دورية أكاديمية
Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review.
| العنوان: | Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review. |
|---|---|
| المؤلفون: | Wei JJ; Graduate school, Beijing University of Chinese Medicine, Beijing 10029, China.; Center for Evidence Based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Guo RJ; Department of Neurology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China., Fu GJ; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Liang X; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Xu ZM; Graduate school, Beijing University of Chinese Medicine, Beijing 10029, China., Jia M; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Zeng ZX; Graduate school, Beijing University of Chinese Medicine, Beijing 10029, China., Du WQ; Graduate school, Beijing University of Chinese Medicine, Beijing 10029, China., Jiao WW; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Sun LJ; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Liu HM; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Guo CL; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Tong CG; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Zhang YL; Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China., Liao X; Center for Evidence Based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. |
| المصدر: | Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan [J Tradit Chin Med] 2022 Feb; Vol. 42 (1), pp. 148-153. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Academy Of Traditional Chinese Medicine Country of Publication: China NLM ID: 8211546 Publication Model: Print Cited Medium: Internet ISSN: 2589-451X (Electronic) Linking ISSN: 02552922 NLM ISO Abbreviation: J Tradit Chin Med Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Beijing : Academy Of Traditional Chinese Medicine Original Publication: [Beijing, China : Pub. Office, Journal of Traditional Chinese Medicine, 1981- |
| مواضيع طبية MeSH: | Acupuncture* , Acupuncture Therapy* , Drugs, Chinese Herbal*/therapeutic use, Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Registries ; Research Design |
| مستخلص: | 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 (ChiCTR), and ClinicalTrials.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 ChiCTR and 53 from ClinicalTrials.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 ChiCTR attached the ethical approval documents. In terms of trial stages, 50 (27.7%) studies were in phase IV. 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 PubMed, 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. |
| References: | Lancet. 2015 Oct 24;386(10004):1698-706. (PMID: 26595643) BMJ. 1995 May 20;310(6990):1313-5. (PMID: 7773049) Zhong Xi Yi Jie He Xue Bao. 2006 Jul;4(4):331-2. (PMID: 16834964) Am J Public Health. 2012 Jan;102(1):72-80. (PMID: 22095335) Zhongguo Zhong Yao Za Zhi. 2020 Apr;45(8):1924-1932. (PMID: 32489079) Lancet. 2018 Nov 10;392(10159):1789-1858. (PMID: 30496104) BMJ Open. 2018 Jul 16;8(7):e021684. (PMID: 30012791) J Tradit Chin Med. 2017 Apr;37(2):159-64. (PMID: 29960286) Stroke. 2019 Nov;50(11):2993-2994. (PMID: 31610762) Headache. 2016 Jul;56(7):1238-40. (PMID: 27411557) BMJ Open. 2019 Feb 19;9(2):e025218. (PMID: 30782928) Geroscience. 2020 Dec;42(6):1499-1525. (PMID: 33011937) Zhongguo Zhong Yao Za Zhi. 2020 Oct;45(19):4766-4775. (PMID: 33164444) J Headache Pain. 2014 Dec 11;15:86. (PMID: 25496532) J Evid Based Med. 2020 May;13(2):137-152. (PMID: 32445289) Int J Nanomedicine. 2019 Aug 28;14:6933-6935. (PMID: 31695367) Cephalalgia. 2018 Jan;38(1):1-211. (PMID: 29368949) Zhongguo Zhong Yao Za Zhi. 2017 May;42(10):1837-1841. (PMID: 29090539) Lancet Public Health. 2020 Dec;5(12):e661-e671. (PMID: 33271079) Eur J Neurol. 2010 Nov;17(11):1318-25. (PMID: 20482606) Lancet Neurol. 2019 Apr;18(4):394-405. (PMID: 30878104) Lancet Neurol. 2018 Nov;17(11):954-976. (PMID: 30353868) Ann Intern Med. 2017 Jun 27;167(2):112-121. (PMID: 28654980) Headache. 2014 Apr;54(4):601-9. (PMID: 24666114) Lancet Neurol. 2019 May;18(5):459-480. (PMID: 30879893) |
| فهرسة مساهمة: | Keywords: Chinese Clinical Trial Registry; ClinicalTrials.gov; Cognitive dysfunction; Critical appraisal; Hemorrhagic stroke; Ischemic stroke; Medicine, Chinese traditional; Tension-type headache |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02275949 |
| المشرفين على المادة: | 0 (Drugs, Chinese Herbal) |
| تواريخ الأحداث: | Date Created: 20220316 Date Completed: 20220503 Latest Revision: 20230510 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC10164634 |
| PMID: | 35294135 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2589-451X |
|---|