A VALIDATED DYSPEPSIA SYMPTOM SCORE

Background. The primary endpoint in clinical trials involving patients with non-ulcer dyspepsia is subjective, i.e., reduction in symptomato logy. Three attributes, reproducibility, responsiveness and validity, are necessary for the use of a symptom scoring system in a clinical tr ial. Methods. The four most common symptoms in 50 dyspeptic patients w ere determined. To check the reproducibility of the symptom score, 48 patients and thirty control subjects were interviewed on two occasions (T0, T1), prior to any diagnostic or therapeutic intervention. Respon siveness was assessed by comparing the symptom scores of patients befo re (T0) and after (T2) treatment. Validity was assessed by comparing t he symptom scores of dyspeptic patients to those of healthy volunteer subjects. Results. Reproducibility The median T0 (16.00 and 6.90) and T1 (15.00 and 6.56) scores of the patients and controls did not signif icantly vary during the one-week interval. Responsiveness The symptom scores at T0 had decreased at T2 for patients with gastro-oesophageal reflux (17.00 to 11.50, p=0.0014), non-ulcer dyspepsia where Helicobac ter pylori was eradicated (16.00 to 7.00, p=0.0014), and duodenal ulce ration (18.50 to 7.50, p=0.0117) while there was an insignificant decr ease (18.00 to 13.00, p=0.0642) in non-ulcer dyspepsia patients who re ceived a prokinetic agent. Validity The mean rank symptom score of 74 patients (71.74) was significantly higher than that of the control pop ulation (26.83), (p=0.0001). The mean time taken to perform the questi onnaire was 3.6 minutes. Conclusion. This questionnaire is suitable fo r the assessment of symptoms in patients with dyspepsia.