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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (6): 581-585.doi: 10.3736/jcim20080607

• Original Clinical Research • Previous Articles     Next Articles

Mahuang Zhisou Capsule in treatment of acute upper respiratory tract infection of external wind-cold syndrome: a multi-center, randomized controlled, and double-blind trial

Ying Zhang1, Jing Chang1(), Rui-ming Zhang1, Liang-li Liu2, Feng-sen Li3, Xin-yue Liang4, Lei Wang1, Bin Mao1, Ting-qian Li1   

  1. 1. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    2. Department of Respiratory Diseases, Affiliated Hospital, Guiyang College of Traditional Chinese Medicine, Guiyang, Guizhou Province 550001, China
    3. Department of Respiratory Diseases, Hubei Academy of Traditional Chinese Medicine, Wuhan, Hubei Province 430073, China
    4. Department of Respiratory Diseases, Xinjiang Municipality Hospital of Traditional Chinese Medicine, Urumchi, Xinjiang Uygur Autonomous Region 830000, China
  • Received:2007-09-28 Online:2008-06-20 Published:2008-06-15
  • Contact: CHANG Jing E-mail:changing815@hotmail.com

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Objective: To evaluate the efficacy and safety of Mahuang Zhisou Capsule (MHZSC), a compound traditional Chinese herbal medicine, in treatment of acute upper respiratory tract infection of wind-cold syndrome.
Methods: A multi-center, double-blind, double dummy, randomized controlled trial was conducted. A total of 240 patients were randomized into treatment group (120 cases, treated with MHZSC) and control group (120 cases, treated with Mahuang Zhisou Pill). The therapeutic course was 3 days.
Results: Seven cases were excluded and three cases lost to follow-up. Two hundred and thirty-three cases entered intention-to-treat (ITT) analysis and 230 cases fitted in per-protocol population set (PPS) analysis. After treatment, the therapeutic effect of upper respiratory tract infection was calculated by ITT and PPS analysis respectively. The significant response rate and total response rate in the treatment group were 78.07% and 98.25％ (ITT and PPS), while the significant response rates in the control group were 70.59% (ITT) and 70.69％ (PPS), and the total response rates were 95.80％ (ITT) and 95.69％ (PPS) respectively. There were no significant differences in clinical efficacy between the two groups (P>0.05).
Conclusion: MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.

Key words: herbal preparations, randomized controlled trials, double blind method, upper respiratory infections, wind-cold, common cold

CLC Number: 

  • R511.6

Table 1

Baseline data in two groups (per-protocol population)"

Item Treatment group Control group Statistic P
Case 114 116
Sex (male/female) 44/70 47/69 0.089 0.766
Average age ($\bar{x}$±s, year) 38.37±11.82 38.16±11.98 0.091 0.927
Course of disease ($\bar{x}$±s, hour) 30.24±12.24 30.06±11.46 0.113 0.910
Severity (mild/moderate/severe) 50/56/8 45/64/7 0.614 0.539
Accumulated score of traditional
Chinese medicine syndrome ($\bar{x}$±s)		 12.46±3.26 12.61±3.14 0.356 0.723
Body temperature ($\bar{x}$±s, ℃) 36.84±0.38 36.89±0.45 1.012 0.313
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