Soy germ extract alleviates menopausal hot flushes: placebo-controlled double-blind trial

Martin Imhof,Marianne Imhof,Anca Gocan,Mathias Schmidt

doi:10.1038/s41430-018-0173-3

Martin Imhof, Marianne Imhof + Show 2 more

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https://doi.org/10.1038/s41430-018-0173-3

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Abstract

Background/objectivesA double-blind, placebo-controlled study was performed to assess the potency of a soy germ preparation for the alleviation of menopausal hot flushes.Subjects/methodsCaucasian women with at least seven hot flushes daily were treated with soy germ extract (100 mg isoflavone glycosides) daily or with placebo for 12 weeks, followed by 12 weeks of open treatment with soy. Outcome parameters were the number of hot flushes and the evaluation of the Greene Climacteric Scale.ResultsA total of 192 women were included. As the hot flush diaries from one study centre were lost, the assessment of hot flushes was based on 136 participants (soy: 54 women; placebo: 82 women). After 12 weeks, 180 women were available for the analysis of Greene Scale and safety (soy and placebo: each 90 women). Hot flushes were reduced by 43.3% (–3.5 hot flushes) with soy and by 30.8% with placebo (–2.6; p < 0.001). After the open treatment phase with soy, both original groups showed a reduction of 68% of hot flushes. A subgroup analysis showed better effects for soy when symptoms were classified as “severe” at baseline. After 12 weeks of double-blind treatment, there was an improvement from baseline values of 71 and 78% with soy with the items “hot flushes” and “sweating”, compared with 24% for both items with placebo. Hormonal safety parameters remained uninfluenced.ConclusionsSoy germ extract with 100 mg of isoflavone glycosides was shown to modestly, but significantly reduce menopausal hot flushes.

Highlights

The health-related effects of soy preparations are mostly attributed to the fraction of isoflavones, with genistein, Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users.One of the earliest health-related observations associated with isoflavone exposure is the inverse relation between soy exposure in Asian societies and the incidence of menopausal hot flushes [5]
It has been maintained that the beneficial effect of isoflavone supplementation on menopausal vasomotor complaints was consistently demonstrated in all clinical trials with an adequate design [8]
A relatively recent metaanalysis of 10 studies reporting hot flush frequencies indicated that isoflavone exposure results in a significantly greater reduction in hot flush frequency compared with placebo [9]

Summary

Introduction

The NAMS did, point to a poor inter-study comparability, especially with respect to natural food and supplements containing isoflavones. The review by NAMS calculated a decrease of daily hot flushes frequency by 24–60% with isoflavone doses of 40–160 mg per day [6]. The US Food and Drug Organisation recommends a minimum of seven hot flushes daily for the performance of studies of menopausal vasomotor complaints [7]. It has been maintained that the beneficial effect of isoflavone supplementation on menopausal vasomotor complaints was consistently demonstrated in all clinical trials with an adequate design [8]. Soy isoflavones have been proposed as a first approach in the treatment of menopausal vasomotor symptoms [18], especially in women who cannot or do not want to be treated by hormone replacement therapy (HRT)

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