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

Lee, JH; Kim, JJ; Hahm, KB; Lee, DH; Kim, N; Kim, SK; Park, JJ; Choi, SR; Lee, ST; Lee, EH; Rhee, JC
World journal of gastroenterology, 12(17):2756-2761, 2006
Journal Title
World journal of gastroenterology
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 thirty-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 patients with functional dyspepsia, ecabet sodium has similar clinical efficacy with cimetidine.
MeSH terms
AdultAge FactorsAnti-Ulcer Agents/adverse effectsAnti-Ulcer Agents/therapeutic use*Cimetidine/therapeutic useDiterpenes, Abietane/adverse effectsDiterpenes, Abietane/therapeutic use*Double-Blind MethodDyspepsia/complicationsDyspepsia/drug therapy*Dyspepsia/physiopathologyFemaleHelicobacter Infections/complicationsHelicobacter Infections/physiopathologyHelicobacter pyloriHumansMaleMiddle AgedProspective StudiesQuality of LifeSex FactorsTreatment Outcome
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Journal Papers > School of Medicine / Graduate School of Medicine > Gastroenterology
Journal Papers > Graduate School of Public Health > Public Health
AJOU Authors
함, 기백이, 은현
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