Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial

Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7–10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0–25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0–24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0–16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD.