A pilot randomized placebo-controlled study of pirlindole in the treatment of primary fibromyalgia

Objectives: The objective of this study was to evaluate the efficacy and safety of pirlindole [75 mg b.i.d.], a reversible and selective inhibitor of monoamine oxidase A [RIMA] in the treatment of primary fibromyalgia syndrome [FMS]. Methods: One hundred patients were included in a four-week double- blind placebo-controlled study. The safety analysis was based on 89 patients [45 pirlindole and 44 placebo] and the efficacy analysis on 61 patients [33 pirlindole and 28 placebo]. The evaluation of the outcome of therapy was based on the results obtained on eight characteristic parameters [pain, morning stiffness, tender pain score, psychological evaluation using the Symptom Checklist-90-Revised, fatigue, sleep disturbance, global evaluation by the patient, global evaluation by the investigator]. Results: When compared with baseline evaluation a significant improvement [P 0.05]. Conclusion: This four-week double-blind placebo-controlled trial suggests that pirlindole [75 mg b.i.d.] might be a well-tolerated and beneficial treatment for FMS patients.SCOPUS: ar.j