BACKGROUND: GERD is common in US adults, and its sequela, Barrett esophagus, is a risk factor for esophageal carcinoma. Modern medical and surgical (laparoscopic fundoplication) therapies are highly effective in controlling GERD symptoms, but there are few data regarding long-term outcomes.
POPULATION STUDIED: The patients studied were part of a Veterans Affairs cooperative study comparing medical and surgical therapy from 1986 to 1988. The enrolled subjects had complicated GERD as determined by GERD Activity Index score and presence of esophagitis, esophageal ulcer, esophageal stricture, or Barrett esophagus.
STUDY DESIGN AND VALIDITY: This study provides the longest follow-up (approximately 10 years) and most complete comparison of outcomes of medical and surgical therapy for severe GERD. In the original trial, patients had been randomized (allocation assignment concealed) to medical treatment with ranitidine and other drugs given continuously or intermittently for symptoms, or to surgery (open Nissen fundoplication). For this follow-up report, the researchers identified the cause of death of those who had died since the original study and re-evaluated those still living. The evaluation consisted of GERD activity scores, endoscopy, 24-hour esophageal pH monitoring, and completion of the 36-item Medical Outcomes Study short form (SF-36) and a questionnaire regarding GERD treatments. Patients discontinued antireflux medications for 1 week before the endoscopy and recording their symptoms. In the original study, baseline characteristics were similar between treatment groups, including frequency of complications such as ulcers and Barrett esophagus. Almost all the patients were men, with a mean age of 67 years. This might limit generalizability, although men have a higher risk of esophageal cancer. Possible limitations included lack of blinding of the investigators to the original treatment assignment, self-reporting of symptoms using a diary (probably similar reliability for both groups), and inability to document if patients stopped use of all antireflux medications in the second week (antacids were allowed).
OUTCOMES MEASURED: The outcomes measured included antireflux medication usage, GERD activity index score off medication, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of additional antireflux operations, SF-36 survey scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma.
RESULTS: In the original study, 165 patients received medical therapy, and 82 had surgery (n=247). In the follow-up study, 239 subjects were located; of these, 79 had died. Of the remaining 160 subjects, 129 participated in the follow-up study. Thus, outcomes were determined for 84% of the original participants (129 survivors and 79 deaths). More medically treated than surgically treated patients reported regular use of antireflux medications (92% vs 62%; P <.001; number needed to treat = 3). Symptom scores were also significantly lower in the surgical group during the week off medication. No significant differences were found between the groups in the endoscopic grade of esophagitis, frequency of treatment of esophageal stricture, subsequent antireflux operations, health survey scores, overall satisfaction with antireflux therapy, or the incidence of esophageal cancer. Mortality was significantly higher in the surgical group during the follow-up period (40% vs 28%; P=.047; number needed to harm = 8). The majority of these deaths were attributed to heart disease. Patients with Barrett esophagus developed esophageal cancer at an annual rate of 0.4%, while the rate was 0.07% in patients with severe GERD but without Barrett esophagus. Esophageal cancer was an uncommon cause of death.
This study revealed no significant differences in outcomes between surgical and medical treatment for severe GERD. Surgical therapy did not eliminate the need for antisecretory medications, although there was less regular use of these medications. Surgery was associated with an unexplained increase in subsequent mortality from heart disease. Esophageal cancer incidence and mortality were rare. Satisfaction with current medical therapy is likely to be even better with the availability of potent proton pump inhibitors. Since surgical mortality from laparoscopic fundoplication exceeds the rate of esophageal cancer in patients with severe GERD, medical therapy for GERD should be the first line of treatment.