RESUMEN
OBJECTIVE: To evaluate the effectiveness and safety of bromhexine for acute bronchitis. METHODS: Cochrane Library , PubMed, Embase, ISI, CBMdisc, CNKI, VIP and WanFang database were retrieved. Systematic review, meta-analysis or randomized controlled trials (RCT) comparing bromhexine with placebo, ambroxol, tanreqing and N-acetylcysteine for acute bronchitis were included. Quality assessment and Meta-analysis were performed for RCT that met the inclusion and exclusion criteria. In addition, the conclusions of the systematic review and Meta-analysis in this aspect were referred. RESULTS: Ten RCTs met the inclusion criteria, all in Chinese. No systematic review or Meta-analysis was retrieved. Five RCTs of bromhexine versus placebo were included. There was no significant difference in clinical overall efficacy [RR=1.22, 95% CI (0.88,1.69), P=0.24]. The pulmonary rale vanishing time and cough vanishing time of bromhexine were obviously shorter than that of placebo with significant difference [MD=-2.32, 95% CI (-3.34, -1.29), P < 0.00001; MD=-2.85, 95%CI(-3.12, -2.59), P < 0.00001]. Significant difference was demonstrated in adverse reaction incidence [RR=17.00, 95% CI(1.01,286.82), P=0.05]. Three RCT of bromhexine versus ambroxol were included. Outcomes of these studies could not be combined. One RCT of bromhexine versus Tanreqing were included. Meta-analysis could not be performed. One RCT of bromhexine versus N-acetylcysteine were included. Meta-analysis could not be performed. CONCLUSION: Based on current evidence, the effectiveness of bromhexine in decurtating course of pulmonary rale and cough are superior to placebo. Clinical overall efficacy is similar between bromhexine and placebo. High risk of adverse reaction incidence still exists with bromhexine. Ambroxol, Tanreqing and N-acetylcysteine exhibit better effectiveness than bromhexine, but more studies are needed to testify the results from the small quantity of studies. Copyright 2012 by the Chinese Pharmaceutical Association.