Prospective randomized controlled study of a Chinese herbal medicine compound Tangzu Yuyang Ointment for chronic diabetic foot ulcers: a preliminary report.

Abstract

AIM OF THE STUDY:

The purpose of this study was to evaluate the efficacy and safety of a topical Chinese herbal medicine (CHM) compound Tangzu Yuyang Ointment (TYO) for treatment of chronic diabetic foot ulcers.

MATERIALS AND METHODS:

This multi-center, prospective, randomized, controlled and add-on clinical trial was conducted at seven centers in the China mainland. Fifty-seven patients with chronic diabetic foot ulcers of Wagner's ulcer grade 1-3 were enrolled in this study. Patients who were randomly assigned to the control group (n=28) received standard wound therapy (SWT), whereas those randomized to the treatment group (n=28) received SWT plus topical TYO. Only 48 patients who finished 24 weeks of observations were entered for data analysis.

RESULTS:

The TYO and SWT groups were comparable for baseline characteristics. Ulcer improvement was 79.2% in the TYO group and 41.7% in the SWT group (P=0.017) at 12 weeks, and 91.7% vs. 62.5% (P=0.036) at 24 weeks. The number of ulcers that were completely healed at 4, 12 and 24 weeks was similar in both groups, as were the numbers of adverse events. Healing time was 96±56 days (n=19) in the TYO group and 75±53 days (n=14) in the SWT group (P=0.271).

CONCLUSION:

TYO plus SWT is more effective than SWT in the management of chronic diabetic foot ulcers and has few side-effects.

• Authors: Shufa Li, Jianyong Zhao, Jianping Liu, Fei Xiang, Debin Lu, Baoying Liu, Jing Xu, Huimin Zhang, Qian Zhang, Xianwen Li, Richeng Yu, Mingjun Chen, Xia Wang, Ye Wang, Bing Chen
• Journal: Journal of ethnopharmacology (J Ethnopharmacol) Vol. 133 Issue 2 Pg. 543-50 (Jan 27 2011) ISSN: 1872-7573 [Electronic] Ireland
• PMID: 21129474 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Crown Copyright © 2010. Published by Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Drugs, Chinese Herbal
• Ointments

Topics

• Adult
• Aged
• Aged, 80 and over
• China
• Diabetic Foot (drug therapy, pathology, therapy)
• Drugs, Chinese Herbal (administration & dosage, adverse effects, therapeutic use)
• Ethnopharmacology
• Female
• Humans
• Male
• Middle Aged
• Ointments
• Phytotherapy
• Plants, Medicinal
• Prospective Studies
• Treatment Outcome
• Wound Healing (drug effects)