Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: Final results of OMAREE, a large-scale clinical experience investigation
2011

Effects of Omeprazole on Symptoms and Quality of Life in Japanese Patients with Reflux Esophagitis

Sample size: 9967 publication 10 minutes Evidence: high

Author Information

Author(s): Yoshida Shigeru, Nii Masahiro, Date Masataka

Primary Institution: AstraZeneca K.K.

Hypothesis

The study investigates the efficacy and safety of omeprazole in improving symptoms and quality of life in Japanese patients with reflux esophagitis.

Conclusion

Omeprazole improved symptoms and quality of life more effectively in Japanese patients with reflux esophagitis than other investigated drugs.

Supporting Evidence

  • 61.7% of patients treated with omeprazole showed satisfactory improvement in symptoms at Week 4.
  • 81.8% of patients treated with omeprazole showed satisfactory improvement in symptoms at Week 8.
  • The overall mean QOLRAD score improved significantly in both treatment groups, but more so in the omeprazole group.
  • 44.0% of patients treated with omeprazole had complete resolution of symptoms at Week 4.
  • 67.2% of patients treated with omeprazole had complete resolution of symptoms at Week 8.
  • Adverse drug reactions were reported in 0.92% of patients treated with omeprazole.

Takeaway

This study shows that a medicine called omeprazole helps people in Japan feel better and live better when they have a problem called reflux esophagitis.

Methodology

A large-scale clinical investigation was conducted to analyze the symptoms and quality of life of Japanese patients with reflux esophagitis and evaluate the effects of omeprazole and other gastrointestinal drugs.

Potential Biases

There may be risks of bias due to the open-label design and reliance on patient-reported outcomes.

Limitations

The study may have limitations related to the observational nature and potential biases in patient reporting.

Participant Demographics

The study included 9967 patients, with a slightly larger number of women than men, and a mean age distribution across different age groups.

Statistical Information

P-Value

< 0.001

Confidence Interval

95% CI for improvement rates at Weeks 4 and 8

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1186/1471-230X-11-15

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