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 : 000C32Efficacy 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 :
- Alimentary pharmacology & therapeutics [ 0269-2813 ] ; 1998.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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.
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<front><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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<fC03 i1="04" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="GER"><s0>Aufbereiten</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Dyspepsie</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Dyspepsia</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Dispepsia</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Homme</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Human</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Hombre</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Essai thérapeutique contrôlé</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Controlled therapeutic trial</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Ensayo terapéutico controlado</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Etude double insu</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Double blind study</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Estudio doble ciego</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Randomization</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Placebo</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Placebo</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Placebo</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Inhibiteur pompe proton</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Proton pump inhibitor</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Inhibidor bomba protón</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Long terme</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Long term</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Largo plazo</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Efficacité traitement</s0>
<s5>21</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>Treatment efficiency</s0>
<s5>21</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA"><s0>Eficacia tratamiento</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE"><s0>Helicobacter pylori</s0>
<s2>NS</s2>
<s5>22</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG"><s0>Helicobacter pylori</s0>
<s2>NS</s2>
<s5>22</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA"><s0>Helicobacter pylori</s0>
<s2>NS</s2>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE"><s0>Benzimidazole dérivé</s0>
<s2>FR</s2>
<s2>FF</s2>
<s5>25</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG"><s0>Benzimidazole derivatives</s0>
<s2>FR</s2>
<s2>FF</s2>
<s5>25</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA"><s0>Benzimidazol derivado</s0>
<s2>FR</s2>
<s2>FF</s2>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Spirillaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Spirillaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Spirillaceae</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Spirillales</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Spirillales</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Spirillales</s0>
<s2>NS</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Bactérie</s0>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Bacteria</s0>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Bacteria</s0>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Appareil digestif pathologie</s0>
<s5>61</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Digestive diseases</s0>
<s5>61</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Aparato digestivo patología</s0>
<s5>61</s5>
</fC07>
<fN21><s1>025</s1>
</fN21>
</pA>
</standard>
</inist>
</record>
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