The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding, and selective outcome reporting), by inconsistency (unexplained variability in results), by indirectness (differences between the outcomes of interest and those reported: only short-term outcomes reported), and by imprecise results (few patients).
A Cochrane review [Abstract] 1 included 2 studies with a total of 230 subjects (mainly women) diagnosed with fibromyalgia that evaluated 2 different monoamine oxidase inhibitors (MAOIs): pirlindole (duration of 4 weeks) and moclobemide (duration of 12 weeks). Pirlindole showed statistically significant results compared with placebo for several outcomes (pain, tender points and overall assessment by the patient and the physician, n=61), whereas moclobemide did not show statistically significant differences between groups (pain MD -0.70, 95% CI -2.07 to 0.67; tender points SMD -0.14, 95% CI -0.65 to 0.36; global assessment by patient MD 0.00, 95% CI -1.24 to 1.24; global assessment by physician SMD-0.29, 95% CI -0.80 to 0.22; n=60).
Pooled results of the two studies (n=121) displayed a modest effect size in pain (MD 1.45, 95% CI -2.71 to -0.20; statistical heterogeneity I2 =59%) and a small effect on tender points (SMD -0.36, 95% CI -0.72 to -0.00). No effect was seen on global assessment by patient. Physical function and sleep disturbance were not measured. The most frequent adverse events were nausea and vomiting.
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