L. Lundell et al., Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease, J AM COLL S, 192(2), 2001, pp. 172-179
BACKGROUND: The efficacy of antireflux surgery (ARS) and proton pump inhibi
tor therapy in the control of gastroesophageal reflux disease is well estab
lished. A direct comparison between these therapies is warranted to assess
the benefits of respective therapies.
STUDY DESIGN: There were 310 patients with erosive esophagitis enrolled in
the trial. There were 155 patients randomized to continuous omeprazole ther
apy and 155 to open antireflux surgery, of whom 144 later had an operation.
Because of various withdrawals during the study course, 122 patients origi
nally having an antireflux operation completed the 5-year followup; the cor
responding figure in the omeprazole group was 133. Symptoms, endoscopy, and
quality-of-life questionnaires were used to document clinical out comes. T
reatment failure was defined to occur if at least one of the following crit
eria were fulfilled: Moderate or severe heartburn or acid regurgitation dur
ing the last 7 days before the respective visit; Esophagitis of at least gr
ade 2; Moderate or severe dysphagia or odynophagia symptoms reported in com
bination with mild heartburn or regurgitation; If randomized to surgery and
subsequently required omeprazole for more than 8 weeks to control symptoms
, or having a reoperation; If randomized to omeprazole and considered by th
e responsible physician ro require antireflux surgery to control symptoms;
If randomized to omeprazole and the patient, for any reason, preferred anti
reflux surgery during the course of the study. Treatment failure was the pr
imary outcomes variable.
RESULTS: When the time to treatment failure was analyzed by use of the inte
ntion to treat approach, applying the life table analysis technique, a high
ly significant difference between the two strategies was revealed (p < 0.00
1), with more treatment failures in patients who originally were randomized
to omeprazole treatment. The protocol also allowed dose adjustment in pati
ents allocated to omeprazole therapy to tither 40 or 60 mg daily in case of
symptom recurrence. The curves subsequently describing the failure rates s
till remained separated in favor of surgery although the difference did not
reach statistical significance (p = 0.088). Quality of life assessment rev
ealed values within normal ranges in both therapy arms during the 5 years.
CONCLUSIONS: In this randomized multicenter trial with a 5-year followup, w
e found antireflux surgery to be more effective than omeprazole in controll
ing gastroesophageal reflux disease as measured by the treatment failure ra
tes. But if the dose of omeprazole was adjusted in case of relapse, the two
therapeutic strategies reached levels of efficacy that were not statistica
lly different. (J Am Coll Surg 2001;192:172-181. (C) 2001 by the American C
ollege of Surgeons).