More clinical research is needed to investigate how reducing alcohol consumption in patients with alcohol-related liver disease (ALD) may slow disease progression and improve outcomes, according to an international task force of experts from more than two dozen institutions including UT Southwestern Medical Center.
In a consensus statement published in Nature Reviews, the group, commissioned by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), issued a set of 28 recommendations to guide the design of future clinical trials addressing alcohol use disorder (AUD) and ALD. The recommendations call for multidisciplinary teams, including experts from hepatology and addiction medicine, and the need to address the stigma of alcoholism.
The task force included hepatologists, addiction medicine specialists, clinical trialists, and members of regulatory agencies. Among its recommendations are definitions for disease categories, criteria for trial participants, treatment considerations, and safety and regulatory concerns.
The article notes that diseases related to alcohol use are among the most stigmatized, resulting in stereotypes that create barriers to treatment, such as ineligibility for liver transplantation. The group proposed that researchers discuss ways to reduce those negative beliefs among all team members in trials for AUD and ALD and, when possible, involve patient representatives and other stakeholders in trial design.