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Introduction Fatigue plays an important role in the daily activity of patients with multiple sclerosis (MS) and strongly influences their quality of life. Numerous clinical trials evaluating various interventions for fatigue in MS have shown only minor benefits. The main aim of the present trial is to evaluate whether 1) acupuncture or 2) mindfulness-based stress reduction (MBSR) in addition to usual care are effective in reducing fatigue in MS patients compared to usual care alone. Methods Within a randomized, three-arm, controlled trial we aim to include 141 MS patients aged 18–65 years with fatigue for at least 3 months and an average score of ≥4 on the Fatigue Severity Scale (FSS). Patients will be randomized into three groups: an acupuncture group receiving 12 weeks of acupuncture in addition to usual care, a MBSR group receiving 12 weeks of MBSR in addition to usual care, and a usual care group continuing their previous treatment. Primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks. To assess the trial’s characteristics regarding efficacy and effectiveness we used the pragmatic explanatory continuum summary (PRECIS-2). Discussion This trial addresses new therapeutic approaches for fatigue in MS. The resulting design is a compromise between scientific rigor and pragmatism. Due to difficulties with recruitment we had to scale down our trial to the groups of usual care and acupuncture. The trial's results will give first evidence whether acupuncture is effective in patients with MS associated fatigue. Trial registration ClinicalTrials.gov identifier NCT01864707, registered on 2 April 2013. [ABSTRACT FROM AUTHOR]

Abstract: Randomised placebo-controlled trials (RCT) are an invaluable tool for testing the efficacy of new treatment strategies. The choice of placebo in an RCT can affect not only patients'' physical and psychological response to a particular intervention, but also the trial setting, the success of patient blinding to the intervention, and therefore the outcome of the study and the efficacy of treatment in general. Therefore the placebo is intrinsically tied to the trial''s methodology and results. However, although placebos are an important component in randomised trials, their quality is often left unquestioned. A placebo which was not properly validated may even have specific effects that lead to false negative results. To address this deficit, we propose a measure of placebo quality using the term placebo to assess the physical aspect of a dummy treatment used in the placebo group of a randomised controlled trial (RCT). The Placebo Quality Checklist (PQC) described here may help investigators select an appropriate placebo and help both investigators and critical readers interpret the findings of studies with more care. [Copyright &y& Elsevier]

Background: Primary dysmenorrhea is common among women of reproductive age. Nonsteroidal anti-inflammatory drugs and oral contraceptives are effective treatments, although the failure rate is around 20% to 25%. Therefore additional evidence-based treatments are needed. In recent years, the use of smartphone applications (apps) has increased rapidly and may support individuals in self-management strategies.Objective: We aimed to investigate the effectiveness of app-based self-acupressure in women with menstrual pain.Materials and Methods: A 2-armed, randomized, pragmatic trial was conducted from December 2012 to April 2015 with recruitment until August 2014 in Berlin, Germany, among women aged 18 to 34 years with self-reported cramping pain of 6 or more on a numeric rating scale (NRS) for the worst pain intensity during the previous menstruation. After randomization, women performed either app-based self-acupressure (n = 111) or followed usual care only (n = 110) for 6 consecutive menstruation cycles. The primary outcome was the mean pain intensity (NRS 0-10) on the days with pain during the third menstruation. Secondary outcomes included worst pain intensity during menstruation, duration of pain, 50% responder rates (reduction of mean pain by at least 50%), medication intake, sick leave days, and body efficacy expectation assessed at the first, second, third, and sixth menstruation cycles.Results: We included 221 women (mean age, 24.0 years; standard deviation [SD], 3.6 years). The mean pain intensity difference during the third menstruation was statistically significant in favor of acupressure (acupressure: 4.4; 95% confidence interval [CI], 4.0-4.7; usual care 5.0; 95% CI, 4.6-5.3; mean difference -0.6; 95% CI, - 1.2 to -0.1; P = .026). At the sixth cycle, the mean difference between the groups (-1.4; 95% CI, -2.0 to -0.8; P < .001) reached clinical relevance. At the third and sixth menstruation cycles, responder rates were 37% and 58%, respectively, in the acupressure group, in contrast to 23% and 24% in the usual care group. Moreover, the worst pain intensity (group difference -0.6; 95% CI, -1.2 to -0.02; and -1.4; 95% CI, -2.0 to -0.7), the number of days with pain (-0.4; 95% CI, -0.9 to -0.01; and -1.2; 95% CI, -1.6 to -0.7) and the proportion of women with pain medication at the third and sixth menstruation cycles (odds ratio [OR], 0.5; 95% CI, 0.3-0.9] and 0.3 (95% CI, 0.2-0.5) were lower in the acupressure group. At the third cycle, hormonal contraceptive use was more common in the usual care group than in the acupressure group (OR, 0.5; 95% CI, 0.3-0.97) but not statistically significantly different at the sixth cycle (OR, 0.6; 95% CI, 0.3-1.1]). The number of sick leave days and body efficacy expectation (self-efficacy scale) did not differ between groups. On a scale of 0 to 6, mean satisfaction with the intervention at the third cycle was 3.7 (SD 1.3), recommendation of the intervention to others 4.3 (1.5), appropriateness of acupressure for menstrual pain 3.9 (1.4), and application of acupressure for other pain 4.3 (1.5). The intervention was safe, and after the sixth cycle, two-thirds of the women (67.6%) still applied acupressure on all days with pain.Conclusion: Smartphone app-delivered self-acupressure resulted in a reduction of menstrual pain compared to usual care only. Effects were increasing over time, and adherence was good. Future trials should include comparisons with other active treatment options. [ABSTRACT FROM AUTHOR]

Traditional medical practice has suffered from male bias, which can lead to sub-optimal treatment options for female patients and increase the incidence of severe side-effects in this population. Mobile health applications, mHealth apps, represent one essential component of the shift towards consumer-centered self-administered individualized health. To prevent sex-specific bias it is important that trials consider sex and gender when developing mHealth apps. We evaluated the inclusion and reporting of sex and gender at all levels in mHealth randomized controlled trials (RCTs). To this end, we conducted a secondary analysis of a large study database addressing the effectiveness of app interventions on clinical outcomes in patients with chronic medical conditions. We followed the 5 steps described in the framework by Arksey and O'Malley and the guidelines of the PRISMA-ScR. Of the 72 app-based RCTs which reported information about sex overall, 62 included individuals of both sexes. The concept of gender was not addressed in any of the studies. The consideration of sex aspects in the design, execution and reporting of mHealth RCTs was minimal or absent. To adequately address the health and preventative needs of the mHealth user population, sex and gender should be systematically included in the research, development and evaluation of mHealth applications. [ABSTRACT FROM AUTHOR]