BACKGROUND:Sclerotherapy is an effective treatment for bleeding esophageal varices in patients with alcoholic liver disease. It has also been suggested that sclerotherapy might be effective in preventing initial episodes of bleeding and improving survival among such patients. METHODS: We conducted a prospective, randomized trial comparing prophylactic sclerotherapy and sham therapy in 281 men with alcoholic liver disease who had at least three variceal channels and no history of variceal bleeding. All the patients underwent endoscopy; 143 received sclerotherapy, and 138 received sham therapy. 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: For unknown reasons, prophylactic sclerotherapy is associated with increased mortality among men with moderate-to-severe alcoholic liver disease and esophageal varices. Sclerotherapy should not be performed until after an initial episode of bleeding from esophageal varices has occurred.
RCT Entities:
BACKGROUND: Sclerotherapy is an effective treatment for bleeding esophageal varices in patients with alcoholic liver disease. It has also been suggested that sclerotherapy might be effective in preventing initial episodes of bleeding and improving survival among such patients. METHODS: We conducted a prospective, randomized trial comparing prophylactic sclerotherapy and sham therapy in 281 men with alcoholic liver disease who had at least three variceal channels and no history of variceal bleeding. All the patients underwent endoscopy; 143 received sclerotherapy, and 138 received sham therapy. 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: For unknown reasons, prophylactic sclerotherapy is associated with increased mortality among men with moderate-to-severe alcoholic liver disease and esophageal varices. Sclerotherapy should not be performed until after an initial episode of bleeding from esophageal varices has occurred.