Background The pathophysiology of Fibromyalgia syndrome (FM) is mostly uncertain and the conventional medication therapy results from empirical research. FM is a common disorder that is estimated to affect 2–4% of the population. Serotonin reuptake inhibitors are now used in FM due to their interference in the serotonin metabolism.
Objectives To evaluate the relative efficacy and tolerability of Sertraline in the long-term treatment of fibromyalgia patients.
Methods Fifty patients who fulfilled the American College of Rheumatology criteria for the classification of fibromyalgia were entered in a 6-month prospective, controlled trial; all patients were treated with Sertraline (50–100 mg/day). Symptomatic treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and/or analgesic was allowed at optimal doses that were established on the basis of each patient?s needs. Five control examinations were planned (at baseline, after 15 days at month 1,2,3, and 6). Primary efficacy measures were (1) patient self assessment of pain on a 10 cm visual analogue scale (VAS), (2) tender point index (TPI) which is the sum of individual tenderness severity at each of the 18 standard ACR tender points and (3) Fibromyalgia Impact Questionnaire (FIQ). Other six secondary clinical efficacy measures were selected: physician and patients’ global assessment of the disease, sleep quality assessment using a 100-mm visual analogue scale, Health Assessment Questionnaire (HAQ) the Hamilton rating scale for depression (HRSD) and the Hamilton rating scale for anxiety (HRSA). Tolerability assessment was based on the occurrence of any adverse events.
Results All primary efficacy measures were significantly improved after 1 month of treatment (p < 0.05) and maintained a significant improvement throughout the study. No further improvement was however observed after 3 months of treatment. Most of the secondary efficacy measures improved significantly; in particular HRDS and HRSA (p < 0.01) improved after 1 month of treatment. After 6 months of treatment, 23 patients (45%) were still on treatment with Sertraline. Most of the withdrawals were due either to inefficacy (12 patients), side-effects (7 patients) or lost to follow-up (8 patients).
Conclusion Our data confirm the long-term efficacy of sertraline in a discrete percentage of patients with fibromyalgia.
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