Background: Chinese proprietary herbal medicines (CPHMs) have a long history in China for treating the common cold; 334 CPHMs are authorized by the China Food and Drug Administration (CFDA) for this purpose.
Objectives: To provide an evidence-based clinical practice guideline of CFDA-approved CPHMs for the common cold to justify their clinical use and recommendation.
Methods: The guideline development group included a variety of expertise in content and methods. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) or systematic reviews of CPHMs for the common cold up to 31 March 2016. We applied the Cochrane 'Risk of bias' tool, used GRADE (Grading of Recommendations, Assessment, Development & Evaluation) to evaluate the strength of the evidence, basing recommendations on findings that incorporated the strength of the evidence.
Results: A total of 334 CPHMs were approved by the CFDA, however, only two had one RCT to support their use for the common cold. For children with a wind-heat type of common cold, Zhubo Houzao powder had a better effect on fever subsidence time (MD -3.24 d, 95% CI -3.53 to -2.95) compared with conventional treatments. For adults with a wind-heat type of common cold, Shufeng Jiedu capsules had a better effect on fever subsidence time (MD -5.5 h, 95% CI -6.33 to -4.67) compared with placebo. All studies had a very high likelihood of bias, and a low quality of evidence due to limitations in their design and implementation, and weak recommendations were made for their CPHM's clinical use. Most of the trials did not report adverse events, and the safety of CPHMs is still uncertain.
Conclusions: Our review revealed the enormous lack of an evidence base in clinical use and policy making in China. We cannot provide confirmation of the beneficial effect of CPHMs for the common cold. To ensure evidence-based clinical practice, future policy makers should pay more attention to the evidence for CPHMs.