Effect of Bergenia ligulata (Wall.) in type 2 diabetes mellitus: A randomized placebo-controlled trial

Abstract

IntroductionGlobally 8.8 % of people aged 20–79 years have diabetes. Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia. Bergenia ligulata (Wall.) is a small, perennial, rhizomatous flowering herb used medicinally in India.The present study aimed to evaluate the effect of B. ligulata rhizome as an adjuvant in decreasing blood glucose levels in type-II diabetes mellitus. MethodsForty patients were enrolled in a single-blind, randomized, placebo-controlled study; twenty patients were assigned to each of the test and control groups. Only those currently using 2 or less oral hypoglycaemic agents were included. Subjects took B. ligulata (4 gm) or placebo in capsule form, orally, for 8 weeks. Fasting blood sugar (FBS) and postprandial blood sugar (PPBS) were measured at baseline, fourth week, and end of the trial. Haemoglobin A1c (HbA1c) and quality of life (Asian Diabetes Quality of Life; ADQOL) scores were measured at baseline and the end of the trial. Data were statistically analyzed using analysis of variance (ANOVA), student's t-test, chi-square, and Fisher exact test to assess the effect of the intervention. ResultsAfter 8 weeks of treatment, the decrease in mean fasting blood sugar (FBS) level showed a significant difference between groups (Cohen's d= -0.457, 95 % confidence intervals (CIs) -0.174 to -1.082). PPBS level was significantly reduced in the test group compared to the control group (Cohen's d= -1.457, 95 % confidence interval (CIs) -0.749 to -2.150). There was a statistically significant reduction in HbA1c level in the test group compared to the control group (Cohen's d= -0.798, 95 % confidence interval (CIs) -0.148 to -1.438). B. ligulata was found to be more effective in improving ADQOL scores than placebo (Cohen's d = 0.762, 95 % confidence interval (CIs) 0.115 to 1.400). No B. ligulata related adverse events were observed. ConclusionB. ligulata appears to be an effective adjuvant treatment for type 2 diabetes mellitus. It reduced FBS, PPBS, and HbA1c and improved ADQOL scores significantly compared to the placebo. However, for more valid results, larger samples are needed. Clinical trial registration noCTRI /2019/05/019087.