THE EFFECTS OF HERACLEUM PERSICUM EXTRACT AS AN ADJUNCTIVE THERAPY ON DYSLIPIDEMIA; A RANDOMIZED OPEN-LABEL CLINICAL TRIAL

Objective: There are many studies which declared the immunomodulatory, anti-inflammatory, analgesic, anticonvulsant, cytotoxic, and antioxidant properties of Heracleum persicum. The aim of this study was to evaluate the potential impacts of supplementation with Heracleum persicum as an adjunctive therapy to atorvastatin on dyslipidemic patients. Methods: A randomized, open-label, clinical trial study was conducted on 100 dyslipidemic cases with the following criteria; total cholesterol >200 mg/dL, LDL-C >130 mg/dL, and HDL-C <35 mg/dL. They were randomly assigned to: (1) H. persicum group (n = 50), receiving atorvastatin (10 mg/day) + H. persicum extract (500 mg/day) for 8 weeks, and (2) atorvastatin group (n = 50), receiving only atorvastatin (20 mg/day) for 8 weeks. Body mass index (BMI), weight, lipid profile, and biomarkers of hepatic and renal injury were determined at baseline and 8 weeks later. Results: From the 100 patients who were included in this trial, 52 cases completed the study (18 and 34 in the H. persicum and atorvastatin groups, respectively). The two groups were not significantly different at baseline regarding gender, weight, BMI, serum lipid profile parameters (comprising total cholesterol, triglycerides, LDL-C, and HDL-C), transaminases (ALT and AST), and ALP (p > 0.05). Serum total cholesterol and LDL-C were decreased in both the H. persicum (p = 0.001) and atorvastatin (p < 0.001) groups. Serum HDL-C was increased in the atorvastatin group (p < 0.05), while no significant change was observed in the H. persicum group (p > 0.05). Serum triglyceride levels remained statistically unchanged in both groups during the study (p > 0.05) (Table 1). Serum ALT and AST levels rose in the atorvastatin (p = 0.049 and 0.013, respectively), but not the H. persicum (p > 0.05) group. No significant change was observed in weight and BMI, serum levels of creatinine, blood urea nitrogen, and fasting blood sugar in either of the groups during the study (p > 0.05). Conclusion: in spite of HDL-C, combination therapy with H. persicum + half dose of atorvastatin (10 mg/day) was as effective as routine dose of atorvastatin (20 mg/day) on serum lipid profile parameters. It was the first survey in this field but future studies should be focused on the pure lipid lowering impact of H. persicum compared to other medications. (Table Presented).