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

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 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.

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  • Authors+Show Affiliations

    ,

    Division of Gastroenterology (111B1), Department of Veterans Affairs Medical Center, 4500 S Lancaster Rd, Dallas, TX 75216, USA. sjspechler@aol.com

    , , , , , , , , , , ,

    Source

    JAMA 285:18 2001 May 09 pg 2331-8

    MeSH

    Adenocarcinoma
    Barrett Esophagus
    Cause of Death
    Esophageal Neoplasms
    Esophageal Stenosis
    Esophagitis
    Esophagoscopy
    Female
    Follow-Up Studies
    Fundoplication
    Gastroesophageal Reflux
    Gastrointestinal Agents
    Humans
    Hydrogen-Ion Concentration
    Male
    Middle Aged
    Proportional Hazards Models
    Randomized Controlled Trials as Topic
    Severity of Illness Index
    Survival Analysis

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, Non-P.H.S.

    Language

    eng

    PubMed ID

    11343480

    Citation

    Spechler, S J., et al. "Long-term Outcome of Medical and Surgical Therapies for Gastroesophageal Reflux Disease: Follow-up of a Randomized Controlled Trial." JAMA, vol. 285, no. 18, 2001, pp. 2331-8.
    Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA. 2001;285(18):2331-8.
    Spechler, S. J., Lee, E., Ahnen, D., Goyal, R. K., Hirano, I., Ramirez, F., ... Williford, W. (2001). Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA, 285(18), pp. 2331-8.
    Spechler SJ, et al. Long-term Outcome of Medical and Surgical Therapies for Gastroesophageal Reflux Disease: Follow-up of a Randomized Controlled Trial. JAMA. 2001 May 9;285(18):2331-8. PubMed PMID: 11343480.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: 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,F, AU - Raufman,J P, AU - Sampliner,R, AU - Schnell,T, AU - Sontag,S, AU - Vlahcevic,Z R, AU - Young,R, AU - Williford,W, PY - 2001/5/10/pubmed PY - 2001/5/26/medline PY - 2001/5/10/entrez SP - 2331 EP - 8 JF - JAMA JO - JAMA VL - 285 IS - 18 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 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. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/11343480/Long_term_outcome_of_medical_and_surgical_therapies_for_gastroesophageal_reflux_disease:_follow_up_of_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/285/pg/2331 DB - PRIME DP - Unbound Medicine ER -