Comparison of outcomes twelve years after antireflux surgery or omeprazole maintenance therapy for reflux esophagitis.
OBJECTIVE
It is important to evaluate the long-term effects of therapies for gastroesophageal reflux disease (GERD). In a 12-year study, we compared the effects of therapy with omeprazole with those of antireflux surgery.


METHODS
This open, parallel group study included 310 patients with esophagitis enrolled from outpatient clinics in Nordic countries. Of the 155 patients randomly assigned to each arm of the study, 154 received omeprazole (1 withdrew before therapy began), and 144 received surgery (11 withdrew before surgery). In patients who remained in remission after treatment, post-fundoplication complaints, other symptoms, and safety variables were assessed.


RESULTS
Of the patients enrolled in the study, 71 who were given omeprazole (46%) and 53 treated with surgery (37%) were followed for a 12-year follow-up period. At this time point, 53% of patients who underwent surgery remained in continuous remission, compared with 45% of patients given omeprazole with a dose adjustment (P = .022) and 40% without dose adjustment (P = .002). In addition, 38% of surgical patients required a change in therapeutic strategy (eg, to medical therapy or another operation), compared with 15% of those on omeprazole. Heartburn and regurgitation were significantly more common in patients given omeprazole, whereas dysphagia, rectal flatulence, and the inability to belch or vomit were significantly more common in surgical patients. The therapies were otherwise well-tolerated.


CONCLUSIONS
As long-term therapeutic strategies for chronic GERD, surgery and omeprazole are effective and well-tolerated. Antireflux surgery is superior to omeprazole in controlling overall disease manifestations, but post-fundoplication complaints continue after surgery.
Lundell
Lars
L
Department of Surgery, Karolinska University Hospital, Huddinge, Sweden. lars.lundell@karolinska.se
Miettinen
Pekka
P
Myrvold
Helge E
HE
Hatlebakk
Jan G
JG
Wallin
Lene
L
Engström
Cecilia
C
Julkunen
Risto
R
Montgomery
Madeline
M
Malm
Anders
A
Lind
Tore
T
Walan
Anders
A
D000328:Adult; D000368:Aged; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D055815:Young Adult
D004791:Enzyme Inhibitors; D009853:Omeprazole