Hernández Muñoz, G., & Pluchino, S. (2003). Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer. Maturitas, 44(Suppl. 1), S59–S65.

The purpose of this study was to examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flashes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055 (also known as black cohosh).

Participants took one tablet twice daily with meals for 60 days. Duration of treatment was five years for tamoxifen, and 12 months for CR BNO 1055. Participants were instructed not to initiate new therapies for hot flashes while participating in the study. Forty-six participants were randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group;mean age = 47 years); 90 participants received tamoxifen plus CR BNO 1055 corresponding to 20 mg of herbal drug (intervention group; mean age = 46 years.).

• The study enrolled 136 breast cancer survivors aged 35–52 years who completed treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy.
• Inclusion Criteria: Premenopausal status with regular menstruation and normal duration of cycle, and breast cancer diagnosis with estrogen receptor–positive tumor.
• Exclusion criteria: Refusal to consider a study treatment for relief of symptoms, history of other cancers, and history of serious chronic medical conditions.

This was a two-arm, randomized and open-label trial. The primary endpoint was to assess the effect of CR BNO 1055 on the frequency and intensity of hot flushes.

Control visits occurred every two months, when the supply of CR BNO 1055 was replaced and clinical assessments made. Hot flashes were considered severe when five or more heat episodes occurred during the day and were accompanied by sweating, sleep disturbances, feeling of irritation, and anxiety. A few episodes of heat with discrete sweating were classified as moderate hot flushes. Participants completed hot flash diaries at baseline, at every control visit, and at the end of the study at 12 months.

The hot flash patterns were significantly different between the two groups using Fisher’s exact test (p < 0.01). Among the 46 study participants included into the usual-care group, 73.9% experienced severe hot flushes and 26.1% moderate symptoms. Among the 90 study participants in the intervention group, at the end of the study, 46.7% were free of hot flashes, and 24.4% reported severe symptoms.

In the intervention group, the administration of CR BNO 1055 in combination with tamoxifen for a 12-month period significantly reduced the vasomotor episodes induced by tamoxifen in breast cancer survivors.

Methodologic problems included an open label trial  and unbalanced arms  (twice as many participants in the Black Cohosh group as in the usual care group).