Efficacy and safety of Qishen Yiqi dripping pills as a complementary treatment for Heart Failure: A protocol of updated systematic review and meta-analysis.

BACKGROUND

Heart failure (HF) has become a serious global public health issue due to its high incidence, high mortality and extremely low quality of life. According to several clinical trials, Qishen Yiqi Dripping pills (QSYQ) combined with routine western medicine treatment can further enhance the curative effect of HF patients. However, most of the trials are small in sample size and poor in quality, which can only provide limited evidence-based medicine. The existing systematic reviews of efficacy and safety has provided evidence for the clinical application of QSYQ to a certain extent, but there are still 3 major defects. Here, we will perform a systematic review and meta-analysis that include the randomized clinical trial (RCT) of CACT-IHF, apply meta-regression and subgroup analysis to cope with multiple confounding factors, and add the clinical efficacy standards of TCM, all-cause death and readmission rates as reliable efficacy evaluation indicators. The purpose of this study was to rigorously evaluate the clinical efficacy and safety of QSYQ in the complementary treatment of HF with a well-designed systematic review and meta-analysis.

METHODS

Following the strict search strategy, 9 databases will be searched to ensure a comprehensive search. We search the database from the establishment until November 30, 2020. This study will include RCTs of QSYQ in HF patients' complementary treatment. Two searchers will independently draft and carry out the search strategy, and the third member will further complete it. Two members independently screen literature, extract data and cross-check, and solve different opinions through discussion or negotiation with the third member. The risk bias will be evaluated based on Cochrane tool of risk of bias. Meta-regression and subgroup analysis are used to check and deal with the heterogeneity. The data analysis will be conducted by the statistical software Stata 16.0.

RESULTS

The results of this research will be delivered in a peer-reviewed journal.

CONCLUSION

This study expects to provide credible and scientific evidence for the efficacy and safety of QSYQ in HF's complementary treatment, and at the same time provide a convenient and effective choice for decision-makers and patients.

PROTOCOL REGISTRATION NUMBER

INPLASY 2020120106.

ETHICAL APPROVAL

Since this study is on the basis of published or registered RCTs, ethical approval and informed consent of patients are not required.