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EDITORIALS: Susan R Davis Phytoestrogen therapy for menopausal symptoms? BMJ 2001; 323: 354-355 [Full text]

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Please declare competing interests transparently

Ron Law   (18 August 2001)

Single Focus Intervention Is Often Too Narrow

Ned Hoke   (19 August 2001)

Published evidence supports a role for phytoestrogens in menopause

Alan Husband   (27 August 2001)

Soy isoflavones : an effective treatment of menopause disturbances

F Firenzuoli, L Gori   (27 August 2001)

Phytoestrogens use in breast cancer

Mario de Lemos   (28 August 2001)

Please declare competing interests transparently 18 August 2001
Ron Law Send response to journal: Re: Please declare competing interests transparently	This is a fascinating editorial -- what was the motive for it? A visit to Susan Davis' website (1) provides some clues. The Jean Hailes Foundation clearly has a very close liaison with the corporate world -- both food (2) and medicine (3) including hormone replacement therapy (4) with with Dr Davis has a personal interest. Their website defines a drug as, "...anything that is taken to change the way the body works normally”, all medicines - whether by prescription or under the umbrella of ‘complementary therapies’, and irrespective of their origin - must be judged by the same standards. The website clearly has an anti complementary medicine bias. When we take water to quench our thirst, this definition makes it a drug -- it effects the way the body works normally. Should water be judged by the same standards as the synthetic drugs that even when used properly kill so many? For such a prominant editorial to be so lacking in transparency is unusual for the British Medical journal -- readers expect a higher standard of professionalism. Ron Law is a University lecturer in management and executive director of the New Zealand National Nutritional Foods Association. He was also a member of the New Zealand Ministry of Health working group advising on the management of medical error in the New Zealand health system. 1. http://www.jeanhailes.org.au/newsletter/October2000/features.htm 2. http://www.jeanhailes.org.au/newsletter/October2000/features.htm#uncle%20tobys 3. http://www.jeanhailes.org.au/media_release/oct202000.htm 4. http://www.jeanhailes.org.au/media_release/aug242000.htm
Single Focus Intervention Is Often Too Narrow 19 August 2001
Ned Hoke, private practice Western US Send response to journal: Re: Single Focus Intervention Is Often Too Narrow	This is welcome science and the carelessness of popular marketing and assumptions are usually a important to unmask. Clinically however this really isn't news. Assisting the menopausal woman to greater comfort isn't merely one thing as the author alludes to in her closing remarks. Supporting and easing hormonal transitions is however, in my opinion, worthy of better interventions than HRT. Appropiately unmasking the silliness of the one to one phytoestrogen story vs. pharmacological estrogen influence does not itself support the latter as the best choice whatsoever looking more broadly again from a clinical view.
Published evidence supports a role for phytoestrogens in menopause 27 August 2001
Alan Husband, Research Director Novogen Limited Send response to journal: Re: Published evidence supports a role for phytoestrogens in menopause	I concur with the views of correspondents Law and Hoke regarding this article (“Please declare competing interests transparently” Ron Law, 18 August 2001; “Single Focus Intervention Is Often Too Narrow” Ned Hoke, 19 August 2001). But there is a deeper concern with this article in that published information has been overlooked by Susan Davis which would have argued against her claims that “There's no good evidence that it's any better than placebo” – in fact there is good published evidence which she has overlooked, demonstrating that isoflavone phytoestrogens are effective not only for managing acute menopause symptoms but also for improved cardiovascular and bone health. Dr Davis referred in her Editorial to published data she claimed showed that an over the counter tablet preparation of isoflavones extracted from red clover had no greater benefit than placebo for vasomotor symptoms.1 While it is correct that in this study the mean response in the placebo group was not statistically different from the treatment group, this was not due to lack of effect in the treatment group but due to inadvertent or deliberate consumption of isoflavone-containing foods in the placebo group – ie. both groups responded with reduced flushing. This was demonstrated by measuring urinary isoflavones in both groups. Indeed, correlation analyses revealed strong positive correlation between reduction in symptoms and urinary isoflavone concentrations. Of greater concern is the fact that published evidence for cardiovascular and bone effects has been overlooked. In double blind placebo controlled trials, systemic arterial compliance, a measure which correlates with improved CVD risk, was significantly improved in women taking a red clover isoflavone supplement,2 the rate of loss of bone density in perimenopausal women taking the same supplement was halved over a 12 month period,3 and HDL cholesterol levels were improved.4 Data reported recently by Clifton-Bligh et al,5 using a modified and more concentrated red clover isoflavone supplement, indicated not only reduced bone loss but improved bone density as well as increased HDL levels after only 3 months of supplementation. It is a pity that in such a learned journal the privilege of Editorial comment can be used not only to present a view biased against natural therapies, but that peer-reviewed published data has been overlooked to achieve this outcome. In addition to a fractional professorial appointment at tThe University of Sydney, AJH is Research Director of Novogen Limited, an Australian pharmaceutical company involved in development and manufacture of red clover isoflavone supplements and research and development of novel prescription drugs based on synthetic isoflavone structures. 1. Baber RJ, Templeman C, Morton T, Kelly GE, West L. Randomised placebo controlled trial of an isoflavone supplement and menopausal symptoms in women. Climacteric 1999; 2: 85-92. 2. Nestel PJ, Pomeroy S, Kay S, Komesaroff P, Behrsing J, Cameron JD, West L. Isoflavones from red clover improve systemic arterial compliance but not plasma lipids in menopausal women. J Clin Endocrinol Metab 1999; 84: 895-898. 3. Atkinson C, Bingham SA, Compston SA, Robins SP. The effects of isoflavone phytoestrogens on bone; preliminary results from a large randomised controlled study. The Endocrine Society 82nd Annual Meeting, Toronto, Canada 2000; p.43 4. Woodside JV, Campbell MJ. Isoflavones and breast cancer. J.Br.Menopause Soc. 2001; 7(Suppl.1): 17-21. 5. Clifton-Bligh PB, Baber RJ, Fulcher GR, Nery ML, Moreton T. The effect of isoflavones extracted from red clover (Rimostil) on lipid and bone metabolism. Menopause 2001; 8: 259-65.
Soy isoflavones : an effective treatment of menopause disturbances 27 August 2001
F Firenzuoli Department of Phytotherapy - Empoli, Italy, L Gori Send response to journal: Re: Soy isoflavones : an effective treatment of menopause disturbances	Soy isoflavones : an effective treatment of menopause disturbances Firenzuoli F, Gori L Department of Phytotherapy, S. Giuseppe Hospital Via Paladini nr.1 - 50053 Empoli, Italy firenzuo@dada.it Dear Editor we think it is very hard to state about soy and soy extracts pharmacological activity that “results from in vitro and in vivo studies are inconsistent” in front of tens of papers showing lowering of haematic cholesterol, coronary vessels vasodilatation, reduction of atherosclerosis and platelet aggregation and estrogenic hormonal activity in ovariectomized animals too. Moreover beneficial pharmacological activities have been confirmed by numerous clinical studies both epidemiological and controlled versus placebo ones. A recent review (1) of scientific literature published during 1999-2001, has confirmed the potential benefits of soy on cardiovascular disease risk factors, and a double blind cross-over trial showed protective effect on cardiovascular disease in diabetic type 2 patients (2). Randomized double blind and placebo controlled studies dealing with soy phytoestrogens have confirmed beneficial effects on bone loss (3) and climacteric hot flashes (4). Recently we reviewed literature (5) about soy phytoestrogens and cancer, we concluded that they have a protective effect against development of breast cancer although the subject deserve further confirmation about treatment of patients already affected by neoplastic disease. In our department we usually administer a dose of 100-200 mg daily of soy isoflavones for treatment of menopause related depression and hot-flashes with about 70% positive clinical results in 226 patients. We counsel soy for prevention of cancer and atherosclerosis but we have still insufficient data. No competing interests. Bibliography 1. Vitolins MZ, Anthony M, Burke GL .: Soy protein isoflavones, lipids and arterial disease. Curr Opin Lipidol 2001 Aug;12(4):433-7. 2. Hermansen K, Sondergaard M, Hoie L, et al .:. Beneficial effects of a soy-based dietary supplement on lipid levels and cardiovascular risk markers in type 2 diabetic subjects. Diabetes Care 2001 Feb;24(2):228-33. 3. Alekel DL, Germain AS, Peterson CT, et al .: Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. Am J Clin Nutr 2000 Sep;72(3):844-52. 4. Upmalis DH; Lobo R; Bradley L, et al.: Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double- blind, randomized, placebo-controlled study. Menopause 2000 Jul- Aug;7(4):236-42. 5. Firenzuoli F, Gori L .: Phytoestrogens : Up-date. Min Med 2001; 92 (Suppl. 1 al N.3) : 82-4.
Phytoestrogens use in breast cancer 28 August 2001
Mario de Lemos, Provincial Drug Information Coordinator British Columbia Cancer Agency Send response to journal: Re: Phytoestrogens use in breast cancer	I am glad that there is more "mainstream" discussion on the pharmacologic action and toxicity of plant-based drugs. These substances have complex mechanisms of actions and may be safe to take in some circumstances but not in others. For example, phytoestrogens may stimulate or inhibit existing breast tumour growth, depending on the amounts taken.(1) Most pharmacy or medical schools stopped teaching pharmacognosy long ago, and are now scrambling to revive them with the increased interest in alternative therapy. It is time we once again look at any substance that is used to treat, prevent or mitigate a medical condition with the same scientific curiosity and scrutiny, irrespective of its source. Reference 1. de Lemos, ML. Effects of soy phytoestrogens genistein and daidzein on breast cancer growth. Annals of Pharmacotherapy. (in press)