This article has been corrected. The original version (PDF) is appended to this article as a supplement.
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 aged 15 to 69 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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Author, Article, and Disclosure Information
From Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, and Beijing Hospital, Ministry of Health, Beijing; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing; Yantai Infectious Disease Hospital, Shandong; Chengdu Infectious Disease Hospital, Sichuan; Beijing Haidian Hospital, Beijing; Beijing Ditan Hospital, Institute of Infectious Diseases, Capital Medical University, Beijing; Renmin Hospital of Wuhan University;
Changxindian Hospital of Fengtai District of Beijing, Beijing; Second Hospital of Chaoyang District of Beijing, Beijing; Second Hospital of Beijing, Beijing; and West China Medical School, West China Hospital, Sichuan University, Sichuan, China.
Note: Drs. C. Wang, B. Cao, Q.Q. Liu, Z.Q. Zou, Z.A. Liang, L. Gu, J.P. Dong, and L.R. Liang contributed equally to this article.
Acknowledgment: The authors thank Drs. Jing Zhao, Lai-Ying Fang, Zhi-Tao Tu, Chun Huang, Xiao-Hui Zhai, Xiao-Li Li, Wei Wu, Ran Li, Yi-Qun Guo, Jing-Ya He, Yong Guo, Yu-Dong Yin, Shufan Song, Na Cui, Lu Bai, and Ling-Ling Su, who participated in collection of clinical data, and Drs. Getu Zhaori, Weili Zhang, and Yiqing Song for assistance in careful editing of the manuscript. They also thank Drs. Hua-Xia Chen, Chun-Jiang Zhao, Xiao-Min Yu, Ran Miao, Ying-Mei Liu, and Li-Li Ren, and Mr. Xiang-Yang Ding for technical support.
Grant Support: By the Beijing Science and Technology Project (grants Z08050700020801and Z09000700090903) and the Beijing Nova Program (grant 2007A037).
Disclosures: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2829.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. B. Cao (e-mail, [email protected]
Corresponding Author: Bin Cao, MD, Department of Infectious Diseases and Clinical Microbiology, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Gongti South Road, No. 8, Beijing, 100020 China (e-mail, [email protected]
Current Author Addresses: Dr. C. Wang: Department of Respiratory Medicine, Capital Medical University; Beijing Institute of Respiratory Medicine; Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders; Beijing Hospital, Ministry of Health, Beijing, 100020 China.
Drs. B. Cao and Gu: Department of Infectious Diseases and Clinical Microbiology, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Gongti South Road, No. 8, Beijing, 100020 China.
Drs. Q.Q. Liu and Jiang: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Hai Yuncang Road, No. 5, Beijing, 100700 China.
Drs. Zou and Guo: Yantai Infectious Disease Hospital, Huan Shan Road, No. 62, Yantai, Shandong Province, 341000 China.
Dr. Z.A Liang: West China Medical School, West China Hospital, Sichuan University, Wainan Guoxue Road, No. 37, Chengdu, Sichuan Province, 610041 China.
Dr. Dong: Beijing Haidian Hospital, Haidian Road, Beijing, 100080 China.
Drs. L.R. Liang, Yang, and Z.X. Cao: Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Gongti South Road, No. 8, Beijing, 100020 China.
Drs. Li and Y.G. Wang: Beijing Ditan Hospital, Institute of Infectious Diseases, Capital Medical University, Jingshun East Road, Beijing, 100018 China.
Dr. Hu: Renmin Hospital of Wuhan University, Ziyang Road No. 99, Wuhan, Hubei Province, 430060 China.
Dr. He: Changxindian Hospital of Fengtai District of Beijing, Beijing, 100072 China.
Dr. Sun: Second Hospital of Chaoyang District of Beijing, Jintai Road, No. 13, Beijing, 100026 China.
Dr. An: Second Hospital of Beijing, Xi Rongxian Road, No. 9, Beijing, 100031 China.
Drs. Wen and Y.L. Liu: Chengdu Infectious Disease Hospital, Jingjusi South Road, Chengdu, Sichuan Province, 610061 China.
Author Contributions: Conception and design: C. Wang, B. Cao, Q.Q. Liu, L. Gu, J.P. Dong, Z.X. Cao, L.D. Jiang.
Analysis and interpretation of the data: B. Cao, L. Gu, L.R. Liang, X.W. Li.
Drafting of the article: B. Cao, L.R. Liang.
Critical revision of the article for important intellectual content: C. Wang, B. Cao, Q.Q. Liu.
Final approval of the article: C. Wang, B. Cao.
Provision of study materials or patients: J.P. Dong, X.W. Li, K. Hu, Y.H. Sun, X.M. Wen, Y.G. Wang, Y.L. Liu.
Statistical expertise: L.R. Liang.
Obtaining of funding: C. Wang.
Administrative, technical, or logistic support: B. Cao, Z.A. Liang, J.P. Dong, X.W. Li.
Collection and assembly of data: B. Cao, Z.Q. Zou, Z.A. Liang, L. Gu, J.P. Dong, L.R. Liang, X.W. Li, K. Hu, X.S. He, Y.H. Sun, Y. An, T. Yang, Y.M. Guo, Y.G. Wang.
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