Salvia officinalis (Sage) Leaf Extract as Add-on to Statin Therapy in Hypercholesterolemic Type 2 Diabetic Patients: a Randomized Clinical Trial

The efficacy and safety of Salvia officinalis combined with statin have not been evaluated in dyslipidemic
diabetes mellitus type 2 (DDMT2) so far. The plant extract antioxidant activity was determined by the DPPH
radical scavenging assay. The total flavonoid, total phenolic and quercetin contents of the capsules containing
the plant extract were also measured. Moreover, the effects of 2-month extract intake (500 mg capsule three
times a day) as add-on to daily use of 15 mg glyburide, 2000 mg metformin and 10 mg atorvastatin on the blood
levels of fasting glucose (FG), 2 h postprandial glucose (2hPPG), glycosylated hemoglobin (HbA1c), total
cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride, high-density lipoprotein cholesterol
(HDL-C), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), creatinine and body
mass index were studied in 50 patients and compared with the placebo group (n=50).The extract IC50 in the DPPH assay was 87.26±0.003 µg/mL (mean±SD), whereas the ascorbic acid IC50 was 5.626± 0.001 µg/mL (mean±SD). The total flavonoid, total phenolic and quercetin contents of the capsule containing the plant extract
were 39.76±3.58 mg of rutin equivalents (mean±SD), 30.33±1.23 mg of gallic acid (mean±SD) and 0.13 mg,
respectively. The extract lowered FG, 2hPPG, HbA1c, TC, LDL-C and triglyceride levels, but increased HDL-C
level compared to the placebo at the endpoint (P<0.05). The extract did not affect the other parameters
significantly and no adverse effect was reported. The extract has substantial antioxidant activity which may be
beneficial for the prevention of the cardiovascular complications of DDMT2. Moreover, addition of the extract
to statin therapy is apparently safe and further improves lipid profile.