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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (2): 139-147.doi: 10.3736/jcim20080207

• Original Clinical Research • Previous Articles     Next Articles

A multiple center, randomized, controlled, double-blinded and double-dummy trial of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with the syndrome of heat attacking the lung and Weifen

Lei Wang1, Rui-ming Zhang1, Yan-ling Zhao2, Guo-xiang Feng3, Ding-ju Pan4, Xi-yuan Huang5, Ting-qian Li1()   

  1. 1. Department of Integrated Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Provice 610041,China
    2. The GCP of the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, Hunan Provice 410007, China
    3. The GCP of the Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, Hunan Prov?ince 410005, China;
    4. The GCP of the Hospital of Guiyang College of Traditional Chinese Medicine, Guiyang, Guizhou Province 550001, China
    5. The GCP of the Hospital of Traditional Chinese Medicine of Hainan Province, Haikou, Hainan Province 570203, China
  • Received:2007-07-10 Online:2008-02-20 Published:2008-02-15
  • Contact: LI Ting-qian E-mail:wunglei@hotmail.com

Objective:To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome.

Methods:The multiple center, double-blinded, double-dummy and randomized controlled method was conducted. Three hundred and sixty patients were randomly divided into the treatment group A (n=120, treated with Yiqing Shuangjie Capsule and Chaihuang analogues), treatment group B (n=120, treated with Yiqing Shuangjie Tablet and Chaihuang analogues) and the control group (n=120, treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues). Every drug was administered 3 pills each time. Patients in the three groups were all treated for 5 days and three times daily. The accumulated scores of syndrome, clinical symptoms, adverse effect and body temperature were recorded before and after the treatment. The safety indexes, such as routine tests of blood, urine and stool, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment.

Results:Three cases were excluded and eighteen cases lost to follow-up. There were 343 patients who entered to the intention-to-treat (ITT) analysis and 339 patients fitted in the per-protocol population set (PPS) analysis. After treatment, the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively. The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A, and the total response rates were 96.46% and 97.27% respectively. The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B, and the total response rates were 97.45% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and the total response rates both were 99.12%. There was significant difference among the three groups (P<0.05). The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively. In the treatment group A, the total obvious effect rates were 84.07% and 85.46% respectively, and the total response rates were 96.46% and 97.27% respectively. In the treatment group B, the rates of total obvious effect were 88.89% and 89.65% respectively, and the total response rates were 97.44% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and total response rates both were 99.12%. There was also statistical significant difference among the three groups (P<0.05). ITT and PPS analysis had the same results. No adverse effect was found in the trial.

Conclusion:Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.

Key words: herbal preparations, randomized controlled trial, double blind method, upper respiratory tract infection, wind-warm syndrome

CLC Number: 

  • R553

Figure 1

The flow diagram of this randomized trial"

Table 1

Basement data of three groups (FAS)"

Item TA TB C Statistic value P
Cases 113 117 113
Sex (M/F) 48/65 59/58 59/54 2.44 0.30
Age($\bar{x}$±s, year) 34.3±12.2 35.8±13.2 34.7±12.3 0.46 0.63
Course ($\bar{x}$±s, h) 14.9±810.3 16.0±10.9 16.7±11.5 0.83 0.44
Body temperature ($\bar{x}$±s, ℃) 37.89±0.39 37.85±0.41 37.92±0.44 0.64 0.53
Severity (mild/moderate/severe) 38/58/17 44/53/20 36/55/22 0.85 0.65
Accumulated score of syndrome ($\bar{x}$±s) 16.02±4.57 15.50±4.69 16.35±5.00 0.93 0.39
Accumulated score of disease ($\bar{x}$±s) 17.76±5.14 17.36±5.31 18.38±5.64 1.05 0.35
Severity of heat syndrome (mild/moderate/severe) 36/59/18 49/52/16 42/49/22 2.17 0.34
Severity of sore throat (mild/moderate/severe) 56/42/15 70/37/10 59/44/10 2.86 0.24
Tongue (normal/abnormal) 8/105 7/110 8/105 0.15 0.93
Pulse condition (normal/abnormal) 36/77 34/83 32/81 0.38 0.83

Table 2

Comparison of therapeutic effects of upper respiratory tract infection among three groups"

Group n Cure
(cases)
Obvious effect
(cases)
Improvement
(cases)
Failure
(cases)
Rate of total obvious
effect (%)
Total response
rate (%)
FAS
TA 113 46 50 13 4 84.96 96.46
TB 117 50 50 14 3 85.47 97.44
C 113 29 53 30 1 72.57 99.12
PPS
TA 110 46 50 11 3 87.27 97.27
TB 116 50 50 13 3 86.21 97.41
C 113 29 53 30 1 72.57 99.12

Table 3

Comparison of therapeutic effects of traditional Chinese medicine symptoms among three groups"

Group n Cure
(cases)
Obvious effect
(cases)
Improvement
(cases)
Failure
(cases)
Rate of total obvious
effect (%)
Total response
rate (%)
FAS
TA 113 48 47 14 4 84.07 96.46
TB 117 54 50 10 3 88.89 97.44
C 113 29 53 30 1 72.57 99.12
PPS
TA 110 48 46 13 3 85.46 97.27
TB 116 54 50 9 3 89.65 97.41
C 113 29 53 30 1 72.57 99.12

Table 4

Comparison of accumulated scores of traditional Chinese medicine symptoms before and after treatment among three groups (PPS) ($\bar{x}$±s)"

Group n Accumulated score Inside group Among groups
Before treatment After treatment Difference t P F P
TA 110 16.02±4.45 2.44±3.32 13.58±4.70 25.67 0.00 1.38 1.38
TB 116 15.58±4.65 2.11±3.01 13.46±4.81 26.19 0.00
C 113 16.35±5.00 3.69±4.06 12.66±3.96 20.89 0.00

Table 5

Comparison of accumulated scores of disease before and after treatment among three groups (PPS) ($\bar{x}$±s)"

Group n Accumulated score Inside group Among groups
Before treatment After treatment Difference t P F P
TA 110 17.76±5.07 2.83±3.74 14.94±5.40 24.86 0.00 1.11 0.33
TB 116 17.44±5.26 2.56±3.43 14.91±5.43 25.52 0.00
C 113 18.38±5.64 4.34±4.76 14.04±4.47 20.22 0.00

Table 6

Comparison of decreasing-time of body temperature among three groups (PPS)"

Group n Failure (cases) Min (h) Max (h) $\bar{x}$±s, h M χ2 P
TA 110 7 0.8 72 9.67±8.80 6
TB 116 7 1 48 10.29±11.80 6 1.28 0.53
C 113 7 1 96 11.73±13.32 6

Table 7

Comparison of resuming-time of body temperature among three groups (PPS)"

Group n Failure (cases) Min (h) Max (h) $\bar{x}$±s, h M χ2 P
TA 110 17 0.5 108 26.17±21.98 12.5
TB 116 21 1 90 25.59±27.92 19 2.03 0.36
C 113 26 1 76 21.97±20.72 15.5

Table 8

Comparison of degree of fever and aversion to cold symptom before and after treatment among three groups (PPS) ($\bar{x}$±s)"

Group n Before treatment (cases) After treatment (cases) Inside group Among groups
- + ++ ++ - + ++ +++ x2 P z P
TA 110 0 36 57 17 101 5 4 0 9.29 0.00
TB 116 0 48 52 16 108 5 3 0 9.53 0.00 7.49 0.024
C 113 0 42 49 22 93 18 1 1 9.47 0.00

Table 9

Comparison of degree of sore throat symptom before and after treatment among three groups (PPS) ($\bar{x}$±s)"

Group n Before treatment (cases) After treatment (cases) Inside group Among groups
- + + + + + - + + + + + + x2 P z P
TA 110 0 54 41 15 73 37 0 0 9.30 0.00
TB 116 0 69 37 10 81 34 1 0 9.29 0.00 9.57 0.008
C 113 0 59 44 10 59 49 4 1 9.14 0.00
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