This randomized, double-blind, controlled 3-month study in China enrolled 244 menopausal women aged 40-60. Women were assigned to either an isopropanolic extract of Black Cohosh containing 40 mg/day or one 2.5 mg tibolone tablet per day, a drug known to reduce hot flashes.
Results: There was a significant trend (57.8%) that women given Black Cohosh respond better than they do to tibolone in terms of efficacy-risk balance and that Black Cohosh was clearly superior to tibolone regarding the safety profile, looking at issues such as abnormal bleeding, endometrial thickening, breast pain, vaginal discharge and edema. The total Kupperman Menopause Index ( measuring hot flashes, profuse sweating, insomnia, nervousness, depressive mood, vertigo, weakness and fatigue, joint pain, headaches and palpitations) declined from 24.7 + 6.1 at baseline to 11.2 + 6.2 and 7.7 + 5.8 after Black Cohosh for 4 and 12 weeks to 11.2 + 7.2 and 7.5 + 6.8 after tibolone treatment.
Bai W, Henneicke-von Zepelin H, Wang S, et al. Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone. Maturitas, Volume 58, Issue 1, Pages 31-41
Comments: These results show that Black Cohsoh had significant benefit in reducing the total score and the individual items of the Kupperman Menopause Index (KMI). This success in treating moderate to severe menopause symptoms in this case was as good as the tibolone drug. The study also concluded that the efficacy-safety balance, a composite of the KMI and the frequency of adverse events was definitely in favor of Black Cohosh and superior to tibolone.
Tibolone is a selective tissue estrogenic activity regulator (STEAR), which expresses estrogenic, progestogenic and androgenic activity. It has not available in the U.S. and in fact, was recently denied approval by the FDA. In Europe and other countries, it is considered to be an effective alternative to HT in treating menopause symptoms.
This is the first study of Black Cohosh in Chinese women. It might interest us to know that psychological symptoms are frequent in Chinese peri- and post-menopausal women. The most common of these are nervousness, depressive mood swings, sleep problems and vertigo. In the current study, these types of symptoms were mild or moderate, at baseline and were significantly reduced at 12 weeks, both in the Black Cohosh group and in the tibolone group.