Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer.
OBJECTIVE
To examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flushes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055.


METHODS
Between May 1999 and December 2001, we accrued 136 breast cancer survivors aged 35-52 years. After treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy, participants were in open-label randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group; n=46) or tamoxifen (same dose and posology) plus CR BNO 1055 (Menofem/Klimadynon, corresponding to 20 mg of herbal drug; intervention group n=90). Duration of treatment was 5 years for tamoxifen, according to international standards for adjuvant therapies, and 12 months for CR BNO 1055. Follow-up included clinical assessment every 2 months; the primary endpoint was to record the number and intensity of hot flushes.


RESULTS
Comparing patients assigned to usual-care group with those assigned to intervention group, the number and severity of hot flushes were reduced after intervention. Almost half of the patients of the intervention group were free of hot flushes, while severe hot flushes were reported by 24.4% of patients of intervention group and 73.9% of the usual-care group (P<0.01).


CONCLUSIONS
Hot flushes were the most frequent adverse reaction to tamoxifen adjuvant therapy in breast cancer survivors. The combined administration of tamoxifen plus CR BNO 1055 for a period of 12 months allowed satisfactory reduction in the number and severity of hot flushes.
Hernández Muñoz
Gerardo
G
Centro Clínico de Maternidad Leopoldo Aguerrevere, Av. Rio Manapire, Parque Humboldt, Prados del Este, Caracas, Venezuela. drgeher@cantv.net
Pluchino
Salvatore
S
D000284:Administration, Oral; D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy; D031885:Cimicifuga; D005260:Female; D019584:Hot Flashes / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D017741:Survivors; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; C475575:Cimicifuga extract BNO 1055; D010936:Plant Extracts; D013629:Tamoxifen