Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study

Abstract

Abstract Background and objective: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as selection rationale, implementation, study design and potential interactions, were adequately reported. Therefore, this study aimed to assess the quality of reporting in the ITCWM interventional randomized controlled trials (RCTs). Methods: Through a search of 7 international electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT (Consolidated Standards of Reporting Trials) with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering design rationale, intervention details, outcome assessment and analysis). The quality of RCTs published in English journals, Chinese journals and dissertations were also compared. Results: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (standard deviation) of the CONSORT (72 score in total), CONSORT for abstract (34 score in total), and ITCWM-related (42 score in total) checklists was 35.67 (4.02), 13.17 (2.14), and 20.93 (3.95), respectively. More than 50% items were evaluated as poor quality (reporting rate＜50%) among each Checklist. Moreover, the reporting quality of publications in English journals was significantly higher than that in Chinese journals regarding the CONSORT compliance (p<0.05), but there were no differences among journals regarding the CONSORT for Abstract and ITCWM-related reporting (p>0.05). The reporting of dissertations was better than journal publications in comparison of the CONSORT and ITCWM-related items (p<0.05). Conclusion: Although CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.