Efficacy and safety of ecabet sodium on functional dyspepsia: A prospective, double-blinded, randomized, multi-center controlled trial

Jun Haeng Lee, Jae J. Kim, Jong Chul Rhee, Ki Baik Hahm, Dong Ho Lee, Nayoung Kim, Sung Kook Kim, Jong Jae Park, Seok Reyol Choi, Jong Hun Lee, Soo Teik Lee, Eun Hyun Lee

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10 Citations (Scopus)

Abstract

Aim: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia. Methods: We performed a multi-center, prospective , randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-II criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients), 400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3, 14, and 28 d after initiating the treatment. Results: Two-hundred and t hirty-six patients completed the clinical trial. After 4 wk of treatment, the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups. There was no clinically significant adverse event in both groups. Conclusion: In pat ients with functional dyspepsia, ecabet sodium has similar clinical efficacy with cimetidine.

Original languageEnglish
Pages (from-to)2756-2761
Number of pages6
JournalWorld Journal of Gastroenterology
Volume12
Issue number17
Publication statusPublished - 2006 May 7

Keywords

  • Cimetidine
  • Ecabet sodium
  • Functional dyspepsia

ASJC Scopus subject areas

  • Gastroenterology

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    Lee, J. H., Kim, J. J., Rhee, J. C., Hahm, K. B., Lee, D. H., Kim, N., Kim, S. K., Park, J. J., Choi, S. R., Lee, J. H., Lee, S. T., & Lee, E. H. (2006). Efficacy and safety of ecabet sodium on functional dyspepsia: A prospective, double-blinded, randomized, multi-center controlled trial. World Journal of Gastroenterology, 12(17), 2756-2761.