4 Efficacy

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 interventional procedure overview.

4.1 In a non-randomised comparative study of 238 patients who had laparoscopic insertion of a magnetic titanium ring or Toupet fundoplication, there was a statistically significant improvement in median Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD‑HRQL) symptom scores from 21 and 15 at baseline to 2 and 3 respectively at 3‑year follow‑up (p<0.001 within both treatment groups; there was no statistically significant difference between the treatment groups). In a non-randomised comparative study of 415 patients who had a magnetic titanium ring or Nissen fundoplication, there was a statistically significant decrease in the median GERD‑HRQL symptom scores from 21 and 19 at baseline to 3 and 4 respectively at 1‑year follow‑up (p<0.001 within groups and p=0.17 for between group comparison). In the same study, a statistically significantly higher proportion of patients who had a magnetic titanium ring, compared with those who had Nissen fundoplication, reported ability for eructation (96% versus 69%, p<0.001), ability for emesis (95% versus 43%, p<0.001) and absence of gas bloat (53% versus 41%, p=0.03). In a case series of 100 patients who had a magnetic titanium ring, there was a 50% or greater reduction in the GERD‑HRQL score for 83% (70/84; 95% confidence interval [CI] 73 to 91) of patients at 5‑year follow‑up; the mean score at baseline was 27 (without proton-pump inhibitors [PPIs]) compared with 4 at 5‑year follow‑up (p<0.001).

4.2 In the case series of 100 patients, the median percentage time that oesophageal pH was less than 4 decreased from 11% at baseline to 3% at 1‑year follow‑up (p<0.001).

4.3 In the non-randomised comparative study of 415 patients, PPI use was reported by 19% of patients who had a magnetic titanium ring and 14% of patients who had Nissen fundoplication at 1‑year follow‑up (p=0.18). In the case series of 100 patients, 89% (76/85) of patients had reduced their average daily dose of PPIs by 50% or more at 5‑year follow‑up (95% CI 81 to 95); 75% of patients reported completely stopping PPIs and 9% reported PPI use only as needed. In a non-randomised comparative study of 249 patients, 82% of patients who had laparoscopic insertion of a magnetic titanium ring reported stopping PPIs at 1‑year follow‑up, compared with 63% of patients who had laparoscopic fundoplication (p=0.009).

4.4 In the non-randomised comparative study of 238 patients, reoperation for recurrent symptoms of heartburn or regurgitation was reported in 2% (3/135) of patients who had a magnetic titanium ring and 4% (4/103) of patients who had Toupet fundoplication (hazard ratio 0.77, 95% CI 0.23 to 2.57, p=0.687). In the non-randomised comparative study of 415 patients, reoperation for recurrent symptoms was reported in less than 1% (1/201) of patients who had a magnetic titanium ring and 1% (2/214) of patients who had Nissen fundoplication.

4.5 In the non-randomised comparative study of 415 patients, patient satisfaction was 88% in those who had a magnetic titanium ring and 89% in those who had Nissen fundoplication (p=0.61) in a propensity matched analysis of 114 patient pairs; 93% and 83% of patients respectively reported that they would have the procedure again (p=0.01). In the case series of 100 patients, 3% and 7% of patients were dissatisfied with their condition at 1‑ and 5‑year follow‑up respectively. In a case series of 44 patients, 91% of patients were satisfied with their current condition at 5‑year follow-up, compared with none at baseline.

4.6 The specialist advisers listed key efficacy outcomes as improved reflux symptoms, freedom from the need to take anti-reflux medication, improved quality of life, and little or no gas bloat syndrome.

  • National Institute for Health and Care Excellence (NICE)