A randomized pilot study of naturopathic medicine in multiple sclerosis

Author(s): Shinto L, Calabrese C, Morris C, Yadav V, Griffith D, et al.

Abstract

Background:Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS.

Objective:To assess quality of life in MS subjects who received interventions designed to "model" the "whole practice" of naturopathy.

Design:A pilot, randomized, controlled study with a 6-month intervention period.

Participants:Participants who met criteria for clinically definite MS.

Interventions:The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care.

Outcome measures:The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety.

Results:Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes.

Conclusions:Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.

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