Objective: Hormone therapy with estrogen alone or combined with progestogen has come into disrepute because of safety concerns. Herbal medicinal products with an estrogenic action caused by their content of phytoestrogens constitute an alternative therapy. However, the estrogenic adverse effects of such products have caused some concern. The pollen extract Femal has been shown to be effective in the treatment of menopausal symptoms like hot flushes and sleeplessness. The present investigation was undertaken to examine if this pollen extract preparation contained phytoestrogens in a concentration sufficient to give the preparation an estrogenic effect.
Methods: Samples of the pollen extract in Femal were subjected to high-performance liquid chromatography analyses of phytoestrogens. The pollen extract was tested for estrogenic activity in the immature rat uterotropic bioassay.
Results: The pollen extracts were found to contain low, subeffective concentrations of daidzin, daidzein, and genistin. Genistein, formononetin, and biochanin A could not be detected. Pollen extract in the high dose of 500 mg kg−1 day−1 did not cause any uterine growth in immature female rats.
Conclusions: The results show that the pollen extract in Femal does not give the preparation any estrogenic effect. Thus, Femal, which has proven clinical efficacy, is a nonestrogenic alternative to hormone therapy in women with menopausal symptoms.
The pollen extract Femal, effective in the treatment of menopausal symptoms, contains only traces of common phytoestrogens and has no uterotropic effect in immature rats. The possibility of a serotonergic mode of action of Femal is discussed.
From 1Gynecological Oncology, Radiumhemmet, Department of Oncology, Karolinska Hospital and Institute, Solna, Stockholm, Sweden; and 2Lerhamn Medical, Nyhamnslage, Sweden.
Received August 23, 2011; revised and accepted November 1, 2011.
Funding/support: Natumin Pharma AB, Huskvarna, Sweden, supported theresearch reported in this article by paying for the high-performance liquid chromatography analyses conducted by DSG Biotec, Aschau/Chiemgau, Germany, and for the uterotropic screening test conducted by RCC Ltd, Itingen, Switzerland. Natumin Pharma AB has used the services of Dr. Muntzing as paid consultant for organizing the research of the estrogenic effects of Femal as reported here.
Financial disclosure/conflicts of interest: Dr. Hellström has no conflicts of interest and no financial relation to Natumin Pharma AB. Dr. Muntzing hasreceived a consultancy fee for organizing the investigations reported here. Dr. Muntzing has also received honoraria for lectures on research conducted on behalf of Natumin Pharma AB.
Address correspondence to: JonasMuntzing, PhD, LerhamnMedical, Hans Fex vag 13, SE-263 76 Nyhamnslage, Sweden. E-mail: firstname.lastname@example.org