The Effect of Bitter Melon (Momordica charantia L.) Leaves Extract on TNF-α Serum Levels and Diabetic Foot Ulcers Improvement : Randomized Controlled Trial

Abstract

Diabetic foot ulcer (DFU) is among the many complications of diabetes and it takes a very long period of time to heal. It can lead to the amputation of the lower limb, thereby resulting to death or in most cases, a bad quality of life. The aim and objective of this study is to assess the effect of bitter melon leaves extracts on serum TNF-α levels and improvement of diabetic foot ulcers. The study technique used here is the randomized, double-blinded, placebo-controlled trial. Thirty patients suffering from DFU participated in the trial and according to PEDIS scores were divided into two groups, of which 15 patients were in the treatment group and administered with bitter melon leaves extract at a dose of 6 g/day and the remaining 15 patients were in the control group and were given placebo. This intervention was done for 4 weeks and the examination of serum TNF-α levels was carried out at baseline and at the end of treatment. The readings of the healing process for diabetic foot ulcers with PEDIS scores were also taken at baseline, weeks 2, 3 and 4. Data were analyzed using the paired t-test and the independent t test. After 4 weeks of treatment, there was a decrease in baseline serum TNF-α levels in the treatment and control groups (29.5 ± 8.6 pg/ml, P = 0.0001 and 202.5 ± 610.2 pg/ml, P = 0.001). There was no effect on serum TNF-α levels (P = 0.28). There was a decrease in PEDIS degrees from baseline, week 2, 3 and 4 in the treatment and control groups (2.7±0.5; 2.7±0.5; 2.7±0.6; 1.9±0.6 and 2.6±0.5; 2.6±0.5; 2.5±0.6; 2.2±0.8). However there was no effect on diabetic foot ulcer improvement both groups in week 2 (P = 0.46), week 3 (P = 0.57) and week 4 (P = 0.29). Bitter melon leaves extracts is proven to have no effect on the serum TNF-α levels and improvement of diabetic foot ulcers.