scholarly journals Sjogren's syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set

2020 ◽  
Author(s):  
Ming Liu ◽  
Ya Gao ◽  
Yuan Yuan ◽  
Shuzhen Shi ◽  
Kelu Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Core Outcome ◽  
Initial List ◽  
Three Phases

Abstract Background: Sjogren's syndrome (SS) is a chronic autoimmune rheumatic disease, and the incidence of 0.03% to 0.3%. There are an increasing number of randomised controlled trials of traditional Chinese medicine (TCM) for SS. However, there are generally some problems in clinical trials: lack of reporting primary or long term outcomes, and the heterogeneous in different clinical trials’ outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders, and reach agreement on the COS and syndromes to be measured and reported in all future TCM trials in patients with SS.Methods: A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (Ⅰ-a) Identifying of a long initial list of outcomes through: (1) systematic literature review; (2) semi-structured qualitative interviews. (Ⅰ-b) Identifying an initial list of TCM syndromes through: (1) systematic literature review; (2) referencing ancient Chinese medical books; (3) retrospective studies of medical records. (Ⅱ) Prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients. (Ⅲ) Through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes.Results: We summarized the actions of COS into three points: direct action, indirect action, final action. Our study is very necessary.Conclusion: After the final COSs is completed, we will publish this research in a journal to promote communication.Trial registration number: Core Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1429.

scholarly journals Sjogren’s syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ming Liu ◽  
Ya Gao ◽  
Yuan Yuan ◽  
Shuzhen Shi ◽  
Kelu Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Core Outcome ◽  
Initial List ◽  
Three Phases

Abstract Background Sjogren’s syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medicine (TCM) for SS. However, there are generally some problems in these published clinical trials: lack of reporting primary or long-term outcomes and the heterogeneous in different clinical trials’ outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders and reach agreement on the COS and syndromes to be measured and reported in all future TCM trials in patients with SS. Methods and analysis A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (I-a) identifying of a long initial list of outcomes through systematic literature review and semi-structured qualitative interviews and (I-b) identifying an initial list of TCM syndromes through (1) systematic literature review, (2) referencing ancient Chinese medical books, and (3) retrospective studies of medical records; (II) prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients; and (III) through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes. Discussion We summarized the actions of COS into three points: direct action, indirect action, and final action. After the final COSs is completed, we will publish this research in a journal to promote communication. Trial registration Core Outcome Measures in Effectiveness Trials Initiative (COMET) number 1429. Registered on 01 December 2019.

Sjogren's Syndrome in Clinical Trials of Traditional Chinese Medicine: Protocol for the Development of a Core Outcome Set

2020 ◽  
Author(s):  
Guangyan Chen ◽  
Yuan Yuan ◽  
Ming Liu ◽  
Bin Pu
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Initial List ◽  
Three Phases

Abstract Background: Sjogren's syndrome (SS) is a chronic autoimmune rheumatic disease, and the incidence of 0.03% to 0.3%. There are an increasing number of randomised controlled trials of Traditional Chinese Medicine (TCM) for SS. However, there are generally some problems in clinical trials: lack of reporting primary or long term outcomes, and the heterogeneous in different clinical trials’ outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders, and reach agreement on the core outcome set (COS) and syndromes to be measured and reported in all future TCM trials in patients with SS. Methods: A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (Ⅰ-a) Identifying of a long initial list of outcomes through: (1) systematic literature review; (2) semi-structured qualitative interviews. (Ⅰ-b) Identifying an initial list of TCM syndromes through: (1) systematic literature review; (2) referencing ancient Chinese medical books; (3) retrospective studies of medical records. (Ⅱ) Prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients. (Ⅲ) Through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes.Results: We summarized the actions of COS into three points: direct action, indirect action, final action. Our study is very necessary.Conclusion: After the final COSs is completed, we will publish this research in a journal to promote communication.Trial registration number: Core Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1429.

scholarly journals Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032256 ◽  
Author(s):  
Ruijin Qiu ◽  
Changming Zhong ◽  
Songjie Han ◽  
Tianmai He ◽  
Ya Huang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Semistructured Interviews

IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at:http://www.comet-initiative.org/studies/details/1243).

scholarly journals Potent Antifungal Activity of Pure Compounds from Traditional Chinese Medicine Extracts against Six OralCandidaSpecies and the Synergy with Fluconazole against Azole-ResistantCandida albicans

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Zhimin Yan ◽  
Hong Hua ◽  
Yanying Xu ◽  
Lakshman P. Samaranayake
Keyword(s):  
Chinese Medicine ◽  
Antifungal Activity ◽  
Traditional Chinese Medicine ◽  
Sjögren's Syndrome ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Hiv Positive ◽  
Pseudolaric Acid B ◽  
Hiv Negative ◽  
Sjögren‘S Syndrome

This study was designed to evaluate thein vitroantifungal activities of four traditional Chinese medicine (TCM) extracts. The inhibitory effects of pseudolaric acid B, gentiopicrin, rhein, and alion were assessed using standard disk diffusion and broth microdilution assays. They were tested against six oralCandidaspecies,Candida albicans, Candida glabrata, Candida tropicalis, Candida krusei, Candida dubliniensis,andCandida guilliermondii, including clinical isolates from HIV-negative, HIV-positive, and Sjögren's syndrome patients. It was found that pseudolaric acid B had the most potent antifungal effect and showed similar antifungal activity to all sixCandidaspp, and to isolates from HIV-negative, HIV-positive, and Sjögren's syndrome patients. The MIC values ranged from 16 to 128 μg/mL. More interestingly, a synergistic effect of pseudolaric acid B in combination with fluconazole was observed. We suggest that pseudolaric acid B might be a potential therapeutic fungicidal agent in treating oral candidiasis.

How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review

2014 ◽  
Vol 33 (9) ◽  
pp. 1313-1322 ◽  
Author(s):  
Wilson Bautista-Molano ◽  
Victoria Navarro-Compán ◽  
Robert B. M. Landewé ◽  
Maarten Boers ◽  
Jamie J. Kirkham ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Randomized Clinical Trials ◽  
Core Outcome ◽  
Core Outcome Sets
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