Fructus Mume Formula in the Treatment of Type 2 Diabetes Mellitus: A Randomized Controlled Pilot Trial

Background. Fructus Mume or Dark Plum (pilule form) has been used for many years in Traditional Chinese Medicine (TCM) and may be a valid treatment for type 2 diabetes mellitus (T2DM). Aim. One aspect toward efficacy validation is the evaluation of the blood glucose-lowering effect of Fructus Mume (FM) with T2DM patients in a randomized controlled trial (RCT). Methods. This pilot study uses a RCT procedure to assess efficacy of FM and Metformin. The trial was for 12 weeks, with 80 T2DM subjects. Both groups were standardized in their diet and exercise routine. Comparisons of several variables were analyzed. Results. No significant differences were found between groups in the fasting and postprandial glucose levels although both had significant decreases. The values of glycosylated hemoglobin were significantly reduced in both groups. For patients whose body mass index (BMI) was <23, neither FM nor Metformin had an effect on BMI; for those with a BMI between 23 and 25 or the BMI was >25, both FM and Metformin significantly reduce the BMI. Conclusions. In this pilot study, it was demonstrated that Fructus Mume formula may reduce the levels of blood glucose in patients with type 2 diabetes.