Abstract
In a prospective study of the risk factors for duodenal ulcer relapse during maintenance (150 mg daily) ranitidine therapy, 1899 patients with chronic ulcer disease were recruited to a multicenter, German trial. Healing of all ulcers was confirmed endoscopically; endoscopy was also obligatory after one and two years or if the patients presented in the interim with symptoms of ulcer relapse. By the end of the first year, 247 patients had experienced at least one relapse and, by the end of the second year, 432 patients had relapsed at least once. The crude one- and two-year relapse rates were 13.0% (95% CI 11.5–14.5) and 22.7% (20.9–24.6%), respectively. Univariate analysis indicated that all seven prospectively defined risk factors were associated with an increased two-year relapse rate; of these, duodenal erosions distant from the healed ulcer [odds ratio (95% CI): 2.23 (1.59–3.15);P<0.0001], smoking, past or present [1.46 (1.12–1.90);P=0.0050], psychological stress [1.38 (1.09–1.74);P=0.0085], heavy physical labor [1.45 (1.06–1.98);P=0.0219], and absence of NSAID intake [1.54 (1.01–2.29);P=0.0464] were independent risk factors on stepwise logistic regression analysis, whereas persistent symptoms at healing [1.29 (1.03–1.62),P=0.0310] and frequent prior relapses [1.45 (1.01–2.04);P=0.0454] were not. Multiple relapses in 107 patients [5.63% (4.60–6.67%)] were associated with duodenal erosions, smoking, stress, and heavy physical labor. The effects of the five independent risk factors were cumulative: two-year relapse rates increased from 15.7% (95% CI 11.3–20.0%) in the presence of no or one risk factors to 40.9% (26.0–55.7%) in the presence of four or five risk factors.
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Isenberg JI, McQuaid KR, Laine L, Rubin W: Acid peptic disorders.In Textbook of Gastroenterology, Vol 1. T Yamada (ed). Philadelphia, Lippincott, 1991, pp 1241–1352
Soll AH: Duodenal ulcer and drug therapy.In Gastrointestinal Disease: Pathophysiology, Diagnosis and Management, 4th ed. MH Sleisenger, JS Fordtran (eds). Philadelphia, WB Saunders, 1989, pp 814–879
Colin-Jones DG: Medical treatment of peptic ulcer.In Disease of the Gut and Pancreas. JJ Misiewicz, RE Pounder, CW Venables (eds). Oxford, Blackwell Scientific, 1987, pp 288–315
Thomson ABR, Mahachai V: Medical management of uncomplicated peptic ulcer disease.In Bockus Gastroenterology, 4th ed. JE Berk, WS Haubrich, MH Kalser, JLA Roth, F Schaffner (eds). Philadelphia, WB Saunders, 1985, pp 1116–1154
Shearman DJC, Finlayson NDC, Carter DC: Peptic ulceration.In Diseases of the Gastrointestinal Tract and Liver, 2nd ed. Edinburgh, Churchill Livingstone, 1989, pp 201–254
McGuigan JE: Peptic ulcer and gastritis.In Harrison's Principles of Internal Medicine, 12th ed. JD Wilson, E Braunwald, KJ Isselbacher, RG Petersdorf, JB Martin, AS Fauci, RT Rook (eds). New York, McGraw-Hill, 1991, pp 1229–1251
Peterson WL: Peptic ulcer: medical therapy.In Cecil Textbook of Medicine, 19th ed. JB Wyngaarden, H Smith, JC Bennett (eds). Philadelphia, WB Saunders, 1992, pp 658–660
Lam SK, Hui WM, Lau WY, Branicki FJ, Lai CL, Lok ASF, Ng MMT, Fok PJ, Poon GP, Choi TK: Sucralfate overcomes adverse effect of cigarette smoking on duodenal ulcer healing and prolongs subsequent remission. Gastroenterology 92:1193–1201, 1987
Armstrong D, Blum AL, Arnold R, Classen M, Fischer M, Goebell H and the RUDER Study Group: RUDER—a prospective multicentre study of risk factors associated with delayed healing of recurrent duodenal ulcers. Gut 34:1319–1326, 1993
Bardhan KD: Six years of continuous cimetidine treatment in peptic ulcer disease: Efficacy and safety. Aliment Pharmacol Ther 2:395–405, 1988
Blasi A, Magiameli A, Castelli G, Girelli M, Familiari L, Ferrau O, Ferrari L, Mignemi G, Gatto G, Pagliaro L, Micalizzi A, Romano S: Long-term (24-month) ranitidine in prevention of duodenal ulcer relapse: comparison of continuous and seasonal treatment. Ital J Gastroenterol 19:141–144, 1987
Bresci G, Capria A, Federici G, Rindi G, Geloni M: Prevention of relapse with various anti-ulcer drugs. Scand J Gastroenterol 21(suppl 121):58–62, 1986
Hameeteman W, Tytgat GNJ, Wiersinga W, v d Boomgard DM, Dees J: A four year study of cimetidine maintenance treatment in peptic ulcer disease. Neth J Med 29:29, 1986 (abstract)
Van Deventer GM, Elashoff JD, Reedy TJ, Scheidman D, Walsh JH: A randomised study of maintenance therapy with ranitidine to prevent recurrence of duodenal ulcer. N Engl J Med 320:1113–1119, 1989
Walan A, Bianchi Porro G, Hentschel E, Bardhan KD, Delattre M: Maintenance treatment with cimetidine in peptic ulcer disease for up to 4 years. Scand J Gastroenterol 22:397–405, 1987
Mehta CR, Patel NR: A network algorithm for performing Fisher's exact test in r × c contingency tables. J Am Stat Assoc 78:427–434, 1983
Gardner MJ, Altman DG: Statistics with Confidence. London, British Medical Journal, 1989, pp 64–70
Fleiss JL: Statistical Methods for Rates and Proportions, 2nd ed. Chichester, Wiley, 1982, pp 56–82
Nasiry RW, McIntosh JH, Byth K, Piper DW: Prognosis of chronic duodenal ulcer: A prospective study of the effects of demographic and environmental factors and ulcer healing. Gut 28:533–540, 1987
Sonnenberg A, Müller-Lissner SA, Vogel E, Schmid P, Gonvers JJ, Peter P, Strohmeyer G, Blum AL: Predictors of duodenal ulcer healing and relapse. Gastroenterology 81:1061–1067, 1981
Sontag S, Graham DY, Belsito A, Weiss J, Farley A, Grunt R, Cohen N, Kinnear D, Davis W, Archambault A, Achord J, Thayer W, Gillies R, Sidorov J, Sabesin SM, Dyck W, Fleshler B, Cleator I, Wenger J, Opekun A Jr: Cimetidine, cigarette smoking and recurrence of duodenal ulcer. N Engl J Med 311:689–693, 1984
Bertschinger P, Lacher G, Aenishänslin W, Baerlocher C, Bernouilli R, Egger G, Eisner M, Fasel J, Fehr HR, Fumagalli I, Gassmann R, Gueller R, Kobler E, Leuthold E, Nuesch HJ, Pace F, Pelloni S, Plancherel P, Realini S, Seiler P, Stocker H, Vetter D, Schmid P, Simonian B, Vogel E, Blum AL: Presenting characteristics of patients with duodenal ulcer and outcome of medical treatment in controlled clinical trials using cimetidine and diethylamine persilate to treat ulcer attack and diethylamine persilate and placebo to prevent relapses. Digestion 36:148–161, 1987
Mason JB, Moshal MG, Naidoo V, Schlemmer L: The effect of stressful life situations on the healing of duodenal ulceration. S Afr Med J 60:734–737, 1981
Classen M, Bethge H, Brunner G, Dirr B, Gabor M, Gail H, Grabner R, Hagenmueller F, Heinkel K, Kaess H, Kerstan E, Kuntzen O, Maier K, Meiderer S, Reichel W, Reissigl H, Schwamberger K, Seifert E, Thaler H, Weiss W, Woerdehoff D, Wotzka R: Effect of sucralfate on peptic ulcer recurrence: a controlled, double-blind, multicentre study. Scand J Gastroenterol 83:61–68, 1983
Tandon RK, Tsapogas MJ: Bleeding peptic ulcer. NY State Med J 35–38, 1975
Sonnenberg A: Dietary salt and gastric ulcer. Gut 27:1138–1142, 1986
Kerrigan DD, Read NW, Houghton LA, Taylor ME, Johnson AG: Disturbed gastroduodenal motility in patients with active and healed duodenal ulceration. Gastroenterology 100:892–900, 1991
Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, Phillips M, Waters TE, Sanderson CR: Prospective, double-blind trial of duodenal ulcer relapse after eradication ofCampylobacter pylori. Lancet 2:1437–1441, 1988
Blum AL, Armstrong D, Dammann H, Fischer M, Greiner L, Haase W, Hoogeboom-Verdegal A, Liszkay M, Stolte M, Sulster M, Simon B and the Talcicamp Study Group: The effect ofHelicobacter pylori on the healing and relapse of duodenal ulcer. Gastroenterology 98:A22, 1990 (Abstract)
Armstrong D, Blum AL, Dammann H, Fischer M, Greiner L, Haase W, Liszkay M, Stolte M, Sulser M, Simon B and the Talcicamp Study Group: Persistent gastritis after ranitidine or antacid therapy predicts relapse of duodenal ulceration. Gut 32:A595, 1991 (Abstract)
Boyd EJS, Wilson JA, Wormsley KG: Smoking impairs therapeutic gastric inhibition. Lancet 1:95–97, 1983
Schachter S: Pharmacological and psychological determinants of smoking. Ann Intern Med 88:104–114, 1978
Peters MN, Richardson CT: Stressful life events, acid hypersecretion and ulcer disease. Gastroenterology 84:114–119, 1983
Holtmann G, Armstrong D, Pöppel E, Bauerfeind A, Goebell H, Arnold R, Classen M, Witzel L, Fischer M, Heinisch M, Blum AL and Members of the RUDER Study Group: Influence of stress on the healing and relapse of duodenal ulcers. A prospective, multicenter trial of 2109 patients with recurrent duodenal ulceration treated with ranitidine. Scand J Gastroenterol 27:917–923, 1992
Markiewicz K, Cholewa M, Lukin M: Gastric basal secretion during exercise and restitution in patients with chronic duodenal ulcer. Acta Hepato-Gastroenterol 26:160–165, 1979
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Armstrong, D., Arnold, R., Classen, M. et al. RUDER—A prospective, two-year, multicenter study of risk factors for duodenal ulcer relapse during maintenance therapy with ranitidine. Digest Dis Sci 39, 1425–1433 (1994). https://doi.org/10.1007/BF02088044
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DOI: https://doi.org/10.1007/BF02088044