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• W2043674601 abstract "We have read with interest the article by Hartigan et al.1Hartigan PM Gebhard RL Gregory PB Sclerotherapy for actively bleeding esophageal varices in male alcoholics with cirrhosis.Gastrointest Endosc. 1997; 46: 1-7Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar regarding the value of emergency injection sclerotherapy in actively bleeding esophageal varices. We agree with the authors that endoscopic sclerotherapy is an effective tool to control overt bleeding from esophageal varices. This assertion is based not only on the results of the present study, but also on those of meta-analysis of randomized trials on the same topic.2Laine L Cook D Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding. A meta-analysis.Ann Intern Med. 1995; 123: 280-287Crossref PubMed Scopus (626) Google Scholar, 3D'Amico G Pagliaro L Bosch J The treatment of portal hypertension: a meta-analytic review.Hepatology. 1995; 22: 332-354Crossref PubMed Google Scholar Several issues can be raised from the reading of this sham-controlled study. The study population consists of 49 patients whose varices were actively bleeding at the time of endoscopy and who belong to a group of 253 cirrhotic patients who were dealt with in previous articles by the authors. A more thorough description of the term “active bleeding” would have been advisable. In addition to spurting or oozing of blood from the varix, does this expression encompass the presence of fresh blood within the gastric cavity? Other endpoints of the study are also not clearly defined. The authors do not fix the limits of the time frame to make a distinction between the acute episode of bleeding and early recurrence of bleeding. According to the guidelines set at a consensus meeting held in Baveno in 1994, the acute bleeding episode was represented by an interval of 48 hours from time zero with no evidence of clinically significant bleeding between 24 and 48 hours.4Burroughs AK Alexandrino P Calés P Fleig W Grace N Minoli G et al.Sore points.in: Proceedings of the Second Baveno International WorkshopPortal hypertension II. Blackwell Science Ltd, Oxford1996: 10-17Google Scholar Recurrent bleeding was defined as any further manifestation of hemorrhage after achieving a 24-hour period of hemostasis.4Burroughs AK Alexandrino P Calés P Fleig W Grace N Minoli G et al.Sore points.in: Proceedings of the Second Baveno International WorkshopPortal hypertension II. Blackwell Science Ltd, Oxford1996: 10-17Google Scholar The distinction is not meaningful because some episodes of recurrent bleeding could in fact represent a lack of control of the index episode. This consideration is particularly important when evaluating a hemostatic method such as injection sclerosis, which is considered to be effective in arresting acute bleeding and in avoiding early recurrence of bleeding. Another point that should be taken into account is the specific design of the study, which compares sclerosis with non-active treatment as the control arm. We agree with Dr. Laine that the study was designed and started a decade ago,5Laine L Management of actively bleeding esophageal varices.Gastrointest Endosc. 1997; 46: 83-84Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar and since then endoscopic and non-endoscopic treatment of portal hypertension has rapidly evolved. Meta-analysis of randomized controlled trials indicates that vasoactive drugs, specifically terlipressin and somatostatin, are highly effective in arresting acute bleeding and in preventing early recurrence of bleeding.3D'Amico G Pagliaro L Bosch J The treatment of portal hypertension: a meta-analytic review.Hepatology. 1995; 22: 332-354Crossref PubMed Google Scholar The most recent study comparing terlipressin and somatostatin shows a similar rate of success for the 2 drugs (80% and 84%, respectively) in halting the acute bleeding episode.6Feu F Ruiz del Arbol L Bañares R Planas R Bosch J et al.Double-blind randomized controlled trial comparing terlipressin and somatostatin for acute variceal hemorrhage.Gastroenterology. 1996; 111: 1291-1299Abstract Full Text Full Text PDF PubMed Scopus (143) Google Scholar Moreover, the effectiveness of continuous administration of either of these drugs during the 5-day, high-risk period that follows hemostasis in preventing the early recurrence of bleeding is similar to that of emergency sclerotherapy.3D'Amico G Pagliaro L Bosch J The treatment of portal hypertension: a meta-analytic review.Hepatology. 1995; 22: 332-354Crossref PubMed Google Scholar, 7Variceal Bleeding Study Group Randomized controlled trial of sclerotherapy versus somatostatin infusion in the prevention of early rebleeding following variceal hemorrhage in patients with cirrhosis.Hepatology. 1993; 18 ([abstract]): 140Google Scholar These studies indicate that vasoactive drugs are an effective, safe therapy for variceal hemorrhage in cirrhotic patients, that can be used as first-line treatment. Moreover, it is accepted that placebo-controlled studies should not be undertaken when a “proved” method of therapy exists.8Rothman KJ Michels KB The continuing unethical use of placebo controls.N Engl J Med. 1994; 331: 394-398Crossref PubMed Scopus (564) Google Scholar Therefore, in the light of current knowledge, use of non-active treatment as a control without administering an accepted backup therapy is probably not acceptable in future studies to evaluate new therapies in acute variceal bleeding. A further aspect that would be worthwhile to emphasize is the incidence of local side effects in the sclerotherapy group. The authors state that injection sclerotherapy can be performed safely, inasmuch as no significant nonulcer complications were seen. However, bleeding caused by sclerosis-induced ulcerations should be considered a major drawback of this procedure, probably the most frequent serious side effect, being present in up to 20% of patients.9Shuman BM Berkman JW Tedesco FJ Griffin JW Assad RT Complications of endoscopic injection sclerotherapy: a review.Am J Gastroenterol. 1987; 82: 823-829PubMed Google Scholar In the present study, esophageal ulcers were the confirmed source of recurrent bleeding in 6, and probably also in another 3, of the 14 patients that had recurrent bleeding. The authors do not mention the course of these episodes of hemorrhage, which is usually severe. Furthermore, complications of therapeutic endoscopy are closely related to operator expertise, and in the specific setting of acute variceal bleeding it is often difficult to have an experienced endoscopist available on a 24-hour basis. Thus, it is conceivable that the overall rate of complications of emergency sclerotherapy may be even higher in general practice than that reported in clinical trials. As pointed out by Dr. Laine, ligation has the potential to reduce the incidence of some of these complications.5 Vasoactive drugs, such as terlipressin and somato-statin, have the advantages of safety, ease of use in the emergency setting (even before endoscopy), and the possibility of continuing administration for several days with the potential to reduce the chance of early resumption of bleeding. Whether pharmacologic and endoscopic therapy have a synergistic effect in achieving hemostasis of the ruptured varix is the aim of current investigations." @default.
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• W2043674601 title "Sclerotherapy in acute variceal bleeding" @default.
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