Objective: To compare the efficacy of sertraline versus physical therapy (ultrasonography and physical therapy) in fibromyalgia.
Design: A 6-month comparative, prospective, randomised study of 70 female patients, aged 42 to 52, with fibromyalgia according to the criteria of the American College of Rheumatology. One group (N=36) underwent 6-month treatment with sertraline, 50 mg/24 h. The other group (N=34) received 15 sessions of 1 W/cm2 ultrasonography on the cervical trigger points plus physical therapy. Variables analyzed on a visual 10-point scale were pain and morning stiffness and sleep disorders by use of the sleep questionnaire of the Medical Outcome Study (MOS). Measurements were taken at the beginning of the study and at 3-month and 6-month follow-up.
Results: Pain significantly diminished in the sertraline group during the entire study (visual numeric scale: 7.2+/-1.1 initially, 5.3+/-?? at 3 months and 3+/-0.7 at 6 months, P<0.05). Morning stiffness and sleep disorder scores were positive only for the sertraline group during the entire 6 months (P<0.05). Results from the MOS questionnaire showed improvement only for the sertraline group. Of the Sertraline group, 83% evaluated the treatment as good or very good, as compared with only 6% of the ultrasonography group. No patient withdrew from the study.
Conclusion: Patients treated with sertraline had a better outcome in terms of pain, morning stiffness and sleep disorders, than the group treated with ultrasonography and physical therapy.