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Efficacy of omeprazole in functional dyspepsia : double-blind, randomized, placebo-controlled trials (the Bond and Opera studies)

Identifieur interne : 000C31 ( PascalFrancis/Curation ); précédent : 000C30; suivant : 000C32

Efficacy of omeprazole in functional dyspepsia : double-blind, randomized, placebo-controlled trials (the Bond and Opera studies)

Auteurs : N. J. Talley [Australie] ; V. Meineche-Schmidt [Australie] ; P. Pare [Australie] ; M. Duckworth [Australie] ; P. R Is Nen [Australie] ; A. Pap [Australie] ; H. Kordecki [Australie] ; V. Schmid [Australie]

Source :

RBID : Pascal:99-0043793

Descripteurs français

English descriptors

Abstract

Background: The efficacy of H2-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functional dyspepsia is unknown. Aim: To evaluate the efficacy of proton pump inhibitor therapy in functional dyspepsia. Methods; Patients (n = 1262) with a clinical diagnosis of functional dyspepsia (persistent or recurrent epigastric pain or discomfort for at least 1 month and a normal upper gastrointestinal endoscopy) were randomized to receive omeprazole 20 mg. 10 mg or identical placebo, for 4 weeks. Symptoms were assessed using validated measures. Helicobacter pylori status was determined pre-entry by a 13C-urea breath test. Results: On an intention-to-treat analysis (n=1248). complete symptom relief was observed in 38% on omeprazole 20 mg, compared with 36% on omeprazole 10 mg and 28% on placebo (P = 0.002 and 0.02. respectively). Among those with ulcer-like and reflux-like dyspepsia, complete symptom relief was achieved in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo (all P < 0.05, except omeprazole 10 mg in ulcer-like dyspepsia. P = 0.08). There was no significant benefit of omeprazole over placebo in dysmotility-like dyspepsia. Symptom relief was similar in H. pylori-positive and negative cases. Conclusions: Omeprazole is modestly superior to placebo in functional dyspepsia at standard (20 mg) and low doses (10 mg) but not in patients with dysmotility-like dyspepsia.
pA  
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A03   1    @0 Aliment. pharmacol. ther.
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A08 01  1  ENG  @1 Efficacy of omeprazole in functional dyspepsia : double-blind, randomized, placebo-controlled trials (the Bond and Opera studies)
A11 01  1    @1 TALLEY (N. J.)
A11 02  1    @1 MEINECHE-SCHMIDT (V.)
A11 03  1    @1 PARE (P.)
A11 04  1    @1 DUCKWORTH (M.)
A11 05  1    @1 RÄISÄNEN (P.)
A11 06  1    @1 PAP (A.)
A11 07  1    @1 KORDECKI (H.)
A11 08  1    @1 SCHMID (V.)
A14 01      @1 Department of Medicine, University of Sydney, Nepean Hospital @2 Penrith, New South Wales @3 AUS @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 5 aut. @Z 6 aut. @Z 7 aut. @Z 8 aut.
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A21       @1 1998
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A43 01      @1 INIST @2 21831 @5 354000071760440020
A44       @0 0000 @1 © 1999 INIST-CNRS. All rights reserved.
A45       @0 38 ref.
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A60       @1 P
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C01 01    ENG  @0 Background: The efficacy of H2-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functional dyspepsia is unknown. Aim: To evaluate the efficacy of proton pump inhibitor therapy in functional dyspepsia. Methods; Patients (n = 1262) with a clinical diagnosis of functional dyspepsia (persistent or recurrent epigastric pain or discomfort for at least 1 month and a normal upper gastrointestinal endoscopy) were randomized to receive omeprazole 20 mg. 10 mg or identical placebo, for 4 weeks. Symptoms were assessed using validated measures. Helicobacter pylori status was determined pre-entry by a 13C-urea breath test. Results: On an intention-to-treat analysis (n=1248). complete symptom relief was observed in 38% on omeprazole 20 mg, compared with 36% on omeprazole 10 mg and 28% on placebo (P = 0.002 and 0.02. respectively). Among those with ulcer-like and reflux-like dyspepsia, complete symptom relief was achieved in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo (all P < 0.05, except omeprazole 10 mg in ulcer-like dyspepsia. P = 0.08). There was no significant benefit of omeprazole over placebo in dysmotility-like dyspepsia. Symptom relief was similar in H. pylori-positive and negative cases. Conclusions: Omeprazole is modestly superior to placebo in functional dyspepsia at standard (20 mg) and low doses (10 mg) but not in patients with dysmotility-like dyspepsia.
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C03 06  X  FRE  @0 Dyspepsie @5 10
C03 06  X  ENG  @0 Dyspepsia @5 10
C03 06  X  SPA  @0 Dispepsia @5 10
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C03 10  X  SPA  @0 Aleatorización @5 16
C03 11  X  FRE  @0 Placebo @5 18
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C03 11  X  SPA  @0 Placebo @5 18
C03 12  X  FRE  @0 Inhibiteur pompe proton @5 19
C03 12  X  ENG  @0 Proton pump inhibitor @5 19
C03 12  X  SPA  @0 Inhibidor bomba protón @5 19
C03 13  X  FRE  @0 Long terme @5 20
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C03 13  X  SPA  @0 Largo plazo @5 20
C03 14  X  FRE  @0 Efficacité traitement @5 21
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C03 14  X  SPA  @0 Eficacia tratamiento @5 21
C03 15  X  FRE  @0 Helicobacter pylori @2 NS @5 22
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C07 04  X  ENG  @0 Digestive diseases @5 61
C07 04  X  SPA  @0 Aparato digestivo patología @5 61
N21       @1 025

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Pascal:99-0043793

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<div type="abstract" xml:lang="en">Background: The efficacy of H
<sub>2</sub>
-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functional dyspepsia is unknown. Aim: To evaluate the efficacy of proton pump inhibitor therapy in functional dyspepsia. Methods; Patients (n = 1262) with a clinical diagnosis of functional dyspepsia (persistent or recurrent epigastric pain or discomfort for at least 1 month and a normal upper gastrointestinal endoscopy) were randomized to receive omeprazole 20 mg. 10 mg or identical placebo, for 4 weeks. Symptoms were assessed using validated measures. Helicobacter pylori status was determined pre-entry by a
<sup>13</sup>
C-urea breath test. Results: On an intention-to-treat analysis (n=1248). complete symptom relief was observed in 38% on omeprazole 20 mg, compared with 36% on omeprazole 10 mg and 28% on placebo (P = 0.002 and 0.02. respectively). Among those with ulcer-like and reflux-like dyspepsia, complete symptom relief was achieved in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo (all P < 0.05, except omeprazole 10 mg in ulcer-like dyspepsia. P = 0.08). There was no significant benefit of omeprazole over placebo in dysmotility-like dyspepsia. Symptom relief was similar in H. pylori-positive and negative cases. Conclusions: Omeprazole is modestly superior to placebo in functional dyspepsia at standard (20 mg) and low doses (10 mg) but not in patients with dysmotility-like dyspepsia.</div>
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<s1>TALLEY (N. J.)</s1>
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<s1>MEINECHE-SCHMIDT (V.)</s1>
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<s1>SCHMID (V.)</s1>
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<s1>Department of Medicine, University of Sydney, Nepean Hospital</s1>
<s2>Penrith, New South Wales</s2>
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<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
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<s0>Background: The efficacy of H
<sub>2</sub>
-receptor antagonists in functional dyspepsia is equivocal and the therapeutic place of proton pump inhibitors in functional dyspepsia is unknown. Aim: To evaluate the efficacy of proton pump inhibitor therapy in functional dyspepsia. Methods; Patients (n = 1262) with a clinical diagnosis of functional dyspepsia (persistent or recurrent epigastric pain or discomfort for at least 1 month and a normal upper gastrointestinal endoscopy) were randomized to receive omeprazole 20 mg. 10 mg or identical placebo, for 4 weeks. Symptoms were assessed using validated measures. Helicobacter pylori status was determined pre-entry by a
<sup>13</sup>
C-urea breath test. Results: On an intention-to-treat analysis (n=1248). complete symptom relief was observed in 38% on omeprazole 20 mg, compared with 36% on omeprazole 10 mg and 28% on placebo (P = 0.002 and 0.02. respectively). Among those with ulcer-like and reflux-like dyspepsia, complete symptom relief was achieved in 40% and 54% on omeprazole 20 mg, and 35% and 45% on omeprazole 10 mg, respectively, compared with 27% and 23% on placebo (all P < 0.05, except omeprazole 10 mg in ulcer-like dyspepsia. P = 0.08). There was no significant benefit of omeprazole over placebo in dysmotility-like dyspepsia. Symptom relief was similar in H. pylori-positive and negative cases. Conclusions: Omeprazole is modestly superior to placebo in functional dyspepsia at standard (20 mg) and low doses (10 mg) but not in patients with dysmotility-like dyspepsia.</s0>
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