Efeito do pantoprazol sódico antes do almoço versus antes do café da manhã no controle da pirose em pacientes com doença do refluxo gastroesofágico: um ensaio clínico randomizado em fase piloto

Abstract

Background and objective: Proton pump inhibitors (PPIs) are the mainstay of pharmacotherapy in gastroesophageal reflux disease (GERD). The objectives of this pilot study were to evaluate the effect of pantoprazole before lunch versus before breakfast on heartburn control and to compare two instruments for heartburn assessment. Methods: Patients with troublesome heartburn combined with erosive esophagitis and/or hiatal hernia were randomized to use pantoprazole 40 mg before breakfast (BB) and placebo before lunch (BL), or vice versa, for 14 days, after a period of up to five days without treatment with PPIs to record baseline heartburn. The main outcome was heartburn control (diurnal, nocturnal and total), measured by a heartburn diary and a weekly questionnaire. Results: Nine patients treated with pantoprazole BB and nine BL completed the study. According to the symptom diary, the pantoprazole BL group had better nocturnal (p = 0.030) and total (p = 0.001) heartburn control than the BB group. Participants considered the heartburn diary superior to the weekly questionnaire. The sample size for a more in-depth future clinical trial was estimated to be 26 patients. Conclusions: In this pilot randomized clinical trial, the administration of pantoprazole before lunch appeared to be superior to its administration before breakfast in the short-term control of heartburn. The heartburn diary was considered superior to the weekly questionnaire. A proper clinical trial is required to confirm this effect of pantoprazole in patients with this GERD phenotype. Keywords: Gastroesophageal Reflux; Esophageal Diseases; Heartburn; Proton Pump Inhibitors.