Effect of Propolis on liver functional indexes in patients with Non-alcoholic fatty liver disease

Effect of Propolis on liver functional indexes in patients with non-alcoholic fatty liver disease

A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 501 patients,

In a double-blind randomized clinical trial, 50 patients with NAFLD who were referred to the gastroenterology clinic of Tohid Hospital in Sanandaj were divided in two groups and treated with Propolis capsules (2 capsules 500 mg, daily) or placebo for 3 months. All subjects receive two groups of dietary and physical activity recommendations during the study.

Inclusion criteria: subjects over 20 years old who were diagnosed with NAFLD by Sonography and increased levels of ALT and AST Exclusion criteria:viral hepatitis; autoimmune liver diseases; diabetes; women who were pregnant or lactating; Use of effective drugs on liver tests in the last 2 months (Statins, Glitazones , Chlorpromazine , Vit E, OCP , Anabolic Steroids, Thionamides , etc.) ; Hemochromatosis ; Cirrhosis ; Alcohol consumption of more than 140cc in men and 70 cc in women per week ; Infectious diseases; herbal allergies, history of allergic reactions to bee products

Intervention group: Propolis, oral capsule, 500 mg, twice a day for three months with standard treatment Control group: placebo containing starch, oral capsule, 500 mg, twice a day for three months with standard treatment

Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Alkaline Phosphatase (ALP); Gamma glutamyl transpeptidase; Albumin; Ferritin; Bilirubin; Cholestrol; Triglyceride; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Grade of fatty liver; En Body Mass Index (BMI)

using block randomization method with a block size of 4. The list of randomization was computer-generated and a person, who was not aware of the nature of the trial, packed the supplements and placebo capsules in numbered bottles based on the list. The other person who was not aware of random sequences allocated the patients to the numbered bottles.

All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.