TY - JOUR
T1 - Efficacy and safety of ecabet sodium on functional dyspepsia
T2 - A prospective, double-blinded, randomized, multi-center controlled trial
AU - Lee, Jun Haeng
AU - Kim, Jae J.
AU - Rhee, Jong Chul
AU - Hahm, Ki Baik
AU - Lee, Dong Ho
AU - Kim, Nayoung
AU - Kim, Sung Kook
AU - Park, Jong Jae
AU - Choi, Seok Reyol
AU - Lee, Jong Hun
AU - Lee, Soo Teik
AU - Lee, Eun Hyun
PY - 2006/5/7
Y1 - 2006/5/7
N2 - 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.
AB - 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.
KW - Cimetidine
KW - Ecabet sodium
KW - Functional dyspepsia
UR - http://www.scopus.com/inward/record.url?scp=33744468272&partnerID=8YFLogxK
U2 - 10.3748/wjg.v12.i17.2756
DO - 10.3748/wjg.v12.i17.2756
M3 - Article
C2 - 16718764
AN - SCOPUS:33744468272
VL - 12
SP - 2756
EP - 2761
JO - World Journal of Gastroenterology
JF - World Journal of Gastroenterology
SN - 1007-9327
IS - 17
ER -