title: Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial.
abstract: Background and study aimUpper endoscopy is the most common method for the diagnosis of upper gastrointestinal tract diseases. The aim of this study was to determine whether premedication with simethicone orN-acetylcysteine improves mucosal visualization during upper endoscopy.Patients and methodsThis was a randomized, double-blind, placebo-controlled study of 297 patients scheduled for upper endoscopy who were premedicated 15 - 30 minutes before the procedure with: 100 mL of water (placebo, group A); water plus 100 mg simethicone (group B); water plus 100 mg simethicone plus 600 mgN-acetylcysteine (group C). The primary outcome measure was the quality of mucosal visualization (score: excellent, adequate or inadequate).ResultsThe addition of simethicone (group B) or simethicone plusN-acetylcysteine to the water (group C) improved the visualization scores of endoscopies compared with water alone (group A). In particular, groups B and C produced a significantly higher percentage of endoscopies with excellent visualization for the esophagus (91.1 % and 86.7 %, respectively, vs. 71.4 % in group A;P< 0.001) and stomach (76.2 % and 74.5 % vs. 38.8 % in group A;P< 0.001). For the duodenum, the use of simethicone also showed an increase in the endoscopies with excellent visualization compared with water alone (85.1 % vs. 73.5 %;P= 0.042). There were no significant differences in scores between groups B and C or between gastric scores in patients with previous subtotal gastrectomy (B and C vs. A): 60.0 % and 42.1 % vs. 28.6 % (P= 0.14). The rate of reported lesions was higher in group B but without statistical significance.ConclusionsPremedication with simethicone resulted in better mucosal visibility. Such premedication might improve diagnostic yield, and should be considered for standard practice. Trial registered at ClinicalTrials.gov (NCT02357303).
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.
authors.forename: Luís
authors.initials: L
authors.lastname: Elvas
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.|CINTESIS - Centre for Research in Health Technologies and Information Systems, Faculty of Medicine, University of Porto, Porto, Portugal.
authors.forename: Miguel
authors.initials: M
authors.lastname: Areia
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.
authors.forename: Daniel
authors.initials: D
authors.lastname: Brito
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.
authors.forename: Susana
authors.initials: S
authors.lastname: Alves
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.
authors.forename: Sandra
authors.initials: S
authors.lastname: Saraiva
authors.affiliation: Gastroenterology Department, Portuguese Oncology Institute, Coimbra, Portugal.
authors.forename: Ana T
authors.initials: AT
authors.lastname: Cadime
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage*; D000328:Adult; D004311:Double-Blind Method; D004386:Duodenum / Q000000981:diagnostic imaging; D004643:Emollients / Q000008:administration & dosage; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004947:Esophagus / Q000000981:diagnostic imaging; D005260:Female; D005767:Gastrointestinal Diseases / Q000175:diagnosis*; D006801:Humans; D007089:Image Enhancement / Q000379:methods; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000000981:diagnostic imaging*; D011292:Premedication / Q000379:methods*; D012841:Simethicone / Q000008:administration & dosage*; D013270:Stomach / Q000000981:diagnostic imaging; D016896:Treatment Outcome
chemical_list: D004643:Emollients; D012841:Simethicone; D000111:Acetylcysteine