Article type
Abstract
Background: Chinese proprietary herbal medicines (CPHMs) have a long history in China for the treatment of common cold; more than 300 CPHMs have been authorized by China Food and Drug Administration (CFDA).
Objectives: To provide an evidence-based recommendation for clinical practice on CFDA approved CPHMs for the common cold.
Methods: CENTRAL, PubMed, EMBASE, SinoMed, CNKI, VIP, and online clinical trial registry websites were searched till 31 March 2016. Parallel-group RCTs of CPHMs compared with no treatment, placebo, or symptomatic treatment were included.
Results: A total of 333 CPHMs were approved by the CFDA, however, only 2 of them had one RCT to support their use.
For adults with wind-heat type of common cold, trial ‘Xu 2015’ showed that Shufeng Jiedu capsule had a better effect on cure rate within 1 days (RR 4.74, 95% CI 2.61 to 8.61) and fever subsidence time (MD -5.50 h, 95% CI -6.33 to -4.67) compared with placebo. For children with wind-cold type of common cold, trial ‘Di 2012’ showed that Ganmao Qingre granules do not have better effect on cure rate within 5 days (RR 1.31, 95% CI 0.78 to 2.19) compared with p-acetaminophenol.
Conclusions: Our study revealed two things, first, there is enormous lack of evidence for clinical use of CPHMs and policy making in China. More importantly, our study brought to light the tremendous scientific waste in the field of TCM. Although more than 13000 clinical trials had been conducted to investigate the effects of CPHMs for common cold, nearly all of them could not be used as clinical evidence due to important defects in study design, such as unclear diagnostic criteria, inappropriate use of control and/or outcome measures. Future policy makers should pay more attention to the evidence making and TCM investigators should attache great importance on the rigour of study design.
Objectives: To provide an evidence-based recommendation for clinical practice on CFDA approved CPHMs for the common cold.
Methods: CENTRAL, PubMed, EMBASE, SinoMed, CNKI, VIP, and online clinical trial registry websites were searched till 31 March 2016. Parallel-group RCTs of CPHMs compared with no treatment, placebo, or symptomatic treatment were included.
Results: A total of 333 CPHMs were approved by the CFDA, however, only 2 of them had one RCT to support their use.
For adults with wind-heat type of common cold, trial ‘Xu 2015’ showed that Shufeng Jiedu capsule had a better effect on cure rate within 1 days (RR 4.74, 95% CI 2.61 to 8.61) and fever subsidence time (MD -5.50 h, 95% CI -6.33 to -4.67) compared with placebo. For children with wind-cold type of common cold, trial ‘Di 2012’ showed that Ganmao Qingre granules do not have better effect on cure rate within 5 days (RR 1.31, 95% CI 0.78 to 2.19) compared with p-acetaminophenol.
Conclusions: Our study revealed two things, first, there is enormous lack of evidence for clinical use of CPHMs and policy making in China. More importantly, our study brought to light the tremendous scientific waste in the field of TCM. Although more than 13000 clinical trials had been conducted to investigate the effects of CPHMs for common cold, nearly all of them could not be used as clinical evidence due to important defects in study design, such as unclear diagnostic criteria, inappropriate use of control and/or outcome measures. Future policy makers should pay more attention to the evidence making and TCM investigators should attache great importance on the rigour of study design.