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.
A systematic literature review and meta-analysis of randomized clinical trials of parenteral glutamine supplementation
