Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study

Prevention Research Center, Yale University School of Medicine, Derby, CT 06418, USA.

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 < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 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.

Ali A, Njike VY, Northrup V, Sabina AB, Williams AL, Liberti LS, Perlman AI, Adelson H, Katz DL. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med. 2009 Mar;15(3):247-57. PubMed PMID: 19250003

Discussion:
The study found that both the treatment group and the placebo group responded well to the intervention, both having improved tender points. However the treatment group (those who got the Myer's Cocktail) also had improved scores for pain and quality of life at 4 weeks after the intervention. This did not occur in the placebo group.

Overall the participants responded well to the treatment with combined significant improvements in tender points, pain and quality of life experienced only in the group that got the Myer's Cocktail.