A pilot, randomized, placebo-controlled study of mindfulness meditation in treating insomnia in multiple sclerosis.

OBJECTIVE: Mindfulness is an established approach to reduce distress and stress reactivity by improving awareness and tolerability of thoughts and emotions. This study compares mindfulness training to sleep hygiene in persons with multiple sclerosis (PWMS) who report chronic insomnia, examining sleep efficiency (SE), self-reported sleep quality and quality of life. METHODS: Fifty-three PWMS were randomized (1:1) in a single-blinded, parallel group design to ten, two-hour weekly sessions of Mindfulness Based Stress Intervention for Insomnia (MBSI-I) over a span of ten weeks or a single, one hour sleep hygiene (SH) session over one day. The primary outcome measure was SE, measured by the Fitbit™ Charge 2 wrist device, at 10 and 16 weeks from the start of study interventions. Self-report outcomes included the Pittsburg Sleep Quality Rating Scale (PSQI), Insomnia Severity Index (ISI) and the Multiple Sclerosis Quality of Life Inventory (MSQLI). Nineteen participants in the MBSI-I group and 24 in the SH group completed the primary study. Subsequently, ten participants in the original SH group participated in the 10-week MSBI-I course and their data was added to the MBSI-I cohort (eMSBI-I). RESULTS: While neither SE nor the PSQI showed significant differences between MBSI-I, eMBSI-I and SH groups, ISI improved in both the MSBI-I and eMBSI-I vs SH at 10 weeks (p = 0.0014 and p = 0.0275) but not 16 weeks. However, pre and post assessments within the MBSI-I and eMBSI-I cohorts did show significant improvement in the PSQI and ISI at 10 and 16 weeks, while SH was significant in the ISI only at 16 weeks. Several quality of life measurements, including fatigue, mental health and cognitive function favored the mindfulness cohorts. CONCLUSION: This pilot study demonstrates beneficial effects of MBSR on insomnia, sleep quality and quality of life in PWMS. TRIAL REGISTRATION: NCT03949296. 14 May 2019.

Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes.

BACKGROUND: Plant-based diets (PBDs) are typically recommended to those at risk of type 2 diabetes mellitus (T2DM). OBJECTIVES: We examined how including eggs, compared with excluding them from PBDs, affected cardiometabolic risk factors in adults at risk of T2DM. METHODS: This was a randomized, controlled, single-blind, crossover trial of 35 adults (mean age: 60.7 y; 25 women, 10 men) at risk of T2DM assigned to 1 of 2 sequence permutations of 2 dietary treatments (plant-based plus eggs, and exclusively plant-based), with a 4-wk washout period. A dietitian counseled participants to exclude or include 2 eggs daily in the context of PBDs for a 6-wk interval. Our primary outcome measure was endothelial function (EF) measured as flow-mediated dilatation. Secondary outcome measures included lipid profile, blood pressure, insulin sensitivity, anthropometry, and dietary intake. Data were analyzed using generalized linear models. RESULTS: Compared with egg exclusion, egg inclusion in the context of PBDs did not adversely affect EF (-1.7% ± 6.5% compared with -1.8% ± 7.5%; P = 0.9805). Likewise, egg inclusion, compared with egg exclusion, did not adversely affect (P = 0.1096-0.9781) lipid profile, blood pressure, insulin sensitivity, or anthropometry. Egg inclusion, compared with egg exclusion, improved reported intakes of selenium (23.1 ± 30.3 µg/d compared with 2.3 ± 34.9 µg/d; P = 0.0124) and choline (172.0 ± 96.0 mg/d compared with -3.4 ± 68.1 mg/d; P < 0.0001). CONCLUSIONS: Consuming 2 eggs daily in the context of PBDs does not adversely affect cardiometabolic risk factors among adults at risk of T2DM. Eggs could be used as an adjuvant to enhance PBDs that are typically recommended for those at risk of T2DM.This trial was registered at clinicaltrials.gov as NCT04316429.

Oats, antioxidants and endothelial function in overweight, dyslipidemic adults.

OBJECTIVE: To determine effects of oat and antioxidant vitamin (C 500 mg, E 400 IU) ingestion on endothelial function in overweight, dyslipidemic adults. DESIGN: Randomized, blinded, placebo-controlled, crossover trial Intervention(s): Subjects (16 males > or = age 35; 14 postmenopausal females) were assigned, in random order, to oats (60 g oatmeal), vitamin E (400 IU) plus vitamin C (500 mg), the combination of oats and vitamins, or placebo, and underwent brachial artery reactivity scans (BARS) following a single dose of each treatment, and again following 6 weeks of daily ingestion, with 2-week washout periods. At each test, a provocation high-fat meal (50 g, predominantly saturated) was administered and subjects were scanned pre, and 3 hours post-ingestion. RESULTS: Mean flow-mediated vasodilation (FMD; measured as percent diameter change before and after treatments) at baseline was 6.35 +/- 3.37. Oats increased FMD non-significantly (p > 0.05) with both single acute dose (from 6.07 +/- 6.25 to 9.22 +/- 8.82) and six weeks of sustained treatment (from 6.01 +/- 10.07 to 8.69 +/- 8.42). The direction of effect was negative for vitamins and the oat/vitamin combination with both acute and sustained treatment. There were no significant differences in FMD change among the treatments in either phase of the study, however when acute and sustained effects were pooled, oat treatment significantly augmented FMD (p < 0.05). CONCLUSIONS: This trial suggests but does not confirm a beneficial influence of oat ingestion on endothelial function in overweight, dyslipidemic adults. Further study of this potential association is warranted.

The evidence base for complementary and alternative medicine: methods of Evidence Mapping with application to CAM.

BACKGROUND: There is widespread concern regarding the adequacy of evidence for specific practices under the rubric of "complementary and alternative medicine" (CAM). OBJECTIVE: To map the evidence pertaining to many commonly used CAM practices. DESIGN: In 2000, the Yale Prevention Research Center was funded by the Centers for Disease Control and Prevention to conduct a "systematic review" of the evidence underlying CAM. The investigative team, working in collaboration with CAM practitioners, developed a systematic and replicable 9-step process termed evidence mapping. The process stipulates means for specifying the boundaries of the subject to be mapped in MeSH terms, and the characteristics used to situate retrieved articles in the overall map of evidence. SETTING: Yale Prevention Research Center, Derby, CT. RESULTS: Steps completed thus far have led to the identification of over 4,000 papers distributed across 207 condition-treatment pairs. Of these pairs, 58% (n = 121) have been studied with one or more RCTs (1,070 total RCTs), and 23% (n = 47) have been the subject of one or more meta-analyses (86 total meta-analyses). Thirty-seven condition/treatment pairs (18%) had no identifiable supporting studies. CONCLUSIONS: The novel methods of evidence mapping reported are useful and practical in characterizing the extent, distribution, and methodologic quality of research pertaining to a broad topic in medicine. Applied to CAM, they suggest that summary judgments about the quantity or quality of underlying evidence are overly simplistic.