I. Veterans Affairs Cooperative Study of Polyenylphosphatidylcholine in Alcoholic Liver Disease: Effects on Drinking Behavior by Nurse/Physician Teams

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Abstract
Background: This multicenter prospective, randomized, double‐blind placebo‐controlled trial was designed to evaluate the effectiveness of polyenylphosphatidylcholine against the progression of liver fibrosis toward cirrhosis in alcoholics. Seven hundred eighty‐nine alcoholics with an average intake of 16 drinks per day were enrolled. To control excessive drinking, patients were referred to a standard 12‐step–based alcoholism treatment program, but most patients refused to attend. Accordingly, study follow‐up procedures incorporated the essential features of the brief‐intervention approach. An overall substantial and sustained reduction in drinking was observed. Hepatic histological and other findings are described in a companion article. Methods: Patients were randomized to receive daily three tablets of either polyenylphosphatidylcholine or placebo. Monthly follow‐up visits included an extensive session with a medical nurse along with brief visits with a study physician (hepatologist or gastroenterologist). A detailed physical examination occurred every 6 months. In addition, telephone consultations with the nurse were readily available. All patients had a liver biopsy before entry; a repeat biopsy was scheduled at 24 and 48 months. Results: There was a striking decrease in average daily alcohol intake to approximately 2.5 drinks per day. This was sustained over the course of the trial, lasting from 2 to 6 years. The effect was similar both in early dropouts and long‐term patients, i.e., those with a 24‐month biopsy or beyond. Conclusions: In a treatment trial of alcoholic liver fibrosis, a striking reduction in alcohol consumption from 16 to 2.5 daily drinks was achieved with a brief‐intervention approach, which consisted of a relative economy of therapeutic efforts that relied mainly on treatment sessions with a medical nurse accompanied by shorter reinforcing visits with a physician. This approach deserves generalization to address the heavy drinking problems commonly encountered in primary care and medical specialty practices.