Published online Aug 27, 2020. doi: 10.4254/wjh.v12.i8.506
Peer-review started: April 13, 2020
First decision: April 29, 2020
Revised: July 9, 2020
Accepted: July 26, 2020
Article in press: July 26, 2020
Published online: August 27, 2020
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.
To analyze the inclusion of racial and ethnic minority groups in clinical trials for NAFLD.
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.
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, I2 94.6%) among studies documenting Hispanic enrollment. Hispanic enrollment increased over time from 15% from 2005-2014 to 37% from 2015-2019.
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.
Core tip: The Hispanic population in the United States is disproportionately affected by non-alcoholic fatty liver disease (NAFLD). Currently, there is no Food and Drug Administration approved treatment for this disease, but several clinical trials are investigating new potential therapies. This study evaluates the inclusion of race and ethnicity in the enrollment of these trials. In a systemic review and meta-analysis of clinical trials for treatment of NAFLD, 44% of eligible trials reported data on race and ethnicity. Despite a high burden of disease, Hispanic participation remained low. Future targeted interventions must take place to increase the enrollment of diverse and representative study populations in clinical trials.