title: Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial.
abstract: BACKGROUND
  Severe gastroesophageal reflux disease (GERD) is a lifelong problem that can be complicated by peptic esophageal stricture and adenocarcinoma of the esophagus.
  
  
  OBJECTIVE
  To determine the long-term outcome of medical and surgical therapies for GERD.
  
  
  METHODS
  Follow-up study conducted from October 1997 through October 1999 of a prospective randomized trial of medical and surgical antireflux treatments in patients with complicated GERD. Mean (median) duration of follow-up was 10.6 years (7.3 years) for medical patients and 9.1 years (6.3 years) for surgical patients.
  
  
  METHODS
  Two hundred thirty-nine (97%) of the original 247 study patients were found (79 were confirmed dead). Among the 160 survivors (157 men and 3 women; mean [SD] age, 67 [12] years), 129 (91 in the medical treatment group and 38 in the surgical treatment group) participated in the follow-up.
  
  
  METHODS
  Use of antireflux medication, Gastroesophageal Reflux Disease Activity Index (GRACI) scores, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of subsequent antireflux operations, 36-item Short Form health survey (SF-36) scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma, compared between the medical antireflux therapy group and the fundoplication surgery group. Information on cause of death was obtained from autopsy results, hospital records, and death certificates.
  
  
  RESULTS
  Eighty-three (92%) of 90 medical patients and 23 (62%) of 37 surgical patients reported that they used antireflux medications regularly (P<.001). During a 1-week period after discontinuation of medication, mean (SD) GRACI symptom scores were significantly lower in the surgical treatment group (82.6 [17.5] vs 96.7 [21.4] in the medical treatment group; P =.003). However, no significant differences between the groups were found in grade of esophagitis, frequency of treatment of esophageal stricture and subsequent antireflux operations, SF-36 standardized physical and mental component scale scores, and overall satisfaction with antireflux therapy. Survival during a period of 140 months was decreased significantly in the surgical vs the medical treatment group (relative risk of death in the medical group, 1.57; 95% confidence interval, 1.01-2.46; P =.047), largely because of excess deaths from heart disease. Patients with Barrett esophagus at baseline developed esophageal adenocarcinomas at an annual rate of 0.4%, whereas these cancers developed in patients without Barrett esophagus at an annual rate of only 0.07%. There was no significant difference between groups in incidence of esophageal cancer.
  
  
  CONCLUSIONS
  This study suggests that antireflux surgery should not be advised with the expectation that patients with GERD will no longer need to take antisecretory medications or that the procedure will prevent esophageal cancer among those with GERD and Barrett esophagus.
authors.affiliation: Division of Gastroenterology (111B1), Department of Veterans Affairs Medical Center, 4500 S Lancaster Rd, Dallas, TX 75216, USA. sjspechler@aol.com
authors.forename: S J
authors.initials: SJ
authors.lastname: Spechler
authors.forename: E
authors.initials: E
authors.lastname: Lee
authors.forename: D
authors.initials: D
authors.lastname: Ahnen
authors.forename: R K
authors.initials: RK
authors.lastname: Goyal
authors.forename: I
authors.initials: I
authors.lastname: Hirano
authors.forename: F
authors.initials: F
authors.lastname: Ramirez
authors.forename: J P
authors.initials: JP
authors.lastname: Raufman
authors.forename: R
authors.initials: R
authors.lastname: Sampliner
authors.forename: T
authors.initials: T
authors.lastname: Schnell
authors.forename: S
authors.initials: S
authors.lastname: Sontag
authors.forename: Z R
authors.initials: ZR
authors.lastname: Vlahcevic
authors.forename: R
authors.initials: R
authors.lastname: Young
authors.forename: W
authors.initials: W
authors.lastname: Williford
mesh_terms: D000230:Adenocarcinoma / Q000453:epidemiology / Q000209:etiology; D001471:Barrett Esophagus / Q000150:complications; D002423:Cause of Death; D004938:Esophageal Neoplasms / Q000453:epidemiology / Q000209:etiology*; D004940:Esophageal Stenosis / Q000453:epidemiology / Q000209:etiology*; D004941:Esophagitis / Q000453:epidemiology / Q000209:etiology*; D004945:Esophagoscopy; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000601:surgery / Q000628:therapy*; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016019:Survival Analysis
chemical_list: D005765:Gastrointestinal Agents