title: Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial.
abstract: BACKGROUND
  Observational studies from Asia suggest that maxingshigan-yinqiaosan may be effective in the treatment of acute H1N1 influenza.
  
  
  OBJECTIVE
  To compare the efficacy and safety of oseltamivir and maxingshigan-yinqiaosan in treating uncomplicated H1N1 influenza.
  
  
  METHODS
  Prospective, nonblinded, randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00935194)
  
  
  METHODS
  Eleven hospitals from 4 provinces in China.
  
  
  METHODS
  410 persons [corrected] aged 15 to 69 [corrected] years with laboratory-confirmed H1N1 influenza.
  
  
  METHODS
  Oseltamivir, 75 mg twice daily; maxingshigan-yinqiaosan decoction (composed of 12 Chinese herbal medicines, including honey-fried Herba Ephedrae), 200 mL 4 times daily; oseltamivir plus maxingshigan-yinqiaosan; or no intervention (control). Interventions and control were given for 5 days.
  
  
  METHODS
  Primary outcome was time to fever resolution. Secondary outcomes included symptom scores and viral shedding determined by using real-time reverse transcriptase polymerase chain reaction.
  
  
  RESULTS
  Significant reductions in the estimated median time to fever resolution compared with the control group (26.0 hours [95% CI, 24.0 to 33.0 hours]) were seen with oseltamivir (34% [95% CI, 20% to 46%]; P < 0.001), maxingshigan-yinqiaosan (37% [CI, 23% to 49%]; P < 0.001), and oseltamivir plus maxingshigan-yinqiaosan (47% [CI, 35% to 56%]; P < 0.001). Time to fever resolution was reduced by 19% (CI, 0.3% to 34%; P = 0.05) with oseltamivir plus maxingshigan-yinqiaosan compared with oseltamivir. The interventions and control did not differ in terms of decrease in symptom scores (P = 0.38). Two patients who received maxingshigan-yinqiaosan reported nausea and vomiting.
  
  
  CONCLUSIONS
  Participants were young and had mild H1N1 influenza virus infection. Missing viral data precluded definitive conclusions about viral shedding.
  
  
  CONCLUSIONS
  Oseltamivir and maxingshigan-yinqiaosan, alone and in combination, reduced time to fever resolution in patients with H1N1 influenza virus infection. These data suggest that maxingshigan-yinqiaosan may be used as an alternative treatment of H1N1 influenza virus infection.
  
  
  BACKGROUND
  Beijing Science and Technology Project and Beijing Nova Program.
authors.affiliation: Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing, China. cyh-birm@263.net
authors.forename: Chen
authors.initials: C
authors.lastname: Wang
authors.forename: Bin
authors.initials: B
authors.lastname: Cao
authors.forename: Qing-Quan
authors.initials: QQ
authors.lastname: Liu
authors.forename: Zhi-Qiang
authors.initials: ZQ
authors.lastname: Zou
authors.forename: Zong-An
authors.initials: ZA
authors.lastname: Liang
authors.forename: Li
authors.initials: L
authors.lastname: Gu
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Dong
authors.forename: Li-Rong
authors.initials: LR
authors.lastname: Liang
authors.forename: Xing-Wang
authors.initials: XW
authors.lastname: Li
authors.forename: Ke
authors.initials: K
authors.lastname: Hu
authors.forename: Xue-Song
authors.initials: XS
authors.lastname: He
authors.forename: Yan-Hua
authors.initials: YH
authors.lastname: Sun
authors.forename: Yu
authors.initials: Y
authors.lastname: An
authors.forename: Ting
authors.initials: T
authors.lastname: Yang
authors.forename: Zhi-Xin
authors.initials: ZX
authors.lastname: Cao
authors.forename: Yan-Mei
authors.initials: YM
authors.lastname: Guo
authors.forename: Xian-Min
authors.initials: XM
authors.lastname: Wen
authors.forename: Yu-Guang
authors.initials: YG
authors.lastname: Wang
authors.forename: Ya-Ling
authors.initials: YL
authors.lastname: Liu
authors.forename: Liang-Duo
authors.initials: LD
authors.lastname: Jiang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000821:virology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007251:Influenza, Human / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D053139:Oseltamivir / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D017201:Virus Shedding; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; C530199:maxingshigan; C558279:yinqiaosan; D053139:Oseltamivir