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Misoprostol, a synthetic PGE1 analog, in the treatment of duodenal ulcers

A multicenter double-blind study

  • Part 4: Clinical and Pharmacological Actions of Misoprostol, a PGE1 Analog
  • Published:
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Abstract

Misoprostol, a synthetic analog of prostaglandin E1, inhibits gastric acid production and is cytoprotective at doses well tolerated by patients in preliminary trials. This multicenter double-blind study was performed in out-patients with endoscopically demonstrated duodenal ulcers, to compare the efficacy in ulcer healing and the safety of two dosages of misoprostol and placebo. Up to six antacid tablets daily were permitted for pain. 308 patients enrolled and were randomized to three treatment groups: placebo, misoprostol 50 μg and misoprostol 200 μg. After two weeks of treatment, the three groups had similar percentages of patients with complete ulcer healing. However, after four weeks, 76.6% of patients taking misoprostol 200 μg q.i.d. had complete healing, compared with 42.6% on misoprostol 50 μg q.i.d. and 51% on placebo (P<0.001, 200 μg versus placebo). Patients taking misoprostol 200 μg used less antacid than the others. Diarrhea, mild and self-limiting, was present in 13% of the 200 μg group versus 5% on placebo. We conclude that misoprostol 200 μg q.i.d. is effective, safe and well tolerated in the treatment of duodenal ulcers.

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Authors and Affiliations

  1. VA Medical Center, Northport, NY

    D. L. Brand MD, W. M. Roufall MD, A. B. R. Thomson MD & E. J. Tapper MD

  2. Division of Gastroenterology-Hepatology, Health Sciences Center, SUNY at Stony Brook, T-17, Room 060, 11794, Stony Brook, NY

    D. L. Brand MD, W. M. Roufall MD, A. B. R. Thomson MD & E. J. Tapper MD

  3. Bowman-Gray School of Medicine, Winston-Salem, NC

    D. L. Brand MD, W. M. Roufall MD, A. B. R. Thomson MD & E. J. Tapper MD

  4. University of Alberta, Edmonton, Alberta, Canada

    D. L. Brand MD, W. M. Roufall MD, A. B. R. Thomson MD & E. J. Tapper MD

  5. Searle Research and Development, G.D. Searle & Co, Skokie, IL

    D. L. Brand MD, W. M. Roufall MD, A. B. R. Thomson MD & E. J. Tapper MD

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  1. D. L. Brand MD
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This paper was prepared on behalf of an international study group.

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Brand, D.L., Roufall, W.M., Thomson, A.B.R. et al. Misoprostol, a synthetic PGE1 analog, in the treatment of duodenal ulcers. Digest Dis Sci 30 (Suppl 11), 147S–158S (1985). https://doi.org/10.1007/BF01309402

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  • DOI: https://doi.org/10.1007/BF01309402

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