A REVIEW OF THE QUALITY OF LIFE BURDEN OF NON-ALCOHOLIC STEATOHEPATITIS

OBJECTIVES: Non-alcoholic steatohepatitis (NASH) is an advanced stage of nonalcoholic fatty liver disease (NAFLD). It can lead to the development of cirrhosis, end-stage liver disease, and complications like hepatocellular carcinoma. This literature review was undertaken to understand the quality-of-life (QOL) burden of NASH. METHODS: We searched electronic databases (MEDLINE, EMBASE, CDSR, CENTRAL, DARE, HTA) for manuscripts on QOL and NASH published in the last 10 years as well as recent abstracts from ISPOR, ISOQOL and major liver congresses. Results were assessed by two independent reviewers and key QOL data extracted. RESULTS: Of 567 de-duplicated references identified, 20 manuscripts remained after review of titles/abstracts and five after full-text review; two additional manuscripts were identified through grey searching, there was one relevant congress abstract. Of the eight included studies, there were five quantitative studies, two clinical trials (herbal medical treatment, YHK and placebo; pioglitazone, vitamin E, and placebo) and one qualitative study. In the quantitative studies QOL was diminished in patients with NASH compared with an age- and sex-matched US population, and compared to those without NASH (SF-36 PCS), but not compared with other chronic liver disease. NAFLD patients with cirrhosis had lower QOL than non-cirrhotic patients. In patients with weight loss, a larger magnitude of QOL improvement was reported in those with NASH versus those without NASH. Neither clinical trial showed a significant QOL change from baseline. A conceptual framework to measure NASH-specific symptoms and impacts was developed in the qualitative study to help guide the development of a patient-reported outcome measure for NASH. CONCLUSIONS: NASH negatively impacts QOL, primarily impacting physical functioning and fatigue. However, the evidence base is limited; further studies are needed to understand the longitudinal QOL burden of NASH in different patient populations. There is a need to quantify the impact of future therapies on QOL.