OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemi...OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemic stroke,hemorrhagic stroke,vascular cognitive impairment,tension-type headache before September 22,2020 on the platform of Chinese Clinical Trial Registry(Chi CTR),and Clinical Trials.gov were searched.Two researchers independently selected the literature and extracted data.RESULTS:A total of 180 interventional clinical trials were included for analysis.Out of 180 trials,127 were from Chi CTR and 53 from Clinical Trials.gov.The countries primary sponsoring the included trials were China(176,97.8%),and the common categories of primary sponsors were hospital(131,72.8%).Among the study design,the largest proportion of allocation was randomized(172,95.6%),interventional model assignment was parallel(163,90.6%),masking was double blind 49(27.2%),and the sample size was≤400(144,80.0%).The trials were most carried out at a single center(102,56.7%).Among the included studies,112(62.2%)registered on Chi CTR attached the ethical approval documents.In terms of trial stages,50(27.7%)studies were in phaseⅣ.The mostly used intervention was Chinese herbal medicines(99,55%),acupuncture(68,37.8%)was the second.By searching the registration number on China National Knowledge Infrastructure Database and Pub Med,38(21.1%)registered trials were published,including 25 protocol studies and 14 research results with one(NCT02275949)published both the protocol and the results.CONCLUSIONS:Irregular and inadequate reporting,untimely update and publication,insufficient information on traditional medicine unique characteristics,and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases.More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.展开更多
OBJECTIVE:To update the current characteristics about the scope and quality of mixed methods research(MMR)in complementary and alternative medicine(CAM)after nearly 10 years.METHODS:A 5-stage approach for conducting a...OBJECTIVE:To update the current characteristics about the scope and quality of mixed methods research(MMR)in complementary and alternative medicine(CAM)after nearly 10 years.METHODS:A 5-stage approach for conducting a scoping review was adopted.Articles published on the top 10 journals in CAM with the highest impact factor in 2020 were screened for MMR.Information of included articles were extracted,and then synthesized to illustrate the current state.Methodological quality was evaluated according to the Mixed Method Appraisal Tool(MMAT)2018 version.RESULTS:A total of 55(55/2991,2%)articles using mixed methods were retrieved,including 17 medical studies and 38 ethnobotanical studies.We performed an in-depth analysis on the 17 medical studies,which studied cancer,stress,pain,fatigue,exercises,mindfulness intervention,herbal medicine use,art and acupuncture.Thirteen pilot studies applied MMR to evaluate the feasibility of interventions or programs(13/17,76%);phenomenology was inferred as the most common philosophical assumptions(13/17,76%);the most applied type of MMR was convergent design(16/17,94%);integration often took place at integration(12/17,71%).Among the 16 eligible studies for quality appraisal,majority were rated as good(14/16,88%),whereas two studies were rated as poorly described.Primarily,a poor rating was due to incomplete reporting of data analysis and citations in qualitative components;lack of confounder controlling and the sampling strategy in quantitative components;poor description of integration and justification for mixed methods.Comparing with the previous review,fewer MMR were published in 2020 in CAM,but the proportion of studies that clearly reported MMR has increased by 4 times(4%→15%).CONCLUSION:CAM researchers need to realize the benefits that MMR can have on conducting further health care research.Our findings highlight that applying MMR will be helpful to understand the complex dynamics and interdisciplinary nature of complex intervention.In addition,addressing a standardized reporting criteria for MMR is recommended.展开更多
基金Supported by NATCM TCM Inheritance and Innovation Hundred-Thousand-Ten Thousand“Talents Project Qi Huang Scholar)-National TCM Leading Personnel Support Program(NATCM Personnel and Education Department[2018]No.12)”Research on optimizing construction of evidence-based ability of traditional Chinese medicine encephalopathy(No.ZZ13-024-3),Special fund for basic scientific research business expenses of central public welfare scientific research institutes。
文摘OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemic stroke,hemorrhagic stroke,vascular cognitive impairment,tension-type headache before September 22,2020 on the platform of Chinese Clinical Trial Registry(Chi CTR),and Clinical Trials.gov were searched.Two researchers independently selected the literature and extracted data.RESULTS:A total of 180 interventional clinical trials were included for analysis.Out of 180 trials,127 were from Chi CTR and 53 from Clinical Trials.gov.The countries primary sponsoring the included trials were China(176,97.8%),and the common categories of primary sponsors were hospital(131,72.8%).Among the study design,the largest proportion of allocation was randomized(172,95.6%),interventional model assignment was parallel(163,90.6%),masking was double blind 49(27.2%),and the sample size was≤400(144,80.0%).The trials were most carried out at a single center(102,56.7%).Among the included studies,112(62.2%)registered on Chi CTR attached the ethical approval documents.In terms of trial stages,50(27.7%)studies were in phaseⅣ.The mostly used intervention was Chinese herbal medicines(99,55%),acupuncture(68,37.8%)was the second.By searching the registration number on China National Knowledge Infrastructure Database and Pub Med,38(21.1%)registered trials were published,including 25 protocol studies and 14 research results with one(NCT02275949)published both the protocol and the results.CONCLUSIONS:Irregular and inadequate reporting,untimely update and publication,insufficient information on traditional medicine unique characteristics,and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases.More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.
基金Supported by the Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences:Design and Application of Mixed Method Research in Traditional Chinese Medicine(No.CI2021B003)Special Project of China Center for Evidence Based Traditional Chinese Medicine:Integrated Innovation and Application of Traditional Trial and Real-World Study of Chinese Medicine in Integrated Chinese and Western Medicine Setting(No.2020YJSZX-3)the Fundamental Research Funds for the Central Public Welfare Research Institutes:the Optimal Subject Setting and Design of Evidence-Based Research Implementation in the Area of Brain Diseases of Traditional Chinese Medicine(No.ZZ13-024-3)
文摘OBJECTIVE:To update the current characteristics about the scope and quality of mixed methods research(MMR)in complementary and alternative medicine(CAM)after nearly 10 years.METHODS:A 5-stage approach for conducting a scoping review was adopted.Articles published on the top 10 journals in CAM with the highest impact factor in 2020 were screened for MMR.Information of included articles were extracted,and then synthesized to illustrate the current state.Methodological quality was evaluated according to the Mixed Method Appraisal Tool(MMAT)2018 version.RESULTS:A total of 55(55/2991,2%)articles using mixed methods were retrieved,including 17 medical studies and 38 ethnobotanical studies.We performed an in-depth analysis on the 17 medical studies,which studied cancer,stress,pain,fatigue,exercises,mindfulness intervention,herbal medicine use,art and acupuncture.Thirteen pilot studies applied MMR to evaluate the feasibility of interventions or programs(13/17,76%);phenomenology was inferred as the most common philosophical assumptions(13/17,76%);the most applied type of MMR was convergent design(16/17,94%);integration often took place at integration(12/17,71%).Among the 16 eligible studies for quality appraisal,majority were rated as good(14/16,88%),whereas two studies were rated as poorly described.Primarily,a poor rating was due to incomplete reporting of data analysis and citations in qualitative components;lack of confounder controlling and the sampling strategy in quantitative components;poor description of integration and justification for mixed methods.Comparing with the previous review,fewer MMR were published in 2020 in CAM,but the proportion of studies that clearly reported MMR has increased by 4 times(4%→15%).CONCLUSION:CAM researchers need to realize the benefits that MMR can have on conducting further health care research.Our findings highlight that applying MMR will be helpful to understand the complex dynamics and interdisciplinary nature of complex intervention.In addition,addressing a standardized reporting criteria for MMR is recommended.
