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May 3, 1995
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 IJ, Michalek JE, Flechas JD, Abraham GE
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