Sun Jin, Zhang Kang, Xiong Wen-Jing, Yang Guo-Yan, Zhang Yun-Jiao, Wang Cong-Cong, Lai Lily, Han Mei, Ren Jun, Lewith George, Liu Jian-Ping
Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Complementary and Integrated Medicine Research Unit, Primary Care and Population Sciences, University of Southampton, Southampton, UK.
BMC Complement Altern Med. 2016 Jul 11;16:201. doi: 10.1186/s12906-016-1174-1.
Qili Qiangxin capsule is a standardized Chinese herbal treatment that is commonly used in China for heart failure (HF) alongside conventional medical care. In 2014, Chinese guidelines for the treatment of chronic HF highlighted Qili Qiangxin capsules as a potentially effective medicine. However, there is at present no high quality review to evaluate the effects and safety of Qili Qiangxin for patients with HF.
We conducted a systematic review and meta-analysis and followed methods described in our registered protocol [PROSPERO registration: CRD42013006106]. We searched 6 electronic databases to identify randomized clinical trials (RCTs) irrespective of blinding or placebo control of Qili Qiangxin used as an adjuvant treatment for HF.
We included a total of 129 RCTs published between 2005 and 2015, involving 11,547 patients, aged 18 to 98 years. Meta-analysis showed no significant difference between Qili Qiangxin plus conventional treatment and conventional treatment alone for mortality (RR 0.53, 95 % CI 0.27 to 1.07). However, compared with conventional treatment alone, Qili Qiangxin plus conventional treatment demonstrated a significant reduction in major cardiovascular events (RR 0.46, 95 % CI 0.34 to 0.64) and a significant reduction in re-hospitalization rate due to HF (RR 0.49, 95 % CI 0.38 to 0.64). Qili Qiangxin also showed significant improvement in cardiac function measured by the New York Heart Association scale (RR 1.38, 95 % CI 1.29 to 1.48) and quality of life as measured by Minnesota Living with Heart Failure Questionnaire (MD -8.48 scores, 95 % CI -9.56 to -7.39). There were no reports of serious adverse events relating to Qili Qiangxin administration. The majority of included trials were of poor methodological quality.
When compared with conventional treatment alone, Qili Qiangxin combined with conventional treatment demonstrated a significant effect in reducing cardiovascular events and re-hospitalization rate, though not in mortality. It appeared to significantly improve quality of life in patients with HF and data from RCTs suggested that Qili Qiangxin is likely safe. This data was drawn from low quality trials and the results of this review must therefore be interpreted with caution. Further research is warranted, ideally involving large, prospective, rigorous trials, in order to confirm these findings.
芪苈强心胶囊是一种标准化的中药制剂,在中国常用于心力衰竭(HF)的治疗,作为传统医疗的辅助手段。2014年,中国慢性HF治疗指南将芪苈强心胶囊列为一种可能有效的药物。然而,目前尚无高质量的综述来评估芪苈强心对HF患者的疗效和安全性。
我们进行了一项系统综述和荟萃分析,并遵循我们注册方案中描述的方法[国际前瞻性系统评价注册平台登记号:CRD42013006106]。我们检索了6个电子数据库,以识别将芪苈强心作为HF辅助治疗的随机临床试验(RCT),无论是否采用盲法或安慰剂对照。
我们共纳入了2005年至2015年发表的129项RCT,涉及11547例年龄在18至98岁之间的患者。荟萃分析显示,芪苈强心联合传统治疗与单纯传统治疗在死亡率方面无显著差异(风险比[RR]0.53,95%置信区间[CI]0.27至1.07)。然而,与单纯传统治疗相比,芪苈强心联合传统治疗在主要心血管事件方面显著降低(RR0.46,95%CI0.34至0.64),因HF导致的再住院率也显著降低(RR0.49,95%CI0.38至0.64)。芪苈强心还使纽约心脏协会心功能分级所衡量的心脏功能显著改善(RR1.38,95%CI1.29至1.48),并使明尼苏达心力衰竭生活质量问卷所衡量的生活质量显著改善(MD -8.48分,95%CI -9.56至-7.39)。没有关于芪苈强心给药相关严重不良事件的报告。纳入的试验大多方法学质量较差。
与单纯传统治疗相比,芪苈强心联合传统治疗在降低心血管事件和再住院率方面显示出显著效果,但在死亡率方面未显示出差异。它似乎能显著改善HF患者的生活质量,RCT数据表明芪苈强心可能是安全的。这些数据来自低质量试验,因此本综述的结果必须谨慎解读。有必要进行进一步研究,理想情况下应涉及大型、前瞻性、严谨的试验,以证实这些发现。