Cimicifuga racemosa for the treatment of hot flushes in XXXX surviving @entity0 .

@entity0 @entity440 @entity1 @entity35922
OBJECTIVES: To examine the effect of Cimicifuga racemosa (CR @entity35922 ) on hot flushes caused by @entity440 adjuvant therapy in young @entity0 survivors. This treatment presents an off-label use of CR @entity35922 . METHODS: Between May 1999 and December 2001, we accrued 136 @entity0 survivors aged 35-52 years. After treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy, @entity1 were in open-label randomly assigned (1-2) to receive @entity440 20 mg per day orally (usual-care group; n=46) or @entity440 (same dose and posology) plus CR @entity35922 (Menofem/Klimadynon, corresponding to 20 mg of herbal drug; intervention group n=90). Duration of treatment was 5 years for @entity440 , according to international standards for adjuvant therapies, and 12 months for CR @entity35922 . Follow-up included clinical assessment every 2 months; the primary endpoint was to record the number and intensity of hot flushes. RESULTS: Comparing @entity1 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 @entity1 of the intervention group were free of hot flushes, while severe hot flushes were reported by 24.4% of @entity1 of intervention group and 73.9% of the usual-care group (P<0.01). CONCLUSIONS: Hot flushes were the most frequent adverse reaction to @entity440 adjuvant therapy in @entity0 survivors. The combined administration of @entity440 plus CR @entity35922 for a period of 12 months allowed satisfactory reduction in the number and severity of hot flushes.
