantar flexion after week 5. Surgery was simple end-to-end open repair, and postoperative treatment was identical to nonsurgical treatment. Outcome measures included the Leppilahti Achilles tendon performance score, isokinetic calf muscle strength, and RAND 36-Item Health Survey at 18-month follow-up. At 18-month follow-up, the mean Leppilahti score was 79.5 and 75.7 for the surgically and nonsurgically treated groups, respectively (mean difference, 3.8; 95% CI, -1.9 to 9.5; P = .19). Angle-specific peak torque results of affected legs showed that surgery resulted in faster and better recovery of calf muscle strength over the entire range of motion of the ankle joint: at 6 months, the difference varied from 16% to 24% (P = .016), favoring the surgically treated group, whereas at 18 months, surgically treated patients had 10% to 18% greater strength results (P = .037). At 18 months, a 14% difference in the peak torque of the affected leg favored the surgical group versus the nonsurgical group (mean peak torque, 110.3 vs 96.5 N·m, respectively; mean difference, 13.6 N·m; 95% CI, 2.0-25.1 N·m; P = .022). The RAND 36-Item Health Survey indicated better results in the domains of physical functioning (P = .006) and bodily pain (P = .037) for surgically treated patients. Surgical and nonsurgical treatments of acute Achilles tendon

  3. CANDIS treatment program for cannabis use disorders: findings from a randomized multi-site translational trial.

    Science.gov (United States)

    Hoch, E; Bühringer, G; Pixa, A; Dittmer, K; Henker, J; Seifert, A; Wittchen, H U

    2014-01-01

    In a recent paper, we reported the efficacy of a modular cognitive-behavioral intervention for treating adolescents and adults with cannabis use disorders (CUD). In this study, we examine the outcome of this intervention after translating it into clinical practice. A multi-site, randomized controlled trial of 279 treatment seekers with ICD-10 cannabis use disorders aged 16- 63 years was conducted in 11 outpatient addiction treatment centers in Germany. Patients were randomly assigned to an Active Treatment (AT, n=149) or Delayed Treatment Control (DTC, n=130). Treatment consisted of 10 sessions of fully manualized individual psychotherapy that combined Cognitive-Behavioral Therapy, Motivational EnhancementTherapy and problem-solving training. Assessments were conducted at baseline, during each therapy session, at post-treatment and at three and six month follow-ups. At post assessment 53.3% of AT patients reported abstinence (46.3% negative urine screenings) compared to 22% of DTC patients (17.7% negative drug screenings) (pcannabis use, number of cannabis dependence criteria, severity of dependence, as well as number and severity of cannabis-related problems. Effect sizes were moderate to high. While abstinence rates in the AT group decreased over the 3-month (negative urine screenings: 32.4%) and 6-month (negative urine screenings: 35.7%) follow-up periods, the effects in secondary outcomes were maintained. The intervention can successfully be translated to and applied in clinical practice. It has the potential to improve access to evidence-based care for chronic CUD patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  4. Pain Reduction After Laser Acupuncture Treatment in Geriatric Patients with Knee Osteoarthritis: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dwi R Helianthi

    2016-09-01

    Full Text Available Aim: to compare the effectiveness of active laser acupuncture with placebo on reducing pain intensity and improving functional outcome in geriatric patients with knee osteoarthritis (OA. Methods: a double-blind randomized controlled trial was conducted in geriatrics with knee OA at Medical Acupuncture Outpatient Clinic, Integrated Geriatric Outpatient Clinic, Rheumatology Outpatient Clinic of Cipto Mangunkusumo Hospital, Jakarta, during May to October 2015. Sixty two patients with knee OA  were randomly assigned into two groups: active laser acupuncture group or placebo laser acupuncture group. Interventions were carried out using a gallium aluminum arsenide laser device at the ST35 Dubi, ST36 Zusanli, SP9 Yinlingquan, GB34 Yanglingquan and EX - LE - 4 Neixiyan acupuncture points on the affected knee for ten sessions of treatment, i.e. twice a week. Patients were assessed using a visual analogue scale (VAS and Lequesne index at baseline, after four sessions, after nine sessions and at 2 weeks after the treatment had been stopped. Results: the VAS scores were significantly improved in the active laser acupuncture group compared to the placebo group. The evaluation of VAS scores was carried out after four treatment sessions (mean difference: 0.39; p<0.001, after nine treatment sessions (mean difference: 37.48; p<0.001 and at 2 weeks post intervention (mean difference: 39.15; p<0.001. The evaluation also showed significant improvement of Lequesne index after four treatment sessions (mean difference: 4.68; p<0.001, after nine treatment sessions (mean difference: 5.90; p<0.001 and at 2 weeks post intervention (mean difference: 6.48; p<0.001. Conclusion: active laser acupuncture is effective in reducing pain.

  5. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial.

    Science.gov (United States)

    Vega, Aurelio; Martín-Ferrero, Miguel Angel; Del Canto, Francisco; Alberca, Mercedes; García, Veronica; Munar, Anna; Orozco, Lluis; Soler, Robert; Fuertes, Juan Jose; Huguet, Marina; Sánchez, Ana; García-Sancho, Javier

    2015-08-01

    Osteoarthritis is the most prevalent joint disease and a common cause of joint pain, functional loss, and disability. Conventional treatments demonstrate only modest clinical benefits without lesion reversal. Autologous mesenchymal stromal cell (MSC) treatments have shown feasibility, safety, and strong indications for clinical efficacy. We performed a randomized, active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs, and we obtain information regarding the efficacy of this treatment. We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients. The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 × 10(6) cells. The control group received intra-articular hyaluronic acid (60 mg, single dose). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping. Feasibility and safety were confirmed and indications of clinical efficacy were identified. The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid. Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas, with cartilage quality improvements in MSC-treated patients. Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves cartilage quality.

  6. Randomized controlled trial of a treatment for anorexia and bulimia nervosa

    Science.gov (United States)

    Bergh, Cecilia; Brodin, Ulf; Lindberg, Greger; Södersten, Per

    2002-01-01

    Evidence for the effectiveness of existing treatments of patients with eating disorders is weak. Here we describe and evaluate a method of treatment in a randomized controlled trial. Sixteen patients, randomly selected out of a group composed of 19 patients with anorexia nervosa and 13 with bulimia nervosa, were trained to eat and recognize satiety by using computer support. They rested in a warm room after eating, and their physical activity was restricted. The patients in the control group (n = 16) received no treatment. Remission was defined by normal body weight (anorexia), cessation of binge eating and purging (bulimia), a normal psychiatric profile, normal laboratory test values, normal eating behavior, and resumption of social activities. Fourteen patients went into remission after a median of 14.4 months (range 4.9–26.5) of treatment, but only one patient went into remission while waiting for treatment (P = 0.0057). Relapse is considered a major problem in patients who have been treated to remission. We therefore report results on a total of 168 patients who have entered our treatment program. The estimated rate of remission was 75%, and estimated time to remission was 14.7 months (quartile range 9.6 ≥ 32). Six patients (7%) of 83 who were treated to remission relapsed, but the others (93%) have remained in remission for 12 months (quartile range 6–36). Because the risk of relapse is maximal in the first year after remission, we suggest that most patients treated with this method recover. PMID:12082182

  7. High-flow oxygen for treatment of cluster headache: a randomized trial.

    Science.gov (United States)

    Cohen, Anna S; Burns, Brian; Goadsby, Peter J

    2009-12-09

    Cluster headache is an excruciatingly painful primary headache syndrome, with attacks of unilateral pain and cranial autonomic symptoms. The current licensed treatment for acute attacks is subcutaneous sumatriptan. To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache. A double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged 18-70 years) with cluster headache as defined by the International Headache Society. Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately. Patients were randomized to the order in which they received the active treatment or placebo. Patients were recruited and followed up between 2002 and 2007 at the National Hospital for Neurology and Neurosurgery, London, England. Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start of an attack of cluster headache or high-flow air placebo delivered alternately for 4 attacks. The primary end point was to render the patient pain free, or in the absence of a diary to have adequate relief, at 15 minutes. Secondary end points included rendering the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for rescue medication 15 minutes after treatment, overall response to the treatment and overall functional disability, and effect on associated symptoms. Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache were available for the analysis. For the primary end point the difference between oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence interval, 14%-26%; for 148 attacks) was significant (Wald test, chi(5)(2) = 66.7, P Treatment of patients with cluster headache at symptom onset using inhaled high-flow oxygen compared with placebo was more likely to result in being pain-free at 15 minutes. isrctn.org Identifier: ISRCTN94092997.

  8. Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

    Science.gov (United States)

    Van Coevorden, Frits; Punt, Cornelis J. A.; Pierie, Jean-Pierre E. N.; Borel-Rinkes, Inne; Ledermann, Jonathan A.; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

    2017-01-01

    Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n  38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. PMID:28376151

  9. Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial

    NARCIS (Netherlands)

    Bonouvrié, L.A.; Becher, J.G.; Vles, J.S.H.; Boeschoten, K.; Soudant, D.; de Groot, V.; van Ouwerkerk, W.J.R.; Strijers, R.L.M.; Foncke, E.; Geytenbeek, J.J.M.; van de Ven, P.M.; Teernstra, O.; Vermeulen, R.J.

    2013-01-01

    Background: Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite

  10. Pulmonary arterial hypertension treatment with carvedilol for heart failure: a randomized controlled trial

    Science.gov (United States)

    Saygin, Didem; Park, Margaret M.; Cheong, Hoi I.; Asosingh, Kewal; Comhair, Suzy A.A.; Stephens, Olivia R.; Roach, Emir C.; Sharp, Jacqueline; Highland, Kristin B.; DiFilippo, Frank P.; Neumann, Donald R.; Tang, W.H. Wilson; Erzurum, Serpil C.

    2017-01-01

    BACKGROUND. Right-sided heart failure is the leading cause of death in pulmonary arterial hypertension (PAH). Similar to left heart failure, sympathetic overactivation and β-adrenoreceptor (βAR) abnormalities are found in PAH. Based on successful therapy of left heart failure with β-blockade, the safety and benefits of the nonselective β-blocker/vasodilator carvedilol were evaluated in PAH. METHODS. PAH Treatment with Carvedilol for Heart Failure (PAHTCH) is a single-center, double-blind, randomized, controlled trial. Following 1-week run-in, 30 participants were randomized to 1 of 3 arms for 24 weeks: placebo, low-fixed-dose, or dose-escalating carvedilol. Outcomes included clinical measures and mechanistic biomarkers. RESULTS. Decreases in heart rate and blood pressure with carvedilol were well tolerated; heart rate correlated with carvedilol dose. Carvedilol-treated groups had no decrease in exercise capacity measured by 6-minute walk, but had lower heart rates at peak and after exercise, and faster heart rate recovery. Dose-escalating carvedilol was associated with reduction in right ventricular (RV) glycolytic rate and increase in βAR levels. There was no evidence of RV functional deterioration; rather, cardiac output was maintained. CONCLUSIONS. Carvedilol is likely safe in PAH over 6 months of therapy and has clinical and mechanistic benefits associated with improved outcomes. The data provide support for longer and larger studies to establish guidelines for use of β-blockers in PAH. TRIAL REGISTRATION. ClinicalTrials.gov NCT01586156 FUNDING. This project was supported by NIH R01HL115008 and R01HL60917 and in part by the National Center for Advancing Translational Sciences, UL1TR000439. PMID:28814664

  11. [A systematic review of randomized controlled clinical trials of abdominal acupuncture treatment of cervical spondylosis].

    Science.gov (United States)

    Wang, Yan-wen; Fu, Wen-bin; Ou, Ai-hua; Fan, Ling; Huang, Ye-fei

    2011-04-01

    To assess the effect and methodological quality of clinically randomized controlled studies on abdominal acupuncture therapy for cervical spondylosis and to make out its current situation, validity and applicability. Using the PubMed, CNKI (China Academic Journals Full-text Database), VIP (VIP Chinese Science and Technology Periodicals Database) and Wanfang Digital Periodicals Electronic Database covering the period of 1989-2009, we did a literature search on the original articles of abdominal acupuncture treatment of cervical spondylosis and selected those accorded with the standards of randomized controlled studies. Animal studies, surveys, and news articles, and those duplicated, being absent in diagnostic criteria and non-randomized controlled trials were excluded. The papers' quality was analyzed by using the Jadad quality assessment scoring system and the therapeutic effect evaluated by using Review Manage 4.2.7 software. A total of 8 papers containing 909 cervical spondylosis patients and written in Chinese were included. These 8 studies used the effective rate as the primary outcome, 2 of them used the McGill Pain Questionnaire scales at the same time. Meta-analysis showed that the abdominal acupuncture group was better than the control group in visual analogue scale score (P acupuncture and routine acupuncture [OR = 3.29, 95% CI (0.13, 82.99)], EA [OR = 2.09, 95% CI (0.36, 11.95)] and traction therapy [OR = 6.06, 95% CI (3.01, 12.18)] in the total effective rate, pain rating index score [WMD = -2.24, 95% CI (-5.29, 0.81)] and the present pain intensity score [WMD = -0.84, 95% CI (-2.13, 0.44)]. At the present, there has been no sufficient evidence to ensure that in the treatment of cervical spondylosis, the abdominal acupuncture therapy is superior to routine acupuncture, EA and traction therapy. Attention should be paid to the randomized controlled study of larger samples and qualified design.

  12. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil.

    Science.gov (United States)

    Alvarez, X Antón; Cacabelos, R; Sampedro, C; Couceiro, V; Aleixandre, M; Vargas, M; Linares, C; Granizo, E; García-Fantini, M; Baurecht, W; Doppler, E; Moessler, H

    2011-08-01

    Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimer's disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinician's Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.

  13. Systematic review and meta-analysis of randomized clinical trials in the treatment of human brucellosis.

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    Julián Solís García del Pozo

    Full Text Available BACKGROUND: Brucellosis is a persistent health problem in many developing countries throughout the world, and the search for simple and effective treatment continues to be of great importance. METHODS AND FINDINGS: A search was conducted in MEDLINE and in the Cochrane Central Register of Controlled Trials (CENTRAL. Clinical trials published from 1985 to present that assess different antimicrobial regimens in cases of documented acute uncomplicated human brucellosis were included. The primary outcomes were relapse, therapeutic failure, combined variable of relapse and therapeutic failure, and adverse effect rates. A meta-analysis with a fixed effect model was performed and odds ratio with 95% confidence intervals were calculated. A random effect model was used when significant heterogeneity between studies was verified. Comparison of combined doxycycline and rifampicin with a combination of doxycycline and streptomycin favors the latter regimen (OR = 3.17; CI95% = 2.05-4.91. There were no significant differences between combined doxycycline-streptomycin and combined doxycycline-gentamicin (OR = 1.89; CI95% = 0.81-4.39. Treatment with rifampicin and quinolones was similar to combined doxycycline-rifampicin (OR = 1.23; CI95% = 0.63-2.40. Only one study assessed triple therapy with aminoglycoside-doxycycline-rifampicin and only included patients with uncomplicated brucellosis. Thus this approach cannot be considered the therapy of choice until further studies have been performed. Combined doxycycline/co-trimoxazole or doxycycline monotherapy could represent a cost-effective alternative in certain patient groups, and further studies are needed in the future. CONCLUSIONS: Although the preferred treatment in uncomplicated human brucellosis is doxycycline-aminoglycoside combination, other treatments based on oral regimens or monotherapy should not be rejected until they are better studied. Triple therapy should not be considered

  14. Systematic Review and Meta-Analysis of Randomized Clinical Trials in the Treatment of Human Brucellosis

    Science.gov (United States)

    Solís García del Pozo, Julián; Solera, Javier

    2012-01-01

    Background Brucellosis is a persistent health problem in many developing countries throughout the world, and the search for simple and effective treatment continues to be of great importance. Methods and Findings A search was conducted in MEDLINE and in the Cochrane Central Register of Controlled Trials (CENTRAL). Clinical trials published from 1985 to present that assess different antimicrobial regimens in cases of documented acute uncomplicated human brucellosis were included. The primary outcomes were relapse, therapeutic failure, combined variable of relapse and therapeutic failure, and adverse effect rates. A meta-analysis with a fixed effect model was performed and odds ratio with 95% confidence intervals were calculated. A random effect model was used when significant heterogeneity between studies was verified. Comparison of combined doxycycline and rifampicin with a combination of doxycycline and streptomycin favors the latter regimen (OR = 3.17; CI95% = 2.05–4.91). There were no significant differences between combined doxycycline-streptomycin and combined doxycycline-gentamicin (OR = 1.89; CI95% = 0.81–4.39). Treatment with rifampicin and quinolones was similar to combined doxycycline-rifampicin (OR = 1.23; CI95% = 0.63–2.40). Only one study assessed triple therapy with aminoglycoside-doxycycline-rifampicin and only included patients with uncomplicated brucellosis. Thus this approach cannot be considered the therapy of choice until further studies have been performed. Combined doxycycline/co-trimoxazole or doxycycline monotherapy could represent a cost-effective alternative in certain patient groups, and further studies are needed in the future. Conclusions Although the preferred treatment in uncomplicated human brucellosis is doxycycline-aminoglycoside combination, other treatments based on oral regimens or monotherapy should not be rejected until they are better studied. Triple therapy should not be considered the current

  15. A Randomized Controlled Trial of Cognitive-Behavioral Treatment for Posttraumatic Stress Disorder in Severe Mental Illness

    Science.gov (United States)

    Mueser, Kim T.; Rosenberg, Stanley D.; Xie, Haiyi; Jankowski, M. Kay; Bolton, Elisa E.; Lu, Weili; Hamblen, Jessica L.; Rosenberg, Harriet J.; McHugo, Gregory J.; Wolfe, Rosemarie

    2008-01-01

    A cognitive-behavioral therapy (CBT) program for posttraumatic stress disorder (PTSD) was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared with treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major…

  16. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

    DEFF Research Database (Denmark)

    Fätkenheuer, G; Duvivier, C; Rieger, A

    2012-01-01

    Etravirine is approved for use in treatment-experienced patients at a dose of 200 mg twice daily. Efavirenz has been associated with greater increases in serum lipids compared with other non-nucleosides in randomized trials of first-line treatment....

  17. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial

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    Worden Katherine A

    2008-10-01

    Full Text Available Abstract Background Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT for prevention of acute otitis media in otitis-prone children. Methods A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments were offered over 3 months. Results No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42. OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10. Conclusion In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media. Trial registration ClinicalTrials.gov Identifier: NCT00010465

  18. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial

    Science.gov (United States)

    Wahl, Richard A; Aldous, Michael B; Worden, Katherine A; Grant, Kathryn L

    2008-01-01

    Background Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT) for prevention of acute otitis media in otitis-prone children. Methods A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male) were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation) plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo) was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments) were offered over 3 months. Results No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42). OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10). Conclusion In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media. Trial registration ClinicalTrials.gov Identifier: NCT00010465 PMID:18831749

  19. OXYTOCIN - AN EMERGING TREATMENT FOR OBESITY AND DYSGLYCEMIA: REVIEW OF RANDOMIZED CONTROLLED TRIALS AND COHORT STUDIES.

    Science.gov (United States)

    Barengolts, Elena

    2016-07-01

    The psychotropic mediator and neuropeptide hormone oxytocin (OXT) is emerging as a promising treatment of metabolic disorders (obesity and dysglycemia). This review focuses on studies relevant to OXT use and its mechanisms of action in metabolic disorders and wellness behavior motivation. Randomized controlled trials (RCTs) and cohort and preclinical studies identified in electronic databases were reviewed. There were only a few RCTs and cohort studies related to OXT and metabolic disorders. Anorexigenic and weight-loss effects of intranasal OXT (IOXT) were evaluated in 3 double-blind RCTs involving 85 subjects. A single dose of 24 IU reduced caloric intake by 122 kcal. The 24 IU 4-times daily dose for 8 weeks produced ~9-kg weight loss (Poxytocin OXTR = oxytocin receptor sOXT = serum oxytocin.

  20. Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial.

    Science.gov (United States)

    Webster, Louise M; Myers, Jenny E; Nelson-Piercy, Catherine; Harding, Kate; Cruickshank, J Kennedy; Watt-Coote, Ingrid; Khalil, Asma; Wiesender, Cornelia; Seed, Paul T; Chappell, Lucy C

    2017-11-01

    Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12 +0 -27 +6 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; P =0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment. URL: https://www.isrctn.com. Unique identifier: ISRCTN40973936. © 2017 American Heart Association, Inc.

  1. A randomized trial of levodopa as treatment for residual amblyopia in older children.

    Science.gov (United States)

    Repka, Michael X; Kraker, Raymond T; Dean, Trevano W; Beck, Roy W; Siatkowski, R Michael; Holmes, Jonathan M; Beauchamp, Cynthia L; Golden, Richard P; Miller, Aaron M; Verderber, Lisa C; Wallace, David K

    2015-05-01

    To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia. Randomized, placebo-controlled trial. One hundred thirty-nine children 7 to 12 years of age with residual amblyopia resulting from strabismus, anisometropia, or both combined (visual acuity [VA], 20/50-20/400) after patching. Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily. Mean change in best-corrected amblyopic-eye VA at 18 weeks. At 18 weeks, amblyopic-eye VA improved from randomization by an average of 5.2 letters in the levodopa group and by 3.8 letters in the placebo group (difference adjusted for baseline VA, +1.4 letters; 1-sided P=0.06; 2-sided 95% confidence interval, -0.4 to 3.3 letters). No serious adverse effects from levodopa were reported during treatment. For children 7 to 12 years of age with residual amblyopia after patching therapy, oral levodopa while continuing to patch 2 hours daily does not produce a clinically or statistically meaningful improvement in VA compared with placebo and patching. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  2. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

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    Adelaida María Castro-Sánchez

    2012-01-01

    Full Text Available Background. Multiple sclerosis (MS is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P<0.028 and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

  3. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial.

    Science.gov (United States)

    Kuru, Bahar; Yıldırım, Selin

    2013-01-01

    One of the success factors in periodontal plastic surgery is the synergistic relationship between involved tissues and vascular supply. Gingiva as a functional unit is unique with a specific vascular configuration and contains the supracrestal portion naturally created to survive over avascular root surfaces. The aim of this randomized controlled trial is to clinically evaluate the treatment of localized gingival recessions by using gingival unit grafts (palatal tissue involving marginal gingiva and papillae) compared with conventional palatal grafts. Seventeen patients with Class I to II recession defects on mandibular anterior teeth were included and randomly divided into two groups. Recessions were treated with gingival unit grafts in group 1 (n = 8) and with palatal grafts in group 2 (n = 9). Clinical parameters including vertical recession (VR), probing depth, keratinized tissue (KT), and attachment level were recorded at baseline and 8 months after surgery. Both treatments produced significant clinical improvements within the groups. Intergroup comparison revealed significantly higher VR reduction, attachment, and KT gain in group 1 than in group 2; mean percentages of the defect coverage were 91.62% ± 9.74% and 68.97% ± 13.67%, respectively (P <0.05). Healing of the gingival unit donor site was uneventful. Within its limits, this study demonstrates the possibility of treating buccal recessions with gingival unit grafts as an alternative technique using gingival donor graft of site-specific vascular configuration, with better defect coverage, clinical, and esthetic improvements compared with palatal grafts.

  4. Is Ceftizoxime an Appropriate Surrogate for Amikacin in Neonatal Sepsis Treatment? A Randomized Clinical Trial

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    Peyman Salamati

    2011-08-01

    Full Text Available Neonatal sepsis, a life-threatening condition, presents with non-specific clinical manifestations and needs immediate empirical antimicrobial therapy. Choosing an appropriate antibiotic regimen covering the most probable pathogens is an important issue. In this study we compared the effectiveness of ceftizoxime and amikacin in the treatment of neonatal sepsis both in combination with ampicillin. In a randomized clinical trial, all term neonates with suspected sepsis referred to Bahrami hospital during March 2008 to March 2010 were evaluated. Patients were randomly recruited into two groups; one group receiving ampicillin and amikacin and the other ampicillin and ceftizoxime. Blood, urine and cerebrospinal fluid cultures, leukocyte count and C-reactive protein level were measured in all neonates. A total of 135 neonates were evaluated, 65 in amikacin group and 70 in ceftizoxime group. 60 neonates (85.7% in ceftizoxime group and 54 neonates (83.1% in amikacin group responded to the treatment (P= 0.673 and χ2 = 0.178. Only 24 (18% blood samples had a report of positive blood culture. The most frequent pathogen was coagulase negative staphylococcus with the frequency of 58.32% of all positive blood samples. Ceftizoxime in combination with ampicillin is an appropriate antimicrobial regimen for surrogating the combination of ampicillin and amikacin to prevent bacterial resistance against them.

  5. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  6. Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Chang, Yung-Sen; Trivedi, Michelle K; Jha, Ayan; Lin, Yen-Feng; Dimaano, Liezeel; García-Romero, Maria T

    2016-03-01

    Atopic dermatitis (AD) is a highly prevalent condition that may be associated with an altered gastrointestinal microbiota that promotes an immune environment more susceptible to allergic disease. Synbiotics, a mixture of prebiotics and probiotics, have been used for the prevention and treatment of AD. To investigate the efficacy of synbiotics for primary prevention and treatment of AD. PubMed/MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the CAB Abstracts Archive searchable database were searched from the inception of all databases to October 15, 2015, with no language restrictions. We included all published randomized clinical trials of synbiotics for prevention and/or treatment of AD. To be included, a publication needed to clearly define the intervention as oral administration of synbiotics (combination of probiotics and prebiotics) and must have included an assessment of AD disease severity, such as the Severity Scoring of Atopic Dermatitis (SCORAD) index, or the incidence of AD as an outcome measure. Only 8 of 257 initially identified studies (3%) met selection criteria. Data extraction was independently done by multiple observers and cross-checked to avoid errors. The quality of the selected studies was critically examined following the Cochrane guidelines. Data were pooled using a random-effects model. The primary outcomes were the SCORAD index (treatment studies) and the relative risk of AD (prevention studies). The hypothesis was formulated before data collection. A total of 257 abstracts were screened to identify 6 treatment studies (369 children enrolled; aged 0 months to 14 years) and 2 prevention studies (1320 children enrolled; up to age 6 months in one study and term neonates aged children aged 1 year or older (weighted mean difference, -7.37; 95% CI, -14.66 to -0.07; P = .048). From the 2 prevention studies included, the pooled relative risk ratio of AD in those treated with synbiotics compared with placebo was 0.44 (95

  7. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Sunay, Didem; Sunay, Melih; Aydoğmuş, Yasin; Bağbancı, Sahin; Arslan, Hüseyin; Karabulut, Ayhan; Emir, Levent

    2011-05-01

    Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies. To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo. The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded. The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk. Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically. Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p=0.001, p=0.001, and p=0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p=0.001) and the acupuncture and placebo groups (p=0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p=0.001). The most important limitation

  8. A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van der Meer Klaas

    2007-02-01

    Full Text Available Abstract Background Subacromial impingement syndrome (SIS is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT, which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. Methods/Design The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT. Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group or continuation of usual medical care (control group. The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. Discussion The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial

  9. Internet-based treatment for adults with depressive symptoms: the protocol of a randomized controlled trial

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    Cuijpers Pim

    2007-12-01

    Full Text Available Abstract Background Depression is a highly prevalent condition, affecting more than 15% of the adult population at least once in their lives. Guided self-help is effective in the treatment of depression. The purpose of this study is to investigate the effectiveness of two Internet-based guided self-help treatments with adults reporting elevated depressive symptoms. Other research questions concern the identification of potential mediators and the search for subgroups who respond differently to the interventions. Methods This study is a randomized controlled trial with three conditions: two treatment conditions and one waiting list control group. The two treatment conditions are Internet-based cognitive behavior therapy and Internet-based problem-solving therapy. They consist of 8 and 5 weekly lessons respectively. Both interventions are combined with support by e-mail. Participants in the waiting list control group receive the intervention three months later. The study population consists of adults from the general population. They are recruited through advertisements in local and national newspapers and through banners on the Internet. Subjects with symptoms of depression (≥ 16 on the Center for Epidemiological Studies Depression scale are included. Other inclusion criteria are having sufficient knowledge of the Dutch language, access to the Internet and an e-mail address. Primary outcome is depressive symptoms. Secondary outcomes are anxiety, quality of life, dysfunctional cognitions, worrying, problem solving skills, mastery, absence at work and use of healthcare. We will examine the following variables as potential mediators: dysfunctional cognitions, problem solving skills, worrying, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics and symptom severity. Data are collected at baseline and at 5 weeks, 8 weeks, 12 weeks and 9 months after baseline. Analyses will be conducted on the intention

  10. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

    Science.gov (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

    2003-06-24

    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  11. A Randomized Controlled Trial of Cognitive Debiasing Improves Assessment and Treatment Selection for Pediatric Bipolar Disorder

    Science.gov (United States)

    Jenkins, Melissa M.; Youngstrom, Eric A.

    2015-01-01

    Objective This study examined the efficacy of a new cognitive debiasing intervention in reducing decision-making errors in the assessment of pediatric bipolar disorder (PBD). Method The study was a randomized controlled trial using case vignette methodology. Participants were 137 mental health professionals working in different regions of the US (M=8.6±7.5 years of experience). Participants were randomly assigned to a (1) brief overview of PBD (control condition), or (2) the same brief overview plus a cognitive debiasing intervention (treatment condition) that educated participants about common cognitive pitfalls (e.g., base-rate neglect; search satisficing) and taught corrective strategies (e.g., mnemonics, Bayesian tools). Both groups evaluated four identical case vignettes. Primary outcome measures were clinicians’ diagnoses and treatment decisions. The vignette characters’ race/ethnicity was experimentally manipulated. Results Participants in the treatment group showed better overall judgment accuracy, p < .001, and committed significantly fewer decision-making errors, p < .001. Inaccurate and somewhat accurate diagnostic decisions were significantly associated with different treatment and clinical recommendations, particularly in cases where participants missed comorbid conditions, failed to detect the possibility of hypomania or mania in depressed youths, and misdiagnosed classic manic symptoms. In contrast, effects of patient race were negligible. Conclusions The cognitive debiasing intervention outperformed the control condition. Examining specific heuristics in cases of PBD may identify especially problematic mismatches between typical habits of thought and characteristics of the disorder. The debiasing intervention was brief and delivered via the Web; it has the potential to generalize and extend to other diagnoses as well as to various practice and training settings. PMID:26727411

  12. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression.

    Science.gov (United States)

    Eisendrath, Stuart J; Gillung, Erin; Delucchi, Kevin L; Segal, Zindel V; Nelson, J Craig; McInnes, L Alison; Mathalon, Daniel H; Feldman, Mitchell D

    2016-01-01

    Due to the clinical challenges of treatment-resistant depression (TRD), we evaluated the efficacy of mindfulness-based cognitive therapy (MBCT) relative to a structurally equivalent active comparison condition as adjuncts to treatment-as-usual (TAU) pharmacotherapy in TRD. This single-site, randomized controlled trial compared 8-week courses of MBCT and the Health Enhancement Program (HEP), comprising physical fitness, music therapy and nutritional education, as adjuncts to TAU pharmacotherapy for outpatient adults with TRD. The primary outcome was change in depression severity, measured by percent reduction in the total score on the 17-item Hamilton Depression Rating Scale (HAM-D17), with secondary depression indicators of treatment response and remission. We enrolled 173 adults; mean length of a current depressive episode was 6.8 years (SD = 8.9). At the end of 8 weeks of treatment, a multivariate analysis showed that relative to the HEP condition, the MBCT condition was associated with a significantly greater mean percent reduction in the HAM-D17 (36.6 vs. 25.3%; p = 0.01) and a significantly higher rate of treatment responders (30.3 vs. 15.3%; p = 0.03). Although numerically superior for MBCT than for HEP, the rates of remission did not significantly differ between treatments (22.4 vs. 13.9%; p = 0.15). In these models, state anxiety, perceived stress and the presence of personality disorder had adverse effects on outcomes. MBCT significantly decreased depression severity and improved treatment response rates at 8 weeks but not remission rates. MBCT appears to be a viable adjunct in the management of TRD. © 2016 S. Karger AG, Basel.

  13. Mobile app for treatment of stress urinary incontinence: A randomized controlled trial.

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    Asklund, Ina; Nyström, Emma; Sjöström, Malin; Umefjord, Göran; Stenlund, Hans; Samuelsson, Eva

    2017-06-01

    To evaluate the effect of a mobile app treatment for stress urinary incontinence (SUI) in women. Randomized controlled trial, conducted 2013-2014 in Sweden. Community-dwelling adult women with ≥1 SUI episode/week recruited through our website and randomized to app treatment (n = 62) or control group (postponed treatment, n = 61). One participant from each group was lost to follow-up. Intervention was the mobile app Tät(®) with a treatment program focused on pelvic floor muscle training (PFMT), and information about SUI and lifestyle factors. Primary outcomes, 3 months after randomization: symptom severity (International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form [ICIQ-UI SF]); and condition-specific quality of life (ICIQ Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]). One hundred and twenty-three women were included (mean age 44.7), with moderate/severe SUI (97.5%, 120/123), mean ICIQ-UI SF score 11.1 (SD 2.8) and mean ICIQ-LUTSqol score 34.4 (SD 6.1) at baseline. At follow-up, the app group reported improvements in symptom severity (mean ICIQ-UI SF score reduction: 3.9, 95% confidence interval 3.0-4.7) and condition-specific quality of life (mean ICIQ-LUTSqol score reduction: 4.8, 3.4-6.2) and the groups were significantly different (mean ICIQ-UI SF score difference: -3.2, -4.3to -2.1; mean ICIQ-LUTSqol score difference: -4.6, -7.8 to -1.4). In the app group, 98.4% (60/61) performed PFMT at follow-up, and 41.0% (25/61) performed it daily. The mobile app treatment was effective for women with SUI and yielded clinically relevant improvements. This app may increase access to first-line treatment and adherence to PFMT. © 2016 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.

  14. EFFICACY OF CITALOPRAM IN TREATMENT OF PATHOLOGICAL SKIN PICKING, A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

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    M Arbabi

    2008-11-01

    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

  15. A Randomized Controlled Trial Evaluating the Effects of Diosmin in the Treatment of Radicular Pain

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    Yinhe Wang

    2017-01-01

    Full Text Available Diosmin has been widely used to treat patients with vascular pain for its potent anti-inflammatory and analgesic effects. To evaluate the therapeutic effects of Diosmin in the treatment of radicular pain, we conducted an investigator-initiated, randomized, active-controlled noninferiority trial between January 1, 2009, and December 1, 2010. Diosmin (50 mg/kg/day was orally administered to treat the radicular pain in 150 patients for one month. Another 150 patients with the same symptom were given 20% 250 ml mannitol (1 g/kg/day for 7 days and dexamethasone (10 mg/day for 3 days intravenously guttae. Short-term relief and long-term relief were measured. Secondary outcomes include improvement in functional and psychological status, return to work, and reduction in anti-inflammatory analgesic drugs intake. Patients treated with oral Diosmin achieved reduction in radicular pain. The total satisfaction rate of Diosmin group was 84.7% [95% confidence interval (CI: 77.9%, 90.0%], and the complete satisfaction rate was 50.7% (95% CI: 42.4%, 58.9%. No statistically significant difference was found between the Diosmin group and the active-control group regarding patient satisfaction. No adverse effects were found during the study period. Our study suggests that clinical application of Diosmin with a dose of 50 mg/kg/day might reduce the radicular pain. This trial is registered with ISRCTN97157037.

  16. Designing randomized-controlled trials to improve head-louse treatment: systematic review using a vignette-based method.

    Science.gov (United States)

    Do-Pham, Giao; Le Cleach, Laurence; Giraudeau, Bruno; Maruani, Annabel; Chosidow, Olivier; Ravaud, Philippe

    2014-03-01

    Head-louse infestation remains a public health problem. Despite published randomized-controlled trials, no consensus-based clinical practice guidelines for its management emerged because of the heterogeneity of trial methodologies. Our study was undertaken to attempt to find an optimal trial framework: minimizing the risk of bias, while taking feasibility into account. To do so, we used the vignette-based method. A systematic review first identified trials on head-louse infestation; 49 were selected and their methodological constraints assessed. Methodological features were extracted and combined by arborescence to generate a broad spectrum of potential designs, called vignettes, yielding 357 vignettes. A panel of 48 experts then rated one-on-one comparisons of those vignettes to obtain a ranking of the designs. Methodological items retained for vignette generation were income level of the population, types of treatments compared, randomization unit, blinding, treatment-administration site, diagnosis method and criteria, and primary outcome measure. The expert panel selected vignettes with cluster randomization, centralized treatment administration, and blinding of the outcome assessor. The vignette method identified optimal designs to standardize future head-louse treatment trials, thereby obtaining valid conclusions and comparable data from future trials, and appears to be a reliable way to generate evidence-based guidelines.

  17. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

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    Stegenga Boudewijn

    2011-01-01

    Full Text Available Abstract Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group received comprehensive treatment once weekly consisting of manual compression of the MTrPs, manual stretching of the muscles and intermittent cold application with stretching. Patients were instructed to perform muscle-stretching and relaxation exercises at home and received ergonomic recommendations and advice to assume and maintain good posture. The control group remained on the waiting list for 3 months. The Disabilities of Arm, Shoulder and Hand (DASH questionnaire score (primary outcome, Visual Analogue Scale for Pain (VAS-P, Global Perceived Effect (GPE scale and the number of muscles with MTrPs were assessed at 6 and 12 weeks in the intervention group and compared with those of a control group. Results Compared with the control group, the intervention group showed significant improvement (P Conclusions The results of this study show that 12-week comprehensive treatment of MTrPs in shoulder muscles reduces the number of muscles with active MTrPs and is effective in reducing symptoms and improving shoulder function in patients with chronic shoulder pain. Trial registration number ISRCTN: ISRCTN75722066

  18. Flixweed vs. Polyethylene Glycol in the Treatment of Childhood Functional Constipation: A Randomized Clinical Trial.

    Science.gov (United States)

    Nimrouzi, Majid; Sadeghpour, Omid; Imanieh, Mohammad Hadi; Shams Ardekani, Mohammadreza; Salehi, Alireza; Minaei, Mohamad Bagher; Zarshenas, Mohammad M

    2015-04-01

    Polyethylene glycol (PEG) is often considered as the first-line treatment for functional constipation in children. Descurainia sophia (L.) Webb et Berth (D. sophia) is a safe recommended medicine in Iranian folk and Traditional Persian Medicine for the treatment of constipation. To clinically compare D. sophia with PEG 4000 (without electrolyte) in pediatric constipation and to assess its efficacy and side effects. 120 patients aged 2 - 12 years with constipation for at least 3 months were included in an 8 weeks lasting randomized controlled trial within two parallel-groups. Children received either PEG, 0.4 g/kg/day, or D. sophia seeds, 2 grams (for children aged 2 - 4 years) and 3 grams (for those aged > 4 years) per day. A total of 109 patients completed the study (56 in D. sophia and 53 in PEG group). At the end of the study, 36 (64.3%) patients in D. sophia group and 29 (54.7%) in PEG group were out of Rome III criteria (P = 0.205). Median weekly stool frequency in 0, 1, 2, 3 weeks of the treatment was found to be 2, 5, 5, 5 in D. sophia and 3, 4, 4, 5 in PEG group (P = 0.139, 0.076, 0.844, 0.294), respectively. The number of patients who suffered flatulence was less (5, 8.9%) in D. sophia group as compared to PEG group (6, 11.3%) at the end of the trial (P = 0.461). D. sophia taste was less tolerated. D. sophia is introduced as a cheap and available medication which can be applied as a safe alternative to conventional PEG in the management of pediatric chronic functional constipation.

  19. Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Panahi, Yunes; Rahimnia, Ali-Reza; Sharafi, Mojtaba; Alishiri, Gholamhossein; Saburi, Amin; Sahebkar, Amirhossein

    2014-11-01

    Treatment of osteoarthritis (OA) is challenging owing to the inefficacy and long-term adverse events of currently available medications including non-steroidal anti-inflammatory drugs. Curcuminoids are polyphenolic phytochemicals with established anti-inflammatory properties and protective effects on chondrocytes. The aim of this study is to investigate the clinical efficacy of curcuminoids in patients suffering from knee OA. A pilot randomized double-blind placebo-control parallel-group clinical trial was conducted among patients with mild-to-moderate knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) or matched placebo (n = 21) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. There was no significant difference in age, gender, body mass index, and VAS, WOMAC and LPFI scores between the study groups at baseline (p > 0.05). Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p  0.05). There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA. Copyright © 2014 John Wiley & Sons, Ltd.

  20. A randomized trial of aripiprazole vs blonanserin for the treatment of acute schizophrenia and related disorders.

    Science.gov (United States)

    Kishi, Taro; Matsuda, Yuki; Matsunaga, Shinji; Mukai, Tomohiko; Moriwaki, Masatsugu; Tabuse, Hideaki; Fujita, Kiyoshi; Iwata, Nakao

    2016-01-01

    There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d) vs blonanserin (4-24 mg/d) in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194). The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS) total score at week 24. Secondary outcomes were PANSS subscale scores, 21-item Hamilton Rating Scale for Depression (HAMD-21) score, response rate, discontinuation rate, and individual adverse events. Forty-four patients were recruited. The discontinuation rate was 86.4% in the aripiprazole group and 68.2% in the blonanserin treatment group. There was no significant difference in mean time to discontinuation between the groups. Although both treatment groups showed significant reductions in the PANSS total score, PANSS subscale scores, and HAMD-21 scores at week 24, the magnitudes of the changes did not differ between the groups. There were no significant differences in the incidences of adverse events including somnolence, extrapyramidal symptoms, prolactin-related adverse events, and weight change between the groups. Our results suggest similar efficacy and safety profiles of aripiprazole and blonanserin in the patients with schizophrenia. Double-blind controlled studies are needed to further explore the efficacy and safety of aripiprazole and blonanserin in schizophrenia.

  1. Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial.

    Science.gov (United States)

    Doi, Marcelo Yugi; Tano, Simone Sayomi; Schultz, Adriane Rocha; Borges, Ricardo; Marchiori, Luciana Lozza de Moraes

    2016-01-01

    Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. To assess the effectiveness of acupuncture therapy for tinnitus. Randomized clinical trial ( 2T9T7Q) with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p=0.0001 and the secondary endpoint, showing improvement in quality of life, with p=0.0001. Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  2. Osteopathic Manipulative Treatment of Back Pain and Related Symptoms during Pregnancy: A Randomized Controlled Trial

    Science.gov (United States)

    LICCIARDONE, John C.; BUCHANAN, Steve; HENSEL, Kendi L.; KING, Hollis H.; FULDA, Kimberly G.; STOLL, Scott T.

    2009-01-01

    Objective: To study osteopathic manipulative treatment (OMT) of back pain and related symptoms during the third trimester of pregnancy. Study design: A randomized, placebo-controlled trial was conducted to compare usual obstetrical care (UOBC) and OMT (UOBC+OMT), UOBC and sham ultrasound treatment (UOBC+SUT), and UOBC only. Outcomes included average pain levels and the Roland Morris-Disability Questionnaire (RMDQ) to assess back-specific functioning. Results: Intention-to-treat analyses included 144 subjects. The RMDQ scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the UOBC+OMT group (effect size, 0.72; 95% CI, 0.31-1.14; P=.001 vs. UOBC only; and effect size, 0.35; 95% CI, −0.06-0.76; P=.09 vs. UOBC+SUT). During pregnancy, back pain decreased in the UOBC+OMT group, remained unchanged in the UOBC+SUT group, and increased in the UOBC only group, although no between-group difference achieved statistical significance. Conclusion: Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy. PMID:19766977

  3. Art therapy as an adjuvant treatment for depression in elderly women: a randomized controlled trial

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    Eliana C. Ciasca

    2018-02-01

    Full Text Available Objective: There are few quantitative studies on art therapy for the treatment of depression. The objective of this study was to evaluate if art therapy is beneficial as an adjuvant treatment for depression in the elderly. Methods: A randomized, controlled, single-blind study was carried out in a sample of elderly women with major depressive disorder (MDD stable on pharmacotherapy. The experimental group (EG was assigned to 20 weekly art therapy sessions (90 min/session. The control group (CG was not subjected to any adjuvant intervention. Patients were evaluated at baseline and after 20 weeks, using the Geriatric Depression Scale (GDS, Beck Depression Inventory (BDI, Beck Anxiety Inventory (BAI, and cognitive measures. Results: Logistic regression analysis adjusted for age revealed that women in EG (n=31 had significant improvement in GDS (p = 0.007, BDI (p = 0.025, and BAI (p = 0.032 scores as compared with controls (n=25. No difference was found in the cognitive measures. Conclusion: Art therapy as an adjunctive treatment for MDD in the elderly can improve depressive and anxiety symptoms. Clinical trial registration: RBR-2YXY7Z

  4. Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marcelo Yugi Doi

    Full Text Available ABSTRACT INTRODUCTION: Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. OBJECTIVE: To assess the effectiveness of acupuncture therapy for tinnitus. METHODS: Randomized clinical trial (REBEC: 2T9T7Q with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. RESULTS: A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p = 0.0001 and the secondary endpoint, showing improvement in quality of life, with p = 0.0001. CONCLUSION: Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus.

  5. A Randomized Controlled Trial of Adjunctive Family Therapy and Treatment as Usual Following Inpatient Treatment for Anorexia Nervosa Adolescents

    Science.gov (United States)

    Godart, Nathalie; Berthoz, Sylvie; Curt, Florence; Perdereau, Fabienne; Rein, Zoé; Wallier, Jenny; Horreard, Anne-Sophie; Kaganski, Irène; Lucet, Réjane; Atger, Frédéric; Corcos, Maurice; Fermanian, Jacques; Falissard, Bruno; Flament, Martine; Eisler, Ivan; Jeammet, Philippe

    2012-01-01

    Research on treatments in anorexia nervosa (AN) is scarce. Although most of the therapeutic programs used in ‘real world practice’ in AN treatment resort to multidisciplinary approaches, they have rarely been evaluated. Objective To compare two multidimensional post-hospitalization outpatients treatment programs for adolescents with severe AN: Treatment as Usual (TAU) versus this treatment plus family therapy (TAU+FT). Method Sixty female AN adolescents, aged 13 to 19 years, were included in a randomized parallel controlled trial conducted from 1999 to 2002 for the recruitment, and until 2004 for the 18 months follow-up. Allocation to one of the two treatment groups (30 in each arm) was randomised. The TAU program included sessions for the patient alone as well as sessions with a psychiatrist for the patient and her parents. The TAU+FT program was identical to the usual one but also included family therapy sessions targeting intra-familial dynamics, but not eating disorder symptoms. The main Outcome Measure was the Morgan and Russell outcome category (Good or Intermediate versus Poor outcome). Secondary outcome indicators included AN symptoms or their consequences (eating symptoms, body mass index, amenorrhea, number of hospitalizations in the course of follow-up, social adjustment). The evaluators, but not participants, were blind to randomization. Results At 18 months follow-up, we found a significant group effect for the Morgan and Russell outcome category in favor of the program with family therapy (Intention-to-treat: TAU+FT :12/30 (40%); TAU : 5/29 (17.2%) p = 0.05; Per Protocol analysis: respectively 12/26 (46.2%); 4/27 (14.8%), p = 0.01). Similar group effects were observed in terms of achievement of a healthy weight (i.e., BMI≥10th percentile) and menstrual status. Conclusions Adding family therapy sessions, focusing on intra-familial dynamics rather than eating symptomatology, to a multidimensional program improves treatment effectiveness in

  6. A randomized controlled trial of adjunctive family therapy and treatment as usual following inpatient treatment for anorexia nervosa adolescents.

    Directory of Open Access Journals (Sweden)

    Nathalie Godart

    Full Text Available UNLABELLED: Research on treatments in anorexia nervosa (AN is scarce. Although most of the therapeutic programs used in 'real world practice' in AN treatment resort to multidisciplinary approaches, they have rarely been evaluated. OBJECTIVE: To compare two multidimensional post-hospitalization outpatients treatment programs for adolescents with severe AN: Treatment as Usual (TAU versus this treatment plus family therapy (TAU+FT. METHOD: Sixty female AN adolescents, aged 13 to 19 years, were included in a randomized parallel controlled trial conducted from 1999 to 2002 for the recruitment, and until 2004 for the 18 months follow-up. Allocation to one of the two treatment groups (30 in each arm was randomised. The TAU program included sessions for the patient alone as well as sessions with a psychiatrist for the patient and her parents. The TAU+FT program was identical to the usual one but also included family therapy sessions targeting intra-familial dynamics, but not eating disorder symptoms. The main Outcome Measure was the Morgan and Russell outcome category (Good or Intermediate versus Poor outcome. Secondary outcome indicators included AN symptoms or their consequences (eating symptoms, body mass index, amenorrhea, number of hospitalizations in the course of follow-up, social adjustment. The evaluators, but not participants, were blind to randomization. RESULTS: At 18 months follow-up, we found a significant group effect for the Morgan and Russell outcome category in favor of the program with family therapy (Intention-to-treat: TAU+FT :12/30 (40%; TAU : 5/29 (17.2% p = 0.05; Per Protocol analysis: respectively 12/26 (46.2%; 4/27 (14.8%, p = 0.01. Similar group effects were observed in terms of achievement of a healthy weight (i.e., BMI≥10(th percentile and menstrual status. CONCLUSIONS: Adding family therapy sessions, focusing on intra-familial dynamics rather than eating symptomatology, to a multidimensional program improves

  7. Contributions of myofascial pain in diagnosis and treatment of shoulder pain. A randomized control trial

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    Gaspar-Calvo Elena

    2009-07-01

    Full Text Available Abstract Background Rotator cuff tendinopathy and subacromial impingement syndrome present complex patomechanical situations, frequent difficulties in clinical diagnosis and lack of effectiveness in treatment. Based on clinical experience, we have therefore considered the existence of another pathological entity as the possible origin of pain and dysfunction. The hypothesis of this study is to relate subacromial impingement syndrome (SIS with myofascial pain syndrome (MPS, since myofascial trigger points (MTrPs cause pain, functional limitation, lack of coordination and alterations in quality of movement, even prior to a tendinopathy. MTrPs can coexist with any degenerative subacromial condition. If they are not taken into consideration, they could perpetuate and aggravate the problem, hindering diagnosis and making the applied treatments ineffective. The aims and methods of this study are related with providing evidence of the relationship that may exist between this condition and MPS in the diagnosis and treatment of rotator cuff tendonitis and/or SIS. Method/design A descriptive transversal study will be made to find the correlation between the diagnosis of SIS and rotator cuff tendonitis, positive provocation test responses, the existence of active MTrPs and the results obtained with ultrasonography (US and Magnetic Renonance Imaging (MRI. A randomized double blinded clinical trial will be carried out in experimental conditions: A Protocolized treatment based on active and passive joint repositioning, stabilization exercises, stretching of the periarticular shoulder muscles and postural reeducation. B. The previously described protocolized treatment, with the addition of dry needling applied to active MTrPs with the purpose of isolating the efficacy of dry needling in treatment. Discussion This study aims to provide a new vision of shoulder pain, from the perspective of MPS. This syndrome can, by itself, account for shoulder pain and

  8. Contributions of myofascial pain in diagnosis and treatment of shoulder pain. A randomized control trial.

    Science.gov (United States)

    Perez-Palomares, Sara; Oliván-Blázquez, Bárbara; Arnal-Burró, Ana M; Mayoral-Del Moral, Orlando; Gaspar-Calvo, Elena; de-la-Torre-Beldarraín, M Luisa; López-Lapeña, Elena; Pérez-Benito, Marina; Ara-Loriente, Victoria; Romo-Calvo, Laura

    2009-07-24

    Rotator cuff tendinopathy and subacromial impingement syndrome present complex patomechanical situations, frequent difficulties in clinical diagnosis and lack of effectiveness in treatment. Based on clinical experience, we have therefore considered the existence of another pathological entity as the possible origin of pain and dysfunction. The hypothesis of this study is to relate subacromial impingement syndrome (SIS) with myofascial pain syndrome (MPS), since myofascial trigger points (MTrPs) cause pain, functional limitation, lack of coordination and alterations in quality of movement, even prior to a tendinopathy. MTrPs can coexist with any degenerative subacromial condition. If they are not taken into consideration, they could perpetuate and aggravate the problem, hindering diagnosis and making the applied treatments ineffective.The aims and methods of this study are related with providing evidence of the relationship that may exist between this condition and MPS in the diagnosis and treatment of rotator cuff tendonitis and/or SIS. A descriptive transversal study will be made to find the correlation between the diagnosis of SIS and rotator cuff tendonitis, positive provocation test responses, the existence of active MTrPs and the results obtained with ultrasonography (US) and Magnetic Renonance Imaging (MRI). A randomized double blinded clinical trial will be carried out in experimental conditions: A Protocolized treatment based on active and passive joint repositioning, stabilization exercises, stretching of the periarticular shoulder muscles and postural reeducation. B. The previously described protocolized treatment, with the addition of dry needling applied to active MTrPs with the purpose of isolating the efficacy of dry needling in treatment. This study aims to provide a new vision of shoulder pain, from the perspective of MPS. This syndrome can, by itself, account for shoulder pain and dysfunction, although it can coexist with real conditions involving

  9. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial.

    Science.gov (United States)

    Dmitrovic, R; Kunselman, A R; Legro, R S

    2013-11-01

    Is a vaginal preparation of sildenafil citrate capable of alleviating acute menstrual pain in patients with primary dysmenorrhea (PD)? A vaginal preparation of sildenafil citrate is capable of alleviating acute menstrual pain in patients with PD with no observed adverse effects. Oral preparations of nitric oxide (NO) donor drugs augment relaxant effects of NO on myometrial cells, reverse the vasoconstriction caused by prostaglandins and successfully alleviate pain, but the incidence of side effects is too high for routine clinical use. Sildenafil citrate inhibits type 5-specific phosphodiesterase (PDE5), thus preventing the degradation of cyclic guanosine monophosphate (cGMP) in the muscle and augmenting the vasodilatory effects of NO. Therefore, by inhibiting PDE5, the tissue remains relaxed and more blood can circulate through. It has been used previously in a vaginal form with no observed side effects, and it enhances endometrial blood flow. A double-blind, randomized, controlled trial comparing vaginal preparation of sildenafil citrate (100 mg single dose) to a placebo in 62 PD patients at the time of painful menstruation was conducted. The primary outcome was total pain relief over 4 consecutive hours (TOPAR4) comparing sildenafil citrate to placebo, where higher TOPAR4 scores represent better pain relief. Secondary outcomes were pain relief as measured by the visual analog scale (VAS) and uterine artery pulsatility index (PI). Subjects were recruited from December 2007 to January 2011. The trial was stopped due to closeout of the funding for the study. Participants were women in good health, were aged 18-35 years and suffered from moderate to severe PD. They were randomized to either vaginal placebo or 100 mg vaginal sildenafil citrate in a 1:1 ratio using random permuted blocks having a block size of 4. At baseline and 1, 2, 3, and 4 h post-treatment, patients were asked to provide assessment of their degree of pain using two scales: (i) pain on the 5-level

  10. Brief relaxation versus music distraction in the treatment of dental anxiety: a randomized controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Schoen, Rainer; Henningsen, Peter; Ronel, Joram; Muehlbacher, Moritz; Loew, Thomas; Tritt, Karin; Nickel, Marius; Doering, Stephan

    2008-03-01

    Dental anxiety is a significant cause of poor dental health. Because patients often prefer nonpharmacological interventions, the clinical effectiveness of clearly structured approaches is of particular interest. This prospective randomized controlled study compares a brief relaxation method (BR) with music distraction (MD) and with a control group (C). The authors randomly assigned 90 patients with dental anxiety to BR, MD or C groups. They assessed the outcomes by means of the state anxiety subscale of the State-Trait Anxiety Inventory. Both BR and MD reduced dental anxiety significantly. In contrast, patients in the C group did not exhibit a significant change in their anxiety level. BR was significantly superior to MD. Stratification according to the patient's general level of dental anxiety revealed that BR also was particularly effective in highly anxious subjects, whereas MD did not have a clinically relevant effect on these subjects. BR appears to be a safe, economically sound and effective nonpharmacological approach to the short-term reduction of dental anxiety. Additional investigations are needed to validate these findings in a larger clinical trial and to determine the long-term effects of this intervention. Relaxation techniques are a pragmatic, effective and cost-saving method of facilitating dental treatment in anxious patients.

  11. The treatment of painful temporomandibular joint clicking with oral splints: a randomized clinical trial.

    Science.gov (United States)

    Conti, Paulo César Rodrigues; dos Santos, Carlos Neanes; Kogawa, Evelyn Mikaela; de Castro Ferreira Conti, Ana Claudia; de Araujo, Carlos dos Reis Pereira

    2006-08-01

    The authors compared the efficacy of bilateral balanced and canine guidance (occlusal) splints in the treatment of temporomandibular joint (TMJ) pain in subjects who experienced joint clicking with a nonoccluding splint in a double-blind, controlled randomized clinical trial. The authors randomly assigned 57 people with signs of disk displacement and TMJ pain into three groups according to the type of splint: bilateral balanced, canine guidance and nonoccluding. The authors followed the groups for six months using analysis of a visual analog scale (VAS), palpation of the TMJ and masticatory muscles, mandibular movements and joint sounds. They used repeated analysis of variance and a chi(2) test to test the hypothesis. The type of guidance used did not influence the pain reduction, yet both occlusal splints were superior to the nonoccluding splint, on the basis of the VAS. Despite similar outcomes in relation to opening, left lateral and protrusive movements, TMJ and muscle pain on palpation, subjects who used the occlusal splints had improved clinical outcomes. The frequency of joint noises decreased over time, with no significant differences among groups. Subjects in the groups using the occlusal splints reported more comfort. The type of lateral guidance did not influence the subjects' improvement. All of the subjects had a general improvement on the VAS, though subjects in the occlusal splint groups had better results that did subjects in the nonoccluding splint group.

  12. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    Directory of Open Access Journals (Sweden)

    Cătălin Pleșea Condratovici

    2016-01-01

    Full Text Available Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS. Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls were included (n=18/group. Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P=0.027. At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.

  13. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial.

    Science.gov (United States)

    Kampmann, Isabel L; Emmelkamp, Paul M G; Hartanto, Dwi; Brinkman, Willem-Paul; Zijlstra, Bonne J H; Morina, Nexhmedin

    2016-02-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women) diagnosed with social anxiety disorder were randomly assigned to individual virtual reality exposure therapy (VRET), individual in vivo exposure therapy (iVET), or waiting-list. Multilevel regression analyses revealed that both treatment groups improved from pre-to postassessment on social anxiety symptoms, speech duration, perceived stress, and avoidant personality disorder related beliefs when compared to the waiting-list. Participants receiving iVET, but not VRET, improved on fear of negative evaluation, speech performance, general anxiety, depression, and quality of life relative to those on waiting-list. The iVET condition was further superior to the VRET condition regarding decreases in social anxiety symptoms at post- and follow-up assessments, and avoidant personality disorder related beliefs at follow-up. At follow-up, all improvements were significant for iVET. For VRET, only the effect for perceived stress was significant. VRET containing extensive verbal interaction without any cognitive components can effectively reduce complaints of generalized social anxiety disorder. Future technological and psychological improvements of virtual social interactions might further enhance the efficacy of VRET for social anxiety disorder. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial.

    Science.gov (United States)

    McKenna, Laurence; Marks, Elizabeth M; Hallsworth, Christopher A; Schaette, Roland

    2017-01-01

    Tinnitus is experienced by up to 15% of the population and can lead to significant disability and distress. There is rarely a medical or surgical target and psychological therapies are recommended. We investigated whether mindfulness-based cognitive therapy (MBCT) could offer an effective new therapy for tinnitus. This single-site randomized controlled trial compared MBCT to intensive relaxation training (RT) for chronic, distressing tinnitus in adults. Both treatments involved 8 weekly, 120-min sessions focused on either relaxation (RT) or mindfulness meditation (MBCT). Assessments were completed at baseline and at treatment commencement 8 weeks later. The primary outcomes were tinnitus severity (Tinnitus Questionnaire) and psychological distress (Clinical Outcomes in Routine Evaluation - Non-Risk, CORE-NR), 16 weeks after baseline. The analysis utilized a modified intention-to-treat approach. A total of 75 patients were randomly allocated to MBCT (n = 39) or RT (n = 36). Both groups showed significant reductions in tinnitus severity and loudness, psychological distress, anxiety, depression, and disability. MBCT led to a significantly greater reduction in tinnitus severity than RT, with a mean difference of 6.3 (95% CI 1.3-11.4, p = 0.016). Effects persisted 6 months later, with a mean difference of 7.2 (95% CI 2.1-2.3, p = 0.006) and a standardized effect size of 0.56 (95% CI 0.16-0.96). Treatment was effective regardless of initial tinnitus severity, duration, or hearing loss. MBCT is effective in reducing tinnitus severity in chronic tinnitus patients compared to intensive RT. It also reduces psychological distress and disability. Future studies should explore the generalizability of this approach and how outcome relates to different aspects of the intervention. © 2017 The Author(s) Published by S. Karger AG, Basel.

  15. Postprison release HIV-risk behaviors in a randomized trial of methadone treatment for prisoners.

    Science.gov (United States)

    Wilson, Monique E; Kinlock, Timothy W; Gordon, Michael S; O'Grady, Kevin E; Schwartz, Robert P

    2012-01-01

    This secondary analysis examined the impact of methadone initiated in prison on postrelease HIV risk behaviors. The parent study was a three-group randomized clinical trial in which participants received drug abuse counseling in prison and were randomly assigned to: (1) passive referral to substance abuse treatment upon release; (2) guaranteed methadone treatment admission upon release; and (3) methadone in prison and guaranteed continuation of methadone upon release. Participants were 211 adult males with preincarceration histories of opiate dependence. The AIDS Risk Assessment was administered at baseline (in prison) and at 1-, 3-, 6-, and 12-month postrelease. Data were analyzed for the entire sample (N = 211) as well as the subsamples who reported injecting drugs in the 30 days prior to incarceration (n = 131) and who reported having unprotected sex in that time frame (n = 144) using generalized linear mixed model on an intent-to-treat basis. There were no significant changes in sex- or drug-risk by Condition over Time. There were significant Time and Condition main effects for the total sample as well as the injector subsample for drug-risk behaviors. There were no significant Condition main effects for HIV sex-risk behaviors, but there were significant Time main effects. Methadone initiated in prison or immediately postrelease is associated with reduced HIV drug-risk compared to counseling in prison without methadone and passive referral to treatment at release. Participation in several drug- and sex-risk behaviors also showed significant declines during the postrelease time periods. Copyright © American Academy of Addiction Psychiatry.

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

    Science.gov (United States)

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

    2012-03-20

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

  17. Laser and photochemotherapy for the treatment of oral mucositis in young patients: Randomized clinical trial.

    Science.gov (United States)

    Medeiros-Filho, João Batista; Maia Filho, Etevaldo Matos; Ferreira, Meire Coelho

    2017-06-01

    The aim of the present study was to evaluate the effect of low-level laser therapy (LLLT) combined with photochemotherapy (PCT) for the treatment of chemotherapy-induced oral mucositis in young patients. A randomized, blind, clinical trial with a split-mouth design was conducted involving a sample of 15 cancer patients aged three to 16 years at the Aldenora Bello Hospital in the city of São Luís, Brazil. The treatments (PCT+LLLT and LLLT alone) were randomly determined for each side of the oral cavity. The patients were blinded to the type of therapy performed on each side. The outcome was the area of the lesion measured in cm2 over an eight-day evaluation period. Treatment and follow up of the lesions under evaluation as well as other lesions occurred until complete remission. Friedman and Wilcoxon tests were employed. Significance was set at a 95% confidence level (α=0.05) and the effect size was calculated. A statistically significant difference was found between therapies for lesion area on Days 6-8 (p=0.020, 0.011 and 0.005, respectively), which was confirmed by the moderate effect size. Lesions submitted to PCT+LLLT had a smaller area at the end of the evaluation period. Based on the present findings, PCT+LLLT had a greater therapeutic effect in comparison to LLLT alone regarding the reduction in the degree of severity of chemotherapy-induced oral mucositis. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia.

    Science.gov (United States)

    Smitherman, Todd A; Walters, A Brooke; Davis, Rachel E; Ambrose, Carrie E; Roland, Malcolm; Houle, Timothy T; Rains, Jeanetta C

    2016-02-01

    Migraine frequently co-occurs with and is triggered by sleep disturbance, particularly insomnia, and the large majority of patients with chronic migraine (CM) have comorbid insomnia. Limited evidence suggests that behavioral regulation of sleep may reduce migraine frequency, but studies to date have not assessed the viability of stimulus control and sleep restriction interventions or included objective measurement of sleep parameters. The aim of this study, thus, was to pilot-test the efficacy of a brief behavioral insomnia intervention for adults with CM and comorbid insomnia; headache diaries and actigraphy were included to assess outcomes throughout the trial. This randomized parallel-arm pilot trial recruited adults with both CM and comorbid insomnia. Participants were randomly assigned to three 30-minute biweekly sessions of cognitive-behavioral therapy for insomnia (CBTi) or control treatment. Participants were blinded to treatment and control conditions to control for outcome expectations. Each treatment condition involved training in and daily practice in 5 instructions/skills. The CBTi group learned and practiced skills pertaining to stimulus control and sleep restriction. The control intervention was the same as used by Calhoun and Ford (2007) and involved training in and daily practice of skills pertaining to keeping a consistent food/liquid intake, range of motion exercises, and acupressure. Participants provided outcome data via daily headache diaries, actigraphy, and self-report measures. The primary outcome was reduction in headache frequency at 2 weeks post-treatment and 6-week follow-up; secondary outcomes included other headache parameters, objective actigraphic and subjective changes in sleep, and treatment effect sizes and perceived credibility. Generalized estimating equations with a binomial logit link and inverse probability weights were used to assess the primary outcome among the intent-to-treat sample, and repeated measures generalized

  19. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial.

    Science.gov (United States)

    Licciardone, John C; Gatchel, Robert J; Aryal, Subhash

    2016-03-01

    Little is known about recovery after spinal manipulation in patients with low back pain (LBP). To assess recovery from chronic LBP after a short regimen of osteopathic manipulative treatment (OMT) in a responder analysis of the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. A randomized double-blind, sham-controlled trial was conducted to determine the efficacy of 6 OMT sessions over 8 weeks. Recovery was assessed at week 12 using a composite measure of pain recovery (10 mm or less on a 100-mm visual analog scale) and functional recovery (2 or less on the Roland-Morris Disability Questionnaire for back-specific functioning). The RRs and numbers-needed-to-treat (NNTs) for recovery with OMT were measured, and corresponding cumulative distribution functions were plotted according to baseline LBP intensity and back-specific functioning. Multiple logistic regression was used to compute the OR for recovery with OMT while simultaneously controlling for potential confounders. Sensitivity analyses were performed to corroborate the primary results. There were 345 patients who met neither of the recovery criteria at baseline in the primary analyses and 433 patients who met neither or only 1 of these criteria in the sensitivity analyses. There was a large treatment effect for recovery with OMT (RR, 2.36; 95% CI, 1.31-4.24; P=.003), which was associated with a clinically relevant NNT (8.9; 95% CI, 5.4-25.5). This significant finding persisted after adjustment for potential confounders (OR, 2.92; 95% CI, 1.43-5.97; P=.003). There was also a significant interaction effect between OMT and comorbid depression (P=.02), indicating that patients without depression were more likely to recover from chronic LBP with OMT (RR, 3.21; 95% CI, 1.59-6.50; P<.001) (NNT, 6.5; 95% CI, 4.2-14.5). The cumulative distribution functions demonstrated optimal RR and NNT responses in patients with moderate to severe levels of LBP intensity and back-specific dysfunction at

  20. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation : a randomized trial

    NARCIS (Netherlands)

    Ahmed, Sheba; Rienstra, Michiel; Crijns, Harry J. G. M.; Links, Thera P.; Wiesfeld, Ans C. P.; Hillege, Hans L.; Bosker, Hans A.; Lok, Dirk J. A.; Van Veldhuisen, Dirk J.; Van Gelder, Isabelle C.

    2008-01-01

    Context Amiodarone effectively suppresses atrial fibrillation but causes many adverse events. Objective To compare major events in patients randomized to receive episodic amiodarone treatment with those who received continuous amiodarone treatment while still aiming to prevent atrial fibrillation.

  1. Internet-based treatment for adults with depressive symptoms: the protocol of a randomized controlled trial.

    Science.gov (United States)

    Warmerdam, Lisanne; van Straten, Annemieke; Cuijpers, Pim

    2007-12-19

    Depression is a highly prevalent condition, affecting more than 15% of the adult population at least once in their lives. Guided self-help is effective in the treatment of depression. The purpose of this study is to investigate the effectiveness of two Internet-based guided self-help treatments with adults reporting elevated depressive symptoms. Other research questions concern the identification of potential mediators and the search for subgroups who respond differently to the interventions. This study is a randomized controlled trial with three conditions: two treatment conditions and one waiting list control group. The two treatment conditions are Internet-based cognitive behavior therapy and Internet-based problem-solving therapy. They consist of 8 and 5 weekly lessons respectively. Both interventions are combined with support by e-mail. Participants in the waiting list control group receive the intervention three months later. The study population consists of adults from the general population. They are recruited through advertisements in local and national newspapers and through banners on the Internet. Subjects with symptoms of depression (> or = 16 on the Center for Epidemiological Studies Depression scale) are included. Other inclusion criteria are having sufficient knowledge of the Dutch language, access to the Internet and an e-mail address. Primary outcome is depressive symptoms. Secondary outcomes are anxiety, quality of life, dysfunctional cognitions, worrying, problem solving skills, mastery, absence at work and use of healthcare. We will examine the following variables as potential mediators: dysfunctional cognitions, problem solving skills, worrying, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics and symptom severity. Data are collected at baseline and at 5 weeks, 8 weeks, 12 weeks and 9 months after baseline. Analyses will be conducted on the intention-to-treat sample. This study evaluates two Internet

  2. Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial.

    Science.gov (United States)

    Rooke, Sally; Copeland, Jan; Norberg, Melissa; Hine, Donald; McCambridge, Jim

    2013-02-15

    Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems. The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles. 225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken--complier average causal effect (CACE) modeling and intention to treat (ITT). Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis

  3. Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial.

    Science.gov (United States)

    Mao, Jun J; Xie, Sharon X; Keefe, John R; Soeller, Irene; Li, Qing S; Amsterdam, Jay D

    2016-12-15

    Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500mg (500mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344. Between March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n=12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20-1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates. Long-term chamomile was safe and significantly reduced moderate

  4. Efficacy of Esomeprazole for Treatment of Poorly Controlled Asthma; a Randomized Controlled Trial

    Science.gov (United States)

    Mastronarde, John G.; Anthonisen, Nicholas R.; Castro, Mario; Holbrook, Janet T.; Leone, Frank T.; Teague, W. Gerald; Wise, Robert A.

    2010-01-01

    Background Gastroesophageal reflux (GER) is common in asthma patients but often has mild or no symptoms. It is not known whether treatment of GER with proton pump inhibitors (PPIs) in poorly-controlled asthmatics without GER symptoms can substantially improve asthma control. Methods 402 asthmatics with inadequate asthma control despite inhaled corticosteroids and absent or minimal GER symptoms were randomly assigned to either esomeprazole 40mg b.i.d. or matching placebo in a parallel-group double-masked clinical trial. Participants were followed for 24 weeks with daily asthma diaries, every 4-week spirometry, and asthma symptom questionnaires. Participants were classified with respect to GER status with ambulatory pH probe monitoring. The primary outcome was the rate of episodes of poor asthma control (EPACs) based on asthma diaries. Results Episodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole treatment groups (2.3 vs 2.5 events/person-year, respectively, P=0.66). There was no treatment effect with respect to components of the EPACs, or secondary outcomes including pulmonary function, airways reactivity, asthma control, symptom scores, nocturnal awakenings, or quality of life. GER documented by pH probe studies in 40% of participants with absent or minimal symptoms did not identify a subgroup benefitting from PPI treatment. Conclusion Despite a high prevalence of asymptomatic GER in patients with poorly controlled asthma, treatment with proton pump inhibitors does not improve control. Silent GER is not a likely cause of poorly controlled asthma. PMID:19357404

  5. Intranasal Lidocaine in Acute Treatment of Migraine: A Randomized Controlled Trial.

    Science.gov (United States)

    Avcu, Nazire; Doğan, Nurettin Özgür; Pekdemir, Murat; Yaka, Elif; Yılmaz, Serkan; Alyeşil, Cansu; Akalın, Latif Erdem

    2017-06-01

    The study aims to evaluate the efficacy and safety of intranasal lidocaine administration for migraine treatment. This single-center, double-blind, randomized, controlled trial was conducted in a tertiary care emergency department. Included patients met the migraine criteria of the International Headache Society. Patients were randomized to intranasal lidocaine or saline solution; all participants received 10 mg of intravenous metoclopramide. Patient pain intensity was assessed with an 11-point numeric rating scale score. The primary outcome measure was the change in pain scores at 15 minutes; secondary outcomes were changes in pain intensity after pain onset and need for rescue medication. Patients (n=162) were randomized into 2 groups with similar baseline migraine characteristics and numeric rating scale scores. The median reduction in numeric rating scale score at 15 minutes was 3 (interquartile range [IQR] 2 to 5) for the lidocaine group and 2 (IQR 1 to 4) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). The reduction in pain score at 30 minutes was 4 (IQR 3 to 7) for the lidocaine group and 5 (IQR 2 to 7) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). Need for rescue medication did not differ between the groups, and local irritation was the most common adverse event in the lidocaine group. Although intranasal lidocaine was found no more efficacious than normal saline solution in our study, future studies should focus on patients who present earlier after headache onset. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  6. Autologous blood injection for treatment of lateral epicondylosis: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chou, Lin-Chuan; Liou, Tsan-Hon; Kuan, Yi-Chun; Huang, Yao-Hsien; Chen, Hung-Chou

    2016-03-01

    To appraise existing evidence of autologous blood injection in treating lateral epicondylosis. Meta-analysis of randomized controlled trials. A comprehensive search of the PubMed, Cochrane, SCOPUS, and CINAHL databases was performed to identify randomized controlled trials that reported the efficacy of autologous blood injection in treating lateral epicondylosis. The selected studies were subjected to a meta-analysis and risk of bias assessment. Patients with lateral epicondylosis. Pain-related measurement in each selected randomized controlled trial was pooled into meta-analysis. Nine randomized controlled trials were included in the analysis. The results of the meta-analysis including the pain scores indicated that autologous blood injection is more effective compared with corticosteroid injection (standard mean difference: -0.75; 95% confidence interval: -1.14 to -0.37) but not more effective compared with platelet-rich plasma injection (standard mean difference: 0.09; 95% confidence interval: -0.66 to 0.84). The risk of bias assessment indicated that all the included trials exhibited a moderate to high risk of bias. Autologous blood injection is more effective than corticosteroid injection but not more effective than platelet-rich plasma injection in treating lateral epicondylosis. However, this evidence is limited by the potential risk of bias. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

    Directory of Open Access Journals (Sweden)

    Roberts Ian

    2011-08-01

    Full Text Available Abstract Background In Traumatic Brain Injury (TBI, large between-centre differences in outcome exist and many clinicians believe that such differences influence estimation of the treatment effect in randomized controlled trial (RCTs. The aim of this study was to assess the influence of between-centre differences in outcome on the estimated treatment effect in a large RCT in TBI. Methods We used data from the MRC CRASH trial on the efficacy of corticosteroid infusion in patients with TBI. We analyzed the effect of the treatment on 14 day mortality with fixed effect logistic regression. Next we used random effects logistic regression with a random intercept to estimate the treatment effect taking into account between-centre differences in outcome. Between-centre differences in outcome were expressed with a 95% range of odds ratios (OR for centres compared to the average, based on the variance of the random effects (tau2. A random effects logistic regression model with random slopes was used to allow the treatment effect to vary by centre. The variation in treatment effect between the centres was expressed in a 95% range of the estimated treatment ORs. Results In 9978 patients from 237 centres, 14-day mortality was 19.5%. Mortality was higher in the treatment group (OR = 1.22, p = 0.00010. Using a random effects model showed large between-centre differences in outcome (95% range of centre effects: 0.27- 3.71, but did not substantially change the estimated treatment effect (OR = 1.24, p = 0.00003. There was limited, although statistically significant, between-centre variation in the treatment effect (OR = 1.22, 95% treatment OR range: 1.17-1.26. Conclusion Large between-centre differences in outcome do not necessarily affect the estimated treatment effect in RCTs, in contrast to current beliefs in the clinical area of TBI.

  8. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kovacs, Francisco M; Urrútia, Gerard; Alarcón, José Domingo

    2011-09-15

    Systematic review. To compare the effectiveness of surgery versus conservative treatment on pain, disability, and loss of quality of life caused by symptomatic lumbar spinal stenosis (LSS). LSS is the most common reason for spine surgery in persons older than 65 years in the United States. Randomized controlled trials (RCTs) comparing any form of conservative and surgical treatment were searched in CENTRAL, MEDLINE, EMBASE, and TripDatabase databases until July 2009, with no language restrictions. Additional data were requested from the authors of the original studies. The methodological quality of each study was assessed independently by two reviewers, following the criteria recommended by the Cochrane Back Review Group. Only data from randomized cohorts were extracted. A total of 739 citations were reviewed. Eleven publications corresponding to five RCTs were included. All five scored as high quality despite concerns deriving from heterogeneity of treatment, lack of blinding, and potential differences in the size of the placebo effect across groups. They included a total of 918 patients in whom conservative treatments had failed for 3 to 6 months, and included orthosis, rehabilitation, physical therapy, exercise, heat and cold, transcutaneous electrical nerve stimulation, ultrasounds, analgesics, nonsteroidal anti-inflammatory drugs, and epidural steroids. Surgical treatments included the implantation of a specific type of interspinous device and decompressive surgery (with and without fusion, instrumented or not). In all the studies, surgery showed better results for pain, disability, and quality of life, although not for walking ability. Results of surgery were similar among patients with and without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it. The advantage of surgery was noticeable at 3 to 6 months and remained for up to 2 to 4 years, although at the end of that period differences tended to be

  9. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Cuijpers, P.; van Straten, A.; Smit, H.F.E.

    2006-01-01

    Background: Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized controlled

  10. Executive function predicts response to antiaggression treatment in schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Krakowski, Menahem I; Czobor, Pal

    2012-01-01

    Despite extensive experience with antipsychotic medications, we have limited capacity to predict which patients will benefit from which medications and for what symptoms. Such prediction is of particular importance for the proper treatment of violence. Our goal was to determine whether executive function predicts outcome of treatment for aggressive behavior and whether such prediction varies across medication groups. Ninety-nine physically aggressive inpatients (aged 18-60 years) with schizophrenia or schizoaffective disorder (diagnosed according to DSM-IV) who completed tests of executive function were randomly assigned in a double-blind, parallel-group, 12-week trial to clozapine (n = 32), olanzapine (n = 32), or haloperidol (n = 35). The number and severity of aggressive events as measured by the Modified Overt Aggression Scale (MOAS) were the outcome measures. Psychopathology and medication side effects were also assessed. The study was conducted from 1999 to 2004. Poor executive function predicted higher levels of aggression, as measured by MOAS scores over the 12-week period, in all 3 medication groups (F(1,98) = 222.2, P aggression in patients with schizophrenia. clinicaltrials.gov Identifier: NCT01123408. © Copyright 2012 Physicians Postgraduate Press, Inc.

  11. Levetiracetam for the treatment of alcohol withdrawal syndrome: a multicenter, prospective, randomized, placebo-controlled trial.

    Science.gov (United States)

    Richter, Christoph; Hinzpeter, Axel; Schmidt, Folkhard; Kienast, Thorsten; Preuss, Ulrich W; Plenge, Thomas; Heinz, Andreas; Schaefer, Martin

    2010-12-01

    Treatment of alcohol withdrawal syndrome (AWS) with benzodiazepines is limited by risk of abuse, intoxication, respiratory problems, and liver toxicity. Alternatives such as carbamazepine and valproate may also have safety problems, such as hepatotoxicity or central nervous adverse effects. We therefore investigated the safety and efficacy of levetiracetam (LV), a newer antiepileptic with a potentially favorable adverse-effect profile, for the treatment of AWS. One hundred six patients were enrolled in a prospective, randomized, double-blind, multicenter, placebo-controlled trial. Levetiracetam was administered in a fixed dose schedule over 6 days. Diazepam was added when symptom triggered as rescue medication. Severity of the AWS was measured with the AWS and Clinical Institute Withdrawal Assessment Scale. Although tolerability and safety data were similar in the LV group when compared with placebo, the total daily and weekly dose of diazepam as rescue medication and the severity of alcohol withdrawal symptoms did not differ significantly between groups. Our data so far do not support an additional effect of LV on the reduction of alcohol withdrawal symptoms.

  12. Continuous Compared With Cyclic Oral Contraceptives for the Treatment of Primary Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Dmitrovic, Romana; Kunselman, Allen R.; Legro, Richard S.

    2013-01-01

    Objective To estimate whether continuous OCP (oral contraceptive pills) will result in more pain relief in primary dysmenorrhea patients than cyclic OCP, which induces withdrawal bleeding with associated pain and symptoms. Material and Methods We conducted a double-blind, randomized controlled trial comparing continuous to a cyclic 21/7 OCP regimen (gestodene 0.075 mg and ethinyl estradiol 20 mcg) for 6 months in 38 primary dysmenorrhea patients. The primary outcome was the difference in subjective perception of pain as measured by the Visual Analog Scale (VAS) over the period of 6 months. Results Twenty-nine patients completed the study. In both groups, pain reduction measured by VAS declined over time and was significant at 6 months compared to baseline with no difference between groups. Continuous regimen was superior to cyclic regimen after one month (mean difference: -27.3; 95% CI: (-40.5,-14.2); p<0.001) and 3 months (mean difference: -17.8; 95% CI: (-33.4,-2.1); p=0.03) of treatment. Secondary outcomes noted no difference between groups in terms of menstrual distress as measured by the Moos Menstrual Distress Questionnaire. After 6 months, there was an increase in weight and decrease in systolic blood pressure in continuous compared with the cyclic group. Conclusions Both regimens of OCP are effective in the treatment of primary dysmenorrhea. Continuous OCP outperforms cyclic OCP in the short term, but this difference is lost after 6 months. PMID:22617578

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

    Science.gov (United States)

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

    2015-06-01

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

  14. Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial.

    Science.gov (United States)

    Olson, Marilyn C; Maciel, Alejandra; Gariepy, Jean Francois; Cullors, Ali; Saldivar, Juan-Sebastian; Taylor, David; Centeno, Joel; Garces, Jorge A; Vaishnavi, Sandeep

    2017-03-16

    Pharmacogenetic testing holds promise as a personalized medicine tool by permitting individualization of pharmacotherapy in accordance with genes influencing therapeutic response, side effects, and adverse events. The authors evaluated the effect on outcomes for patients diagnosed with neuropsychiatric disorders of pharmacogenetics (PGx)-guided treatment compared to usual standard of care. This was a prospective, randomized study of 237 patients at an outpatient community-based psychiatric practice conducted between April 2015 and October 2015. Baseline patient assessments and a buccal swab were collected for pharmacogenetic testing at study initiation. For the experimental group, PGx results were provided to the clinicians as guides to treatment. Control subjects were treated according to the usual standard of care with no clinician reference to their PGx results. Neuropsychiatric Questionnaire (NPQ) and Symbol Digit Coding Test (SDC) scores and adverse drug events, hospitalizations, and medication information were collected at 30, 60, and 90 days. More than half (53%) of patients in the control group reported at least 1 adverse drug event compared to 28% of patients with PGx-guided medication management (P = .001). NPQ and SDC scores improved for both groups, but no statistical difference in efficacy as measured by these assessments was observed within the 90-day observation period. Pharmacogenetic testing may facilitate psychiatric drug therapy with greater tolerability and similar efficacy compared to standard of care. ClinicalTrials.gov Identifier: NCT02411123​​.

  15. Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial.

    Science.gov (United States)

    Raghav, Kumar; Van Wijk, A J; Abdullah, Fawzia; Islam, Md Nurul; Bernatchez, Marc; De Jongh, Ad

    2016-02-27

    Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET. This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis. This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia. ISRCTN25824611 , Date of registration: 26 October 2015.

  16. A randomized comparative trial in the management of Alcohol Dependence: Individualized Homoeopathy versus standard Allopathic Treatment

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2016-01-01

    Full Text Available Objectives: This study was undertaken to compare the effects of IH with standard allopathic (SA treatment. Methods: A randomized controlled, open-label, comparative trial, was conducted, in which alcohol dependents were screened verbally using the CAGE scale. The participants 80 patients fulfilling the inclusion criteria were randomized either IH (n=40 or SA (n=40 and treated cum followed up for 12 months. The primary outcome was more than 50% reduction in the Severity of Alcohol Dependence Questionnaire [SADQ] rating scale at 12 th month. Data analysis was done for both intention-to-treat (ITT and per-protocol (PP populations. Results: ITT analysis reflected 80% (n = 32 of the patients in IH and 37.5% (n = 15 of the patients in the SA responding to CI before 2.4 treatment with absolute difference was 42.5% (42.5 [95% confidence interval [CI]: 23.0, 61.6] and estimated effect: 6.6 (95% C.I: 2.4, 18.2, P = 0.0002. A significant difference favoring IH was also observed in three out of four domains of WHO QOL-BREF. Statistically significant difference was found in the number of drinking days (median difference: −24.00; CI: −39.0-−8.0; P = 0.001 and number of drinks per drinking day (median difference: −6.3 [95% CI: −11.3-−1.9]; P = 0.004, favoring IH. The results showed a similar trend in PP analysis. Medicines found useful were Sulphur, Lycopodium clavatum, Arsenicum album, Nux vomica, Phosphorus, and Lachesis. Conclusion: The results conclude that IH is not inferior to SA in the management of AD patients. More rigorous studies with large sample size are however desirable.

  17. Role of magnesium supplementation in the treatment of depression: A randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Emily K Tarleton

    Full Text Available Current treatment options for depression are limited by efficacy, cost, availability, side effects, and acceptability to patients. Several studies have looked at the association between magnesium and depression, yet its role in symptom management is unclear. The objective of this trial was to test whether supplementation with over-the-counter magnesium chloride improves symptoms of depression. An open-label, blocked, randomized, cross-over trial was carried out in outpatient primary care clinics on 126 adults (mean age 52; 38% male diagnosed with and currently experiencing mild-to-moderate symptoms with Patient Health Questionnaire-9 (PHQ-9 scores of 5-19. The intervention was 6 weeks of active treatment (248 mg of elemental magnesium per day compared to 6 weeks of control (no treatment. Assessments of depression symptoms were completed at bi-weekly phone calls. The primary outcome was the net difference in the change in depression symptoms from baseline to the end of each treatment period. Secondary outcomes included changes in anxiety symptoms as well as adherence to the supplement regimen, appearance of adverse effects, and intention to use magnesium supplements in the future. Between June 2015 and May 2016, 112 participants provided analyzable data. Consumption of magnesium chloride for 6 weeks resulted in a clinically significant net improvement in PHQ-9 scores of -6.0 points (CI -7.9, -4.2; P<0.001 and net improvement in Generalized Anxiety Disorders-7 scores of -4.5 points (CI -6.6, -2.4; P<0.001. Average adherence was 83% by pill count. The supplements were well tolerated and 61% of participants reported they would use magnesium in the future. Similar effects were observed regardless of age, gender, baseline severity of depression, baseline magnesium level, or use of antidepressant treatments. Effects were observed within two weeks. Magnesium is effective for mild-to-moderate depression in adults. It works quickly and is well tolerated

  18. Individual and Group Cognitive-Behavioral Treatment for Work-Related Stress Complaints and Sickness Absence: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Vente, W.de; Kamphuis, J.H.; Emmelkamp, P.M.G.; Blonk, R.W.B.

    2008-01-01

    Work-related stress is widespread and can lead to long-term absenteeism and work disability. Cognitive-behavioral treatment (CBT) has demonstrated effectiveness in treating psychopathology but has only rarely been tested in clinical samples with work-related stress. A randomized controlled trial was

  19. Treatment of Posttraumatic Stress Disorder by Trained Lay Counselors in an African Refugee Settlement: A Randomized Controlled Trial

    Science.gov (United States)

    Neuner, Frank; Onyut, Patience Lamaro; Ertl, Verena; Odenwald, Michael; Schauer, Elisabeth; Elbert, Thomas

    2008-01-01

    Traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries. The objective of this study was to examine whether trained lay counselors can carry out effective treatment of posttraumatic stress disorder (PTSD) in a refugee settlement. In a randomized controlled dissemination trial in Uganda with 277…

  20. Cognitive Behavioral Treatment of PTSD in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Johnson, Dawn M.; Zlotnick, Caron; Perez, Sara

    2011-01-01

    Objective: This study was designed to explore the acceptability, feasibility, and initial efficacy of a new shelter-based treatment for victims of intimate partner violence (IPV; i.e., Helping to Overcome PTSD through Empowerment [HOPE]). Method: A Phase I randomized clinical trial comparing HOPE (n = 35) with standard shelter services (SSS) (n =…

  1. A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

    Science.gov (United States)

    Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin

    2012-01-01

    The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…

  2. Guided online or face-to-face cognitive behavioral treatment for insomnia: A randomized wait-list controlled trial

    NARCIS (Netherlands)

    Lancee, J.; van Straten, A.; Morina, N.; Kaldo, V.; Kamphuis, J.H.

    2016-01-01

    Study Objectives: To compare the efficacy of guided online and individual face-to-face cognitive behavioral treatment for insomnia (CBT-I) to a wait-list condition. Methods: A randomized controlled trial comparing three conditions: guided online; face-to-face; wait-list. Posttest measurements were

  3. Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial

    NARCIS (Netherlands)

    van Dam, D.; Ehring, T.; Vedel, E.; Emmelkamp, P.M.G.

    2013-01-01

    Background: This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). Methods: Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was

  4. Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years median follow-up of a randomized controlled trial

    NARCIS (Netherlands)

    Terlou, A.; van Seters, M.; Ewing, P.C.; Aaronson, N.K.; Gundy, C.M.; Heijmans-Antonissen, C.; Quint, W.G.V.; Blok, L.J.; van Beurden, M.; Helmerhorst, T.J.M.

    2011-01-01

    Objective Recently we reported on the efficacy of imiquimod for treating vulvar intraepithelial neoplasia (VIN) in a placebo-controlled, double-blinded randomized clinical trial (RCT). Four weeks after treatment, a complete response was observed in 35% of patients and a partial response in 46%. All

  5. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures.

    Science.gov (United States)

    Evans, Avery J; Kip, Kevin E; Brinjikji, Waleed; Layton, Kennith F; Jensen, Mary L; Gaughen, John R; Kallmes, David F

    2016-07-01

    We present the results of a randomized controlled trial evaluating the efficacy of vertebroplasty versus kyphoplasty in treating vertebral body compression fractures. Patients with vertebral body compression fractures were randomly assigned to treatment with kyphoplasty or vertebroplasty. Primary endpoints were pain (0-10 scale) and disability assessed using the Roland-Morris Disability Questionnaire (RMDQ). Outcomes were assessed at 3 days, 1 month, 6 months, and 1 year following the procedure. 115 subjects were enrolled in the trial with 59 (51.3%) randomly assigned to kyphoplasty and 56 (48.7%) assigned to vertebroplasty. Mean (SD) pain scores at baseline, 3 days, 30 days, and 1 year for kyphoplasty versus vertebroplasty were 7.4 (1.9) vs 7.9 (2.0), 4.1 (2.8) vs 3.7 (3.0), 3.4 (2.5) vs 3.6 (2.9), and 3.0 (2.8) vs 2.3 (2.6), respectively (p>0.05 at all time points). Mean (SD) RMDQ scores at baseline, 3 days, 30 days, 180 days, and 1 year were 17.3 (6.6) vs 16.3 (7.4), 11.8 (7.9) vs 10.9 (8.2), 8.6 (7.2) vs 8.8 (8.5), 7.9 (7.4) vs 7.3 (7.7), 7.5 (7.2) vs 6.7 (8.0), respectively (p>0.05 at all time points). For baseline to 12-month assessment in average pain and RMDQ scores, the standardized effect size between kyphoplasty and vertebroplasty was small at -0.36 (95% CI -1.02 to 0.31) and -0.04 (95% CI -1.68 to 1.60), respectively. Our study indicates that vertebroplasty and kyphoplasty appear to be equally effective in substantially reducing pain and disability in patients with vertebral body compression fractures. NCT00279877. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Agitation predicts response of depression to botulinum toxin treatment in a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marc Axel Wollmer

    2014-03-01

    Full Text Available In a randomized, controlled trial (n=30 we showed that botulinum toxin injection to the glabellar region produces a marked improvement in the symptoms of major depression. We hypothesized that the mood-lifting effect was mediated by facial feedback mechanisms. Here we assessed if agitation, which may be associated with increased dynamic psychomotor activity of the facial musculature, can predict response to the treatment. To test this hypothesis we re-analyzed the data of the scales from our previous study on a single item basis and compared the baseline scores in the agitation item (item 9 of the Hamilton Depression Rating Scale (HAM-D between responders (n=9 and participants who did not attain response (n=6 among the recipients of onabotulinumtoxinA (n=15. Results: Responders had significantly higher item 9 scores at baseline (1.56+0.88 vs. 0.33+0.52, t(13=3.04, d=1.7, p=0.01, while no other single item of the HAM-D or the Beck Depression Inventory was associated with treatment response. The agitation score had an overall precision of 78% in predicting response in a receiver operating characteristic (ROC analysis (area under the curve, AUC=0.87. These data provide a link between response to botulinum toxin treatment with a psychomotor manifestation of depression and thereby indirect support of the proposed facial feedback mechanism of action. Moreover, it suggests that patients with agitated depression may particularly benefit from botulinum toxin treatment.

  7. Evaluation of the interdisciplinary PSYMEPHY treatment on patients with fibromyalgia: a randomized control trial.

    Science.gov (United States)

    Martín, Josune; Torre, Fernando; Aguirre, Urko; González, Nerea; Padierna, Angel; Matellanes, Begoña; Quintana, José Ma

    2014-04-01

    Fibromyalgia (FM) is a chronic disorder that can have a devastating effect on patients' lives. This study assessed the efficacy of a 6-week interdisciplinary treatment that combines coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) compared with standard pharmacologic care. The study was a randomized controlled trial (54 participants in the PSYMEPHY group and 56 in the control group [CG] ) with follow-up at 6 months. PSYMEPHY patients were also assessed at 12 months. The main outcomes were changes in total Fibromyalgia Impact Questionnaire (FIQ) score, pain, fatigue, morning tiredness, anxiety, and use of pain coping strategies as measured by the FIQ, the visual analog scale, and the Coping with Chronic Pain Questionnaire. After the 6-month assessment, patients in the CG were offered the PSYMEPHY treatment, and completed all of the instruments immediately after treatment, and at 6- and 12-month follow-up visits (N = 93). Subjects received therapy at two different outpatient clinical locations. Fibromyalgia patients. Six months after the intervention, significant improvements in total FIQ score (P = 0.04), and pain (P = 0.03) were seen in the PSYMEPHY group compared with controls. Twelve months after the intervention, all patients in the PSYMEPHY group maintained statistically significant improvements in total FIQ score, and pain, and showed an improvement in fatigue, rested, anxiety, and current pain compared with baseline. Data from the control patients who underwent the PSYMEPHY intervention corroborated the initial results. This study highlights the beneficial effects of an interdisciplinary treatment for FM patients in a hospital pain management unit. A 6-week interdisciplinary intervention showed significant improvement in key domains of fibromyalgia, as quality of life, pain, fatigue, rested, and anxiety at 12 months. Wiley Periodicals, Inc.

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

    Science.gov (United States)

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

    2014-07-01

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

  9. Levomepromazine versus chlorpromazine in treatment-resistant schizophrenia: a double-blind randomized trial

    Science.gov (United States)

    Lal, Samarthji; Thavundayil, Joseph X.; Nair, N.P. Vasavan; Annable, Lawrence; Ng Ying Kin, Ng M.K.; Gabriel, Antoine; Schwartz, George

    2006-01-01

    Objective We compared the effect of levomepromazine (LMP) with chlorpromazine (CPZ) in treatment-resistant schizophrenia (TRS). Methods We carried out a double-blind, parallel group study (n = 19/arm) with balanced randomization in blocks of 4 and stratification by sex. Subjects entered a 30-week trial, of which phases I–III were open: phase I (wk 0–6) baseline; phase II (wk 7–9) stepwise transition to haloperidol (HAL), 30 mg/d, plus benztropine (BT), 4 mg/d; phase III (wk 10–15) HAL, 40–60 mg/d, plus BT, 4–6 mg/d; phase IV (wk 16–20) stepwise transition to LMP or CPZ (500 mg/d) following randomization; phase V (wk 21–28) stepwise increase of LMP or CPZ (600–1000 mg/d, dose reduction permitted) to establish optimum dose; and phase VI (wk 29–30) optimized dose maintained. Criteria for TRS were based on those established by Kane et al in 1988. The criterion for a response to treatment was a reduction of 25% or more in total Brief Psychiatric Rating Scale score. Results Both LMP (p = 0.007) and CPZ (p = 0.030) improved TRS relative to baseline. Although there was no significant difference between the 2 groups in treatment response at study end point, hierarchical linear modelling of longitudinal outcome revealed a significant (p = 0.006) advantage of LMP over CPZ for the BPRS total score. Ten of 19 participants on LMP and 8 of 19 on CPZ met the criterion for treatment response, and 9 of the 18 responders did so on 200–700 mg/d phenothiazine. The mean dose of responders was 710 (standard deviation [SD] 265) mg/d (LMP) and 722 (SD 272) mg/d (CPZ). Akathisia was associated with a nonresponse to phenothiazines (p = 0.010). BPRS scores increased significantly on HAL (p = 0.006). Two of 19 participants on LMP and 5 of 19 on CPZ withdrew early from the study. Conclusion LMP and CPZ may be useful in the management of TRS. A modest advantage of LMP compared with CPZ was seen in longitudinal analysis. High doses of neuroleptics may contribute to TRS

  10. Randomized Controlled Trial of a Computerized Interactive Media-Based Problem Solving Treatment for Depression.

    Science.gov (United States)

    Sandoval, Luis R; Buckey, Jay C; Ainslie, Ricardo; Tombari, Martin; Stone, William; Hegel, Mark T

    2017-05-01

    This study evaluated the efficacy of an interactive media-based, computer-delivered depression treatment program (imbPST) compared to a no-treatment control condition (NTC) in a parallel-group, randomized, controlled trial conducted in an outpatient psychiatric research clinic. 45 adult participants with major depressive disorder or dysthymia were randomized to receive either 6 weekly sessions of imbPST or no treatment (No Treatment Control; NTC). The primary outcome measure was the Beck Depression Inventory II (BDI-II). There was a significant Group x Time interaction effect [F (1.73, 43)= 58.78; p<.001; η2=.58, Cohens d=1.94], such that the patients receiving imbPST had a significantly greater reduction in depressive symptoms compared to the patients in the NTC condition. Participants in the imbPST group improved their depression symptoms significantly from moderate (BDI-II=21.9±4.20) to mild levels of depression (BDI-II=17.9±4.0) after receiving 3 weekly sessions of imbPST (p<0.001), and progressed to still milder levels of depression after six weekly sessions (BDI-II=14.5±3.7, p<0.001). NTC participants showed no significant reduction in BDI-II scores (BDI-II=21.8±4.2 pre, BDI-II=21.5±5.2 post, N.S.). Additionally, 40% of the imbPST group showed a clinically significant and reliable change in depression levels while none of the NTC group met this criterion. imbPST participants rated the program highly usable on the system usability scale (SUS) after the first session (SUS Session 1=74.6±7.2) and usability scores increased significantly by the last session (SUS Session 6=85.4±5.6). We conclude that imbPST is an effective, engaging, and easily used depression treatment program that warrants further evaluation with heterogeneous depressed populations in a stand-alone, self-administered fashion. Copyright © 2016. Published by Elsevier Ltd.

  11. Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial

    Science.gov (United States)

    Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

    2016-01-01

    Purpose: Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early…

  12. A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).

    Science.gov (United States)

    de Kunder, Suzanne L; Rijkers, Kim; van Kuijk, Sander M J; Evers, Silvia M A A; de Bie, Rob A; van Santbrink, Henk

    2016-10-06

    With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. Multicenter blinded Randomized Controlled Trial (RCT; blinding for the patient and statistician, not for the clinician and researcher). A total of 144 patients over 18 years old with symptomatic single level lumbar degenerative, isthmic or iatrogenic spondylolisthesis whom are candidates for LIF (lumbar interbody fusion) surgery through a posterior approach will be randomly allocated to TLIF or PLIF. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary clinical outcome measures are: change in disability measured with Oswestry Disability Index (ODI) and change in quality adjusted life years (QALY) measured with EQ-5D-5L. Secondary clinical outcome measures are: Short Form (36) Health Survey (SF-36), VAS back pain, VAS leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity related costs (iPCQ) and medical costs (iMCQ). Measurements will be carried out at five fixed time points (pre

  13. Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Kang Wu

    Full Text Available This study aimed to examine the effects of carbocysteine in OSAS patients.A total of 40 patients with moderate to severe obstructive sleep apnea syndrome (OSAS were randomly divided into two groups. One group was treated with 1500 mg carbocysteine daily, and the other was treated with continuous positive airway pressure (CPAP at night. Before treatment and after 6 weeks of treatment, all patients underwent polysomnography and completed questionnaires. Treatment compliance was compared between the two groups. Plasma was collected for various biochemical analyses. Endothelial function was assessed with ultrasound in the carbocysteine group.The proportion of patients who fulfilled the criteria for good compliance was higher in the carbocysteine group (n = 17 than in the CPAP group (n = 11; 100% vs. 64.7%. Compared with baseline values, the carbocysteine group showed significant improvement in their Epworth Sleepiness Scale score (10.18 ± 4.28 vs. 6.82 ± 3.66; P ≤ 0.01, apnea-hypopnea index (55.34 ± 25.03 vs. 47.56 ± 27.32; P ≤ 0.01, time and percentage of 90% oxygen desaturation (12.66 (2.81; 50.01 vs. 8.9 (1.41; 39.71; P ≤ 0.01, and lowest oxygen saturation level (65.88 ± 14.86 vs. 70.41 ± 14.34; P ≤ 0.01. Similar changes were also observed in the CPAP group. The CPAP group also showed a decreased oxygen desaturation index and a significant increase in the mean oxygen saturation after treatment, but these increases were not observed in the carbocysteine group. Snoring volume parameters, such as the power spectral density, were significantly reduced in both groups after the treatments. The plasma malondialdehyde level decreased and the superoxide dismutase and nitric oxide levels increased in both groups. The endothelin-1 level decreased in the CPAP group but did not significantly change in the carbocysteine group. Ultrasonography showed that the intima-media thickness decreased (0.71 ± 0.15 vs. 0.66 ± 0.15; P ≤ 0.05 but that flow

  14. Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Thorup, Anne; Petersen, Lone

    2006-01-01

    Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

  15. A Randomized Trial of a Multimodal Community-Based Prisoner Reentry Program Emphasizing Substance Abuse Treatment

    Science.gov (United States)

    Grommon, Eric; Davidson, William S., II; Bynum, Timothy S.

    2013-01-01

    Prisoner reentry programs continue to be developed and implemented to ease the process of transition into the community and to curtail fiscal pressures. This study describes and provides relapse and recidivism outcome findings related to a randomized trial evaluating a multimodal, community-based reentry program that prioritized substance abuse…

  16. The Role of Treatment Fidelity on Outcomes during a Randomized Field Trial of an Autism Intervention

    Science.gov (United States)

    Mandell, David S; Stahmer, Aubyn C; Shin, Sujie; Xie, Ming; Reisinger, Erica; Marcus, Steven C

    2013-01-01

    This randomized field trial comparing Strategies for Teaching based on Autism Research and Structured Teaching enrolled educators in 33 kindergarten-through-second-grade autism support classrooms and 119 students, aged 5-8 years in the School District of Philadelphia. Students were assessed at the beginning and end of the academic year using the…

  17. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  18. A randomized trial of treatment for acute anterior cruciate ligament tears

    DEFF Research Database (Denmark)

    Frobell, Richard B; Roos, Ewa M; Roos, Harald P

    2010-01-01

    BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...

  19. Randomized Trial of Treatment for Children with Sexual Behavior Problems: Ten-Year Follow-Up

    Science.gov (United States)

    Carpentier, Melissa Y.; Silovsky, Jane F.; Chaffin, Mark

    2006-01-01

    This study prospectively follows 135 children 5-12 years of age with sexual behavior problems from a randomized trial comparing a 12-session group cognitive-behavioral therapy (CBT) with group play therapy and follows 156 general clinic children with nonsexual behavior problems. Ten-year follow-up data on future juvenile and adult arrests and…

  20. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial

    NARCIS (Netherlands)

    Kampmann, I.L.; Emmelkamp, P.M.G.; Hartanto, D.; Brinkman, W.P.; Zijlstra, B.J.H.; Morina, N.

    2016-01-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women)

  1. Value of information analyses of economic randomized controlled trials: the treatment of intermittent claudication

    NARCIS (Netherlands)

    Koerkamp, Bas Groot; Spronk, Sandra; Stijnen, Theo; Hunink, M. G. Myriam

    2010-01-01

    The aim of this study is to design the optimal study comparing endovascular revascularization and supervised exercise training for patients with intermittent claudication and to demonstrate value of information (VOI) analysis of patient-level data from an economic randomized controlled trial to

  2. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  3. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvements in several clinical outcomes. The aim of the present study is to investigate the effect of OMT on LOS in premature infants. Methods A randomized controlled trial was conducted on preterm newborns admitted to a single NICU between 2008-2009. N=110 subjects free of medical complications and with gestational age >28 and an important role in the management of preterm infants hospitalization. Trial registration ClinicalTrials.gov, NCT01544257. PMID:23622070

  4. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial.

    Science.gov (United States)

    Alam, Murad; Han, Sandra; Pongprutthipan, Marisa; Disphanurat, Wareeporn; Kakar, Rohit; Nodzenski, Michael; Pace, Natalie; Kim, Natalie; Yoo, Simon; Veledar, Emir; Poon, Emily; West, Dennis P

    2014-08-01

    Neocollagenesis can be achieved using a dermal rolling needle device, thereby reducing the appearance of acne scars. To determine the efficacy of a needling device for treatment of acne scars. We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. The study took place from November 30, 2009, through July 27, 2010. Twenty healthy adults (age range, 20-65 years) with acne scars on both sides of the face were enrolled. Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects. For each participant, one side of the face was randomized for needling. Three needling treatments were performed at 2-week intervals. Two blinded dermatologists separately rated participants' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system. Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months (mean difference, 3.4; 95% CI, 0.2-6.5; P = .03) and nominally but not significantly lower compared with baseline at 3 months (mean difference, 2.4; 95% CI, -0.01 to 4.8; P = .052). In the control group, mean scar scores did not vary significantly from baseline at 3 months (mean difference, 1.0; 95% CI, -1.4 to 3.4; P = .96) and at 6 months (mean difference, 0.4; 95% CI, -2.3 to 3.5; P > .99). The needling procedure was not particularly painful, with a mean pain rating of 1.08 of 10. Participants perceived a 41% mean improvement in overall scar appearance on the treated side. No adverse events were reported. After 3 needling treatments, there was improvement in the appearance of acne scars over time compared with the control group, with minimal pain reported. clinicaltrials.gov Identifier: NCT00974870.

  5. Metformin Treatment and Homocysteine: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Qianying Zhang

    2016-12-01

    Full Text Available The aim of this systematic review is to assess whether metformin could change the concentration of serum homocysteine (Hcy with and without simultaneous supplementation of B-group vitamins or folic acid. A literature search was conducted in PubMed, EmBase, and Cochrane Central Register of Controlled Trials (CENTRAL to identify randomized controlled trials (RCTs reporting the concentration of serum Hcy in metformin-treated adults. Meta-analysis was applied to assess the association between metformin and the changes of Hcy concentration. Twelve publications were included in this study. In the overall analysis, metformin administration was not statistically associated with the change of Hcy when compared with the control treatment (mean difference (MD, 0.40 μmol/L; 95% confidence interval (CI, −0.07~0.87 μmol/L, p = 0.10. In the subgroup analysis, metformin was significantly associated with an increased concentration of Hcy in the absence of exogenous supplementation of folic acid or B-group vitamins (MD, 2.02 μmol/L; 95% CI, 1.37~2.67 μmol/L, p < 0.00001, but with a decreased concentration of serum Hcy in the presence of these exogenous supplementations (MD, −0.74 μmol/L; 95% CI, −1.19~−0.30 μmol/L, p = 0.001. Therefore, although the overall effect of metformin on the concentration of serum Hcy was neutral, our results suggested that metformin could increase the concentration of Hcy when exogenous B-group vitamins or folic acid supplementation was not given.

  6. Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Trevelyan, Esmé G; Turner, Warren A; Robinson, Nicola

    2015-04-12

    Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain. An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback. Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible

  7. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

    Science.gov (United States)

    Scott, JoAnna M; deCamp, Allan; Juraska, Michal; Fay, Michael P; Gilbert, Peter B

    2017-04-01

    Stepped wedge designs are increasingly commonplace and advantageous for cluster randomized trials when it is both unethical to assign placebo, and it is logistically difficult to allocate an intervention simultaneously to many clusters. We study marginal mean models fit with generalized estimating equations for assessing treatment effectiveness in stepped wedge cluster randomized trials. This approach has advantages over the more commonly used mixed models that (1) the population-average parameters have an important interpretation for public health applications and (2) they avoid untestable assumptions on latent variable distributions and avoid parametric assumptions about error distributions, therefore, providing more robust evidence on treatment effects. However, cluster randomized trials typically have a small number of clusters, rendering the standard generalized estimating equation sandwich variance estimator biased and highly variable and hence yielding incorrect inferences. We study the usual asymptotic generalized estimating equation inferences (i.e., using sandwich variance estimators and asymptotic normality) and four small-sample corrections to generalized estimating equation for stepped wedge cluster randomized trials and for parallel cluster randomized trials as a comparison. We show by simulation that the small-sample corrections provide improvement, with one correction appearing to provide at least nominal coverage even with only 10 clusters per group. These results demonstrate the viability of the marginal mean approach for both stepped wedge and parallel cluster randomized trials. We also study the comparative performance of the corrected methods for stepped wedge and parallel designs, and describe how the methods can accommodate interval censoring of individual failure times and incorporate semiparametric efficient estimators.

  8. Acupuncture for the treatment of major depressive disorder: a randomized controlled trial.

    Science.gov (United States)

    Andreescu, Carmen; Glick, Ronald M; Emeremni, Chetachi A; Houck, Patricia R; Mulsant, Benoit H

    2011-08-01

    Over 50% of patients with major depressive disorder (MDD) either do not tolerate or do not respond to antidepressant medications. Several preliminary studies have shown the benefits of acupuncture in the treatment of depression. We sought to determine whether a 2-point electroacupuncture protocol (verum acupuncture) would be beneficial for MDD, in comparison to needling at nonchannel scalp points with sham electrostimulation (control acupuncture). Fifty-three subjects aged 18-80 years, recruited via advertisement or referral, were included in the primary analysis of our randomized controlled trial, which was conducted from March 2004 through May 2007 at UPMC Shadyside, Center for Complementary Medicine, in Pittsburgh, Pennsylvania. Inclusion criteria were mild or moderate MDD (according to the Structured Clinical Interview for DSM-IV Axis I Disorders) and a score of 14 or higher on the Hamilton Depression Rating Scale (HDRS). Exclusion criteria included severe MDD, seizure disorder or risk for seizure disorder, psychosis, bipolar disorder, chronic MDD, treatment-resistent MDD, and history of substance abuse in the prior 6 months. Patients were randomized to receive twelve 30-minute sessions of verum versus control acupuncture over 6 to 8 weeks. The HDRS was the primary outcome measure. The UKU Side Effect Rating Scale was used to assess for adverse effects. Twenty-eight subjects were randomized to verum electroacupuncture and 25 to control acupuncture. The 2 groups did not differ with regard to gender, age, or baseline severity of depression. Both groups improved, with mean (SD) absolute HDRS score decreases of -6.6 (5.9) in the verum group and -7.6 (6.6) in the control group, corresponding to 37.5% and 41.3% relative decreases from baseline. There were no serious adverse events associated with either intervention, and endorsement of adverse effects was similar in the 2 groups. We were unable to demonstrate a specific effect of electroacupuncture

  9. Levothyroxine Treatment of Euthyroid Children with Autoimmune Hashimoto Thyroiditis: Results of a Multicenter, Randomized, Controlled Trial.

    Science.gov (United States)

    Dörr, Helmuth G; Bettendorf, Markus; Binder, Gerhard; Karges, Beate; Kneppo, Carolin; Schmidt, Heinrich; Voss, Egbert; Wabitsch, Martin; Dötsch, Jörg

    2015-01-01

    Levothyroxine (L-T4) treatment of euthyroid children with Hashimoto thyroiditis (HT) is a controversial issue. We conducted a prospective, randomized, controlled clinical trial. Out of 79 identified euthyroid patients, 59 started the study; 25 patients (21 female, 4 male; age: 11.8 ± 2.3 years) received L-T4 at a mean dose of 1.6 µg/kg (SD, 0.8) daily, and 34 (27 female, 7 male; age: 12.6 ± 1.2 years) were not treated. Patients developing subclinical hypothyroidism during follow-up (n = 13) were treated with L-T4 and removed from the observation group. As the main outcome measures, thyroid gland volume (determined by ultrasound) as well as serum levels of TSH, free T4, and antibodies against thyroid peroxidase and thyroglobulin were assessed every 6 months for 36 months. At the start, the mean thyroid volume (standard deviation score, SDS) was 2.5 in the treatment group and 1.6 in the observation group. There was a constant decline in mean thyroid volume (SDS) from 2.13 (month 12) to 1.12 (month 30) in the treated group, with a delta thyroid volume of -1.01 SDS. In the observation group, the mean delta thyroid volume increased to +0.27 SDS. The change of the delta thyroid volume was statistically significantly different between both groups during the 12- and 30-month time points (p thyroid function and serum thyroid antibodies. L-T4 treatment can decrease the thyroid volume in euthyroid children with HT, but the effect is limited to a definite time period. © 2015 S. Karger AG, Basel.

  10. Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial.

    Science.gov (United States)

    Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy

    2014-06-19

    Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients' adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity. In-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically. The low fidelity to the trial intervention can be explained by two main factors. The first was nurses' tendency to 'ration' the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make. This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as 'street level bureaucrats' who may profoundly affect the way an intervention is administered. Current Controlled Trials ISRCTN50689131, registered 21 April 2009. The trial protocol is available at the following web address: http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa.

  11. Efficacy of Omega-3 Treatment for Vasomotor Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Cohen, Lee S.; Joffe, Hadine; Guthrie, Katherine A.; Ensrud, Kristine E.; Freeman, Marlene; Carpenter, Janet S.; Learman, Lee A.; Newton, Katherine M.; Reed, Susan D.; Manson, JoAnn E.; Sternfeld, Barbara; Caan, Bette; Freeman, Ellen W.; LaCroix, Andrea Z.; Tinker, Lesley F.; LaForce, Cathryn Booth; Larson, Joseph C.; Anderson, Garnet L.

    2013-01-01

    Objective To determine the efficacy and tolerability of omega-3 fatty acids in reducing VMS frequency and bother in peri- and postmenopausal women. Methods Three-by-two factorial, randomized, controlled 12-week trial. Eligible women were randomized to double-blind comparison of omega-3s (n=177) or placebo (n=178) capsules, and simultaneously to yoga (n=107), aerobic exercise (n=106), or their usual physical activity (n=142). Participants received 12 weeks of omega-3 dosage at a dose of 1.8 grams daily. Each capsule contained ethyl eicosapentaenoic acid (EPA; 425 mg) and docosahexaenoic acid (DHA; 100 mg) and other omega-3s (90mg). Primary outcomes were VMS frequency and bother. Secondary outcomes included sleep quality (Pittsburg Sleep Quality Index), insomnia symptoms (Insomnia Severity Index), depressive symptoms (Physician's Health Questionnaire-8), and anxiety (Generalized Anxiety Disorder-7). Results The mean baseline frequency of VMS/day was 7.6 (95% confidence interval [CI] 7.0, 8.2). After 12 weeks, reduction in VMS frequency for omega-3 (−2.5, 95% CI −3.0, −1.9) did not differ significantly from that in placebo (−2.7, 95% CI −3.3, −2.2), with a relative difference of 0.3 fewer hot flashes per day (95% CI −0.5, 1.0, p=0.28). Changes in VMS bother at 12 weeks were also similar between groups, with no relative difference on a 4-point scale (95% CI −0.1, 0.2, p=0.36). Omega-3s compared with placebo showed no improvement in self-reported sleep or mood (p>0.09 for all comparisons). Conclusion Among healthy peri- and postmenopausal sedentary women, 12 weeks of omega-3 treatment compared with placebo did not improve VMS frequency, VMS bother, sleep, or mood compared to placebo. PMID:23982113

  12. Efficacy of omega-3 for vasomotor symptoms treatment: a randomized controlled trial.

    Science.gov (United States)

    Cohen, Lee S; Joffe, Hadine; Guthrie, Katherine A; Ensrud, Kristine E; Freeman, Marlene; Carpenter, Janet S; Learman, Lee A; Newton, Katherine M; Reed, Susan D; Manson, Joann E; Sternfeld, Barbara; Caan, Bette; Freeman, Ellen W; LaCroix, Andrea Z; Tinker, Lesley F; Booth-Laforce, Cathryn; Larson, Joseph C; Anderson, Garnet L

    2014-04-01

    This study aims to determine the efficacy and tolerability of omega-3 fatty acids in reducing vasomotor symptoms (VMS) frequency and bother in perimenopausal and postmenopausal women. This study was a 12-week, three-by-two factorial, randomized controlled trial. Eligible women were randomized to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules, and simultaneously to yoga (n = 107), aerobic exercise (n = 106), or their usual physical activity (n = 142). Participants received 1.8 g of omega-3 daily for 12 weeks. Each capsule contained ethyl eicosapentaenoic acid (425 mg), docosahexaenoic acid (100 mg), and other omega-3s (90 mg). Primary outcomes were VMS frequency and bother. Secondary outcomes included sleep quality (Pittsburgh Sleep Quality Index), insomnia symptoms (Insomnia Severity Index), depressive symptoms (Physician's Health Questionnaire-8), and anxiety (Generalized Anxiety Disorder-7). The mean baseline frequency of VMS per day was 7.6 (95% CI, 7.0 to 8.2). After 12 weeks, the reduction in VMS frequency with omega-3 (-2.5; 95% CI, -3.0 to -1.9) did not differ significantly from that with placebo (-2.7; 95% CI, -3.3 to -2.2), with a relative difference of 0.3 fewer hot flashes per day (95% CI, -0.5 to 1.0; P = 0.28). Changes in VMS bother at 12 weeks were also similar between groups, with no relative difference on a four-point scale (95% CI, -0.1 to 0.2; P = 0.36). Omega-3s compared with placebo showed no improvement in self-reported sleep or mood (P > 0.09 for all comparisons). Among healthy, sedentary perimenopausal and postmenopausal women, a 12-week treatment with omega-3 does not improve VMS frequency, VMS bother, sleep, or mood compared with placebo.

  13. Treatment of tympanic membrane perforation using bacterial cellulose: a randomized controlled trial.

    Science.gov (United States)

    Silveira, Fábio Coelho Alves; Pinto, Flávia Cristina Morone; Caldas Neto, Sílvio da Silva; Leal, Mariana de Carvalho; Cesário, Jéssica; Aguiar, José Lamartine de Andrade

    2016-01-01

    Promising treatments for tympanic membrane perforation closure have been studied. Therapies derived from tissue engineering probably eliminate the need for conventional surgery. Bacterial cellulose is presented as an alternative that is safe, biocompatible, and has low toxicity. To investigate the effect on healing of direct application of a bacterial cellulose graft on the tympanic membrane compared to the conventional approach with autologous fascia. Randomized controlled trial. Forty patients with tympanic membrane perforations secondary to chronic otitis media were included, and were randomly assigned to an experimental group (20), treated with a bacterial cellulose graft (BC) and control group (20), treated with autologous temporal fascia (fascia). We evaluated the surgical time, hospital stay, time of epithelialization and the rate of tympanic perforation closure. Hospital costs were compared. The statistical significance level accepted was established at p<0.05. The closure of perforations was similar in both groups. The average operation time in the fascia group was 76.50 min versus 14.06 min bacterial cellulose in the group (p=0.0001). The hospital cost by the Brazilian public health system was R$ 600.00 for the bacterial cellulose group, and R$ 7778.00 for the fascia group (p=0.0001). Bacterial cellulose grafts promoted the closure of the tympanic membrane perforations, and were demonstrated to be innovative, effective, safe, minimally invasive, efficacious and to have a very low cost. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  14. [Hydrocortisone for the treatment of refractory hypotension: a randomized controlled trial].

    Science.gov (United States)

    Salas, G; Travaglianti, M; Leone, A; Couceiro, C; Rodríguez, S; Fariña, D

    2014-06-01

    Systemic hypotension is a common sign in critically sick infants. Several studies have suggested that the use of short series of corticosteroids increases arterial blood pressure and reduces the inotropic support needs in preterm neonates with hypotension. There are a small number of reports on the use of hydrocortisone (HC) for the treatment of refractory hypotension in infants. To assess the effectiveness of hydrocortisone in the reduction of inotropic support in infants with refractory hypotension. infants who required dopamine ≥ 14 μg/kg/min and/or epinephrine. prospective, controlled, randomized, double blind trial with placebo. 2.5mg/kg every 12 hours, for 48 hours intravenously (intervention group [IG]); placebo: isotonic saline 1.25 ml/kg/doses intravenously (placebo group [PG]) every 12 hours, for 48 hours. Randomization was performed in blocks with blind assignment. A total of 50 infants with refractory systemic hypotension were prospectively recruited. Patient characteristics were similar in both groups. Requirements for inotropic support at 48 hrs were achieved in 60%, of the IG versus 24% of the PG (P=.009, RR: 2.5, 95% CI, 1.16-5.38). A significant association was observed between the administration of HC in infants treated with epinephrine and the presence of hyperglycemia (P =.008). In patients with refractory hypotension hydrocortisone administration reduced the need for inotropic support. Further studies with a greater number of patients are needed to confirm the effectiveness of HC as a therapeutic tool in these infants. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  15. Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rong Pei-Jing

    2012-12-01

    Full Text Available Abstract Background Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD is far from satisfactory. Vagus nerve stimulation (VNS is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response. This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention. Design One hundred twenty cases (60 males of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period. Discussion This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity, resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of

  16. Autologous blood versus corticosteroid local injection for treatment of Lateral Epicondylosis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ajit Singh,

    2013-08-01

    Full Text Available Objective: The objective of the present single blinded prospective randomized control trial was assessment of efficacy of autologous blood injection versus local steroid injection in treatment of lateral epicondylosis of elbow. Methodology: Using a pre-post experimental design, a total of sixty patients of previously untreated lateral epicondylosis were selected; Group 1 (n=30 was administered single injection of autologous blood and Group 2 (n=30 single local corticosteroid injection. Assessment was done at baseline, 2 weeks, 6 weeks and 12 weeks using PRTEE (Patient Rated Tennis Elbow Evaluation score. Results: Pre injection parameters showed no difference between groups (chi square test, p > 0.005. Analysis between groups showed significant decrease in steroid group at very short term - 2 weeks (unpaired t test, p < 0.005.There was no difference between groups at 6 weeks. There was a significant improvement in blood group at medium term -12 weeks (unpaired t test, p < 0.05. Conclusion: Both the interventions were effective in reducing pain and improving functional status of patients in short term, but autologous blood was more effective in longer run.

  17. Antipsychotic polypharmacy in clozapine resistant schizophrenia: a randomized controlled trial of tapering antipsychotic co-treatment

    Directory of Open Access Journals (Sweden)

    Jari Tiihonen

    2012-01-01

    Full Text Available There is a considerable disparity between clinical practice and recommendations based on meta-analyses of antipsychotic polypharmacy in clozapine resistant schizophrenia. For this reason, we investigated the clinical response to reducing the use olanzapine that had been previously added on clozapine treatment among seriously ill hospitalized patients. In a randomized controlled trial with crossover design, we studied volunteer patients (N = 15 who had olanzapine added on to clozapine in a state mental hospital. Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures. Polypharmacy is widely used in treating schizophrenia, and usually, add-on medications are started because of worsening of the clinical state. A major confounding feature of these add-ons is whether observed improvements are caused by the medication or explained by the natural fluctuating course of the disorder. The present study, in spite of its small size, indicates the necessity of reconsidering the value of polypharmacy in treating schizophrenia.

  18. A double blind randomized trial of ketofol versus propofol for endodontic treatment of anxious pediatric patients.

    Science.gov (United States)

    Mittal, N; Goyal, A; Gauba, K; Kapur, A; Jain, K

    2013-01-01

    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.

  19. Qigong exercise for the treatment of fibromyalgia: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Chan, Cecilia L W; Wang, Chong-Wen; Ho, Rainbow T H; Ng, Siu-Man; Ziea, Eric T C; Wong, Vivian Taam

    2012-07-01

    The study objective was to summarize and critically assess the evidence available from randomized controlled trials (RCTs) of qigong exercise for patients with fibromyalgia (FM). Thirteen (13) databases were searched up to February 2011. RCTs testing the effects of qigong exercise among patients with FM were included. For each included study, data were extracted and study quality was evaluated using the Jadad Scale. Four (4) RCTs met the inclusion criteria. One (1) RCT demonstrated beneficial effects of qigong exercise for FM. Two (2) RCTs testing the effectiveness of qigong as a part of a treatment package compared with group education or daily activities failed to show favorable effects of qigong exercise for adult patients with FM. Another RCT comparing qigong with aerobic exercise among children with FM showed effects in favor of aerobic exercise. Given methodological flaws in the included studies, it is still too early to draw a conclusion about the effectiveness of qigong exercise for FM. Further rigorously designed RCTs are warranted.

  20. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

    Science.gov (United States)

    2011-01-01

    Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group received comprehensive treatment once weekly consisting of manual compression of the MTrPs, manual stretching of the muscles and intermittent cold application with stretching. Patients were instructed to perform muscle-stretching and relaxation exercises at home and received ergonomic recommendations and advice to assume and maintain good posture. The control group remained on the waiting list for 3 months. The Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score (primary outcome), Visual Analogue Scale for Pain (VAS-P), Global Perceived Effect (GPE) scale and the number of muscles with MTrPs were assessed at 6 and 12 weeks in the intervention group and compared with those of a control group. Results Compared with the control group, the intervention group showed significant improvement (P pain (mean difference, 13.8; 95% CI, 2.6 to 25.0), on the VAS-P2 for pain in the past 7 days (mean difference, 10.2; 95% CI, 0.7 to 19.7) and VAS-P3 most severe pain in the past 7 days (mean difference, 13.8; 95% CI, 0.8 to 28.4). After 12 weeks, 55% of the patients in the intervention group reported improvement (from slightly improved to completely recovered) versus 14% in the control group. The mean number of muscles with active MTrPs decreased in the intervention group compared with the control group (mean difference, 2.7; 95% CI, 1.2 to 4.2). Conclusions The results of this study show that 12-week comprehensive treatment of MTrPs in shoulder muscles reduces the number of muscles with active

  1. Pulse versus daily oral Alfacalcidol treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sawalmeh O

    2018-01-01

    with treatment. This study also highlights the importance of monitoring and preventing malnutrition in hemodialysis patients and maintaining optimal glycemic control in diabetic hemodialysis patients. Keywords: end-stage kidney disease, hemodialysis, alfacalcidol, parathyroid hormone, hyperparathyroidism, randomized controlled trials, pulse therapy

  2. Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials

    OpenAIRE

    Ewald, H; Kirby, J.; Rees, K; W. Robertson

    2017-01-01

    Background An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. Methods A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. Inclusion criteria: randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child,...

  3. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    OpenAIRE

    Falgun Indravadan Vyas; Devang Ashwinkumar Rana; Patel, Piyush M.; Varsha Jitendra Patel; Bhavsar, Rekha H.

    2014-01-01

    Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, al...

  4. A Randomized Controlled Trial of Cognitive-Behavioral Treatment of Posttraumatic Stress Disorder in Severe Mental Illness

    OpenAIRE

    Mueser, Kim T.; Rosenberg, Stanley D.; Xie, Haiyi; Jankowski, M. Kay; Bolton, Elisa E.; Lu, Weili; Jessica L Hamblen; Rosenberg, Harriet J.; McHugo, Gregory J.; Wolfe, Rosemarie

    2008-01-01

    A cognitive-behavioral therapy (CBT) program for PTSD was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared to treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major mood disorder (85%) or schizophrenia or schizoaffective disorder (15%), of whom 25% also had borderline personality disorder. Eighty-one percent of clients assigned to CBT participat...

  5. Group Parent-Child Interaction Therapy: A Randomized Control Trial for the Treatment of Conduct Problems in Young Children

    OpenAIRE

    Niec, LN; Barnett, ML; Prewett, MS; Chatham, JRS

    2016-01-01

    Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems.Eighty-one families with 3- to 6-year-old children (71.6% boys, 8...

  6. The Effect of Probiotic in Treatment of Infantile Colic: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fatemeh Dorreh

    2017-07-01

    Full Text Available Background: Infantile colic imposes a heavy financial burden on families and the healthcare system. This study was conducted to evaluate the effect of Pedilact on the treatment of infantile colic. Materials and Methods: In this randomized clinical trial, 84 infant younger than 3 months with infantile colic were divided in two groups of 42 cases each- probiotic and standard treatment. This study was done in Arak city, Iran between 2013 and 2016. The population of the study consisted of breastfed infants and formula-fed infants younger than 3 months (less than 13 weeks who referred to Amir Kabir Hospital and pediatric clinics presenting crying and restlessness symptoms consistent with the modified Wessel criteria. In the treatment group, in addition to the main treatment, five drops of Pedilact (Iran was daily administered for 28 days. In both groups, the main treatment was instructed to the parents and they were advised to do the following techniques to pacify the infant: making relaxing sounds or vocals, applying peaceful and rhythmic rocking motion, walking, and using mild tremor-like movements. Results: In Pedilact and control groups, 54.75% and 28.57% of the cases were male, respectively. 23 infants (75.61% in the Pedilact group and 33 infants (82.5% in the control group were breastfed infants. The mean age of infants in Pedilact and control groups were 6.64 + 2.90 and 6.69 + 5.97, respectively.There was no significant difference between the Pedilact and control groups in terms of mean duration of crying time during a day (P= 0.075, and the number of crying attacks per day (P= 0.127, there was a significant decrease in both variables over time, but the mean for hours of sleep in the group receiving the standard treatment was significantly higher than that of the group receiving Pedilact (P= 0.001. Conclusion: There was no significant difference between the control and Pedilact groups in terms of crying time during a day and the number of

  7. The Qure study: Q fever fatigue syndrome – response to treatment; a randomized placebo-controlled trial

    Science.gov (United States)

    2013-01-01

    Background Q fever is a zoonosis that is present in many countries. Q fever fatigue syndrome (QFS) is one of the most frequent sequelae after an acute Q fever infection. QFS is characterized by persistent fatigue following an acute Q fever infection, leading to substantial morbidity and a high socio-economic burden. The occurrence of QFS is well-documented, and has been described in many countries over the past decades. However, a treatment with proven efficacy is not available. Only a few uncontrolled studies have tested the efficacy of treatment with antibiotics on QFS. These studies suggest a positive effect of long-term treatment with a tetracycline on performance state; however, no randomized controlled trials have been performed. Cognitive behavioral therapy (CBT) has been proven to be an effective treatment modality for chronic fatigue in other diseases, but has not yet been tested in QFS. Therefore, we designed a trial to assess the efficacy of long-term treatment with the tetracycline doxycycline and CBT in patients with QFS. Methods/design A randomized placebo-controlled trial will be conducted. One-hundred-eighty adult patients diagnosed with QFS will be recruited and randomized between one of three groups: CBT, long-term doxycycline or placebo. First, participants will be randomized between CBT and medication (ratio 1:2). A second double-blinded randomization between doxycycline and placebo (ratio 1:1) will be performed in the medication condition. Each group will be treated for six months. Outcome measures will be assessed at baseline and post intervention. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment, level of psychological distress, and Coxiella burnetii PCR and serology. Discussion The Qure study is the first randomized placebo-controlled trial, which evaluates the efficacy of long-term doxycycline and of cognitive behavioral therapy in patients with QFS. The results of this study will provide

  8. Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

    Science.gov (United States)

    Laurenssen, Elisabeth M P; Westra, Dieuwertje; Kikkert, Martijn J; Noom, Marc J; Eeren, Hester V; van Broekhuyzen, Anna J; Peen, Jaap; Luyten, Patrick; Busschbach, Jan J V; Dekker, Jack J M

    2014-05-22

    Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning

  9. Brief Strategic Family Therapy Versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    Science.gov (United States)

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, José

    2012-01-01

    Objective To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at 8 community treatment agencies nationwide. Randomization encompassed both adolescents’ families (n = 480) and the agency therapists (n = 49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post randomization. Secondary outcomes included treatment engagement (≥2 sessions), retention (≥8 sessions), and participants’ reports of family functioning 4, 8, and 12 months following randomization. Results No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher, χ2(1) = 5.40, p family members in treatment and in improving parent reports of family functioning, χ2(2) = 9.10, p < .011. Conclusions We discuss challenges in treatment implementation in community settings and provide recommendations for further research. PMID:21967492

  10. Cannabinoids for the Treatment of Chronic Non-Cancer Pain: An Updated Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Lynch, M E; Ware, Mark A

    2015-06-01

    An updated systematic review of randomized controlled trials examining cannabinoids in the treatment of chronic non-cancer pain was conducted according to PRISMA guidelines for systematic reviews reporting on health care outcomes. Eleven trials published since our last review met inclusion criteria. The quality of the trials was excellent. Seven of the trials demonstrated a significant analgesic effect. Several trials also demonstrated improvement in secondary outcomes (e.g., sleep, muscle stiffness and spasticity). Adverse effects most frequently reported such as fatigue and dizziness were mild to moderate in severity and generally well tolerated. This review adds further support that currently available cannabinoids are safe, modestly effective analgesics that provide a reasonable therapeutic option in the management of chronic non-cancer pain.

  11. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial.

    Science.gov (United States)

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Griffiths, Mark D

    2017-02-01

    The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first-generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. A RCT employing intent-to-treat analysis. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. Statement of contribution What is already known on this subject? Designing interventions to treat fibromyalgia syndrome (FMS) continues to be a challenge. There is growing interest into the applications of mindfulness-based interventions for treating FMS. Second-generation mindfulness-based interventions (SG-MBIs) are a key new direction in mindfulness research. What does this study add? Meditation awareness training - an SG-MBI - resulted

  12. Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

    Science.gov (United States)

    Pagoto, S; Schneider, K L; Whited, M C; Oleski, J L; Merriam, P; Appelhans, B; Ma, Y; Olendzki, B; Waring, M E; Busch, A M; Lemon, S; Ockene, I; Crawford, S

    2013-11-01

    Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression. In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 (s.d.: 10.8) years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6 and 12 months. Main outcome measures included weight loss and depression symptoms. Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6 months (BA=-3.0%, s.e.=-0.65%; LI=-3.7%, s.e.=0.63%; P=0.48) or 12 months (BA=-2.6%, s.e.=0.77%; LI=-3.1%, s.e.=0.74%; P=0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6 months (BA mean change=-12.5, s.d.=0.85; LI mean change=-9.2, s.d.=0.80, P=0.005) and 12 months (BA mean change=-12.6, s.d.=0.97; LI mean change=-9.9, s.d.=0.93; P=0.045). Participants who experienced depression remission by 6 months (61.2%) lost greater weight (mean=-4.31%; s.e.=0.052) than those who did not (39.7%; mean=-2.47%, s.e.=0.53; P=.001). Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within 1 year. Improvement in depression is associated with greater weight loss.

  13. Reducing TV watching during adult obesity treatment: two pilot randomized controlled trials.

    Science.gov (United States)

    Raynor, Hollie A; Steeves, Elizabeth Anderson; Bassett, David R; Thompson, Dixie L; Gorin, Amy A; Bond, Dale S

    2013-12-01

    The more time adults spend being sedentary, the greater the risk of obesity. The effect of reducing television (TV) watching, a prominent sedentary behavior, on weight loss has not been tested in an adult standard behavioral obesity intervention, and the mechanisms by which reducing TV watching influences energy balance behaviors are not well understood. Two, 8-week, pilot, randomized controlled trials were conducted examining the effect of a reduced TV watching prescription on energy balance behaviors and weight loss within an adult standard behavioral obesity intervention. In the first study, participants (n=24) were randomized into one of two conditions: (a) reduce energy intake and increase moderate to vigorous physical activity (MVPA) (INCREASE PA); or (b) reduce energy intake and decrease TV watching (DECREASE TV). As findings from the first pilot study did not show an increase in MVPA in the DECREASE TV group, the second study was designed to examine the effect of adding a reduced TV prescription to a standard intervention to optimize outcomes. In Pilot Study 2, participants (n=28) were randomized to INCREASE PA or to INCREASE PA+DECREASE TV. Outcomes included objectively measured TV watching and MVPA, self-reported light physical activity (LPA-Pilot Study 2 only), self-reported dietary intake while watching TV, and weight. Conditions with TV watching prescriptions significantly reduced TV watching. Both studies showed medium to large effect sizes for conditions with TV watching prescriptions to show greater reductions in dietary intake while watching TV. Pilot Study 1 found a trend for an increase in MVPA in INCREASE PA and Pilot Study 2 found significant increases in MVPA in both conditions. Pilot Study 2 found a significant increase in LPA in the INCREASE PA+DECREASE TV. Results indicate adding a TV watching prescription to a standard obesity intervention did not enhance increases in MVPA, but may assist with reducing dietary intake while TV watching and

  14. Bacterial vaginosis: a double-blind randomized trial of the effect of treatment of the sexual partner

    DEFF Research Database (Denmark)

    Vejtorp, M; Bollerup, A C; Vejtorp, L

    1988-01-01

    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...... 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...

  15. Evidence-based Status of Pulsed Radiofrequency Treatment for Patients with Shoulder Pain: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Liu, An; Zhang, Wei; Sun, Miao; Ma, Chiyuan; Yan, Shigui

    2016-04-01

    Review the current evidence-based status of pulsed radiofrequency (PRF) treatment for patients with shoulder pain based on randomized controlled trials (RCTs) to provide a comprehensive analysis and a balanced view of the strengths and weaknesses of this treatment. PubMed, EMBASE, the Cochrane Library, and ISI Web of Science were searched up to July 2014, using the Boolean operators as follows: shoulder pain OR painful shoulder AND pulsed radiofrequency). All prospective randomized controlled trials of PRF treatment for patients with shoulder pain were retrieved. No limitation of the language or publication year existed in our analysis. Five of 114 studies that involved PRF treatment met the inclusion criteria of this review article. These studies compared the clinical outcomes of PRF with those of other treatments such as intra-articular corticosteroid injection and conventional transcutaneous electrical nerve stimulation. All the studies reported improvements in passive range of motion (PROM), visual analog scale (VAS), and Shoulder Pain and Disability Index (SPADI) in PRF treatment that persisted for at least 12 weeks. In addition, no complications were reported in all trials. The use of PRF treatment for patients with shoulder pain was observed to result in good clinical efficacy for at least 12 weeks with no complication reported. However, it is still unclear from the currently available publications whether PRF is superior to other treatment techniques such as intra-articular corticosteroid and conventional transcutaneous electrical nerve stimulation. © 2015 World Institute of Pain.

  16. Racial variation in treatment preferences and willingness to randomize in the Spine Patient Outcomes Research Trial (SPORT).

    Science.gov (United States)

    Arega, Addisalem; Birkmeyer, Nancy J O; Lurie, Jon D N; Tosteson, Tor; Gibson, Jennifer; Taylor, Brett A; Morgan, Tamara Shawver; Weinstein, James N

    2006-09-01

    Analysis of baseline data for patients enrolled in Spine Patient Outcomes Research Trial (SPORT), a project conducting three randomized and three observational cohort studies of surgical and nonoperative treatments for intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). To explore racial variation in treatment preferences and willingness to be randomized. Increasing minority participation in research has been a priority at the NIH. Prior studies have documented lower rates of participation in research and preferences for invasive treatment among African-Americans. Patients enrolled in SPORT (March 2000 to February 2005) that reported data on their race (n = 2,323) were classified as White (87%), Black (8%), or Other (5%). Treatment preferences (nonoperative, unsure, surgical), and willingness to be randomized were compared among these groups while controlling for baseline differences using multivariate logistic regression. RESULTS.: There were numerous significant differences in baseline characteristics among the racial groups. Following adjustment for these differences, Blacks remained less likely to prefer surgical treatment among both IDH (White, 55%; Black, 37%; Other, 55%, P = 0.023) and SpS/DS (White, 46%; Black, 30%; Other, 43%; P = 0.017) patients. Higher randomization rates among Black IDH patients (46% vs. 30%) were no longer significant following adjustment (odds ratio [OR] = 1.45, P = 0.235). Treatment preference remained a strong independent predictor of randomization in multivariate analyses for both IDH (unsure OR = 3.88, P race and willingness to be randomized.

  17. A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

    DEFF Research Database (Denmark)

    Jemec, G B E; Ullman, S; Goodfield, M

    2009-01-01

    BACKGROUND: In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). OBJECTIVES: To compare the efficacy and safety of R-salbutamol cream 0.5% vs. placebo...... on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial. METHODS: Thirty-seven patients with at least one newly developed DLE lesion were randomized - 19 to the R-salbutamol cream 0.5% and 18 to placebo - and treated twice daily for 8 weeks. Efficacy was evaluated......-salbutamol cream 0.5% was safe and well tolerated. Statistically significant effects were seen on scaling/hypertrophy, induration, pain and itching as well as patient global assessment, suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE....

  18. Vegetarian diet in the treatment of mild hypertension: a randomized controlled trial.

    Science.gov (United States)

    Margetts, B M; Beilin, L J; Armstrong, B K; Vandongen, R

    1985-12-01

    The effect on blood pressure of an ovo-lacto-vegetarian (OLV) diet was assessed in a randomized controlled crossover trial. Fifty-eight mild untreated hypertensive subjects recruited from the Perth Centre for the 1983 National Heart Foundation (NHF) Risk Factor Prevalence Survey were randomly allocated to one of three groups: the first maintained their usual diet throughout 12 weeks; the other two were given an OLV diet for either the first or second 6 weeks of the 12-week trial. A significant fall in systolic blood pressure, on average of the order of 5 mmHg, was associated with eating an OLV diet. Blood pressure change was unrelated to change in urinary sodium, potassium or body weight, but was related to initial blood pressures. Although an OLV diet may have an adjunctive role in control of mild hypertension, in view of likely problems with acceptability the dietary components responsible for the blood pressure changes need to be identified.

  19. A randomized control trial of a vegetarian diet in the treatment of mild hypertension.

    Science.gov (United States)

    Margetts, B M; Beilin, L J; Armstrong, B K; Vandongen, R

    1985-01-01

    The effect of an ovo-lacto-vegetarian (OLV) diet on blood pressure was assessed in a randomized, controlled, crossover trial in 58 mild untreated hypertensive subjects recruited from the Perth Centre for the 1983 NHF Risk Factor Prevalence Survey. Subjects were randomly allocated to one of three groups; the first maintained their usual diet throughout 12 weeks; the other two were given an OLV diet for either the first or second 6 weeks of the 12-week trial. Introduction of an OLV diet was associated with a significant fall in systolic blood pressure, on average of the order of 5 mmHg, which was unrelated to change in urinary sodium, potassium or body weight. It was concluded that a vegetarian diet may have an adjunctive role in control of mild hypertension, but that in view of likely problems with acceptability those dietary components responsible for the blood pressure differences need to be identified.

  20. Low-level laser therapy for temporomandibular disorders (tmd) treatment: a systematic review of randomized trials

    OpenAIRE

    Leite, Priscila; Melo, Nicole; Silva, Pâmela; Montenegro, Robinsom; Bonan, Paulo; Batista, André

    2014-01-01

    AIM: Conducting a systematic review of randomized clinical trials focusing on the efficacy of LLLT on pain control in patients with TMD, diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). MATERIAL AND METHODS: Search was performed at PubMed/MEDLINE database with the terms: (1) “Laser AND temporomandibular disorders”; (2) “Laser AND temporomandibular disorders AND RDC/TMD”; (3) “Low-level laser therapy AND temporomandibular disorders”; (4) “Low-level laser...

  1. Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moseley, Merrick J; Wallace, Michael P; Stephens, David A; Fielder, Alistair R; Smith, Laura C; Stewart, Catherine E

    2015-04-25

    Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly, spatial visual function. Treatment typically requires a period of refractive correction ('optical treatment') followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching ('dose'), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance. A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit. This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical

  2. Treatment of hepatitis C virus-related cirrhosis: a randomized, controlled trial of interferon alfa-2b versus no treatment.

    Science.gov (United States)

    Valla, D C; Chevallier, M; Marcellin, P; Payen, J L; Trepo, C; Fonck, M; Bourliere, M; Boucher, E; Miguet, J P; Parlier, D; Lemonnier, C; Opolon, P

    1999-06-01

    To examine the effects of interferon (IFN) therapy on clinical, biochemical, and histological features in patients with compensated hepatitis C virus (HCV)-related cirrhosis, we have conducted a randomized, controlled trial of IFN therapy versus observation. Eight centers included a total of 99 patients with biopsy-proven cirrhosis. IFN-alpha2b, 3 million units three times per week, or no antiviral therapy was given for 48 weeks. Twenty-three patients dropped out. End-of-treatment biochemical response was not observed in any of the 39 controls but was observed in 6 of the 47 treated patients (P <.02); sustained biochemical response was obtained in only 2 treated patients. Controls and treated patients did not significantly differ with regard to the changes in serum level of albumin, bilirubin, alpha-fetoprotein, in plasma prothrombin, in histological activity, or liver collagen content. During trial or follow-up (160 +/- 57 weeks), hepatocellular carcinoma developed in 9 controls and 5 treated patients (NS); decompensation of cirrhosis occurred in 5 controls and 7 treated patients. Seven controls and 10 treated patients died. In conclusion, in patients with compensated HCV-related cirrhosis, a 48-week course of IFN therapy is safe and is able to induce end-of-treatment biochemical response in a significant proportion of patients. However, a 48-week course of IFN therapy usually fails to achieve sustained response and, within the limit of this study, did not significantly improve the 3-year outcome. Therefore, a longer course of IFN therapy or combination therapy with ribavirin should be evaluated in patients with HCV-related cirrhosis.

  3. Cost effectiveness of arthrocentesis as initial treatment for temporomandibular joint arthralgia: A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L.M.; Stant, A.D.; Quik, E.H.; Huddleston Slater, J.J.R.; Stegenga, B.

    2013-01-01

    Objective: To determine the cost effectiveness of arthrocentesis as initial treatment compared to care as usual (CAU) for temporomandibular joint (TMJ) arthralgia. Materials and methods: 80 patients were randomly allocated to arthrocentesis as initial treatment (n = 40) or CAU (n = 40).

  4. Mentalization-Based Treatment for Self-Harm in Adolescents: A Randomized Controlled Trial

    Science.gov (United States)

    Rossouw, Trudie I.; Fonagy, Peter

    2012-01-01

    Objective: We examined whether mentalization-based treatment for adolescents (MBT-A) is more effective than treatment as usual (TAU) for adolescents who self-harm. Method: A total of 80 adolescents (85% female) consecutively presenting to mental health services with self-harm and comorbid depression were randomly allocated to either MBT-A or TAU.…

  5. Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Nicholls JL

    2018-01-01

    Full Text Available Judith L Nicholls,1 Muhammad A Azam,1,2 Lindsay C Burns,1,2 Marina Englesakis,3 Ainsley M Sutherland,1 Aliza Z Weinrib,1,2 Joel Katz,1,2,4 Hance Clarke1,4 1Pain Research Unit, Department of Anesthesia and Pain Medicine, Toronto General Hospital, 2Department of Psychology, York University, 3Library and Information Services, University Health Network, 4Department of Anesthesia, University of Toronto, Toronto, ON, Canada Background: Inadequately managed pain is a risk factor for chronic postsurgical pain (CPSP, a growing public health challenge. Multidisciplinary pain-management programs with psychological approaches, including cognitive behavioral therapy (CBT, acceptance and commitment therapy (ACT, and mindfulness-based psychotherapy, have shown efficacy as treatments for chronic pain, and show promise as timely interventions in the pre/perioperative periods for the management of PSP. We reviewed the literature to identify randomized controlled trials evaluating the efficacy of these psychotherapy approaches on pain-related surgical outcomes. Materials and methods: We searched Medline, Medline-In-Process, Embase and Embase Classic, and PsycInfo to identify studies meeting our search criteria. After title and abstract review, selected articles were rated for risk of bias. Results: Six papers based on five trials (four back surgery, one cardiac surgery met our inclusion criteria. Four papers employed CBT and two CBT-physiotherapy variant; no ACT or mindfulness-based studies were identified. Considerable heterogeneity was observed in the timing and delivery of psychological interventions and length of follow-up (1 week to 2–3 years. Whereas pain-intensity reporting varied widely, pain disability was reported using consistent methods across papers. The majority of papers (four of six reported reduced pain intensity, and all relevant papers (five of five found improvements in pain disability. General limitations included lack of large-scale data

  6. Exercise and quality of life during and after treatment for breast cancer: results of two randomized controlled trials.

    Science.gov (United States)

    Cadmus, Lisa A; Salovey, Peter; Yu, Herbert; Chung, Gina; Kasl, Stanislav; Irwin, Melinda L

    2009-04-01

    To determine the effect of exercise on quality of life in (a) a randomized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and (b) a similar trial among post-treatment survivors. Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and randomized to a 6-month, home-based exercise program (n=25) or a usual care group (n=25). In a separate trial, 75 post-treatment survivors were randomized to a 6-month, supervised exercise intervention (n=37) or to usual care (n=38). Participants in both studies completed measures of happiness, depressive symptoms, anxiety, stress, self-esteem, and quality of life at baseline and 6 months. Forty-five participants completed the trial for newly diagnosed survivors and 67 completed the trial for post-treatment survivors. Good adherence was observed in both studies. Baseline quality of life was similar for both studies on most measures. Exercise was not associated with quality of life benefits in the full sample of either study; however exercise was associated with improved social functioning among post-treatment survivors who reported low social functioning at baseline (p<0.05). Exercise did not affect quality of life in either recently diagnosed or post-treatment breast cancer survivors; however this may be due in part to relatively high baseline functioning among participants in both studies. Strategies for future research include limiting enrollment to survivors who report reduced quality of life on screening questionnaires and targeting survivor subgroups known to be at particular risk for quality of life impairment. (c) 2009 John Wiley & Sons, Ltd.

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

    Directory of Open Access Journals (Sweden)

    Tania Cursino de Menezes Couceiro

    2015-06-01

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

  8. Dynamic lumbopelvic stabilization for treatment of stress urinary incontinence in women: Controlled and randomized clinical trial.

    Science.gov (United States)

    de Souza Abreu, Nathalia; de Castro Villas Boas, Bia; Netto, José Murilo Bastos; Figueiredo, André Avarese

    2017-11-01

    To compare the results of the dynamic lumbopelvic stabilization (DLS) exercises with exercises for the pelvic floor muscles (PFM) in women with stress urinary incontinence. Randomized controlled clinical trial comparing 17 women submitted to the DLS with 16 women submitted to the exercises for the PFM. The evaluated outcomes were incontinence severity, quality of life (QoL), and impression of improvement in three moments. Significance was set at 5%. For socio-demographic and clinical variables, only climacteric was more prevalent in the DLS group (82% vs. 44%, P = 0.02). Soon after the intervention, there was no difference between the groups in relation to the outcomes evaluated. In the evaluation after 90 days, the DLS group presented better values for the severity of the losses (4.1 ± 2.6 vs. 5.7 ± 2.4, P = 0.006, d = 0.64), daytime frequency (4.6 ± 0.4 vs. 6.2 ± 0.6, P < 0.001, d = 2.67), and nighttime frequency (0.4 ± 0.3 vs. 1.4 ± 0.5, P < 0.001, d = 2.50), QoL and impression of improvement (P < 0.001). After treatment, the DLS plus PFM exercise patients had results similar to those performing PFM exercises alone. However, the DLS plus PFM exercises were superior in the outcomes of incontinence severity, QoL, and impression of improvement in the post-90-day evaluation, showing longer lasting effect. © 2017 Wiley Periodicals, Inc.

  9. Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Sahebnasagh, Adeleh; Ghasemi, Arash; Akbari, Jafar; Alipour, Abbas; Lashkardoost, Hossein; Ala, Shahram; Salehifar, Ebrahim

    2017-11-01

    Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). There was a significant (p Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively. A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.

  10. Type and amount of dietary protein in the treatment of metabolic syndrome: a randomized controlled trial.

    Science.gov (United States)

    Hill, Alison M; Harris Jackson, Kristina A; Roussell, Michael A; West, Sheila G; Kris-Etherton, Penny M

    2015-10-01

    Food-based dietary patterns emphasizing plant protein that were evaluated in the Dietary Approaches to Stop Hypertension (DASH) and OmniHeart trials are recommended for the treatment of metabolic syndrome (MetS). However, the contribution of plant protein to total protein in these diets is proportionally less than that of animal protein. This study compared 3 diets varying in type (animal compared with plant) and amount of protein on MetS criteria. Sixty-two overweight adults with MetS consumed a healthy American diet for 2 wk before being randomly allocated to either a modified DASH diet rich in plant protein (18% protein, two-thirds plant sources, n = 9 males, 12 females), a modified DASH diet rich in animal protein (Beef in an Optimal Lean Diet: 18.4% protein, two-thirds animal sources, n = 9 males, 11 females), or a moderate-protein diet (Beef in an Optimal Lean Diet Plus Protein: 27% protein, two-thirds animal sources, n = 10 males, 11 females). Diets were compared across 3 phases of energy balance: 5 wk of controlled (all foods provided) weight maintenance (WM), 6 wk of controlled weight loss (minimum 500-kcal/d deficit) including exercise (WL), and 12 wk of prescribed, free-living weight loss (FL). The primary endpoint was change in MetS criteria. All groups achieved ∼5% weight loss at the end of the WL phase and maintained it through FL, with no between-diet differences (WM compared with WL, FL, P protein source or amount. Our findings demonstrate that heart-healthy weight-loss dietary patterns that emphasize either animal or plant protein improve MetS criteria similarly. This study was registered at clinicaltrials.gov as NCT00937638. © 2015 American Society for Nutrition.

  11. Caffeine as symptomatic treatment for Parkinson disease (Café-PD): A randomized trial.

    Science.gov (United States)

    Postuma, Ronald B; Anang, Julius; Pelletier, Amelie; Joseph, Lawrence; Moscovich, Mariana; Grimes, David; Furtado, Sarah; Munhoz, Renato P; Appel-Cresswell, Silke; Moro, Adriana; Borys, Andrew; Hobson, Douglas; Lang, Anthony E

    2017-10-24

    To assess effects of caffeine on Parkinson disease (PD). In this multicenter parallel-group controlled trial, patients with PD with 1-8 years disease duration, Hoehn & Yahr stages I-III, on stable symptomatic therapy were randomized to caffeine 200 mg BID vs matching placebo capsules for 6-18 months. The primary research question was whether objective motor scores would differ at 6 months (Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale [MDS-UPDRS]-III, Class I evidence). Secondary outcomes included safety and tolerability, motor symptoms (MDS-UPDRS-II), motor fluctuations, sleep, nonmotor symptoms (MDS-UPDRS-I), cognition (Montreal Cognitive Assessment), and quality of life. Sixty patients received caffeine and 61 placebo. Caffeine was well-tolerated with similar prevalence of side effects as placebo. There was no improvement in motor parkinsonism (the primary outcome) with caffeine treatment compared to placebo (difference between groups -0.48 [95% confidence interval -3.21 to 2.25] points on MDS-UPDRS-III). Similarly, on secondary outcomes, there was no change in motor signs or motor symptoms (MDS-UPDRS-II) at any time point, and no difference on quality of life. There was a slight improvement in somnolence over the first 6 months, which attenuated over time. There was a slight increase in dyskinesia with caffeine (MDS-UPDRS-4.1+4.2 = 0.25 points higher), and caffeine was associated with worse cognitive testing scores (average Montreal Cognitive Assessment = 0.66 [0.01, 1.32] worse than placebo). Caffeine did not provide clinically important improvement of motor manifestations of PD (Class I evidence). Epidemiologic links between caffeine and lower PD risk do not appear to be explained by symptomatic effects. NCT01738178. This study provides Class I evidence that for patients with PD, caffeine does not significantly improve motor manifestations. © 2017 American Academy of Neurology.

  12. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial.

    Science.gov (United States)

    Bron, Carel; de Gast, Arthur; Dommerholt, Jan; Stegenga, Boudewijn; Wensing, Michel; Oostendorp, Rob A B

    2011-01-24

    Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs) cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group received comprehensive treatment once weekly consisting of manual compression of the MTrPs, manual stretching of the muscles and intermittent cold application with stretching. Patients were instructed to perform muscle-stretching and relaxation exercises at home and received ergonomic recommendations and advice to assume and maintain good posture. The control group remained on the waiting list for 3 months. The Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score (primary outcome), Visual Analogue Scale for Pain (VAS-P), Global Perceived Effect (GPE) scale and the number of muscles with MTrPs were assessed at 6 and 12 weeks in the intervention group and compared with those of a control group. Compared with the control group, the intervention group showed significant improvement (P < 0.05) on the DASH after 12 weeks (mean difference, 7.7; 95% confidence interval (95% CI), 1.2 to 14.2), on the VAS-P1 for current pain (mean difference, 13.8; 95% CI, 2.6 to 25.0), on the VAS-P2 for pain in the past 7 days (mean difference, 10.2; 95% CI, 0.7 to 19.7) and VAS-P3 most severe pain in the past 7 days (mean difference, 13.8; 95% CI, 0.8 to 28.4). After 12 weeks, 55% of the patients in the intervention group reported improvement (from slightly improved to completely recovered) versus 14% in the control group. The mean number of muscles with active MTrPs decreased in the intervention group compared with the control group (mean difference, 2.7; 95% CI, 1.2 to 4.2). The results of this study show that 12-week

  13. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

    Directory of Open Access Journals (Sweden)

    Oedegaard Ketil J

    2010-02-01

    Full Text Available Abstract Background The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed. Methods/Design A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks. A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual. Discussion This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry. Trial registration NCT00664976

  14. [Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies].

    Science.gov (United States)

    Jian, Wen-Jia; Shi, Jing; Tian, Jin-Zhou; Ni, Jing-Nian

    2015-01-01

    Chinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD. CNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results. Seven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group. The methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.

  15. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S

    2011-01-01

    BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg....... Recruitment was terminated early due to expiry date of trial medication. RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after...

  16. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dunlop Boadie W

    2012-07-01

    Full Text Available Abstract Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD. Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1 cognitive behavior therapy (CBT, 16 sessions; (2 duloxetine (30–60 mg/d; or (3 escitalopram (10–20 mg/d. Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI, immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12

  17. INCANT: a transnational randomized trial of Multidimensional Family Therapy versus treatment as usual for adolescents with cannabis use disorder

    Directory of Open Access Journals (Sweden)

    Grichting Esther

    2010-04-01

    Full Text Available Abstract Background In 2003, the governments of Belgium, France, Germany, the Netherlands and Switzerland agreed that there was a need in Europe for a treatment programme for adolescents with cannabis use disorders and other behavioural problems. Based on an exhaustive literature review of evidence-based treatments and an international experts meeting, Multidimensional Family Therapy (MDFT was selected for a pilot study first, which was successful, and then for a joint, transnational randomized controlled trial named INCANT (INternational CAnnabis Need for Treatment. Methods/design INCANT is a randomized controlled trial (RCT with an open-label, parallel group design. This study compares MDFT with treatment as usual (TAU at and across sites in Brussels, Berlin, Paris, The Hague and Geneva. Assessments are at baseline and at 3, 6, 9 and 12 months after randomization. A minimum of 450 cases in total is required; sites will recruit 60 cases each in Belgium and Switzerland, and a maximum of 120 each in France, Germany and the Netherlands. Eligible for INCANT are adolescents from 13 through 18 years of age with a cannabis use disorder (dependence or abuse, with at least one parent willing to take part in the treatment. Randomization is concealed to, and therefore beyond control by, the researcher/site requesting it. Randomization is stratified as to gender, age and level of cannabis consumption. Assessments focus on substance use; mental function; behavioural problems; and functioning regarding family, school, peers and leisure time. For outcome analyses, the study will use state of the art latent growth curve modelling techniques, including all randomized participants according to the intention-to-treat principle. INCANT has been approved by the appropriate ethical boards in Belgium, France, Germany, the Netherlands, Switzerland, and the University of Miami Miller School of Medicine. INCANT is funded by the (federal Ministries of Health of Belgium

  18. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Schmitt, J; Rosumeck, S; Thomaschewski, G; Sporbeck, B; Haufe, E; Nast, A

    2014-02-01

    Dermatologists may choose from various conventional and biological systemic agents to treat patients with moderate-to-severe psoriasis. We set out to analyse systematically the efficacy and tolerability of approved treatments for moderate-to-severe psoriasis. We undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the efficacy of systemic treatment approved for moderate-to-severe psoriasis. Efficacy was assessed as the proportion of participants with 75% improvement in Psoriasis Area and Severity Index at primary efficacy measurement (week 8-16). Safety was summarized as rates of adverse events and withdrawals. Direct and indirect comparative efficacy was assessed by random effects meta-analysis of risk differences (RDs). In total, 48 eligible RCTs totalling 16 696 patients (11 178 randomized to biologics, 1888 to conventional treatments) were identified. In placebo-controlled trials, infliximab was the most efficacious [RD 76%, 95% confidence interval (CI) 73-79%]. Adalimumab (RD 61%, 95% CI 56-67%), and ustekinumab 45 mg (RD 63%, 95% CI 59-66%) and 90 mg (RD 67%, 95% CI 60-74%) each had similar efficacy. These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept, the nonsignificant superiority of ciclosporin over MTX, and the dose-dependent efficacy of etanercept and ustekinumab. Fumaric acid is as efficacious as MTX. Safety of treatments could not be pooled due to a lack of standardization in reporting across trials. In conclusion, the qualitative and quantitative evidence is much stronger for biological interventions than for conventional treatments. © 2013 British Association of Dermatologists.

  19. Exercise training for people following curative intent treatment for non-small cell lung cancer: a randomized controlled trial ?

    OpenAIRE

    Cavalheri, Vinicius; Jenkins, Sue; Cecins, Nola; Gain, Kevin; Phillips, Martin J; Sanders, Lucas H.; Hill, Kylie

    2017-01-01

    Objective In people following curative intent treatment for non-small cell lung cancer, to investigate the effects of supervised exercise training on exercise capacity, physical activity and sedentary behavior, peripheral muscle force, health-related quality of life, fatigue, feelings of anxiety and depression, and lung function. Method This pilot randomized controlled trial included participants 6?10 weeks after lobectomy for non-small cell lung cancer or, for those who required adjuvant che...

  20. Treatment-enhanced paired action contributes substantially to change across multiple health behaviors: secondary analyses of five randomized trials

    OpenAIRE

    Yin, Hui-Qing; Prochaska, James O.; Rossi, Joseph S.; Redding, Colleen A.; Paiva, Andrea L.; Blissmer, Bryan; Velicer, Wayne F.; Johnson, Sara S.; Kobayashi, Hisanori

    2013-01-01

    The dominant paradigm of changing multiple health behaviors (MHBs) is based on treating, assessing, and studying each behavior separately. This study focused on individuals with co-occurring baseline health-risk behavior pairs and described whether they changed over time on both or only one of the behaviors within each pair. Data from five randomized trials of computer-tailored interventions (CTIs) that simultaneously treated MHBs were analyzed. The differences between treatment and control p...

  1. Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Ward Alexandra

    2002-07-01

    Full Text Available Abstract Background Gastric ulcers are a frequent problem in the United States. Proton pump inhibitors have been shown to increase healing rates and improve clinical symptoms. The objective of this study is to compare gastric ulcer healing rates for patients treated with a proton pump inhibitor (PPI (omeprazole, rabeprazole, pantoprazole, or lansoprazole, an histamine 2- receptor antagonist (ranitidine or placebo. Methods A literature search was conducted to identify randomized, controlled clinical trials that included a PPI in at least one treatment arm and assessed the gastric ulcer healing rates endoscopically. The healing rates were estimated for each treatment at specific time points, and Rate Ratios (RR and 95% confidence intervals (CI were estimated for each trial. Results Sixteen trials met the inclusion criteria: four compared a PPI versus placebo, nine compared a PPI versus ranitidine (no trials of rabeprazole versus ranitidine met the inclusion criteria, and three compared a newer PPI (lansoprazole, pantoprazole or rabeprazole versus omeprazole. In relation to ranitidine, the pooled RR of PPIs (lansoprazole, omeprazole and pantoprazole was 1.33 (95% CI 1.24 to 1.42 at four weeks. In each trial, greater improvement in the studied clinical symptoms was found with the newer PPIs (rabeprazole, pantoprazole and lansoprazole when compared to omeprazole. Conclusion In this study treatment with PPIs resulted in higher healing rates than ranitidine or placebo. This evidence suggests that the first choice for gastric ulcer treatment for the greater relief of symptoms is one of the newer PPIs.

  2. Effect of myofascial techniques for treatment of persistent arm pain after breast cancer treatment: randomized controlled trial.

    Science.gov (United States)

    De Groef, An; Van Kampen, Marijke; Vervloesem, Nele; Dieltjens, Evi; Christiaens, Marie-Rose; Neven, Patrick; Vos, Lore; De Vrieze, Tessa; Geraerts, Inge; Devoogdt, Nele

    2017-09-01

    To investigate the effect of myofascial therapy in addition to a standard physical therapy program for treatment of persistent arm pain after finishing breast cancer treatment. Double-blinded (patient and assessor) randomized controlled trial. University Hospitals Leuven, Belgium. A total of 50 patients with persistent arm pain and myofascial dysfunctions after breast cancer treatment. Over three months, all patients received a standard physical therapy program. The intervention group received in addition 12 sessions of myofascial therapy, and the control group received 12 sessions of placebo therapy. Main outcome parameters were pain intensity (primary outcome) (maximum visual analogue scale (VAS) (0-100)), prevalence rate of arm pain, pressure hypersensitivity (pressure pain thresholds (kg/cm(2)) and pain quality (McGill Pain Questionnaire). Measures were taken before and after the intervention and at long term (6 and 12 months follow-up). Patients in the intervention group had a significantly greater decrease in pain intensity compared to the control group (VAS -44/100 vs. -24/100, P = 0.046) with a mean difference in change after three months between groups of 20/100 (95% confidence interval, 0.4 to 39.7). After the intervention, 44% versus 64% of patients still experienced pain in the intervention and control group, respectively ( P = 0.246). No significant differences were found for the other outcomes. Myofascial therapy is an effective physical therapy modality to decrease pain intensity at the arm in breast cancer survivors at three months, but no other benefits at that time were found. There were no long-term effects at 12 months either.

  3. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

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    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  4. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial.

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    Phillips, Craig L; Grunstein, Ronald R; Darendeliler, M Ali; Mihailidou, Anastasia S; Srinivasan, Vasantha K; Yee, Brendon J; Marks, Guy B; Cistulli, Peter A

    2013-04-15

    Continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) therapy are commonly used to treat obstructive sleep apnea (OSA). Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes. To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA. In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes. Cardiovascular (24-h blood pressure, arterial stiffness), neurobehavioral (subjective sleepiness, driving simulator performance), and quality of life (Functional Outcomes of Sleep Questionnaire, Short Form-36) were compared between treatments. Our primary outcome was 24-hour mean arterial pressure. A total of 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices. CPAP was more efficacious than MAD in reducing AHI (CPAP AHI, 4.5 ± 6.6/h; MAD AHI, 11.1 ± 12.1/h; P health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness. Clinical trial registered with https://www.anzctr.org.au (ACTRN 12607000289415).

  5. Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

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    Marta Sacchetti

    2015-01-01

    Full Text Available Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP, a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

  6. Can racial disparities in optimal gout treatment be reduced? evidence from a randomized trial

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    Singh Jasvinder A

    2012-02-01

    Full Text Available Abstract There is a disproportionate burden of gout in African-Americans in the U.S. due to a higher disease prevalence and lower likelihood of receiving urate-lowering therapy (ULT, compared to Caucasians. There is an absence of strong data as to whether the response to ULT differs by race/ethnicity. BMC Musculoskeletal Disorders recently published a secondary analyses of the CONFIRMS trial, a large randomized controlled, double-blind trial of 2,269 gout patients. The authors reported that the likelihood of achieving the primary study efficacy end-point of achieving serum urate Please see related article: http://www.biomedcentral.com/1471-2474/13/15

  7. [Some factors affecting treatment outcome in a randomized clinical trial of borderline patients].

    Science.gov (United States)

    Delaney, Jill C; Yeomans, Frank; Stone, Michael H; Haran, Catherine

    2008-01-01

    At the Personality Disorders Institute we have been investigating the efficacy of Transference-Focused Psychotherapy (TFP), a twice weekly manualized psychodynamic psychotherapy for borderline personality disorder compared to Dialectical Behavior Therapy (DBT) and Supportive Psychotherapy (SP) in a randomized clinical trial of 90 borderline patients. We will first present some developmental foundations of BPD, followed by a discussion of the theoretical foundations of TFP. We will then discuss patient characteristics that have an impact on outcome. We will present both clinical and empirical data in a discussion of individual cases that were representative of a sample of borderline patients treated in Transference-Focused Psychotherapy (TFP).

  8. The utility of the random controlled trial for evaluating sexual offender treatment: the gold standard or an inappropriate strategy?

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    Marshall, W L; Marshall, L E

    2007-06-01

    This paper examines the scientific, practical, and ethical issues surrounding the employment of the Random Controlled Trial (RCT) in the evaluation of sexual offender treatment. Consideration of these issues leads us to conclude that the RCT design is not suitable for determining the effectiveness of sexual offender treatment. We also examine the RCT study by Marques et al. (Sexual Abuse: A Journal of Research and Treatment and Evaluation 17:79-107, 2005) that is often held up as the model for the evaluation of sexual offender treatment. We found several problems with this study that, in our opinion, reduce its relevance for deciding whether treatment is effective with these clients. Finally, we examine two alternative strategies for evaluating treatment that may allow treatment providers to more readily examine, and report, the results of their programs.

  9. Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials.

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    Terhorst, Lauren; Schneider, Michael J; Kim, Kevin H; Goozdich, Lee M; Stilley, Carol S

    2011-09-01

    The purpose of this study was to systematically review the literature for randomized trials of complementary and alternative medicine (CAM) interventions for fibromyalgia (FM). A comprehensive literature search was conducted. Databases included the Cochrane library, PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health, Natural Medicines Comprehensive Database Manual, Alternative and Natural Therapy Index System (MANTIS), Index for Chiropractic Literature, and Allied and Complementary Medicine (AMED). Inclusion criteria were (a) subjects were diagnosed with fibromyalgia and (b) the study design was a randomized controlled trial that compared a CAM therapy vs a control group. Studies were subgrouped by CAM treatment into 11 categories. Evidence tables and forest plots were organized to display quality ratings and effect sizes of each study. The literature search yielded 1,722 results; 102 abstracts were selected as potential articles for inclusion. Sixty studies met criteria and were rated by 2 reviewers; 18 were rated as good quality; 20, moderate; 18, low; and 4, very low. Synthesis of information for CAM categories represented by more than 5 studies revealed that balneotherapy and mind-body therapies were effective in treating FM pain. This study analyzed recent studies and focused exclusively on randomized controlled trials. Despite common use of manual therapies such as massage and manipulation to treat patients with FM, there is a paucity of quality clinical trials investigating these particular CAM categories. Most of these studies identified were preliminary or pilot studies, thus had small sample sizes and were likely underpowered. Two CAM categories showed the most promising findings, balneotherapy and mind-body therapies. Most of the other CAM categories showed a trend favoring the treatment group. It appears that several CAM therapies show some preliminary treatment effect for FM pain, but larger trials that are more adequately powered are

  10. Hypnotic Taper with or without Self-Help Treatment of Insomnia: A Randomized Clinical Trial

    Science.gov (United States)

    Belleville, Genevieve; Guay, Catherine; Guay, Bernard; Morin, Charles M.

    2007-01-01

    This study aimed to assess the efficacy of a minimal intervention focusing on hypnotic discontinuation and cognitive-behavioral treatment (CBT) for insomnia. Fifty-three adult chronic users of hypnotics were randomly assigned to an 8-week hypnotic taper program, used alone or combined with a self-help CBT. Weekly hypnotic use decreased in both…

  11. Specific music therapy techniques in the treatment of primary headache disorders in adolescents: a randomized attention-placebo-controlled trial.

    Science.gov (United States)

    Koenig, Julian; Oelkers-Ax, Rieke; Kaess, Michael; Parzer, Peter; Lenzen, Christoph; Hillecke, Thomas Karl; Resch, Franz

    2013-10-01

    Migraine and tension-type headache have a high prevalence in children and adolescents. In addition to common pharmacologic and nonpharmacologic interventions, music therapy has been shown to be efficient in the prophylaxis of pediatric migraine. This study aimed to assess the efficacy of specific music therapy techniques in the treatment of adolescents with primary headache (tension-type headache and migraine). A prospective, randomized, attention-placebo-controlled parallel group trial was conducted. Following an 8-week baseline, patients were randomized to either music therapy (n = 40) or a rhythm pedagogic program (n = 38) designed as an "attention placebo" over 6 sessions within 8 weeks. Reduction of both headache frequency and intensity after treatment (8-week postline) as well as 6 months after treatment were taken as the efficacy variables. Treatments were delivered in equal dose and frequency by the same group of therapists. Data analysis of subjects completing the protocol showed that neither treatment was superior to the other at any point of measurement (posttreatment and follow-up). Intention-to-treat analysis revealed no impact of drop-out on these results. Both groups showed a moderate mean reduction of headache frequency posttreatment of about 20%, but only small numbers of responders (50% frequency reduction). Follow-up data showed no significant deteriorations or improvements. This article presents a randomized placebo-controlled trial on music therapy in the treatment of adolescents with frequent primary headache. Music therapy is not superior to an attention placebo within this study. These results draw attention to the need of providing adequate controls within therapeutic trials in the treatment of pain. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

  12. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial.

    Science.gov (United States)

    Rouzé, Anahita; Loridant, Séverine; Poissy, Julien; Dervaux, Benoit; Sendid, Boualem; Cornu, Marjorie; Nseir, Saad

    2017-11-01

    The aim of this study was to determine the impact of a biomarker-based strategy on early discontinuation of empirical antifungal treatment. Prospective randomized controlled single-center unblinded study, performed in a mixed ICU. A total of 110 patients were randomly assigned to a strategy in which empirical antifungal treatment duration was determined by (1,3)-β-D-glucan, mannan, and anti-mannan serum assays, performed on day 0 and day 4; or to a routine care strategy, based on international guidelines, which recommend 14 days of treatment. In the biomarker group, early stop recommendation was determined using an algorithm based on the results of biomarkers. The primary outcome was the percentage of survivors discontinuing empirical antifungal treatment early, defined as a discontinuation strictly before day 7. A total of 109 patients were analyzed (one patient withdraw consent). Empirical antifungal treatment was discontinued early in 29 out of 54 patients in the biomarker strategy group, compared with one patient out of 55 in the routine strategy group [54% vs 2%, p empirical antifungal treatment among critically ill patients with suspected invasive Candida infection. These results confirm previous findings suggesting that early discontinuation of empirical antifungal treatment had no negative impact on outcome. However, further studies are needed to confirm the safety of this strategy. This trial was registered at ClinicalTrials.gov, NCT02154178.

  13. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression.

    Science.gov (United States)

    Hellerstein, David J; Stewart, Jonathan W; McGrath, Patrick J; Deliyannides, Deborah A; Batchelder, Sarai T; Black, Sarah R; Withers, Amy; O'Shea, Donna; Chen, Ying

    2012-07-01

    ). Responder and remitter analyses significantly favored duloxetine treatment. The response rate was 65.5% for duloxetine versus 25.0% for placebo (χ(2)(1) = 9.43, P = .003); and the remitter rate was 55.2% for duloxetine versus 14.3% for placebo (χ(2)(1) = 10.46, P = .002). After 10 weeks, duloxetine-treated subjects did not differ significantly better from placebo-treated subjects on the SAS (time-by-drug group effect on analysis of variance: F(1,46) = 0.35, P = .555) or on the GAF (time-by-drug group effect on analysis of variance: F(1,51) = .01, P = .922). Results on the 24-item HDRS, CGI, and CDRS suggest that duloxetine is efficacious in acute treatment of chronic nonmajor depressive disorder. Response and remission rates also differed significantly, favoring duloxetine treatment, but BDI, GAF, and social functioning (Social Adjustment Scale) did not. Duloxetine appears to be effective in acute treatment of nonmajor chronic depression. ClinicalTrials.gov identifier: NCT00360724. © Copyright 2012 Physicians Postgraduate Press, Inc.

  14. Moxibustion treatment for primary osteoporosis: A systematic review of randomized controlled trials.

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    Fanping Xu

    Full Text Available Primary osteoporosis (POP has a serious impact on quality of life for middle-aged and elderly, which particularly increase the risk of fracture. We conducted the systematic review to evaluate the effects of moxibustion for POP in randomized controlled trials (RCTs.Eight databases were searched from their inception to July 30, 2016. The RCTs reporting the moxibustion as a monotherapy or in combination with conventional therapy for POP were enrolled. The outcomes might be fracture incidence, quality of life, clinical symptoms, death attributed to osteoporosis, adverse effect, bone mineral density (BMD, and biochemical indicators. Literature selection, data abstraction, quality evaluation, and data analysis were in accordance with Cochrane standards.Thirteen trials including 808 patients were included. Meta-analysis was not conducted because of the obvious clinical or statistical heterogeneity. Limited evidence suggested that moxibustion plus anti-osteoporosis medicine might be more effective in relieving the pain (visual analogue scale scores average changed 2 scores between groups, 4 trials, increasing the BMD of femoral neck (average changed 0.4 g/cm2 between groups, 3 trials, and improving the level of bone gla protein, osteoprotegerin and bone alkaline phosphatase (2 trials compared with anti-osteoporosis medicine alone. However, the quality of previous studies was evaluated as generally poor. The safety evidence of moxibustion was still insufficient. Due to the paucity of high-quality studies, there was no definite conclusion about the efficacy and safety of moxibustion treating POP although parts of positive results were presented. Future research should pay attention to the dose-response relation and fracture incidence of moxibustion for POP.

  15. Vertebral body stenting versus kyphoplasty for the treatment of osteoporotic vertebral compression fractures: a randomized trial.

    Science.gov (United States)

    Werner, Clément M L; Osterhoff, Georg; Schlickeiser, Jannis; Jenni, Raphael; Wanner, Guido A; Ossendorf, Christian; Simmen, Hans-Peter

    2013-04-03

    In the treatment of vertebral compression fractures, vertebral body stenting with an expandable scaffold inserted before application of the bone cement was developed to impede secondary loss of vertebral height encountered in patients treated with balloon kyphoplasty. The purpose of this study was to clarify whether there are relevant differences between balloon kyphoplasty and vertebral body stenting with regard to perioperative and postoperative findings. In a two-armed randomized controlled trial, patients with a total of 100 fresh osteoporotic vertebral compression fractures were treated with either balloon kyphoplasty or vertebral body stenting. The primary outcome was the post-interventional change in the kyphotic angle on radiographs. The secondary outcomes were the maximum pressure of the balloon tamp during inflation, radiation exposure time, perioperative complications, and cement leakage. The mean reduction (and standard deviation) of kyphosis (the kyphotic correction angle) was 4.5° ± 3.6° after balloon kyphoplasty and 4.7° ± 4.2° after vertebral body stenting (p = 0.972). The mean pressures were 24 ± 5 bar (348 ± 72 pounds per square inch [psi]) during vertebral body stenting and 16 ± 6 bar (233 ± 81 psi) during balloon kyphoplasty (p = 0.014). There were no significant differences in radiation exposure time.None of the patients underwent revision surgery, and postoperative neurologic sequelae were not observed. Cement leakage occurred at twenty-five of the 100 vertebral levels without significant differences between the two intervention arms (p = 0.230). Intraoperative material-related complications were observed at one of the fifty vertebral levels in the balloon kyphoplasty group and at nine of the fifty levels in the vertebral body stenting group. No beneficial effect of vertebral body stenting over balloon kyphoplasty was found among patients with painful osteoporotic vertebral fractures with regard to kyphotic correction, cement leakage

  16. One-Session treatment of specific phobias in youths: a randomized clinical trial.

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    Ost, L G; Svensson, L; Hellström, K; Lindwall, R

    2001-10-01

    Sixty children, ages 7-17 years, who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) diagnosis for various specific phobias were randomized to (a) 1-session exposure treatment alone, (b) 1-session treatment with a parent present, or (c) wait-list control group for 4 weeks. After the waiting period, the wait-list patients were rerandomized to the active treatments. The patients' phobias were assessed with behavioral approach tests (approach behavior, experienced anxiety, and physiological reactions), whereas general anxiety, depression, phobic tendencies, and anxiety sensitivity were assessed with self-report inventories. Assessments were done pre-, post-, and 1-year following treatment. Results showed that both treatment conditions did significantly better than the control condition, whereas the treatment groups did equally well on most measures, and the effects were maintained at follow-up. The implications of these results are discussed.

  17. Transarterial RAdioembolization versus ChemoEmbolization for the treatment of hepatocellular carcinoma (TRACE: study protocol for a randomized controlled trial

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    Seinstra Beatrijs A

    2012-08-01

    Full Text Available Abstract Background Hepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10 to 15% of hepatocellular carcinoma patients are suitable candidates for treatment with curative intent, such as hepatic resection and liver transplantation. A majority of patients have locally advanced, liver restricted disease (Barcelona Clinic Liver Cancer (BCLC staging system intermediate stage. Transarterial loco regional treatment modalities offer palliative treatment options for these patients; transarterial chemoembolization (TACE is the current standard treatment. During TACE, a catheter is advanced into the branches of the hepatic artery supplying the tumor, and a combination of embolic material and chemotherapeutics is delivered through the catheter directly into the tumor. Yttrium-90 radioembolization (90Y-RE involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor. 90Y-RE is increasingly used in clinical practice for treatment of intermediate stage hepatocellular carcinoma, but its efficacy has never been prospectively compared to that of the standard treatment (TACE. In this study, we describe the protocol of a multicenter randomized controlled trial aimed at comparing the effectiveness of TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage hepatocellular carcinoma. Methods/design In this pragmatic randomized controlled trial, 140 patients with unresectable (BCLC intermediate stage hepatocellular carcinoma, with Eastern Cooperative Oncology Group performance status 0 to 1 and Child-Pugh A to B will be randomly assigned to either 90Y-RE or TACE with drug eluting beads. Patients assigned to 90Y-RE will first receive a diagnostic angiography, followed by the actual transarterial treatment, which can be divided into two sessions in case

  18. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    Science.gov (United States)

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. 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). 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). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  19. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Franciane Schneider

    2015-04-01

    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.

  20. Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

    Science.gov (United States)

    Vos-Vromans, D C W M; Smeets, R J E M; Huijnen, I P J; Köke, A J A; Hitters, W M G C; Rijnders, L J M; Pont, M; Winkens, B; Knottnerus, J A

    2016-03-01

    The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. Four rehabilitation centres in the Netherlands. A total of 122 patients participated in the trial. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial. © 2015 The Association for the Publication of the Journal of Internal Medicine.

  1. Comparison of 2 Dosages of Stretching Treatment in Infants with Congenital Muscular Torticollis: A Randomized Trial.

    Science.gov (United States)

    He, Lu; Yan, Xiaohua; Li, Jinling; Guan, Buyun; Ma, Liying; Chen, Ying; Mai, Jianning; Xu, Kaishou

    2017-05-01

    To compare the short-term efficacy of 2 dosages of stretching treatment on the clinical outcomes in infants with congenital muscular torticollis. This was a prospective randomized controlled study. Fifty infants with congenital muscular torticollis who were randomly assigned to 100-times stretching group and 50-times stretching group received stretching treatment for the affected sternocleidomastoid muscle. The outcomes including the head tilt, the cervical passive range of motion, and the muscle function of cervical lateral flexors determined by the muscle function scale were assessed at baseline and at 4 and 8 weeks after treatment. The sternocleidomastoid muscle growth analyzed by the thickness ratio of sternocleidomastoid muscles was measured using ultrasonography at baseline and 8 weeks after treatment. Except the ratio of muscle function scale scores, the postintervention outcomes were all significantly improved in both groups compared with baseline (P stretching group showed greater improvement compared with 50-times stretching group in head tilt and cervical passive range of motion at 4 and 8 weeks after treatment (P Stretching treatment of 2 dosages may effectively improve head tilt, cervical passive range of motion, and sternocleidomastoid muscle growth in infants with congenital muscular torticollis. The stretching treatment of 100 times per day is likely to associate with greater improvement in head tilt and cervical passive range of motion.

  2. Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Reich, K; Burden, A D; Eaton, J N; Hawkins, N S

    2012-01-01

    Ustekinumab, a novel monoclonal antibody for the treatment of moderate to severe plaque-type psoriasis, has recently received regulatory approval in Europe, bringing the total number of biologic agents licensed in this indication to five. To assist treatment selection in daily practice it is essential to understand the benefit/risk profile of these agents and in the absence of a clinical trial comparing all available biologics a number of reviews have used statistical techniques to generate estimates of the comparative effectiveness of these therapies through the available network of randomized clinical trials. These estimates have previously been published for a limited range of psoriasis biologic treatments, although, to date no review has compared all the currently available agents in Europe. To estimate the comparative effectiveness of all biologic agents indicated in the treatment of moderate to severe psoriasis currently available in Europe based on the primary trial endpoints. A number of databases were searched for details of randomized controlled trials of available biologics in the treatment of plaque-type psoriasis in adults. Comparative effectiveness was estimated based on the reported Psoriasis Area and Severity Index (PASI) 50, 75 and 90 response rates. A network meta-analysis conducted on the ordered probit scale and implemented as a Bayesian hierarchical model provided estimates for the probability of response and relative risk vs. placebo, based on all observed comparisons. Twenty trials were included in the meta-analysis including patients with a mean disease duration of 18-22years. Based on the indirect comparison and given a placebo PASI 50 response of 13%, infliximab had the highest predicted mean probability of response at PASI levels 50 (93%), 75 (80%) and 90 (54%), followed by ustekinumab 90 mg at 90%, 74% and 46%, respectively, and then ustekinumab 45mg, adalimumab, etanercept and efalizumab. The ordered probit model allowed a

  3. Effects of teriparatide versus alendronate for treatment of postmenopausal osteoporosis: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Ya-Kang; Qin, Si-Qing; Ma, Tao; Song, Wei; Jiang, Ren-Qi; Guo, Jian-Bin; Li, Kun; Zhang, Yu-Min

    2017-05-01

    Osteoporosis remains a clinical challenge. Teriparatide is an anabolic drug and alendronate is an antiresorptive agent; both are used in the treatment of osteoporosis. Comprehensive reviews investigating the comparative safety and efficacy of teriparatide versus alendronate are scarce. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and efficacy of teriparatide versus alendronate for the treatment of postmenopausal osteoporosis. We conducted a comprehensive literature review of the PubMed, EMBASE, Cochrane Controlled Trials Registry, and the China Academic Journal Network Publishing databases for relevant RCTs of teriparatide versus alendronate in postmenopausal osteoporosis patients. Outcome measures were percentage change in lumbar spine and femoral neck bone mineral density (BMD) and incidence of vertebral and nonvertebral fractures. Effect size was reported as weighted mean differences (WMDs) for continuous outcomes and odds ratios (OR) for dichotomous outcomes, with associated 95% confidence intervals (CIs). Six trials involving 618 patients were included. The meta-analysis demonstrated a significant increase in lumbar spine BMD (WMD: 3.46, 95% CI: 2.15-4.77, P osteoporosis patients treated with teriparatide compared with alendronate for 6 to 18 months. These beneficial effects were apparent in the lumbar spine at 12 months of treatment (WMD: 4.49, 95% CI: 2.57-6.40, P osteoporosis. The efficacy and safety of long-term teriparatide and alendronate treatment in postmenopausal osteoporosis should be further investigated in clinical trials.

  4. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial.

    Science.gov (United States)

    Van Gerwen, Lucas J; Spinhoven, Philip; Van Dyck, Richard

    2006-12-01

    In a long-standing fear-of-flying program, persons with fear of flying (N=150) were after a diagnostic assessment and individual preparation phase randomly assigned to either a 1-day behavioral group treatment (BGT) program, a 2-day cognitive-behavioral group treatment (CBGT) program or a waiting list (WL) control group. A post-treatment flight on a commercial airline measured participants' ability to fly. Different self-report flight anxiety questionnaires were completed before, during and after treatment at 3-, 6- and 12-month follow-up. Results indicated that both treatments were superior to the WL, and equally effective on the flying test and later independent flying, but also that the 2-day CBGT program was significantly more effective than the 1-day BGT program on subjective measures of fear and self-efficacy.

  5. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F

    2005-01-01

    -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......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....... In addition, there was no significant difference in the secondary outcome measures, improvement in the visual function measures and MRI, at any time during follow-up. At baseline, a significantly higher number of patients in the IVIG group had one or more enhancing lesions on MRI and IVIG-treated patients had...

  6. Asthma control cost-utility randomized trial evaluation (ACCURATE: the goals of asthma treatment

    Directory of Open Access Journals (Sweden)

    Honkoop Persijn J

    2011-11-01

    Full Text Available Abstract Background Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control: 1. sufficiently controlled asthma 2. strictly controlled asthma 3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker Design 720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year, will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health care and productivity will be compared to differences in the number of limited activity days and in quality adjusted

  7. Does visceral osteopathic treatment accelerate meconium passage in very low birth weight infants?- A prospective randomized controlled trial.

    Science.gov (United States)

    Haiden, Nadja; Pimpel, Birgit; Kreissl, Alexandra; Jilma, Bernd; Berger, Angelika

    2015-01-01

    To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants. This study was a prospective, randomized, controlled trial in premature infants with a birth weight osteopathic treatment 3 times during their first week of life or no treatment. Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6-9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed. Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants. Clinical trials.gov: NCT02140710.

  8. Does visceral osteopathic treatment accelerate meconium passage in very low birth weight infants?- A prospective randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Nadja Haiden

    Full Text Available To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants.This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment.Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6-9 days, n = 21 in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20, in the control group (p = 0.11. However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02, and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14. Osteopathic treatment was tolerated well and no adverse events were observed.Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants.Clinical trials.gov: NCT02140710.

  9. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial.

    Science.gov (United States)

    Kaldo, Viktor; Jernelöv, Susanna; Blom, Kerstin; Ljótsson, Brjánn; Brodin, Maria; Jörgensen, Mia; Kraepelien, Martin; Rück, Christian; Lindefors, Nils

    2015-08-01

    To evaluate if internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-i) with brief therapist support outperforms an active control treatment. Adults diagnosed with insomnia were recruited via media (n = 148) and randomized to either eight weeks of ICBT-i or an active internet-based control treatment. Primary outcome was the insomnia severity index (ISI) assessed before and after treatment, with follow-ups after 6 and 12 months. Secondary outcomes were use of sleep medication, sleep parameters (sleep diary), perceived stress, and a screening of negative treatment effects. Hierarchical Linear Mixed Models were used for intent-to-treat analyses and handling of missing data. ICBT-i was significantly more effective than the control treatment in reducing ISI (Cohen's d = 0.85), sleep medication, sleep efficiency, sleep latency, and sleep quality at post-treatment. The positive effects were sustained. However, after 12 months the difference was no longer significant due to a continuous decrease in ISI among controls, possibly due to their significantly higher utilization of insomnia relevant care after treatment. Forty-six negative effects were reported but did not differ between interventions. Supported ICBT-i is more effective than an active control treatment in reducing insomnia severity and treatment gains remain stable one year after treatment. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials

    Science.gov (United States)

    Licciardone, John C; Brimhall, Angela K; King, Linda N

    2005-01-01

    Background Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain. Methods Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses. Results Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up. Conclusion

  11. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    King Linda N

    2005-08-01

    Full Text Available Abstract Background Osteopathic manipulative treatment (OMT is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain. Methods Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses. Results Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001. Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long

  12. Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials.

    Science.gov (United States)

    Holland, Edward J; Whitley, Walter O; Sall, Kenneth; Lane, Stephen S; Raychaudhuri, Aparna; Zhang, Steven Y; Shojaei, Amir

    2016-07-22

    Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.

  13. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial

    Science.gov (United States)

    Kropff, Martin; Baylon, Honorata Giongco; Hillengass, Jens; Robak, Tadeusz; Hajek, Roman; Liebisch, Peter; Goranov, Stefan; Hulin, Cyrille; Bladé, Joan; Caravita, Tommaso; Avet-Loiseau, Herve; Moehler, Thomas M.; Pattou, Claire; Lucy, Lela; Kueenburg, Elisabeth; Glasmacher, Axel; Zerbib, Robert; Facon, Thierry

    2012-01-01

    Background Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. Design and Methods We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. Results In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. Conclusions Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. (Clinical trial registration number: NCT00452569) PMID:22133776

  14. Intermittent claudication--surgical reconstruction or physical training? A prospective randomized trial of treatment efficiency.

    Science.gov (United States)

    Lundgren, F; Dahllöf, A G; Lundholm, K; Scherstén, T; Volkmann, R

    1989-01-01

    This study reports the initial evaluation of treatment efficiency in 75 patients with intermittent claudication who were randomized to three treatment groups: 1) reconstructive surgery, 2) reconstructive surgery with subsequent physical training, and 3) physical training alone. Before treatment, there were no statistically significant differences between the groups in age, sex, smoking habits, symptom duration of claudication, ankle-arm blood pressure quotient (ankle-index), maximal plethysmographic calf blood flow, symptom-free and maximal walking distance, the history of other atherosclerotic manifestations or in the medical treatment. The walking performance was improved in all three groups at follow-up 13 +/- 0.5 months after randomization. Surgery was most effective, but the addition of training to surgery improved the symptom-free walking distance even further. In pooled observations of the three groups, age, symptom duration, and a history of myocardial ischemic disease correlated negatively with walking performance after treatment. In the operated group, the duration of claudication and a history of myocardial ischemic disease correlated negatively with the walking performance. This was not the case when patients were censored if limited by other symptoms than intermittent claudication after treatment. In the trained group, the duration of claudication correlated negatively to symptom-free and maximal walking distance. Ankle-index and maximal plethysmographic calf blood flow after treatment and the change of these variables with treatment correlated positively with both symptom-free and maximal walking distance when results were pooled for all patients. Although this mainly was a consequence of the improved blood flow after surgery, the change of maximal plethysmographic calf blood flow also correlated with symptom-free but not with maximal walking distance in the trained group. The results demonstrate that, compared with physical training alone, operation

  15. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  16. Chinese Herbal Bath Therapy for the Treatment of Knee Osteoarthritis: Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Bo Chen

    2015-01-01

    Full Text Available Objective. Chinese herbal bath therapy (CHBT has traditionally been considered to have analgesic and anti-inflammatory effects. We conducted the first meta-analysis evaluating its benefits for patients with knee osteoarthritis (OA. Methods. We searched three English and four Chinese databases through October, 2014. Randomized trials evaluating at least 2 weeks of CHBT for knee OA were selected. The effects of CHBT on clinical symptoms included both pain level (via the visual analog scale and total effectiveness rate, which assessed pain, physical performance, and wellness. We performed random-effects meta-analyses using mean difference. Results. Fifteen studies totaling 1618 subjects met eligibility criteria. Bath prescription included, on average, 13 Chinese herbs with directions to steam and wash around the knee for 20–40 minutes once or twice daily. Mean treatment duration was 3 weeks. Results from meta-analysis showed superior pain improvement (mean difference = −0.59 points; 95% confidence intervals [CI], −0.83 to −0.36; p<0.00001 and higher total effectiveness rate (risk ratio = 1.21; 95% CI, 1.15 to 1.28; p<0.00001 when compared with standard western treatment. No serious adverse events were reported. Conclusion. Chinese herbal bath therapy may be a safe, effective, and simple alternative treatment modality for knee OA. Further rigorously designed, randomized trials are warranted.

  17. Cognitive-Behavioral Treatment of Insomnia and Depression in Adolescents: A Pilot Randomized Trial

    OpenAIRE

    Clarke, Greg; McGlinchey, Eleanor L.; Hein, Kerrie; Gullion, Christina M; Dickerson, John F.; Leo, Michael C.; Harvey, Allison G.

    2015-01-01

    We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12–20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n=20), or an experimental condition consisting of CBT-I combined with CBT-D (n=21).

  18. The effectiveness of anxiety treatment on alcohol-dependent patients with a comorbid phobic disorder: a randomized controlled trial.

    Science.gov (United States)

    Schadé, Annemiek; Marquenie, Loes A; van Balkom, Anton J L M; Koeter, Maarten W J; de Beurs, Edwin; van den Brink, Wim; van Dyck, Richard

    2005-05-01

    Evidence has emerged which indicates that the post-treatment relapse rate for alcohol-dependent patients with a comorbid anxiety disorder is higher than for alcohol-dependent patients without a comorbid anxiety disorder. The question raised by this evidence is whether the relapse rate in these dually diagnosed patients could be reduced if they were given additional treatment for the comorbid anxiety disorder. We attempted to answer this question by conducting a trial among patients with a double diagnosis of alcohol dependence and agoraphobia or social phobia. We conducted a 32-week randomized controlled trial among 96 abstinent patients with a primary diagnosis of alcohol dependence and a comorbid anxiety disorder involving agoraphobia or social phobia. The patients were randomly assigned to an intensive psychosocial relapse-prevention program on its own (n = 49) or in combination with an anxiety treatment program comprising cognitive behavioral therapy (CBT) and optional pharmacotherapy consisting of an SSRI (n = 47). The primary outcome measure was the percentage of patients who suffered an alcohol relapse during a 32-week period. The secondary outcome measures were total abstinence, a reduction in the days of heavy drinking, and less severe anxiety symptoms. Although the additional therapy clearly reduced the anxiety symptoms, it had no significant effect on the alcohol relapse rates. Anxiety treatment for alcohol-dependent patients with a comorbid anxiety disorder can alleviate anxiety symptoms, but it has no significant effect on the outcome of alcohol treatment programs.

  19. Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods.

    Science.gov (United States)

    Morin, Mélanie; Dumoulin, Chantale; Bergeron, Sophie; Mayrand, Marie-Hélène; Khalifé, Samir; Waddell, Guy; Dubois, Marie-France

    2016-01-01

    Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Joutsiniemi, Titta; Timonen, Susanna; Leino, Riitta; Palo, Pertti; Ekblad, Ulla

    2014-03-01

    To test the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP). In the randomized (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered and itching scores were assessed before the treatment and weekly thereafter. The effects of UDCA on liver function and fetoplacental hormone production were measured with covering laboratory testing: serum levels of alanine aminotransferase (ALAT), total bile acids (TBA), estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time, fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome were recorded and analyzed. UDCA was well tolerated. A significant improvement in itching scores was detected in 2 weeks in the group receiving UDCA. Serum levels of ALAT and TBA fell after 2 weeks treatment. The other laboratory values were not modified by the treatment. UDCA improves maternal itching scores and liver function tests without interfering with the fetoplacental estrogen production in patients with ICP. UDCA is well tolerated by pregnant women. No fetal or neonatal side-effects could be detected.

  1. Rationale and Design of a Randomized Clinical Trial Comparing Stress Reduction Treatment to Usual Cardiac Care: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial

    Science.gov (United States)

    Donahue, Rebecca G.; Lampert, Rachel; Dornelas, Ellen; Clemow, Lynn; Burg, Matthew M.

    2010-01-01

    Objective Present the design of a multicenter randomized trial testing the effects of Stress Reduction Treatment (SRT) on the prevalence of shock treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. Methods New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the past 6 months (n=304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6-, 12-, and 24-months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), ATP events, medication changes, hospitalizations, deaths, and quality of life. Results Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on lab stress induced and 24-hour arrhythmogenic electrophysiological indices from pre- to post-treatment, and both quality of life and measures of anger across the 2-years of the study. Conclusions The RISTA Trial is the first large scale randomized clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia provoked shock and improve quality of life. PMID:20028832

  2. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder.

    Science.gov (United States)

    Bateman, Anthony; Fonagy, Peter

    2009-12-01

    This randomized controlled trial tested the effectiveness of an 18-month mentalization-based treatment (MBT) approach in an outpatient context against a structured clinical management (SCM) outpatient approach for treatment of borderline personality disorder. Patients (N=134) consecutively referred to a specialist personality disorder treatment center and meeting selection criteria were randomly allocated to MBT or SCM. Eleven mental health professionals equal in years of experience and training served as therapists. Independent evaluators blind to treatment allocation conducted assessments every 6 months. The primary outcome was the occurrence of crisis events, a composite of suicidal and severe self-injurious behaviors and hospitalization. Secondary outcomes included social and interpersonal functioning and self-reported symptoms. Outcome measures, assessed at 6-month intervals, were analyzed using mixed effects logistic regressions for binary data, Poisson regression models for count data, and mixed effects linear growth curve models for self-report variables. Substantial improvements were observed in both conditions across all outcome variables. Patients randomly assigned to MBT showed a steeper decline of both self-reported and clinically significant problems, including suicide attempts and hospitalization. Structured treatments improve outcomes for individuals with borderline personality disorder. A focus on specific psychological processes brings additional benefits to structured clinical support. Mentalization-based treatment is relatively undemanding in terms of training so it may be useful for implementation into general mental health services. Further evaluations by independent research groups are now required.

  3. Internal fixation vs conservative treatment for displaced distal radius fractures: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yu, Guang Shu; Lin, Yan Bin; Le, Li Sheng; Zhan, Mei Feng; Jiang, Xiao Xiang

    2016-05-01

    The aim of the present study was to compare clinical outcomes of internal fixation and conservative approach in the treatment of displaced distal radius fractures. Reports of studies were retrieved from the PubMed, Cochrane Library, EMBASE, BIOSIS, Ovid, CNKI, and Wanfang Data databases, as well as other sources. Methodological quality of the trials was critically assessed, and relevant data were extracted. Review Manager (RevMan) meta-analysis software (version 5.0; Cochrane Collaboration, London, UK) was used for data analysis. A total of 10 randomized controlled trials, which included 653 patients, were eligible for inclusion in the present meta-analysis, 7 of which were in English, and 3 of which were in Chinese. The trials had medium risk of bias. Results of meta-analysis showed that patients undergoing conservative treatment for distal radius fractures had better restoration of pronation (MD=1.80, 95% confidence interval [CI]=0.18-3.42, p=0.03; heterogeneity p=0.17, I2=43%), but shorter restoration of radial length (MD=2.62, 95% CI=1.47-3.76, pheterogeneity p=0.02, I2=73%). Wrist range of motion other than pronation, grip strength, radiographic parameters other than radial length, and rates of complications were not significantly different between the 2 treatments. Very few clinical differences were found between results of internal fixation and conservative treatment for displaced distal radius fractures. Best course of of treatment must be determined based on concrete conditions.

  4. Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomized multicenter Phase III trial.

    Science.gov (United States)

    Scheller, Christian; Wienke, Andreas; Tatagiba, Marcos; Gharabaghi, Alireza; Ramina, Kristofer F; Ganslandt, Oliver; Bischoff, Barbara; Zenk, Johannes; Engelhorn, Tobias; Matthies, Cordula; Westermaier, Thomas; Antoniadis, Gregor; Pedro, Maria Teresa; Rohde, Veit; von Eckardstein, Kajetan; Kretschmer, Thomas; Kornhuber, Malte; Steighardt, Jörg; Richter, Michael; Barker, Fred G; Strauss, Christian

    2016-03-01

    A pilot study of prophylactic nimodipine and hydroxyethyl starch treatment showed a beneficial effect on facial and cochlear nerve preservation following vestibular schwannoma (VS) surgery. A prospective Phase III trial was undertaken to confirm these results. An open-label, 2-arm, randomized parallel group and multicenter Phase III trial with blinded expert review was performed and included 112 patients who underwent VS surgery between January 2010 and February 2013 at 7 departments of neurosurgery to investigate the efficacy and safety of the prophylaxis. The surgery was performed after the patients were randomly assigned to one of 2 groups using online randomization. The treatment group (n = 56) received parenteral nimodipine (1-2 mg/hr) and hydroxyethyl starch (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 56) was not treated prophylactically. Intent-to-treat analysis showed no statistically significant effects of the treatment on either preservation of facial nerve function (35 [67.3%] of 52 [treatment group] compared with 34 [72.3%] of 47 [control group]) (p = 0.745) or hearing preservation (11 [23.4%] of 47 [treatment group] compared with 15 [31.2%] of 48 [control group]) (p = 0.530) 12 months after surgery. Since tumor sizes were significantly larger in the treatment group than in the control group, logistic regression analysis was required. The risk for deterioration of facial nerve function was adjusted nearly the same in both groups (OR 1.07 [95% CI 0.34-3.43], p = 0.91). In contrast, the risk for postoperative hearing loss was adjusted 2 times lower in the treatment group compared with the control group (OR 0.49 [95% CI 0.18-1.30], p = 0.15). Apart from dose-dependent hypotension (p nimodipine can be recommended in VS surgery.

  5. Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial.

    Science.gov (United States)

    Ruwaard, Jeroen; Lange, Alfred; Broeksteeg, Janneke; Renteria-Agirre, Aitziber; Schrieken, Bart; Dolan, Conor V; Emmelkamp, Paul

    2013-01-01

    Manualized cognitive-behavioural treatment (CBT) is underutilized in the treatment of bulimic symptoms. Internet-delivered treatment may reduce current barriers. This study aimed to assess the efficacy of a new online CBT of bulimic symptoms. Participants with bulimic symptoms (n = 105) were randomly allocated to online CBT, bibliotherapy or waiting list/delayed treatment condition. Data were gathered at pre-treatment, post-treatment and 1-year follow-up. The primary outcome measures were the Eating Disorder Examination Questionnaire (EDE-Q) and the frequency of binge eating and purging episodes. The secondary outcome measure was the Body Attitude Test. Dropout from Internet treatment was 26%. Intention-to-treat ANCOVAs of post-test data revealed that the EDE-Q scores and the frequency of binging and purging reduced more in the online CBT group compared with the bibliotherapy and waiting list groups (pooled between-group effect size: d = 0.9). At 1-year follow-up, improvements in the online CBT group had sustained. This study identifies online CBT as a viable alternative in the treatment of bulimic symptoms. Copyright © 2012 John Wiley & Sons, Ltd.

  6. Patient navigation for breast and colorectal cancer treatment: a randomized trial.

    Science.gov (United States)

    Fiscella, Kevin; Whitley, Elizabeth; Hendren, Samantha; Raich, Peter; Humiston, Sharon; Winters, Paul; Jean-Pierre, Pascal; Valverde, Patricia; Thorland, William; Epstein, Ronald

    2012-10-01

    There is limited high-quality evidence about the impact of patient navigation (PN) on outcomes for patients with diagnosed cancer. We pooled data from two sites from the national Patient Navigation Research Program. Patients (n = 438) with newly diagnosed breast (n = 353) or colorectal cancer (n = 85) were randomized to PN or usual care. Trained lay navigators met with patients randomized to PN to help them assess treatment barriers and identify resources to overcome barriers. We used intent-to-treat analysis to assess time to completion of primary treatment, psychologic distress (impact of events scale), and satisfaction (patient satisfaction with cancer-related care) within 3 months after initiation of cancer treatment. The sample was predominantly middle-aged (mean age = 57) and female (90%); 44% were race-ethnic minorities (44%), 46% reported lower education levels, 18% were uninsured, and 9% reported a non-English primary language. The randomized groups were comparable in baseline characteristics. Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment, satisfaction with cancer-related care, or psychologic distress. Subgroup analysis showed that socially disadvantaged patients (i.e., uninsured, low English proficiency, and non-English primary language) who received PN reported higher satisfaction than those receiving usual care (all P < 0.05). Navigated patients living alone reported greater distress than those receiving usual care. Although the primary analysis showed no overall benefit, the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals. PN for cancer patients may not necessarily reduce treatment time nor distress. 2012 AACR

  7. A randomized, controlled clinical trial of intravenous lipid emulsion as an adjunctive treatment for permethrin toxicosis in cats.

    Science.gov (United States)

    Peacock, Rachel E; Hosgood, Giselle; Swindells, Katrin L; Smart, Lisa

    2015-01-01

    To assess for any clinical benefit of intravenous lipid emulsion (ILE) for permethrin toxicosis in cats by comparing the progression of clinical signs of cats before and after treatment with ILE to cats treated with a saline control. To accomplish this objective, a clinical staging system for cats with permethrin toxicosis was developed and validated. Prospective, multicenter, randomized, controlled clinical trial. University veterinary teaching hospital and 12 private veterinary emergency hospitals. Thirty-four client-owned cats with permethrin toxicosis. A clinical staging system was designed based on abnormalities found on physical examination of cats with permethrin toxicosis. The clinical staging system had 6 stages, ranging from Stage A for cats with no abnormalities to Stage F for cats with grand mal seizures. The system was validated for intraviewer and interviewer variability. Cats in the clinical trial were randomized to receive 15 mL/kg of either intravenous 0.9% saline (control) or 20% ILE over 60 minutes. For each cat, a clinical stage was recorded at set time points before and after the randomized treatment was administered. The distribution of clinical stage stratified over time was compared across treatment groups. The clinical staging system showed excellent repeatability (P = 1.0) and reliability (P = 1.0). In the clinical trial, there was a significant difference in the distribution of clinical stages over time (P permethrin toxicosis in ILE-treated cats improved earlier compared to control cats, suggesting ILE may be a useful adjunctive therapy in the treatment of permethrin toxicosis in cats. © Veterinary Emergency and Critical Care Society 2015.

  8. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

    Science.gov (United States)

    Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

    2012-06-01

    Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

  9. Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fassett Robert G

    2008-08-01

    Full Text Available Abstract Background The main hypothesis of this study is that Oxpentifylline administration will effectively treat erythropoietin- or darbepoietin-resistant anaemia in chronic kidney disease patients. Methods/design Inclusion criteria are adult patients with stage 4 or 5 chronic kidney disease (including dialysis patients with significant anaemia (haemoglobin ≤ 110 g/L for at least 3 months for which there is no clear identifiable cause and that is unresponsive to large doses of either erythropoietin (≥ 200 IU/kg/week or darbepoetin (≥ 1 μg/kg/week. Patients will be randomized 1:1 to receive either placebo (1 tablet daily or oxpentifylline (400 mg daily per os for a period of 4 months. During this 4 month study period, haemoglobin measurements will be performed monthly. The primary outcome measure will be the difference in haemoglobin level between the 2 groups at the end of the 4 month study period, adjusted for baseline values. Secondary outcome measures will include erythropoiesis stimulating agent dosage, Key's index (erythropoiesis stimulating agent dosage divided by haemoglobin concentration, and blood transfusion requirement. Discussion This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their chronic kidney disease patients determine whether oxpentifylline represents a safe and effective strategy for treating erythropoiesis stimulating agent resistance in chronic kidney disease. Trial Registration Australian New Zealand Clinical Trials Registry Number ACTRN12608000199314.

  10. Treatment of new-onset atrial fibrillation in noncardiac intensive care unit patients: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kanji, Salmaan; Stewart, Robert; Fergusson, Dean A; McIntyre, Lauralyn; Turgeon, Alexis F; Hébert, Paul C

    2008-05-01

    Atrial fibrillation is a common problem associated with morbidity and mortality in critically ill patients; however, evidence-based treatment recommendations are lacking. The objective of this systematic review was to evaluate the efficacy of pharmacologic rhythm control of new-onset atrial fibrillation in noncardiac, critically ill adults. Citations identified from an electronic search of Medline, the Cochrane register of controlled trials, and Embase databases (1966 to August 2006) were independently reviewed by two investigators. All prospective randomized controlled trials evaluating pharmacologic rhythm conversion regimens for new-onset atrial fibrillation in (noncardiac surgery) critically ill adult patients were included. The primary end point was atrial fibrillation resolution. Using a standardized data extraction form, data related to study design, population characteristics, pharmacologic intervention, and outcome measures were collected. Four trials met inclusion criteria from 1995 citations screened. Of the 143 evaluable patients in these trials 89 (76%) had atrial fibrillation while the remaining ones had other atrial tachyarrhythmias. Drugs evaluated for rhythm conversion included amiodarone (n = 26), procainamide (n = 14), magnesium (n = 18), flecainide (n = 15), esmolol (n = 28), verapamil (n = 15), and diltiazem (n = 27). The definition of treatment success ranged from conversion within 1 hr to conversion within 24 hrs. No study evaluated maintenance of conversion, and one study included hemodynamically unstable patients. Lack of methodologic homogeneity prevented any pooled analysis. Using the current published literature, we cannot recommend a standard treatment for atrial fibrillation in noncardiac critically ill adult patients. Clinical trials evaluating rhythm conversion in critically ill populations outside of cardiac surgery are lacking. Further trials that address goals of care in hemodynamically stable and unstable patients and utilize

  11. A Randomized Placebo-controlled Double Blind Clinical Trial of Quercetin for Treatment of Oral Lichen Planus

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    Maryam Amirchaghmaghi

    2015-03-01

    Full Text Available Background and aims. Standard treatment of oral lichen planus (OLP includes topical or systemic corticosteroids that have many adverse effects. A trend toward alternative natural or herbal drugs has attended recently. This study was con-ducted to evaluate the effect of quercetin in treatment of erosive-atrophic OLP. Materials and methods. Thirty patients participated in this randomized clinical trial from April 2010 to June 2010 (Trial Registration Number: NCT01375101. Patients were randomly allocated in two groups. Both groups received the standard treatment (dexamethasone mouthwash and nystatin suspension. Experimental group received oral 250 mg quercetin hydrate capsules (bid and the control group received placebo capsules. The pain and severity of the lesions were recorded at the initial visit and the follow-ups. All recorded data were analyzed with chi-square, Mann-Whitney, t-test, Wilcoxon and Friedman tests using SPSS 11.5. Results. There were no significant differences between the two groups in severity of the lesions and pain in the follow-ups.According to the Friedman test, there was a significant reduction in pain (P = 0.01 and severity indices (P = 0.00 in the case group. These differences were not observed in the control group (P = 0.26, SI; and P = 0.86, PI. No adverse effect of quercetin was reported. Conclusion. According to the results, no significant therapeutic effect can be considered for quercetin in treatment of OLP.

  12. Suicide prevention after traumatic brain injury: a randomized controlled trial of a program for the psychological treatment of hopelessness.

    Science.gov (United States)

    Simpson, Grahame K; Tate, Robyn L; Whiting, Diane L; Cotter, Rachel E

    2011-01-01

    To evaluate the efficacy of a psychological treatment to reduce moderate to severe hopelessness after severe traumatic brain injury (TBI). Randomized controlled trial. Participants were aged between 18 and 65 years, experienced posttraumatic amnesia more than 1day and moderate to severe hopelessness (Beck Hopelessness Scale [BHS]) and/or suicide ideation. Intervention comprised a 20-hour manualized group cognitive behavior therapy program. Participants were randomly allocated using concealed allocation (treatment n = 8; wait-list n = 9); all remained in their allocated group. Outcome variables were collected by assessors blind to group allocation. No between-groups differences were observed on demographic, injury, cognitive, and psychosocial variables at baseline (time 1). A significant group-by-time interaction was found for BHS in the treatment group (F1,15 = 13.20, P = .002), reflecting a reduction in mean BHS scores between time 1 and time 2 (posttreatment) with no main effects for group or time. At 3-month follow-up (time 3), the treatment gains were maintained or improved for 75% (6/8) of participants. Secondary outcome variables (suicide ideation, depression, social problem solving, self-esteem, hopefulness) displayed no significant group-by-time interactions or main effects. This trial provides initial evidence for the efficacy of a psychological intervention in reducing hopelessness among long-term survivors with severe TBI.

  13. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

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    Julia R G Raifman

    Full Text Available BACKGROUND: Low rates of adherence to artemisinin-based combination therapy (ACT regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. METHODS: Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. RESULTS: 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028. Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252. CONCLUSION: The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722734.

  14. The syndromic management of vaginal discharge using single-dose treatments: a randomized controlled trial in West Africa.

    Science.gov (United States)

    Pépin, Jacques; Sobela, François; Khonde, Nzambi; Agyarko-Poku, Thomas; Diakité, Soumaila; Deslandes, Sylvie; Labbé, Annie-Claude; Sylla, Mohamed; Asamoah-Adu, Comfort; Frost, Eric

    2006-09-01

    To evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge. A randomized controlled effectiveness trial compared single-dose tinidazole plus fluconazole (TF) with treatment for 7 days with metronidazole plus 3 days of treatment with vaginal clotrimazole (MC) among 1570 women presenting with vaginal discharge at primary health care institutions in Ghana, Guinea, Mali and Togo. Participants were randomly allocated to one of the two treatments by research nurses or physicians using precoded envelopes. Effectiveness was assessed by symptomatic response on day 14. CLINICAL IDENTIFIER ClinicalTrials.gov NCT00313131. The two treatment regimens had similar effectiveness: complete resolution was seen in 66% (TF) and 64% (MC) and partial resolution in 33% (TF) and 34% (MC) of participants (P = 0.26). Effectiveness was similar among subgroups with vulvovaginal candidiasis, Trichomonas vaginalis vaginitis or bacterial vaginosis. The two treatment regimens had a similar effectiveness among human immunodeficiency virus (HIV)-infected (TF: n = 76, 71% complete resolution, 28% partial; MC: n = 83, 72% complete resolution, 25% partial, P = 0.76) and HIV-uninfected women (TF: n = 517, 68% complete, 32% partial; MC: n = 466, 65% complete, 33% partial, P = 0.20). Cervical infections with Neisseria gonorrhoeae, Chlamydia trachomatis and Mycoplasma genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or T. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. Four-fifths of women not relieved by a single dose of TF had a favourable response when MC was administered as second-line treatment. Single-dose TF is as effective as multiple-dose MC in the syndromic management of vaginal discharge, even among women with HIV-infection. Given its low price and easier adherence, TF should be considered as a first

  15. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Micoulaud-Franchi, Jean-Arthur; Geoffroy, Pierre Alexis; Fond, Guillaume; Lopez, Régis; Bioulac, Stéphanie; Philip, Pierre

    2014-01-01

    We undertook a meta-analysis of published Randomized Controlled Trials (RCT) with semi-active control and sham-NF groups to determine whether Electroencephalogram-neurofeedback (EEG-NF) significantly improves the overall symptoms, inattention and hyperactivity/impulsivity dimensions for probably unblinded assessment (parent assessment) and probably blinded assessment (teacher assessment) in children with Attention Deficit Hyperactivity Disorder (ADHD). A systematic review identified independent studies that were eligible for inclusion in a random effects meta-analysis. Effect sizes for ADHD symptoms were expressed as standardized mean differences (SMD) with 95% confidence intervals. Five identified studies met eligibility criteria, 263 patients with ADHD were included, 146 patients were trained with EEG-NF. On parent assessment (probably unblinded assessment), the overall ADHD score (SMD = -0.49 [-0.74, -0.24]), the inattention score (SMD = -0.46 [-0.76, -0.15]) and the hyperactivity/impulsivity score (SMD = -0.34 [-0.59, -0.09]) were significantly improved in patients receiving EEG-NF compared to controls. On teacher assessment (probably blinded assessment), only the inattention score was significantly improved in patients receiving EEG-NF compared to controls (SMD = -0.30 [-0.58, -0.03]). This meta-analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms. Future investigations should pay greater attention to adequately blinded studies and EEG-NF protocols that carefully control the implementation and embedding of training.

  16. The empirical antibiotic treatment of nosocomial spontaneous bacterial peritonitis: Results of a randomized, controlled clinical trial.

    Science.gov (United States)

    Piano, Salvatore; Fasolato, Silvano; Salinas, Freddy; Romano, Antonietta; Tonon, Marta; Morando, Filippo; Cavallin, Marta; Gola, Elisabetta; Sticca, Antonietta; Loregian, Arianna; Palù, Giorgio; Zanus, Giacomo; Senzolo, Marco; Burra, Patrizia; Cillo, Umberto; Angeli, Paolo

    2016-04-01

    Spontaneous bacterial peritonitis (SBP) is a common, life-threatening complication of liver cirrhosis. Third-generation cephalosporins have been considered the first-line treatment of SBP. In 2014, a panel of experts suggested a broader spectrum antibiotic regimen for nosocomial SBP, according to the high rate of bacteria resistant to third-generation cephalosporins found in these patients. However, a broader-spectrum antibiotic regimen has never been compared to third-generation cephalosporins in the treatment of nosocomial SBP. The aim of our study was to compare meropenem plus daptomycin versus ceftazidime in the treatment of nosocomial SBP. Patients with cirrhosis and nosocomial SBP were randomized to receive meropenem (1 g/8 hours) plus daptomycin (6 mg/kg/day) or ceftazidime (2 g/8 hours). A paracentesis was performed after 48 hours of treatment. A reduction in ascitic fluid neutrophil count <25% of pretreatment value was considered a treatment failure. The primary outcome was the efficacy of treatment defined by the resolution of SBP after 7 days of treatment. Thirty-two patients were randomized and 31 were analyzed. The combination of meropenem plus daptomycin was significantly more effective than ceftazidime in the treatment of nosocomial SBP (86.7 vs. 25%; P < 0.001). Ninety-day transplant-free survival (TFS) was not significantly different between the two groups. In the multivariate analysis, ineffective response to first-line treatment (hazard ratio [HR]: 20.6; P = 0.01), development of acute kidney injury during hospitalization (HR: 23.2; P = 0.01), and baseline mean arterial pressure (HR: 0.92; P = 0.01) were found to be independent predictors of 90-day TFS. The combination of meropenem plus daptomycin is more effective than ceftazidime as empirical antibiotic treatment of nosocomial SBP. Efficacy of the empirical antibiotic treatment is a strong predictor of 90-day survival in patients with nosocomial SBP. © 2015 by the American

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

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    Maneeton B

    2013-07-01

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

  18. A two-year randomized trial of obesity treatment in primary care practice.

    Science.gov (United States)

    Wadden, Thomas A; Volger, Sheri; Sarwer, David B; Vetter, Marion L; Tsai, Adam G; Berkowitz, Robert I; Kumanyika, Shiriki; Schmitz, Kathryn H; Diewald, Lisa K; Barg, Ronald; Chittams, Jesse; Moore, Reneé H

    2011-11-24

    Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices. We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss. Of the 390 participants, 86% completed the 2-year trial, at which time, the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P=0.003 and P=0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events. Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss

  19. Double-blind randomized trial of bismuth subsalicylate and clindamycin for treatment of Helicobacter pylori infection.

    Science.gov (United States)

    Westblom, T U; Madan, E; Subik, M A; Duriex, D E; Midkiff, B R

    1992-01-01

    We evaluated clindamycin and bismuth subsalicylate (Pepto-Bismol) for treatment of Helicobacter pylori infection. Patients with culture or histology positive for H. pylori were randomized to receive two tablets of bismuth subsalicylate four times daily for 4 weeks or bismuth combined with 2 weeks of 300 mg clindamycin four times daily. Clinical symptoms were recorded before and after treatment by means of visual analog scales. Patients in both treatment arms showed improvement in clinical scores for abdominal pain, heartburn, and gas or bloating. Microbiologic cure was achieved in only 1 of 11 patients treated with bismuth alone and in none of 7 treated with bismuth/clindamycin. Successful eradication of H. pylori may require combination of multiple antibiotics, as recommended at the IXth World Congress of Gastroenterology, or pharmacokinetic modulators such as H2-blockers or omeprazole.

  20. Application of a Computer-Assisted Navigation System (CANS) in the Delayed Treatment of Zygomatic Fractures: A Randomized Controlled Trial.

    Science.gov (United States)

    Gong, Xi; He, Yang; An, Jingang; Yang, Yao; Huang, Xiuling; Liu, Meng; Zhao, Yangyang; Zhang, Yi

    2017-07-01

    The delayed treatment of zygomatic complex (ZMC) fracture presents a difficult challenge to surgeons. The aim of this study was to compare the treatment effects of delayed surgery of ZMC fractures with and without a computer-assisted navigation system (CANS). In this observer-blinded single-site randomized clinical trial, patients with unilateral ZMC fracture were included and randomized 1:1 to delayed treatment with or without CANS. The primary outcome measurement was the absolute bilateral differences of the ZMC eminence and width based on computed tomographic (CT) measurements 48 to 72 hours after surgery. One hundred three patients with unilateral ZMC fracture without immediate treatment were enrolled, and 78 were randomized to each group. Postoperative CT measurements showed that the bilateral difference in ZMC eminence was significantly less for the navigation group than for the control group (1.24 vs 2.22 mm; P CANS improved ZMC symmetry in patients with unilateral ZMC fracture who had delayed treatment by allowing for more accurate implementation of the preoperative plan. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  1. Probiotics for the Treatment of Pediatric Helicobacter Pylori Infection: A Randomized Double Blind Clinical Trial

    Science.gov (United States)

    Khodadad, Ahmad; Farahmand, Fatemeh; Najafi, Mehri; Shoaran, Maryam

    2013-01-01

    Objective Helicobacter pylori is recognized as a major etiological factor in the pathogenesis of gastritis and peptic ulcer disease. H. Pylori eradication has a failure rate of more than 30% in pediatric patients, particularly because of poor compliance, antibiotic resistance and occurrence of side-effects. This study was aimed to determine whether adding the probiotics to a standard anti-H. pylori regimen could minimize the gastrointestinal side-effect prevalence and improve the eradication rate. Methods Double-blind randomized placebo controlled study conducted at Children's Medical Center in Tehran, Iran. Sixty six H. pylori positive children were treated with a triple drug treatment protocol (omeprazole+amoxycillin+furazolidon) and randomly allocated to receive either probiotic or placebo. All patients underwent esophagogastroduodendoscopy. H. pylori infection was diagnosed by either rapid urease test (RUT) or histology. H. pylori status was assessed after 4-8 weeks of the completion of treatment with stool H. pylori antigen test. The side effects of the treatment were determined in each group. Findings Mean age of patients was 9.09 (range 3-14) years, 44 (65.7%) patients were boys (sex ratio 2:1). All 66 patients completed the course of treatment and follow-up. The rate of H. pylori eradication was significantly higher in probiotic group (P=0.04). In probiotic supplemented children there was a lower rate of nausea/vomiting (P=0.02) and diarrhea (P=0.039) during treatment. Conclusion This study showed that probiotics have positive effect on the eradication of H. pylori infection. Adjuvant therapy with probiotic is recommended in order to reduce the frequency of antibiotic induced side-effects during treatment with antibiotics. PMID:23446685

  2. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sidney Glina

    2011-12-01

    Full Text Available PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs. As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174 or ketoprofen 100 mg IV plus placebo (n = 164. 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174 or ketoprofen 100 mg IV(n = 164 plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID at 30 minutes by visual analog scale (VAS (per-protocol population. An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD mPID30 min was 33.84 (24.61 and 35.16 (26.01 for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

  3. A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis.

    Science.gov (United States)

    Chan, Wah-Kheong; Nik Mustapha, Nik Raihan; Mahadeva, Sanjiv

    2017-04-15

    Silymarin is a complex mixture of 6 major flavonolignans and other minor polyphenolic compounds derived from the milk thistle plant Silybum marianum; it has shown antioxidant, anti-inflammatory and antifibrotic effects, and may be useful in patients with nonalcoholic fatty liver disease (NAFLD). We aimed to study the efficacy of silymarin in patients with nonalcoholic steatohepatitis (NASH)-the more severe form of NAFLD. We performed a randomized, double-blind, placebo-controlled trial of consecutive adults with biopsy-proven NASH and a NAFLD activity score (NAS) of 4 or more at a tertiary care hospital in Kuala Lumpur, Malaysia, from November 2012 through August 2014. Patients were randomly assigned to groups given silymarin (700 mg; n = 49 patients) or placebo (n = 50 patients) 3 times daily for 48 weeks. After this 48-week period, liver biopsies were repeated. The primary efficacy outcome was a decrease of 30% or more in NAS; findings from 48-week liver biopsies were compared with those from the baseline biopsy. Secondary outcomes included changes in steatosis, lobular inflammation, hepatocyte ballooning, NAS and fibrosis score, and anthropometric measurements, as well as glycemic, lipid, and liver profiles and liver stiffness measurements. The percentage of patients achieving the primary efficacy outcome did not differ significantly between the groups (32.7% in the silymarin group vs 26.0% in the placebo group; P = .467). A significantly higher proportion of patients in the silymarin group had reductions in fibrosis based on histology (reductions of 1 point or more; 22.4%) than did the placebo group (6.0%; P = .023), and based on liver stiffness measurements (decrease of 30% or more; 24.2%) than did the placebo group (2.3%; P = .002). The silymarin group also had significant reductions in mean aspartate aminotransferase to platelet ratio index (reduction of 0.14, P = .011 compared with baseline), fibrosis-4 score (reduction of 0.20, P = .041 compared

  4. Surgical vs conventional therapy for weight loss treatment of obstructive sleep apnea: a randomized controlled trial.

    Science.gov (United States)

    Dixon, John B; Schachter, Linda M; O'Brien, Paul E; Jones, Kay; Grima, Mariee; Lambert, Gavin; Brown, Wendy; Bailey, Michael; Naughton, Matthew T

    2012-09-19

    Obstructive sleep apnea (OSA) is strongly related to obesity. Weight loss is recommended as part of the overall management plan for obese patients diagnosed with OSA. To determine whether surgically induced weight loss is more effective than conventional weight loss therapy in the management of OSA. A randomized controlled trial of 60 obese patients (body mass index: >35 and apnea-hypopnea index (AHI) of 20 events/hour or more. These patients had been prescribed continuous positive airway pressure (CPAP) therapy to manage OSA and were identified via accredited community sleep clinics. The trial was conducted between September 2006 and March 2009 by university- and teaching hospital-based clinical researchers in Melbourne, Australia. Patients with obesity hypoventilation syndrome, previous bariatric surgery, contraindications to bariatric surgery, or significant cardiopulmonary, neurological, vascular, gastrointestinal, or neoplastic disease were excluded. Patients were randomized to a conventional weight loss program that included regular consultations with a dietitian and physician, and the use of very low-calorie diets as necessary (n = 30) or to bariatric surgery (laparoscopic adjustable gastric banding; n = 30). The primary outcome was baseline to 2-year change in AHI on diagnostic polysomnography scored by staff blinded to randomization. Secondary outcomes were changes in weight, CPAP adherence, and functional status. Patients lost a mean of 5.1 kg (95% CI, 0.8 to 9.3 kg) in the conventional weight loss program compared with 27.8 kg (95% CI, 20.9 to 34.7 kg) in the bariatric surgery group (P weight loss group and by 25.5 events/hour (95% CI, 14.2 to 36.7 events/hour) in the bariatric surgery group. The between-group difference was -11.5 events/hour (95% CI, -28.3 to 5.3 events/hour; P = .18). CPAP adherence did not differ between the groups. The bariatric surgery group had greater improvement in the Short Form 36 physical component summary score (mean, 9.3 [95

  5. Systematic review of randomized controlled trials of candidate treatments for cognitive impairment in depression and methodological challenges in the field

    DEFF Research Database (Denmark)

    Miskowiak, K. W.; Ott, C. V.; Petersen, Jeff Zarp

    2016-01-01

    Cognitive impairment is a core feature of Major Depressive Disorder (MDD) but treatments targeting cognition are lacking. Numerous pre-clinical and clinical studies have investigated potential cognition treatments, but overall the evidence is conflicting. We conducted a systematic search following...... the PRISMA guidelines on PubMed and PsychInfo to evaluate the extant evidence and methodological challenges in randomized controlled trials (RCTs) of biological, psychological and behavioural candidate treatments targeting cognition in MDD. Inclusion criteria were RCTs with a placebo control assessing...... potential pro-cognitive effects of candidate treatments in MDD. Two independent authors reviewed the studies and assessed their risk of bias with the Cochrane Collaboration׳s Risk of Bias tool. Twenty-eight eligible studies (24 biological and four psychological or behavioural studies) were identified...

  6. Predictors of treatment response for depression and inadequate social support--the ENRICHD randomized clinical trial.

    Science.gov (United States)

    Cowan, Marie J; Freedland, Kenneth E; Burg, Matthew M; Saab, Patrice G; Youngblood, Marston E; Cornell, Carol E; Powell, Lynda H; Czajkowski, Susan M

    2008-01-01

    To determine whether the 'dose' of treatment exposure, delivery of specific components of cognitive behavior therapy (CBT), patient adherence and/or use of antidepressants predict favorable depression and social support outcomes after 6 months of cognitive behavioral treatment. Secondary analyses of the intervention arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial involving persons with acute myocardial infarction (MI): n = 641 for the depression outcomes and n = 523 for the social support outcomes. The outcome measures were, for depression: the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HAM-D); for social support: the ENRICHD Social Support Instrument (ESSI) and Perceived Social Support Scale (PSSS). Better depression outcomes (measured by the BDI) were receiving a high number of depression-specific intervention components, p homework assignments, p homework assignments, p homework assignments, p homework assignments is important for both outcomes. Other components of the ENRICHD intervention that were designed to improve social support had no discernible effects on outcomes. Intervention refinements may be needed in order to achieve better results in future post-MI clinical trials. A greater emphasis on CBT homework adherence could improve both depression and social support outcomes. 2008 S. Karger AG, Basel

  7. Randomized trial of trigger point acupuncture treatment for chronic shoulder pain: a preliminary study.

    Science.gov (United States)

    Itoh, Kazunori; Saito, Shingo; Sahara, Shunsaku; Naitoh, Yuki; Imai, Kenji; Kitakoji, Hiroshi

    2014-04-01

    There is evidence for the efficacy of acupuncture treatment for chronic shoulder pain, but it remains unclear which acupuncture modes are most effective. We compared the effect of trigger point acupuncture (TrP), with that of sham (SH) acupuncture treatments, on pain and shoulder function in patients with chronic shoulder pain. The participants were 18 patients (15 women, 3 men; aged 42-65 years) with nonradiating shoulder pain for at least 6 months and normal neurological findings. The participants were randomized into two groups, each receiving five treatment sessions. The TrP group received treatment at trigger points for the muscle, while the other group received SH acupuncture treatment on the same muscle. Outcome measures were pain intensity (visual analogue scale, VAS) and shoulder function (Constant-Murley Score: CMS). After treatment, pain intensity between pretreatment and 5 weeks after TrP decreased significantly (pShoulder function also increased significantly between pretreatment and 5 weeks after TrP (pshoulder pain. Copyright © 2014. Published by Elsevier B.V.

  8. Extension traction treatment for patients with discogenic lumbosacral radiculopathy: a randomized controlled trial.

    Science.gov (United States)

    Moustafa, Ibrahim M; Diab, Aliaa A

    2013-01-01

    To investigate the effects of lumbar extension traction in patients with unilateral lumbosacral radiculopathy due to L5-S1 disc herniation. A randomized controlled study with six-month follow-up. University research laboratory. Sixty-four patients with confirmed unilateral lumbosacral radiculopathy due to L5-S1 disc herniation and a lumbar lordotic angle less than 39°, randomly assigned to traction or control group. The control group (n = 32) received hot packs and interferential therapy, whereas the traction group (n = 32) received lumbar extension traction in addition to hot packs and interferential therapy. Absolute rotatory angle, back and leg pain rating scale, Oswestry Disability Index, Modified Schober test, H-reflex (latency and amplitude) and intervertebral movements were measured for all patients three times (before treatment, after 10 weeks of treatment and at six-month follow-up). There was a significant difference between the traction group and the control group adjusted to baseline values at 10 weeks post treatment with respect to: absolute rotatory angle (P traction group receiving lumbar extension traction in addition to hot packs and interferential therapy had better effects than the control group with regard to pain, disability, H-reflex parameters and segmental intervertebral movements.

  9. Randomized Trial of a Hypnosis Intervention for Treatment of Hot Flashes Among Breast Cancer Survivors

    Science.gov (United States)

    Elkins, Gary; Marcus, Joel; Stearns, Vered; Perfect, Michelle; Rajab, M. Hasan; Ruud, Christopher; Palamara, Lynne; Keith, Timothy

    2008-01-01

    Purpose Hot flashes are a significant problem for many breast cancer survivors. Hot flashes can cause discomfort, disrupted sleep, anxiety, and decreased quality of life. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. On the basis of previous case studies, this study was developed to evaluate the effect of a hypnosis intervention for hot flashes. Patients and Methods Sixty female breast cancer survivors with hot flashes were randomly assigned to receive hypnosis intervention (five weekly sessions) or no treatment. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least 1 month. The major outcome measure was a bivariate construct that represented hot flash frequency and hot flash score, which was analyzed by a classic sums and differences comparison. Secondary outcome measures were self-reports of interference of hot flashes on daily activities. Results Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency × average severity) decreased 68% from baseline to end point in the hypnosis arm (P hypnosis intervention (P Hypnosis appears to reduce perceived hot flashes in breast cancer survivors and may have additional benefits such as reduced anxiety and depression, and improved sleep. PMID:18809612

  10. Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Kwan-Il; Nam, Hae Jeong; Kim, Mia; Lee, Junhee; Kim, Kyuseok

    2017-06-17

    The incidence of preadolescent acne among women is increasing. Acne deteriorates the quality of life; conventional treatment options are limited and have not been effective against acne, particularly acne associated with menstruation. Despite evidence that acne associated with menstruation abnormalities naturally improves when menstruation recovers to normal, there have only been few studies on the effects of dysmenorrhea treatment on acne. Therefore- we designed this study to assess the effects of gyejibokryung-hwan (GBH) and dangguijagyag-san (DJS), which are widely used in dysmenorrhea treatment, on acne associated with menstruation cycle. This is a protocol for a randomized, double-blind, parallel-group, placebo-controlled and multicenter trial. One hundred and sixteen participants with dysmenorrhea accompanied by acne vulgaris will be recruited at three centers and randomized into two groups, the herbal treatment group and placebo group. The participants will receive GBH or DJS based on pattern identification or placebo granules thrice daily for 8 weeks, with an 8-week follow up. The primary outcome will be the mean percentage change in the count of inflammatory acne lesions. The secondary outcomes would be based on dysmenorrhea numeric rating scale, verbal multidimensional scoring system for dysmenorrhea, acne numeric rating scale, investigator's static global assessment scale of facial acne vulgaris, and safety testing. Adverse events will also be reported. The effects of GBH or DJS used in dysmenorrhea treatment on acne associated with the menstrual cycle will be evaluated. The findings of this trial will provide evidence regarding the effect of herbal medicine in improving acne vulgaris associated with menstruation in women. Korean Clinical Trial Registry ( http://cris.nih.go.kr ; registration number: KCT0002259). Date of registration: March 10, 2017.

  11. Health extension workers improve tuberculosis case detection and treatment success in southern Ethiopia: a community randomized trial.

    Directory of Open Access Journals (Sweden)

    Daniel G Datiko

    Full Text Available BACKGROUND: One of the main strategies to control tuberculosis (TB is to find and treat people with active disease. Unfortunately, the case detection rates remain low in many countries. Thus, we need interventions to find and treat sufficient number of patients to control TB. We investigated whether involving health extension workers (HEWs: trained community health workers in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia. METHODOLOGY/PRINCIPAL FINDING: We carried out a community-randomized trial in southern Ethiopia from September 2006 to April 2008. Fifty-one kebeles (with a total population of 296, 811 were randomly allocated to intervention and control groups. We trained HEWs in the intervention kebeles on how to identify suspects, collect sputum, and provide directly observed treatment. The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts. Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles. The mean case detection rate was higher in the intervention than in the control kebeles (122.2% vs 69.4%, p<0.001. In addition, more females patients were identified in the intervention kebeles (149.0 vs 91.6, p<0.001. The mean treatment success rate was higher in the intervention than in the control kebeles (89.3% vs 83.1%, p = 0.012 and more for females patients (89.8% vs 81.3%, p = 0.05. CONCLUSIONS/SIGNIFICANCE: The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate, possibly because of an improved service access. This could be applied in settings with low health service coverage and a shortage of health workers. TRIAL REGISTRATION: ClinicalTrials.gov NCT00803322.

  12. Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

    Science.gov (United States)

    Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

    2015-01-01

    The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. © 2015 by the Wound Healing Society.

  13. Preschool-based social communication treatment for children with autism: 12-month follow-up of a randomized trial.

    Science.gov (United States)

    Kaale, Anett; Fagerland, Morten W; Martinsen, Egil W; Smith, Lars

    2014-02-01

    This study reports 12-month follow-up data from a randomized controlled trial of preschool-based social communication treatment for young children with autism. A total of 61 children (48 males) with autism, 29 to 60 months of age, had earlier been randomized either to 8 weeks of preschool-based social communication treatment in addition to standard preschool program (n = 34) or to standard preschool program only (n = 27). Significant short-term effects on targeted social communication skills have previously been published. Long-term gains in social communication, language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions, Early Social Communication Scales, Reynell Developmental Language Scale, and Social Communication Questionnaire. Compared with those in the control group, the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up. However, no effects were detected on language and global ratings of social functioning and communication. The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline, whereas nonverbal IQ and expressive language had no moderating effect. This study is the first to show that, similar to specialist-delivered treatment, preschool-based treatment may produce small but possibly clinically important long-term changes in social communication in young children with autism. The treatment did not affect language and global ratings of social functioning and communication. More studies are needed to better understand whether treatment effects may be improved by increasing the intensity and duration of the treatment. Clinical trial registration information--Joint Attention Intervention and Young Children With Autism; http://clinicaltrials.gov/; NCT00378157. Copyright © 2014 American Academy of Child and Adolescent Psychiatry

  14. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial.

    Science.gov (United States)

    Botella, Cristina; Pérez-Ara, M Ángeles; Bretón-López, Juana; Quero, Soledad; García-Palacios, Azucena; Baños, Rosa María

    2016-01-01

    Although in vivo exposure is the treatment of choice for specific phobias, some acceptability problems have been associated with it. Virtual Reality exposure has been shown to be as effective as in vivo exposure, and it is widely accepted for the treatment of specific phobias, but only preliminary data are available in the literature about the efficacy of Augmented Reality. The purpose of the present study was to examine the efficacy and acceptance of two treatment conditions for specific phobias in which the exposure component was applied in different ways: In vivo exposure (N = 31) versus an Augmented Reality system (N = 32) in a randomized controlled trial. "One-session treatment" guidelines were followed. Participants in the Augmented Reality condition significantly improved on all the outcome measures at post-treatment and follow-ups. When the two treatment conditions were compared, some differences were found at post-treatment, favoring the participants who received in vivo exposure. However, these differences disappeared at the 3- and 6-month follow-ups. Regarding participants' expectations and satisfaction with the treatment, very positive ratings were reported in both conditions. In addition, participants from in vivo exposure condition considered the treatment more useful for their problem whereas participants from Augmented Reality exposure considered the treatment less aversive. Results obtained in this study indicate that Augmented Reality exposure is an effective treatment for specific phobias and well accepted by the participants.

  15. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Cristina Botella

    Full Text Available Although in vivo exposure is the treatment of choice for specific phobias, some acceptability problems have been associated with it. Virtual Reality exposure has been shown to be as effective as in vivo exposure, and it is widely accepted for the treatment of specific phobias, but only preliminary data are available in the literature about the efficacy of Augmented Reality. The purpose of the present study was to examine the efficacy and acceptance of two treatment conditions for specific phobias in which the exposure component was applied in different ways: In vivo exposure (N = 31 versus an Augmented Reality system (N = 32 in a randomized controlled trial. "One-session treatment" guidelines were followed. Participants in the Augmented Reality condition significantly improved on all the outcome measures at post-treatment and follow-ups. When the two treatment conditions were compared, some differences were found at post-treatment, favoring the participants who received in vivo exposure. However, these differences disappeared at the 3- and 6-month follow-ups. Regarding participants' expectations and satisfaction with the treatment, very positive ratings were reported in both conditions. In addition, participants from in vivo exposure condition considered the treatment more useful for their problem whereas participants from Augmented Reality exposure considered the treatment less aversive. Results obtained in this study indicate that Augmented Reality exposure is an effective treatment for specific phobias and well accepted by the participants.

  16. Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial.

    Directory of Open Access Journals (Sweden)

    Gustavo Adolfo Sierra Romero

    2017-06-01

    Full Text Available There is insufficient evidence to support visceral leishmaniasis (VL treatment recommendations in Brazil and an urgent need to improve current treatments. Drug combinations may be an option.A multicenter, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of (i amphotericin B deoxycholate (AmphoB (1 mg/kg/day for 14 days, (ii liposomal amphotericin B (LAMB (3 mg/kg/day for 7 days and (iii a combination of LAMB (10 mg/kg single dose plus meglumine antimoniate (MA (20 mg Sb+5/kg/day for 10 days, compared to (iv standard treatment with MA (20 mg Sb+5/kg/day for 20 days. Patients, aged 6 months to 50 years, with confirmed VL and without HIV infection were enrolled in the study. Primary efficacy endpoint was clinical cure at 6 months. A planned efficacy and safety interim analysis led to trial interruption.378 patients were randomized to the four treatment arms: MA (n = 112, AmphoB (n = 45, LAMB (n = 109, or LAMB plus MA (n = 112. A high toxicity of AmphoB prompted an unplanned interim safety analysis and this treatment arm was dropped. Per intention-to-treat protocol final analyses of the remaining 332 patients show cure rates at 6 months of 77.5% for MA, 87.2% for LAMB, and 83.9% for LAMB plus MA, without statistically significant differences between the experimental arms and comparator (LAMB: 9.7%; CI95% -0.28 to 19.68, p = 0.06; LAMB plus MA: 6.4%; CI95% -3.93 to 16.73; p = 0.222. LAMB monotherapy was safer than MA regarding frequency of treatment-related adverse events (AE (p = 0.045, proportion of patients presenting at least one severe AE (p = 0.029, and the proportion of AEs resulting in definitive treatment discontinuation (p = 0.003.Due to lower toxicity and acceptable efficacy, LAMB would be a more suitable first line treatment for VL than standard treatment. ClinicalTrials.gov identification number: NCT01310738.ClinicalTrials.gov NCT01310738.

  17. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Lisa Conboy

    Full Text Available Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists.This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52 or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52. Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P and the secondary outcome is the McGill Pain scale.Of the 104 subjects who underwent randomization, 85 completed the protocol (82%. A clinically and statistically significant average improvement of 9.4 points (p = 0.03 in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04 compared to group 2.Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.ClinicalTrials.gov NCT01305811.

  18. Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET: Study protocol for a randomized phase II trial

    Directory of Open Access Journals (Sweden)

    Palma David A

    2012-07-01

    Full Text Available Abstract Background Stereotactic ablative radiotherapy (SABR has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control. Survival outcomes for patients with oligometastatic disease treated with SABR appear promising, but conclusions are limited by patient selection, and the lack of adequate controls in most studies. The goal of this multicenter randomized phase II trial is to assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone. Methods After stratification by the number of metastases (1-3 vs. 4-5, patients will be randomized between Arm 1: current standard of care treatment, and Arm 2: standard of care treatment + SABR to all sites of known disease. Patients will be randomized in a 1:2 ratio to Arm 1:Arm 2, respectively. For patients receiving SABR, radiotherapy dose and fractionation depends on the site of metastasis and the proximity to critical normal structures. This study aims to accrue a total of 99 patients within four years. The primary endpoint is overall survival, and secondary endpoints include quality of life, toxicity, progression-free survival, lesion control rate, and number of cycles of further chemotherapy/systemic therapy. Discussion This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with oligometastatic disease, and will inform the design of a possible phase III study. Trial registration Clinicaltrials.gov identifier: NCT01446744

  19. Intravaginal stimulation randomized trial.

    Science.gov (United States)

    Smith, J J

    1996-01-01

    The effectiveness of intravaginal electrical stimulation was compared to standard therapy in the treatment of genuine stress urinary incontinence and detrusor instability. A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment. Of the women 18 with stress urinary incontinence were randomized to electrical stimulation or Kegel exercise and 38 with detrusor instability were randomized to anticholinergic therapy or electrical stimulation. Of patients using electrical stimulation in the stress urinary incontinence group 66% improved and 72% of the patients with detrusor instability treated with electrical stimulation improved. These rates were not statistically significant when compared to traditional therapy. Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability.

  20. Cognitive behaviour therapy for chronic fatigue syndrome in adults: face to face versus telephone treatment: a randomized controlled trial.

    Science.gov (United States)

    Burgess, Mary; Andiappan, Manoharan; Chalder, Trudie

    2012-03-01

    Previous research has shown that face to face cognitive behaviour therapy (CBT) is an effective treatment for chronic fatigue syndrome (CFS)/Myalgic Encephalomyelitis (ME). However, some patients are unable to travel to the hospital for a number of reasons. The aim of this study was to assess whether face to face CBT was more effective than telephone CBT (with face to face assessment and discharge appointment) for patients with CFS. Patients aged 18-65 were recruited from consecutive referrals to the Chronic Fatigue Syndrome (CFS) Research and Treatment Unit at The South London and Maudsley NHS Trust in London. Participants were randomly allocated to either face to face CBT or telephone CBT by a departmental administrator. Blinding of participants and care givers was inappropriate for this trial. A parallel-groups randomised controlled trial was used to compare the two treatments. The primary outcomes were physical functioning and fatigue. Significant improvements in the primary outcomes of physical functioning and fatigue occurred and were maintained to one year follow-up after discharge from treatment. Improvements in social adjustment and global outcome were noted and patient satisfaction was similar in both groups. Results from this study indicate that telephone CBT with two face to face appointments is a mild to moderately effective treatment for CFS and may be offered to patients where face to face treatment is not a viable option. Despite these encouraging conclusions, dropout was relatively high and therapists should be aware of this potential problem.

  1. Treatment of severe fear of childbirth with haptotherapy: design of a multicenter randomized controlled trial.

    Science.gov (United States)

    Klabbers, Gert A; Wijma, Klaas; Paarlberg, K Marieke; Emons, Wilco Hm; Vingerhoets, Ad Jjm

    2014-10-08

    About six percent of pregnant women suffer from severe fear of childbirth. These women are at increased risk of obstetric labour and delivery interventions and pre- and postpartum complications, e.g., preterm delivery, emergency caesarean section, caesarean section at maternal request, severe postpartum fear of childbirth and trauma anxiety. During the last decade, there is increasing clinical evidence suggesting that haptotherapy might be an effective intervention to reduce fear of childbirth in pregnant women. The present study has been designed to evaluate the effects of such intervention. Included are singleton pregnant women with severe fear of childbirth, age ≥ 18 year, randomised into three arms: (1) treatment with haptotherapy, (2) internet psycho-education or (3) care as usual. The main study outcome is fear of childbirth. Measurements are taken at baseline in gestation week 20-24, directly after the intervention is completed in gestation week 36, six weeks postpartum and six months postpartum. Secondary study outcomes are distress, general anxiety, depression, somatization, social support, mother-child bonding, pregnancy and delivery complications, traumatic anxiety symptoms, duration of delivery, birth weight, and care satisfaction. The treatment, a standard haptotherapeutical treatment for pregnant women with severe fear of childbirth, implies teaching a combination of skills in eight one hour sessions. The internet group follows an eight-week internet course containing information about pregnancy and childbirth comparable to childbirth classes. The control group has care as usual according to the standards of the Royal Dutch Organisation of Midwives and the Dutch Organization of Obstetrics and Gynaecology. This trial was entered in the Dutch Trial Register and registered under number NTR3339 on March 4th, 2012.

  2. Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ewald, H; Kirby, J; Rees, K; Robertson, W

    2014-09-01

    An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Short-term perioperative treatment with ambroxol reduces pulmonary complications and hospital costs after pulmonary lobectomy: a randomized trial.

    Science.gov (United States)

    Refai, Majed; Brunelli, Alessandro; Xiumé, Francesco; Salati, Michele; Sciarra, Valeria; Socci, Laura; Di Nunzio, Luca; Sabbatini, Armando

    2009-03-01

    To assess in a randomized clinical trial the influence of perioperative short-term ambroxol administration on postoperative complications, hospital stay and costs after pulmonary lobectomy for lung cancer. One hundred and forty consecutive patients undergoing lobectomy for lung cancer (April 2006-November 2007) were randomized in two groups. Group A (70 patients): ambroxol was administered by intravenous infusion in the context of the usual therapy on the day of operation and on the first 3 postoperative days (1000 mg/day). Group B (70 patients): fluid therapy only without ambroxol. Groups were compared in terms of occurrence of postoperative complications, length of stay and costs. There were no dropouts from either group and no complications related to treatment. The two groups were well matched for perioperative and operative variables. Compared to group B, group A (ambroxol) had a reduction of postoperative pulmonary complications (4 vs 13, 6% vs 19%, p=0.02), and unplanned ICU admission/readmission (1 vs 6, 1.4% vs 8.6%, p=0.1) rates. Moreover, the postoperative stay and costs were reduced by 2.5 days (5.6 vs 8.1, p=0.02) and 2765 Euro (2499 Euro vs 5264 Euro, p=0.04), respectively. Short-term perioperative treatment with ambroxol improved early outcome after lobectomy and may be used to implement fast-tracking policies and cut postoperative costs. Nevertheless, other independent trials are needed to verify the effect of this treatment in different settings.

  4. On the covariate-adjusted estimation for an overall treatment difference with data from a randomized comparative clinical trial.

    Science.gov (United States)

    Tian, Lu; Cai, Tianxi; Zhao, Lihui; Wei, Lee-Jen

    2012-04-01

    To estimate an overall treatment difference with data from a randomized comparative clinical study, baseline covariates are often utilized to increase the estimation precision. Using the standard analysis of covariance technique for making inferences about such an average treatment difference may not be appropriate, especially when the fitted model is nonlinear. On the other hand, the novel augmentation procedure recently studied, for example, by Zhang and others (2008. Improving efficiency of inferences in randomized clinical trials using auxiliary covariates. Biometrics 64, 707-715) is quite flexible. However, in general, it is not clear how to select covariates for augmentation effectively. An overly adjusted estimator may inflate the variance and in some cases be biased. Furthermore, the results from the standard inference procedure by ignoring the sampling variation from the variable selection process may not be valid. In this paper, we first propose an estimation procedure, which augments the simple treatment contrast estimator directly with covariates. The new proposal is asymptotically equivalent to the aforementioned augmentation method. To select covariates, we utilize the standard lasso procedure. Furthermore, to make valid inference from the resulting lasso-type estimator, a cross validation method is used. The validity of the new proposal is justified theoretically and empirically. We illustrate the procedure extensively with a well-known primary biliary cirrhosis clinical trial data set.

  5. Meta-analysis of randomized trials comparing fusion surgery to non-surgical treatment for discogenic chronic low back pain.

    Science.gov (United States)

    Wang, Xin; Wanyan, Pingping; Tian, Jin Hui; Hu, Long

    2015-01-01

    Chronic low back pain causes socioeconomic burdens. Whether lumbar fusion is more effective than nonsurgical treatment of discogenic low back pain (DLBP) is controversial. Several randomized controlled trials that compared conservative treatment and fusion surgery had conflicting conclusions. To compare between the effectiveness of lumbar fusion and nonsurgical intervention in patients with chronic low back pain caused by disc degeneration. PubMed, the Cochrane Library, EMBASE, the Science Citation Index, Chinese Biomedical Literature Database, and references of relevant papers published from 1990 to 2013 were searched. Related data matching standards established for this research were extracted and statistically analyzed by using the RevMan (5.2) software. Meta-analysis of 6 randomized controlled trials with a total of 889 patients revealed no difference in Oswestry Disability Index (ODI) score for DLBP between the fusion surgery and nonsurgical groups (mean difference, 1.94; 95% confidence interval [CI], -6.02 to 2.14). Postsurgical complication rate significantly differed between the 2 groups (risk ratio, 22.11; 95% CI, 55.99-81.60). Fusion surgery was not superior to nonsurgical treatment in terms of changes in ODI scores for DLBP. Fusion surgery resulted in surgical complications. Longer follow-up observation is necessary regarding condition-specific disability, pain, and life satisfaction.

  6. Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment

    DEFF Research Database (Denmark)

    Gottrup, Finn; Cullen, Breda Mary; Karlsmark, Tonny

    2013-01-01

    Collagen/oxidized regenerated cellulose (ORC)/silver therapy has been designed to facilitate wound healing by normalizing the microenvironment and correcting biochemical imbalances in chronic wounds. The aim of this study was to compare collagen/ORC/silver therapy to control (standard treatment......). Patients with diabetic foot ulcers were randomized to either collagen/ORC/silver (24) or control treatment (15). Wound area measurements and wound fluid samples were taken weekly. Protease levels were measured in wound fluid samples to investigate differences between responders (≥50% reduction in wound...... area by week 4) and nonresponders (wound area by week 4). There were significantly more responders in the collagen/ORC/silver group compared with the control group (79% vs. 43%, p = 0.035). There were significantly fewer withdrawals from the study because of infection in the collagen...

  7. An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Campos, Daniel; Bretón-López, Juana; Botella, Cristina; Mira, Adriana; Castilla, Diana; Baños, Rosa; Tortella-Feliu, Miquel; Quero, Soledad

    2016-08-20

    Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the Internet, increasing their advantages and reaching more people in need. The Internet has been established as an effective way to treat a wide range of mental disorders. However, as far as we know, no controlled studies exist on FP treatment via the Internet. This study aims to evaluate the efficacy of an Internet-based treatment for FP (NO-FEAR Airlines) versus a waiting list control group. Secondary objectives will be to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance, and study the patients' acceptance of the program. This paper presents the study protocol. The study is a randomized controlled trial. A minimum of 57 participants will be randomly assigned to three conditions: a) NO-FEAR Airlines totally self-applied, b) NO-FEAR Airlines with therapist guidance, or c) a waiting list control group (6 weeks). Primary outcomes measures will be the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes will be included to assess other relevant clinical measures, such as the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Analyses of post-treatment flights will be conducted. Treatment acceptance and preference measures will also be included. Intention-to-treat and per protocol analyses will be

  8. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial.

    Science.gov (United States)

    Lancee, Jaap; van Straten, Annemieke; Morina, Nexhmedin; Kaldo, Viktor; Kamphuis, Jan H

    2016-01-01

    To compare the efficacy of guided online and individual face-to-face cognitive behavioral treatment for insomnia (CBT-I) to a wait-list condition. A randomized controlled trial comparing three conditions: guided online; face-to-face; wait-list. Posttest measurements were administered to all conditions, along with 3- and 6-mo follow-up assessments to the online and face-to-face conditions. Ninety media-recruited participants meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia were randomly allocated to either guided online CBT-I (n = 30), individual face-to-face CBT-I (n = 30), or wait-list (n = 30). At post-assessment, the online (Cohen d = 1.2) and face-to-face (Cohen d = 2.3) intervention groups showed significantly larger treatment effects than the wait-list group on insomnia severity (insomnia severity index). Large treatment effects were also found for the sleep diary estimates (except for total sleep time), and anxiety and depression measures (for depression only in the face-to-face condition). Face-to-face treatment yielded a statistically larger treatment effect (Cohen d = 0.9) on insomnia severity than the online condition at all time points. In addition, a moderate differential effect size favoring face-to-face treatment emerged at the 3- and 6-mo follow-up on all sleep diary estimates. Face-to-face treatment further outperformed online treatment on depression and anxiety outcomes. These data show superior performance of face-to-face treatment relative to online treatment. Yet, our results also suggest that online treatment may offer a potentially cost-effective alternative to and complement face-to-face treatment. Clinicaltrials.gov, NCT01955850. A commentary on this article appears in this issue on page 13. © 2016 Associated Professional Sleep Societies, LLC.

  9. Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain: A Randomized Controlled Trial

    Science.gov (United States)

    Licciardone, John C.; Minotti, Dennis E.; Gatchel, Robert J.; Kearns, Cathleen M.; Singh, Karan P.

    2013-01-01

    PURPOSE We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. METHODS A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. RESULTS There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. CONCLUSIONS The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients. PMID:23508598

  10. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Licciardone, John C; Minotti, Dennis E; Gatchel, Robert J; Kearns, Cathleen M; Singh, Karan P

    2013-01-01

    We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

  11. Internet-Based Exercise Therapy Using Algorithms for Conservative Treatment of Anterior Knee Pain: A Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Tae Won Benjamin; Gay, Nic; Khemka, Arpit; Garino, Jonathan

    2016-12-14

    Conservative treatment remains the first-line option, and there is significant medical evidence showing that home-based exercise therapy for the treatment of common causes of knee pain is effective. SimpleTherapy created an online platform that delivers Internet-based exercise therapy for common causes of knee pain. The system is driven by an algorithm that can process the user's feedback to provide an adaptive exercise regimen. This triple-armed, pragmatic randomized pilot was designed to evaluate if this telerehabilitation platform is safe and effective. We hypothesized that a home-based, algorithm-driven exercise therapy program can be safe for use and even improve compliance over the standard of care, the paper handout. After an independent internal review board review and approval, the website trial.simpletherapy.com was opened. Once the trial was open for enrollment, no changes to the functionality or user interaction features were performed until the trial had closed. User accrual to the website was done using website optimization and social media postings tied to existence of knee pain. Consent was obtained online through checkboxes with third-party signature confirmation. No fees were charged to any patient. Patients were recruited online from an open access website. Outcomes were self-assessed through questionnaires with no face-to-face clinician interaction. A triple-arm randomized controlled trial was used with arm 1 being a static handout of exercises, arm 2 being a video version of arm 1, and arm 3 being a video-based, algorithm-driven system that took patient feedback and changed the exercises based on the feedback. Patients used household items and were not supervised by a physical therapist or clinician. Patients were reminded at 48-hour intervals to complete an exercise session. A total of 860 users found the trial and initiated the registration process. These 860 were randomized, and the demographic distribution shows the randomization was

  12. Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial.

    Science.gov (United States)

    van Dam, Debora; Ehring, Thomas; Vedel, Ellen; Emmelkamp, Paul M G

    2013-06-19

    This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was added on to Treatment As Usual (TAU), consisting of an intensive cognitive behavioral inpatient or day group treatment for SUD. The outcomes of the combined treatment (TAU + SWT) were compared to TAU alone in a sample of 34 patients. Results showed a general reduction of SUD symptoms for both TAU + SWT and TAU. Treatment superiority of TAU + SWT was neither confirmed by interaction effects (time x condition) for SUD or PTSD symptoms, nor by a group difference for SUD diagnostic status at post-treatment. However, planned contrasts revealed that improvements for PTSD severity over time were only significant within the TAU + SWT group. In addition, within the TAU + SWT group the remission of PTSD diagnoses after treatment was significant, which was not the case for TAU. Finally, at post-treatment a trend was noticed for between group differences for the number of PTSD diagnoses favoring TAU + SWT above TAU. In sum, the current study provides preliminary evidence that adding a trauma-focused treatment on to standard SUD treatment may be beneficial.

  13. Improving the Multidisciplinary Treatment of Chronic Pain by Stimulating Body Awareness: A Cluster-randomized Trial.

    Science.gov (United States)

    Van der Maas, Lia C C; Köke, Albère; Pont, Menno; Bosscher, Ruud J; Twisk, Jos W R; Janssen, Thomas W J; Peters, Madelon L

    2015-07-01

    Because of methodological flaws and a lack of theoretical foundation of body awareness (BA) in previous effect studies of interventions directed to stimulate BA, it is impossible to attribute treatment effects to this specific component of a multidisciplinary treatment. Therefore, this study evaluated short-term and long-term effects of a multidisciplinary pain rehabilitation program with and without psychomotor therapy (PMT), which focused on BA (measured by the scale of body connection) as a primary target of intervention. Ninety-four patients clustered in 20 treatment groups were cluster randomized, using a biased-coin design, to multidisciplinary treatment as usual with or without PMT. Outcome variables were health-related quality of life, disability, and depression. BA, catastrophizing, and self-efficacy were measured as potential process variables. Assessments were performed at baseline, directly after treatment, and at 3, 6, and 12 month follow-ups. The data were analyzed by linear mixed-model analysis according to the intention-to-treat principle. Data of all 94 patients were used for analyses. After treatment, significant differences favoring PMT were found between conditions on depression (regression coefficient [RC]=-5.01; 95% confidence interval [CI], -8.81 to -1.21), BA (RC=0.23; 95% CI, 0.04 to 0.42) and catastrophizing (RC=-4.76; 95% CI, -8.03 to -1.48). These differences were no longer significant for depression at the 3-month follow-up and for catastrophizing at the 6-month follow-up. No clinical meaningful differences were found between treatment conditions in the primary outcome measures health-related quality of life and disability. However, this is the first long-term RCT that has shown that PMT improves BA in patients with chronic pain and shows good effect size and a significant decrease for catastrophizing.

  14. Topical terbinafine in the treatment of cutaneous leishmaniasis: triple blind randomized clinical trial.

    Science.gov (United States)

    Farajzadeh, Saeedeh; Heshmatkhah, Amireh; Vares, Behrooz; Mohebbi, Elham; Mohebbi, Azadeh; Aflatoonian, Mahin; Eybpoosh, Sana; Sharifi, Iraj; Aflatoonian, Mohammad Reza; Shamsi Meymandi, Simin; Fekri, Ali Reza; Mostafavi, Mahshid

    2016-12-01

    Leishmaniasis is a spectrum of disease condition with considerable health impacts, caused by different species of Leishmania . This disease is currently endemic in 98 countries and territories in the world. There are many treatment modalities for cutaneous leishmaniasis. The use of topical terbinafine in the treatment of cutaneous leishmaniasis has recently been considered. Eighty-eight participants more than two years old with proven acute CL by a positive direct smear were randomly allocated to one of the two study arms: first group received meglumine antimoniate (Glucantime) 20 mg/kg/day intramuscular injection (IM) plus a placebo ointment (Mahan Vaseline) for 20 days. The second group received meglumine antimoniate (Glucantime) 20 mg/kg/day IM plus topical terbinafine, for 20 days and were monitored closely by dermatologist during the course of the study. Crude regression analysis showed that there was no significant difference between placebo and intervention group regarding partial or complete treatment (partial treatment: HR crude  = 1.1, CI 95 % = 0.7-1.7; complete treatment: HR crude  = 1.1, CI 95 % = 0.8-1.7). Although, there was no statistically significant different between the two treatment groups, but clinically it seems that the treatment rate in those who receive glucantime plus terbinafine was more effective than the other group. However this rate depended on the type of lesions. As data indicated ulcerated nodules, papules and plaque in experimental group have been completely improved two times faster than placebo group. Ulcerated nodules, nodules and plaque were partially improved faster in those used tebinafine than placebo ointment.

  15. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273

    Directory of Open Access Journals (Sweden)

    Zhao Peng

    2002-05-01

    Full Text Available Abstract Background Etoricoxib is a highly selective COX-2 inhibitor which was evaluated for the treatment of rheumatoid arthritis (RA. Methods Double-blind, randomized, placebo and active comparator-controlled, 12-week study conducted at 67 sites in 28 countries. Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of prestudy NSAIDs. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio. Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints, and patient and investigator global assessments of disease activity. Key secondary measures included the Stanford Health Assessment Questionnaire, patient global assessment of pain, and the percentage of patients who achieved ACR20 responder criteria response (a composite of pain, inflammation, function, and global assessments. Tolerability was assessed by adverse events and routine laboratory evaluations. Results 1171 patients were screened, 891 patients were randomized (N = 357 for placebo, N = 353 for etoricoxib, and N = 181 for naproxen, and 687 completed 12 weeks of treatment (N = 242 for placebo, N = 294 for etoricoxib, and N = 151 for naproxen. Compared with patients receiving placebo, patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints (p Conclusions In this study, etoricoxib 90 mg once daily was more effective than placebo and similar in efficacy to naproxen 500 mg twice daily for treating patients with RA over 12 weeks. Etoricoxib 90 mg was generally well tolerated in RA patients.

  16. A Randomized Controlled Trial of Two Syntactic Treatment Procedures With Cantonese-Speaking, School-Age Children With Language Disorders.

    Science.gov (United States)

    To, Carol K S; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y H

    2015-08-01

    In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment arm. Seven children did not receive treatment as assigned. Intervention in both arms targeted the same complex syntactical structures. The SC group focused on sentence combination training, whereas the NAR group made use of narratives in which the target structures were embedded. Pretest and posttest performances measured using a standardized language assessment were subjected to analyses of covariance mixed-effect-model analyses of variance. Children in both treatment arms demonstrated significant growth after 4 months of intervention. The main effect between treatment arms and time was not significant after controlling the pretest performance, suggesting that both treatment approaches showed similar effects. The main effect of time was significant. This study provided evidence to support language intervention in the school years in Cantonese-speaking children. However, neither approach was shown to be more efficacious than the other. Future researchers could examine the effects of a longer treatment period and include functional outcome measures.

  17. Efficacy and safety of oral tinidazole and metronidazole in treatment of bacterial vaginosis: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Zahra Abbaspoor

    2014-05-01

    Full Text Available Aims: Oral metronidazole 500 mg twice a day for one week is currently the treatment of choice for bacterial vaginosis (BV. Complete treatment by this regimen takes time and occurs less often. This drug has significant side effects too. Using a drug in the shortest treatment course may increases the success of treatment. To evaluate the effectiveness and safety of oral tinidazole compare to metronidazole in treatment of BV.Methods: In this randomized, controlled, double-blind, comparative, clinical trial, 110 non-pregnant women aged between 15-45 years with confirmed diagnosis of BV by Amsels criteria were randomly assigned to receive either 2 g tinidazole tablet once daily for 2 days (n=55 or 500 mg metronidazole table twice daily for 7 days (n=55.The cure and recurrence rate were evaluated in both groups after 2 and 4 weeks follow up visits. For statistical analysis t-test,   test, fisher's exact test and Mann-Whitney test were used.Results: The results showed that cure rate after 2 weeks in tinidazole tablet group was 84.6٪ and in metronidazole group was 85.4٪ (p=0.9, and after 4 weeks recurrence rate in tinidazole and metronidazole groups was 6.9٪and 12.1٪respectively (P=0.3.Conclusions: Tinidazole table 2 g once daily for 2 days is as effective as metronidazole tablet 500 mg twice a day for 7 days in treatment of BV.

  18. Memantine as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ghaleiha, Ali; Asadabadi, Mahtab; Mohammadi, Mohammad-Reza; Shahei, Maryam; Tabrizi, Mina; Hajiaghaee, Reza; Hassanzadeh, Elmira; Akhondzadeh, Shahin

    2013-05-01

    Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication. It is also associated with ritualistic and stereotypical behaviour. Recent studies propose both hyper-and hypoglutamatergic ideologies for autism. The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism. Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d. Children were assessed at baseline and after 2, 4, 6, 8 and 10 wk of starting medication protocol. The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist-Community (ABC-C). Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability, stereotypic behaviour and hyperactivity. Eight side-effects were observed over the trial, out of the 25 side-effects that the checklist included. The difference between the two groups in the frequency of side-effects was not significant. The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated. This trial is registered with the Iranian Clinical Trials Registry (IRCT1138901151556N10; www.irct.ir).

  19. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  20. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel.

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-02-01

    Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in 'Pain Now' for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less 'Pain Now' and 'Pain Typical' at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on 'Pain at Best' sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.

  1. Efficient treatment allocation in 2 × 2 cluster randomized trials, when costs and variances are heterogeneous.

    Science.gov (United States)

    Lemme, Francesca; van Breukelen, Gerard J P; Berger, Martijn P F

    2016-10-30

    Typically, clusters and individuals in cluster randomized trials are allocated across treatment conditions in a balanced fashion. This is optimal under homogeneous costs and outcome variances. However, both the costs and the variances may be heterogeneous. Then, an unbalanced allocation is more efficient but impractical as the outcome variance is unknown in the design stage of a study. A practical alternative to the balanced design could be a design optimal for known and possibly heterogeneous costs and homogeneous variances. However, when costs and variances are heterogeneous, both designs suffer from loss of efficiency, compared with the optimal design. Focusing on cluster randomized trials with a 2 × 2 design, the relative efficiency of the balanced design and of the design optimal for heterogeneous costs and homogeneous variances is evaluated, relative to the optimal design. We consider two heterogeneous scenarios (two treatment arms with small, and two with large, costs or variances, or one small, two intermediate, and one large costs or variances) at each design level (cluster, individual, and both). Within these scenarios, we compute the relative efficiency of the two designs as a function of the extents of heterogeneity of the costs and variances, and the congruence (the cheapest treatment has the smallest variance) and incongruence (the cheapest treatment has the largest variance) between costs and variances. We find that the design optimal for heterogeneous costs and homogeneous variances is generally more efficient than the balanced design and we illustrate this theory on a trial that examines methods to reduce radiological referrals from general practices. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

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    Poeze Martijn

    2011-05-01

    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

  3. Randomized controlled trial of compact fluorescent lamp versus standard phototherapy for the treatment of neonatal hyperbilirubinemia.

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    Sarin, Monica; Dutta, Sourabh; Narang, Anil

    2006-07-01

    Special blue tube lights of standard length are used in most neonatal units to deliver phototherapy. Of late, special blue compact fluorescent lamp phototherapy equipments have been introduced in India, which are claimed to be better than standard tube lights. To compare special blue compact fluorescent lamp (CFL) phototherapy with special blue standard-length tube lights (STL). This randomized, controlled trial was conducted in a level III NICU. Neonates, otherwise healthy, of gestation greater than 34 weeks with hyperbilirubinemia requiring phototherapy, were included. Rh iso-immunized babies, those who underwent prior exchange transfusion and whose parents declined to consent were excluded. By stratified block randomization, babies were allocated to receive phototherapy by CFL or STL. CFL and STL were both special blue lights with irradiance maintained above 15 microWatts/nm/cm2. Total serum bilirubin (TSB) was measured 12 hourly till phototherapy was stopped or an exchange transfusion was done. Temperature and clinical and laboratory parameters of dehydration were recorded 12 hourly till 72 hrs. Nursing staff answered an objectivized proforma about the disadvantageous effects on nurses. Fifty babies were enrolled in each group. Baseline characteristics, causes of jaundice, hemolysis, baseline TSB and irradiance were similar in both groups. Mean duration of phototherapy (P = 0.98) was similar in both groups. Kaplan-Meier analysis of phototherapy duration showed no difference in the survival curves of the 2 groups (P = 0.6). Axillary temperature was similar in both groups and no baby was dehydrated. Nursing staff reported no significant differences between CFL and STL visavis glare hurting the eyes, giddiness and headache. CFL phototherapy has no superiority over STL phototherapy in terms of efficacy and adverse effects on the neonate and effects on nursing staff.

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

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    S Ashraffodin Ghoshegir

    2015-01-01

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

  5. EEG Neurofeedback treatments in children with ADHD: An updated meta-analysis of Randomized Controlled Trials

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    Jean-Arthur eMicoulaud Franchi

    2014-11-01

    Full Text Available Objective We undertook a meta-analysis of published Randomized Controlled Trials (RCT with semi-active control and sham-NF groups to determine whether EEG-NF significantly improves the overall symptoms, inattention and hyperactivity/impulsivity dimensions for probably unblinded assessment (parent assessment and probably blinded assessment (teacher assessment in children with Attention Deficit Hyperactivity Disorder (ADHD.Data Sources A systematic review identified independent studies that were eligible for inclusion in a random effects meta-analysis.Data Extraction Effect sizes for ADHD symptoms were expressed as standardized mean differences (SMD with 95% confidence intervals.ResultsFive identified studies met eligibility criteria, 263 patients with ADHD were included, 146 patients were trained with EEG-NF. On parent assessment (probably unblinded assessment, the overall ADHD score (SMD=-0.49 [-0.74, -0.24], the inattention score (SMD=-0.46 [-0.76, -0.15] and the hyperactivity/impulsivity score (SMD=-0.34 [-0.59, -0.09] were significantly improved in patients receiving EEG-NF compared to controls. On teacher assessment (probably blinded assessment, only the inattention score was significantly improved in patients receiving EEG-NF compared to controls (SMD=-0.30 [-0.58, -0.03]. ConclusionsThis meta-analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms. Future investigations should pay greater attention to adequately blinded studies and EEG-NF protocols that carefully control the implementation and embedding of training.

  6. Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Coffin, Phillip Oliver; Santos, Glenn-Milo; Das, Moupali; Santos, Deirdre M; Huffaker, Shannon; Matheson, Tim; Gasper, James; Vittinghoff, Eric; Colfax, Grant N

    2013-04-01

    To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems (MEMS)], sexual risk behavior and abstinence from methamphetamine. Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio (RR) 0.88, 95% confidence interval (CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms (MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness (P methamphetamine use significantly among actively using, dependent adults. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

  7. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

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    Welch Martha G

    2012-02-01

    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  8. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU

    Science.gov (United States)

    2012-01-01

    Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group). Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of

  9. Is paromomycin an effective and safe treatment against cutaneous leishmaniasis? A meta-analysis of 14 randomized controlled trials.

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    Dae Hyun Kim

    Full Text Available BACKGROUND: High cost, poor compliance, and systemic toxicity have limited the use of pentavalent antimony compounds (SbV, the treatment of choice for cutaneous leishmaniasis (CL. Paromomycin (PR has been developed as an alternative to SbV, but existing data are conflicting. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials, without language restriction, through August 2007, to identify randomized controlled trials that compared the efficacy or safety between PR and placebo or SbV. Primary outcome was clinical cure, defined as complete healing, disappearance, or reepithelialization of all lesions. Data were extracted independently by two investigators, and pooled using a random-effects model. Fourteen trials including 1,221 patients were included. In placebo-controlled trials, topical PR appeared to have therapeutic activity against the old world and new world CL, with increased local reactions, when used with methylbenzethonium chloride (MBCL compared to when used alone (risk ratio [RR] for clinical cure, 2.58 versus 1.01: RR for local reactions, 1.60 versus 1.07. In SbV-controlled trials, the efficacy of topical PR was not significantly different from that of intralesional SbV in the old world CL (RR, 0.70; 95% confidence interval, 0.26-1.89, whereas topical PR was inferior to parenteral SbV in treating the new world CL (0.67; 0.54-0.82. No significant difference in efficacy was found between parenteral PR and parenteral SbV in the new world CL (0.88; 0.56-1.38. Systemic side effects were fewer with topical or parenteral PR than parenteral SbV. CONCLUSIONS/SIGNIFICANCE: Topical PR with MBCL could be a therapeutic alternative to SbV in selected cases of the old world CL. Development of new formulations with better efficacy and tolerability remains to be an area of future research.

  10. A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis.

    Science.gov (United States)

    Krause, David S; Simjee, A E; van Rensburg, Christo; Viljoen, Johann; Walsh, Thomas J; Goldstein, Beth P; Wible, Michele; Henkel, Timothy

    2004-09-15

    Anidulafungin is a novel antifungal agent of the echinocandin class. This randomized, double-blind, double-dummy study compared the efficacy and safety of intravenous anidulafungin to that of oral fluconazole in 601 patients with endoscopically and microbiologically documented esophageal candidiasis. Patients received intravenous anidulafungin (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14-21 days). At the end of therapy, the rate of endoscopic success for anidulafungin (242 [97.2%] of 249 treated patients) was found to be statistically noninferior to that for fluconazole (252 [98.8%] of 255 treated patients; treatment difference, -1.6%; 95% confidence interval, -4.1 to 0.8). The safety profile of anidulafungin was similar to that of fluconazole; treatment-related adverse events occurred in 9.3% and 12.0% of patients, respectively. Laboratory parameters were similar between treatment arms. Anidulafungin is as safe and effective as oral fluconazole for the treatment of esophageal candidiasis, when assessed at the completion of therapy.

  11. Meta-analysis of randomized, controlled trials comparing particular doses of griseofulvin and terbinafine for the treatment of tinea capitis.

    Science.gov (United States)

    Gupta, Aditya K; Drummond-Main, Chris

    2013-01-01

    Two oral antifungal agents, griseofulvin and terbinafine, have regulatory approval in the United States, but it is unknown whether one has superior overall efficacy. Genus-specific differences in efficacy are believed to exist for the two agents. It is not clear at what doses and durations of treatment these differences apply. The goals of this meta-analysis were to determine whether a statistically significant difference in efficacy exists between these agents at a given dose and duration of each in tinea capitis infections overall and to determine whether a genus-specific difference in efficacy exists for these two treatments at a given dose and duration of each. We performed a literature search for clinically and methodologically similar randomized controlled trials comparing 8 weeks of griseofulvin (6.25-12.5 mg/kg/day) to 4 weeks of terbinafine (3.125-6.25 mg/kg/day) in the treatment of tinea capitis. A meta-analysis was performed using the Mantel-Haenszel method and random effects model; results were expressed as odds ratios with 95% confidence intervals. Meta-analysis of randomized controlled trials did not show a significant difference in the overall efficacy of the two drugs at the doses specified, but specific efficacy differences were observed based on the infectious species. For tinea capitis caused by Microsporum spp., griseofulvin is superior (p = 0.04), whereas terbinafine is superior for Trichophyton spp. infection (p = 0.04). Our results support species-specific differences in treatment efficacy between griseofulvin and terbinafine and provide a clinical context in which this knowledge may be applied. © 2012 Wiley Periodicals, Inc.

  12. Psychiatric treatment following participation in the CapOpus randomized trial for patients with comorbid cannabis use disorder and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Orlovska, Sonja; Fohlmann, Allan

    2013-01-01

    Randomized trials targeting cannabis use disorders in patients with psychosis have generally been unsuccessful. One of the largest such trials was the CapOpus trial, which had an impact on the number of monthly joints used, but not on the number of days with cannabis use or positive or negative...

  13. Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

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    Gluud Christian

    2008-07-01

    Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. Design The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1 specialized addiction treatment plus treatment as usual or 2 treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient. The primary outcome measure will be changes in amount of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

  14. Randomized trial - oxybutynin for treatment of persistent plantar hyperhidrosis in women after sympathectomy