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
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.
