Therapeutic effect of Jinzhen oral liquid for hand foot and mouth disease: a randomized, multi-center, double-blind, placebo-controlled trial.
BACKGROUND
No specific antiviral agent against hand foot and mouth disease (HFMD) is available for clinical practice today.


OBJECTIVE
To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD.


METHODS
In this randomized, double-blind, placebo-controlled trial, 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up. The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature (fever clearance).


RESULTS
There were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever. Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days (95% CI, 4.6 to 5.2 days), compared with 5.7 days (95% CI, 5.4 to 6.0 days) in the placebo group (P = 0.0036). The median time of fever clearance was shorter in the 79 children who received Jinzhen (43.41 hrs, 95% CI, 37.05 to 49.76) than that in the 93 children who received placebo (54.92 hrs, 95% CI, 48.16 to 61.68) (P = 0.0161). Moreover, Jinzhen reduced the risk of symptoms by 28.5% compared with placebo (HR, 0.7150, 95% CI, 0.5719 to 0.8940, P = 0.0032). More importantly, treatment failure rate was significantly lower in the Jinzhen group (8.04%) compared with that in the placebo group (15.00%) (P = 0.0434). The incidence of serious adverse events did not differ significantly between the two groups (9 in Jinzhen group vs. 18 in placebo, P = 0.075).


CONCLUSIONS
Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo.


BACKGROUND
Chinese Clinical Trial Registry (http://www.chictr.org/en/) ChiCTR-TRC-10000937.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Jun
J
Liu
Department of Infectious Disease, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, Anhui, China.
Guo-Liang
GL
Zhang
Department of Infectious Disease, Infectious Disease Hospital of Cangzhou City, Cangzhou, Hebei, China.
Gui-Qin
GQ
Huang
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Li
L
Li
Department of Infectious Disease, Infectious Disease Hospital of Tangshan City, Tangshan, Hebei, China.
Chun-Ping
CP
Li
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Mei
M
Wang
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Xiao-Yan
XY
Liang
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Di
D
Xie
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Chang-Ming
CM
Yang
Department of Infectious Disease, The Fifth People's Hospital of Guiyang City, Guiyang, Guizhou, China.
Yan
Y
Li
Department of Infectious Disease, Infectious Disease Hospital of Cangzhou City, Cangzhou, Hebei, China.
Xiu-Rong
XR
Sun
Department of Infectious Disease, Infectious Disease Hospital of Cangzhou City, Cangzhou, Hebei, China.
Hong-Sen
HS
Zhang
Department of Infectious Disease, Infectious Disease Hospital of Tangshan City, Tangshan, Hebei, China.
Bai-Song
BS
Wan
Department of Infectious Disease, Infectious Disease Hospital of Tangshan City, Tangshan, Hebei, China.
Wei-Hua
WH
Zhang
Department of Epidemiology and Biostatistics, Nanjing Medical University, Nanjing, Jiangsu, China.
Hao
H
Yu
Department of Epidemiology and Biostatistics, Nanjing Medical University, Nanjing, Jiangsu, China.
Ru-Yang
RY
Zhang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Ya-Nan
YN
Yu
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Zhong
Z
Wang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Yong-Yan
YY
Wang
D000284:Administration, Oral; D000818:Animals; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004770:Enterovirus / Q000187:drug effects / Q000502:physiology; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000503:physiopathology; D006232:Hand, Foot and Mouth Disease / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007223:Infant; D008297:Male; D010919:Placebos; D016896:Treatment Outcome
D000998:Antiviral Agents; D004365:Drugs, Chinese Herbal; D010919:Placebos