Fibromyalgia syndrome (FMS) is a prevalent and debilitating condition for which definitive therapy is lacking and urgently needed. Characterized by widespread pain and muscle tenderness, the syndrome affects roughly 6 million people in the United States alone. Conventional therapies targeting a variety of theories regarding etiology and pathogenesis have largely proved ineffective. As a result, the great majority of FMS sufferers seek complementary/alternative medicine (CAM) therapies for palliation of their symptoms, but often with limited success. Intravenous micronutrient therapy (IVMT) with the Myer's Cocktail has emerged as a popular treatment for fibromyalgia. While the theoretical rationale for this treatment approach is limited, a therapeutic effect is plausible, and the empirical evidence supporting it appears to be strong. An on-line survey of treatment clinics representing 12,000 patient experiences with IVMT conducted exclusively in support of this application suggests that the therapy is very safe and often (60-80%) effective. Despite its popularity, and the increasing prevalence of its use, IVMT has not been subjected to formal investigation. We therefore propose a randomized, double-blind, placebo-controlled pilot study of IVMT for fibromyalgia with validated functional and pain measures as the outcomes of interest. The study will be conducted in 4 phases over a 12-month period with assessment of treatment effect based primarily on the tender point index (TPI) derived from the examination of a dedicated, board-certified research rheumatologist blinded to the subjects' treatment status. The study will be conducted out of the Yale-Griffin Prevention Research Center, in collaboration with the Integrative Medicine Center in Derby, CT, a partnership already actively involved in CAM outcomes research with CDC funding. The proposed pilot study is designed to demonstrate feasibility and safety, and is adequately powered to provide evidence of treatment efficacy. Follow-up study will be indicated if pilot data are encouraging as anticipated; a consortium of sites (the Northeast Regional CAM Consortium) in which the applicant is a member has already expressed interest in participating in follow-up study pending results of the pilot. The identification of an effective, safe, inexpensive therapy for fibromyalgia would represent a great advance, and a major contribution to the public health.
| Ali, Ather; Njike, Valentine Yanchou; Northrup, Veronika et al. (2009) Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med 15:247-57 |
