LONG-TERM TREATMENT OF ALCOHOLIC LIVER-DISEASE WITH PROPYLTHIOURACIL .2. INFLUENCE OF DROP-OUT RATES AND OF CONTINUED ALCOHOL-CONSUMPTION IN A CLINICAL-TRIAL

Although propylthiouracil has previously been shown to reduce the risk of mortality in alcoholic liver disease by 60%, generalized use of pr opylthiouracil for this condition has not occurred. Additional data ar e therefore presented on four aspects to provide a better assessment o f its therapeutic effectiveness. First, the characteristics and the pr ognosis of dropouts were virtually identical in both the drug and plac ebo groups. Also the methodology and analysis employed were designed t o control for dropouts, thus providing an accurate interpretation of t he outcome. Secondly, since 97% of the patients continued to drink, ab stinence was not a precondition for the beneficial effect of propylthi ouracil. However, the beneficial effect was observed most clearly in t hose patients who continued to drink at lower levels, whereas lower le vel drinking per se did not afford protection in placebo patients. Thi rdly, serious side effects or clinical hypothyroidism occurred extreme ly rarely in these patients, many of whom have now received propylthio uracil for over 4 years. Fourthly, we discuss why the outcome in long- term clinical trials in alcoholic liver disease cannot be compared wit h effects observed in clinical trials lasting only a few weeks. (C) Jo urnal of Hepatology.