FM: Intravenous Micronutrient Therapy (Myers' Cocktail)

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Intravenous Micronutrient Therapy (Myers' Cocktail) for Fibromyalgia:

A Placebo-Controlled Pilot Study.

J Altern Complement Med. 2009 Feb 28. [Epub ahead of print]

Ali A, Njike VY, Northrup V, Sabina AB, AL, Liberti LS,

Perlman AI, Adelson H, Katz DL.

Prevention Research Center, Yale University School of Medicine, Derby, CT.

PMID: 19250003

Abstract

Objectives: Intravenous micronutrient therapy (IVMT), and

specifically the Myers' Cocktail, is a popular approach for treating

fibromyalgia syndrome (FMS) among complementary and alternative

medicine practitioners, but its efficacy is uncertain. This trial

assessed the feasibility, safety, and provided insights into the

efficacy of this therapy.

Design: This was a randomized, double-blind, placebo-controlled pilot

study. Locations: The study locations were an academic research

center, teaching hospital, and affiliated Integrative Medicine Center

in Derby, CT.

Subjects: The subjects were 34 adults with American College of

Rheumatology (ACR)-defined FMS. Intervention: Subjects were randomly

assigned either to treatment (weekly infusions of IVMT) or to placebo

(weekly infusions of lactated Ringer's solution) for 8 weeks.

Outcome measures: Primary outcome was change in the Tender Point

Index, assessed 8 and 12 weeks after initiation. Secondary measures

included a Visual Analog Scale to assess global pain, and validated

measures of physical function (Fibromyalgia Impact Questionnaire),

mood (Beck Depression Index), and quality of life (Health Status

Questionnaire 2.0).

Results: Clinically significant improvements were noted (of a

magnitude similar to other effective interventions). However, in part

because of the high placebo response and the small sample size, no

statistically significant differences were seen between groups, in

any outcome measure, at 8 and 16 weeks. Statistically significant

within-group differences were seen in both the intervention and

placebo groups, demonstrating a treatment effect for both IVMT and

placebo. At 8 weeks, the IVMT group experienced significantly

improved tender points, pain, depression, and quality of life

directly following treatment (all p </= 0.02), while the placebo

group experienced significantly improved tender points only (p </=

0.05). The treatment effects of IVMT persisted at 4 weeks

postintervention for tender points, pain, and quality of life, while

placebo effects persisted only for tender points. A single minor

adverse event was noted in one subject in the intervention group.

Conclusions: This first controlled pilot study established the safety

and feasibility of treating FMS with IVMT. Most subjects experienced

relief as compared to baseline, but no statistically significant

differences were seen between IVMT and placebo. The efficacy of IVMT

for fibromyalgia, relative to placebo, is as yet uncertain.