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 a nd safety of pirlindole [75 mg b.i.d.], a reversible and selective inh ibitor of monoamine oxidase A [RIMA] in the treatment of primary fibro myalgia syndrome [FMS]. Methods: One hundred patients were included in a four-week double-blind placebo-controlled study. The safety analysi s was based on 89 patients [45 pirlindole and 44 placebo] and the effi cacy analysis on 61 patients [33 pirlindole and 28 placebo]. The evalu ation of the outcome of therapy was based on the results obtained on e ight characteristic parameters [pain, morning stiffness, tender pain s core, 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] was noticed for all th e parameters with pirlindole whereas three parameters only [tender poi nt score, psychological score, global evaluation by the patient; P < 0 .05] were significantly improved by the placebo. Moreover, at the end of the four-week treatment period, pirlindole appeared to be significa ntly superior to placebo on four parameters [pain, tender point score, global evaluation by the patient and the investigator]. Side-effects were observed in 40% of the pirlindole-treated patients and 3 6.4% of the placebo-treated patients leading to 13.3% and 6.8% drop-outs, resp ectively. These differences were not statistically significant [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.