Introduction Non-alcoholic fatty liver disease (NAFLD) may progress to cirrhosis and end-stage liver disease. Worldwide the prevalence is increasing in line with the global obesity epidemic. To date there is no agreed pharmacological therapy for this condition. Omega-3 fatty acids have been suggested as a treatment for NAFLD. The aim of this study was to elucidate the effect of omega-3 fatty acids in patients with NAFLD in a placebo-controlled, double-blind randomised trial.
Method 50 subjects with a clinical diagnosis of NAFLD were randomised to 4 grams daily of omega-3 fatty acids or placebo for six months. Subjects were reassessed three months after the end of treatment to ascertain if any changes observed had regressed. The primary endpoint of the study was change in ultrasound grade of steatosis at six months. Secondary endpoints included change in serum liver function tests (LFTs) and health-related quality of life scored by WHOQOL-BREF.
Results The subjects were closely matched at baseline. In the omega-3 arm of the study 14% subjects had increased grade of steatosis whilst 18% had decreased steatosis. The remaining 68% were unchanged. In the placebo group with 16% decreased; 11% increased and 74% were unchanged. On statistical analysis, there was no significant difference between omega-3 and placebo in change in ultrasound assessment grade of the liver at 6 months compared with baseline (difference 5.5% (99% CI -22.3 – 33.3); p = 0.70). Similarly there was no significant difference between participants who received omega-3 and those who received placebo in change in secondary outcome measures i.e. grade of steatosis on ultrasound at nine months, serum liver function tests, serum lipids and health related quality of life scores at either six or nine months.
Conclusion The results of this clinical trial do not support the use of omega-3 fatty acids as a treatment for NAFLD.
Disclosure of interest None Declared.
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