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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (4): 383-391.doi: 10.3736/jcim20070405

• Original Clinical Research • Previous Articles     Next Articles

Multicentric randomized double blinded clinical study of Yiqi Tongmai Oral Liquid against angina pectoris in patients with coronary heart disease

Shuo Zhang1,2, Yan-qin Song3, Wang Yue1,2, Xing-rong Mao4, Chuan-xia Ju1,2, Meng-jiu Dong5, Qiong-li Zheng6, Xiao-hua Dai7, Zhong-ye Li8, 9   

  1. $con.affStr
    4. Qili Pharmaceutical Research Institute in Sichuan Province, Chengdu, Sichuan Province 610031, China;
  • Online:2007-07-31 Published:2007-05-15

Objective:

To study the efficacy and safety of Yiqi Tongmai Oral Liquid (YQTM), a traditional compound Chinese herbal medicine, in treating angina pectoris in patients with coronary heart disease.

Methods:

A multicentric, randomized, double blinded and paralleled controlled trial was conducted on 110 patients in trial group treated with YQTM, and 109 patients in control group treated with Shuxin Oral Liquid (SX). Cure and effective rates in both groups were evaluated. Frequency and duration of angina attack were counted and measured. Coronary angiography (CAG), electrocardiogram (ECG) and flat exercise test were taken in both groups. Blood lipid indexes, such as cholesterol (CH), triglyceride (TG), low-density lipoprotein (LDL), high density lipoprotein (HDL), were determined at pre- and post-treatment. The hemodynamic indexes, such as whole blood viscosity (J2), high-shear reduced viscosity (Eh), low-shear reduced viscosity (Ei), red cell aggregation index (Lb), red cell rigidity index (Rh), fibrinogen (Fb), blood sedimentation rate (BSR) and hematocrit (HCT), were determined at pre-and post-treatment. The indicated scores of symptoms and signs of traditional Chinese medicine (TCM) pattern, such as chest pain, chest constriction, breath shortness, palpitation, fatigue, dim complexion, spontaneous perspiration and tongue proper, tongue coating were evaluated in week 0, 1, 2, 3, 4 during the treatment course. The safety indexes, such as body temperature, pulse, respiration and blood pressure were observed. Routine tests of blood, urine and stool, hepatic function test and renal function test were taken at pre- and post-treatment.

Results:

There was no significant difference between the total effective rate of the trial group and that of the control group, which were 91.82% and 85.32%, respectively (P>0.05). Trial group's percentile of cure rate is significantly higher than that of the control group P<). The frequency and duration of angina attack, the positive ratio of CAG and flat exercise test of both groups were lowered, while the effect of the trial group on frequency and duration of angina attack was better. No significant difference was found in ECG features between the two groups (P>0.05). The levels of CH, TG and LDL of both groups were lowered significantly (P<0.05). The effect of lowering CH, TG and LDL of the trial group was stronger than that of the control group (P<0.05). The hemodynamic indexes, such as J2, Eh, Ei, Lb, Rh, Fb, BSR and HCT were improved significantly in both groups (P<0.05). The improvements of J2, Eh, Ei, Lb, Rh, Fb and SR in the trial group were greater than those of control group (P<0.05). The TCM symptoms and signs, such as chest pain, chest constriction, breath shortness, palpitation, fatigue, dim complexion, spontaneous perspiration were improved significantly in both groups (P<0.05). The improvements of chest constriction, palpitation, fatigue and spontaneous perspiration in the trial group were greater than those of the control group (P<0.05). The total indicated score of TCM symptoms and signs was lowered more significantly than that of the control group P<). No significant changes were found at pre- and post-treatment in safety indexes, such as routine tests for blood, urine and stool, hepatic function test and renal function test. There was no significant difference in safety features of both groups (P>0.05).

Conclusion:

Yiqi Tongmai Oral Liquid bears good therapeutic effect on angina pectoris without adverse reaction, and is superior to Shuxin Oral Liquid. Yiqi Tongmai Oral Liquid is a new effective and safe medicine for the treatment of angina pectoris in patients with coronary heart disease.

Key words: coronary heart disease, angina pectoris, multicentric studies, randomized controlled trial, double blinded method

CLC Number: 

  • R541.42

Table 1

General information before treatment for control and trial groups"

ItemTrial (n=110)Control (n=109)P
Age (?x±s, years)59.93±6.0759.69±5.770.765
Gender
Male (cases)47410.440
Femail (cases)6368
Course of disease (?x±s, months)51.71±47.1146.98±41.530.435
Whether antianginal drugs used
Yes (cases)73750.699
No (cases)3734

Table 2

Therapeutic effects on angina pectoris for control and trial groups"

Groupn Excellent (%)Effective (%)Ineffective (%)Total effective ratio
Trial11058(52.73)43(39.09)9(8.18)91.82%
Control10932(29.36)61(55.96)16(14.68)85.32%

Table 3

Frequency and duration of angina attack within 48 h before and after treatment in control and trial groups(ヌ±S)"

Groupn Angina attack index
FrequencyDuration (min)
Trial
Before treatment1104.8±0.8**17.1±2.2**
After treatment1101.2±0.56.6±0.8
Control
Before treatment1094.7±0.9**17.2±2.4**
After treatment1092.1±0.610.5±0.9

Table 4

ECG effects for control and trial groups"

Groupn Excellent (%)Effective (%)Ineffective (%)Total effective ratio
Trial11060 (54.55)49 (44.55)1 (0.91)99.09%
Control10956 (51.38)52 (47.71)1 (0.92)99.08%

Table 5

Effects on blood lipid indexes for control and trial groups (ヌ±S, mmol/L)"

Groupn CholesterolTriglycerideLow density lipoproteinHigh density lipoprotein
Trial
Before treatment1105.87±0.90**1.88±0.78**4.33±0.31**1.23±0.31
After treatment1103.45±0.840.97±0.422.25±0.341.18±0.34
Control
Before treatment1095.62±0.43**1.92±0.72*4.12±0.28*1.38±0.27
After treatment1094.52±0.561.54±0.553.12±0.451.24±0.29

Table 6

Effects on hemodynamic indexes for control and trial groups(ヌ±S)"

Groupn Whole blood
viscosity (mPa·s)
High-shear reduced
viscosity (mPa·s)
Low-shear reduced
viscosity (mPa·s)
Erythrocyte aggregation
index
Trial
Before treatment1104.16±0.70**4.07±2.54**22.17±4.08**10.47±4.29**
After treatment1102.83±0.57△△2.11±2.53△△17.06±3.988.22±3.55
Control
Before treatment1094.62±0.51*3.95±1.77*20.66±3.75*11.33±3.85*
After treatment1094.03±0.683.12±1.8719.01±2.5610.01±3.44
Groupn Erythrocyte
rigidity index
Fibrinogen
(g/L)
Blood sedimentation
rate (mm/h)
Hematocrit
Trial
Before treatment1105.41±0.64**3.60±0.76**25.40±17.06*0.41±0.08
After treatment1104.73±0.622.43±0.7921.10±11.670.39±0.06
Control
Before treatment1094.95±0.63**3.01±0.21*28.54±11.38**0.39±0.04
After treatment1094.15±0.452.53±0.4221.83±13.770.34±0.05

Table 7

Indicated scores of TCM symptoms and signs in control and trial groups(ヌ±S)"

TCM symptoms
& signs
Groupn Score in treatment courseIntergroup
comparison
Intragroup
comparison
Week 0Week 1Week 2Week 3Week 4
Chest painTrial1102.07±0.731.71±0.641.49±0.430.96±0.240.65±0.15P<0.01P>0.05
Control1092.11±0.661.94±0.721.60±0.471.28±0.500.97±0.21P<0.01
Constriction in chestTrial1103.31±0.732.75±0.842.05±0.931.67±0.691.29±0.74P<0.01P<0.05
Control1093.28±0.872.95±0.772.50±0.981.89±0.851.67±0.34P<0.01
Shortness of breathTrial1101.45±0.751.09±0.640.89±0.250.66±0.160.54±0.11P<0.01P>0.05
Control1091.50±0.701.29±0.710.93±0.320.72±0.230.56±0.31P<0.01
PalpitationTrial1101.58±0.791.18±0.460.85±0.270.70±0.100.49±0.17P<0.01P<0.01
Control1091.61±0.691.39±0.721.09±0.700.86±0.370.75±0.24P<0.01
FatigueTrial1101.16±0.750.96±0.230.77±0.170.52±0.130.38±0.12P<0.01P<0.01
Control1091.42±0.661.26±0.430.96±0.260.76±0.250.63±0.32P<0.01
Dim complexion Trial1100.85±0.180.65±0.140.54±0.130.45±0.210.37±0.15P<0.05P>0.05
Control1090.88±0.490.78±0.240.67±0.560.52±0.190.44±0.12P<0.05
Spontaneous perspirationTrial1100.88±0.270.68±0.280.53±0.120.37±0.240.25±0.15P<0.01P<0.01
Control1091.18±0.480.91±0.330.71±0.170.57±0.270.44±0.42P<0.01
Texture of tongueTrial1100.85±0.360.79±0.410.74±0.440.73±0.450.60±0.49P>0.05P>0.05
Control1090.81±0.400.74±0.440.72±0.450.69±0.470.66±0.48P>0.05
Pulse qualityTrial1100.66±0.470.64±0.480.58±0.500.46±0.400.42±0.31P>0.05P>0.05
Control1090.70±0.460.67±0.470.63±0.480.61±0.490.58±0.50P>0.05

Table 8

Total integration scores of TCM symptoms and signs for control and trial groups(ヌ±S)"

Groupn Score in treatment course
Week 0Week 1Week 2Week 3Week 4
Trial11012.82±3.55**10.45±2.92**8.44±3.15**6.53±3.16**4.99±3.12**
Control10913.50±3.2911.94±3.449.81±3.407.91±3.616.71±3.90
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