| Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy: Statistical analysis plan for a multicenter trialOA |
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| 作者姓名： | Ruiming Zhao Huijuan Cao Lingyun Sun Tong Zhang Yun Xu Shaohua Yan Jun Mao Jianping Liu Yutong Fei Yufei Yang |
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| 作者单位： | 1. Graduate School, Beijing University of Chinese Medicine;2. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine;3. Department of Oncology, Xiyuan Hospital of China Academy of Chinese Medicine Sciences;4. Integrative Medicine Service, Memorial Sloan Kettering Cancer Center |
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| 基金项目： | funded by the Key R&D project of the Ministry of Science and Technology,China (2017YFC1700604)； |
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| 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 treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective: To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical anal...
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| 收稿时间： | 6 May 2022 |
Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy: Statistical analysis plan for a multicenter trial |
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| Institution: | 1. Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China;2. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China;3. Department of Oncology, Xiyuan Hospital of China Academy of Chinese Medicine Sciences, Beijing 100091, China;4. Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York 10041, USA |
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| Abstract: | BackgroundPatients 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 treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.ObjectiveTo evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical analysis plan (SAP) is intended to enhance the transparency and research quality of our randomized controlled trial.MethodsOur study is a multicenter, double-blind, randomized controlled clinical trial. This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula. To attenuate possible selection bias in the final report, we declared the overall trial design, outcome measures, subgroup analyses, and safety measures. Also, we described the data management and statistical analysis methods in detail.ConclusionThe SAP provides more detailed information than the trial protocol for data management and statistical analysis methods. Further post-hoc analyses can be performed by referring to the SAP, and possible selection bias can be attenuated. |
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| Keywords: | Statistical analysis plan Colon cancer Chemotherapy Randomized controlled trial Traditional Chinese medicine Capecitabine Oxaliplatin Treatment duration |
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