Trad KS, Barnes WE, Simoni G, Shughoury AB, Raza M, Heise J,Turgeon DG, Fox MA
Gastroenterol. May 2013; 144(5):S163-4.
BACKGROUND & AIM:
Transoral fundoplication (TF) has previously been shown to be a safe and effective treatment alternative for a selected gastroesophageal reflux disease (GERD) patient population. The aim of this prospective, multicenter, open-label, randomized study was to compare the safety and efficacy of the TF procedure against maximum dose PPI in controlling the chronic manifestations of GERD.
Between June and August 2012, in 7 U.S. centers, 63 patients with objective evidence of GERD and abnormal esophageal acid exposure (48-h pH monitoring) were randomized. Block randomization of nine allocations was carried out by an independent statistician using computer-generated random number program and was sent to the investigators in sealed opaque envelopes. Patients in PPI group continued on maximum daily dose or increased to the maximum daily dose, per approved dosage. Patient in TF group underwent fundoplication with EsophyX2 device and discontinued PPIs 2 weeks after procedure. Primary outcome was elimination (if scores >2 at screening were ≤2 at follow-up) of daily bothersome/troublesome GERD symptoms, as evaluated by GERD-Health Related Quality of Life, Reflux Symptom Index and Reflux Disease Questionnaires. Secondary outcomes were normalization of distal esophageal acid exposure, PPI usage and healing of esophagitis.
Of 63 patients, 40 were allocated to the TF and 23 to the PPI group. Three patients did not complete 6-month follow up (1 TF, 2 PPI) leaving 39 patients in the TF and 21 patients in the PPI group for data analysis. The two groups were well matched for all baseline characteristics (Table 1). Teams led by surgeons (4 centers) and gastroenterologists (3 centers) performed TF procedures. There were no serious complications. Globally, at 6-month follow-up, 62% (24/39) of TF patients experienced the elimination of all daily bothersome/troublesome GERD symptoms (off PPIs) vs. 5% (1/21) of PPI patients, p < 0.001. There were significant differences between the groups for the elimination of the majority of GERD symptoms (Table 2). Esophageal acid exposure, as evaluated by the % time pH < 4, was normalized in 54 % (20/39) of patients in the TF group (off PPIs) vs. 52% (11/21) of patients in the PPI group (on maximum daily dose), p =1.000. Esophagitis was healed in 90% (18/20) of patients in the TF group vs. 38% (5/13) in the PPI group, p = 0.004. Ninety percent (35/39) of patients in the TIF group were off PPIs at 6-month follow-up. De novo dysphagia, bloating and flatulence were not observed in the TF group.
This study provides the first Level I evidence demonstrating that TF is superior to maximal dose PPI in eliminating daily bothersome chronic GERD symptoms including heartburn in selected GERD patients. Both therapies achieved similar normalization of distal esophageal acid exposure.
Link to abstract: Trad KS, et al; Gastroenterolog. May 2013; 144(5):S163-4.