Objective: To observe the effect of Ruyiping, a traditional Chinese compound herbal medicine composed of 5 Chinese herbs for removing toxic materials and dissipating nodules from Runing II, another traditional Chinese compound herbal medicine for treating breast cancer, in preventing recidivation and metastasis in breast cancer patients after operation.

Methods: Eighty patients with breast cancer after operation were randomly divided into Ruyiping group and Runing II group, and prescribed Ruyiping and Runing II on the basis of chemotherapy, radiotherapy and endocrine therapy respectively for two years.

Results: There were two patients with metastasis and three patients lost to follow-up in Ruyiping group and three and two in Runing II group. The recidivation and metastasis rates were 5.41% and 7.89% respectively. The difference between the two groups was not statistically significant (P>0.05). The difference of disease-free survival time between the two groups was also not statistically significant.

Conclusions: The effect of Ruyiping in preventing recidivation and metastasis is similar to that of Runing II. Ruyiping is the essential component of Runing II for preventing recidivation and metastasis. The result provides some clinical evidences for the theory that "Yudu Pangcuan" (vestigial poison invasion elsewhere) is the essential pathogenesis of breast cancer's recidivation and metastasis and the utilization of "Sanjie Jiedu" (dispersing accumulation and detoxification) is the therapeutic principle in preventing recidivation and metastasis after operation.

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