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Evidence for complementary therapies to replace HRT

Now that patients may be asking about alternatives to HRT, Professor Edzard Ernst considers the trial data available

Three-quarters of peri-menopausal women use some form of complementary or alternative medicine1. Given the increasing uncertainties concerning HRT this figure is likely to rise even further.

GPs are therefore bombarded with questions about the value of complementary therapies for menopausal symptoms. The list of complementary therapies advocated seems endless; in seven books I found 68 different treatments recommended for menopausal symptoms, yet trial data is scarce

(see above).

Dietary supplements

Dietary supplements include herbal and other natural products. For most of them the trial evidence is too weak for firm recommendations2, but three supplements stand out because they have been submitted to more extensive research.

Black cohosh Four randomised controlled trials of black cohosh (Cimifuga racemosa) extracts have yielded some promising, but not compelling, evidence for efficacy3. The small beneficial effects observed in some studies could be explained by central effects, but oestrogenic actions cannot be ruled out. Adverse effects of black cohosh are rare, mild and transient4.

Red clover So far, 11 randomised controlled trials of red clover (Trifolium pratense) extracts have been published. Our meta-analysis of this data indicates a significant but small reduction in frequency of hot flushes in women receiving active treatment compared with those taking placebo5. The average difference was 1.5 hot flushes per day. No serious safety problems have been recorded.

Soy extracts Soy extracts are rich in phytoestrogens and have long been popular for controlling menopausal symptoms. Our systematic review found 13 relevant randomised controlled trials6, the results of which are split almost down the middle. Promising evidence of efficacy, therefore, does not exist. However, the contradictions in this area are remarkable; existing trials are heterogeneous in every possible way, so firm recommendations are impossible.

Acupuncture

Very few rigorous trials have tested the effectiveness of acupuncture. Even though acupuncture's results are positive and, in the right hands, safe7, the value for controlling menopausal symptoms remains unclear, not least because the therapeutic effects on menopausal symptoms (if any) seem small and transitory.

Reflexology

We conducted a randomised controlled trial with 76 menopausal women receiving either reflexology foot massages or a sham treatment for their menopausal symptoms8. Symptoms such as hot flushes, anxiety and depression responded well in both groups, and there was no

suggestion that real reflexology was more effective than sham reflexology.

Relaxation

Three small randomised controlled trials are available. They uniformly suggest significant but small benefits in terms of frequency and severity of hot flushes. It is unclear which form of relaxation is best – biofeedback, muscle relaxation or relaxation training.

Spinal manipulation

A randomised controlled trial tested the effects of regular osteopathic treatments (once weekly for 10 weeks) in 30 women with menopausal symptoms and compared the results with a sham intervention9. The findings favoured active treatment for a range of symptoms, including depression and hot flushes. This study requires independent replication before firm recommendations can be made.

Discussion

Given the popularity of complementary therapies for menopausal symptoms, the evidence is disappointing. For most interventions that are regularly recommended we have no good studies at all. Where trials are available the data is scarce and often contradictory.

This leaves GPs in a difficult position when trying to advise their patients responsibly. The best course of action is to be honest about the uncertainty. The most convincing data exists for HRT. No complementary therapy has been shown to rival its efficacy in controlling symptoms of the menopause.

If patients don't want HRT they should be told that relaxation therapies are a good, risk-free option for alleviating symptoms. Many patients will ask about 'natural' supplements. They should be told that black cohosh, red clover and soy extracts have all shown some promise, but that sadly there are two important caveats with all of these – the data is not convincing and they may have similar hormonal effects to HRT.

Patients will also ask about a host of other treatments, not least because they are aggressively marketed. They can be told there is no good evidence to suggest these treatments do more good than harm. Perhaps they should also be reminded of some simple common sense – if it sounds too good to be true, it probably is.

Main points for GPs

lThe majority of women suffering from menopausal symptoms try complementary therapies – even if they don't tell their GP

lMost forms of complementary medicine have not been submitted to clinical trials

lThose that have been trialled have generated mixed results

lThe best evidence is for relaxation therapy and red clover supplements

lThe risks of these two treatments are minimal

lThe area merits further research

Edzard Ernst is professor in complementary medicine, Peninsula Medical School, Exeter

References

1. Newton KM et al. Use of alternative therapies for menopause symptoms:

results of a population-based survey.

Obstet Gynecol 2002;100:18-25

2. Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomised, controlled trials.

Ann Intern Med 2002;137:805-13

3. Borrelli F, Ernst E. Cimifuga racemosa: a systematic review of its clinical efficacy. Eur J Clin 2002;58:235-41

4. Huntley A, Ernst E. A systematic

review of the safety of black cohosh. Menopause 2003;10:58-64

5. Thompson Coon J et al. The role of red clover isoflavones in women's reproductive health: a systematic review and meta-analysis of randomised clinical trials. (submitted for publication) 2003

6. Huntley A, Ernst E. Soy for the treatment of perimenopausal symptoms – a systematic review. Maturitas 2004;47:1-9

7. Melchart D et al. Prospective investigation of adverse effects of acupuncture in 97,733 patients.

Arch Intern Med 2004;164:104-5

8. Williamson J et al. Randomised controlled trial of reflexology for menopausal symptoms.

Br J Obstet Gynaecol 2002;109:1050-5

9. Cleary C, Fox JP. Menopausal symptoms: an osteopathic investigation. Complement Ther Med 1994;2:181-6

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