This article is more than 5 years old. Information may no longer be current.
Surgery superior to medical therapy for certain patients with refractory heartburn
Click Here to Manage Email Alerts
WASHINGTON — Laparoscopic Nissen fundoplication was superior to medical therapy among carefully selected patients with heartburn refractory to proton pump inhibitors, according to new research.
“The differences in treatment success rates at one year were dramatic,” Stuart J. Spechler, MD, of the Dallas VA Medical Center and Baylor University Medical Center said during his presentation.
To compare medical and surgical therapies for patients with PPI-refractory heartburn, Spechler and colleagues enrolled 366 patients (280 men; mean age 48.5 years) from 10 VA medical centers, 288 (78.7%) of whom were excluded by pre-randomization procedures designed to exclude non-GERD disorders. The remaining patients then underwent multichannel intraluminal impedance and pH (MII-pH) monitoring, and those with a positive symptom association for acid or non-acid reflux, and/or abnormal acid reflux were then randomly assigned to laparoscopic Nissen fundoplication, medical therapy with 20 mg omeprazole twice daily plus up to 20 mg baclofen three times daily (or up to 100 mg desipramine if baclofen failed), or placebo.
Treatment success at 1 year served as the primary endpoint, which researchers defined as at least 50% improvement from the baseline GERD-HRQL score.
Among the 78 randomized patients (21% of the original group; 64 men; 54 white; mean age, 45.4 years), 37 had positive symptom association based on MII-pH, 15 had abnormal acid reflux, and 25 had both. Surgery was performed in 27, medical therapy was given to 25 and placebo to 26.
Therapeutic success at one year was achieved by 66.7% of those who underwent surgery, by 28% of those who received medical therapy, and by 11.5% of those who received placebo. Surgery was significantly more successful compared with both medical therapy (P = .007) and placebo (P < .0001), while medical and placebo groups showed statistically comparable success rates.
Four of the surgical patients, four of those who received medical therapy and three who received placebo experienced serious adverse events.
“In those highly select 78 patients with truly PPI refractory reflux-related heartburn ... laparoscopic Nissen fundoplication was significantly superior to medical therapy, and active medical therapy was not significantly better than placebo,” Spechler said. “For patients with heartburn not responding to PPIs, this study shows that systematic workup can identify a minority subgroup of patients who respond to antireflux surgery.” – by Adam Leitenberger
Reference:
Spechler S, et al. Abstract 615. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Disclosures: Spechler reports financial relationships with Takeda, Ironwood and UpToDate. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.
Perspective
Back to Top
Kenneth DeVault, MD, FACG
This VA cooperative trial was one of the more important studies presented at Digestive Disease Week. Surgery was effective in a very selected group of patients with well-established reflux disease that were refractory to medical therapy. The real answer from this study is a bit more complicated and really surrounds how patients were both excluded and selected for the study. Of the 366 patients who entered the trial, 288 were excluded prior to randomization and 108 were excluded due to technical issues and failure to follow up, which is an expected number in a study of this type. Most importantly, another 99 were excluded due to negative ambulatory pH testing and 42 had greater than 50% improvement during a 2-week trial of omeprazole 20 mg twice daily. There were several other exclusions leading to the 78 randomized patients.
Once randomized, patients either had surgery, increased medical therapy or placebo with success rates of 66.7%, 28% and 11.5% respectively. Surgery was statistically superior to both other groups. The medical therapy beyond PPI (baclofen and imipramine) is not well established but actually did more than double the response rate (not statistically significant in these small samples). Thus, surgery is effective in refractory GERD in a well-selected subset of patients, but one would expect that more effective medical therapy would also reach significance in an optimally powered study as well as in selected patients in clinical practice.
Click Here to Manage Email Alerts