Prospective single blind placebo-controlled randomized clinical trial to assess the efficacy and safety of metformin in promoting wound healing and weight reduction in non-diabetic overweight post-operative female patients
Keywords:
Metformin, Wound healing, Weight reduction, Non-diabetic overweight post-operative female patientsAbstract
Background: Obesity is an important preventable risk factor that can affect wound healing. Oral hypoglycemic drug metformin apart from its antihyperglycemic and not hypoglycemic property has been reported to promote wound healing in non-diabetic animal studies and weight reduction in non-diabetic individuals. Hence, this: prospective randomized study single-blind placebo-controlled study was designed with the aim to assess the efficacy and safety of metformin in wound healing and weight reduction in a tertiary care hospital in Pondicherry during the period between December 2012 and January 2014.
Methods: 215 non-diabetic post-operative patients with body mass index (BMI) of 25-29.9 kg/m2 from the Department of Obstetrics and Gynecology included after obtaining informed consent received tablet metformin 500 mg or placebo B.D from 2nd post-operative day up-to 30 days. Fasting blood sugar, postprandial blood sugar, BMI were recorded initially, and at the end. Clinical evaluation of wound was done on 8th, 15th and 30th post-operative days. Unpaired t-test was applied to compare the two groups for quantitative analysis and Chi-square test to analyze the qualitative outcome by using GraphPad prism - 6 software. p<0.05 was considered to be statistically significant.
Results: Surgical site infection of 13.3% and 3.3% was observed in control and metformin groups respectively. Wound healing promoting effect of metformin was evidenced by p=0.0087 and 0.01 on 8th and on 15th day. Weight reducing effect was evidenced by p=0.0001 on comparing BMI. No significant hypoglycemia was observed. No adverse drug reaction was reported.
Conclusions: Our study has shown metformin having best wound healing and weight reducing effect without producing hypoglycemia. Long-term studies on all types of surgeries in both males and females including emergencies are suggested.
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