Harrison 2003.
Methods | Generation of allocation sequence: adequate, computer‐generated randomisation table. Allocation concealment: adequate, performed by a pharmacy. Blinding: adequate, double blinding. Follow‐up: adequate. |
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Participants | Inclusion criteria:
‐ clinical and histologic diagnosis of NASH
‐ age >18 years
‐ liver biopsy within the past 6 months for elevated aminotransferases
‐ well compensated liver disease (Hb at least 12 g/dl for women and 13 g/dl for men, white blood cell count of greater than 3.000/mm3, neutrophil count of greater than 1500/mm3, platelets greater than 70.000/mm3, serum albumin greater than 1.4 mg/dl and a serum creatinine less than 1.4 mg/dl). Exclusion criteria: ‐ other causes for chronic liver disease (hepatitis B and C, hereditary hemochromatosis, alpha‐1 antitrypsin deficiency, Wilson's disease, or autoimmune liver disease) ‐ use of drugs associated with the development of steatohepatitis ‐ prior surgical procedures ‐ evidence of decompensated liver disease, such as a history of ascites, bleeding varices, hepatic encephalopathy ‐ pregnancy ‐ total parental nutrition within the past 6 months ‐ a history of organ transplant ‐ other conditions that have been known to cause NASH or worsen the disease ‐ a history of alcohol consumption greater than 10 g/day. Characteristics of included patients: n = 49 Mean age = 51 Males = 44% |
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Interventions | Vitamin E 1000 IU and Vitamin C 1000 mg per day versus placebo for six months. All patients in both groups were given the same 1600‐calorie diet and written exercise plan as outlined by the National Institutes of Health and the National Heart, Lung and Blood Institute. | |
Outcomes | Biochemical and histological outcomes were assessed before and after treatment. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |