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.


CONCLUSIONS
Raloxifen was superior to placebo in the treatment of menopausal patients with fibromyalgia.
Tabriz University of Medical Sciences, Iran. shahramsd2005@yahoo.com
Shahram
S
Sadreddini
Mahshid
M
Molaeefard
Hamid
H
Noshad
Mohamadreza
M
Ardalan
Amirhossein
A
Asadi
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D010147:Pain Measurement; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D004965:Estrogen Antagonists; D020849:Raloxifene Hydrochloride