NAFLD Drug Therapy Review Offers Little Clarity on Optimal Treatment

A total of 77 trials were included in which pharmacological interventions were compared with one another, or placebo
A total of 77 trials were included in which pharmacological interventions were compared with one another, or placebo

A review of drug therapies in the treatment of non-alcoholic fatty liver disease (NAFLD) found very low quality evidence to support these pharmacological interventions in the treatment of this disease. Findings from the study were published in the Cochrane Library of Systematic Reviews.

NAFLD is an accumulation of fat in the liver independent of significant alcohol consumption, medications, or diseases affecting the liver (ie, hepatitis C virus, Wilson's disease). In order to compare the benefits and risks of these treatments, researchers performed an extensive literature search to find randomized clinical trials in patients with NAFLD (trials where patients underwent liver transplant were excluded). These studies included pharmacological interventions where treatments were either compared with one another or with placebo. Seventy-seven trials (n=6287) were identified; 41 trials (n=3829) included information for one or more outcomes (ie, mortality at max follow-up, serious adverse events, health-related quality of life [QoL]). In general, almost all the trials were at high risk for bias and evidence was considered very low quality. 

Pharmacological interventions where at least two or more trials reported on at least one outcome were included in this review:

Antioxidants vs. no intervention:

  • No mortality reported in either group (87 patients, 1 trial, very low quality evidence)
  • No serious side effects reported (87 patients, 1 trial, very low quality evidence)
  • No difference in the number of serious adverse events between the two groups (rate ratio 0.89, 95% CI: 0.36–2.19; 254 patients; 2 trials; very low quality evidence)
  • Health-related QoL not reported in any trials

Bile acids vs. no intervention:

  • No difference between groups in mortality at max follow-up (OR 5.11, 95% CI: 0.24–107.34; 659 patients; 4 trials; very low quality evidence)
  • No difference in proportion of patients with serious side effects (OR 1.56, 95% CI: 0.84–2.88; 404 patients; 3 trials; very low quality evidence)
  • No difference in number of serious adverse events  (rate ratio 1.01, 95% CI: 0.66–1.54; 404 patients; 3 trials; very low quality evidence)
  • Health-related QoL not reported in any trials

Thiazolidinediones vs. no intervention:

  • No mortality reported in either group (74 patients; 1 trial; very low quality evidence)
  • No serious side effects reported  (194 patients; 2 trials; very low quality evidence)
  • No difference in number of serious adverse events  (rate ratio 0.25, 95% CI: 0.06–1.05; 357 participants; 3 trials; very low quality evidence)
  • Health-related QoL not reported in any trials

Given the low quality of evidence presented in this review, the authors concluded that they were "very uncertain about the effectiveness of pharmacological treatments for people with NAFLD including those with steatohepatitis." Larger, well-designed, randomized studies are needed to get a better understanding of what the optimal treatments are for these patients.

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