Selective estrogen receptor modulators (SERMs) for uterine leiomyomas.

BACKGROUND: Uterine fibroids are benign tumors that arise from individual smooth muscle cells of the uterus. Selective estrogen receptor modulators (SERMs) are ER ligands that act as estrogens in some tissues, while blocking estrogen action in others. There have been many clinical studies of various SERMs for uterine fibroid. However, their effectiveness is controversial.

OBJECTIVES: To evaluate the evidence for the effectiveness and safety of selective estrogen receptor modulators in women with uterine fibroids.

SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, the Register of Chinese trials developed by the Chinese Cochrane Centre, and the Chinese Med Database, Chinese Biomedical Disc (CBMDisc 1978 to July 2004); VIP (1989 to October 2005)); China National Knowledge Infrastructure (CNKI 1994 to 2003) in October 2005. We hand searched a number of journals, and searched reference lists, databases of ongoing trials and the Internet.

SELECTION CRITERIA: We included randomized controlled studies of selective estrogen receptor modulators versus other forms of medical therapy or placebo in women in the reproductive age (18 to 45 years old) with confirmed uterine fibroid.

DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality. As the studies identified were not sufficiently similar and not of sufficient quality, we did not do a meta-analysis but summarized the data in a narrative format.

MAIN RESULTS: Three studies involving 215 participants were included, trial size varied from 25 to 100. Comparison interventions included no treatment, Poly vitamins, and leuprolide acetate depot plus raloxifene versus leuprolide plus placebo tablet. There was a tendency towards fibroid reduction with selective estrogen receptor modulators (SERMs), although this was not significant in all studies. All three studies mentioned adverse reactions but no detailed data were acquired in the included studies.

AUTHORS' CONCLUSIONS: There is no evidence from the limited number of studies that SERMs reduce the size of fibroids or improve clinical outcomes. Further studies are required to establish evidence of benefit of SERMs in treating women with uterine fibroids.