Systematic Evaluation And Methodological Study On The Treatment Of Breast Cancer Endocrine Therapy By Traditional Chinese Medicine

Objective:1. To understand the direction and today’s condition of drug use of traditional Chinese medicine in the endocrine therapy for breast cancer.2.Data obtained by the system evaluation will be used study the problems existing in the clinical trials of traditional Chinese medicine, and to provide suggestions for the follow-up tests, in order to provide more evidences of evidence-based medicine for traditional Chinese medicine.Methods:According to the systematic review writing manuals produced by Cochrane collaboration network, we proceeded the literature screening, feature description of the literature included in, risk bias assessment, data extraction, statistical analysis and results report. By searching the databases included CNKI、VIP、Wan Fang、PubMed and Web of Science, we obtained the clinical trials of Chinese herbal medicine intervention for breast cancer from 2000 to 2015. Cochrane risk assessment table are for bias risk assessment of the test, to find problems in clinical trials and through the longitudinal comparation of the intervention of the traditional Chinese medicine (TCM) to explore drug laws. The tests which the similar intervention measures and outcome measures are the same are given Meta analysis with REVMAN5.3 statistical software.Results:47 clinical trials of endocrine therapy for breast cancer by Chinese medicine intervention were obtained through the network and manual retrieval. All the included studies can be evaluation of sample size is between 25 to 115, there were 3133 endocrine therapy of breast cancer patients, in which treatment group is 1577, an average of 34±10, control group is 1556, average 33±10 people. The average age of the treatment group was 50.93±8.2 years old, and the control group was 50.67±8.2 years old. In trials of only 14 studies explicitly into group of syndromes,15 test using the proprietary Chinese medicines tested,2 using the Chinese medicine of saponin of litchi seed capsules, two counts of using traditional Chinese medicine decoction combined with Chinese medicine,1 using Xiaoyaosan decoction or pill, only 1 trial using granule,1 trial did not explain the forms of traditional Chinese medicine, more than 25 trials were decoctions. Except for traditional Chinese medicine, based in including a total of 96 kinds of traditional Chinese medicine, which cited frequency more than 10 times respectively:Fuling 16 times, Rhizoma Atractylodis Macrocephalae 15 times, licorice 15 times, Rehmannia glutinosa 13 times, bupleurum 12 times, angelica 12 times, Rhizoma Anemarrhenae 11 times, from the reference frequency of the traditional Chinese medicine, most of the tests still focus on liver nourishing spleen and kidney. Respectively gave meta analysis on the card’s score, symptom score and estradiol, the results showed that the intervention of traditional Chinese medicine endocrine therapy for breast cancer can improve the quality of life of patients without infulences on sex hormone levels, but because of the literature method therapeutics low, heterogeneity is larger, and there are publication bias, and this can not provide strong evidence.12 trials using the random number table group,27 trials only simple instructions "were randomly divided into---" and don’t know way of grouping, also eight trials were used in hospitalization time, number, group order, draw, dice, odd and even number, different sources of hospital, the computer randomly assigned to implement the grouping. Only 1 trials were double-blind trial,2 trials using a single blind. The rest of the trials did not mention the blind method, as these trials did not mention the use of placebo, so that the remaining 44 trials were considered without blind method. Only eight test outcomes as the objective indexes can be considered without blind act does not affect the outcome and the remaining 39 test outcomes involving card’s score, Kupperman score, TCM symptom score of patient reported outcome measures, without the blind method is likely to affect the outcome. Because of the inappropriate use of the blind method, patients and researchers who have no blind method or single blind trial can predict the patient’s information, use of a double-blind trial did not mention random hidden events. A total of nine trials are shedding cases, of which five experiments did not specify the cause of loss; of the other four tests, three due to experimental group and control group off similar number of cases and was lost to follow-up cases that do not affect outcomes.1 items due to the smaller sample size, that may have an impact on the outcome. Because most of the research program with the results published in the same period, can not predict the test plan,no enough evidences can be got to prove whether the coverage of all the outcome measures. But in the inclusion of the 47 trials, there are still 2 trials did not publish in the full report of the test report.Conclusion:Although the system evaluation results showed that the intervention of traditional Chinese medicine in endocrine therapy for breast cancer shows obvious advantages, but as the test method learn improper use of lead into the test quality is generally low, unable to provide evidence of evidence-based medicine. The standard of traditional Chinese medicine intervention in clinical experimental research method should be further strengthened.