title: Efficacy and safety of ecabet sodium on functional dyspepsia: a prospective, double-blinded, randomized, multi-center controlled trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  In patients with functional dyspepsia, ecabet sodium has similar clinical efficacy with cimetidine.
authors.affiliation: Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, #50 Irwon-Dong, Gangnam-gu, Seoul 135-710, Korea. leejh@smc.samsung.co.kr
authors.forename: Jun Haeng
authors.initials: JH
authors.lastname: Lee
authors.forename: Jae J
authors.initials: JJ
authors.lastname: Kim
authors.forename: Ki-Baik
authors.initials: KB
authors.lastname: Hahm
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Nayoung
authors.initials: N
authors.lastname: Kim
authors.forename: Sung Kook
authors.initials: SK
authors.lastname: Kim
authors.forename: Jong Jae
authors.initials: JJ
authors.lastname: Park
authors.forename: Seok Reyol
authors.initials: SR
authors.lastname: Choi
authors.forename: Jong Hun
authors.initials: JH
authors.lastname: Lee
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lee
authors.forename: Eun Hyun
authors.initials: EH
authors.lastname: Lee
authors.forename: Jong Chul
authors.initials: JC
authors.lastname: Rhee
mesh_terms: D045784:Abietanes / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000367:Age Factors; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002927:Cimetidine / Q000627:therapeutic use; D004311:Double-Blind Method; D004415:Dyspepsia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000503:physiopathology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D045784:Abietanes; D000897:Anti-Ulcer Agents; C061681:ecabet; D002927:Cimetidine