The Effect of Salacia Reticulata Extract Biscuits on Blood Sugar Control of Type 2 Diabetes Mellitus Patients: A Two-Period, Two-Sequence, Crossover, Randomized, Triple-Blind, Placebo-Controlled, Clinical Trial

Background Traditional physicians in Sri Lanka and India use extracts from the plant Salacia reticulata, or Kothala Himbutu (KH) to treat diabetes. The effect of a KH biscuit, taken as snack, on glycemic control was investigated patients with type 2 Methodology This triple-blind, randomized, placebo-controlled, two-period, two-sequence, crossover study conducted Internal Medical Clinic, Teaching Hospital Anuradhapura. A research assistant opened computer-generated random numbers enclosed sealed envelope performed treatment allocation. group outcome masked researchers, patients, analysts. Both placebo biscuit were identical. primary measure HbA1c. Intention analyses used. Glycemic stability assured run-in period, severe renal, liver, heart disease excluded. If needed insulin, they withdrawn trial. Results From January 2014 May 2016, 230 screened, 136 randomized. Of them, 62 allocated, 58 completed 71 69 biscuit. After washout period crossover, 57 65 baseline mean HbA1c level 8.45% (68.9 mmol/mol) 8.65% (71.0 for placebo-KH KH-placebo groups. At end trial, levels 8.23% (66.4 8.53% (69.3 mmol/mol), respectively. unadjusted reduced 0.10% (95% CI = -0.12, 0.32) after 0.35% 0.10, 0.60) biscuits, values 8.46% 8.19, 8.73) (69 mmol/mol 95% 66, 72) 8.19% 7.90, 8.48) (66 63, 69), paired sample t-test shows that reduction not significant biscuits (p 0.324), while it is 0.003). Analysis multiple imputations confirmed difference between reducing level. Conclusions snack reduces by 0.25% compared without serious renal liver adverse effects. can be safely recommended