[2009] [SAT0471] A DOUBLE BLIND CLINICAL TRIAL: TREATMENT OF FIBROMYALGIA IN POST-MENOPAUSAL WOMEN WITH EVISTA
S. Sadreddini1, M. Molaeefard2, H. Noshad3, M. Ardalan3, A. Asadi3 1Rheumatology, Tabriz university of medical sciences; 2rheumatology, Tabriz university (medical sciences); 3rheumatology, Tabriz university of medical sciences, Tabriz, Iran (Islamic Republic of)
Background: Raloxifene (Evista) has been found to function as an estrogen antagonist when acting through estrogen receptor β on genes containing estrogen response elements but function as a partial agonist when acting on genes through estrogen receptor α. It may be as an ideal alternative to hormone replacement therapy. Previous studies have shown that estrogen is strongly implicated in the regulation of mood and behaviour and in the pathobiology of mood disorders. It acts as a psychomodulator during periods of decreased estrogen levels. There are also growing evidences suggesting that estrogen may be efficacious as a sole antidepressant for depressed perimenopausal women (1). A low estrogen level is responsible for affective symptoms, including depressed mood, anxiety, sleep disturbances and fatigue (2). It has been shown that Estrogen can induce the transcription of opiates in estrogen receptor-positive cells derived from the superficial layers of the spinal dorsal horn (3, 4). These endogenous opiates act on enkephalinergic neurons to mediate inhibition of nociceptive relay cells, both in primary afferent fibers as well as in pain-modulating fibers descending from the brainstem (5). Efficacy of testosterone on pain in fibromyalgia (6) is supported by the discovery of aromatase-positive cells in the spinal cord dorsal horn of higher vertebrates (quail), where initial processing of pain sensation occurs (7) and the presence of aromatase, which converts testosterone to 17_ estradiol, is very interesting.
Objectives: This study compared Raloxifen (Evista) with placebo in the treatment of fibromyalgia.
Methods: A total of 100 menopausal women with fibromyalgia enrolled from Feb 2005 until Oct 2006 entered a double blind randomized study comparing Raloxifen, and placebo over 16 weeks of treatment.
Fifty patients received Raloxifen and 49 (98%) completed the study, 50 received Placebo and 47 (94%) completed the study.
Raloxifen in doses of 60 mg/every other day or identical placebo were given over 16 weeks of follows 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.
Results: Raloxifen produced a significantly higher response rate than placebo in treating fibromyalgia, in improving pain and fatigue symptoms, reduction in the number of tender points, sleep disturbance and recovery of activities in daily living as measured by the Stanford Health Assessment Questionnaire (HAQ). The mean age of Raloxifen group was lower than placebo group but the mean duration of disease and menopause was not significantly different between them so it doesn't seem that the difference of age can explain the better effect of Raloxifen in this study.
There was no effect of Raloxifen on HAD score among fibromyalgia patients.
Conclusion: Given the doses of medication used in this study, Raloxifen was superior to placebo in the treatment of menopausal patients with fibromyalgia.
Disclosure of Interest: None declared
Ann Rheum Dis 2009;68(Suppl3):694
Fibromyalgia
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