Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Aug 27;12(8):506-518.
doi: 10.4254/wjh.v12.i8.506.

Racial disparities in nonalcoholic fatty liver disease clinical trial enrollment: A systematic review and meta-analysis

Parita Patel  1 , Charles Muller  1 , Sonali Paul  2
Affiliations

Racial disparities in nonalcoholic fatty liver disease clinical trial enrollment: A systematic review and meta-analysis

Parita Patel et al. World J Hepatol. .

Abstract

Background: Non-alcoholic fatty liver disease (NAFLD) has a heterogeneous distribution across racial and ethnic groups, with a disproportionate burden among Hispanics. Although there are currently no approved therapies for treatment of NAFLD, several therapies have been investigated in clinical trials.

Aim: To analyze the inclusion of racial and ethnic minority groups in clinical trials for NAFLD.

Methods: We performed a systematic review of North American, English-language, prospective studies for NAFLD therapies published from 2005 to 2019. Racial and ethnic enrollment data were recorded for each eligible study. Meta-analysis was performed to compute pooled prevalence of different racial and ethnic groups, followed by further subgroup analyses. These analyses were based on diagnosis of non-alcoholic steatohepatitis (NASH) and timing of study on enrollment by ethnicity. Descriptive statistics were performed to compare racial and ethnic study enrollment to previously reported NAFLD population prevalence.

Results: Thirty-eight studies met criteria for inclusion in the systematic review. When reported, median age of enrolled subjects was 49 years (range 41.5-58) with 56% female participants. NAFLD was defined through biopsy findings in 79% (n = 30) of the studies. Of the included articles, treatment modalities ranged from medications (n = 28, 74%), lifestyle interventions (n = 5, 13%), bariatric surgery (n = 4, 11%) and phlebotomy (n = 1, 2%). Twenty-eight studies (73%) included racial and/or ethnic demographic information, while only 17 (45%) included information regarding Hispanic participation. Of the 2983 patients enrolled in all eligible trials, a total of only 346 (11.6%) Hispanic participants was reported. Meta-analysis revealed a pooled Hispanic prevalence of 24.3% (95% confidence interval 16.6-32.0, I 2 94.6%) among studies documenting Hispanic enrollment. Hispanic enrollment increased over time from 15% from 2005-2014 to 37% from 2015-2019.

Conclusion: In a meta-analysis of NAFLD trials, documentation of racial/ethnic demographic data occurred in less than half of studies. Standardization of reporting of race/ethnicity and targeted interventions toward minority recruitment are needed to improve diversity of enrollment.

Keywords: Hispanic; Meta-analysis; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; Racial disparities.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Summary of review process of all PubMed articles using search terms.
Figure 2
Figure 2
Pooled prevalence of Hispanic patients among studies reporting ethnicity.
Figure 3
Figure 3
Percentage of Hispanic enrollment in trials. A: Percentage of Hispanic enrollment in trials; B: Percentage of Hispanic enrollment in trials grouped by year.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64:73–84. - PubMed
    1. Charlton MR, Burns JM, Pedersen RA, Watt KD, Heimbach JK, Dierkhising RA. Frequency and outcomes of liver transplantation for nonalcoholic steatohepatitis in the United States. Gastroenterology. 2011;141:1249–1253. - PubMed
    1. Rich NE, Oji S, Mufti AR, Browning JD, Parikh ND, Odewole M, Mayo H, Singal AG. Racial and Ethnic Disparities in Nonalcoholic Fatty Liver Disease Prevalence, Severity, and Outcomes in the United States: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018;16:198–210.e2. - PMC - PubMed
    1. Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008;40:1461–1465. - PMC - PubMed
    1. US Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiologic Health. Collection of Race and Ethnicity Data in Clinical Trials. [cited 2018 December 1]. In Food and Drug Administration 2005. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents....