Black cohosh for ovulation induction in women with PCOS.
Kamel HH. 2013. Role of phyto-oestrogens in ovulation induction in women with polycystic ovarian syndrome. Eur J Obstet Gynecol Reprod Biol 186:60-63.
Polycystic ovarian syndrome (PCOS) is the most common endocrinopathy of women of reproductive age, characterised by hyperandrogenism, hyperinsulinaemia, long-term metabolic disturbances and menstrual irregularities, including anovulatory cycles.
In reproductive medicine, the first line choice for pharmacological ovulation induction is with selective oestrogen receptor modulators, with clomiphene citrate (CC) being the most extensively studied. Whilst trials of CC have demonstrated efficacy in ovulation induction and resultant pregnancy, there are numerous side effects associated with the drug including multiple pregnancy risk, undesirable anti-oestrogenic effects in the endocervix, endometrium and ovary, vasomotor flushes, mood swings, visual disturbances, breast tenderness, pelvic discomfort and nausea. Accordingly, there is interest in other ovulation inducing agents with demonstrable efficacy and a good safety profile.
Cimicifuga racemosa (black cohosh) is commonly used as an alternative agent to hormonal therapy for the treatment of menopausal complaints, but the mechanism of action and its receptor selectivity are not well understood. This prospective, randomised controlled study was undertaken to investigate the role of C. racemosa (Klimadynon, Bionorica) in women with PCOS, as assessed through ovulation induction, hormonal profile correction and pregnancy rate. One hundred women with PCOS were recruited from the Gynaecology Clinic at Minia University Hospital, Egypt. The women were randomised to receive either 20mg Klimadynon twice daily orally for ten days, starting from the second day of the cycle or CC 50mg (control) twice daily for five days, starting from the second day of the cycle. Both groups continued treatment for three successive cycles.
Women were evaluated at baseline with history taking, general examination, local pelvic examination, transvaginal ultrasound examination to document criteria of PCOS and blood sampling to measure follicle stimulating hormone (FSH), luteal hormone (LH) and mid-luteal progesterone levels. Following each cycle of treatment, blood samples were taken to reassess FSH, LH and progesterone levels. Transvaginal ultrasound evaluation was performed on day 14 to document follicles and endometrial thickness. In both groups, human chorionic gonadotropin was given when the leading follicle reached 18mm or more, when timed intercourse was advised.
In total, 89 cases were included for analysis at the end of the third cycle (Klimadynon n=43, CC n=46). Baseline characteristics for both groups were comparable, with no statistically significant differences between the groups in terms of FSH, LH or FSH/LH ratio. Following treatment, hormonal changes were observed in both groups, however a greater effect was noted in the Klimadynon group, particularly with the LH level and FSH/LH ratio showing a significant difference present in all three treatment cycles. In the first cycle, the progesterone level increased to a significantly higher level than the CC group, though non-significant for the remaining cycles. The endometrial thickness was greater in the Klimadynon group than the CC group across all three cycles. There were no significant differences observed between groups with regard to pregnancy rate or hyper-stimulation cases.
In discussing the results, the author highlights that a reduction in LH has a positive effect on symptoms of excessive androgens in women with PCOS, influencing better ovulation and implantation rates whilst increasing the sensitivity of the ovarian tissue to circulating FSH. Additionally, the increasing thickness of the endometrium may improve the implantation rate and improve pregnancy outcome, but it is not understood if the thickness increased in response to endogenously induced oestrogen or a direct effect of Klimadynon.
Earlier and higher pregnancy rates were reported for the Klimadynon group compared to the CC group, though it should be noted this was not statistically significant. Given the relatively small numbers of the trial, further studies with larger sample sizes are required to gain further insight into this parameter. The study does not explain drop out rates nor fully describe safety profile and adverse effects - hence, whilst the author reported that Klimadynon induced ovulation in women with POCS with fewer side effects compared with CC, the data is provided is not sufficient to support this claim. Further investigation to support the potential role of C. racemosa in ovulation induction may be warranted to get a better understanding of the mechanism of action, efficacy, safety and optimal duration of therapy.
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|Title Annotation:||polycystic ovarian syndrome|
|Publication:||Australian Journal of Herbal Medicine|
|Date:||Mar 1, 2015|
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