[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].
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).


CONCLUSIONS
MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China.
Ying
Y
Zhang
Jing
J
Chang
Rui-ming
RM
Zhang
Liang-li
LL
Liu
Feng-sen
FS
Li
Xin-yue
XY
Jiang
Lei
L
Wang
Bin
B
Mao
Ting-qian
TQ
Li
D000293:Adolescent; D000328:Adult; D000368:Aged; D002214:Capsules; D003937:Diagnosis, Differential; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D055815:Young Adult
D002214:Capsules; D004365:Drugs, Chinese Herbal