Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: Follow-up of a randomized controlled trial

S. J. Spechler, E. Lee, D. Ahnen, R. K. Goyal, I. Hirano, Francisco C Ramirez, J. P. Raufman, R. Sampliner, T. Schnell, S. Sontag, Z. Reno Vlahcevic, R. Young, W. Williford

Research output: Contribution to journalArticle

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Abstract

Context: 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. Design and Setting: 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. Participants: 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. Main Outcome Measures: 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. Conclusion: This study suggests that antirefiux 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.

Original languageEnglish (US)
Pages (from-to)2331-2338
Number of pages8
JournalJournal of the American Medical Association
Volume285
Issue number18
StatePublished - May 9 2001
Externally publishedYes

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Gastroesophageal Reflux
Randomized Controlled Trials
Esophageal Stenosis
Barrett Esophagus
Therapeutics
Esophagitis
Esophageal Neoplasms
Adenocarcinoma
Fundoplication
Death Certificates
Survival
Hospital Records
Incidence
Group Psychotherapy
Health Surveys
Survivors
Cause of Death
Digestion
Autopsy
Heart Diseases

ASJC Scopus subject areas

  • Medicine(all)

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Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease : Follow-up of a randomized controlled trial. / Spechler, S. J.; Lee, E.; Ahnen, D.; Goyal, R. K.; Hirano, I.; Ramirez, Francisco C; Raufman, J. P.; Sampliner, R.; Schnell, T.; Sontag, S.; Reno Vlahcevic, Z.; Young, R.; Williford, W.

In: Journal of the American Medical Association, Vol. 285, No. 18, 09.05.2001, p. 2331-2338.

Research output: Contribution to journalArticle

Spechler, SJ, Lee, E, Ahnen, D, Goyal, RK, Hirano, I, Ramirez, FC, Raufman, JP, Sampliner, R, Schnell, T, Sontag, S, Reno Vlahcevic, Z, Young, R & Williford, W 2001, 'Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: Follow-up of a randomized controlled trial', Journal of the American Medical Association, vol. 285, no. 18, pp. 2331-2338.
Spechler, S. J. ; Lee, E. ; Ahnen, D. ; Goyal, R. K. ; Hirano, I. ; Ramirez, Francisco C ; Raufman, J. P. ; Sampliner, R. ; Schnell, T. ; Sontag, S. ; Reno Vlahcevic, Z. ; Young, R. ; Williford, W. / Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease : Follow-up of a randomized controlled trial. In: Journal of the American Medical Association. 2001 ; Vol. 285, No. 18. pp. 2331-2338.
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T1 - Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease

T2 - Follow-up of a randomized controlled trial

AU - Spechler, S. J.

AU - Lee, E.

AU - Ahnen, D.

AU - Goyal, R. K.

AU - Hirano, I.

AU - Ramirez, Francisco C

AU - Raufman, J. P.

AU - Sampliner, R.

AU - Schnell, T.

AU - Sontag, S.

AU - Reno Vlahcevic, Z.

AU - Young, R.

AU - Williford, W.

PY - 2001/5/9

Y1 - 2001/5/9

N2 - Context: 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. Design and Setting: 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. Participants: 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. Main Outcome Measures: 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. Conclusion: This study suggests that antirefiux 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.

AB - Context: 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. Design and Setting: 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. Participants: 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. Main Outcome Measures: 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. Conclusion: This study suggests that antirefiux 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.

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