Improved glycemic control and lipid profile in hyperlipidemic type 2 diabetic patients consuming Salvia officinalis L. leaf extract: a randomized placebo. Controlled clinical trial.

OBJECTIVES

Evaluation of the efficacy and safety of Salvia officinalis L. (S. officinalis) leaf extract in the treatment of hyperlipidemic type 2 diabetic patients.

DESIGN

Randomized placebo-controlled parallel group study.

SETTING

Diabetes Clinic (Karaj City, Alborz Province of Iran).

INTERVENTIONS

The efficacy and safety of taking S. officinalis leaf extract (one 500 mg capsule t.i.d. for 3 months) in treatment of 40 hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) type 2 diabetic patients were evaluated and compared with the placebo group (n=40).

MAIN OUTCOME MEASURES

Fasting blood levels of glucose, glycosylated hemoglobin (HbA1c), total cholesterol, triglyceride, LDL-C (low density lipoprotein cholesterol), HDL-C (high density lipoprotein cholesterol), SGOT (serum glutamic-oxaloacetic transaminase), SGPT (serum glutamic-pyruvic transaminase) and creatinine.

RESULTS

The extract lowered fasting glucose, HbA1c, total cholesterol, triglyceride and LDL-C but increased HDL-C compared to baseline at endpoint. Percent difference mean (95% confidence interval) between the extract and placebo groups in terms of effects on fasting glucose, HbA1c, total cholesterol, triglyceride, LDL-C and HDL-C at endpoint were 32.2 (26.5, 37.9), 22.7 (16.8, 28.6), 16.9 (9.7, 24.1), 56.4 (36.1, 76.7), 35.6 (29.9, 41.3) and 27.6 (15.8, 39.4) (P=0.001, P=0.01, P=0.01, P=0.009, P<0.001 and P=0.008), respectively. Moreover, the extract did not have any significant effects on the other parameters compared to the placebo group at endpoint (P>0.05). No adverse effects were reported.

CONCLUSIONS

S. officinalis leaves may be safe and have anti-hyperglycemic and lipid profile improving effects in hyperlipidemic type 2 diabetic patients.