This was a prospective, non-randomized, open-label observational study conducted over two years, in Germany. The purpose of the study was to evaluate the use, safety and effectiveness of black cohosh alone or in combination with St. Johnâ€™s wort on menopausal symptoms.
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. Johnâ€™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.