Indena studies support Soyselect

Italian plant extract company Indena reported that studies to explore the effectiveness of its soy extract, Soyselect, showed that it may be a safe and effective therapy for relief of menopausal symptoms in women who refuse or have contraindications for HRT.

The company said the trials proved that after a six-week treatment the extract reduces all menopausal symptoms by 45 per cent.

Soyselect is a patented extract with a double standardisation of isoflavones (13-17 per cent) and saponins (25 per cent). Two clinical trials on the product, carried out at the Policlinico Gemelli in Rome, and at the Columbia Hospital in New York, have been published in the scientific journal Menopause​.

According to Indena, the studies are the only clinical studies on a standardised soy extract performed according to the double blind, randomised, placebo-controlled method.

Setting out to test the efficacy of these active principles with pharmaco-toxicological and clinical methods, the study, carried out in conjunction with Policlinico Gemelli, recorded a progressive reduction of the number of hot flushes per week. During six weeks in the clinic, 39 women in menopause, divided randomly into two groups, were administered 50mg daily of soy isoflavones or a placebo. The number of hot flushes was significantly lower in the group treated with Soyselect compared with those receiving the placebo, and no side effects from the oestrogens were reported.

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 company added that its results are in line with epidemiological data showing, in certain oriental populations such as the Japanese, a lower incidence of symptoms related to menopause and post-menopause - a result of the soy-rich diet.

Indena explained that the efficacy of Soyselect is due to the presence of two different molecules - 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 are effective when administered orally.

Indena has applied for an Italian patent for the product and an international extension in the US, Japan, Canada and Australia.