Personal non-commercial use only

ABSTRACT. Objective. To investigate the effect of an orally administered probiotic on disease activity, fatigue, quality of life, and intestinal symptoms in patients with active spondyloarthritis. Methods. Patients with active spondyloarthritis [defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 3, Bath Ankylosing Spondylitis Functional Index (BASFI) ≥ 3, Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) ≥ 2, or peripheral joint count ≥ 2] were randomized to oral probiotic or placebo for 12 weeks. Patients and assessors were blinded to treatment allocation. The primary outcome measure was 10% improvement in the BASFI. Additional outcome measures were improvements in the ASsessments in Ankylosing Spondylitis (ASAS)-endorsed core domains: pain, spinal mobility, patient global, peripheral joint and entheseal scores, stiffness, C-reactive protein, and fatigue. The ASAS20 criteria, a composite measure of response, were also applied. Quality of life and bowel symptoms were quantified using the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) and Dudley Inflammatory Bowel Symptom Questionnaire (DISQ). Results. Sixty-three patients were randomized to oral probiotic (n = 32) or placebo (n = 31). All patients completed the trial. No significant difference was noted between groups in any of the core domains. The mean BASFI fell from 3.5 ± 2.0 to 2.9 ± 1.9 in the probiotic group and from 3.6 ± 1.9 to 3.1 ± 2.2 in the placebo group (p = 0.839). The mean BASDAI fell from 4.2 ± 2.2 to 3.2 ± 2.1 in the probiotic group and 4.5 ± 2.0 to 3.9 ± 2.2 in the placebo group (p = 0.182). No significant adverse events were recorded in the probiotic-treated group. Conclusion. In this randomized controlled trial, the probiotic combination administered did not demonstrate significant benefit over placebo, despite a theoretical rationale for this therapy

Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review

Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods. A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric‚ and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results. From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions. There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials