Advances in Therapy 1998 (Jan); 15 (1): 45–52
The reproducible quality of phytopharmaceuticals-herbal medicines is an essential prerequisite for good efficacy and tolerability in the treatment of functional disorders. In clinical trials and scientific investigations, standardized assessments (ie, validated, internationally recognized and accepted scales) provide the basis for establishing clinical efficacy and tolerability. Extracts (ethanolic and isopropanolic aqueous, Remifemin®) of the rootstock of the herb Cimicifuga racemosa (black cohosh) are active ingredients developed for the treatment of gynecologic disorders, particularly climacteric symptoms. Drug-monitoring and clinical studies documenting experience with C. racemosa rootstock extracts comprise the database of this herbal treatment for menopausal symptoms (eg, hot flashes, profuse sweating, sleep disturbances, depressive moods). These studies show good therapeutic efficacy and tolerability profiles for C. racemosa. In addition, clinical and experimental investigations indicate that the rootstock of C. racemosa does not show hormone-like activity, as was originally postulated.