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2009-07-29 10:32:42 UTC
1: Gastroenterology. 2009 Jul;137(1):80-7, 87.e1. Epub 2009 Apr 10.
Comment in:
Gastroenterology. 2009 Jul;137(1):20-2.
Proton-pump inhibitor therapy induces acid-related symptoms in healthy
volunteers after withdrawal of therapy.
Reimer C, Søndergaard B, Hilsted L, Bytzer P.
Department of Medical Gastroenterology, Køge University Hospital,
Copenhagen University, Copenhagen, Denmark.
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.
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.
RESULTS:
unThere 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).
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.
PMID: 19362552
Comment in:
Gastroenterology. 2009 Jul;137(1):20-2.
Proton-pump inhibitor therapy induces acid-related symptoms in healthy
volunteers after withdrawal of therapy.
Reimer C, Søndergaard B, Hilsted L, Bytzer P.
Department of Medical Gastroenterology, Køge University Hospital,
Copenhagen University, Copenhagen, Denmark.
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.
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.
RESULTS:
unThere 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).
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.
PMID: 19362552