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.
Department of Integrated TCM and Western Medicine, Beijing Youan Hospital Affiliated with Capital Medical University, Beijing 100069, China.
Xiuhui
X
Li
Department of Pediatrics, Kaifeng Children's Hospital, Kaifeng, Henan 475003, China.
Xi
X
Zhang
Department of Integrated TCM and Western Medicine, Beijing Youan Hospital Affiliated with Capital Medical University, Beijing 100069, China.
Jianbo
J
Ding
Department of Pediatrics, Guangzhou Medical Center for Women & Children, Guangzhou, Guangdong 510623, China.
Yi
Y
Xu
Department of Pediatrics, First Hospital Affiliated with Guangxi Medical University, Nanning, Guangxi 530021, China.
Dan
D
Wei
Department of Integrated TCM and Western Medicine, Beijing Youan Hospital Affiliated with Capital Medical University, Beijing 100069, China.
Yimei
Y
Tian
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100700, China.
Wei
W
Chen
Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai 201203, China.
Jihan
J
Huang
Beijing Institute of Hepatology, Beijing Youan Hospital Affiliated with Capital Medical University, Beijing 100069, China.
Tao
0000-0003-0675-0163
T
Wen
Department of Communicable Diseases, Children's Hospital of Hunan Province, Changsha, Hunan 410007, China.
Shuangjie
S
Li