Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) combined with Western medicine in the treatment of patients with common hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial.
Methods A total of 452 patients with common HFMD were randomly assigned to receive Western medicine alone (n = 220) or combined with TCM (Reduning or Xiyanping injections) (n = 232). The primary outcome was the incidence rate of rash/herpes disappearance within 5 days, while secondary outcomes included the incidence rate for fever, cough, lethargy, agitation, and vomiting clearance within 5 days.
Results The rash/herpes disappearance rate was 45.5% (100/220) in Western medicine therapy group, and 67.2% (156/232) in TCM and Western medicine combined therapy group, with significant difference (P < 0.001). Moreover, TCM remarkably increased the incidence rate of secondary disappearance, which was 56.4% in Western medicine therapy group and 71.4% in TCM and Western medicine combined therapy group (P = 0.001). No drug-related adverse events were observed.
Conclusions It’s suggested that the integrative TCM and Western medicine therapy achieved a better therapeutic efficacy. TCM may become an important complementary therapy on relieving the symptoms of HFMD.