title: Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice.
abstract: Objective. To investigate whether patients on long-term antisecretory medication need to continue treatment to control symptoms. Methods. A double-blinded randomised placebo-controlled trial in general practices in Denmark. Patients aged 18-90 who were treated with antisecretory drugs on a long-term basis were randomized to esomeprazole 40 mg or identical placebo. Outcome measures were time to discontinuation with trial medication due to failed symptom control analysed as survival data. The proportion of patients stopping trial medication during the one-year follow-up was estimated. Results. A total of 171 patients were included with a median prior duration of antisecretory treatment of four years (range: 0.5 to 14.6 years). 86 patients received esomeprazole 40 mg and 85 patients received placebo. At 12 months, statistically significantly more patients in the placebo group had discontinued (73% (62/85)) compared with the esomeprazole group (21% (18/86); p < 0.001). Conclusions. Long-term users of antisecretory drugs showed a preference for the active drug compared to placebo. However, 27% of patients continued on placebo throughout the study and did not need to reinstitute usual treatment. One in five patients treated with esomeprazole discontinued trial medication due to unsatisfactory symptom control. Discontinuation of antisecretory treatment should be considered in long-term users of antisecretory drugs. This trial is registered with Trial registration ClinicalTrials.gov ID: NCT00120315.
authors.affiliation: Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J. B. Winslows Vej 9A, Odense, Denmark.
authors.forename: Jon Eik
authors.initials: JE
authors.lastname: Zwisler
authors.affiliation: Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J. B. Winslows Vej 9A, Odense, Denmark.
authors.forename: Dorte Ejg
authors.initials: DE
authors.lastname: Jarbøl
authors.affiliation: Department of Emergency Medicine, Odense University Hospital, 5000 Odense, Denmark.
authors.forename: Annmarie Touborg
authors.initials: AT
authors.lastname: Lassen
authors.affiliation: Research Unit for General Practice and Section of General Practice, Department of Public Health, Copenhagen University, 1014 Copenhagen K, Denmark.
authors.forename: Jakob
authors.initials: J
authors.lastname: Kragstrup
authors.affiliation: Department of Internal Medicine, Regional Hospital Herning, 7400 Herning, Denmark.
authors.forename: Niels
authors.initials: N
authors.lastname: Thorsgaard
authors.affiliation: Department of Medical Gastroenterology, Odense University Hospital, 5000 Odense, Denmark.
authors.forename: Ove B
authors.initials: OB
authors.lastname: Schaffalitzky de Muckadell