Effectiveness and safety of Stevia rebaudiana dried leaves as an adjuvant in the short-term treatment of type 2 diabetes: A randomized, controlled, cross-over and double-blinded trial

Abstract

Recent randomized controlled trials have demonstrated the utility of stevioside and related compounds, extracted and refined from stevia leaf plant, to improve blood glucose and blood pressure in patients with type 2 diabetes. However, up till date, no well-designed trials have shown that the dried leaves of the stevia plant have similar effects in medical use. A randomized, controlled, cross-over and double-blinded study was conducted to assess the effectiveness and safety of Stevia rebaudiana leaves to reduce blood glucose and mean arterial pressure in Sahrawi patients with type 2 diabetes. One hundred and fourteen patients (80 women and 34 men) participated in a cross-over study consisting of an intake of tea sweetened with dried leaves of S. rebaudiana (study group) or refined sugar (control group), after a wash out period of two days. Capillary blood glucose, hearth rate and blood pressure were then determined at minutes 0 (baseline), 30, 60, 120 and 240 after the ingestion. In all patients, blood glucose reduction of - 35.8% (95%CI -27.0 to -44.6%) were observed in the S. rebaudiana group compared to an increase in the control group (+8.1%, 95%CI 3.1 to 13.2% [p<0.0001]). Only in patients with previous hypertension (n=58 [51.3%]), mean arterial pressure increased after control intake (+8.5%, 95%CI 3.8 to 13.6% [p<0.02]) while it decreased (-11.5%, 95%CI -6.0 to -16.1%; [p <0.01]) in the study group. Major hypoglycemia, arterial hypotension, or other adverse effects were not observed. According to study conditions, dried leaves of S. rebaudiana, in short-term use, reduced significantly postprandial blood glucose in all patients, and it decreased mean blood pressure in hypertensive patients without detectable adverse effects throughout 24 h after ingestion.