ORLANDO, Florida — Patients with gastroesophageal reflux disease (GERD) might benefit more from transoral incisionless fundoplication than from continued treatment with proton-pump inhibitors (PPIs), according to a prospective randomized multicenter study.
"In this study, transoral incisionless fundoplication was superior to maximal-dose PPIs in eliminating daily troublesome typical and atypical symptoms in selected patients," said lead author Karim Trad, MD, a surgeon at George Washington University School of Medicine and Health Sciences in Washington, DC. He said the results "establish for the first time that, for some patients, the procedure is better than maximal-dose PPI therapy for controlling a range of GERD symptoms."
The surgery is based on traditional fundoplication, but takes a transoral rather than a laparoscopic approach. The procedure reconstructs the gastroesophageal valve restoring its competency and re-establishing the barrier to reflux.
Dr. Trad presented the study results during a late-breaking abstract session here at Digestive Disease Week 2013.
The study known as TEMPO (Transoral Incisionless Fundoplication Esophyx vs Medical PPI Open Label Trial) was designed to compare the safety and efficacy of surgery to drug therapy.
The researchers enrolled 63 patients at 3 gastroenterology practices and 4 general surgery practices in the United States. All patients had objective evidence of GERD and abnormal esophageal acid exposure, had experienced symptoms for a median of 10 years, and had been on PPIs for a median of 8 years.
About half the study cohort had esophagitis. The difference in hiatal hernia was not significant in the surgery and PPI groups (92% vs 76%). The percent of time with a pH below 4 at baseline was about 9% in each group. All patients were comprehensively assessed for daily symptoms and troublesome regurgitation. At screening, there were no significant differences between the groups in quality-of-life scores assessed with a variety of instruments.
The researchers randomly assigned patients to have surgery or to remain on or increase to maximal-dose PPI therapy. Patients in surgery group underwent fundoplication with the EsophyX2 device and discontinued PPIs 2 weeks after the procedure.
The primary outcome, the elimination of daily bothersome or troublesome symptoms, was evaluated with the GERD-Health-Related Quality of Life Scale, Reflux Symptom Index, and the Reflux Disease Questionnaire. Secondary outcomes were normalization of distal esophageal acid exposure, PPI usage, and healing of esophagitis.
"Transoral incisionless fundoplication was superior to PPIs in eliminating a range of atypical symptoms," Dr. Trad reported. "We are talking about the total elimination of symptoms at 6 months, not a 50% reduction. This is a very compelling result."
Daily bothersome heartburn, evaluated with the Reflux Symptom Index, was eliminated in 90% of patients with surgery, and 90% of this group completely discontinued PPI use. There were significant improvements in a range of end points with surgery.
"In every comparison except for swallowing, transoral incisionless fundoplication was superior to and significantly different from PPIs," he noted.
Elimination of bloating and flatulence was significantly more likely with surgery than with PPIs (P < .001); however, dysphagia was similar in the 2 groups (92% vs 75%).
Table. TEMPO 6-Month Outcomes
|End Point||Surgery||PPI||P Value|
|Elimination of daily troublesome atypical reflux disease symptoms||84% to 100%*||13% to 78%*||.04 to <.001|
|Elimination of regurgitation||97%||50%||<.001|
|Elimination of atypical symptoms and regurgitation||62%||5%||<.001|
|Elimination of heartburn||90%||13%||<.001|
Table. TEMPO Change in Scores From Baseline to 6 Months
|End Point||Surgery||P Value||PPI||P Value|
|Reduction in Reflux Symptom Index||22.0 to 4.6||<.001||22.6 to 19.6||NS|
|Reduction in Reflux Disease Questionnaire score||3.2 to 0.2||<.001||3.4 to 2.0||<.001|
|Reduction in GERD-Health-Related Quality of Life score||26.3 to 5.2||<.001||26.4 to 18.9||<.001|
"No transoral incisionless fundoplication patients reported de novo postfundoplication side effects, such as dysphagia, gas bloating, and flatulence, which are commonly associated with laparoscopic antireflux procedures," he added.
Nearly three quarters of the surgery group reported being satisfied with their current health condition at 6 months, compared with only 5% of the PPI group (P < .001).
The normalization of distal esophageal acid exposure was similar in the surgery and PPI groups (54% vs 52%).
"Importantly, 100% of the transoral incisionless fundoplication group used PPIs daily before the surgery; this was reduced to 8% after treatment," Dr. Trad reported. PPI use was completely discontinued in 90% of the surgery group, and was used only on demand in 2%. In patients who continued to need PPIs, quality-of-life scores significantly improved for all measures.
"In the minority of patients who were back on PPIs, transoral incisionless fundoplication appeared to be a useful therapeutic adjunct," he noted.
"Transoral incisionless fundoplication could become a useful tool for the management of patients with chronic GERD, incomplete response to PPI therapy, and favorable endoscopic characteristics of the gastroesophageal junction," Dr. Trad concluded.
Lauren Gerson, MD, from Stanford University in Palo Alto, California, was asked by Medscape Medical News to comment on the study findings.
She questioned why the rates of dysphagia were so high in the study population and why the esophagitis healing rates were low with PPIs. "It makes you wonder if these patients had esophageal spasm, ineffective motility, or something like that, and would therefore be refractory," she said.
"The benefit of transoral incisionless fundoplication is that the patient does not need to undergo laparoscopy, but is it as effective as conventional fundoplication? It would be nice to see the 2 procedures compared," she said.
Dr. Gerson said she "strongly commends" Dr. Trad's team for doing pH monitoring, which was not done in most previous studies of this treatment approach. This study is an improvement over those that just looked at quality of life. "I think the percent time that pH is less than 4 is a more accurate measure of normalization."
Dr. Trad reports receiving support for speaking and teaching for EndoGastric Solutions, the maker of the EsophyX device used in the study. Dr. Gerson has disclosed no relevant financial relationships.
Digestive Disease Week (DDW) 2013. Abstract 925h. Presented May 21, 2013.
Medscape Medical News © 2013 WebMD, LLC
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Cite this: Surgery Trumps Proton Pump Inhibitors for Acid Reflux - Medscape - May 28, 2013.