A controlled trial of Orlistat (Xenical) for patients with non-alcoholic steatohepatitis (NASH)

INTERVENTION: Orlistat (Xenical) one tablet (120 mg) three times a day for one year, along with a weight reducing diet and two multivitamin tablets a day versus diet and multivitamins alone. CONDITION: Nonalcoholic steatohepatitis ; Digestive System ; Non‐alcoholic steatohepatitis PRIMARY OUTCOME: Overall necroinflammatory grade or fibrosis stage on repeat liver biopsy. A change of one point in grade or stage will be considered significant. SECONDARY OUTCOME: 1. Liver biochemistry (alanine transaminase, aspartate transaminase, gamma, glutamyl transferase); 2. Insulin sensitivity assessed by HOMA index (derived from fasting glucose and insulin measurements); 3. Body mass index (BMI); 4. Quality of life assessed by the chronic liver disease questionnaire (CLDQ) INCLUSION CRITERIA: 1. Adult more than 18 but less than 75 years Children will not be included in this study for three reasons: 1.1. The development of NASH in children may be due to different age‐related metabolic processes than in adults 1.2. Children with NASH are always obese and their elevated aminotransferases normalise with weight loss or vitamin E treatment 1.3. The natural history of NASH in children is unknown and may not be sufficient to warrant the risk of using a new class of drug and performing a follow up liver biopsy. Orlistat is not approved for use in children 2. Body mass index (BMI) more than 28 kg/m^2. Orlistat is only licensed for patients with this degree of obesity 3. Liver biopsy obtained no more than six months before randomisation with a pathology report confirming that the histological diagnosis is consistent with NASH. A longer time period would increase the chances that the liver pathology had altered since the original biopsy 4. No mo