Treatment of fibromyalgia syndrome with Super Malic: a randomized, double blind, placebo controlled, crossover pilot study.
OBJECTIVE
To study the efficacy and safety of Super Malic, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM).


METHODS
Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed.


RESULTS
No clear treatment effect attributable to Super Malic was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks.


CONCLUSIONS
These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.
Russell
I J
IJ
Department of Medicine, University of Texas Health Science Center, San Antonio 78284-7874, USA.
Michalek
J E
JE
Flechas
J D
JD
Abraham
G E
GE
D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D008276:Magnesium Hydroxide / Q000627:therapeutic use*; D008293:Malates / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos
D004338:Drug Combinations; D008293:Malates; D010919:Placebos; C098187:Super Malic; C030298:malic acid; D008276:Magnesium Hydroxide