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.