Abstract
Objective: This study aimed to clarify the efficacy and safety of Xinbao pill (XBP) as an adjunctive treatment for chronic heart failure (CHF). Methods: Randomized controlled trials (RCTs) on the efficacy and safety of XBP in the treatment of CHF were searched from the six databases. The risk of bias assessment tool recommended by Cochrane Handbook 5.1 were used to assess the methodological quality of the included studies. RevMan 5.3 software was used for meta-analysis. The subgroup and sensitivity analyses were also performed. The grading recommendations assessment, development, and evaluation (GRADE) technique were used to assess the evidence’s certainty. Results: Nine RCTs with a total of 882 patients were identified in this study. The meta-analysis demonstrated that XBP as adjunctive therapy was superior to conventional medicine alone for the treatment of CHF in improving the left ventricular ejection fraction (LVEF; MD = 5.34; 95% CI 4.68 to 5.99; p < 0.001), the total effective rate (RR = 1.21; 95% CI, 1.14 to 1.29; p < 0.001), the cardiac output (MD = 0.56; 95% CI 0.42 to 0.70; p < 0.001), the stroke volume (MD = 3.42; 95% CI 2.03 to 4.81; p < 0.001) and the 6-min walking distance (6-MWD; MD = 31.95; 95% CI 21.83 to 42.06; p < 0.001), meanwhile reducing the left ventricular end-diastolic diameter (LVEDD; MD = −3.22; 95% CI −4.03 to −2.42; p < 0.001) and left ventricular end-systolic dimension (LVESD; MD = −2.93; 95% CI −3.80 to −2.06; p < 0.001). Regarding safety, a total of 2.4% (11/456) adverse reactions occurred in the XBP groups while 3.9% (18/456) in the control group. The outcomes’ evidentiary quality ranged from “very low” to “moderate”. Conclusion: This study indicated that XBP as adjunctive therapy combined with conventional medicine seemed to be safe and more effective than conventional medicine alone in treating CHF. However, due to the poor methodological quality of the included RCTs, further well-designed RCTs are required to confirm the efficacy and safety of XBP.
Highlights
Chronic heart failure (CHF) is a significant and rising global public health issue affecting approximately 64.3 million individuals worldwide (Disease and Prevalence, 2018; Groenewegen et al, 2020)
This study aims to answer two clinical questions for Xinbao pill (XBP): 1) whether XBP as an adjunct treatment combined with conventional medicine was more effective than conventional medicine alone; 2) whether XBP as an adjunct treatment was safe when used in combination with conventional medicine
Following a thorough examination of the full text, one of the literature was excluded for the control group was treated conventional medicine combined with betaloc tablets, while the intervention group was treated with conventional medicine combined with XBP, which did not meet the standards of intervention measures
Summary
Chronic heart failure (CHF) is a significant and rising global public health issue affecting approximately 64.3 million individuals worldwide (Disease and Prevalence, 2018; Groenewegen et al, 2020). The occurrence of recognized heart failure is believed to be between 1 and 2% of the overall adult population in developed countries (Townsend et al, 2021). It was responsible for an estimated $31 billion (£22.5 billion) in health spending in 2012, accounting for more than 10% of total health spending in the United States for cardiovascular illnesses (Writing Group et al, 2016). The available drug treatment options for CHF still do not meet current medical needs, and the 5 years survival rate of patients is only 56.7% (Jones et al, 2019). Many studies have demonstrated that traditional Chinese medicine has a substantial effect on treating CHF in recent years (Hao et al, 2017)
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