Effect of multifactorial treatment on non-alcoholic fatty liver disease in metabolic syndrome: a randomised study

Curr Med Res Opin. 2006 May;22(5):873-83. doi: 10.1185/030079906X104696.


Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome (MetS). There is no established treatment for NAFLD.

Aim: To evaluate a multifactorial intervention in the treatment of NAFLD.

Methods: A prospective, open-label, randomised study in non-diabetic patients (n = 186) with MetS (follow-up: 54 weeks). All patients had both biochemical and ultrasonographic evidence of NAFLD at baseline. Other causes of liver disease were excluded. Patients received lifestyle advice and treatment for hypertension (mainly inhibitors of the renin-angiotensin system), impaired fasting glucose (metformin), obesity (orlistat) and dyslipidaemia [randomly allocated to atorvastatin 20 mg/day (n = 63) or micronised fenofibrate 200 mg/day (n = 62) or both drugs (n = 61)]. Liver ultrasonography was assessed at baseline and at the end of the study.

Results: At the end of treatment, 67% of patients on atorvastatin, 42% on fenofibrate and 70% on combination treatment no longer had biochemical plus ultrasonographic evidence of NAFLD (p < 0.05 vs. baseline for all comparisons). The percentage of patients who no longer had evidence of NAFLD was significantly higher (p < 0.009) in the atorvastatin and combination groups compared with the fenofibrate group. This effect was independently related to drug treatment, as well as to reductions in high-sensitivity C-reactive protein, waist circumference, body weight, triglycerides, low-density lipoprotein-cholesterol, total cholesterol, systolic blood pressure and glucose. Four patients discontinued treatment because of adverse effects.

Conclusions: Multifactorial intervention in MetS patients with both biochemical and ultrasonographic evidence of NAFLD offsets surrogate markers of NAFLD (i.e. elevated aminotransferase plus echogenic liver).

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anti-Obesity Agents / therapeutic use
  • Atorvastatin
  • Diet, Fat-Restricted
  • Drug Therapy, Combination
  • Dyslipidemias / drug therapy
  • Fatty Liver / diagnostic imaging
  • Fatty Liver / drug therapy*
  • Fatty Liver / etiology
  • Female
  • Fenofibrate / therapeutic use*
  • Heptanoic Acids / therapeutic use*
  • Humans
  • Hypolipidemic Agents / therapeutic use*
  • Lactones / therapeutic use
  • Male
  • Metabolic Syndrome / drug therapy*
  • Metabolic Syndrome / physiopathology
  • Middle Aged
  • Orlistat
  • Prevalence
  • Prospective Studies
  • Pyrroles / therapeutic use*
  • Risk Factors
  • Treatment Outcome
  • Ultrasonography
  • Weight Loss


  • Anti-Obesity Agents
  • Heptanoic Acids
  • Hypolipidemic Agents
  • Lactones
  • Pyrroles
  • Orlistat
  • Atorvastatin
  • Fenofibrate