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Reduction of menopausal symptoms without use of oestrogens: the efficiency of a particular soy extract is scientifically demonstated
Milan, August 1st 2002 - The Italian company, Indena, which researches and produces active plant principles and extracts, has undertaken pharmaco toxicological and clinical studies to explore the
effectiveness of its soy extract, Soyselect®.
Soyselect® is a special patented extract characterised by a double standardisation of isoflavones (13-17%)
and saponins (not less than 18%).
Two clinical trials on Soyselect®, carried out at the Policlinico Gemelli in Rome, and at
the Columbia Hospital in New York, have been published in the scientific journal Menopause. The two
studies mentioned represent today the only clinical studies on a standardised Soy extract performed
according to the double blind, randomised, placebo-controlled method.
These evaluations have proved the excellent clinical effect of Soyselect®, which, after a six-week treatment, reduces all menopausal symptoms by 45%. These results are in line with epidemiological data, which highlight in certain oriental populations, including the Japanese, a lower incidence of symptoms related to menopause and postmenopause.
Responsible for these differences is the soy enriching the oriental diet. Indena therefore, set
out to test the efficacy of these active principles with pharmaco toxicological and clinical methods, thereby corroborating the epidemiological data.
In the clinical study conducted by Indena in conjunction with Policlinico Gemelli, a progressive diminution
of the number of hot flushes per week was recorded. During the 6 weeks in clinic, 39 women in
menopause, divided randomly in two groups, were administered 50 mg/day of soy isoflavones and
placebo. The diminution of hot flushes was significantly greater in the group treated with Soyselect® compared with those receiving placebo while no aspecific or correlated side-effect was found with regard
to oestrogens. It was concluded that treatment with Soyselect® is well-tolerated and effective against
climacteric symptoms and may be recommended for women who cannot undergo hormone therapy.
The efficacy of Soyselect® is guaranteed due to the presence of two different specific molecular classes:
the isoflavones and the saponins.
Isoflavones are able to imitate some of the biological effects of
oestrogens on menopausal and post-menopausal complaints without any simultaneous increase in
neoplastic risk.
Thanks to their ability to lower cholesterol, saponins are an effective instrument in
preventing cardiovascular damage and, administered orally, are an excellent vehicle for the isoflavonic
component.
Soyselect® may be a safe and efficacious therapy for relief of menopausal symptoms in women who refuse
or have indications for not using HRT. In consideration of its high degree of innovation, the Indena
product has applied for the Italian patent and an international extension in the USA, Japan, Canada and
Australia.
(1) Published in Food and Chemical Toxicology 37 (1999) 493-502 and Breast Cancer Reasearch and Treatment 69
(2001) 153-164
(2) Published in Menopause: The Journal of the North American Menopause Society Vol 7, No. 2 (2000) 105-111; Vol
7, No. 4 (2000) 236-242
