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'Nutrients Direct': Myers' Cocktail and FMS
Abstract & Commentary
By Russell H. Greenfield, MD
Synopsis: This small pilot study represents the first controlled assessment of intravenous micronutrient therapy for fibromyalgia. No statistically significant benefit over placebo was identified, though clinical benefit was apparent, and feasibility was established. Regardless of one's bias regarding this type of care, further study is needed.
Source: Ali A, et al. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: A placebo-controlled pilot study. J Altern Complement Med 2009;15:247-257.
The authors of this double-blind, placebo-controlled, randomized study set out to assess the feasibility, efficacy, and safety of intravenous micronutrient therapy, specifically using the Myers' cocktail, for the treatment of fibromyalgia. By trial's end, data were evaluable on 31 adults (30 women; mean age, approximately 51 years) with American College of Rheumatology (ACR)-defined fibromyalgia syndrome (FMS). Subjects were recruited through advertisements and presentations to FMS support groups, and initial screening took place by phone. Eligible subjects went through a two-week run-in period to assess stability of FMS medication use and then were randomly selected to receive once-a-week infusions for a total of eight weeks of Myers' cocktail (IVMC) or lactated Ringer's solution (placebo) via antecubital fossa slow IV push using a 25 g butterfly needle. Blinding was maintained with the use of an opaque sheet that was placed over the syringe and cannula. Rescue treatment with NSAIDs was permitted as necessary within strict guidelines, and subjects had to agree to stop all vitamin/mineral supplements, as well as other CAM therapies, during the trial. The primary outcome measure was change in the Tender Point Index at the end of the eight-week intervention and after a further four-week wash-out period (12 weeks after the start of infusion therapy) as assessed by a single rheumatologist who was blind to treatment assignment. Secondary measures included global pain assessment as determined by visual analog scale (VAS), and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire).
Results of the IVMC intervention were equivocal. While the IVMC group experienced improvements so did the placebo group, such that between-group comparisons showed improvements that were clinically, but not statistically, significant. At eight weeks the IVMC group had improvements in tender points, pain, depression, and quality of life, while the placebo group experienced improvements only in tender points. This latter treatment effect persisted in the placebo group when assessments were repeated four weeks later; treatment effects in the IVMC group persisted four weeks later only for tender points, pain, and quality of life. The consistency and magnitude of treatment effects were greater in the IVMT group than in the placebo group. The authors conclude that IVMC therapy for the treatment of FMS is feasible but its effectiveness remains unclear.
The Myers' cocktail derives from the work of John Myers, MD, and later modification by Alan Gaby, MD. The rationale for this type of clinical intervention stems from the observation that enhanced levels of micronutrients can be achieved using intravenous administrations as compared with oral dosing, thereby making treatment of deficiency states more efficient, and that some of these same nutrients can exert pharmacologic effects.1 The constituents of the Myers' cocktail as used in this study were:
5 mL magnesium chloride hexahydrate (20%)
3 mL calcium gluconate (10%)
1 mL hydroxycobalamin (1,000 mg/mL)
1 mL pyridoxine hydrochloride (100 mg/mL)
1 mL dexpanthenol (250 mg/mL)
1 mL B-100 B complex containing a combination of 100 mg thiamine HCl, 2 mg riboflavin, 2 mg pyridoxine HCl, 2 mg panthenol, and 100 mg niacinamide
2% benzyl alcohol
5 mL vitamin C (500 mg/mL)
20 mL sterile water
Proponents of this form of therapy report clinical experience with benefit in the setting of at least FMS, migraine headaches, and asthma, but readily acknowledge the lack of scientific study of IVMC.
About 3-4% of U.S. women suffer from FMS, approximately 10 times the prevalence in men, and people experiencing FMS often seek complementary and alternative medical (CAM) therapies for relief of their symptoms at least in part due to the paucity of effective conventional medical options. The etiology of FMS has yet to be fully characterized but the clinical picture is notable for a predominance of widespread pain and muscle tenderness often accompanied by chronic fatigue, sleep disturbances, and a depressed mood. The ACR's criteria for a diagnosis of FMS include: 1) continuous presence of widespread (all four quadrants of the body, including axial) musculoskeletal pain of undetermined etiology for three months or more; and 2) pain in 11 of 18 tender point sites on digital palpation. Some practitioners believe that IVMC may benefit people with FMS due to a combination of modest volume expansion and provision of intravenous magnesium. In general, IVMC appears to be quite safe in experienced hands. Patients should be made aware of the potential for a sensation of heat during administration, and among general precautions espoused,1 extreme caution needs to be taken with people who may be hypokalemic or who are taking digoxin.
The current pilot trial is the first controlled study of IVMC for FMS and succeeds in establishing feasibility for this type of intervention. The small sample size precludes sweeping conclusions, even in the absence of statistically significant benefit, but the foundation has been laid for further investigation. Many practitioners, especially those conventionally trained, may harbor negative perceptions regarding this form of care, but one cannot argue that a growing number of infusion therapy medical centers are appearing across the country. This reviewer does not presently recommend IVMC but desires additional data to help better classify intravenous micronutrient therapy as an underutilized therapeutic strategy or a treatment no better than placebo.
1. Gaby AR. Intravenous nutrient therapy: The Myers' cocktail. Altern Med Rev 2002;7:389-403.