Background: Chinese herbal medicines are widely used in treating hand, foot and mouth disease (HFMD) in China. Single clinical studies have shown positive results of Chinese herbal medicines on HFMD compared with Western medication. A systematic review was conducted to critically appraise the available evidence on the potential benefits and harms of Chinese herbal medicines' use in HFMD. Methods: Randomized controlled trials comparing Chinese herbal medicines with no treatment, placebo, or Western medications for HFMD were included. Databases searched included: PubMed, the Cochrane Library, Chinese Biomedical Database, China Network Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan Fang Database. All searches ended in July 2011. Four authors extracted data and assessed the study quality independently. RevMan 5.0.25 software was used for data analysis with effect estimate presented as relative risk and mean difference with a 95% confidence interval. Results: Seventy six trials were included, with generally poor methodological quality. According to the results of each single trial and meta-analysis of 18 trials, herbal medicine with or without active drugs may have effect for reducing fever clearance time, rash subsidence time, oral symptoms healing time and healing time of HFMD. Conclusions: This review suggests herbal medicine, combined with Western medications or used separately might improve symptoms of HMFD. However the current evidence is not of sufficient quality to allow unconditional recommendations to be made about the wider application of any kind of herbal medicine for the treatment of HFMD. (C) 2011 Elsevier GmbH. All rights reserved.