A study on the efficacy of rebamipide for patients with proton pump inhibitor-refractory non-erosive reflux disease.

Abstract

BACKGROUND AND AIM:

Reflux symptoms in patients with non-erosive reflux disease (NERD) cannot be easily controlled by treatment with proton pump inhibitors (PPI). The anti-inflammatory function of rebamipide may be effective for protecting the esophageal mucosa. This prospective randomized multicenter placebo-controlled study was performed to clarify the efficacy of rebamipide for NERD patients whose reflux symptoms were refractory to PPI treatment.

METHODS:

One hundred forty-nine patients were enrolled on the basis of a QUEST score of over 6 and absence of endoscopically proven esophageal mucosal breaks. All the patients were initially administered 15 mg of lansoprazole for 4 weeks, and the symptoms were then assessed using QUEST and GSRS. PPI-refractory patients were randomly assigned to administration of rebamipide or placebo t.i.d. for 4 weeks.

RESULTS:

Three of the 149 patients were lost to follow-up, and 60 among the remaining 146 patients were found to be PPI-refractory. Among these PPI-refractory patients, 31 were randomly assigned to a rebamipide group and 29 to a placebo group. At the end of drug administration, the QUEST and GSRS scores did not differ between the rebamipide and placebo groups, although a significantly higher proportion of patients in the rebamipide group showed amelioration of abdominal pain and diarrhea.

CONCLUSION:

Administration of rebamipide cannot effectively control reflux symptoms in NERD patients whose symptoms are refractory to PPI therapy.

• Authors: Kyoichi Adachi, Kenji Furuta, Hiroto Miwa, Tadayuki Oshima, Masaharu Miki, Yoshinori Komazawa, Katsuhiko Iwakiri, Takahisa Furuta, Tomoyuki Koike, Tomohiko Shimatani, Yoshikazu Kinoshita
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 57 Issue 6 Pg. 1609-17 (Jun 2012) ISSN: 1573-2568 [Electronic] United States
• PMID: 22367114 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Proton Pump Inhibitors
• Quinolones
• Lansoprazole
• rebamipide
• Alanine

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles (adverse effects, therapeutic use)
• Adult
• Aged
• Aged, 80 and over
• Alanine (analogs & derivatives, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Resistance
• Esophageal pH Monitoring
• Esophagoscopy (methods)
• Female
• Follow-Up Studies
• Gastroesophageal Reflux (diagnosis, drug therapy)
• Humans
• Lansoprazole
• Male
• Middle Aged
• Prospective Studies
• Proton Pump Inhibitors (adverse effects, therapeutic use)
• Quinolones (therapeutic use)
• Recurrence
• Reference Values
• Risk Assessment
• Severity of Illness Index
• Statistics, Nonparametric
• Treatment Outcome
• Young Adult