Mebeverine and the Influence of Labeling in Adolescents With Irritable Bowel Syndrome or Functional Abdominal Pain Not Otherwise Specified: A 2 × 2 Randomized, Placebo-Controlled Trial
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Le résumé fourni par la source
BACKGROUND & AIMS: Pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified lack effective pharmacologic interventions. The efficacy of mebeverine, an antispasmodic agent, and the effect of labeling within a pediatric cohort were evaluated. METHODS: This randomized trial was conducted across 13 hospitals. Participants (12-17 years) with irritable bowel syndrome or functional abdominal pain-not otherwise specified received mebeverine (200 mg twice daily) or placebo for 8 weeks. Treatment was labeled as "mebeverine or placebo" (blinded trial label) or "mebeverine" (mebeverine label), creating the following 4 groups: (1) mebeverine-blinded trial label, (2) mebeverine-mebeverine label, (3) placebo-blinded trial label, and (4) placebo-mebeverine label. Randomization (1:1:1:1) was masked to physicians, except for drug labeling. Primary end point was treatment success (>50% reduction of abdominal pain intensity and frequency) after 8 weeks. The key secondary end point was adequate relief of symptoms. RESULTS: Of the 269 randomized patients, treatment success was similar between those receiving mebeverine (groups 1 and 2) (n = 31 [23.4%]) and placebo (groups 3 and 4) (n = 30 [22.0%]; odds ratio [OR], 1.08; 95% CI, 0.59-1.99; P = .81). Treatment success was higher in groups with the mebeverine label (groups 2 and 4) (n = 42 [31.6%]) compared with the blinded trial label (groups 1 and 3) (n = 19 [14.1%]; OR, 2.84; 95% CI, 1.52-5.34; P = .001). Adequate relief rates were similar between mebeverine (n = 55 [41.0%]) and placebo groups (n = 61 [45.5%]; OR, 0.83; 95% CI, 0.51-1.35; P = .46), but higher in mebeverine-labeled groups (n = 67 [50.4%]) compared with blinded trial-labeled groups (n = 49 [36.3%]; OR, 1.78; 95% CI, 1.1-2.9; P = .02). Adverse events were mild and infrequent. CONCLUSIONS: Mebeverine was ineffective in treatment of pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified. However, a positive drug label significantly enhanced treatment outcomes compared with a blinded trial label. (International Clinical Trials Registry Platform, Number: NL-OMON55563.).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Mebeverine and the Influence of Labeling in Adolescents With Irritable Bowel Syndrome or Functional Abdominal Pain Not Otherwise Specified: A 2 × 2 Randomized, Placebo-Controlled Trial
- Date Crossref
- 01/07/2025
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Amsterdam University Medical Centers pays non établi dans la noticeÉtablissement de santé
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Amsterdam Gastroenterology Endocrinology Metabolism pays non établi dans la noticeÉtablissement de santé
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Amsterdam Reproduction Development pays non établi dans la noticeÉtablissement de santé
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University of Amsterdam Department of Pediatric Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Emma Kinderziekenhuis pays non établi dans la noticeÉtablissement de santé
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St. Antonius Ziekenhuis pays non établi dans la noticeOrganisme public
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Maasstad Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Medisch Spectrum Twente pays non établi dans la noticeÉtablissement de santé
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Spaarne Gasthuis pays non établi dans la noticeÉtablissement de santé
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Amphia Ziekenhuis pays non établi dans la noticeÉtablissement de santé
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Radboud University Nijmegen pays non établi dans la noticeUniversité ou école supérieure
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Catharina Ziekenhuis pays non établi dans la noticeÉtablissement de santé
Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology Metabolism et Amsterdam Reproduction Development, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.