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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

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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

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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**△
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