To investigate the clinical effect and the safety of Shuangxiangcao preparation in the treatment of common-type hand, foot and mouth disease (HFMD).

Total of 293 children with HFMD in our hospital from October 2010 to June 2012 were enrolled. They were divided into three groups in randomly. The patients in Chinese Medicine spray group were given Shuangxiangcao spray twelve times a day, patients in Chinese Medicine decoction group were given Shuangxiangcao decoction triple a day, while patients in control group were given ribavirin injection once a day, all for seven days.

The western medicine therapeutice index and Chinese Medicine curative effect index in Shuangxiangcao preparation had no significant differences compared with the control group (P all > 0.05), but the temperature recovery time was significantly shorter than that in control group (F = 5.723, P = 0.004). At the end of treatment, liver and kidney function recovered in all patients, and blood routine and myocardial enzymes recovered in most patients, while the abnormal rate of lactic acid dehydrogenase in Shuangxiangcao preparation was significantly lower than that of control group (χ²= 8.222, P = 0.016). After treatment, 250 patients (85.32%) were curred, 38 patients (12.97%) improved and 5 cases (1.71%) worsened. The cure rate and improvement rate in Shuangxiangcao Preparation were significantly higher than those of the control group (F = 4.85, 6.795; P = 0.045, 0.033), but the deterioration rate had no significant difference.

Shuangxiangcao spray and Shuangxiangcao decoction had same efficacy to ribavirin in common-type HFMD, furthermore, they have some advantages in fever relief and myocardial protection. They are safety, convenient and worth promoting the application.