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


METHODS
This was a randomized, double-blind, placebo-controlled pilot study.


METHODS
The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT.


METHODS
The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS.


METHODS
Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks.


METHODS
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
Ather
A
Prevention Research Center, Yale University School of Medicine, Derby, CT 06418, USA. david.katz@yale.edu
Njike
Valentine Yanchou
VY
Northrup
Veronika
V
Sabina
Alyse B
AB
Williams
Anna-Leila
AL
Liberti
Lauren S
LS
Perlman
Adam I
AI
Adelson
Harry
H
Katz
David L
DL
D000328:Adult; D001205:Ascorbic Acid / Q000008:administration & dosage*; D002125:Calcium Gluconate / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D015636:Magnesium Chloride / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010205:Pantothenic Acid / Q000008:administration & dosage*; D010865:Pilot Projects; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage*
D004338:Drug Combinations; D015636:Magnesium Chloride; D014803:Vitamin B Complex; D010205:Pantothenic Acid; D001205:Ascorbic Acid; D002125:Calcium Gluconate