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Efficacy of misoprostol (twice daily dosage) in acute healing of duodenal ulcer

A multicenter double-blind controlled trial

  • Prostaglandins in Peptic Ulcer Disease
  • Clinical Efficacy of Misoprostol
  • Published:
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Abstract

This study was undertaken to evaluate the efficacy of misoprostol taken twice daily for the healing of duodenal ulcer. Three hundred thirty patients with endoscopically proven duodenal ulcer participated in a multicenter, double-blind, controlled trial comparing placebo with misoprostol 200 μg and 400 μg twice daily for up to four weeks. Patient characteristics were similar in all three treatment groups. Ulcers were between 0.3 cm and 2.0 cm in length. Healing was determined by endoscopy at two weeks; if ulcers were not healed, endoscopy was repeated at four weeks. All patients were given Al(OH)3 antacid (up to 54 meq a day) to be used as needed for pain. Healing rates at four weeks for a total of 280 evaluable patients in the three treatment groups were as follows: misoprostol 400 μg bid, 65.4%; misoprostol 200 μg bid, 52.9%; and placebo, 42.2%. Misoprostol 400 μg bid was superior to placebo (P=0.002) in healing ulcers. However, the healing rate for misoprostol 200 μg bid did not differ significantly from placebo. The percentage of nonsmokers who healed at four weeks was higher than that of smokers in both misoprostoltreatment groups, although the difference was not analyzed for statistical significance. There were no differences in antacid consumption or pain relief among the three experimental groups during the study. Diarrhea was the most common side effect but was mild and self-limiting, occurring in 8.9%, 5.9%, and 1.8% of the misoprostol 400 μg, 200 μg, and placebo groups, respectively. These results indicate that misoprostol 400 μg, 200 μg, and for four weeks is effective and safe for the treatment of duodenal ulcers.

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References

  1. Bright-Asare P, Whiten JT: Prostaglandins, gastroduodenal ulcer and hemorrhagic gastritis. Clin Physiol Biochem 2:101–110, 1984

    Google Scholar 

  2. Binder HJ, Cocco A, Crossley RJ, Finkelstein W, Font R, Friedman G, Groake J, Hughes W, Johnson AF, McGuigan JE, Summers R, Vlahcevic R, Wilson EC, Winship DH: Cimetidine in the treatment of duodenal ulcer: A multicenter double blind study. Gastroenterology 74:380–388, 1978

    Google Scholar 

  3. Dobrilla G, Barbara L, Bianchi Porro G, Felder M, Mazzacca G, Miglioli L, Pera A, Petrillo M, Sabbatini F, Verme G: Placebo controlled studies with ranitidine in duodenal ulcer. Scand J Gastroenterol 69(Suppl):101–107, 1981

    Google Scholar 

  4. Giannikopoulos JG, Lim PE, Bright-Asare P: Ranitidine and placebo in short-term treatment of duodenal ulcer—a double-blind randomized controlled trial. Gastroenterology 84:1165, 1983 (abstract)

    Google Scholar 

  5. Langman MJS, Henry DA, Bell GD, Burnham WR, Ogilvy A: Cimetidine and ranitidine in duodenal ulcer. Br Med J 281:473–474, 1980

    Google Scholar 

  6. Lam SK, Lam KC, Lai CL, Yeung CK, Yam LYC, Wong WS: Treatment of duodenal ulcer with antacid and sulpiride: A double-blind controlled study. Gastroenterology 76:315–322, 1979

    Google Scholar 

  7. Peterson WL, Sturdevant RAL, Frankl HD, Richardson CT, Isenberg JI, Elashoff JD, Sones JQ, Gross RA, McCallum RW, Fordtran JS: Healing of duodenal ulcer with an antacid regimen. N Engl J Med 297:341–345, 1977

    Google Scholar 

  8. McHardy GG: A multicenter, double blind trial of sucralfate and placebo in duodenal ulcer. J Clin Gastroenterol 3(Suppl): 147–152, 1981

    Google Scholar 

  9. Hollander D: Efficacy of sucralfate for duodenal ulcers: A multicenter, double-blind trial. J Clin Gastroenterol 3(Suppl): 153–157, 1981

    Google Scholar 

  10. Hinsdale JG, Engel JJ, Wilson DE: Prostaglandin E in peptic ulcer disease. Prostaglandins 6:495–600, 1974

    Google Scholar 

  11. Bright-Asare P, Kauffman GL: 16,16-Dimethyl prostaglandin E2 (dmPGE2) reduces 5-fluorouracil (5-FU) induced and mitomycin-induced gastric mucosal injury in dogs. Cancer 54(1):28–31, 1984

    Google Scholar 

  12. Robert A: Cytoprotection by prostaglandins. Gastroenterology 77:761–767, 1979

    Google Scholar 

  13. Dajani EZ, Driskill DR, Bianchi RG, Collins PW, Pappo R: SC-29333, a potent inhibitor of canine gastric secretion. Am J Dig Dis 21:1049–1057, 1976

    Google Scholar 

  14. Colton DG, Driskill DR, Phillips EL, Poy P, Dajani EZ: Effect of SC-29333, an inhibitor of gastric secretion, on canine gastric mucosal blood flow and serum gastrin levels. Arch Int Pharmacodyn Ther 236:86–95, 1978

    Google Scholar 

  15. Cohen MM, Clark L, Armstrong L, D'Souza J: Reduced aspirin-induced fecal blood loss with simultaneous administration of misoprostol (PGE methyl analogue). Gastroenterology 84:1127, 1983 (abstract)

    Google Scholar 

  16. Sontag SJ, Mazure PA, Pontes JF, Beker SG, Dajani EZ: Misoprostol in the treatment of duodenal ulcer: A multicenter, double-blind, placebo-controlled study. Dig Dis Sci 30(Suppl):159S-163S, 1985

    Google Scholar 

  17. Brand DL, Roufail WM, Thomson ABR, Tapper EJ: Misoprostol, a synthetic PGE1 analog, in the treatment of duodenal ulcers: A multicenter double-blind study. Dig Dis Sci 30(Suppl):147S-158S, 1985

    Google Scholar 

  18. Brown MB: Screening effects of multidimensional contingency tables. Appl Stat 25(1):37–46, 1976

    Google Scholar 

  19. Dixon WJ (ed): BMDP Statistical Software. Berkeley, California, University of California Press, 1981, Procedures P4F and IL, pp 143–206, 555–575

    Google Scholar 

  20. Conover WJ: Practical Nonparametric Statistics, ed 2, New York, John Wiley & Sons, 1980, pp 130–133 and Table A3

    Google Scholar 

  21. Sokal RR, Rohlf FJ: Biometry, ed 2. San Francisco, WH Freeman, 1981, pp 432–437

    Google Scholar 

  22. Korman MG, Hansky J, Merrett AC, Schmidt GT: Ranitidine in duodenal ulcer: Incidence of healing and effect of smoking. Dig Dis Sci 27:712–715, 1982

    Google Scholar 

  23. Korman MG, Shaw RG, Hansky J, Schmidt GT, Stern AI: Influence of smoking on healing rate of duodenal ulcer in response to cimetidine or high dose antacid. Gastroenterology 80:1451–1453, 1981

    Google Scholar 

  24. Korman MG, Hansky J, Eaves ER, Schmidt GT: Influence of cigarette smoling on healing and relapse in duodenal ulcer disease. Gastroenterology 85:871–874, 1983

    Google Scholar 

  25. Sontag SJ, 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

    Google Scholar 

  26. Ippoliti A, Elashoff J, Valenzuela J, Cano R, Frankl H, Samloff M, Koretz R: Recurrent ulcer after successful treatment with cimetidine or antacid. Gastroenterology 85:875–880, 1983

    Google Scholar 

  27. Konturek SJ, et al: Comparison of carprofen and indomethacin on gastric secretion, mucosal integrity, and prostaglandin generation in normal subjects and duodenal ulcer patients. Gastroenterology 84:1213, 1983 (abstract)

    Google Scholar 

  28. Fung WP, Karim SMM: Effect of 15(R),15-methyl prostaglandin E2 on the heating of gastric ulcers—double-blind endoscopic study. Med J Aust 2:127–128, 1976

    Google Scholar 

  29. Vantrappen G, Jassens SJ, Popiela T, Kulig J, Tytgat GNJ, Huibregtse K, Lambert R, Pauchard JP, Robert A: Effect of 15(R),15-methyl prostaglandin E2 (arbaprostil) on healing of duodenal ulcer. Gastroenterology 83:357–863, 1982

    Google Scholar 

  30. Kirkendall JW, Evaul J, Johnson LF: Effect of cigarette smoking on gastrointestinal physiology and non-neoplastic digestive disease. J Clin Gastroenterol 6:65–78, 1978

    Google Scholar 

  31. McCready DR, Cohen MM: Effect of smoking on the pentagastrin stimulated gastric secretion in man. Surg Forum 35:200–202, 1984

    Google Scholar 

  32. Baker R, Jaffe BM, Venables CW: Endogenous prostaglandins in peptic ulcer disease. Gut 20:394–399, 1979

    Google Scholar 

  33. Sharon P, Cohen F, Zifroni A, Karmeli F, Ligumski M, Rachmilewitz D: Prostanoid synthesis by cultured gastric and duodenal mucosa: Possible role in the pathogenesis of duodenal ulcer. Scand J Gastroenterol 18:1045–1049, 1983

    Google Scholar 

  34. Ahlquist DA, Dozois RR, Zinsmeister AR, Malagelada JR: Duodenal prostaglandin synthesis and acid load in health and in duodenal ulcer disease. Gastroenterology 85:522–528, 1983

    Google Scholar 

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Authors and Affiliations

  1. Digestive Diseases Research Center, King/Drew Medical Center, Los Angeles, California

    Peter Bright-Asare MD (Coinvestigator), Stephen J. Sontag MD (Coinvestigator), Ronald J. Gould MD (Coinvestigator), Douglas L. Brand MD (Coinvestigator) & Walter M Roufail MD (Coinvestigator)

  2. Edward Hines, Jr. Hospital, Hines, Illinois

    Peter Bright-Asare MD (Coinvestigator), Stephen J. Sontag MD (Coinvestigator), Ronald J. Gould MD (Coinvestigator), Douglas L. Brand MD (Coinvestigator) & Walter M Roufail MD (Coinvestigator)

  3. St. Louis University Hospitals, Missouri

    Peter Bright-Asare MD (Coinvestigator), Stephen J. Sontag MD (Coinvestigator), Ronald J. Gould MD (Coinvestigator), Douglas L. Brand MD (Coinvestigator) & Walter M Roufail MD (Coinvestigator)

  4. Northport VA Medical Center, Northport, New York

    Peter Bright-Asare MD (Coinvestigator), Stephen J. Sontag MD (Coinvestigator), Ronald J. Gould MD (Coinvestigator), Douglas L. Brand MD (Coinvestigator) & Walter M Roufail MD (Coinvestigator)

  5. Forsyth Medical Specialists, Winston-Salem, North Carolina

    Peter Bright-Asare MD (Coinvestigator), Stephen J. Sontag MD (Coinvestigator), Ronald J. Gould MD (Coinvestigator), Douglas L. Brand MD (Coinvestigator) & Walter M Roufail MD (Coinvestigator)

Authors
  1. Peter Bright-Asare MD
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  2. Stephen J. Sontag MD
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  3. Ronald J. Gould MD
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  4. Douglas L. Brand MD
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  5. Walter M Roufail MD
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Additional information

United States: Naurang M. Agrawal, MD, Tulane University, School of Medicine, New Orleans, Louisiana; Simmy Bank, MD, Long Island Jewish-Hillside Medical Center, New Hyde Park, New York; John Banwell, MD, University Hospital/Department of Gastroenterology, Cleveland, Ohio; Sharad Bellapravalu, MD, VA Medical Center, Phoenix, Arizona; Richard E. Brownstein, MD, Albany, Georgia; Robert Burakoff, MD, Evans Medical Foundation, University Hospital, Boston, Massachusetts; Robert E. Davis, MD, Houston, Texas; John J. Ferry, MD, Omaha Health Professions Center, Omaha, Nebraska; Joseph E. Greenen, MD, St. Luke's Hospital, Racine, Wisconsin; Ioannis Giannikopoulos, MD, Digestive Diseases Research Center, King/Drew Medical Center, Los Angeles, California; James P. Hosler, MD, Grand Prairie, Texas; Douglas Howell, MD, Portland Gastroenterology Association, Portland, Maine; Hooshang Meshkinpour, MD, University of California, Irvine Medical Center; Orange, California; Ray Mohram, MD, St. Louis Medical Specialist, Bridgeton, Misscuri; Edward J. Ramsey, MD, Richmond Gastroenterology Associates, Richmond, Virginia; Arvey I. Rogers, MD, University of Miami, Department of Gastroenterology Miami, Florida; Thomas Schnell, Edward Hines, Jr. Hospital, Hines, Illinois; Fernando Villa, MD, Martha Washington Hospital, Chicago, Illinois; Z. Reno Vlahcevic, MD, McGuire VA Medical Center, Richmond, Virginia; Gary Weaver, MD, The Mary Imogene Bassett Hospital, Department of Med. Gastroenterology, Cooperstown, New York; Joycelyn T. Whiten, PhD, Digestive Diseases Research Center, King/Drew Medical Center, Los Angeles, California.Canada: IGM Cleator, MD, St. Paul's Hospital, Vancouver, BC; Alain Farley, MD, Montreal, Quebec; Gerald Iliffe, MD, Health Science Center, Winnepeg; David A. Lloyd, MD, St. Joseph's Hospital, Division of Gastroenterology, London, Ontario; A.B.R. Thomson, MD, University of Alberta Hospital, Edmonton, Alberta; John Wright, MD: Toronto Western Hospital, Toronto, Ontario.

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Bright-Asare, P., Sontag, S.J., Gould, R.J. et al. Efficacy of misoprostol (twice daily dosage) in acute healing of duodenal ulcer. Digest Dis Sci 31 (Suppl 2), 63S–67S (1986). https://doi.org/10.1007/BF01309325

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