Shugan Tiaoyinyang Fang in Ameliorating Symptoms Caused by Tamoxifen after Breast Cancer Surgery and Improving the Quality of Life: a RCT

OBJECTIVE To evaluate the clinical effects of Shugan Tiaoyinyang Fang on treatment of symptoms caused by oral Tamoxifen. METHODS 80 patients with breast cancer who had been treated with Tamoxifen for more than one year and had obvious endocrine disorders were randomly and equally divided into two groups， namely the treatment group of 40 cases orally taking Shugan Tiaoyinyang Fang and Tamoxifen twice a day for 60 days and the control group of 40 cases only orally taking Tamoxifen. The amended kuppermann scores were adopted to evaluate the improvement of the symptoms， KPS was adopted to evaluate patients' quality of life and laboratory tests were used to evaluate drug safety.RESULTS The Kuppermann scores of the treatment group degreased significantly after 15-day treatment to the end of the study (P<0.05~0.01)， while only some of the symptoms of patients in the control group were improved， such as vertigo， joint pain， headache， palpitation (P<0.05~0.01). The Kuppermann scores of the treatment group degreased significantly with statistical differences after treatment compared with those before treatment (P<0.05)， while those of the control group were not changed obviously (P>0.05). The KPS scores of the treatment group improved significantly， compared with the control group (P<0.05). The laboratory test results showed that the blood test and hepatic and renal function test were normal for all the patients and there was a significant decrease of the triglyceride level in the treatment group (P<0.01) . CONCLUSION Shugan Tiaoyinyang Fang can effectively ameliorate the symptoms caused by Tamoxifen improve patients' life quality reduce the blood lipid level and lessen the side effects of Tamoxifen in clinic.