Puerarin in the Treatment of Diabetic Peripheral Neuropathy: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

TIAN Haoming ¹ , WEI Dong ² , JIA Haiyan ¹

1. Division of Endocrinology; Department of Internal Medicine; West China Hospital; Sichuan University; Chengdu 610041; China2. Department of Internal Medicine; The Second People’s Hospital of Chengdu 610041; China;

Corresponding author：

Keywords：

Puerarin; Diabetic peripheral neuropathy; Systematic review; Randomized controlled trials; Quasi-randomized controlled trials; Meta-analysis

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Objective 　To systematically evaluate the effectiveness and safety of Puerarin on diabetic peripheral neuropathy.
Methods 　A systematic review and evaluation of all available relevant randomized or quasi-randomized controlled trials of Puerarin for diabetic peripheral neuropathy from Cochrane Controlled Trials Register (150 issue of 2003), Medline (1966-2003. 2), EMbase (1984-2001. 12. 4), and the Chinese Biological Medicine Database (1978-2003. 2) were performed. The selection of studies, data extraction, and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical symptoms, sensory nerve and motor nerve conduction velocities, and severe adverse events of Puerarin.
Results 　Ten randomized controlled clinical trials including 726 patients met the inclusion criteria. At the end of the treatment, compared to general treatment or vitamin B, Puerarin showed significant positive effects on the total effect rate of therapy and increased peripheral nerve conduction velocity. No severe adverse events were observed during the treatment period. However, most included trials show some degree of study design or analysis defect.
Conclusions 　Our analysis suggests that Puerarin appears to be an effective and safe treatment for diabetic peripheral neuropathy. However, due to the low quality trials included in this review, more rigorously designed, randomized, double-blind, placebo-controlled trials of Puerarin for diabetic peripheral neuropathy are needed to further assess its usefulness in diabetes peripheral neuropathy patients.

Citation： TIAN Haoming,WEI Dong,JIA Haiyan. Puerarin in the Treatment of Diabetic Peripheral Neuropathy: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2004, 04(8): 556-562. doi: Copy

1.	［1］Qian RL. Chief editor. Diabetes clinical guideline [M].Fist. Beijing: Beijing Medical University Press, 2000:201.
2.	钱荣立.主编.糖尿病临床指南[M].第1版.北京:北京医科大学出版社,2000:201.
3.	［2］Partanen J, Niskanen L, Lehtinen J, Mervaala E, Siitonen O, Uusitupa M. Natural history of peripheral neuropathy in patients with non-insulin-dependent diabetes mellitus[J]. N Engl J Med, 1995; 333(2) : 89-94.
4.	［3］Diabetes Control and Complication Trial Research Group.The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in InsulinDependent Diabetes Mellitus [ J ]. N Engl J Med , 1993; 329(14): 977 -986.
5.	［4］Nathan D M. Long-term complications of diabetes mellitus [J]. N Engl J Med, 1993; 328(23): 1 676-1 685.
6.	［5］Xie YC, Sun JD, Chen WP, Wu G. Effects of Puerarin injection on diabetic peripheral neuropathy: Analysis of 31 cases [J]. Journal of Guangdong Medical College, 1998; 16 ( 1 -2): 39 -40.
7.	谢英才,孙晶丹,陈文璞,武革.普乐林注射液治疗糖尿病性周围神经病变31例疗效观察[J].广东医学院学报,1998;16(1～2):39～40.
8.	［6］Tang ZM. Treatment of diabetic peripheral neuropathy with Puerarin injection[J]. Anthology of Medicine, 2000; 19(5):651 - 652.
9.	唐志民.葛根素注射液治疗糖尿病周围神经病变的疗效观察[J].医学文选,2000;19(5):651～652.
10.	［7］Lin JY, Dai L, Xu JG. Effects of Puerarin on diabetic peripheral neuropathy [ J ]. Chinese Journal of Diabetes, 2000; 8(5): 269 -271.
11.	林甲宜,戴伦,徐结桂.葛根素注射液治疗糖尿病周围神经病变的疗效观察[J].中国糖尿病杂志,2000;8(5):269～271.
12.	［8］Wang YP, Wang GQ. Clinical Efficacy of Puerarin on older diabetic patients with peripheral neuropathy[J]. Journal of Mudanjing Medical College, 2001; 22(3): 38-39.
13.	王艳萍,王桂琴.葛根素治疗老年糖尿病周围神经病变疗效观察[J].牡丹江医学院学报,2001;22(3):38～39.
14.	［9］Chen X, Tang K. Effects of Puerarin on 32 diabetic peripheral neuropathy[J]. ShanXi Journal of Traditional Chinese Medi cine, 2001; 22(3): 132-133.
15.	谌曦,唐昆.葛根素治疗糖尿病周围神经病变32例[J].陕西中医,2001;22(3):132～133.
16.	［10］Tan SZ. Effects of Puerarin injection on diabetic peripheral neuropathy[J]. Journal of Chen Zhou Medical College, 2001;3(1): 13.
17.	谭树志.葛根素注射液治疗糖尿病周围神经病变的临床观察[J].郴州医专学报,2001;3(1):13.
18.	［11］Zhu HP. , Pu RC, Xiong J. Effects of Puerarin on diabetic peripheral neuropathy [J]. Journal of Chinese Physician,2001; 3(4):310-311.
19.	朱惠平,卜如春,熊锦.葛根素治疗糖尿病周围神经病变疗效观察[J].中国医师杂志,2001;3(4):310～311.
20.	［12］Lou XJ. Clinical Efficacy of Puerarin on 56 diabetic peripheral neuropathy[J]. Clinical Medicine, 2002; 22 (1): 55.
21.	楼晓佳.葛根素治疗周围神经病变例临床观察[J].临床医学,2002;22(1):55.
22.	［13］Chen GZ, Fang M, Wang JR, Chen X. Effects of Puerarin on diabetic peripheral neuropathy [J]. Herald of Medicine,2003; 22(3): 171 -172.
23.	陈国钟,方明,王吉如,陈霞.葛根素治疗糖尿病性周围神经病变[J].医药导报,2003;22(3):171～172.
24.	［14］Xu L. Effects of Puerarin on diabetic peripheral neuropathy [J]. Chinese Journal of Misdiagnostics, 2003; 3(2): 250 -251.
25.	徐磊.葛根素治疗糖尿病周围神经病变疗效观察[J].中国误诊学杂志,2003;3(2):250～251.
26.	［15］Sun YX, Su JQ. Mechanism of Puerarin on dilatation of blood vessels[J]. Chinese Traditional and Herbal Drugs, 2002; 33(8): 733 - 734.
27.	孙云翔,粟锦迁.葛根素扩血管作用及其机制初探[J].中草药,2002;33(8):733～734.
28.	［16］Wang XQ, Fu J. Research proceedings on pharmacological effects of Puerarin[J]. Journal of Beijing University of Traditional Chinese Medicine, 1994; 17(3): 39 -41.
29.	王晓青,傅静.葛根的药理作用研究进展[J].北京中医药大学学报,1994;17(3):39～41.
30.	［17］D. Ziegler. The design of trials for treatment of diabetic neuropathy[J]. Neuropathy Res Commun, 1997 ; 21 ( 1 ): 83 -91.
31.	［18］Pfeifer MA, Schumer MP. Clinical trials of diabetic neuropathy: past, present and future[J]. Diabetes, 1995; 44(12) :1 355-1 361.
32.	［19］Dyck PJ, O’ Brien PC. Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy[J]. Diabetes Care, 1989;12(9): 649 -652.
33.	［20］Dyck PJ, Davies JL, Litchy WJ, O’ Brien PC. Longtiudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort[J]. Neurology, 1997; 49(1): 229-239.
34.	［21］Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant α-lipoic acid[J].Diabetes Care, 1999; 22(8): 1 296-1 301.
35.	［22］Hotta N, Toyta T, Matsuoka K, Shingeta Y, Kikkawa R,Kaneko T, Takahashi A, Sugimura K, Koike Y, Ishii J,Sakamoto N. Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy[J]. Diabetes Care, 2001; 24(10): 1 776-1 782.
36.	［23］Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR,Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH.Quantitative sensory testing. Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology [J]. Neurology, 2003; 60(6): 898 -904.
37.	［24］Sun JQ, Liu PF. Pyrexia caused by Puerarin injection-six cases reports [J]. Journal of Chinese Circulation, 1998; 13(2):88.
38.	孙建强,刘佩风.普乐林静脉滴注致发热反应六例[J].中国循环杂志,1998;13(2):88.
39.	［25］Li SE, He SP. Hypersensitive effects caused by Puerarin: five cases reports [ J ]. Chinese Journal of Pharmacoepidemiology,1997; 6(4): 251.
40.	李淑娥,何绥平.普乐林引起过敏反应5例[J].药物流行病学杂志,1997;6(4):251.
41.	［26］Xin PQ, Sun MB. Elevated alanine aminotransferase caused by Puerarin injection- two cases reports [J]. Chinese Journal of Hospital Pharmacy, 1999; 19(5):308.
42.	辛培乾,孙明波.静脉滴注普乐林注射液致丙氨酸转氨酶增高2例[J].中国医院药学杂志,1999;19(5):308.
43.	［27］Lu QZ. Adverse effects of Puerarin: A systemic reviews [J]. Chinese Journal of Pharmacoepidemiology, 2001; 10(4): 185 -187.
44.	陆奇志.葛根素不良反应国内文献的系统性综述[J].药物流行病学杂志,2001;10(4):185～187.

1. ［1］Qian RL. Chief editor. Diabetes clinical guideline [M].Fist. Beijing: Beijing Medical University Press, 2000:201.
2. 钱荣立.主编.糖尿病临床指南[M].第1版.北京:北京医科大学出版社,2000:201.
3. ［2］Partanen J, Niskanen L, Lehtinen J, Mervaala E, Siitonen O, Uusitupa M. Natural history of peripheral neuropathy in patients with non-insulin-dependent diabetes mellitus[J]. N Engl J Med, 1995; 333(2) : 89-94.
4. ［3］Diabetes Control and Complication Trial Research Group.The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in InsulinDependent Diabetes Mellitus [ J ]. N Engl J Med , 1993; 329(14): 977 -986.
5. ［4］Nathan D M. Long-term complications of diabetes mellitus [J]. N Engl J Med, 1993; 328(23): 1 676-1 685.
6. ［5］Xie YC, Sun JD, Chen WP, Wu G. Effects of Puerarin injection on diabetic peripheral neuropathy: Analysis of 31 cases [J]. Journal of Guangdong Medical College, 1998; 16 ( 1 -2): 39 -40.
7. 谢英才,孙晶丹,陈文璞,武革.普乐林注射液治疗糖尿病性周围神经病变31例疗效观察[J].广东医学院学报,1998;16(1～2):39～40.
8. ［6］Tang ZM. Treatment of diabetic peripheral neuropathy with Puerarin injection[J]. Anthology of Medicine, 2000; 19(5):651 - 652.
9. 唐志民.葛根素注射液治疗糖尿病周围神经病变的疗效观察[J].医学文选,2000;19(5):651～652.
10. ［7］Lin JY, Dai L, Xu JG. Effects of Puerarin on diabetic peripheral neuropathy [ J ]. Chinese Journal of Diabetes, 2000; 8(5): 269 -271.
11. 林甲宜,戴伦,徐结桂.葛根素注射液治疗糖尿病周围神经病变的疗效观察[J].中国糖尿病杂志,2000;8(5):269～271.
12. ［8］Wang YP, Wang GQ. Clinical Efficacy of Puerarin on older diabetic patients with peripheral neuropathy[J]. Journal of Mudanjing Medical College, 2001; 22(3): 38-39.
13. 王艳萍,王桂琴.葛根素治疗老年糖尿病周围神经病变疗效观察[J].牡丹江医学院学报,2001;22(3):38～39.
14. ［9］Chen X, Tang K. Effects of Puerarin on 32 diabetic peripheral neuropathy[J]. ShanXi Journal of Traditional Chinese Medi cine, 2001; 22(3): 132-133.
15. 谌曦,唐昆.葛根素治疗糖尿病周围神经病变32例[J].陕西中医,2001;22(3):132～133.
16. ［10］Tan SZ. Effects of Puerarin injection on diabetic peripheral neuropathy[J]. Journal of Chen Zhou Medical College, 2001;3(1): 13.
17. 谭树志.葛根素注射液治疗糖尿病周围神经病变的临床观察[J].郴州医专学报,2001;3(1):13.
18. ［11］Zhu HP. , Pu RC, Xiong J. Effects of Puerarin on diabetic peripheral neuropathy [J]. Journal of Chinese Physician,2001; 3(4):310-311.
19. 朱惠平,卜如春,熊锦.葛根素治疗糖尿病周围神经病变疗效观察[J].中国医师杂志,2001;3(4):310～311.
20. ［12］Lou XJ. Clinical Efficacy of Puerarin on 56 diabetic peripheral neuropathy[J]. Clinical Medicine, 2002; 22 (1): 55.
21. 楼晓佳.葛根素治疗周围神经病变例临床观察[J].临床医学,2002;22(1):55.
22. ［13］Chen GZ, Fang M, Wang JR, Chen X. Effects of Puerarin on diabetic peripheral neuropathy [J]. Herald of Medicine,2003; 22(3): 171 -172.
23. 陈国钟,方明,王吉如,陈霞.葛根素治疗糖尿病性周围神经病变[J].医药导报,2003;22(3):171～172.
24. ［14］Xu L. Effects of Puerarin on diabetic peripheral neuropathy [J]. Chinese Journal of Misdiagnostics, 2003; 3(2): 250 -251.
25. 徐磊.葛根素治疗糖尿病周围神经病变疗效观察[J].中国误诊学杂志,2003;3(2):250～251.
26. ［15］Sun YX, Su JQ. Mechanism of Puerarin on dilatation of blood vessels[J]. Chinese Traditional and Herbal Drugs, 2002; 33(8): 733 - 734.
27. 孙云翔,粟锦迁.葛根素扩血管作用及其机制初探[J].中草药,2002;33(8):733～734.
28. ［16］Wang XQ, Fu J. Research proceedings on pharmacological effects of Puerarin[J]. Journal of Beijing University of Traditional Chinese Medicine, 1994; 17(3): 39 -41.
29. 王晓青,傅静.葛根的药理作用研究进展[J].北京中医药大学学报,1994;17(3):39～41.
30. ［17］D. Ziegler. The design of trials for treatment of diabetic neuropathy[J]. Neuropathy Res Commun, 1997 ; 21 ( 1 ): 83 -91.
31. ［18］Pfeifer MA, Schumer MP. Clinical trials of diabetic neuropathy: past, present and future[J]. Diabetes, 1995; 44(12) :1 355-1 361.
32. ［19］Dyck PJ, O’ Brien PC. Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy[J]. Diabetes Care, 1989;12(9): 649 -652.
33. ［20］Dyck PJ, Davies JL, Litchy WJ, O’ Brien PC. Longtiudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort[J]. Neurology, 1997; 49(1): 229-239.
34. ［21］Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant α-lipoic acid[J].Diabetes Care, 1999; 22(8): 1 296-1 301.
35. ［22］Hotta N, Toyta T, Matsuoka K, Shingeta Y, Kikkawa R,Kaneko T, Takahashi A, Sugimura K, Koike Y, Ishii J,Sakamoto N. Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy[J]. Diabetes Care, 2001; 24(10): 1 776-1 782.
36. ［23］Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR,Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH.Quantitative sensory testing. Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology [J]. Neurology, 2003; 60(6): 898 -904.
37. ［24］Sun JQ, Liu PF. Pyrexia caused by Puerarin injection-six cases reports [J]. Journal of Chinese Circulation, 1998; 13(2):88.
38. 孙建强,刘佩风.普乐林静脉滴注致发热反应六例[J].中国循环杂志,1998;13(2):88.
39. ［25］Li SE, He SP. Hypersensitive effects caused by Puerarin: five cases reports [ J ]. Chinese Journal of Pharmacoepidemiology,1997; 6(4): 251.
40. 李淑娥,何绥平.普乐林引起过敏反应5例[J].药物流行病学杂志,1997;6(4):251.
41. ［26］Xin PQ, Sun MB. Elevated alanine aminotransferase caused by Puerarin injection- two cases reports [J]. Chinese Journal of Hospital Pharmacy, 1999; 19(5):308.
42. 辛培乾,孙明波.静脉滴注普乐林注射液致丙氨酸转氨酶增高2例[J].中国医院药学杂志,1999;19(5):308.
43. ［27］Lu QZ. Adverse effects of Puerarin: A systemic reviews [J]. Chinese Journal of Pharmacoepidemiology, 2001; 10(4): 185 -187.
44. 陆奇志.葛根素不良反应国内文献的系统性综述[J].药物流行病学杂志,2001;10(4):185～187.

Chinese Journal of Evidence-Based Medicine

Puerarin in the Treatment of Diabetic Peripheral Neuropathy: A Systematic Review

Abstract Full text Figures/Tables Video References Cited by

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