Oesophageal radiofrequency fails to deliver in PPI-refractory heartburn
In heartburn patients who do not respond to proton pump inhibitor (PPI) treatment, the oesophageal radiofrequency procedure falls short of relieving symptoms and reducing PPI use, a study has shown.
Sixty-two patients (mean age, 51.2 years) were randomized to undergo radiofrequency (n=29) or a sham procedure (n=33). All patients had moderate‐to‐severe heartburn, defined by at least three events a week and not improved by continuous PPI treatment (single dose, n=15; double dose, n=47).
According to 24-hour pH-impedance monitoring on PPIs, 29 patients had functional heartburn, 17 reflux hypersensitivity, 10 persisting gastroesophageal reflux disease, and six were not classified (normal reflux parameters but no symptoms recorded).
The oesophageal radiofrequency procedure was performed under general anaesthesia after endotracheal intubation. A flexible radiofrequency catheter was introduced, and four needle electrodes were deployed into the muscular layer of the oesophageal wall to deliver the energy. The sham procedure followed the same protocols but without delivering the energy.
Intention‐to‐treat analysis showed that more patients in the sham group than in the active treatment group achieved the primary endpoint of clinical success at week 24 (5 vs 1), although the difference was not significant. Success was defined by intake of fewer than seven PPI doses over the 2 preceding weeks and adequate symptom control, as determined by the patient.
Oesophageal radiofrequency neither reduced the number of days without heartburn and days on PPI in the previous 2 weeks nor increased the number of patients discontinuing PPI compared with sham.
No pH‐impedance parameter predicted clinical response, and the occurrence of adverse events was similar in both groups.