Abstract
Objective Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration's tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee's heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.
Highlights
Heart failure is a public health problem in clinical cardiology nowadays. ere are about 3% to 5% people suffering from heart failure (HF) according to epidemiological surveys worldwide. e morbidity of HF is about 2% in developed countries and 1.3% in China, which means nearly 18 million people are having HF in China
Evidence-Based Complementary and Alternative Medicine of people over 65 years with HF is about 10%, indicating that people are more likely to suffer from heart failure when they get older. e 1-year mortality rate is ranged from 20% to 40% in different countries in patients who are readmitted for heart failure, about 50% of HF patients died within five years after diagnosis, and the 10-year mortality is more than 90%
The results indicated a benefit in the Fuzi formulae (FZF) overall, the beneficial results were uncertain despite the moderate quality of the evidence (Table 6)
Summary
Heart failure is a public health problem in clinical cardiology nowadays. ere are about 3% to 5% people suffering from heart failure (HF) according to epidemiological surveys worldwide. e morbidity of HF is about 2% in developed countries and 1.3% in China, which means nearly 18 million people are having HF in China. Ere are about 3% to 5% people suffering from heart failure (HF) according to epidemiological surveys worldwide. Evidence-Based Complementary and Alternative Medicine of people over 65 years with HF is about 10%, indicating that people are more likely to suffer from heart failure when they get older. Current treatments for HF are relatively fixed, including diuretics, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, aldosterone receptor antagonists, digitalis, and vasodilating agents, according to the guidelines for CHFST. These drugs only achieve good short-term effects. It is beneficial to HF patients in relieving symptoms and improving indicators despite of its toxicity as known. is study aimed at investigating the efficacy and safety of FZF on the treatment of HF and providing reference for clinical diagnosis and treatment
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