Abstract

Purpose: To evaluate the beneficial effect and safety of a Chinese herbal formula, Qili Qiangxin, for patients with heart failure. Methods: We searched six electronic databases until June 2014 for randomized controlled trials (RCTs) of Qili Qiangxin for patients with heart failure. After independent identification of included trials and data extraction, we performed data analysis and quality assessment of the included trials using Review Manager 5.2 and GRADEpro software. We conducted the review based on our registered protocol [PROSPERO registration: CRD42013006106]. Results: A total of 121 RCTs (123 publications) published between 2005 and 2014 were included, involving 10,731 heart failure patients aged from 18 to 98 years old. The methodological quality of majority of included trials was poor. Meta-analysis showed no significant difference between Qili Qiangxin plus conventional treatment and conventional treatment alone for mortality (RR 0.48, 95%CI 0.20 to 1.14; n=483 patients). However, Qili Qiangxin plus conventional treatment reduced the major cardiovascular events (RR 0.47, 95%CI 0.31 to 0.70; n=168 patients) and re-hospitalization due to heart failure (RR 0.51, 95%CI 0.37 to 0.70; n=465 patients) compared with conventional treatment alone. Qili Qiangxin improved NYHA levels (RR 1.40, 95%CI 1.30 to 1.50; n=4147 patients) and quality of life (MD -8.48 scores, 95% CI -9.56 to -7.39; n=792 patients) measured by Minnesota Living with Heart Failure Questionnaire (lower scores better). There were no serious adverse events reported to Qili Qiangxin. Conclusion:Qili Qiangxin appears to be beneficial in reducing cardiovascular events, re-hospitalization and quality of life in patients with heart failure. It appears to be safe. This finding was based on low quality of clinical trials and must be interpreted with caution. Further large, rigorous trials are warranted to confirm the benefit. Contact: Jin Sun, sunjin sunshine@163.com

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