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RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFICACY OF MOSAPRIDE PLUS OMEPRAZOLE COMBINATION THERAPY TO OMEPRAZOLE MONOTHERAPY IN GASTROESOPHAGEAL REFLUX DISEASE

Authors Yutaka Yamaji, Yoshihiro Isomura, Shuntaro Yoshida, Atsuo Yamada, Yoshihiro Hirata, Kazuhiko Koike First published: 1 September 2014 Full publication history

Conflict of interest: the authors' institute has received grants from Dainippon Sumitomo Pharmaceutical Co. Ltd and AstraZeneca K.K for general medical research efforts.

Abstract

Objective

We investigated whether the prokinetic activity of mosapride, a 5-hydroxytryptamine 4 receptor agonist, in combination with proton pump inhibitor (PPI) would ameliorate symptoms of gastroesophageal reflux disease (GERD) in Japanese patients.

Methods

Patients who experienced reflux symptoms more than twice weekly were eligible for this study. In all,

60 patients were randomized to receive mosapride 5 mg thrice daily combined with omeprazole 10 mg

once daily (GO group), or omeprazole alone (O group) for 4 weeks. The patients completed the frequency scale for the symptoms of GERD (FSSG) at the beginning and the end of the study. The

primary outcome compared changes in the FSSG reflux-related symptom (RS) score between treatment groups during the study period.

Results

The FSSG RS scores significantly decreased both in the GO group and the O group, with no differences in improvement between the groups (−5.86 for the GO group vs −4.89 for the O group, P = 0.49). In non- erosive reflux disease (NERD) patients the improvement was significantly lower than that in erosive

GERD patients (−4.00 vs −7.67, P = 0.02). However, the addition of mosapride was effective in subgroup

analyses of specific symptoms, such as burping.

Conclusions

Combining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone. Both regimens provided less relief from reflux symptoms in NERD than in erosive GERD patients. The addition of mosapride ameliorated reflux in patients with symptoms like burping.

Cure of gastric ulcer disease after cure of Helicobacter pylori infection--German Gastric Ulcer Study.

BACKGROUND:

Helicobacter pylori infection is associated with gastric ulcer disease in about 75% of cases.

OBJECTIVE:

The aim of this study was to determine whether H. pylori eradication reduces gastric ulcer relapse rates.

DESIGN:

The study was randomized, controlled, multicentric and investigator blinded, and was conducted at three university hospitals, two teaching hospitals, and by six practising gastroenterologists.

METHODS:

During a period of 1 year 152 patients with gastric ulcers were randomly assigned to one of two

treatment regimens: omeprazole 20 mg daily in the morning for 8 weeks (74 patients), or bismuth subsalicylate 600 mg three times daily for 8 weeks combined with 500 mg amoxicillin twice daily and 1000 mg tinidazole twice daily for the first 10 days (triple therapy) (78 patients). Follow-up examinations were performed 6, 12 and 18 months after treatment and whenever ulcer symptoms occurred.

RESULTS:

Of the 152 randomized patients five were excluded because of gastric cancer, 10 missed follow-up examinations and seven receiving triple therapy terminated treatment because of side effects. Of the remaining 130 patients, five of 69 (7.2%) in the omeprazole and six of 61 (9.8%) in the triple group were

H. pylori negative. After 8 weeks' therapy, the gastric ulcer was healed in 85.9% (omeprazole) and in 81.8% triple) in H. pylori-positive patients, and in 80% (omeprazole) and 16.7% (triple) in H. pylori- negatives. H. pylori was eradicated in 8.1% of the patients who received omeprazole monotherapy and in 78.2% receiving triple therapy, and in 8.1% and 69.4% in an intention-to-treat analysis. The subsequent relapse rates during a follow-up period of 12 months were 50% in the omeprazole group and 4% in the triple group. Gastric ulcer relapse was observed in 49% of patients who were H. pylori positive and in 2% who were H. pylori negative after treatment.

CONCLUSION:

The data show that the presence of H. pylori is an important predictor of gastric ulcer relapse and that

eradication of H. pylori may heal gastric ulcer disease.

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow AerobicallyFifth Edition. Approved Standard NCCLS Document M7-A5, Vol, 20, No. 2, NCCLS, Wayne, PA, January 2000.

In a foreign multinational randomized, double-blind study of 105 patients with endoscopically documented duodenal ulcer, 20 mg and 40 mg of omeprazole were compared with 150 mg b.i.d. of ranitidine at 2, 4 and 8 weeks. At 2 and 4 weeks both doses of omeprazole were statistically superior (per protocol) to ranitidine, but 40 mg was not superior to 20 mg of omeprazole, and at 8 weeks there was no significant difference between any of the active drugs.

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow