Efficacy of Raloxifen in treatment of fibromyalgia in menopausal women.

BACKGROUND: This study compared Raloxifen (Evista) with placebo in treatment of fibromyalgia.

METHODS: One hundred menopausal women with fibromyalgia enrolled in a double-blind randomized study from Feb 2005 until Oct 2006. We compared efficacy of Raloxifen, and placebo over 16 weeks of treatment. Fifty patients received Raloxifen 49 of which (98%) completed the study and 47 (94%) of 50 patients who received placebo completed the study. Raloxifen in 60 mg or identical placebo dose was given every other day over 16 weeks and patients were followed up. Improved recovery for a treatment group was assessed by a significantly higher mean score from baseline to the end of the treatment trial, compared with patients treated with placebo, on measures of Stanford Health Assessment Questionnaire (HAQ); Iranian version of Hospital Anxiety and Depression questionnaire (IHAD); sleep disturbance; number of tender points; reduction of pain and fatigue based on Visual Analogue Score (VAS).

RESULTS: Raloxifen produced a significantly higher response rate than placebo in treating fibromyalgia by improving pain and fatigue, reducing of the tender point count, sleep disturbance and recovery of usual activities as measured by the Stanford Health Assessment Questionnaire (HAQ). The significant effect of Raloxifen on HAD score among patients with fibromyalgia was not seen.

CONCLUSION: Raloxifen was superior to placebo in the treatment of menopausal patients with fibromyalgia.