Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were
      divided into three groups; group 1 included 34 patients received Vit. E 400 mg twice a day,
      group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34
      patients received PTX 400 mg twice daily for 3 months. The following parameters were measured
      both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and
      chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total
      cholesterol, triglyceride, LDL, HDL.
    

Detailed description: 
      This was a 3-month, prospective, randomized, and single blind study. Participants were
      recruited from the outpatient clinic and hepatology, gastroenterology and infectious diseases
      department at Kafrelsheikh University Hospital between February 2020 and January 2021.
      Two-hundred and five Egyptian patients diagnosed with NAFLD with potential clinical inclusion
      criteria were invited for a screening session to determine their eligibility for the study.
      Patients were enrolled in the study if they are > 18 years old, had evidence for NASH;
      persistently elevated alanine aminotransferase (ALT) >1.5 times the upper limit of normal),
      imaging (ultrasound) showing fatty infiltration, and histological evidence of NASH after
      biopsy (macrovascular steatosis, ballooning degeneration of hepatocytes, scattered lobular
      inflammation and apoptotic bodies).One hundred and forty-six patients were excluded from the
      study either because they did not meet the inclusion criteria (n = 135) or refused to enroll
      in the study (n =11). Qualifying participants (n = 102) were randomly assigned to one of the
      three treatment groups using a computer-generated randomization sequence. Group I (n = 34)
      received 400 IU Vitamin E (Vitamin E 400 IU®, MEPACO Pharmaceutical Company, Sharqia, Egypt)
      twice daily for 3 months. Group II (n =34) received 250 mg Ursodeoxycholic acid (Ursofalk 250
      mg®, MINAPHARM Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months. Group III (n =
      34) received 400 mg sustained release (SR) Film-Coated Tablets of pentoxifylline (Trental 400
      mg®, SANOFI Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months. Patients were
      followed up every week to ensure compliance, drug adherence and to report side effects or
      drop out from the study.The following parameters were measured both before and after
      intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and
      CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride,
      LDL, HDL.
    

Intervention name(s): Vitamin E; Ursodeoxycholic acid; Pentoxifylline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vitamin E is one of the body's most effective chain-breaking antioxidants that has shown to delay the pathogenesis of NASH.; is a metabolic by-product of intestinal bacteria and has been proven to be useful in the non-surgical treatment of cholesterol gallstones and primary biliary cirrhosis (PBC); it is a well-tolerated medication that improves blood
viscosity and erythrocyte rheological characteristics in individuals with peripheral vascular disease 20. In addition, PTX is a nonspecific phosphodiesterase inhibitor that increases cyclic adenosine monophosphate (cAMP) levels while decreasing TNF-a gene transcription
Other intervention name(s): Alpha-Tocopherol; Ursofalk; Trental
Intervention MeSH terms: Vitamin E; Tocopherols; alpha-Tocopherol; Pentoxifylline; Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, and single blind study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vitamin E, Ursodeoxycholic acid, Pentoxifylline, NASH