Responsiveness of measures of heartburn improvement in non-erosive reflux disease.
BACKGROUND
When measuring treatment effect on symptoms, the treatment success variable should be as responsive as possible. The aim of the study was to investigate the responsiveness of various treatment success variables in patients with symptoms of heartburn.


METHODS
A total of 1640 patients with non-erosive reflux disease (NERD) were treated with proton pump inhibitors for 4 weeks. Treatment success variables were based on a symptom questionnaire (Gastrointestinal Symptom Rating Scale) and on investigator-assessed heartburn, measured at baseline and after 4 weeks of treatment. The rates of treatment success were compared with patients' perceived change in symptoms, assessed by the Overall Treatment Effect questionnaire.


RESULTS
Generally, more stringent treatment success criteria (i.e., those demanding the better response) translated into more responsive treatment success variables. For example, the treatment success variable 'no heartburn' at 4 weeks was more responsive than the variable 'at most mild heartburn' at 4 weeks. Treatment success variables based on change from baseline to 4 weeks were, in general, less responsive than those based on the week 4 assessments only.


CONCLUSIONS
In patients with NERD, responsiveness varied among different treatment success definitions, with more demanding definitions (based on the 4-week assessment) giving better responsiveness.
Junghard
Ola
O
Biostatistics, AstraZeneca R&D, Mölndal, Sweden. ola.junghard@astrazeneca.com
Halling
Katarina
K
D000328:Adult; D000368:Aged; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000523:psychology; D006356:Heartburn / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D017060:Patient Satisfaction; D054328:Proton Pump Inhibitors; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires
D054328:Proton Pump Inhibitors; D009853:Omeprazole