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Prevention of variceal bleeding with band ligation
HEPATOLOGY Vol. 26, No. 6, 1997
CORRESPONDENCE
TJ. Rapid HCV clearance with high induction interferon (IFN) doses is important for sustained response [Abstract]. Gastroenterology 1997; 112(suppl 4):1312A.
1693
4. Perelson AS, Essunger P, Cao Y, Vesanen M, Hurley A, Saksela K, Markowitz M, et al. Decay characteristics of HIV-1 infected compartments during combination therapy. Nature 1997;387:188-191.
Prevention of Variceal Bleeding With Band Ligation To the Editor: We read with interest the recent paper by Lay et al.1 The authors should be congratulated for having been able to select a group of patients with an extremely high risk of first bleeding by means of Beppu’s2 score. This, however, contrasts with the prospective validation of Beppu’s score that we made in the North-Italian Endoscopic Club study,3 because in that study patients with a Beppu’s score of 00.38 or lower had a 2-year incidence of bleeding of 41%, which is much lower than the figure of 60% reported by Lay et al. Moreover, in our series, patients with such values of Beppu’s score represented only 15% of the whole series, as compared with 30% in the series presented by Lay et al. As it has been shown that the higher the bleeding rate in the control group, the higher will be the efficacy of prophylactic treatment,4 it is not surprising that variceal band ligation was also very effective in preventing first bleeding in the study by Lay et al. In such conditions, endoscopic sclerotherapy was also very effective.5 However, the possibility exists for banding, as it does for sclerotherapy, that further studies might be less fortunate in selecting very-high-risk patients. Under such circumstances, the value of band ligation remains to be established. Another important point concerns the handling of patients in the control group. In the study by Lay et al., such patients ‘were randomly allocated . . . to the control group’. The only other information that we have about the follow-up of these patients is in the Results section, where the authors state, ‘‘the follow-up was indeed different in the two groups’’ and then continue, ‘‘the follow-up, including endoscopic treatment (?) had been the same . . .’’. It is not clear how many endoscopies were carried out in the control patients and in patients in the active treatment group. Even more importantly, it has now been confirmed that medical therapy with non-selective beta-blockers is very effective in preventing the first variceal bleed in cirrhotics.4 In one meta-analysis6 beta-blockers were also shown to reduce bleeding-related mortality. Accordingly, three International Consensus Conferences,7-8 including the recent AASLD Single Topic Symposium on Portal Hypertension and Variceal Bleeding (Reston, VA, June 23-24,1996) concluded that beta-blockers are the first choice treatment in the prevention of first bleeding in cirrhosis. In view of this, the ethical appropriateness of comparing a new treatment, such as banding, with ‘no treatment’ is highly
AID
Hepa 0029
/
5p2a$$1041
11-21-97 11:20:20
questionable. A comparison between banding and beta-blockers would have been mandatory. The authors do state in the discussion that, although they had considered using betablockers in the control patients, ‘‘they did not have enough patients to proceed with such a study’’. This is hardly a justification. The authors do not indicate how they calculated the sample size of the study, and, therefore, we do not know the ‘a priori’ hypothesis they made about the rate of bleeding in the control group and the expected therapeutic gain in the banding group. Even if they had admitted that such calculation had been made and if they had shown that a number of patients larger than that available to the authors was needed to appropriately compare banding with beta-blockers, this would not constitute an ethical justification for the authors to perform a study comparing banding to nothing. Instead, a multicenter design should have been considered to collect enough patients to perform the appropriate study, i.e., a comparison between banding and beta-blockers. ROBERTO DE FRANCHIS, M.D. MASSIMO PRIMIGNANI, M.D. Gastroenterology and Gastrointestinal Endoscopy Service Institute of Internal Medicine University of Milan Milan, Italy REFERENCES 1. Lay CS, Tsai YT, Teg CY, et al. Endoscopic variceal ligation in prophylaxis of first variceal bleeding in cirrhotic patients with high-risk esophageal patients. HEPATOLOGY 1997;25:1346-1350. 2. Beppu K, Inokuch K, Koyanagi N, et al. Prediction of variceal hemorrhage by esophageal endoscopy. Gastro Endoscopy 1981;27:213-218. 3. North Italian Endoscopic Club for the study and treatment of esophageal varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. N Engl J Med 1988;319:983-989. 4. Pagliaro L, D’Amico G, Soerensen TIA, et al. Prevention of first bleeding in cirrhosis. A meta-analysis of randomized clinical trials of nonsurgical treatment. Ann Intern Med 1992;117:59-70. 5. Paquet KJ. Prophylactic endoscopic sclerosing treatment of the esophageal wall in varices: a prospective controlled randomized trial. Endoscopy 1982;14:4-5. 6. Poynard T, Cale`s P, Pasta L, et al. b-adrenergic-antagonists in the prevention of first gastrointestinal bleeding in patients with cirrhosis and esophageal varices. An analysis of data and prognostic factors in 589 patients from four randomized clinical trials. N Eng J Med 1991;324:1532-1538. 7. de Franchis R, Pascal JP, Ancona E, et al. Definitions, methodology and therapeutic strategies in Portal Hypertension. A consensus development workshop. J Hepatol 1992;15:256-261. 8. de Franchis R. Developing consensus in Portal Hypertension. J Hepatol 1996;25:390-394
hepas
WBS: Hepatology
CORRESPONDENCE
TJ. Rapid HCV clearance with high induction interferon (IFN) doses is important for sustained response [Abstract]. Gastroenterology 1997; 112(suppl 4):1312A.
1693
4. Perelson AS, Essunger P, Cao Y, Vesanen M, Hurley A, Saksela K, Markowitz M, et al. Decay characteristics of HIV-1 infected compartments during combination therapy. Nature 1997;387:188-191.
Prevention of Variceal Bleeding With Band Ligation To the Editor: We read with interest the recent paper by Lay et al.1 The authors should be congratulated for having been able to select a group of patients with an extremely high risk of first bleeding by means of Beppu’s2 score. This, however, contrasts with the prospective validation of Beppu’s score that we made in the North-Italian Endoscopic Club study,3 because in that study patients with a Beppu’s score of 00.38 or lower had a 2-year incidence of bleeding of 41%, which is much lower than the figure of 60% reported by Lay et al. Moreover, in our series, patients with such values of Beppu’s score represented only 15% of the whole series, as compared with 30% in the series presented by Lay et al. As it has been shown that the higher the bleeding rate in the control group, the higher will be the efficacy of prophylactic treatment,4 it is not surprising that variceal band ligation was also very effective in preventing first bleeding in the study by Lay et al. In such conditions, endoscopic sclerotherapy was also very effective.5 However, the possibility exists for banding, as it does for sclerotherapy, that further studies might be less fortunate in selecting very-high-risk patients. Under such circumstances, the value of band ligation remains to be established. Another important point concerns the handling of patients in the control group. In the study by Lay et al., such patients ‘were randomly allocated . . . to the control group’. The only other information that we have about the follow-up of these patients is in the Results section, where the authors state, ‘‘the follow-up was indeed different in the two groups’’ and then continue, ‘‘the follow-up, including endoscopic treatment (?) had been the same . . .’’. It is not clear how many endoscopies were carried out in the control patients and in patients in the active treatment group. Even more importantly, it has now been confirmed that medical therapy with non-selective beta-blockers is very effective in preventing the first variceal bleed in cirrhotics.4 In one meta-analysis6 beta-blockers were also shown to reduce bleeding-related mortality. Accordingly, three International Consensus Conferences,7-8 including the recent AASLD Single Topic Symposium on Portal Hypertension and Variceal Bleeding (Reston, VA, June 23-24,1996) concluded that beta-blockers are the first choice treatment in the prevention of first bleeding in cirrhosis. In view of this, the ethical appropriateness of comparing a new treatment, such as banding, with ‘no treatment’ is highly
AID
Hepa 0029
/
5p2a$$1041
11-21-97 11:20:20
questionable. A comparison between banding and beta-blockers would have been mandatory. The authors do state in the discussion that, although they had considered using betablockers in the control patients, ‘‘they did not have enough patients to proceed with such a study’’. This is hardly a justification. The authors do not indicate how they calculated the sample size of the study, and, therefore, we do not know the ‘a priori’ hypothesis they made about the rate of bleeding in the control group and the expected therapeutic gain in the banding group. Even if they had admitted that such calculation had been made and if they had shown that a number of patients larger than that available to the authors was needed to appropriately compare banding with beta-blockers, this would not constitute an ethical justification for the authors to perform a study comparing banding to nothing. Instead, a multicenter design should have been considered to collect enough patients to perform the appropriate study, i.e., a comparison between banding and beta-blockers. ROBERTO DE FRANCHIS, M.D. MASSIMO PRIMIGNANI, M.D. Gastroenterology and Gastrointestinal Endoscopy Service Institute of Internal Medicine University of Milan Milan, Italy REFERENCES 1. Lay CS, Tsai YT, Teg CY, et al. Endoscopic variceal ligation in prophylaxis of first variceal bleeding in cirrhotic patients with high-risk esophageal patients. HEPATOLOGY 1997;25:1346-1350. 2. Beppu K, Inokuch K, Koyanagi N, et al. Prediction of variceal hemorrhage by esophageal endoscopy. Gastro Endoscopy 1981;27:213-218. 3. North Italian Endoscopic Club for the study and treatment of esophageal varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. N Engl J Med 1988;319:983-989. 4. Pagliaro L, D’Amico G, Soerensen TIA, et al. Prevention of first bleeding in cirrhosis. A meta-analysis of randomized clinical trials of nonsurgical treatment. Ann Intern Med 1992;117:59-70. 5. Paquet KJ. Prophylactic endoscopic sclerosing treatment of the esophageal wall in varices: a prospective controlled randomized trial. Endoscopy 1982;14:4-5. 6. Poynard T, Cale`s P, Pasta L, et al. b-adrenergic-antagonists in the prevention of first gastrointestinal bleeding in patients with cirrhosis and esophageal varices. An analysis of data and prognostic factors in 589 patients from four randomized clinical trials. N Eng J Med 1991;324:1532-1538. 7. de Franchis R, Pascal JP, Ancona E, et al. Definitions, methodology and therapeutic strategies in Portal Hypertension. A consensus development workshop. J Hepatol 1992;15:256-261. 8. de Franchis R. Developing consensus in Portal Hypertension. J Hepatol 1996;25:390-394
hepas
WBS: Hepatology