Abstract :
Background: Non-ulcer dyspepsia (functional dyspepsia) was a very common disorder in clinical practice. Non-ulcer dyspepsia can be classified into functional dyspepsia and non-Helicobacter pylori gastritis. Unfortunately, treatment of dyspepsia in non-H. pylori gastritis does not complete symptoms resolution.
Objective:
To evaluate effect of rebamipide combined omeprazole on symptom improvement compared with placebo combined omeprazole.
Patients and Methods:
This study was a double-blinded, randomized placebo-controlled, single-center study, with concealed allocation. Patient with dyspeptic symptoms of 4 weeks or longer were randomized to receive rebamipide 100 mg.t.i.d. combined with omeprazole 20 mg.o.d. (Group A) or an identical placebo combined with omeprazole (Group B). All patients had esophagogastroduodenoscopic biopsy for the evidence of non-H. pylori gastritis, such as a negative rapid urease test and negative histology for H. pylori. Symptom improvement was evaluated in terms of symptom-score and global assessment score at before treatment and 2 weeks, 4 weeks and 8 weeks after treatment.
Results:
Twenty-four patients were enrolled. There were 14 patients in group A (placebo combined omeprazole) and 10 patients in group B (rebamipide combined omeprazole). Group A mean age was 49.10 ±11.06 yrs. There were 20% male and symptom score was 11.10 ± 5.55. Group B mean age was 47.71 ± 10.99 yrs. There were 21.43% male and symptom score was 10.14 ±4.75. The symptom improvement was significantly superior in group A in term of symptom score (p = 0.001, 95%CI = 2.74-8.55) and global assessment (p <0.001, 95%CI = 1.60-3.40) compare with group B.
Conclusion:
Rebamipide combined with omeprazole resulted in a significant reduction in the overall symptom scores, bloating symptom, and improvement of the global assessment improvement score at 8 weeks after treatment. In non-H. pylori gastritis subjects, rebamipide is useful as an adjunctive agent in combination with omeprazole in the treatment of functional dyspepsia . |
file/Thai-Journal-of-gastroenterology-vol-10-no-2-2110233.pdf