Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy:Statistical analysis plan for a multicenter trial

作     者：Ruiming Zhao Huijuan Cao Lingyun Sun Tong Zhang Yun Xu Shaohua Yan Jun Mao Jianping Liu Yutong Fei Yufei Yang Ruiming Zhao;Huijuan Cao;Lingyun Sun;Tong Zhang;Yun Xu;Shaohua Yan;Jun Mao;Jianping Liu;Yutong Fei;Yufei Yang

作者机构：Graduate SchoolBeijing University of Chinese MedicineBeijing 100029China Centre for Evidence-Based Chinese MedicineBeijing University of Chinese MedicineBeijing 100029China Department of OncologyXiyuan Hospital of China Academy of Chinese Medicine SciencesBeijing 100091China Integrative Medicine ServiceMemorial Sloan Kettering Cancer CenterNew York 10041USA 

出 版 物：《Journal of Traditional Chinese Medical Sciences》 (中医科学杂志（英文）)

年 卷 期：2023年第10卷第1期

页      面：58-63页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：funded by the Key R&D project of the Ministry of Science and Technology China(2017YFC1700604) 

主　　题：Statistical analysis plan Colon cancer Chemotherapy Randomized controlled trial Traditional Chinese medicine Capecitabine Oxaliplatin Treatment duration 

摘      要：Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to *** an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of ***:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo *** statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled ***:Our study is a multicenter,double-blind,randomized controlled clinical *** trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen *** attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety ***,we described the data management and statistical analysis methods in ***:The SAP provides more detailed information than the trial protocol for data management and statistical analysis *** post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.