Background Vasomotor symptoms, such as hot flushes and night sweats, are very common during themenopausal transition. Hormone replacement therapy has traditionally been used as a very effective treatment but concerns over increased risks of some chronic diseases havemarkedly increased the interest of women in alternatives. Some of the most popular of these are treatments based on foods or supplements enriched with phytoestrogens, plant- derived chemicals that have oestrogenic action. Objectives To assess the efficacy, safety and acceptability of foods and supplements based on high levels of phytoestrogens for reducing hot flushes and night sweats in postmenopausal women. Search strategy Searches were undertaken of the following electronic databases: the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of randomised trials, Cochrane Register of Controlled Trials (CENTRAL) (March 2007), MEDLINE (1966 toMarch 2007), EMBASE ( 1980 to March 2007), AMED ( 1985 to March 2007), PsycINFO ( 1986 to March 2007) and CINAHL (1982 to March 2007). Attempts were made to access grey literature by letters to pharmaceutical companies and searches of ongoing trial registers. Reference lists of included trials were also searched. Selection criteria Studies were included if they were randomised, had peri- or postmenopausal participants with vasomotor symptoms, a duration of at least 12 weeks and where the intervention was a food or supplement with high levels of phytoestrogens (and not combined with other herbal treatments). Trials of women who had breast cancer or a history of breast cancer were excluded. Data collection and analysis Selection of trials, data extraction and quality assessment were undertaken by at least two authors. Most of the trials were too dissimilar to combine in meta-analysis and their results are provided in table format. Studies were grouped into broad categories: dietary soy, soy extracts, red clover extracts and other types of phytoestrogen. Five trials used Promensil, a red clover extract; these trials were combined in a meta-analysis and summary effect measures were calculated. Main results Thirty trials comparing phytoestrogens with control met the inclusion criteria. Very few trials had data suitable for combining in metaanalysis. Of the five trials with data suitable for pooling that assessed daily frequency of hot flushes, there was no significant difference overall in the frequency of hot flushes between Promensil ( a red clover extract) and placebo ( WMD=-0.6, 95% CI -1.8 to 0.6). There was no evidence of a difference in percentage reduction in hot flushes in two trials between Promensil and placebo ( WMD= 20.2, 95% CI - 12.1 to 52.4). Individual results from the remaining trials were compared. Some of the trials found that phytoestrogen treatments alleviated the frequency and severity of hot flushes and night sweats when compared to placebo but many of the trials were of low quality and were underpowered. There was a strong placebo effect in most trials with a reduction in frequency ranging from 1% to 59% with placebo. There was no indication that the discrepant results were due to the amount of isoflavone in the active treatment arm, the severity of vasomotor symptoms or trial quality factors. There was also no evidence that the treatments caused oestrogenic stimulation of the endometrium ( an adverse effect) when used for up to two years. Authors' conclusions There is no evidence of effectiveness in the alleviation of menopausal symptoms with the use of phytoestrogen treatments.
