Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1 A systematic review of 20 studies including 1441 patients reported oesophageal acid exposure from 11 studies (364 patients). The mean percentage of time that the pH was less than 4 decreased from 10% at baseline to 7% (p=0.0003) at mean 12‑month follow‑up. A crossover randomised controlled trial (RCT) of 22 patients comparing endoscopic radiofrequency ablation against sham reported that there were no significant changes in oesophageal acid exposure at 3‑ or 6‑month follow‑up. An RCT of 43 patients reported abnormal oesophageal acid exposure in 94% (17/18) of patients treated by radiofrequency ablation and in 75% (9/12) of patients treated with proton pump inhibitors (PPIs) alone at 6‑month follow‑up (p=0.27).

4.2 A non-randomised comparative study of 126 patients treated by radiofrequency ablation or endoluminal full-thickness plication reported that the percentage of time the pH was less than 4 reduced from 11% at baseline to 9% at mean 5‑month follow‑up (not significant) and from 10% at baseline to 6% at mean 8‑month follow-up (p=0.05), respectively.

4.3 The RCT of 43 patients reported oesophagitis (diagnosed by endoscopy) in 53% (10/19) of patients treated by radiofrequency ablation and 54% (7/13) of patients treated with PPIs alone at 6‑month follow‑up (p=0.97).

4.4 The systematic review of 20 studies including 1441 patients reported the mean gastro-oesophageal reflux disease health-related quality of life score in 9 studies (433 patients), which improved from 26.1 at baseline to 9.3 after treatment (p=0.0001, mean follow‑up 20 months). In the same review, 6 studies with 299 patients reported that the mean SF‑36 (physical) score improved from 36 to 46 points at mean 10‑month follow‑up (p=0.0001). Five studies (264 patients) reported that the mean SF‑36 (mental) score improved from 47 to 55 at mean 10‑month follow‑up (p=0.0015).

4.5 The systematic review of 20 studies reported a pooled heartburn score from 9 studies (525 patients) of 3.6 at baseline and 1.2 at mean 24‑month follow‑up (p=0.0001; lower scores indicate less severe symptoms). The crossover RCT of 22 patients comparing radiofrequency ablation against sham reported a significant improvement in symptom score at 3 months compared with baseline in the active treatment group (from 14.7 to 8.3; p<0.005) but not in the sham group (from 16.1 to 15.6; not significant). When patients in the sham group were subsequently treated by radiofrequency ablation, the symptom score significantly improved to 7.2 (p<0.05) at 3‑month follow‑up. The RCT of 43 patients treated by endoscopic radiofrequency ablation or PPIs alone reported symptoms fewer than 3 times a week in 80% (16/20) and 40% (6/15) of patients respectively at 6‑month follow‑up (p=0.01). At 12‑month follow‑up, 69% (11/20) of patients in the radiofrequency ablation group had symptoms fewer than 3 times a week compared with 62% (8/14) of patients in the control group (p=0.71). There were no statistically significant differences in the individual symptom scores.

4.6 The crossover RCT of 22 patients reported no significant change in medication use from baseline in either group at 6‑month follow‑up. The RCT of 43 patients reported that 13% (3/23) and 17% (4/23) of patients in the radiofrequency ablation group at 6 and 12 months respectively were able to stop PPIs completely compared with none of the control patients.

4.7 The specialist advisers listed key efficacy outcomes as long‑term objective evidence (pH studies), long‑term symptomatic control, quality of life and decreasing or stopping PPIs.