Chinese Journal of Integrative Medicine

, Volume 23, Issue 12, pp 887–892 | Cite as

Effect of integrated Chinese and Western medicine therapy on severe hand, foot and mouth disease: A prospective, randomized, controlled trial

  • Xiu-hui Li
  • Shuang-jie Li
  • Yi Xu
  • Dan Wei
  • Qing-sheng Shi
  • Qing-xiong Zhu
  • Tong Yang
  • Jian-bo Ding
  • Yi-mei Tian
  • Ji-han Huang
  • Kun Wang
  • Tao WenEmail author
  • Xi ZhangEmail author
Original Article



To evaluate the efficacy and safety of Chinese medicine (CM) plus Western medicine (WM) in the treatment of pediatric patients with severe hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial.


A total of 451 pediatric patients with severe HFMD were randomly assigned to receive WM therapy alone (224 cases, WM therapy group) or CM [Reduning Injection (热 毒宁注射液) or Xiyanping Injection (喜炎平注射液)] plus WM therapy (227 cases, CM plus WM therapy group) for 7–10 days, according to a web-based randomization system. The primary outcome was fever clearance time, which was presented as temperature decreased half-life time. The secondary outcomes included the rate of rash/herpes disappearance within 120 h, as well as the rate for cough, runny nose, lethargy and weakness, agitation or irritability, and vomiting clearance within 120 h. The drug-related adverse events were also recorded.


The temperature decreased half-life time was 40.4 h in the WM therapy group, significantly longer than 27.2 h in the CM plus WM therapy group (P<0.01). Moreover, the rate for rash/herpes disappearance within 120 h was 43.6% (99/227) in the CM plus WM therapy group, significantly higher than 29.5% (66/224) in the WM therapy group (P<0.01). In addition, the rate for cough, lethargy and weakness, agitation or irritability disappearance within 120 h was 32.6% (74/227) in the CM plus WM therapy group, significantly higher than 19.2% (43/224) in the WM therapy group (P<0.01). No drug-related adverse events were observed during the course of the study.


The combined CM and WM therapy achieved a better therapeutic efficacy in treating severe HFMD than the WM therapy alone. Reduning or Xiyanping Injections may become an important complementary therapy to WM for relieving the symptoms of severe HFMD. (Registration No. NCT01145664)


hand foot and mouth disease Reduning Injection Xiyanping Injection Chinese medicine 


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Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine and Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Xiu-hui Li
    • 1
  • Shuang-jie Li
    • 2
  • Yi Xu
    • 3
  • Dan Wei
    • 4
  • Qing-sheng Shi
    • 5
  • Qing-xiong Zhu
    • 6
  • Tong Yang
    • 7
  • Jian-bo Ding
    • 1
  • Yi-mei Tian
    • 1
  • Ji-han Huang
    • 8
  • Kun Wang
    • 8
  • Tao Wen
    • 9
    Email author
  • Xi Zhang
    • 10
    Email author
  1. 1.Department of Integrated Traditional Chinese Medicine and Western MedicineBeijing Youan Hospital Affiliated to Capital Medical UniversityBeijingChina
  2. 2.Department of Communicable DiseasesChildren’s Hospital of Hunan ProvinceChangshaChina
  3. 3.Department of PediatricsGuangzhou Medical Center for Women and ChildrenGuangzhouChina
  4. 4.Department of PediatricsFirst Hospital Affiliated to Guangxi Medical UniversityNanningChina
  5. 5.Department of Internal MedicineHandan Maternal and Child Health HospitalHandan, Hebei ProvinceChina
  6. 6.Department of Internal MedicineChildren’s Hospital of Jiangxi ProvinceNanchangChina
  7. 7.Department of PediatricsThe People’s Hospital of LiuzhouLiuzhou, Guangxi ProvinceChina
  8. 8.Center for Drug Clinical ResearchShanghai University of Chinese MedicineShanghaiChina
  9. 9.Medical Research Center, Beijing Chaoyang HospitalCapital Medical UniversityBeijingChina
  10. 10.Department of PediatricsKaifeng Children’s HospitalKaifeng, Henan ProvinceChina

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