Despite a re-evaluation of risks in recent years, hormone replacement therapy is still surrounded by controversy. Almost 30% of women in a recent survey sought a natural approach to combat climacteric symptoms. Nevertheless, a large proportion of patients felt that they wanted a good safety profile and strong evidence base for treatment. This article seeks to review the evidence supporting non-hormonal approaches to treatment. There is only conflicting evidence at best to support alpha-2 agonists, e.g. clonidine and limited evidence for dihydroepiandrosterone and natural progesterones. There is limited randomized controlled trial data for gabapentin, selective norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs), many of these studies being related to breast cancer patients. Of the herbal medicinal products, the largest evidence base rests with phytoestrogens. A Cochrane Database review looking at all types of phytoestrogens, e.g. red clover extracts, dietary soya and soya extracts concluded that there was no evidence to support improvement in climacteric symptoms and the meta-analysis of a 178 studies on soy products was inconsistent. Nevertheless, other studies disagree. Mammographic density is not affected by soy or phytoestrogen products and recent in vitro work shows only a weakly proliferative effect of soy isoflavone on breast cancer cells and evidence that soy isoflavone blocks the proliferative effect of estradiol on these cells. There are no studies looking at clinical outcome measures for cardiovascular disease but a number of studies looking at biochemical markers including arterial wall stiffness and apolipo protein B. Recent studies have also looked at the effects of red clover isoflavone on mood and depression, using specific depression rating scales. Finally, it is important to note that herbal medicinal products should not be used without caution. Some may produce quite marked side-effects in high doses and others can interact with pre-existing medication. A strategy for which patients are suitable for herbal medicinal products is reviewed.

BACKGROUND:

Menopause is described as the transition from the reproductive phase of a women to the non reproductive. Changes in hormone levels might lead to complaints and health consequences especially during peri- and postmenopause. Hormone therapy has a potential damaging health risk profile and is recommended for temporal limited therapy for acute vasomotor symptoms only.

OBJECTIVE:

The present HTA-report aims to assess the effectiveness and the cost-effectiveness of alternative treatment methods for women with postmenopausal symptoms in Germany regarding patient relevant endpoints (reduction of symptoms and frequency of adverse events and improvement of quality of life).

METHODS:

A systematic literature search was carried out in 33 relevant databases in September 2010. Citations were selected according to pre-defined criteria and were extracted and evaluated.

RESULTS:

In the systematic research 22 studies are identified for the effectiveness evaluation, 22 primary studies and one review. High doses of isolated genistein reduce the frequency/intensity of hot flashes while low doses of genistein show no significant effect. Intake of isoflavone extract such as genistein, daidzein, glycitein in various combinations does not have an effect on improvement of cognitive function or vaginal dryness. The effect of black cohosh and hop extract for menopausal complaints cannot be determined since results are heterogenous. The combination of isoflavone, black cohosh, monk’s pepper, valerian and vitamin E has a positive effect on menopause symptoms. Ginkgo biloba shows no significant effect on menopause symptoms and cognitive improvement beside mental flexibility. Acupuncture has a significant influence on hot flashes especially in severe cases.

DISCUSSION/CONCLUSION:

No final statement can be drawn regarding the effectiveness of alternative treatment methods due to qualitative shortcomings of included studies and a general limited availability of studies in this field. Furthermore, the generalization of the present HTA is limited due to the inclusion of only postmenopausal women.