Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

CHANG Jing ,  LI Tingqian , WAN Meihua , ZHANG Ying

Department of Integrated Chinese Medicine and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding?author：

LI Tingqian, Email: litingqian@163.com

Keywords：

Chinese medicine and pharmacology; Randomized controlled trial; Quality assessment; Consolidated standards of reporting trials

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Objective 　To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005.
Method　 Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test.
Results 　There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%).
Conclusion 　There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.

Citation： CHANG Jing,LI Tingqian,WAN Meihua,ZHANG Ying. Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2006, 06(3): 171-178. doi: Copy

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1. 王家良. 臨床流行病學. 第2版. 上海: 上海科學技術出版社; 2001.
2. Moher, Kenneth FS, Douglas GA, et al. CONSORT聲明: 提高平行報告質量的修訂建議. 中國循證醫學雜志, 2005; 5(9): 702-707.
3. Douglas GA, Kenneth FS, Moher D, et al. 報告隨機對照試驗的CONSORT聲明修訂版: 說明與詳述（一）. 中國循證醫學雜志, 2005; 5(9): 712-714.
4. Douglas GA, Kenneth FS, Moher D, et al. 報告隨機對照試驗的CONSORT聲明修訂版: 說明與詳述（二）. 中國循證醫學雜志, 2005; 5(10): 786-787.
5. Douglas GA, Kenneth FS, Moher D, et al. 報告隨機對照試驗的CONSORT聲明修訂版: 說明與詳述（三）. 中國循證醫學雜志, 2005; 5(11): 863-865.
6. 遲煥海, 毛兵, 王蕾, 等.《成都中醫藥大學學報》隨機對照臨床試驗文獻評價. 華西醫學, 2000; 15(3): 272-273.
7. 夏慶, 毛兵, 陳光遠, 等.《北京中醫藥大學學報》臨床治療試驗論文的評價. 華西醫學, 2001; 16(1): 4-5.
8. 孫維蜂, 孫桂華, 徐偉, 等. 升降膠囊治療功能性消化不良肝郁脾虛證的臨床研究. 廣州中醫藥大學學報, 2003; 20(2): 99-101.
9. 王臻. 立愈散合米非司酮治療圍絕經期功能性子宮出血100例療效觀察. 北京中醫藥大學學報, 2005; 28(3): 92.
10. 符德玉, 周端, 顧仁樾, 等. 活血潛鎮膠囊對高血壓病（血瘀陽亢證）血管內皮細胞功能影響. 上海中醫藥大學學報, 2000;14(2): 18-20.
11. 湯水福, 陳剛毅, 陳銘, 等. 健脾益氣固攝法治療腎移植術后腹水外滲的初步臨床觀察. 廣州中醫藥大學學報, 2005; 22(3): 182-164.
12. 陳沛泉, 簡華香, 符林春, 等. 雙氫青蒿素和奎寧對惡性瘧原蟲早期配子體作用的隨機比較. 廣州中醫藥大學學報, 2001; 18(1): 22-24.
13. 嵇波, 陳家旭, 魯兆麒, 等. 逍遙散對人體神經內分泌免疫系統的影響. 北京中醫藥大學學報, 2003; 26(6): 68-71.
14. 梁超, 譚漪, 余潔, 等. 金朱止瀉片治療濕熱泄瀉的臨床觀察, 附449例病例報告. 成都中醫藥大學學報, 2000; 23(2): 11-13.
15. 徐鳳洲, 何勇. 參附脫毒膠囊治療阿片類戒斷癥狀的臨床觀察, 附321例臨床報告. 成都中醫藥大學學報, 2001; 24(3): 14-17.
16. 高炬, 張錚詰, 朱培庭. 錦紅片治療急性膽道感染的臨床研究. 上海中醫藥大學學報, 2002; 16(3): 42-43.
17. 何莉, 黃河, 熊遠青, 等. 黃芪對新生兒缺氧缺血性腦病的神經功能保護和免疫調節作用. 廣州中醫藥大學學報, 2005;22(1): 23-25.
18. 鄭曉輝, 曾展鵬, 黃楓. 中藥配合交鎖髓內釘內固定術治療股骨干骨折. 廣州中醫藥大學學報, 2000; 17(2): 140-141..
19. 王文萍, 王垂杰, 劉放, 等. 中藥復方腸安泰預防大腸癌術后轉移80例臨床觀察. 北京中醫藥大學學報, 2003; 26(2): 60-62.
20. 朱瑋華, 陳偉民, 徐衛平. 四草二根湯治療小兒急性腎炎臨床觀察. 北京中醫藥大學學報, 2000; 23(3): 64-65.
21. 何裔婷, 方堅, 彭劍虹, 等. 雷公藤涂膜劑治療膝骨關節炎的臨床研究. 廣州中醫藥大學學報, 2004; 21(4): 278-280..
22. 宋建平, 陳沛泉, 徐穎, 等. 兩種雙氫青蒿素復方治療海南島無并發癥惡性瘧疾的臨床對照研究. 廣州中醫藥大學學報,2004; 21(1): 9-12.
23. 程航, 李祥云. 峻竣煎內服結合中藥灌腸治療輸卵管阻塞性不孕102例. 上海中醫藥大學學報, 2005; 19(2): 22-23.
24. 崔飛嬋, 陳瓊嫡, 梁馨雨. 疏風散寒活血化瘀法治療冷性蕁麻疹的臨床觀察. 廣州中醫藥大學學報, 2005; 22(5): 352-354.
25. 董莉, 孟煒, 陸建英. 更欣方對更年期抑郁癥患者漢密爾頓積分及內分泌免疫系統的影響. 上海中醫藥大學學報, 2004; 18(2): 23-25.
26. 譚毅, 黃偉, 葉欣, 等. 男性免疫性不育癥中醫階梯性治療臨床研究. 上海中醫藥大學學報, 2004; 18(3): 21-23.
27. 沈志峰, 劉小凡, 孟曉露. 中藥外敷治療兒童支氣管哮喘寒飲停肺證88例的臨床觀察. 成都中醫藥大學學報, 2005;28(3): 30-32.
28. 范世平, 馬曉霖, 陳振芳. 中藥保留灌腸防治多性腺瘤性結腸息肉內鏡治療后再復發. 北京中醫藥大學學報, 2003; 26(3): 74-75.
29. Douglas GA. CONSORT說明文件的制定. 中國循證醫學雜志, 2005; 5(9): 708-711.
30. Wang JL. Clinical Epidemiology. 2nd ed. Shanghai: Shanghai science and technology publishing house; 2001.
31. Moher D, Kenneth FS, Douglas GA, et al. The CONSORT Statement: Revised Recommendation for Improving the Quality of Reports of Parallel-group Randomised Trials. Chin J Evid-based Med, 2005; 5(9): 702-707.
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Chinese Journal of Evidence-Based Medicine

Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine

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