Efficacy and safety of ecabet sodium on functional dyspepsia: a prospective, double-blinded, randomized, multi-center controlled trial.
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.
Lee
Jun Haeng
JH
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
Kim
Jae J
JJ
Hahm
Ki-Baik
KB
Lee
Dong Ho
DH
Kim
Nayoung
N
Kim
Sung Kook
SK
Park
Jong Jae
JJ
Choi
Seok Reyol
SR
Lee
Jong Hun
JH
Lee
Soo Teik
ST
Lee
Eun Hyun
EH
Rhee
Jong Chul
JC
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
D045784:Abietanes; D000897:Anti-Ulcer Agents; C061681:ecabet; D002927:Cimetidine