A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.
Level 4 - case-series / case-control
Single-arm uncontrolled intervention study (case series design)
PubMed 24476345 · doi:10.1089/acm.2013.0188
What was done
This was a single-arm, open-label pilot study evaluating the feasibility and effect on fatigue of a 12-month multimodal intervention in patients with secondary progressive multiple sclerosis. Out of 13 subjects enrolled in a 2-week run-in phase, 10 were eligible and entered the 12-month study. The intervention consisted of a modified paleolithic diet with supplements, stretching and strengthening exercises combined with electrical stimulation of trunk and lower limb muscles, meditation, and massage. Adherence was recorded through daily logs, safety via monthly questionnaires and blood tests, and perceived fatigue using the Fatigue Severity Scale (FSS) at baseline and months 1, 2, 3, 6, 9, and 12.
What was found
Eight of the 10 participants completed the 12-month study, and 6 fully adhered to the regimen. Average adherence exceeded 90% of days for diet and 75% of days for exercise and muscle stimulation. Participants averaged 13.3 minutes of meditation and 7.2 minutes of massage per day. No adverse side effects were reported. Among completers, group average FSS scores decreased from 5.7 at baseline to 3.32 at 12 months (p = 0.0008).
Why it matters
The study shows that an intensive, multi-component lifestyle and physical intervention is feasible for patients with secondary progressive multiple sclerosis and may provide substantial relief from fatigue.
Limits
The study is severely limited by a very small sample size (n = 10 enrolled, n = 8 completed) and the lack of a control group, preventing distinction between intervention effects and placebo response or natural disease fluctuations. Because multiple therapies were combined simultaneously, the specific contribution or efficacy of individual components cannot be determined.
Cited by
- supports Dr. Terry Wahls has published studies showing positive clinical results using a functional medicine diet and lifestyle approach for multiple sclerosis.