Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial

Ann Intern Med. 2011 Aug 16;155(4):217-25. doi: 10.7326/0003-4819-155-4-201108160-00005.


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.

Design: Prospective, nonblinded, randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00935194)

Setting: Eleven hospitals from 4 provinces in China.

Patients: 410 persons [corrected] aged 15 to 69 [corrected] years with laboratory-confirmed H1N1 influenza.

Intervention: 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.

Measurements: 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.

Limitations: Participants were young and had mild H1N1 influenza virus infection. Missing viral data precluded definitive conclusions about viral shedding.

Conclusion: 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.

Primary funding source: Beijing Science and Technology Project and Beijing Nova Program.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Drug Combinations
  • Drug Therapy, Combination
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Fever / drug therapy
  • Fever / virology
  • Humans
  • Influenza A Virus, H1N1 Subtype*
  • Influenza, Human / complications
  • Influenza, Human / drug therapy*
  • Influenza, Human / virology
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Oseltamivir / adverse effects
  • Oseltamivir / therapeutic use*
  • Prospective Studies
  • Virus Shedding
  • Vomiting / chemically induced
  • Young Adult


  • Antiviral Agents
  • Drug Combinations
  • Drugs, Chinese Herbal
  • maxingshigan
  • yinqiaosan
  • Oseltamivir

Associated data

  • ClinicalTrials.gov/NCT00935194