Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.

Autor: Zerbib F; Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France., Sacher-Huvelin S; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France., Coron E; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France., Coffin B; Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France., Melchior C; Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France., Ponchon T; Gastroenterology Department, CHU de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France., Cholet F; Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France., Chabrun E; Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France., Vavasseur F; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France., Gorbatchef C; Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France., Zalar A; Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France., Mion F; Digestive Physiology Department, Hospices Civils de Lyon, Université de Lyon, Inserm U1082 LabTau, Lyon, France., Robaszkiewicz M; Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France., Le Rhun M; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France., Leroy M; Methodology and Biostatistics Department, CHU de Nantes, Université de Nantes, Nantes, France., Paul Galmiche J; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France., Bruley des Varannes S; Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.
Jazyk: angličtina
Zdroj: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2020 Aug; Vol. 52 (4), pp. 637-645. Date of Electronic Publication: 2020 Jul 13.
DOI: 10.1111/apt.15936
Abstrakt: Background: Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.
Aim: To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.
Methods: A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.
Results: Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.
Conclusion: This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.
(© 2020 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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