METHODS: RESULTS: The two patient groups were well matched at entry with respect to the extent of
liver disease and other clinical indexes, except that other medical illnesses were significantly more common in the
sclerotherapy group. The study's data-monitoring board terminated the trial 22.5 months after it began because the rate of mortality from all causes was significantly higher in the
sclerotherapy group (32.2 percent) than in the
sham-therapy group (17.4 percent, P = 0.004), despite the fact that the men who received
sclerotherapy had significantly fewer episodes of esophageal variceal
bleeding. The causes of death varied, and there is no obvious explanation for the excess mortality in the
sclerotherapy group. After the termination of treatment, the excess mortality rate in the
sclerotherapy group promptly declined. There were 53 episodes of upper gastrointestinal
bleeding (including 10 from
esophageal varices and 9 from esophageal
ulcers) in the
sclerotherapy group and 40 episodes (including 19 from
esophageal varices) in the
sham-therapy group. Complications of
sclerotherapy were frequent but seldom life-threatening.
CONCLUSIONS: