Evidence-based Medicine Study To Assess The Clincal Efficacy Of Chinese Medicine For Diabetic Foot

BackgroundDiabetic foot ulcer is one of the common complications in people with diabetes mellitus. It bring a large disease burden in terms of labour capability, quality of life, and health care resources. Chinese herbal medicine is widely used as an effective intervention for diabetic foot ulcers in China. However, their efficacy lack of scientific evidence and need further systematic assessment to gain baseline data and scientific evidence. The work mention above can also provide the basis for further clinical validation studies.ObjectivesThis study was composed of two parts: systematic review and clinical trial.The purpose of systematic review was to assess the beneficial effects and risks of Chinese herbal medicines for foot ulcers in diabetic people.The purpose of this clinical trial was to observe the efficacy and safety of a kind of Chinese herbal medicine compound—Tangzu Yuyang Ointment(TYO), the formula and preparation method of which were prescripted by Chinese medicine experts and based on this systematic review result mentioned above, for treatment of chronic diabetic foot ulcers.Materials and methodsIn this systematic review, we searched the Cochrane Wounds Group Specialised Register, the Cochrane Controlled Trials Register in The Cochrane Library(Issue 1, 2010), MEDLINE(1996 to 05/2010), EMBASE(1974 to 5/2010), Chinese BioMedical Database(CBM, 1979 to 5/2010) and Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS 1982 to 5/2010); Allied and Complementary Medicine Database(AMED, 1985 to 5/2010). Two authors extracted data and assessed study quality independently. The efficacy and measuring the healing of ulceration, quality of life, number of amputation, symptom improvement, foot infection, adverse events and costs of Chinese herbal medicines for diabetic foot ulcers in randomised controlled trials extracted were evaluated.This multi-center, 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 ssigned to the control group (n = 29) 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 entered for data analysis.ResultsThirteen RCTs involved 807 patients with diabetic foot ulcer were included in this systematic review, and these trials were of high risk of bias. Due to the heterogeneity of interventions, meta-analysis was not performed. Chinese herbal medicine plus conventional therapy appeared significantly better than ulcer wound care or hot water soaking or placebo plus conventional therapy on shortening healing time of foot ulcer, Chinese herbal medicine (wet compress or soaking) plus conventional therapy showed beneficial effect compared with conventioanl therapy plus ulcer care on increasing number of patients with ulcer healing for 100%, and on shrinking the ulcer surface area. But there was no difference between herbal medicine plus conventional therapy and placebo plus conventional therapy, or conventional therapy alone, or between herbal soaking and hot water soaking based on conventional therapy on increasing the number of patients with ulcer healing of 100%. Five RCTs reported outcome of adverse events and no serious adverse events were observed.In this randomdized controlled clinical trial,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 This systematic review show that there is no sufficient evidence to support or refute the use of Chinese herbal medicines for diabetic foot ulcers due to variations of the herbal interventions and the poor quality of trials. More rigorous randomised clinical trials is required to clarify whether Chinese herbal medicines can accelerate aid the healing of diabetic foot ulcer.In this RCT study, TYO plus SWT is more effective than SWT in the improvement of chronic diabetic foot ulcers and has few side-effects.