Background:The patent traditional Chinese medicine (PTCM) sales totaled 35.04 billion dollars in 2015, and PTCMs used in respiratory tract diseases were 10.88% - 12.61% of all diseases in 2007-2014, ranked fourth. Relevant guidelines were few.
Objectives:To compare the evidence base (results of systematic review) of orally taken PTCMs for acute lower respiratory tract infections (ALRTIs) with the recommendations in clinical practice guidelines.
Methods:We searched PubMed, Cochrane Library, Embase and four Chinese databases until September 2016 for 1) randomised controlled trials (RCTs) testing orally taken PTCMs for ALRTIs, to conduct a systematic review; and, 2) clinical practice guidelines for ALRTIs containing PTCM recommendations, to evaluate the quality of the guidelines and the PTCM recommendations. Two reviewers independently screened study, extracted study data and assessed risk of bias. Agreements were achieved. Quality of evidence/guidelines was assessed with GRADE approaches. Evidence base and recommendations in guidelines were compared.
Results:4808 literatures were identified. 31 RCTs (5454 patients) were included for systematic review. PTCMs compared to placebo reduced severity of cough (3 trials, 948 patients, risk ratio (RR) 2.50, 1.16 to 5.43; low certainty); increased global rating of success (3 trials, 948 patients, RR 1.70, 1.44 to 2.01; low certainty); reduced global assessment of severity of symptoms (1 trial, 478 patients, RR 4.01, 2.76 to 5.81; moderate certainty). 22 trials (4740 patients) compared effects of different PTCMs. 18 PTCMs were recommended in traditional Chinese medicine guidelines for ALRTIs. 16 of them had no evidence from clinical trials.
Conclusions: The evidence base of PTCMs for ALRTIs was weak. Few TCPMs were recommended in guidelines. However the recommendations were based on almost no clinical research evidence. Rigorous clinical researches are badly needed to inform the massive clinical use. Further training in evidence-based medicine methods for traditional Chinese medicine guideline developers are greatly needed.