While a very-low fat, plant-based diet was well adhered to and tolerated, it resulted in no significant improvement on brain MRI, relapse rate or disability as assessed by EDSS scores in subjects with RRMS over one year. The diet group however showed significant improvements in measures of fatigue, BMI and metabolic biomarkers. The study was powered to detect only very large effects on MRI activity so smaller but clinically meaningful effects cannot be excluded. The diet intervention resulted in a beneficial effect on the self-reported outcome of fatigue but these results should be interpreted cautiously as a wait-list control group may not completely control for a placebo effect and there was a baseline imbalance on fatigue scores between the groups. If maintained, the improved lipid profile and BMI could yield long-term vascular health benefits. Longer studies with larger sample sizes are needed to better understand the long-term health benefits of this diet.

Objectives: This trial examined the efficacy of a stress management program in reducing neuroimaging markers of multiple sclerosis (MS) disease activity. Methods:A total of 121 patients with relapsing forms of MS were randomized to receive stress management therapy for MS (SMT-MS) or a wait-list control condition. SMT-MS provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up. The primary outcome was the cumulative number of new gadolinium-enhancing (Gdϩ) brain lesions on MRI at weeks 8, 16, and 24. Secondary outcomes included new or enlarging T2 MRI lesions, brain volume change, clinical exacerbation, and stress.Results: SMT-MS resulted in a reduction in cumulative Gdϩ lesions (p ϭ 0.04) and greater numbers of participants remained free of Gdϩ lesions during the treatment (76.8% vs 54.7%, p ϭ 0.02), compared to participants receiving the control treatment. SMT-MS also resulted in significantly reduced numbers of cumulative new T2 lesions (p ϭ 0.005) and a greater number of participants remaining free of new T2 lesions (69.5% vs 42.7%, p ϭ 0.006). These effects were no longer detectable during the 24-week post-treatment follow-up period. Conclusions:This trial indicates that SMT-MS may be useful in reducing the development of new MRI brain lesions while patients are in treatment. Classification of evidence:This study provides Class I evidence that SMT-MS, a manualized stress management therapy program, reduced the number of Gdϩ lesions in patients with MS during a 24-week treatment period. This benefit was not sustained beyond 24 weeks, and there were no clinical benefits.Trial registration: ClinicalTrials.gov, number NCT00147446. Neurology ® 2012;79:412-419 GLOSSARY BIPS ϭ Brief Inventory of Perceived Stress; DMT ϭ disease-modifying therapy; EDSS ϭ Expanded Disability Status Scale; Gd؉ ϭ gadolinium-enhancing; ITT ϭ intent-to-treat; LES ϭ Life Events Scale; MS ϭ multiple sclerosis; NNT ϭ number needed to treat; RCT ϭ randomized controlled clinical trial; SMT-MS ϭ stress management therapy for multiple sclerosis; UCSF ϭ University of California San Francisco.Accumulating evidence suggests an association between stress and disease activity in multiple sclerosis (MS).1 Stressful life events have also been shown to precede new gadolinium-enhancing (Gdϩ) MRI brain lesions, a more objective measure of disease activity, by approximately 4 -8 weeks.2 Several studies have indicated that more adaptive coping moderates the effect of stress on the development of new Gdϩ lesions 3 and is associated with fewer exacerbations. 4 Cognitive behavioral stress management therapies (SMTs) teach coping skills that are aimed at enhancing a patient's ability to prevent stressful events from occurring and improving the capacity to manage their responses to those stressful events that do arise.The primary aim of this multicenter randomized controlled clinical trial (RCT) was to examine the efficacy of a well-validated SMT for MS (SMT-MS) 5 in reducing the occurrence of new Gdϩ les...

Lipoic acid (LA) is an antioxidant that suppresses and treats an animal model of multiple sclerosis (MS), experimental autoimmune encephalomyelitis. The purpose of this study was to determine the pharmacokinetics (PK), tolerability and effects on matrix metalloproteinase-9 (MMP-9) and soluble intercellular adhesion molecule-1 (sICAMP-1) of oral LA in patients with MS. Thirty-seven MS subjects were randomly assigned to one of four groups: placebo, LA 600 mg twice a day, LA 1200 mg once a day and LA 1200 mg twice a day. Subjects took study capsules for 14 days. We found that subjects taking 1200 mg LA had substantially higher peak serum LA levels than those taking 600 mg and that peak levels varied considerably among subjects. We also found a significant negative correlation between peak serum LA levels and mean changes in serum MMP-9 levels (T = -0.263, P =0.04). There was a significant dose response relationship between LA and mean change in serum sICAM-1 levels (P =0.03). We conclude that oral LA is generally well tolerated and appears capable of reducing serum MMP-9 and sICAM-1 levels. LA may prove useful in treating MS by inhibiting MMP-9 activity and interfering with T-cell migration into the CNS.

Fatigue: Take Control is a novel program to teach fatigue management to people with multiple sclerosis (MS) following recommendations in the Fatigue and Multiple Sclerosis guideline. Fatigue: Take Control includes six 2-hour group sessions with DVD viewing, discussion and homework and accompanying participant and leader workbooks. While many people have participated in Fatigue: Take Control programs, its efficacy has not been determined. The objective of this study was to determine whether participation in Fatigue: Take Control reduces fatigue and increases self-efficacy in people with MS. Thirty participants were randomly assigned to a group who immediately participated in the program (FTC) or a wait-list group (WL). The primary outcome was the Modified Fatigue Impact Scale (MFIS) and secondary outcomes were the Multiple Sclerosis Self-Efficacy Scale (MSSE) and the Fatigue Severity Scale (FSS). The MFIS was administered on 10 occasions. Other measures were administered on four occasions. A mixed model tested the effects using all observations. Compared with the WL, the FTC group had significantly more improvement on the MFIS [F(1, 269) = 7.079, p = 0.008] and the MSSE [F(1, 111) = 5.636, p = 0.019]. No significant effect was found for the FSS. Across all visits, fatigue was significantly lower and self-efficacy was significantly higher for the FTC group compared with the WL group. This pilot study demonstrated significant effects in fatigue and self-efficacy among subjects taking the Fatigue: Take Control program, suggesting that this comprehensive program based on the Fatigue and Multiple Sclerosis guideline may be beneficial in MS.