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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.

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.

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  • Authors+Show Affiliations

    ,

    Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing, China. cyh-birm@263.net

    , , , , , , , , , , , , , , , , , ,

    Source

    Annals of internal medicine 155:4 2011 Aug 16 pg 217-25

    MeSH

    Adolescent
    Adult
    Aged
    Antiviral Agents
    Drug Combinations
    Drug Therapy, Combination
    Drugs, Chinese Herbal
    Female
    Fever
    Humans
    Influenza A Virus, H1N1 Subtype
    Influenza, Human
    Male
    Middle Aged
    Nausea
    Oseltamivir
    Prospective Studies
    Virus Shedding
    Vomiting
    Young Adult

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    21844547

    Citation

    Wang, Chen, et al. "Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan-yinqiaosan in the Treatment of H1N1 Influenza: a Randomized Trial." Annals of Internal Medicine, vol. 155, no. 4, 2011, pp. 217-25.
    Wang C, Cao B, Liu QQ, et al. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med. 2011;155(4):217-25.
    Wang, C., Cao, B., Liu, Q. Q., Zou, Z. Q., Liang, Z. A., Gu, L., ... Jiang, L. D. (2011). Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Annals of Internal Medicine, 155(4), pp. 217-25. doi:10.7326/0003-4819-155-4-201108160-00005.
    Wang C, et al. 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. PubMed PMID: 21844547.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. AU - Wang,Chen, AU - Cao,Bin, AU - Liu,Qing-Quan, AU - Zou,Zhi-Qiang, AU - Liang,Zong-An, AU - Gu,Li, AU - Dong,Jian-Ping, AU - Liang,Li-Rong, AU - Li,Xing-Wang, AU - Hu,Ke, AU - He,Xue-Song, AU - Sun,Yan-Hua, AU - An,Yu, AU - Yang,Ting, AU - Cao,Zhi-Xin, AU - Guo,Yan-Mei, AU - Wen,Xian-Min, AU - Wang,Yu-Guang, AU - Liu,Ya-Ling, AU - Jiang,Liang-Duo, PY - 2011/8/17/entrez PY - 2011/8/17/pubmed PY - 2011/10/7/medline SP - 217 EP - 25 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 155 IS - 4 N2 - 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. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/21844547/Oseltamivir_compared_with_the_Chinese_traditional_therapy_maxingshigan_yinqiaosan_in_the_treatment_of_H1N1_influenza:_a_randomized_trial_ L2 - https://www.annals.org/article.aspx?doi=10.7326/0003-4819-155-4-201108160-00005 DB - PRIME DP - Unbound Medicine ER -