SciCombinator

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Concept: Pharmaceutical industry

414

The effects of probiotic supplementation on fecal microbiota composition in healthy adults have not been well established. We aimed to provide a systematic review of the potential evidence for an effect of probiotic supplementation on the composition of human fecal microbiota as assessed by high-throughput molecular approaches in randomized controlled trials (RCTs) of healthy adults.

Concepts: Epidemiology, Gut flora, Evidence-based medicine, Systematic review, Randomized controlled trial, Effectiveness, Pharmaceutical industry, Meta-analysis

393

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 < 0.001), with moderate to large effect sizes. 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 < 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.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Concepts: Low back pain, Randomized controlled trial, Statistical significance, Pharmaceutical industry, Clinical research, Placebo, Acupuncture, Effect size

384

Case reports describe persistent erectile dysfunction (PED) associated with exposure to 5α-reductase inhibitors (5α-RIs). Clinical trial reports and the manufacturers' full prescribing information (FPI) for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure.

Concepts: Clinical trial, Effectiveness, ClinicalTrials.gov, Pharmaceutical industry, Adverse drug reaction, Erectile dysfunction, Exposure

350

Previous studies indicate that in published reports, trial results can be distorted by the use of “spin” (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of “spin” in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted.

Concepts: Cohort study, Experimental design, Epidemiology, Clinical trial, Randomized controlled trial, ClinicalTrials.gov, Evaluation methods, Pharmaceutical industry

270

Recent insights into the role of the human microbiota in cognitive and affective functioning have led to the hypothesis that probiotic supplementation may act as an adjuvant strategy to ameliorate or prevent depression.

Concepts: Psychology, Gut flora, Randomized controlled trial, Escherichia coli, Pharmaceutical industry, Probiotic, Seasonal affective disorder, Emotion

255

There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity.

Concepts: Epidemiology, Obesity, Randomized controlled trial, ClinicalTrials.gov, Weight loss, Pharmaceutical industry, Dieting, Information technology

242

The aim of this study was to determine the cumulative effect of a routine (hot-to-) cold shower on sickness, quality of life and work productivity.

Concepts: Epidemiology, Clinical trial, Randomized controlled trial, Pharmaceutical industry, Clinical research, Hygiene

222

BACKGROUND: Medical schools are grappling with how best to manage industry involvement in medical education. OBJECTIVE: To describe a case study of industry-supported undergraduate medical education related to opioid analgesics. METHOD: Institutional case study. RESULTS: As part of their regular curriculum, Canadian medical students attended pain pharmacotherapy lectures that contained questionable content about the use of opioids for pain management. The lectures were supported by pharmaceutical companies that market opioid analgesics in Canada and the guest lecturer was a member of speakers bureaus of the same companies. These conflicts of interests were not fully disclosed. A reference book that reinforced some of the information in the lectures and that was paid for by a sponsoring company was made available to students. This is the first report of an association between industry sponsorship and the dissemination of potentially dangerous information to medical students. CONCLUSIONS: This case demonstrates the need for better strategies for preventing, identifying and dealing with problematic interactions between the pharmaceutical industry and undergraduate medical education. These might include the avoidance of unnecessary conflicts of interest, more disclosure of conflicts, an open process for dealing with recognised problems and internationally harmonised conflict of interest policies.

Concepts: Pharmacology, Medicine, Physician, Opioid, Pain, Pharmaceutical industry, Medical school, Conflict of interest

190

Obesity is associated with increased mortality, and weight loss trials show rapid improvement in many mortality risk factors. Yet, observational studies typically associate weight loss with higher mortality risk. The purpose of this meta-analysis of randomized controlled trials (RCTs) of weight loss was to clarify the effects of intentional weight loss on mortality.

Concepts: Experimental design, Epidemiology, Clinical trial, Medical statistics, The Canon of Medicine, Randomized controlled trial, Pharmaceutical industry, Clinical research

181

Industry-sponsored clinical drug studies are associated with publication of outcomes that favor the sponsor, even when controlling for potential bias in the methods used. However, the influence of sponsorship bias has not been examined in preclinical animal studies. We performed a meta-analysis of preclinical statin studies to determine whether industry sponsorship is associated with either increased effect sizes of efficacy outcomes and/or risks of bias in a cohort of published preclinical statin studies. We searched Medline (January 1966-April 2012) and identified 63 studies evaluating the effects of statins on atherosclerosis outcomes in animals. Two coders independently extracted study design criteria aimed at reducing bias, results for all relevant outcomes, sponsorship source, and investigator financial ties. The I(2) statistic was used to examine heterogeneity. We calculated the standardized mean difference (SMD) for each outcome and pooled data across studies to estimate the pooled average SMD using random effects models. In a priori subgroup analyses, we assessed statin efficacy by outcome measured, sponsorship source, presence or absence of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. The effect of statins was significantly larger for studies sponsored by nonindustry sources (-1.99; 95% CI -2.68, -1.31) versus studies sponsored by industry (-0.73; 95% CI -1.00, -0.47) (p value<0.001). Statin efficacy did not differ by disclosure of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. Possible reasons for the differences between nonindustry- and industry-sponsored studies, such as selective reporting of outcomes, require further study.

Concepts: Atherosclerosis, Medical statistics, Effectiveness, Pharmaceutical industry, Clinical research, Pre-clinical development, Effect size, Sponsor