Systematic Review of Mind-Body Interventions to Treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Background and Objectives: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic condition distinguished by disabling fatigue associated with post-exertional malaise, as well as changes to sleep, autonomic functioning, and cognition. Mind-body interventions (MBIs) utilize the ongoing interaction between the mind and body to improve health and wellbeing. Purpose: To systematically review studies using MBIs for the treatment of ME/CFS symptoms. Materials and Methods: MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane CENTRAL were searched (inception to September 2020). Interventional studies on adults diagnosed with ME/CFS, using one of the MBIs in comparison with any placebo, standard of care treatment or waitlist control, and measuring outcomes relevant to the signs and symptoms of ME/CFS and quality of life were assessed for inclusion. Characteristics and findings of the included studies were summarized using a descriptive approach. Results: 12 out of 382 retrieved references were included. Seven studies were randomized controlled trials (RCTs) with one including three reports (1 RCT, 2 single-arms); others were single-arm trials. Interventions included mindfulness-based stress reduction, mindfulness-based cognitive therapy, relaxation, Qigong, cognitive-behavioral stress management, acceptance and commitment therapy and isometric yoga. The outcomes measured most often were fatigue severity, anxiety/depression, and quality of life. Fatigue severity and symptoms of anxiety/depression were improved in nine and eight studies respectively, and three studies found that MBIs improved quality of life. Conclusions: Fatigue severity, anxiety/depression and physical and mental functioning were shown to be improved in patients receiving MBIs. However, small sample sizes, heterogeneous diagnostic criteria, and a high risk of bias may challenge this result. Further research using standardized outcomes would help advance the field.

Surveys of parents and clinicians concerning the minimally important difference of probiotic therapy for prevention of paediatric antibiotic-associated diarrhoea.

OBJECTIVES: To establish the minimally important difference (MID) that would prompt parents and clinicians to use probiotics for prevention of paediatric antibiotic-associated diarrhoea (AAD) and to obtain parent and clinician opinion about the most important outcomes in clinical trials of AAD. METHODS: In this survey, parents of children presenting to the emergency department of a Canadian tertiary care children's hospital and paediatricians working in that hospital were approached. A range of potential MIDs were presented and participants selected one that they would require to use probiotics for AAD prevention. In addition, participants were asked to rate a list of outcomes they would consider to be important in clinical trials of AAD. RESULTS: In total, 127 parents and 45 paediatricians participated. About 51% (64/125) of parents and 51% (21/41) of clinicians responding to the MID question reported they would use probiotics if it reduced the risk of AAD by 39% (ie, reduce the risk of AAD from 19% to 12%). The most important outcomes to parents, in descending order, were need for hospitalisation, prevention of dehydration, disruption of normal daily activities, diarrhoea duration and physician revisit. Paediatricians considered need for hospitalisation along with physician revisit as the most important outcomes. They rated prevention of dehydration, diarrhoea duration and stool frequency as important outcomes as well. CONCLUSION: There is good agreement between parents and clinicians regarding how effective probiotics would need to be in preventing AAD in order to warrant use. This information, along with outcomes perceived to be most important, will help in the design of future clinical trials.

Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

OBJECTIVE: Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. METHODS: Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. RESULTS: Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. CONCLUSION: Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials.