BACKGROUND
Heartburn often co-exists with functional dyspepsia (FD) and pathological gastroesophageal reflux has been reported in up to 50% of FD patients without reflux symptoms.1,2 Proton pump inhibitors (PPI) are the first-line treatment for both FD and heartburn. Patients with epigastric pain syndrome (EPS), but not postprandial distress syndrome (PDS), benefit from PPI treatment.3,4 PPIs should be considered for de-prescribing, namely in non-erosive reflux disease and FD.5 However, discontinuation of prolonged PPI therapy is followed by rebound acid hypersecretion and often by symptom recurrence.
AIMS AND METHODS
Aims are to assess whether endoscopy-negative patients reporting heartburn (ENH) or EPS: 1) belong to the same clinical category, 2) benefit from the same treatment, and 3) benefit from the mucosal protective agent Poliprotect (Aboca, Sansepolcro, Italy) in the PPI deprescription phase of a randomised controlled trial.
Methods were reported in a published randomised controlled trial.6 Briefly, patients with ENH (n=81; 63% female) or EPS (n=45; 67% female) started omeprazole (20 mg once daily) for 4 weeks. At PPI withdrawal, they started Poliprotect (made from Aloe vera, Malva sylvestris, Althaea officinalis, limestone, nahcolite, Glycyrrhiza glabra, Matricaria recutita) 1.55 g tablet on demand for 4 weeks. Visual Analogue Scale (VAS) assessed daily symptom severity. A 50% VAS decrease from basal values defined a responder. Antacid was used as the rescue medicine. Post hoc analysis of data. Statistics with Wilcoxon rank sum test, and 2-sample test for equality of proportions, with continuity corrections.
RESULTS
Demography, Gastrointestinal Symptom Rating Scale (GSRS), and Gastrointestinal Quality of Life Index (GIQLY) scores did not differ between ENH and EPS. During deprescription, Poliprotect on-demand intake (mean [M] ± standard deviation [SD]) was 2.36 (2.14) tablets/day. VAS score (M [95% CI]) was 25.6 (21.0–30.2) and 25.2 (18.5–31.9) at the end of PPI treatment and 25.7 (20.8–30.5) and 21.4 (15.1–27.7) at the end of the deprescription in ENH and EPS, respectively. Rescue medicine consumption (M±SD; not significant) was 9.1±12.1 sachets and 8.7±10.8 during the 4-week PPI treatment and 11.1±12.2 and 20.2±23.4 during the 4 weeks of deprescribing in patients with ENH and EPS, respectively. Responders’ rate was 48% and 51.3% at the end of PPI treatment and 51.3% and 55% at the end of the deprescription in ENH and EPS, respectively. Of the entire sample, 43% were non-responders at the end of PPI treatment, and 33.3% of them became responders at the end of the deprescribing phase. GSRS symptoms and GIQLY quality of life items were superimposable at the end of PPI treatment and the end of deprescription, in ENH and EPS. Treatment satisfaction was reported on the Overall Treatment Effect questionnaire by 82.8% and 85.7% at the end of PPI treatment and 81.3% and 95% at the end of the deprescription phase in ENH and EPS, respectively.
CONCLUSION
Patients that are upper endoscopy-negative with heartburn and EPS cannot be distinguished by demography; accompanying gastrointestinal symptoms; gastrointestinal, physical, mental, and social items of quality of life; symptom severity; and response to treatment. The clinical use of the symptoms of heartburn, epigastric pain, or burning to differentiate patients with typical reflux-like symptoms from EPS is not supported by the present data. It would therefore appear that patients with EPS and endoscopy-negative heartburn belong to the same clinical therapeutic category. At PPI deprescription, Poliprotect, at the mean daily intake of 2.3 tablets appears equally effective in patients with ENH and EPS in: 1) counteracting the rebound acid hypersecretion effect, 2) maintaining the beneficial effect obtained with the previous PPI treatment, and 3) reverting one-third of PPI non-responders to responders without any additional request for antacids.
