The Journal of Alternative and Complementary Medicine has published our paper, A Multimodal Intervention for Patients with Secondary Progressive Multiple Sclerosis: Feasibility and Effect on Fatigue, available here. The paper details the success of the first 10 subjects that we enrolled in the study, which uses diet, vitamins, stress reduction, exercise, and electrical stimulation of muscles to augment the effectiveness of the exercise program. Our study showed that intervention had very good compliance measures, is well tolerated, and has minimal side effects. In addition, the perceived fatigue was markedly reduced as compared to baseline fatigue levels. Group average fatigue severity (FSS) scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. We have not found any papers in the MS literature that report such a large favorable change on perceived fatigue. Such a large favorable change for fatigue is very exciting as fatigue is the most disabling symptom for those with MS and many other conditions.
If you want to read the abstract I have it in its entirety below.
Abstract Background: Multiple sclerosis is an autoimmune disease influenced by environmental factors. Objectives: The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. Design/setting: This was a single-arm, open-label intervention study in an outpatient setting. Interventions: A multimodal intervention including a modified Paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. Outcome measures: Adherence to each component of the intervention was calculated using daily logs. Side effects were assessed using a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. Results: Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. Conclusions: In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.
We now have 20 subjects that have completed 12 months in the study. We are analyzing study data and working on the next round of papers and grants. We anticipate many more papers coming from these data and many more grant applications. This is a very big deal: I know of no other laboratory that is prospectively studying the impact of diet and lifestyle choices on quality of life and function for any autoimmune condition. The type of research that my lab is doing is absolutely groundbreaking and over time, with enough positive studies, will lead to significant changes in the medical establishment. Having the funds to collect the pilot data like this study allows me to then write for grants much more successfully. If you want to be part of the team that makes these studies possible, please make a generous donation to the Wahls Research fund here.
For those who want to know more about the types of interventions that we are studying, I discuss them in detail in my book, The Wahls Protocol: How I Beat Progressive MS Using Paleo Principles and Functional Medicine. If you have multiple sclerosis, fatigue, and some level of gait disability, you can learn more here about the Wahls Paleo Diet and Progressive Multiple Sclerosis trial that we are currently recruiting for, including eligibility criteria and how to be screened for the study.