Quality Assessement on the Studies of Traditional Chinese Medicine for Coronary Heart Disease Angina_Chinese Journal of Evidence-Based Medicine

Authors：

ZHOU Likun , DUAN Xin , AN Ning , WU Taixiang , LIU Guanjian

Department of Clinical Epidemiology; West China Hospital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

Coronary heart disease angina; Randomized controlled trial; Quality assessment of study; Traditional Chinese medicine

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Objective 　To assess the quality of randomised controlled trials on traditional Chinese medicine (TCM) for coronary heart disease (CHD) angina published from 1977 to 2002.
Method 　We did electronic search in Medline, Embase and hand searched 83 journals of traditional Chinese medicine (the earliest published in 1977 and the latest in June 2002). We assessed the quality of obstained studies.
Results 　Four hundred and forty articles met the criteria,of which 33 (7.5%) described randomization. None of them mentioned allocation concealment; 94.77% (417 studies) mentioned diagnosis criteria; only one mentioned the calculation basement of sample size; 84.09% (370 studies) mentioned comparability of baseline. Fifty three studies (12.05%) noted double-blind; 28 studies used single blind. Twenty-five studies used double-blind. Drop-outs were described in 7 cases without intention-to-treat (ITT); 159 studies applied statistical methods properly, while 4 did not. Ten studies never mentioned statistical methods; 73.18％ (322 studies) used forms to express their results.
Conclusions 　Till now, the quantity and quality of RCTs of traditional Chinese medicine for coronary heart disease angina were inadequate. Some well designed scientific methods were not adequately applied.

Citation： ZHOU Likun,DUAN Xin,AN Ning,WU Taixiang,LIU Guanjian. Quality Assessement on the Studies of Traditional Chinese Medicine for Coronary Heart Disease Angina. Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 258-262. doi: Copy

1.	［1］Yan YH, Zhu CY. The effect observation of Integrated Traditional and Western Medicine for CHD angina[J]. Hebei Journal of Integrated Traditional and Western Medicine, 1998;7(11):1 809-1 810.
2.	闫韵洪,祝存英中西医结合治疗冠心病心绞痛的疗效观察[J].河北中西医结合杂志,1998;7(11):1 809～1 810.
3.	［2］Fu Wei, Ding FZ, Lin Qing. Therapy of 50 cases about CHD angina by Fangxiangwentong method [ J ]. Acta Chinese Medicine and Pharmacology, 2000 ;2 ( 2 ) :9.
4.	付伟,丁凤朱,林青.芳香温通法治疗冠心病心绞痛50例体会[J]中医药学报,2000;2(2):9.
5.	［3］Xu XM. The clinical observation of 160 cases about compound Danshendiwan for angina [ J ]. Chinese Traditional drugs,2000 ;31 ( 1 ) :44,72.
6.	徐象明复方丹参滴丸治疗心绞痛160例临床疗效观察[J]中草药,2000;31(1):44,72.
7.	［4］Wang ZX. The experience of self-made Qingxinxiaotan soup for angina[J]. Journal ofBeijing TCM, 2000; (3) :14-15.
8.	王志祥.自拟清心消痰汤治疗痰热型胸痹心痛的体会[J].北京中医,2000;(3):14～15.
9.	［5］Hu J, Huang XB. The clinical observation of Xinxuening for angina[J]. Beijing Journal of TCM , 1994;(4): 50-51.
10.	胡杰,黄小波心血宁治疗胸痹的临床观察[J]北京中医杂志,1994;(4):50～51.
11.	［6］WangJL. Clinicalepidemiology[M]. The 2nd edition. Shanghai:Shanghai science and technology publish house, 2001.
12.	王家良.临床流行病学[M]第2版上海:上海科学技术出版社,2001年.
13.	［7］Shen SG, Han XJ. The clinical observation of Zhengxintai Capsule for CHD angina [ J]. Journal of Emergency in Traditional Chinese Medicine, 2001; 10 ( 2 ) :64-66.
14.	沈绍功,韩学杰.正心泰胶囊治疗冠心病心绞痛临床观察[J].中国中医急症,2001;10(2):64～66.
15.	［8］Xiao B, Tang B, Guo JY. The assessment of Tetromethylpragin and Low molecular weight heparin for unstable CHD angina[J]. Modern Journal of Integrated Chinese Traditional and Western Medicine, 2001 ;10(22) :2 156-2 157.
16.	肖彬,汤蓓,郭静芸.川芎嗪与低分子肝素治疗不稳定心绞痛评价[J].现代中西医结合杂志,2001;10(22):2156～2157.
17.	［9］Yang HB. The clinical observation of Shexiangbaoxinwan for curing CHD angina[J]. Journal of Practical TCM, 2000; 16(10) :5-6.
18.	杨焕斌麝香保心丸治疗冠心病心绞痛临床观察[J].实用中医药杂志,2000:16(10):5～6.
19.	［10］Zhang Y, Fan P. The clinical observation of 36 cases about compound Guanxintong for CHD angina [J ]. Journal of TCM, 2001 ;42(10) :602-603.
20.	张毅,范平.冠心通合剂治疗冠心病心绞痛36例临床观察[J].中医杂志,2001;42(10):602 603.
21.	［11］Li XZ, ShiJP, HuJX. The clinical effect observation of Tianbaoning and isosorbide dinitrate for curing CHD angina[J ]. Journal of Practical Integrated Emergency Chinese Traditional and Western Medicine, 1998 ;5 ( 3 ): 106-107.
22.	李秀芝,史建萍,胡锦霞联用天保宁与消心痛治疗心绞痛临床疗效观察[J].中西医结合实用临床急救,1998;5(3):106～107.
23.	［12］Gao FJ, Zhang SJ. The comparison of Sini soup and isosorbide mononitrate for curing CHD angina [ J]. Modern Journal of Integrated Chinese Traditional and Western Medicine, 2001 ;10(2) :128-129.
24.	高富杰,张淑君.四逆汤和单硝酸异山梨酯治疗心绞痛的比较[J].现代中西医结合杂志,2001;10(2):128～129.
25.	［13］Yuan JQ, Liu B, Guo WZ, Wang QX, Yang BJ, Yuan HW, Zhou YX. The clinical research of 116 cases about compound power made of Panax Sanqi and amber [ J ].Journal of TCM , 1992;33(9) :29-30.
26.	袁今奇,刘珀,郭文征,王庆宪,杨百景,袁洪文,周云霄人参三七琥珀末治疗冠心病心绞痛116例临床观察[J].中医杂志,1992;33(9):29～30.
27.	［14］Wang HG, Jiang F, Sun DX. The clinical research of Dalijiuxinwan for curing CHD angina[J]. Henan TCM, 1998;18(3) :150-151.
28.	王皓光,姜凤,孙德喜.大力救心丸治疗冠心病心绞痛的临床研究[J].河南中医,1998;18(3):150～151.
29.	［15］Wang ZH, Wang HJ. The effect observation of100 cases about Dalijiuxinwan for curing CHD angina [J ]. Journal of Emergency in Traditional Chinese Medicine, 2001 ;10( 1 ) :19-20.
30.	王振华,王慧杰.大力救心丸治疗冠心病心绞痛100例疗效观察[J].中国中医急诊,2001;10(1):19～20.
31.	［16］Hu GH, Tan YS. The clinical and experimental research of Xintongling for CHD angina [ J ]. Chinese Journal of Traditional Medical Science and Technology, 1994; 1 ( 5 ) :6-8.
32.	胡国恒,谭元生.心痛灵治疗冠心病心绞痛的临床及试验研究[J].中国中医药科技,1994;1(5):6～8.
33.	［17］Sun L, Dai PS, Shao J. Curing 40 cases of CHD angina by Fufangdanshendiwan [ J ]. Tianjin Journal of TraditionalChinese Medicine, 2000;17(3) :6-7.
34.	孙灵,戴培胜,邵杰.复方丹参滴丸治疗冠心病心绞痛40例[J].天津中医,2000;17(3):6～7.
35.	［18］Yan XH, Zhu GA. The effect observation of Xintongkoufuye and isosorbide dinitrate for coronary artherosclerosis CHD angina [ J ]. Chinese Tranditional and Morden Emergency Journal, 1999 ;6(8) :365-366.
36.	阎旭龙,朱国安.联用心通口服液与硝酸异山梨醇酯治疗冠状动脉粥样硬化性心脏病心绞痛疗效观察[J].中国中西医结合急救杂志,1999;6(8):365～366.
37.	［19］Shang ZC, Liang HL, Zheng SZ. The clinical research of Yifukoufuye[J] . Journal of Beijing university of TCM, 1995;18(5) :56-57.
38.	尚炽昌,梁华龙,郑绍周.薏附口服液治疗寒湿型冠心病心绞痛的临床研究[J].北京中医药大学学报,1995;18(5):56～57.

1. ［1］Yan YH, Zhu CY. The effect observation of Integrated Traditional and Western Medicine for CHD angina[J]. Hebei Journal of Integrated Traditional and Western Medicine, 1998;7(11):1 809-1 810.
2. 闫韵洪,祝存英中西医结合治疗冠心病心绞痛的疗效观察[J].河北中西医结合杂志,1998;7(11):1 809～1 810.
3. ［2］Fu Wei, Ding FZ, Lin Qing. Therapy of 50 cases about CHD angina by Fangxiangwentong method [ J ]. Acta Chinese Medicine and Pharmacology, 2000 ;2 ( 2 ) :9.
4. 付伟,丁凤朱,林青.芳香温通法治疗冠心病心绞痛50例体会[J]中医药学报,2000;2(2):9.
5. ［3］Xu XM. The clinical observation of 160 cases about compound Danshendiwan for angina [ J ]. Chinese Traditional drugs,2000 ;31 ( 1 ) :44,72.
6. 徐象明复方丹参滴丸治疗心绞痛160例临床疗效观察[J]中草药,2000;31(1):44,72.
7. ［4］Wang ZX. The experience of self-made Qingxinxiaotan soup for angina[J]. Journal ofBeijing TCM, 2000; (3) :14-15.
8. 王志祥.自拟清心消痰汤治疗痰热型胸痹心痛的体会[J].北京中医,2000;(3):14～15.
9. ［5］Hu J, Huang XB. The clinical observation of Xinxuening for angina[J]. Beijing Journal of TCM , 1994;(4): 50-51.
10. 胡杰,黄小波心血宁治疗胸痹的临床观察[J]北京中医杂志,1994;(4):50～51.
11. ［6］WangJL. Clinicalepidemiology[M]. The 2nd edition. Shanghai:Shanghai science and technology publish house, 2001.
12. 王家良.临床流行病学[M]第2版上海:上海科学技术出版社,2001年.
13. ［7］Shen SG, Han XJ. The clinical observation of Zhengxintai Capsule for CHD angina [ J]. Journal of Emergency in Traditional Chinese Medicine, 2001; 10 ( 2 ) :64-66.
14. 沈绍功,韩学杰.正心泰胶囊治疗冠心病心绞痛临床观察[J].中国中医急症,2001;10(2):64～66.
15. ［8］Xiao B, Tang B, Guo JY. The assessment of Tetromethylpragin and Low molecular weight heparin for unstable CHD angina[J]. Modern Journal of Integrated Chinese Traditional and Western Medicine, 2001 ;10(22) :2 156-2 157.
16. 肖彬,汤蓓,郭静芸.川芎嗪与低分子肝素治疗不稳定心绞痛评价[J].现代中西医结合杂志,2001;10(22):2156～2157.
17. ［9］Yang HB. The clinical observation of Shexiangbaoxinwan for curing CHD angina[J]. Journal of Practical TCM, 2000; 16(10) :5-6.
18. 杨焕斌麝香保心丸治疗冠心病心绞痛临床观察[J].实用中医药杂志,2000:16(10):5～6.
19. ［10］Zhang Y, Fan P. The clinical observation of 36 cases about compound Guanxintong for CHD angina [J ]. Journal of TCM, 2001 ;42(10) :602-603.
20. 张毅,范平.冠心通合剂治疗冠心病心绞痛36例临床观察[J].中医杂志,2001;42(10):602 603.
21. ［11］Li XZ, ShiJP, HuJX. The clinical effect observation of Tianbaoning and isosorbide dinitrate for curing CHD angina[J ]. Journal of Practical Integrated Emergency Chinese Traditional and Western Medicine, 1998 ;5 ( 3 ): 106-107.
22. 李秀芝,史建萍,胡锦霞联用天保宁与消心痛治疗心绞痛临床疗效观察[J].中西医结合实用临床急救,1998;5(3):106～107.
23. ［12］Gao FJ, Zhang SJ. The comparison of Sini soup and isosorbide mononitrate for curing CHD angina [ J]. Modern Journal of Integrated Chinese Traditional and Western Medicine, 2001 ;10(2) :128-129.
24. 高富杰,张淑君.四逆汤和单硝酸异山梨酯治疗心绞痛的比较[J].现代中西医结合杂志,2001;10(2):128～129.
25. ［13］Yuan JQ, Liu B, Guo WZ, Wang QX, Yang BJ, Yuan HW, Zhou YX. The clinical research of 116 cases about compound power made of Panax Sanqi and amber [ J ].Journal of TCM , 1992;33(9) :29-30.
26. 袁今奇,刘珀,郭文征,王庆宪,杨百景,袁洪文,周云霄人参三七琥珀末治疗冠心病心绞痛116例临床观察[J].中医杂志,1992;33(9):29～30.
27. ［14］Wang HG, Jiang F, Sun DX. The clinical research of Dalijiuxinwan for curing CHD angina[J]. Henan TCM, 1998;18(3) :150-151.
28. 王皓光,姜凤,孙德喜.大力救心丸治疗冠心病心绞痛的临床研究[J].河南中医,1998;18(3):150～151.
29. ［15］Wang ZH, Wang HJ. The effect observation of100 cases about Dalijiuxinwan for curing CHD angina [J ]. Journal of Emergency in Traditional Chinese Medicine, 2001 ;10( 1 ) :19-20.
30. 王振华,王慧杰.大力救心丸治疗冠心病心绞痛100例疗效观察[J].中国中医急诊,2001;10(1):19～20.
31. ［16］Hu GH, Tan YS. The clinical and experimental research of Xintongling for CHD angina [ J ]. Chinese Journal of Traditional Medical Science and Technology, 1994; 1 ( 5 ) :6-8.
32. 胡国恒,谭元生.心痛灵治疗冠心病心绞痛的临床及试验研究[J].中国中医药科技,1994;1(5):6～8.
33. ［17］Sun L, Dai PS, Shao J. Curing 40 cases of CHD angina by Fufangdanshendiwan [ J ]. Tianjin Journal of TraditionalChinese Medicine, 2000;17(3) :6-7.
34. 孙灵,戴培胜,邵杰.复方丹参滴丸治疗冠心病心绞痛40例[J].天津中医,2000;17(3):6～7.
35. ［18］Yan XH, Zhu GA. The effect observation of Xintongkoufuye and isosorbide dinitrate for coronary artherosclerosis CHD angina [ J ]. Chinese Tranditional and Morden Emergency Journal, 1999 ;6(8) :365-366.
36. 阎旭龙,朱国安.联用心通口服液与硝酸异山梨醇酯治疗冠状动脉粥样硬化性心脏病心绞痛疗效观察[J].中国中西医结合急救杂志,1999;6(8):365～366.
37. ［19］Shang ZC, Liang HL, Zheng SZ. The clinical research of Yifukoufuye[J] . Journal of Beijing university of TCM, 1995;18(5) :56-57.
38. 尚炽昌,梁华龙,郑绍周.薏附口服液治疗寒湿型冠心病心绞痛的临床研究[J].北京中医药大学学报,1995;18(5):56～57.

Chinese Journal of Evidence-Based Medicine

Quality Assessement on the Studies of Traditional Chinese Medicine for Coronary Heart Disease Angina

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