GI tract

Refractory heartburn: patient selection important before surgery


Surgery can be effective in a highly selected group of patients with true PPI-refractory, reflux-related heartburn, research shows.

A US randomised controlled trial compared laparoscopic Nissen fundoplication versus omeprazole plus baclofen and desipramine if required (active medical treatment) or omeprazole plus placebo (control medical treatment).

The 78 participants were mostly white, male veterans referred for PPI-refractory heartburn who had not responded to a two-week trial of twice-daily omeprazole and after systematic evaluation were designated to have reflux-related heartburn.

Endoscopy, esophageal biopsy, esophageal manometry and multichannel intraluminal impedance–pH monitoring had previously ruled out patients with non-GERD diagnoses such as eosinophilic oesphagitis.

The study found treatment success at 12-months, defined as a >50% reduction in the GERD-HRQL score from baseline, was 67% in the surgical group versus 28% with active medical therapy and 12% with the control therapy.

The numbers of serious adverse events were few and similar in each treatment group. One surgical patient had a herniated Nissen fundoplication requiring repeat surgery and complicated by postoperative pneumonia.

“We conclude that systematic workup including esophageal MII-pH monitoring can identify a subgroup of patients with PPI-refractory heartburn, including those with reflux hypersensitivity, who can have a response to antireflux surgery,” the study said.

It noted however that only a minority of the original cohort of 366 patients fitted the criteria for randomisation.

In particular, some patients with a gastroenterology referral for PPI-refractory heartburn actually benefitted from omeprazole twice daily “with explicit instruction on how to take it properly”.

An accompanying editorial in the NEJM by Australian gastroenterologist Professor Nick Talley said the results of the surgical intervention were “striking” and the one-year outcome diminished the likelihood of a powerful placebo response to surgery.

“However, 79% of the patients who were enrolled did not meet the criteria for surgery, and furthermore, the results may not be generalisable beyond male veterans,” he said.

“For these and other reasons considered below, the findings should not translate into more patients with refractory heartburn being offered surgery without each case being judiciously evaluated on its merits, and only after extended trials of medical therapy.”

He said medical therapy had to include escalation to twice daily dosing, education to take the PPIs before meals, and trials of different agents.

“Unfortunately, we still have little to offer patients who despite a complete workup have troublesome reflux after surgery (as occurred in one third of surgical patients in this trial), aside from repeat esophageal testing and yet another trial of acid suppression.”

“We need personalised medical options that target the underlying causes of GERD.”

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