Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma) : a 6-month clinical study demonstrates no systemic estrogenic effect

Objective: This study sought to confirm the efficacy and safety of the currently recognized dose of Cimicifugae racemosae rhizoma (40 mg/day) and to evaluate a higher dose and its associated physiological effects. Methods: We conducted a controlled, randomized, double-blinded parallel group study of perimenopausal and postmenopausal women treated with two different doses (39 mg and 127.3 mg) of a unique C. racemosa preparation over a 24-week period. Efficacy and tolerability were determined by the Kupperman Menopause Index, Self-Rating Depression Scale (SDS), a global assessment of tolerability, adverse events, routine hematology, and biochemical tests. To determine if the unique C. racemosa preparation exerts its effect through an estrogen-identical mode of action, we investigated vaginal cytology and gynecologically relevant hormones. Results: Both perimenopausal and postmenopausal patients tolerated the treatment well, and menopausal symptoms decreased regardless of dose (responder rate 70% and 72%, re...