title: [Treatment of upper respiratory infection by fangfeng tongsheng granule: a randomized controlled study].
abstract: OBJECTIVE
  To evaluate the clinical effectiveness and safety of Fangfeng Tongsheng Granule (FTG) in the treatment of upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome).
  
  
  METHODS
  A randomized, double-blinded, multi-centered, placebo-parallel-controlled clinical trial was adopted. Totally 324 patients were enrolled and assigned to two groups, 216 patients in the treatment group and 108 patients in the control group. Those in the treatment group took FTG at the daily dose of 3 g, twice per day, the therapeutic course being 3 days. Those with axillary temperature more than 37 degrees C took one more time before medication. Those in the control group took simulated agent granules the same dose and dosage as the treatment group. The effect of Chinese medical syndrome (ECMS), the rate of temperature-dropping-to-normal (RT), the time of temperature-dropping-to-normal (TT), the curative effect of single symptom (CESS) and adverse reactions were observed.
  
  
  RESULTS
  Totally 203 completed the trial in the treatment group and 101 in the control group. In the treatment group, the cured-effective rate was 55.67% (113/ 101), the total effective rate was 93.10% (189/101), the ECMS score decreased by 9.24 +/- 4.46, while they were 5.94% (6/101), 36.63% (37/101), and 3.27 +/- 3.29, respectively in the control group (P < 0.01). The RT was 87.50% (98/112) in the treatment group and 58.49% (31/53) in the control group (P < 0.01). The TT in the treatment group was superior to that of the control group (P < 0.01). As for CESS, all of the three primary symptoms and nine secondary symptoms were improved more obviously in the treatment group than in the control group. The integral decreased obviously, showing statistical difference (P < 0.01). The decrease was more obvious in the treatment group than in the control group (P < 0.01). There was no adverse event related to FTG.
  
  
  CONCLUSIONS
  FTG was effective and safe in treating upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome).
authors.affiliation: Department of Emergency, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Shuo
authors.initials: S
authors.lastname: Wang
authors.affiliation: The National Drug Clinical Trials Institution, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Ting
authors.initials: T
authors.lastname: Zhao
authors.affiliation: Department of Emergency, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Wen-Sheng
authors.initials: WS
authors.lastname: Qi
authors.affiliation: Yantai Tianzheng Pharmaceutical Co., Ltd., Shandong 264003, China.
authors.forename: Yong-Jun
authors.initials: YJ
authors.lastname: Liu
authors.affiliation: Department of Emergency, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Xiu-Jie
authors.initials: XJ
authors.lastname: Yang
authors.affiliation: Department of Emergency, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Ting-Ting
authors.initials: TT
authors.lastname: Mo
authors.affiliation: The National Drug Clinical Trials Institution, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Respiration, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
authors.forename: Gui-Ying
authors.initials: GY
authors.lastname: Liu
authors.affiliation: Department of Respiration, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Gao
authors.affiliation: Department of Respiration, Jinan Municipal Hospital of Traditional Chinese Medicine, Jinan 250012, China.
authors.forename: Rong-Kui
authors.initials: RK
authors.lastname: Liu
authors.affiliation: Department of Respiration, Yantai Yuhuangding Hospital, Shandong 264000, China.
authors.forename: Huan-Sheng
authors.initials: HS
authors.lastname: Ji
authors.affiliation: Urgent-care Centre, Yantai Municipal Hospital of Traditional Chinese Medicine, Shandong 264000, China.
authors.forename: Shi-Ling
authors.initials: SL
authors.lastname: Guan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019661:Apiaceae; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal