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Selective estrogen receptor modulators (SERMs) for uterine leiomyomas

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Abstract

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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 methods

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.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

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Selective estrogen receptor modulators (SERMs) for uterine leiomyomas

Selective estrogen receptor modulators (SERMs) are a novel synthetic estrogen receptor (ER) ligand, which may be useful for women with uterine fibroids. Three randomized clinical trials evaluating the beneficial and harmful effects of SERMs are included in this review. However due to the small number of participants in the included studies, as well as the poor quality of some studies, the authors were not able to recommend their use or non use in women with uterine fibroids.