Validation of a Patient Reported Outcome Instrument, the Reflux Symptom Questionnaire Electronic Diary (Resq-ED), in Patients With a Partial Response to PPI Therapy

Abstract

Gastro Intestinal Disorders-Symptom Severity Index) by devoting a score from 0 to 5 for each symptom, before and after the treatment. The study is still ongoing. Results: Thirty six patients were classified as pH-positive patients while 46 of them were allocated to pHnegative groups. With the FX, OM and PL, sub-group analysis showed significant improvement of heartburn/regurgitation severity score in pH-positive patients (p, 0,004, 0.005, 0.035, respectively) and also in those with negative pH monitoring result(p, 0.0001, 0.001, 0.035, respectively). Mean decrement in heartburn/regurgitation score for FX, OM and PL for pH-positive patients was 0.74 ± 0.22, 0.71 ± 0.3, 1.14 ± 0.68 respectively, while for the patients with negative pH monitoring result it was 0.78 ± 0.33, 1.32 ± 0.45, 0.6 ± 0.45, respectively. Interestingly, the mentioned symptom severity score decrements did not differ significantly between 3 medications in either pH positive or pH negative patients (p, 0.35, 0.2, respectively). Conclusion: FX, OM and PL produced a clinically significant improvement in symptom severity in NERD patients. Besides, there was no significant difference in extent of symptom severity improvement among 3 medications. Our findings support that: 1) A considerable portion of response to PPIs and antidepressants in NERD patients may be explained as placebo effect. 2) Acid does not play a major role in development of heartburn and regurgitation in NERD patients and this may be a reason for why most of these patients fail to respond to PPI treatment. 3) Psychological comorbidities are likely to have an important role in symptom development and poor symptomatic response in patients with NERD even in those with positive pH monitoring result.