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A randomized trial was conducted to compare medical versus surgical treatment for refractory heartburn.
Systematic workup demonstrated truly proton-pump
inhibitors (PPI0-refractory and reflux-related heartburn in only a minority of
patients among patients referred to Veterans Affairs (VA) gastroenterology
clinics for heartburn unrelieved by PPIs. Notably, surgery demonstrated
superiority to medical treatment for that highly selected subgroup.
A randomized trial was conducted to compare medical versus
surgical treatment for refractory heartburn.
From 29 August 2012 to 2 December 2015, the study recruited 366 patients (mean age, 48.5 years; 280 men) with follow-up ending on 31 December 2016. After screening, 78 participants underwent randomization.
For PPI-refractory heartburn, patients who were referred to VA gastroenterology clinics were given 20 mg of omeprazole twice daily for two weeks. Subjects having persistent heartburn underwent multichannel intraluminal impedance-pH monitoring, esophageal biopsy, endoscopy, and esophageal manometry.
If individuals were found to have reflux-related heartburn, they were randomly allocated to receive active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms, n=25), surgical treatment (laparoscopic Nissen fundoplication, n=27), or control medical treatment (omeprazole plus placebo, n=26).
Treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) score (range, 0 to 50, with elevated scores depicting worse symptoms) at one year was the primary outcome parameter.
Compared to the active or control medical treatment, the incidence of treatment success with surgery was substantially superior as depicted from the following figure and table:
Figure 1: Treatment success at 1 year (%) between the surgery, active medical treatment and control medical treatment group
The difference in the occurrence of treatment success was 39
percentage points for surgery versus active medical treatment, 55 percentage
points for surgery versus control medical treatment, and 16 percentage points
for active medical treatment versus control medical treatment.
For refractory heartburn, surgery
is superior to medical treatment.
The New England Journal of Medicine
Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn
S.J. Spechler et al.
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