Non-hormonal therapy

Marco Gambacciani and Paula Marco Gambacciani and Paula AlbertazziAlbertazzi

Is there a proven place for Is there a proven place for phytoestrogens in the menopause?phytoestrogens in the menopause?

• Phytoestrogens are estrogens derived from plants

• We need :• Differentiation of different agents

• Standardization of dosages

• Safety and efficacy labelling

• Currently, there is no reliable evidence confirming a

substantial role for phytoestrogens in the treatment of

postmenopausal women

• Their increasing promotion should not be endorsed by the

medical profession by accepting promotional materials in

journals or at meetingsGinsburg J, Prelevic G. Ginsburg J, Prelevic G. ClimactericClimacteric 1999;2:75-8 1999;2:75-8

EditorialsEditorials

Phytoestrogen therapy for Phytoestrogen therapy for menopausal symptoms?menopausal symptoms?

• There's no good evidence that it's any better than placebo

• Women experiencing mild menopausal symptoms may gain relief by dietary

modification and lifestyle changes, such as reducing smoking and consumption of

caffeine and alcohol, stress management, and increased exercise

• However, there is no evidence to support the belief that even a very high intake of

soy products will alleviate hot flushes, night sweats, and other symptoms such as

vaginal dryness, mood changes, and musculoskeletal symptoms

• No absolute conclusions can be drawn from the few studies of the effects of

phytoestrogens on bone. As with other interventions of unproved efficacy, long-term

randomized trials will be required to determine the place (if any) of phytoestrogens

in the management of postmenopausal women

Davis SR. Davis SR. BMJBMJ 2001;323:354- 2001;323:354-55

Not all placebos are equally Not all placebos are equally pleasingpleasing

• Given the 57% reduction in hot flushes seen in the placebo groups of randomized, controlled trials of oral HRT, there is understandable scepticism about claims for the efficacy of products, usually complementary medicine, which find a reduction in vasomotor symptoms equal to or less than the normal 57% placebo effect

• A statistically significant effect may be claimed in such studies because the placebo effect was unusually small

Sturdee DW, MacLennan AH. Climacteric 2006;9:401–3

Non-hormonal therapies for Non-hormonal therapies for menopausal hot flushesmenopausal hot flushes

• Few high-quality trials have been published; most of them have methodological deficiencies. Hence, generalizability is limited

• Red clover isoflavone extracts had no effects and results were mixed for soy isoflavone extracts

• The effects are less than for estrogen• The SSRIs or SNRIs, clonidine, and gabapentin trials

provide some evidence for efficacy• These therapies may be useful for highly symptomatic

women who cannot take estrogen • Possible adverse effects and the high cost in different

countries may restrict use for many women

IMS Position Statement, February 2007

Alternative treatments

• The efficacy and safety of complementary alternative medicines (CAMs) have not been demonstrated and further studies are required.

• SSRIs, SNRIs and gabapentin are effective in reducing vasomotor symptoms in short-term studies. The long-term safety needs further evaluation.