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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (5): 417-426.doi: 10.3736/jcim20100504

• Original Clinical Research • Previous Articles     Next Articles

Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke

the Project Group for Demonstration Study of Syndrome Differentiation Protocol Effect Evaluation of Acute Ischemic Stroke ,Yan Huanga, Jian-wen Guoa   

  1. a The First Department of Neurology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510120, Guangdong Province, China
  • Received:2009-07-06 Accepted:2010-02-05 Online:2010-05-20 Published:2010-05-15
  • Contact: Yan Huang E-mail:stroketcm15@yahoo.com.cn

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Background

The morbidity of stroke is high. Traditional Chinese medicine is commonly used for patients with ischemic stroke in China, but the efficacy need be further proved.
Objective

To assess the efficacy and safety of an herbal medicine treatment regimen integrating traditional Chinese medicine and Western medicine for ischemic stroke patients with yin pattern syndrome. Design, setting, participants and interventions: A multicenter, randomized and controlled clinical trial was adopted. A total of 537 patients with acute ischemic stroke were enrolled in 22 hospitals from July 2005 to October 2006, among whom 274 were assigned to group A (herbal group) and administered with Western medicine plus herbal medicine treatment, and the other 263 in group B (control group) with Western medicine plus placebo. The patients in two groups were all treated for 21 days.Main outcome measures: The primary endpoint of outcome measures was Barthel index. The secondary endpoints included National Institutes of Health Stroke Scale, the modified Rankin criteria, Stroke Specific Quality of Life, and Stroke Scale of Traditional Chinese Medicine. The adverse effects of the treatment were also observed.
Results

A total of 622 randomization numbers were applied by the centers and 16 numbers were lost for mishandling, so a total of 606 patients were included. Fifteen patients were excluded (5 in group A, and 10 in group B), and 54 (25 in group A, and 29 in group B) lost in follow-up. A total of 537 patients completed the trial and a per-protocol set analysis was conducted. There were no statistical differences in age, sex, pulse rate, heart rate, respiratory rate, blood pressure, medical history, neurological deficit scores, scores on Glasgow Coma Scale, and lesion size of intracerebral ischemia between the two groups at baseline (P>0.05). Twelve patients, including 5 in group A and 7 in group B, died during the 90 days of research period, and no significant difference was found between the two groups. Compared with Western medicine alone, herbal medicine treatment could improve the neurological deficit at day 21, activities of daily living at day 90 of follow-up, and the patient-reported outcome at days 21, 60, and 90 (P< 0.05). Independent living ability of the patients was also improved (67.9% of group A vs 59.3% of group B, 0-1 at modified Rankin criteria). Moreover, the herbal medicine treatment showed a tendency in improving quality of life at a time-dependent manner. Adverse events, including gastrointestinal adverse events, skin symptoms, hemorrhagic tendency, and aminotransferase increase, happened in 76 cases from both groups, and no significant difference was found between the two groups. Correlation analysis showed that aminotransferase increase was not related to the herbal medicine treatment, but to the lipid-lowering drugs.
Conclusion

The present research demonstrates that the herbal medicine treatment shows effects on neurological deficit and patient-reported outcome at day 21, activities of daily living and handicap at day 60, and handicap, activities of daily living and patient-reported outcome at 3-month follow-up.

Key words: Stroke, Yin syndrome, Treatment outcome, TCM WM therapy, Safety, Randomized controlled trail, Multicenter study

Figure 1

Flow diagram of this randomized trial"

"

Number of cases Cause of death Random number (group)
1 Intracerebral hemorrhage breaking into the ventricals led to hernia 612 (B)
1 Mixed-type shock 562 (A)
1 Upper gastrointestinal bleeding and infection 141 (B)
1 Heart failure, dysfunction of circulation 604 (B)
1 Recurrence of stroke, asking for discharge and died during the course 250 (B)
1 Large area infarction led to hernia; family members abandoned rescue 033 (A)
1 Auricular fibrillation led to large area infarction 415 (B)
1 Pulmonary infection and died of respiratory failure 120 (B)
1 Sudden infarction in the brain stem 200 (A)
1 Unclear cause 541 (B)
1 Myocardial infarction possible 010 (A)
1 Sudden cardiac arrest 418 (A)

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Group Survival patients Dead patients Total
Group A 269 (51.2) 5 (41.7) 274
Group B 256 (48.8) 7 (58.3) 263
Total 525 12 537

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Time point Group A Group B t P 95% confidence interval
n Score (x±s) n Score (x±s) Lower Upper
Day 7 271 5.97±3.69 262 6.34±4.39 –1.052 0.293 –1.06 0.32
Day 14 270 4.63±3.63 260 5.28±4.79 –1.780 0.076 –1.39 0.07
Day 21 269 3.65±3.42 260 4.52±4.81 –2.397 0.017 –1.59 –0.16

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Time point Group BI [Case (%)] χ2 P OR 95% confidence interval
<75 ≥75 ower Upper
Day 21 Group A 103 (38.3) 166 (61.7) 0.73 0.39 0.86 0.61 1.22
Group B 109 (41.9) 151 (58.1)
Day 60 Group A 72 (26.8) 197 (73.2) 1.22 0.27 0.81 0.55 1.18
Group B 80 (31.1) 177 (68.9)
Day 90 Group A 50 (18.6) 219 (81.4) 4.79 0.03 0.63 0.42 0.96
Group B 68 (26.6) 188 (73.4)

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Time point Group Patients with different GOS scores [Cases (%)] Total number R Z P
1 2 3-4 5
Day 21 Group A 125 (45.8) 94 (34.4) 50 (18.3) 4 (1.5) 273 257.74 –1.760 0.078
Group B 96 (36.5) 111 (42.2) 53 (20.2) 3 (1.1) 263 279.67
Day 60 Group A 150 (54.7) 85 (31.0) 34 (12.4) 5 (1.8) 274 251.81 –2.857 0.004
Group B 114 (43.3) 92 (35.0) 51 (19.4) 6 (2.3) 263 286.91
Day 90 Group A 163 (59.5) 78 (28.5) 28 (10.2) 5 (1.8) 274 253.69 –2.596 0.009
Group B 130 (49.4) 83 (31.6) 43 (16.3) 7 (2.7) 263 284.95

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Time point Group Patients with different mRS scores [Cases (%)] Total number R Z P
0-1 2-3 4-5 Dead
Day 21 Group A 144 (52.7) 86 (31.5) 39 (14.3) 4 (1.5) 273 262.04 –1.078 0.281
Group B 123 (46.8) 99 (37.6) 38 (14.4) 3 (1.1) 263 275.21
Day 60 Group A 162 (59.1) 85 (31.0) 22 (8.0) 5 (1.8) 274 260.63 –1.438 0.150
Group B 141 (53.6) 87 (33.1) 29 (11.0) 6 (2.3) 263 277.72
Day 90 Group A 186 (67.9) 66 (24.1) 17 (6.2) 5 (1.8) 274 256.90 –2.169 0.030
Group B 156 (59.3) 75 (28.5) 25 (9.5) 7 (2.7) 263 281.60

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Time point Group A Group B t P 95% confidence interval
n Score (x±s) n Score (x±s) Lower Upper
Day 14 270 169.94±42.29 260 168.04±43.44 0.512 0.609 –5.41 9.22
Day 21 269 183.65±42.30 260 179.82±45.48 1.004 0.316 –3.67 11.33
Day 60 269 195.54±39.06 257 190.72±42.78 1.350 0.178 –2.19 11.83
Day 90 268 202.19±37.65 256 195.75±42.07 1.849 0.065 –0.40 13.29

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Time point Group A Group B t P 95% confidence interval
n Score (x±s) n Score (x±s) Lower Upper
Baseline 274 11.00±5.76 263 9.99±5.47 2.085 0.038 0.06 1.96
Day 7 271 9.02±5.64 262 8.98±5.29 0.087 0.931 –0.89 0.97
Day 14 270 6.86±5.20 260 7.55±5.35 –1.516 0.13 –1.59 0.21
Day 21 269 5.44±4.30 260 6.28±5.23 –2.027 0.043 –1.66 –0.03
Day 60 269 4.13±3.61 257 5.17±4.94 –2.75 0.006 –1.79 –0.30
Day 90 269 3.30±3.06 256 4.47±4.04 –3.717 0.001 –1.78 –0.55

"

Time point Group A Group B t P 95% confidence interval
n Score (x±s) n Score (x±s) Lower Upper
Baseline 274 10.09±5.95 263 9.51±5.55 1.17 0.242 –0.39 1.56
Day 7 271 8.37±5.57 262 8.46±5.34 –0.188 0.851 –1.02 0.84
Day 14 270 6.25±5.00 260 7.05±5.44 –1.768 0.078 –1.69 0.09
Day 21 269 4.94±4.31 260 5.77±5.09 –2.042 0.042 –1.64 –0.03
Day 60 269 3.72±3.53 257 4.78±4.96 –2.794 0.005 –1.79 –0.31
Day 90 269 2.86±3.06 256 4.05±4.06 –3.787 0.001 –1.81 –0.57

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Time point Regression coefficient Model checking CMH test
β0 β1 β2 β3 β4 χ2 P χ2CMH P
Day 21 0.76 — -0.15 — — 14.5 0.00 0.17 0.68
Day 60 1.31 — — -0.09 — 8.39 0.00 2.10 0.15
Day 90 1.51 — — -0.09 — 7.99 0.01 4.23 0.04

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ID Name of the hospital Person in charge N Group A Group B
n Drop-off Exclude Death PPS n Drop-off Exclude Death PPS
(1) Guangdong Provincial Hospital of Traditional Chinese Medicine Yan HUANG,
Ye-feng CAI		 60 21 1 1 1 18 39 2 2 1 34
(2) The First Affiliated Hospital of
Henan College of Chinese Medicine		 Xin-zhi WANG, Bao-liang WANG 46 24 0 1 0 23 22 2 0 0 20
(3) People's Hospital of Sichuan
Province		 You-song YANG 47 21 3 0 0 18 26 4 1 2 19
(4) Longhua Hospital, Shanghai Jian PEI 52 29 4 0 2 23 23 2 0 0 21
(5) Zhejiang Provincial Hospital of
Chinese Medicine		 Mei CHEN 10 1 0 0 9 11 2 0 0 9
(6) Dongzhimen Hospital, Beijing Yi-huai ZOU 21 8 3 0 0 5 13 3 1 0 9
(7) Huashan Hospital, Shanghai Qiang DONG 14 7 4 1 0 2 7 2 0 0 5
(8) Zhongshan Hospital, Shanghai Wei FAN 19 7 0 0 0 7 12 0 0 1 11
(9) The Affiliated Hospital of Hubei
College of Chinese Medicine		 Ming-jiu DONG 30 17 1 0 0 16 13 0 0 0 13
(10) Fuoshan Hospital of Traditional
Chinese Medicine		 Wei GU 32 12 0 0 0 12 20 3 0 0 17
(11) The First Affiliated Hospital, Guangxi University of Chinese Medicine Shao-long DONG 17 8 0 1 0 7 9 0 1 1 7
(12) Jinan TCM Hospital of Shandong
Province		 Xiao-lan CAO,
Shi-ke ZHAO		 31 17 2 0 0 15 14 1 0 0 13
(13) Shanghai Hospital of Traditional
Chinese Medicine		 Yi LIU 11 9 0 0 0 9 2 0 0 0 2
(14) Shuguang Hospital, Shanghai Jiang-lei WEI 28 21 0 0 1 20 7 0 1 0 6
(15) Yueyang Hospital of Integrated
Traditional Chinese and Western
Medicine, Shanghai		 Tao WANG 24 13 0 0 0 13 11 1 1 0 9
(16) The Affiliated Hospital of Shaanxi
College of Chinese Medicine		 Jun LI 33 18 2 0 1 15 15 2 0 0 13
(17) Xinjiang District Hospital of Traditional Chinese Medicine Dong-qing AN 20 7 2 0 0 5 13 1 1 1 10
(18) The Second Affiliated Hospital of Sun Yat-sen University Jun LIU 24 10 0 0 0 10 14 1 1 0 12
(19) Zhongshan City Hospital of Traditional Chinese Medicine Ji-lin TAN 37 25 2 1 0 22 12 1 1 0 10
(20) Ruikang Hospital, Guangxi
University of Chinese Medicine		 Ding REN 12 6 0 0 0 6 6 1 0 0 5
(21) The Second Affiliated Hospital of
Wenzhou Medical School		 Xiao-tong WANG 16 10 0 0 0 10 6 1 0 0 5
(22) Taizhou City Hospital of
Traditional Chinese Medicine Total		 Yuan-tao CHEN 11 4 0 0 0 4 7 0 0 1 6
606 304 25 5 5 269 302 29 10 7 256

"

Name of the department Person in charge
(1) DME Center, Guangdong Provincial Hospital of Traditional Chinese Medicine Ai-hua OU
(2) DME Center, Guangzhou University of Chinese Medicine Wei-xiong LIANG
(3) Jiangsu Provincial Hospital of Chinese Medicine Ning-ning XIONG, Jian-dong ZOU
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