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

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.

• Authors: 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
• Journal: World journal of gastroenterology (World J Gastroenterol) Vol. 12 Issue 17 Pg. 2756-61 (May 07 2006) ISSN: 1007-9327 [Print] United States
• PMID: 16718764 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Abietanes
• Anti-Ulcer Agents
• ecabet
• Cimetidine

Topics

• Abietanes (adverse effects, therapeutic use)
• Adult
• Age Factors
• Anti-Ulcer Agents (adverse effects, therapeutic use)
• Cimetidine (therapeutic use)
• Double-Blind Method
• Dyspepsia (complications, drug therapy, physiopathology)
• Female
• Helicobacter Infections (complications, physiopathology)
• Helicobacter pylori
• Humans
• Male
• Middle Aged
• Prospective Studies
• Quality of Life
• Sex Factors
• Treatment Outcome