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Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy.
- Source :
-
Gastroenterology [Gastroenterology] 2009 Jul; Vol. 137 (1), pp. 80-7, 87.e1. Date of Electronic Publication: 2009 Apr 10. - Publication Year :
- 2009
-
Abstract
- Background & Aims: Rebound acid hypersecretion (RAHS) has been demonstrated after 8 weeks of treatment with a proton-pump inhibitor (PPI). If RAHS induces acid-related symptoms, this might lead to PPI dependency and thus have important implications.<br />Methods: A randomized, double-blind, placebo-controlled trial with 120 healthy volunteers was conducted. Participants were randomized to 12 weeks of placebo or 8 weeks of esomeprazole 40 mg/d followed by 4 weeks with placebo. The Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly. A score of >2 on 1 of the questions regarding heartburn, acid regurgitation, or dyspepsia was defined as a clinically relevant acid-related symptom.<br />Results: There were no significant differences between groups in GSRS scores at baseline. GSRS scores for acid-related symptoms were significantly higher in the PPI group at week 10 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .023), week 11 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .009), and week 12 (1.3 +/- 1.2 vs 1.0 +/- 0.3; P = .001). Forty-four percent (26/59) of those randomized to PPI reported > or = 1 relevant, acid-related symptom in weeks 9-12 compared with 15% (9/59; P < .001) in the placebo group. The proportion reporting dyspepsia, heartburn, or acid regurgitation in the PPI group was 13 of 59 (22%) at week 10, 13 of 59 (22%) at week 11, and 12 of 58 (21%) at week 12. Corresponding figures in the placebo group were 7% at week 10 (P = .034), 5% at week 11 (P = .013), and 2% at week 12 (P = .001).<br />Conclusions: PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal. This study indicates unrecognized aspects of PPI withdrawal and supports the hypothesis that RAHS has clinical implications.
- Subjects :
- Adolescent
Adult
Double-Blind Method
Drug Administration Schedule
Dyspepsia metabolism
Esomeprazole administration & dosage
Female
Gastric Mucosa metabolism
Gastroesophageal Reflux metabolism
Heartburn metabolism
Humans
Male
Middle Aged
Proton Pump Inhibitors administration & dosage
Reference Values
Severity of Illness Index
Time Factors
Treatment Outcome
Young Adult
Dyspepsia chemically induced
Esomeprazole adverse effects
Gastric Acid metabolism
Gastric Mucosa drug effects
Gastroesophageal Reflux chemically induced
Heartburn chemically induced
Proton Pump Inhibitors adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 137
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 19362552
- Full Text :
- https://doi.org/10.1053/j.gastro.2009.03.058