Reporting Quality Assessment of Noninferiority and Equivalence Randomized Controlled Trials Related to Traditional Chinese Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Yuntao ,  LIANG Weixiong

DME Center, Guang Zhou Chinese Medicine University, Guangzhou 510405, China;

Corresponding author：

LIANG Weixiong, Email: liangwx@public.guangzhou.gd.cn

Keywords：

Traditional Chinese medicine; Noninferiority trial; Equivalence trial; Randomized controlled trial; Reporting quality assessment; CONSORT statement

DOI：

10.7507/1672-2531.20110057

Video：

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Objective 　To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM).
Methods 　The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs.
Results 　A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion.
Conclusion 　The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.

Citation： LIU Yuntao,LIANG Weixiong. Reporting Quality Assessment of Noninferiority and Equivalence Randomized Controlled Trials Related to Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2011, 11(3): 336-340. doi: 10.7507/1672-2531.20110057 Copy

1.	2 Campbell K M, Elbourne D R, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ , 2004, 328: 702-708.
2.	温泽淮, 赖世隆, 梁伟雄, 等. 进一步改善中医药临床试验报告的质量. 中国中西医结合杂志, 2004, 24(11): 1022-1025.
3.	Gagnier JJ, Boon H, Rochon P, et al . Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med , 2006, 144(5): 364-367.
4.	Piaggio G, Elbourne D R, Ahman D G, et al . Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA , 2006, 295(10): 1152-1160.
5.	朱成斌, 詹思延. 如何撰写高质量的流行病学研究论文第八讲非劣效性和等效性随机对照试验的报告规范—CONSORT声明的扩展. 中国流行病学杂志, 2007, 28(8): 821-825.
6.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范: 征求意见稿. 中国循证医学杂志, 2007, 7(8): 601-605.
7.	吴以岭, 李涛, 李妍, 等. 超微粉碎工艺通心络胶囊治疗中风病的临床研究. 中国中药杂志, 2007, 32(18): 1928-1931.
8.	王云飞, 李晓庆, 吴焕林. 邓铁涛经验方微粉制剂治疗高血压病的临床研究. 辽宁中医杂志, 2009, 36(8): 1326-1627.
9.	王长洪, 高文艳, 林一帆, 等. 复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎的研究. 现代中西医结合杂志, 2009, 18(13): 1453-1455.
10.	张琼, 陈志扬, 吴林彬, 等. 红花黄色素冻干粉针剂与红花黄色素滴注液治疗冠心病心绞痛(心血瘀阻证)的临床非劣性试验. 中国循证医学杂志, 2005, 5(4): 276-286.
11.	黄继汉, 郑青山, 高蕊, 等. 牛黄降压片治疗原发性高血压病(肝火亢盛证)的临床等效性试验. 中国循证医学杂志, 2004, 4(4): 249-254.
12.	何玲. 牛黄汤与牛黄冲剂临床等效性观察. 安徽中医临床杂志, 2001, 13(5): 364-365.
13.	邓高丕, 陶莉莉, 缪江霞, 等. 寿胎丸加味方合煎与单煎混合浓缩颗粒的临床等效性研究. 中药材, 2001, 24(9): 694-695.
14.	史丽丽, 赵晓晖, 王瑛, 等. 乌灵胶囊治疗焦虑、抑郁状态的随机双盲对照研究. 中华神经科杂志, 2009, 42(11): 776-779.
15.	柏晋梅, 杨爱枫. 清肺定喘胶囊治疗热哮型支气管哮喘临床观察. 山西中医, 2010, 26(3): 20-21.
16.	蒋萌, 熊宁宁, 严道南, 等. 植物药仙露贝滴剂治疗急性鼻窦炎的非劣效性临床研究. 中国临床药理学与治疗学, 2003, 8(3): 286-288.
17.	荣华, 蓝小琴. 黄芪注射液治疗冠心病心绞痛(气虚血瘀证)的临床观察. 湖北中医杂志, 2007, 29(10): 17-18.
18.	张燕萍, 赵丹, 林琳, 等. 苏黄止咳胶囊治疗咳嗽变异型哮喘140例临床研究. 中华中医药杂志, 2007, 22(11): 773-776.
19.	郭小燕, 钟成梁, 胡思源. 小儿咳喘灵泡腾片治疗小儿咳嗽风热犯肺证(急性上呼吸道感染)的临床研究. 中医药学刊, 2006, 24(6): 1067-1068.
20.	吴泰相, 李幼平, 卞兆祥, 等. 实施临床试验报告规范, 提高临床试验透明度. 中国循证医学杂志, 2007, 7(8): 551-554.
21.	Schulz K, Altman DG, Hill C, et al . Does the CONSORT checklist improve the quality of reports of randomized controlled trials?A systematic review. Med J Aust , 2006, 185(5): 263-267.
22.	司婕, 毛兵, 刘艾然. 《中国循证医学杂志》发表的中医药随机对照试验质量评价. 中国循证医学杂志, 2010, 10(3): 362-363.

1. 2 Campbell K M, Elbourne D R, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ , 2004, 328: 702-708.
2. 温泽淮, 赖世隆, 梁伟雄, 等. 进一步改善中医药临床试验报告的质量. 中国中西医结合杂志, 2004, 24(11): 1022-1025.
3. Gagnier JJ, Boon H, Rochon P, et al . Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med , 2006, 144(5): 364-367.
4. Piaggio G, Elbourne D R, Ahman D G, et al . Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA , 2006, 295(10): 1152-1160.
5. 朱成斌, 詹思延. 如何撰写高质量的流行病学研究论文第八讲非劣效性和等效性随机对照试验的报告规范—CONSORT声明的扩展. 中国流行病学杂志, 2007, 28(8): 821-825.
6. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范: 征求意见稿. 中国循证医学杂志, 2007, 7(8): 601-605.
7. 吴以岭, 李涛, 李妍, 等. 超微粉碎工艺通心络胶囊治疗中风病的临床研究. 中国中药杂志, 2007, 32(18): 1928-1931.
8. 王云飞, 李晓庆, 吴焕林. 邓铁涛经验方微粉制剂治疗高血压病的临床研究. 辽宁中医杂志, 2009, 36(8): 1326-1627.
9. 王长洪, 高文艳, 林一帆, 等. 复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎的研究. 现代中西医结合杂志, 2009, 18(13): 1453-1455.
10. 张琼, 陈志扬, 吴林彬, 等. 红花黄色素冻干粉针剂与红花黄色素滴注液治疗冠心病心绞痛(心血瘀阻证)的临床非劣性试验. 中国循证医学杂志, 2005, 5(4): 276-286.
11. 黄继汉, 郑青山, 高蕊, 等. 牛黄降压片治疗原发性高血压病(肝火亢盛证)的临床等效性试验. 中国循证医学杂志, 2004, 4(4): 249-254.
12. 何玲. 牛黄汤与牛黄冲剂临床等效性观察. 安徽中医临床杂志, 2001, 13(5): 364-365.
13. 邓高丕, 陶莉莉, 缪江霞, 等. 寿胎丸加味方合煎与单煎混合浓缩颗粒的临床等效性研究. 中药材, 2001, 24(9): 694-695.
14. 史丽丽, 赵晓晖, 王瑛, 等. 乌灵胶囊治疗焦虑、抑郁状态的随机双盲对照研究. 中华神经科杂志, 2009, 42(11): 776-779.
15. 柏晋梅, 杨爱枫. 清肺定喘胶囊治疗热哮型支气管哮喘临床观察. 山西中医, 2010, 26(3): 20-21.
16. 蒋萌, 熊宁宁, 严道南, 等. 植物药仙露贝滴剂治疗急性鼻窦炎的非劣效性临床研究. 中国临床药理学与治疗学, 2003, 8(3): 286-288.
17. 荣华, 蓝小琴. 黄芪注射液治疗冠心病心绞痛(气虚血瘀证)的临床观察. 湖北中医杂志, 2007, 29(10): 17-18.
18. 张燕萍, 赵丹, 林琳, 等. 苏黄止咳胶囊治疗咳嗽变异型哮喘140例临床研究. 中华中医药杂志, 2007, 22(11): 773-776.
19. 郭小燕, 钟成梁, 胡思源. 小儿咳喘灵泡腾片治疗小儿咳嗽风热犯肺证(急性上呼吸道感染)的临床研究. 中医药学刊, 2006, 24(6): 1067-1068.
20. 吴泰相, 李幼平, 卞兆祥, 等. 实施临床试验报告规范, 提高临床试验透明度. 中国循证医学杂志, 2007, 7(8): 551-554.
21. Schulz K, Altman DG, Hill C, et al . Does the CONSORT checklist improve the quality of reports of randomized controlled trials?A systematic review. Med J Aust , 2006, 185(5): 263-267.
22. 司婕, 毛兵, 刘艾然. 《中国循证医学杂志》发表的中医药随机对照试验质量评价. 中国循证医学杂志, 2010, 10(3): 362-363.

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Reporting Quality Assessment of Noninferiority and Equivalence Randomized Controlled Trials Related to Traditional Chinese Medicine

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