Chinese Proprietary Herbal Medicine Listed in ‘China National Essential Drug List’ for Common Cold: A Systematic Literature Review

Objective
Chinese proprietary herbal medicines (CPHMs) have long history in China for the treatment of common cold, and lots of them have been listed in the ‘China national essential drug list’ by the Chinese Ministry of Health. The aim of this review is to provide a well-round clinical evidence assessment on the potential benefits and harms of CPHMs for common cold based on a systematic literature search to justify their clinical use and recommendation.
Methods
We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the ‘China national essential drug list’ for common cold. There was no restriction on study design.
Results
A total of 33 CPHMs were listed in ‘China national essential drug list 2012’ for the treatment of common cold but only 7 had supportive clinical evidences. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) were included; no other study design was identified. All studies were conducted in China and published in Chinese between 1995 and 2012. All included studies had poor study design and methodological quality, and were graded as very low quality.
Conclusions
The use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.

研究目的
中国中成药（Chinese proprietary herbal medicines, CPHMs）在治疗普通感冒方面拥有悠久的应用历史，其中多款已被原卫生部纳入《国家基本药物目录》。本综述旨在通过系统文献检索，全面评估中国中成药治疗普通感冒的潜在获益与风险，为其临床应用与推荐提供依据。

研究方法
本研究检索了建库至2013年3月31日的CENTRAL、MEDLINE、EMBASE、SinoMed、CNKI、VIP、中国重要会议论文全文数据库、中国学位论文全文数据库以及在线临床试验注册网站，以获取纳入《国家基本药物目录》的中国中成药治疗普通感冒的临床研究。研究设计无任何限制。

研究结果
2012年版《国家基本药物目录》中共收录33种用于治疗普通感冒的中国中成药，但其中仅7种具备支持性临床证据。本综述共纳入6项随机对照试验（randomised controlled trials, RCTs）与7项病例系列研究（case series, CSs），未发现其他研究设计类型的文献。所有研究均于1995年至2012年间在中国开展，且以中文发表。纳入的所有研究均存在研究设计与方法学质量欠佳的问题，被评为极低质量等级。

研究结论
现有可靠证据尚不支持中国中成药用于普通感冒的治疗。未来需开展设计严谨的安慰剂对照随机对照试验，以验证中国中成药针对普通感冒的临床疗效主张。