Surgery offers sustained advantage over medication for GORD relief
Minimal access surgery provides sustained improvements in relief from symptoms of gastro-oesophageal reflux disease (GORD) when compared with medical management, according to a study which also suggests any adverse effects of surgery are uncommon and short-lived.
Five-year follow-up of the REFLUX clinical trial including 357 patients with GORD, recruited from 21 UK centres, of whom 178 were randomised to undergo laparoscopic fundoplication and 179 to receive medical management. The trial also included a parallel group of 453 patients recruited according to their preference for surgery or medical management.
The primary outcome was self-reported health-related quality of life measured by the REFLUX score, a validated questionnaire incorporating assessment of reflux related and other gastrointestinal symptoms as well as side effects and complications of both treatments. Secondary outcomes included other health status measures and complications.
Scores on the REFLUX questionnaire were higher among patients randomised to surgery than those randomised to medical management throughout follow-up, from three months to five years. Although differences between groups narrowed over time, the mean difference in score at five years was a statistically significant 8.5.
At five years, heartburn, regurgitation and belching were reported less frequently in the group randomised to surgery than to medication, while there was no difference between groups in ‘difficulty swallowing’, ‘wind from the bowel’ or ‘wanting to be sick but being unable’.
Quality of life as determined by SF-36 scores favoured the surgical group across all domains throughout follow-up, but differences had declined over time and by five years only the general health and role emotional domains were statistically improved with surgery versus medical management.
Of a total of 364 patients who underwent fundoplication (randomised or preferred), 16 (4.4%) had a subsequent reflux related re-operation and 12 (3.3%) had a late complication.
What this means for GPs
The researchers say further research is needed to establish the longer-term risks of morbidity associated with surgery, but the benefits of laparoscopic fundoplication may outweigh the short-term risks among some patients.
They conclude: ‘Five-year follow-up of trial participants confirmed sustained benefits of surgery as an alternative to drug treatment for GORD. Adverse effects of surgery were uncommon and generally observed soon after surgery. Unlike in some other studies, unwanted long-term symptoms were not associated with surgery in this trial.’