SUBSCRIBE
Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (7): 622-628.doi: 10.3736/jcim20090705

• Original Clinical Research • Previous Articles     Next Articles

Therapeutic effects of modified Danggui Sini Decoction on plasma level of advanced glycation end products in patients with Wagner grade 0 diabetic foot: A randomized controlled trial

Wei-hua Youa,Ping Wangb,Mao-qing Lib,Yu Zhangc,Yu-lan Pengd,Feng-ling Zhange   

  1. a Department of Internal Medicine, Maoming Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine,Maoming 525000,Guangdong Province,China
    b First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong Province, China
    c Department of Ultrasound, Maoming Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Maoming 525000,Guangdong Province,China
    d School of Traditional Chinese Medicine, Changsha Medical University, Changsha 420219, Hunan Province, China
    e Department of Electrocardiography, Nanning Second People’ s Hospital,Nanning 530031,Guangxi Zhuang Autonomous Region, China;
  • Received:2009-01-04 Accepted:2009-03-31 Online:2009-07-20 Published:2009-07-15
  • Contact: Yu Zhang E-mail:402411212@qq.com

RichHTML

1

PDF (PC)

57

Like

Background

Many studies have demonstrated association between advanced glycation end products (AGEs) and diabetic angiopathy. There are certain advantages of traditional Chinese medicine (TCM) therapy in treatment of these diseases.
Objective

To evaluate the therapeutic effects and safety of modified Danggui Sini Decoction, a compound traditional Chinese herbal medicine for nourishing blood to warm meridians, on plasma level of AGEs in patients with Wagner grade 0 diabetic foot ulcers of blood stasis or/and kidney yang deficiency syndrome.Design, setting, participants and interventions: A random and positive control method was adopted. Seventy-two cases of Wagner classification of grade 0 diabetic foot ulcers with blood stasis or/and kidney yang deficiency syndrome were randomly divided into treatment group and control group. There were thirty-six cases in each group. All the patients were collected from Maoming Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine. Patients received oral and written information about the clinical procedures before giving their written informed consent. The study was approved by the Ethics Committee of Maoming Hospital of Traditional Chinese Medicine. The patients in the treatment group were treated with modified Danggui Sini Decoction, and the patients in the control group were treated with cilostazol. A course of treatment was 14 days, and the patients in the two groups were treated for 3 courses.Main outcome measures: The changes of clinical symptoms, ankle-brachial index (ABI), electromyography, lower extremity arteries measured by ultrasonic Doppler, fasting blood glucose, hemoglobin A1c, fibrinogen, and plasma level of AGEs were detected in the two groups before and after treatment. The safety of modified Danggui Sini Decoction was assessed by laboratory data and adverse events.
Results

There were statistical differences in clinical efficacy, ABI, lower extremity arteries hemodynamics, and nerve conduction velocity between the two groups (P<0.05, P<0.01). The plasma level of AGEs after treatment was significantly decreased in the two groups, and the level of AGEs in the treatment group was lower than that in the control group (P<0.05).
Conclusion

Modified Danggui Sini Decoction can improve clinical symptoms in patients with diabetic foot ulcers of Wagner grade 0 and it shows therapeutic effects on diabetes complicated with vascular diseases.

Key words: Diabetic foot, Wagner grade 0, Danggui Sini Decoction, Glycosylation end products, Randomized controlled trial

"

Item n Treatment group Control group
Male/Female (Cases) 36 17/19 20/16
Age ($\bar{x}$±s, years) 36 63.35±7.04 64.09±7.30
Diabetic duration ($\bar{x}$±s, years) 36 5.14±2.88 4.77±1.52
Diabetic foot duration ($\bar{x}$±s, months) 36 24.0±18.2 21.6±17.2

Figure 1

Flow diagram of this randomized trial"

"

Group n Diameter (cm) Blood flow (mL/min) Peak flow (cm/s)
Control
Before treatment 36 0.18±0.03 22.04±5.35 32.86±4.43
After treatment 36 0.20±0.04* 24.54±5.19* 36.26±3.93**
Treatment
Before treatment 36 0.18±0.04 21.70±5.12 34.05±5.36
After treatment 36 0.26±0.05**△△ 34.46±8.11**△ 41.14±5.50**△△

"

Group n Diameter (cm) Blood flow (mL/min) Peak flow (cm/s)
Control
Before treatment 36 0.42±0.05 197.41±17.46 50.55±5.22
After treatment 36 0.45±0.05* 209.85±22.67* 53.45±5.36*
Treatment
Before treatment 36 0.40±0.06 196.73±26.85 52.25±9.42
After treatment 36 0.52±0.07**△△ 269.18±22.14**△△ 60.53±8.79**△△

"

Group n MNCV (m/s) SNCV (m/s) ABI
Control
Before treatment 36 38.57±4.35 32.25±3.57 1.09±0.31
After treatment 36 39.75±4.58 33.96±3.66 1.18±0.29
Treatment
Before treatment 36 37.75±5.21 32.46±3.92 1.08±0.32
After treatment 36 43.46±4.32**△ 38.25±4.06**△ 1.24±0.30△

"

Group n FBG (mmol/L) HbA1c (%) FIB (g/L) AGEs (mg/L)
Control
Before treatment 36 10.7±0.9 8.9±1.7 7.89±0.82 38.4±11.8
After treatment 36 7.2±0.6** 6.8±1.9** 5.21±0.74* 31.3±10.8*
Treatment
Before treatment 36 10.1±1.4 8.7±2.1 7.87±1.05 37.2±9.8
After treatment 36 6.9±0.8** 6.7±0.7* 4.02±0.81*△△ 26.6±8.6**△
[1] Boulton AJ . The diabetic foot: a global view[J]. Diabetes Metab Res Rev, 2000,16(1):S2-S5
doi: 10.1002/(ISSN)1520-7560
[2] Fryberg RG . Diabetic foot ulcerations: management and adjunctive therapy[J]. Clin Podiatr Med Surg, 2003,20(4):709-728
doi: 10.1016/S0891-8422(03)00069-7 pmid: 14636034
[3] Zeng WH, Lai GM, Gan EH . Analysis of risk factors for diabetes foot amputation[J]. Zhongguo Tang Niao Bing Za Zi, 2002,10(4):252-253
曾文和, 赖国民, 甘尔惠 . 糖尿病足截肢危险因素分析[J]. 中国糖尿病杂志, 2002,10(4):252-253
[4] Jensen LJ, Stergaard J, Flyvbjerg A . AGE-RAGE and AGE cross-link interaction: important players in the pathogenesis of diabetic kidney disease[J]. Horm Metab Res, 2005,37(1):26-34
[5] State Administration of Traditional Chinese Medicine. Diagnostic and therapeutic effect evaluation criteria of diseases and syndromes in traditional Chinese medicine[M]. Nanjing: Nanjing University Press, 1994: 59-60
国家中医药管理局. 中医病证诊断疗效标准[M]. 南京: 南京大学出版社, 1994: 59-60
[6] World Health Organization . Definition, diagnosis and classification of diabetes mellitus and its complication, report of a WHO consultation. 1999: 1
[7] Li SM. Diagnosis and treatment of diabetic foot and its complication[M]. Beijing: People’s Medical Publishing House, 2002: 168-169
李仕明 . 糖尿病足与相关并发症的诊治[M]. 北京: 人民卫生出版社, 2002: 168-169
[8] Xue ZR . Classification of diabetic foot and progress of diagnosis and treatment[J]. Nei Ke Ji Wei Zhong Zheng Za Zi, 2002,8(1):32-35
doi: 10.3969/j.issn.1007-1024.2002.01.014
许樟荣 . 糖尿病足病变的分类与诊治进展[J]. 内科急危重症杂志, 2002,8(1):32-35
doi: 10.3969/j.issn.1007-1024.2002.01.014
[9] Basta G, Schmidt AM, De Caterina R . Advanced glycation end products and vascular inflammation: implications for accelerated atherosclerosis in diabetes[J]. Cardiovasc Res, 2004,63(4):582-592
doi: 10.1016/j.cardiores.2004.05.001
[10] Enomoto M, Adachi H, Yamagishi S, Takeuchi M, Furuki K, Hino A, Hiratsuka A, Takajo Y, Imaizumi T . Positive association of serum levels of advanced glycation end products with thrombogenic markers in humans[J]. Metabolism, 2006,55(7):912-917
doi: 10.1016/j.metabol.2006.02.019
[11] Forbes JM, Yee LT, Thallas V, Lassila M, Candido R, Jandeleit-Dahm KA, Thomas MC, Burns WC, Deemer EK, Thorpe SR, Cooper ME, Allen TJ . Advanced glycation end product interventions reduce diabetes-accelerated atherosclerosis[J]. Diabetes, 2004,53(7):1813-1823
doi: 10.2337/diabetes.53.7.1813 pmid: 15220206
[12] Basta G, Lazzerini G, Del Turco S, Ratto GM, Schmidt AM, De Caterina R . At least 2 distinct pathways generating reactive oxygen species mediate vascular cell adhesion molecule-1 induction by advanced glycation end products[J]. Arterioscler Thromb Vasc Biol, 2005,25(7):1404-1407
[13] Frank GD, Eguchi S, Motley ED . The role of reactive oxygen species in insulin signaling in the vasculature[J]. Antioxid Redox Signal, 2005,7(7-8):1053-1061
doi: 10.1089/ars.2005.7.1053 pmid: 15998260
[14] Chang Z, Lu Y . Filtering the active ingredients of Chinese medicine with AGEs platform[J]. Nanjing Zhong Yi Yao Da Xue Xue Bao, 2004,20(3):167-168
常在, 陆茵 . AGEs平台筛选中药及中药有效成分[J]. 南京中医药大学学报, 2004,20(3):167-168
[15] Xu HQ, Zhu Q, Li X, Zhang AH, Guo R . Inhibition of non-enzymic advanced glycation end products(AGEs) in vitro by seven TCMs[J]. Zhong Cao Yao, 2002,33(2):145-147
doi: 10.3321/j.issn:0253-2670.2002.02.024
许惠琴, 朱荃, 李祥, 张爱华, 郭戎 . 7味中药对体外非酶糖化终产物生成的抑制作用[J]. 中草药, 2002,33(2):145-147
doi: 10.3321/j.issn:0253-2670.2002.02.024
[16] Wang YJ, Wang XK, Chen LP . Effects of Danggui Sini Decoction and Lulutong Injection on treating diabetes leg arteriosclerosis obliterans[J]. Zhongguo Zhong Yi Ji Chu Yi Xue Za Zi, 2004,10(1):60-62
汪艳娟, 王行宽, 陈丽萍 . 当归四逆汤合路路通注射液治疗糖尿病下肢动脉硬化闭塞症的临床观察[J]. 中国中医基础医学杂志, 2004,10(1):60-62
[1] Chiung-Hui Huang, Mei-Ling Yeh, Fang-Pey Chen, Daphne Wu. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(4): 321-328.
[2] Maryam Azimi, Hanieh Niayesh, Mahboobeh Raeiszadeh, Sedigheh Khodabandeh-shahraki. Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation: A double-blind randomized controlled tria. Journal of Integrative Medicine, 2022, 20(3): 230-236.
[3] Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Ana Elisa Madureira Padula, Livia Mitchiguian Hotta, Amarilysde Toledo Cesar, José Nelson Martins Diniz, Helen de Freitas Santos, Edson Zangiacomi Martinez. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). Journal of Integrative Medicine, 2022, 20(3): 221-229.
[4] Xin Wang, Wen-juan Song, Yi Ruan, Bing-chu Li, Can Lü, Nian Huang, Fan-fu Fang, Wei Gu. Core muscle functional strength training for reducing the risk of low-back pain in military recruits: An open-label randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 145-152.
[5] Meng-zhu Zhao, Chen Zhao, Shuang-shuang Tu, Xu-xu Wei, Hong-cai Shang. Evaluating the methodology of studies conducted during the global COVID-19 pandemic: A systematic review of randomized controlled trials. Journal of Integrative Medicine, 2021, 19(4): 317-326.
[6] Si-chun Gu, Jie Zhou, Qing Ye, Can-xing Yuan. Pingchan granule for depressive symptoms in Parkinson’s disease: A randomized, double-blind, placebo-controlled trial. Journal of Integrative Medicine, 2021, 19(2): 120-128.
[7] Jie Wu, Shu-wei Duan, Hong-tao Yang, Yue-yi Deng, Wei Li, Ya-ni He, Zhao-hui Ni, Yong-li Zhan, Shan Lin, Zhi-yong Guo, Jun Zhu, Jing-ai Fang, Xu-sheng Liu, Li-hua Wang, Rong Wang, Nian-song Wang, Xiao-hong Cheng, Li-qun He, Ping Luo, Shi-ren Sun s, Ji-feng Sun, Ai-ping Yin, Geng-ru Jiang, Hong-yu Chen, Wen-hu Liu, Hong-li Lin, Meng Liang, Lu Ma, Ming Chen, Li-qun Song, Jian Chen, Qing Zhu, Chang-ying Xing, Yun Li, Ji-ning Gao, Rong-shan Li, Ying Li, Hao Zhang, Ying Lu, Qiao-ling Zhou, Jun-zhou Fu, Qiang He, Guang-yan Cai, Xiang-mei Chen. Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial. Journal of Integrative Medicine, 2021, 19(2): 111-119.
[8] Xian Wang, Xuan Yin, Xiu-tian Guo, Yan Wang, Wen-qi Jin, Ai-jun Mao, Lixing Lao, Zhang-jin Zhang, Jie Zhang, Shi-fen Xu. Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial. Journal of Integrative Medicine, 2020, 18(6): 492-498.
[9] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[10] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[11] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[12] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[13] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[14] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[15] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[2] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[3] Xi Lin, Jian-ping Liu. Herbal medicines for viral myocarditis. Journal of Chinese Integrative Medicine, 2008, 6(1): 76
[4] Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[5] Liang-ping Hu, Hui Gao. Discrimination of errors in statistical analysis of medical papers published in the first issue of 2006 in Journal of Chinese Integrative Medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 98-106
[6] Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035
[7] Wei Xu, Meng Shi, Jian-gang Liu, Cheng-long Wang . Collagen protein expressions in ischemic myocardium of rats with acute myocardial infarction and effects of qi-tonifying, yin-tonifying and blood-activating herbs and detoxifying and blood-activating herbs. Journal of Chinese Integrative Medicine, 2010, 8(11): 1041-1047
[8] Tao Wang , Feng Qin. Effects of Chinese herbal medicine Xiaoyao Powder on monoamine neurotransmitters in hippocampus of rats with postpartum depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1075-1079
[9] Ying Xu , Chang-chun Zeng , Xiu-yu Cai , Rong-ping Guo , Guang Nie , Ying Jin. Chromaticity and optical spectrum colorimetry of the tongue color in different syndromes of primary hepatic carcinoma. Journal of Chinese Integrative Medicine, 2012, 10(11): 1263-1271
[10] Xiang-ying Mao , Qin Bian , Zi-yin Shen. Analysis of the osteogenetic effects exerted on mesenchymal stem cell strain C3H10T1/2 by icariin via MAPK signaling pathway in vitro. Journal of Chinese Integrative Medicine, 2012, 10(11): 1272-1278
Journal of Integrative Medicine, ISSN: 2095-4964 CN 31-2083/R
Copyright © Journal of Integrative Medicine
Powered by Beijing Magtech Co. Ltd
沪公网安备31010602003416号      沪ICP备18017633号-3