Clinical Research
Copyright ©2006 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. May 7, 2006; 12(17): 2756-2761
Published online May 7, 2006. doi: 10.3748/wjg.v12.i17.2756
Efficacy and safety of ecabet sodium on functional dyspepsia: A prospective, double-blinded, randomized, multi-center controlled trial
Jun Haeng Lee, Jae J Kim, 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, Jong Chul Rhee
Jun Haeng Lee, Jae J Kim, Jong Chul Rhee, Department of Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea
Ki-Baik Hahm, Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
Dong Ho Lee, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, Gyeonggi-do, Korea
Sung Kook Kim, Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea
Jong Jae Park, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
Seok Reyol Choi, Jong Hun Lee, Department of Internal Medicine, Dong-A University, Busan, Korea
Soo Teik Lee, Department of Internal Medicine, Chonbuk National University College of Medicine, Chonju, Korea
Eun Hyun Lee, Department of Preventive Medicine, Graduate School of Public Health, Ajou University, Suwon, Korea
Correspondence to: Jong Chul Rhee, MD, 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
Telephone: +82-2-34013409 Fax: +82-2-34103849
Received: October 10, 2005
Revised: October 20, 2006
Accepted: November 10, 2005
Published online: May 7, 2006
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 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.

Keywords: Functional dyspepsia; Ecabet sodium; Cimetidine