Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.
Adolescent
Adult
Aged
Combined Modality Therapy
Double-Blind Method
Drug Resistance
/ radiation effects
Female
France
Gastroesophageal Reflux
/ complications
Heartburn
/ drug therapy
Humans
Male
Middle Aged
Placebos
Proton Pump Inhibitors
/ therapeutic use
Radiofrequency Therapy
/ methods
Severity of Illness Index
Treatment Failure
Young Adult
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
23
05
2020
revised:
04
06
2020
accepted:
11
06
2020
pubmed:
14
7
2020
medline:
2
12
2020
entrez:
14
7
2020
Statut:
ppublish
Résumé
Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs. To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn. 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. 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. 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.
Sections du résumé
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.
Substances chimiques
Placebos
0
Proton Pump Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT01682265']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
637-645Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 John Wiley & Sons Ltd.
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