Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 42, Cultural West Road, Jinan, 250011, Shandong, People's Republic of China,
Qual Life Res. 2014 May;23(4):1177-92. doi: 10.1007/s11136-013-0582-7. Epub 2013 Nov 21.
Chronic heart failure (CHF) is not only a leading cause of death, hospitalization, and rehospitalization, but also significantly decreases quality of life (QoL). This study aims to evaluate published clinical trials of oral Chinese herbal medicine (OCHM) for improvement of QoL in patients with CHF that employ the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score as an outcome measure.
A systematic literature search was performed using five databases up to June 2013 to identify randomized control trials (RCTs). RCTs involving OCHM plus conventional medicine treatment (CMT) with or without blinding, compared with CMT with or without placebo, with MLHFQ score as an outcome measure were identified. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Review of Interventions. RevMan 5.2.5 and Stata 11.0 were used for data analysis.
Thirty-eight RCTs with a total of 3,170 participants were identified. The majority of the included trials were assessed to be of high clinical heterogeneity and poor methodological quality. The main results of meta-analysis showed improvement of total MLHFQ score when OCHM plus CMT compared with CMT with or without placebo [MD = -5.71 (-7.07, -4.36), p < 0.01].
There is some encouraging evidence of OCHM combined with CMT for the improvement of QoL in CHF patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed.
慢性心力衰竭（CHF）不仅是导致死亡、住院和再住院的主要原因，还显著降低了生活质量（QoL）。本研究旨在评估已发表的口服中药（OCHM）改善 CHF 患者生活质量的临床试验，这些临床试验采用明尼苏达州心力衰竭生活质量问卷（MLHFQ）评分作为疗效评估指标。
系统检索了截至 2013 年 6 月的五个数据库，以确定涉及 OCHM 联合常规药物治疗（CMT）加或不加盲法，与 CMT 加或不加安慰剂，以 MLHFQ 评分为疗效评估指标的随机对照试验（RCT）。采用 Cochrane 干预系统评价手册独立评估 RCT 的方法学质量。RevMan 5.2.5 和 Stata 11.0 用于数据分析。
共纳入 38 项 RCT，总计 3170 例患者。大多数纳入的试验被评估为具有较高的临床异质性和较差的方法学质量。荟萃分析的主要结果显示，OCHM 联合 CMT 与 CMT 加或不加安慰剂相比，总 MLHFQ 评分有所改善[MD=-5.71（-7.07，-4.36），p<0.01]。
有一些令人鼓舞的证据表明，OCHM 联合 CMT 可改善 CHF 患者的生活质量。然而，由于纳入试验的样本量小、临床异质性高、方法学质量差，证据仍然较弱。此外，需要进一步开展大样本量和设计良好的试验。
