Objective To explore the condition and quality of domestic clinical therapeutic studies on integrated traditional Chinese and western medicine for posthepatitic cirrhosis in recent 30 years. Methods Jadad scale was used to score 121 literatures selected from January 1980 to January 2010 in periodicals of domestic authoritative resources databases, such as CNKI, VIP, WanFang Data, and CBM. Systematic reviews were conducted to 39 randomized controlled trials (RCTs) literatures of treating posthepatitic cirrhosis with integrated traditional Chinese medicine and western medicine scored two or more points. Results In 30 years, the main problems existing in domestic posthepatitic cirrhosis clinical research of integrated traditional Chinese and western medicine were as follows: the design of clinical RCTs was not strict enough; there was deficiency in the use of blind method; the standardized and uniformed research standard were insufficiency; the sample content was low without specific estimation methods; there was lack of analyses in compliance with cases falling off or without follow-up; and the report of adverse reaction and the quality of life research was neglected. Conclusion Posthepatitic cirrhosis therapy of integrated traditional Chinese and western medical is of “personalized” and “diversified” characteristics. Its therapeutic effects are significantly better than those of pure western medicine and worthy to be popularized in the clinic. However, the quality and level of its clinical scientific research methods still need further improvement.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
ObjectiveTo systematically review the methods of clinical practice guidelines for integration traditional Chinese medicine (TCM) and western medicine (WM), in order to benefit the integration of TCM and WM in the future. MethodsThe PubMed, Web of Science, CNKI, WanFang Data,VIP databases, Yimaitong website, National Guideline Clearinghouse (NGC), Guidelines International Network (GIN), National Institute for Health and Clinical Excellence (NICE) were electronically searched to collect clinical practice guidelines of integrated TCM and WM. The search time limit was from the inception of the database to July 2022. Two researchers independently screened the literature, extracted data, and then, descriptive analysis was performed using qualitative methods. ResultsA total of 54 guidelines were included. There were 25 guidelines that adopted the "combination of disease and syndrome" model of integrated TCM and WM, among which 20 adopted the "combination of disease period and syndrome" model, and the number of these guidelines increased with the time sequence. Among the 26 guidelines that provide ideas for the integration of TCM and WM, 22 guidelines clarify the relationship between the application of TCM and WM, among which 5 guidelines have A grade of quality evaluation, and a total of 61 articles were extracted to clarify the relationship between TCM and WM. ConclusionAt the present stage, the recommendations of TCM and WM in most guidelines of integrated TCM and WM are still independent of each other, and there is no special thinking and research on how to integrate TCM and WM evidence organically to generate recommendations with important guiding value for actual diagnosis and treatment, which is difficult to truly guide clinical practice.