Responsiveness of measures of heartburn improvement in non-erosive reflux disease
2007

Heartburn Treatment Success in Patients with Non-Erosive Reflux Disease

Sample size: 1640 publication Evidence: moderate

Author Information

Author(s): Junghard Ola, Halling Katarina

Primary Institution: AstraZeneca R&D

Hypothesis

The study aims to investigate the responsiveness of various treatment success variables in patients with symptoms of heartburn.

Conclusion

In patients with NERD, responsiveness varied among different treatment success definitions, with more demanding definitions giving better responsiveness.

Supporting Evidence

  • More stringent treatment success criteria translated into more responsive treatment success variables.
  • 61.3% of patients had no heartburn at 4 weeks according to investigator assessment.
  • The treatment success variable 'no heartburn' showed a 74.5 percentage point difference in success rates between patients who were 'unchanged' and those who were 'a very great deal better'.
  • Treatment success variables based on change from baseline to 4 weeks were generally less responsive than those based on the week 4 assessments only.

Takeaway

This study looked at how well different ways of measuring heartburn treatment success worked, finding that stricter measures were better at showing improvement.

Methodology

Patients with non-erosive reflux disease were treated with proton pump inhibitors for 4 weeks, and treatment success was assessed using various questionnaires.

Potential Biases

Potential bias due to the study being conducted by employees of AstraZeneca.

Limitations

The study may not generalize to all patients with gastro-esophageal reflux disease as it focused on those with non-erosive reflux disease.

Participant Demographics

{"male_female_ratio":"47:53","age_distribution":{"<50":54,"50 to <65":34,"≥ 65":12},"history_of_heartburn":{"<12 months":11,"1–5 years":35,">5 years":53},"overall_heartburn_severity":{"mild":21,"moderate":62,"severe":18}}

Digital Object Identifier (DOI)

10.1186/1477-7525-5-32

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