Chen Wei, Lewith George, Wang Li-qiong, Ren Jun, Xiong Wen-jing, Lu Fang, Liu Jian-ping
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Primary care and population Sciences, Medical School, University of Southampton, Southampton, United Kingdom.
PLoS One. 2014 Oct 20;9(10):e110560. doi: 10.1371/journal.pone.0110560. eCollection 2014.
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.
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.
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.
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.
中成药在中国治疗普通感冒已有悠久历史,其中许多已被中国卫生部列入“国家基本药物目录”。本综述的目的是通过系统的文献检索,对中成药治疗普通感冒的潜在益处和危害进行全面的临床证据评估,以证明其临床应用和推荐的合理性。
我们检索了Cochrane系统评价数据库、医学索引数据库、荷兰医学文摘数据库、中国生物医学文献数据库、中国知网、维普资讯、中国重要会议论文全文数据库、中国博士学位论文全文数据库以及在线临床试验注册网站,检索时间范围从各数据库建库至2013年3月31日,以查找列入“国家基本药物目录”用于治疗普通感冒的中成药的临床研究。对研究设计没有限制。
2012年版“国家基本药物目录”中共有33种中成药用于治疗普通感冒,但仅有7种有支持性的临床证据。共纳入6项随机对照试验和7个病例系列研究;未发现其他研究设计。所有研究均在中国进行,发表时间为1995年至2012年之间,且均为中文发表。所有纳入研究的设计和方法学质量均较差,质量等级为极低。
目前尚无有力证据支持使用中成药治疗普通感冒。需要进一步开展设计严谨的安慰剂对照随机试验,以证实中成药的临床疗效。