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.

6141 women at 1287 outpatient gynecology offices were treated with recommended doses of black cohosh isopropanol extract,Remefemin (1 cap bid) or Remifemin plus combination with St. Johns wort (1 or 2 tablets bid) at the discretion of the clinician.

Treatment responses were assessed on the menopause rating scale (MRS), an established standard for evaluating menopause symptoms. The primary effectiveness variable was the change in the MRS subscore PSYCHE (including depressive mood, nervousness, irritability, impaired performance and memory) from baseline to month three.

Of the enrolled women, 3027 received the black cohosh only and 3114 received the black cohosh/St. Johns wort combination. During the study, 244 women changed treatment from monotherapy to the combination product and 87 women changes from the combination product to monotherapy.

Women receiving combination therapy had significantly higher PSYCHE scores, i.e. worse symptoms than those in the black cohosh group. More women in the combination group had clightly more concomitant diseases.

The symptom scores improved in both groups. The changes in the PSYCHE symptoms were greater in the combination therapy group than in the black cohosh only group at month 3 and 6. The greatest effects, with both treatments, were seen with hot flushes and night sweats and these were similar. Results were evident at month 3, and even more so, at month 6.

Both treatments were very well tolerated. The rate of adverse events related to the treatments was very small, at 0.16% or 10 cases. Seven cases were in the black cohosh only group and three in the combination group.

Briese V, Stammwitz U, Friede M, Henneicke-von Zepelin H. Black cohosh with or without St. John’s wort for symptom-specific climacteric treatment – Results of a large-scale, controlled, observational study. Maturitas 2007; 57(4): 405-414.

Commentary: The results from the large study supports the effectiveness of black cohosh preparations alone or in combination with St. Johns wort for relief common menopausal symptoms such as hot flushes/nightsweats and psychological symptoms. The combination of the two herbs, appears to be the best approach for symptoms that include depressive moods, nervousness, irritability, and impaired memory.

Rebbeck T, Troxel A, Norman S, et al. A retrospective case-control study of the use of hormone-related supplements and association with breast cancer. Int. J. Cancer 2007; 120:1523-1528.

Comments: Women included in the study were those with a first primary, invasive, breast cancer of stage I, II, III, of any grade and any tissue type (ductal, lobular, mucinous, papillary, mixed.) Women with ductal carcinoma in situ or lobular carcinoma in situ were excluded.

This is not the first study that has indicated anti-proliferative, anti-estrogenic effects of black cohosh on breast cancer cells, especially estrogen receptor (ER) positive breast cancer cells. In the current study, black cohosh and/or Remifemin persisted irrespective of ER status. On the other hand, the effect of black cohosh and/or Remifemin varied by progesterone receptor (PR) status. The effect was significant in PR positive tumors but not in PR negative tumors. This suggests that PR status may be related to the protective effects of black cohosh on the breast.

While the researchers in this study, incorrectly describe black cohosh as containing phytoestrogens, this study is yet one more positive finding on the safety of black cohosh for breast cancer survivors with menopausal symptoms.

This population-based cased-control study in Philadelphia consisted of 949 breast cancer cases and 1,524 controls. Herbal supplements including Black Cohosh, ginseng and red clover were the most prevalent preparations. After adjusting for potential confounding factors, Black Cohosh use was associated with a 61 percent reduction in the risk of breast cancer with an odds ratio of 0.39, 95% CI: 0.22-0.70. The breast protective effect was similar for a specific Black Cohosh preparation, Remifemin, odds ratio 0.47, 95%, CI: 0.27-0.82.

Comments: Women included in the study were those with a first primary, invasive, breast cancer of stage I, II, III, any grade and any tissue type (ductal, lobular, mucinous, papillary, mixed.) Women with ductal carcinoma in situ or lobular carcinoma in situ were excluded. This is not the first study that has indicated antiproliferative, antiestrogenic effects of Black Cohosh on breast cancer cells, especially estrogen receptor (ER) + breast cancer cells. In the current study, Black Cohosh and/or Remifemin persisted irrespective of ER status. On the other hand, the effect of Black Cohosh and/or Remifemin varied by progesterone receptor (PR) status. The effect was significant in PR positive tumors but not in PR negative tumors. This suggests that PR activity may be related to the protective effects of Black Cohosh on the breast.

While the researchers in this study, incorrectly describe Black Cohosh as containing phytoestrogens, this study is yet one more positive finding on the safety of Black Cohosh for breast cancer survivors with menopause symptoms.