Healthcare Professionals

Promensil is licensed by Health Canada for efficacy, safety and quality under NPN 80015467, NPN 80016071 and NPN 80016069. Promensil maintains a valid Site License #300872 for the importation and storage of products under strict government regulation.

A panel of 8 international menopause experts from AustraliaconsultationSheet, USA, Canada, United Kingdom, and The Netherlands, has developed guidelines to assist practitioners in treating menopausal patients. The new treatment algorithm for vasomotor symptoms was written by Dr Lila Nachtigall, Professor of Obstetrics & Gynaecology at the New York University School of Medicine and colleagues, and has been published in 2006 in The Journal of Obstetrics and Gynaecology Canada. 54

The guidelines endorse the conservative use of hormone therapy and integrates complementary and lifestyle approaches for mildly and moderately symptomatic women. For women with less severe symptoms it is appropriate to first trial lifestyle modification and a complementary therapy. Hormone therapy is an appropriate second line therapy for women who have not achieved satisfactory management of vasomotor symptoms.

Promensil is an appropriate first line therapy for patients with mild or moderate vasomotor symptoms. HT is an appropriate second line option for women who have not gained adequate relief after an 8-12 week trial, and for women with severe menopausal symptoms. The guidelines exclude women with premature ovarian failure or with a high risk of osteoporosis.

Download the Treatment Algorithm

To assist you and your patients in a consultation, print out the Menopause Patient Consultation Sheet, which outlines menopause, the symptoms and treatment options. Talking through this consultation sheet will assist you and your patients to cover the important information about menopause.

Download the Consulation Sheet

To date, all of the clinical trials with PharmaCare isoflavone supplements in post-menopausal women required that no HRT was taken in recent months. In practice, it is anticipated that some time will be needed to allow the body to adjust to the change from synthetic hormones to the natural isoflavone approach. The following suggestions should be discussed by doctor and patient before any changeover is contemplated:

The patient should not take HRT and Promensil at the same time. The two therapies shouldn't be combined because of the potential risk of competitive inhibition.

Promensil is a natural health product based on isoflavones extracted from red clover hay. Nature takes time: the patient should have realistic expectations that Promensil will take weeks to become completely effective.

When HRT is stopped, the patient can start taking Promensil Double Strength daily for at least 2 months. The higher dose is recommended as it takes time for Promensil 3 to 6 weeks to become effective. There will be a period during the changeover that the patient will feel uncomfortable as menopause symptoms increase for a few weeks then begin to subside when Promensil becomes effective. Make sure the patient takes Promensil every day with a meal to help it absorb into the body.

Given that isoflavones are naturally occurring substances found in the diet, the oral contraceptive pill and isoflavones are expected to be compatible. However, this has not been confirmed in a clinical trial. It is recommended that women should consult their healthcare professional about taking any dietary supplement whilst taking prescribed medication.

As 40 mg per day is the daily dietary dose both men and women are exposed to every day of their life in Japan, it is anticipated that isoflavones will not interfere with the normal menstrual cycle.

The safety of exposing the foetus to high levels of isoflavones has not been established. There are no known epidemiological studies linking high isoflavone intake with foetal abnormalities in populations with 30-100 mg per day consumption of isoflavones.

However, it has been found that exposure of pregnant rats to very high dosages of genistein (14-70 mg/kg) resulted in decreased birth weight, decreased anogenital distance at birth and delayed onset of puberty, although there was no effect on parturition, rate of stillbirth, or pituitary responsiveness to GnRH in neonates 51. As there are no conclusive data on this issue, it is therefore recommended that isoflavone supplementation be avoided during pregnancy.

As isoflavones are secreted in breast milk, the recommended dosage of 40 mg per day should not be exceeded during lactation 17. This means that levels of dietary isoflavones should remain within the range found in women with a high consumption of legumes.

A 3 year study conducted by Trevor Powles et al, of Parkside Oncology Unit, London and published in Menopause International Vol. 14 No.1 March 2008 59 supports the growing body of evidence that treatment with red clover isoflavones is safe and well tolerated in healthy women. This randomized, double blind, placebo controlled trial studied the effects of red clover isoflavones on women with at least one first degree relative with breast cancer.

In a review article, examining whether consuming isoflavone rich foods should be recommended for breast cancer survivors, the author stated that there was not enough convincing evidence on either sides of the controversy 18. The author's conclusion was that if women enjoyed consumption of isoflavone rich foods in moderation it should not be discouraged. In light of this, and of the epidemiological, in vitro, animal and clinical evidence currently available, Promensil need not necessarily be discouraged if the patient and doctor consider the benefits and potential risks.

The controversy is due to observed estrogenicity of isoflavones in various experimental systems. However, the preferential binding of isoflavones to ER-ß over ER-α, and the relative distribution of the ER's in the body, suggest that isoflavones do not have a proliferative effect on reproductive tissue like breast and uterus.
In support of this, in a clinical trial, isoflavone supplements did not affect breast tissue density in pre-menopausal women, and showed a trend towards decreasing breast density in post-menopausal women 8. This effect of isoflavones is opposite to the effect of HRT on breast tissue density.

Women on tamoxifen will also experience menopausal symptoms. There is not currently clinical data available on the use of Promensil with tamoxifen. In vitro studies have found a synergistic inhibitory effect of genistein and tamoxifen on breast cancer cell lines.

Unopposed estrogen replacement therapy in women with an intact uterus is associated with an increased risk of uterine cancer, due to thickening of the uterine wall. For this reason estrogen replacement therapy is prescribed in conjunction with progesterone.

It is not necessary to take progesterone with Promensil, since in clinical trials, Promensil did not stimulate growth of the endometrium. Three clinical studies have investigated endometrial changes with Promensil treatment 3,9,10. In all trials endometrial thickness was determined by transvaginal ultrasound. Study durations were 12 weeks 10 and 8 weeks 3, using 40 mg Promensil once daily, and 12 weeks with Promensil 50 mg once daily 9. All studies showed no significant change in endometrial thickness from trial start to end. Hale et al. also evaluated changes in Ki-67 antigen, an endometrial proliferative marker. No significant difference in Ki-67 was determined between the placebo and treatment group over the 12 week study period 9.

No product-related adverse reactions or interactions have been reported in clinical trials. However, it is proposed that the administration of proton pump inhibitors or H2 receptor antagonists may reduce the efficacy of concomitant isoflavone supplementation, although this has not been formally studied. Similarly, antibiotics may reduce the efficacy of supplementation for up to 6 weeks, by reducing the number of gut flora. If this situation occurs, patients are advised to increase their intake of L. acidophilus.

No studies have investigated whether high levels of isoflavones are either agonistic or antagonistic with steroidal drugs. However, as isoflavones do exhibit weak anti- estrogenic effects through competitive inhibition, isoflavone dietary supplements should be taken with care if reproductive hormones are being prescribed.

No product-related adverse reactions or interactions have been reported in clinical trials. However, it is proposed that the administration of proton pump inhibitors or H2 receptor antagonists may reduce the efficacy of concomitant isoflavone supplementation, although this has not been formally studied. Similarly, antibiotics may reduce the efficacy of supplementation for up to 6 weeks, by reducing the number of gut flora. If this situation occurs, patients are advised to increase their intake of L. acidophilus.

PharmaCare isoflavone supplements are not known to contain any substances which may influence the formation of a thrombus. No blood clotting events have been reported in clinical trials. Similarly, these supplements do not contain coumestans such as coumestrol, nor any compounds associated with coagulation. Further, these supplements do not contain vitamin K, and are not known to affect the action of warfarin. Nevertheless, any patient receiving warfarin should be monitored regularly when changing their diet or commencing a dietary supplement.