The Study On Quality Control Based On "A Randomized、Double-blind、 Placebo Controlled Clinical Study On HuoXueTongLuo Formula For Peripheral Neurpathy Induced By Chemotherapy"

Objective: To summarize the experience of multicenter randomized controlled clinical research in quality control, based on appraising the process of the clinical study efficacy and safety of the clinical that Huo xue tong luo formula treat Peripheral neurotoxicity induced by chemotherapy.Method:We designed the clinical study program and gradually implement it, while conducted quality control study and drafted monitoring plan. We regularly summarized problems of study progress and quality to deal with them timely, from that to gain experience. The clinical trial was a multicenter, randomized, double-blind block, parallel-group study, which consisted of five centers, Xiyuan Hospital, Guang’anmen Hospital, Dongzhimen Hospital, China-Japan Friendship Hospital, the 309 Hospital of Chinese People’s Liberation Army. The number of cases of these hospitals in charge were included:56,32,40,32, 24.184 CIPN patients, who met the inclusion criteria, were randomly divided by 2:1:1 ratio into experimental group(92cases)、positive control group(46cases)and the placebo group(46cases). They were respectively treated with Huoxuetongluo formula、Huangqiguizhiwuwu formula and placebo dextrin to soak hands and foots. The temperature of the wash water was 35 ℃ to 40 ℃. The intervention time were 14 days,20 minutes per day.Result:The problems were exposed in three main areas:Firstly, subjective evaluation was difficult to control. Secondly, the project presented asymmetry that loose in the beginning and tight at last. Each center progress were obviously different. The progress was related to the attention of center principal. Thirdly, the data management was influenced by the progress, slightly lagging behind. Research data was still blind. We could conclude the following three possible results. Result 1:there was no statistically significant difference among the three groups(P>0.05). Result 2:there was statistically significant difference among the three groups(P<0.05).Result 3:there was statistically significant difference between two of the three groups(P<0.05).Conclusions:Training and feedback before the study begin should be emphasized if the evaluation index is subjectivity. Conducting additional training is necessary. We suggest to perform intensive monitoring plan at the beginning of the study and pay more attention on the principal of the center. Date management work should be launched as earlier as possible. There are three main possible conclusions. The first one:effect in treating CIPN of Huoxuetongluo formula and Huangqiguizhiwuwu formula are equal to placebo. The second one:Huoxuetongluo formula is effective in treating CIPN, while Huangqiguizhiwuwu formula may be effective for some people, or, conversely. The third one:Huoxuetongluo formula or Huangqiguizhiwuwu formula is effective in treating CIPN.