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 treat...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 analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our 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.Conclusion:The 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.展开更多
Objective:The aim of this review was to identify the possible mechanisms behind cupping therapy by employing an evidence-based approach,and to explore its possible regional and systemic effects in the human body.Metho...Objective:The aim of this review was to identify the possible mechanisms behind cupping therapy by employing an evidence-based approach,and to explore its possible regional and systemic effects in the human body.Methods:We searched six electronic databases and four online trial registries for articles published up to January 1,2020.Clinical studies on the mechanisms of retained cupping,flashing cupping,moving cupping,and vacuum cupping were considered for this review.The methodological qualities of controlled studies were assessed using the National Institute for Clinical Excellence methodology checklist,the Newcastle-Ottawa Scale,and the Cochrane risk of bias tool.Characteristic statistical description and qualitative summary of results were used for data analysis.Results:Thirty-eight studies(37 full texts and one abstract)were included in this study.Due to the clinical heterogeneity among the studies,we could not conduct a meta-analysis.The results showed that the key factors that contribute to the efficacy of cupping therapy are negative pressure and temperature.Cupping therapy mainly causes local and systemic changes in hemodynamics,immune regulation,metabolism,and pain relief.Conclusion:We identified negative pressure as the key element behind cupping therapy.Cupping therapy may cause redistribution of oxygen at the cupping site and in neighboring tissues,thereby inducing a therapeutic effect by increasing regional blood flow.It may also induce metabolic change,immunomodulation,and neuromodulation.However,additional rigorous clinical research needs to be conducted to further clarify the mechanism behind cupping therapy.展开更多
基金funded by the Key R&D project of the Ministry of Science and Technology,China(2017YFC1700604).
文摘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 analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our 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.Conclusion:The 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.
基金This review is supported by the National Natural Science Foundation of China(81804000)the National Natural Science Foundation of China:Major Program(81830115).
文摘Objective:The aim of this review was to identify the possible mechanisms behind cupping therapy by employing an evidence-based approach,and to explore its possible regional and systemic effects in the human body.Methods:We searched six electronic databases and four online trial registries for articles published up to January 1,2020.Clinical studies on the mechanisms of retained cupping,flashing cupping,moving cupping,and vacuum cupping were considered for this review.The methodological qualities of controlled studies were assessed using the National Institute for Clinical Excellence methodology checklist,the Newcastle-Ottawa Scale,and the Cochrane risk of bias tool.Characteristic statistical description and qualitative summary of results were used for data analysis.Results:Thirty-eight studies(37 full texts and one abstract)were included in this study.Due to the clinical heterogeneity among the studies,we could not conduct a meta-analysis.The results showed that the key factors that contribute to the efficacy of cupping therapy are negative pressure and temperature.Cupping therapy mainly causes local and systemic changes in hemodynamics,immune regulation,metabolism,and pain relief.Conclusion:We identified negative pressure as the key element behind cupping therapy.Cupping therapy may cause redistribution of oxygen at the cupping site and in neighboring tissues,thereby inducing a therapeutic effect by increasing regional blood flow.It may also induce metabolic change,immunomodulation,and neuromodulation.However,additional rigorous clinical research needs to be conducted to further clarify the mechanism behind cupping therapy.
