Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes

Journal of Chinese Integrative Medicine

Volumn 10, Issue 3, 2012, Pages 279-292

  Ma, Li Xin ^a   Wang, Yu Yi ^a   Li, Xin Xue ^a   Liu, Jian Ping ^a  

^a BEIJING UNIVERSITY OF CHINESE MEDICINE   (China)

Author keywords

Chinese patent drugs; Diabetes mellitus; Randomized controlled trials; Systematic review; Treatment outcome; Type 2

Indexed keywords

CHINESE DRUG;

CHINESE MEDICINE; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTPATIENT; POSTMARKETING SURVEILLANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW;

EID: 84863344411     PISSN: 16721977     EISSN: None     Source Type: Journal    
DOI: 10.3736/jcim20120306     Document Type: Review

References (62)

1. American Diabetes Association. Standards of medical care in diabetes - 2010. Diabetes Care. 2010; 33(Suppl 1): S11-S61.
2. Chinese Diabetes Society. Excerpts of the China Guideline for Diabetes Prevention and Treatment (2007 edition). XinYiXue. 2010; 41(3): 208-210. Chinese.
3. Liu JP. The quality of randomized controlled trials and countermeasures in the studies of traditional Chinese medicine. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2003; 23(1): 62-64. Chinese.
4. Wang JL. Clinical epidemiology: clinical research design, measurement and evaluation. 3rd ed. Shanghai: Shanghai Scientific and Technical Publishers. 2009: 451-468. Chinese.
5. Song MX, Yang M. Newly compiled traditional Chinese patent medicine. 2nd ed. Beijing: People's Medical Publishing House. 2011. Chinese.
6. Shao ML. State essential drugs (traditional Chinese patent medicine). Beijing: People's Medical Publishing House. 2007: 151-186. Chinese.
7. National Pharmacopoeia Committee. Clinical guide of the Chinese pharmacopeia: traditional Chinese medicine (2005 edition). Beijing: People's Medical Publishing House. 2005: 407-455. Chinese.
8. National Pharmacopoeia Committee. Pharmacopoeia of the People's Republic of China 2010 Vol I. Beijing: China Science and Technology Press. 2010: 401-1247. Chinese.
9. Ministry of Human Resources and Social Security of the People's Republic of China. Catalogue of medicines for national basic medical, industry and commerce and maternity insurances. Beijing: China Labour and Social Security Publishing House. 2009: 75-129. Chinese.
10. World Health Organization. Definition, diagnosis and classification of diabetes mellitus and its complications: report of a WHO consultation. Part 1: Diagnosis and classification of diabetes mellitus. Geneva: World Health Organization. 1999: 3-7.
11. State Administration of Traditional Chinese Medicine. Guidelines for the clinical application of Chinese patent medicine. Beijing: State Administration of Traditional Chinese Medicine. 2010: 4. Chinese.
12. State Food and Drug Administration. Drug registration regulation. (2007-07-10) [2011-09-10]. http://www.sfda.gov.cn/WS01/CL0053/24529.html. Chinese.
13. Xiao YX, Ni Q, Yan XF, Lin L. Standardized terminology for clinical manifestations of basic syndromes of type 2 diabetes (1). Beijing Zhong Yi Yao. 2011; 30(5): 327-328. Chinese.
14. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Chichester: Wiley &. Sons Ltd. 2008: 187.
15. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010; 8: 18.
16. Hao SL. Clinical study on the treatment of type 2 diabetes mellitus with Shenqi Jiangtang Capsule combined with insulin. Shi Yong Zhong Xi Yi Jie He Lin Chuang. 2008; 8(4): 21-22. Chinese.
17. Hong YQ, Wang HJ. Effects of Shenqi Jiangtang Granule on serum C-reactive protein in type 2 diabetes patients with metabolic syndrome. Zhongguo Wu Zhen XueZaZhi. 2009; 9(21): 5098-5099. Chinese.
18. Zhang JJ, Yang SJ, Shen W. Clinical observation on the treatment of type 2 diabetes by Shenqi Jiangtang particles and Novolin 5OR. Anhui Zhong Yi Xue Yuan Xue Bao. 2007; 26(2): 14-15. Chinese with abstract in English.
19. Pei YM, Tian JL, Zhang YZ, Zhang HW. Effect of Jinqi Melbine on the functions of pancreatic island in the early type 2 diabetic patients. Tianjin Yi Yao. 2005; 33 (5): 294-296. Chinese with abstract in English.
20. Wang HP. Effects of Jinqi Jiangtang Tablet on pancreatic islet function of patients with mild to moderate type 2 diabetes mellitus. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006; 26(8): 709. Chinese.
21. Zhang YM. Jinqi Jiangtang Tablet for 80 elderly patients with newly diagnosed type 2 diabetes mellitus. Tianjin YiYao. 2009; 37(8): 700-701. Chinese.
22. Qi FL, Xu J, Wang B, Chen YJ, Yin QX, Ke BS. Study on the effects of Jinqi Hypoglycemic Tablet on serum P-SLT, TNF-a and HbAlc levels in patients with type two diabetes mellitus. Fang She Mian Yi Xue Za Zhi. 2007; 20(1): 40-42. Chinese with abstract in English.
23. Shen PL. Hypoglycemic and lipid-regulating activities of Jinqi Jiangtang Tablet on diabetes. Tianjin Yi Yao. 2005; 33(12): 803. Chinese.
24. Li LF, Wu YH. Jinqi Jiangtang Tablet in treatment of type 2 diabetes patients with insulin resistance. Tianjin YiYao. 2006; 34(9): 654-656. Chinese.
25. Yu P, Wu JL, Fu ZQ, Li L. Clinical observation of treatment effects of Jinqi Jiangtang Tablet combined with glipizide controlled-release tablets in elderly diabetes patients. Zhongguo Zhong Yi Yao Ke Ji. 2007; 14(2): 123-124. Chinese.
26. Xu J, Qi FL, Wang B, Ke BS, Chen YJ, Yin QX. Effect of combined Jinqi Hypoglycemic Tablet with conventional Western medicine treatment on plasma ET-1 and sICAM-1 levels in patients with DM2. Fang She Mian Yi Xue Za Zhi. 2006; 19(2): 122-124. Chinese with abstract in English.
27. Gao YF, Lu XX, Cao YX, Ding LB, Lu FY, Feng YM. Effect of Jinlida particles with NoVoNorm tablet on /?-cell pancreatic function of type 2 diabetes. Shizhen Guo Yi Guo Yao. 2007; 18(12): 3031-3032. Chinese with abstract in English.
28. Zheng X. Effects of Chinese herbal medicine combined with Western medicine on type 2 diabetes mellitus. Shi Yong Zhong Yi Yao Za Zhi. 2001; 17(3): 27. Chinese.
29. Liu LL. Analysis of metformin with clonidine in the treatment of T2DM. Zhonghua Zhong Yi Yao Xue Kan. 2009; 27(3): 671-672. Chinese with abstract in English.
30. Zhou P. Clinical study of glibenclamide in combination with Kelening treatment in non-insulin dependent diabetes mellitus. Zhongguo Zhong Xi Yi Jie He Za Zhi. 1997; 17(1): 29-31. Chinese with abstract in English.
31. Wei DX, Zhang YZ, Lin W, Zhao YG, Tang XL. Study of type 2 diabetes treated with Liuwei Dihuang peros liquid assistantly. Xian Dai Zhong Xi Yi Jie He Za Zhi. 2007; 16 (5): 582-583. Chinese with abstract in English.
32. Guan X, Huang F, Wu JZ, Yu JY. Influence of Liuwei Dihuang Pills and Ginkgo biloca Leave to the lipotoxicity and insulin resistance in early time of type 2 diabetes mellitus. Liaoning Zhong Yi Za Zhi. 2006; 33(11): 1423-1426. Chinese with abstract in English.
33. Wang XX, Sun ZL, Yu JY, Yang BQ, Wang Y. Effect of Liuwei Dihuang Soft Capsule and Ginkgo Leaf Tablet on serum regulated upon activation, normal T cell expressed and secreted in patients with diabetes mellitus type 2. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2007; 27 (4): 315-317. Chinese with abstract in English.
34. Lin JY, Li XQ, Liu XH, Luo L, Wang YJ. Effect of Liuwei Dihuang Pill and Jingui Shenqi Pill on peripheral insulin resistance, insulin release rate, polyol metabolism, oxidative stress and quality of life in patients with type 2 diabetes mellitus. Beijing: Proceedings of the 7th Conference of Integrated Traditional Chinese and Western Medicine for Diabetes. 2004: 148-151. Chinese.
35. Cheng HQ, Huang JN, Chen Y, Zhao XL, Zhang GD, Wei LX. Effect of Shengjin Xiaoke Capsule in 50 patients with type 2 diabetes mellitus. Shandong Zhong Yi Za Zhi. 1997; 16(4): 156-158. Chinese.
36. Zhu LQ, Gu QK, Liang QT, Lu YZ, Liu YH, Mao KL. Clinical research on improving insulin resistance in type 2 diabetes mellitus with Chinese medicine Tang-maikang. Tianjin Zhong Yi Yao. 2009; 26 (3): 192194. Chinese with abstract in English.
37. Du W, Guo JZ, Jin J. Effect of Tangmaikang Granule combined with metformin in newly diagnosed type 2 diabetes mellitus patients. Ningxia Yi Ke Da Xue Xue Bao. 2010; 32(1): 93-94. Chinese.
38. Zhou JT, Lin TH, Zhou ZZ. Effect of Tangmaikang Granule in 60 patients with type 2 diabetes mellitus. Zhongguo Shi Yong Yi Yao. 2009; 4(29): 107-108. Chinese.
39. Cheng PR, Zhou HD, Jin XC, Chen YP, Zhang CX, Xie DJ. Effect of Tangmaikang Granule on blood glucose fluctuations in patients with type 2 diabetes mellitus. Zhong Yi Yao Dao Bao. 2010; 16(11): 3436. Chinese.
40. Pan H. Effect of insulin combined with Tangmaikang Granule in 41 patients with type 2 diabetes mellitus. Yi Yao Dao Bao. 2008; 27(4): 413-414. Chinese.
41. Niu YF, Chen XW, Li ZN, Liu L. Effects of Xiaoke Pill on /?-cell physiological function and insulin resistance. Zhongguo Xian Dai Zhong Yao. 2006; 8 (6): 26-28, 30. Chinese.
42. Shi MY. Effect of Xiaoke Pill compared with glib-enclamide on secondary drug failure in patients with type 2 diabetes mellitus. Anhui Zhong Yi Lin Chuang ZaZhi 2000; 12(3): 173-175. Chinese.
43. Liu L. Effect of Tangmaikang Granule in 60 patients with type 2 diabetes mellitus. Shanghai Yi Yao. 2000; 21(12): 21-23. Chinese.
44. Li X, Chang HY. Effect of Yulan Jiangtang Capsule in patients with type 2 diabetes mellitus. Zhong Xi Yi Jie He Xin Nao Xue Guan Bing Za Zhi. 2010; 8(9): 1046-1048. Chinese.
45. Cheng HQ, Guo YY, Wei ZX. Clinical observation of the effect of Yusanxiao Capsule in patients with type 2 diabetes mellitus. Zhongguo Zhong Yi Yao Xin Xi Za Zhi. 1997; 4(7): 25-26. Chinese.
46. Yuan XY, Yang SJ, Wen ZQ, Li F. Effect of Tianmai Xiaoke Tablet combined with metformin in patients with type 2 diabetes mellitus. Hebei Yi Yao. 2011; 33(10): 1543-1544. Chinese.
47. Yuan XY, Yang SJ, Wen ZQ, Li F. Effect of Tianmai Xiaoke Tablet combined with insulin in patients with type 2 diabetes mellitus. Hebei Yi Yao. 2011; 33(12): 1811-1812. Chinese.
48. Hu ZX, Xiong JB. Effect of Jiangtangning Capsule on 70 patients with type 2 diabetes mellitus. Zhongguo Zhong Yi Yao Xin Xi Za Zhi. 2006; 13(4): 50-51. Chinese.
49. Shen XL, Xia YQ. Observation of the clinical effect of integrative therapy in 50 patients with type 2 diabetes mellitus. Zhong Yi Yao Tong Bao. 2010; 9(5): 48-50. Chinese.
50. Wen ZQ, Yuan XY, Yang SJ, Li F. Comparison study of the clinical effects of insulin combined with Tianmai Xiaoke Tablet or pioglitazone hydrochloride in patients with type 2 diabetes mellitus. Xian Dai Zhong Xi Yi Jie HeZaZhi. 2011; 20(9): 1079-1080. Chinese.
51. Xiong WX, Wang L. Effect of Shenqi Shanyao Formula in patients with type 2 diabetes mellitus. Zhongguo Liao Yang Yi Xue. 2009; 18(3): 265-267. Chinese.
52. Zhang XK, Han LP. Effect of Qiyao Xiaoke Capsule combined with gliclazide sustained-released tablet in 81 patients with type 2 diabetes mellitus. In: Lin L. Integrative medicine study on endocrine and metabolic diseases: clinical and basic research. Beijing: Military Medical Science Press. 2010: 152-155. Chinese.
53. Zhang WS, Zhao SZ. Effect of Tangniaole Capsule in patients with type 2 diabetes mellitus. Zhongguo Wu Zhen Xue Za Zhi. 2008; 8(6): 1352-1353. Chinese.
54. Krishnan JA, Schatz M, Apter AJ. A call for action: comparative effectiveness research in asthma. J Allergy Clin Immunol. 2011; 127(1): 123-127.
55. Calvert M, Wood J, Freemantle N. Designing real-world trials to meet the needs of health policy makers at marketing authorization. J Clin Epidemiol. 2011; 64 (7): 711-717.
56. Liu JP. Relationship of translational medicine, evidence-based medicine and clinical therapeutic efficacy assessment of traditional Chinese medicine. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2011; 31 (4): 444-445. Chinese.
57. Tian F, Xie YM. Real-world study: a potential new approach to effectiveness evaluation of traditional Chinese medicine interventions. J Chin Integr Med. 2010; 8 (4): 301-306. Chinese with abstract in English.
58. Xu D, Zhang Z, Zhang HY, Yang GL. The application comparison between explanatory and pragmatic clinical trials in clinical study of traditional Chinese medicine. Zhonghua Zhong Yi Yao Xue Kan. 2011; 29(7): 15291532. Chinese with abstract in English.
59. Zheng XY. Guidelines for clinical research on Chinese herbal medicines (trial implementation). Beijing: China Medical Science Press. 2002: 233-234. Chinese.
60. Liu JP. Clinical research methodology for evidence-based traditional Chinese medicine. Beijing: People's Medical Publishing House. 2009: 27. Chinese.
61. Hu LP, Bao XL. General issues and precautions in the design for clinical trials of investigational new drugs. J Chin Integr Med. 2011; 9(2): 138-142. Chinese with abstract in English.
62. Castro M. Placebo versus best-available-therapy control group in clinical trials for pharmacologic therapies: Which is better? Proc Am Thorac Soc. 2007; 4(7): 570-573.