A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease

Autor: Andrés Cárdenas, Maria L. Botero, Fernando Sierra-Arango, Jennifer D. Forero, José A. De la Hoz-Valle, D. M. Castaño, Erika D. Pérez-Riveros, Gerardo Ardila Duarte
Přispěvatelé: [Sierra-Arango F, Castaño DM, Forero JD] Gastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, Bogotá, Colombia. School of Medicine, Universidad de los Andes, Bogotá, Colombia. [Pérez-Riveros ED, Ardila Duarte G] Fundación Santa Fe de Bogotá, Bogotá, Colombia. [Botero ML] Servei de Patologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus
Jazyk: angličtina
Rok vydání: 2019
Předmět:
N of 1 trial
medicine.medical_specialty
Article Subject
Nerd
Digestive System Diseases::Gastrointestinal Diseases::Esophageal Diseases::Deglutition Disorders::Esophageal Motility Disorders::Gastroesophageal Reflux [DISEASES]
características del estudio::estudio clínico::ensayo clínico::ensayo clínico controlado::ensayo clínico controlado aleatorizado [CARACTERÍSTICAS DE PUBLICACIONES]
Study Characteristics::Clinical Study::Clinical Trial::Controlled Clinical Trial::Randomized Controlled Trial [PUBLICATION CHARACTERISTICS]
Gastroenterology
enfermedades del sistema digestivo::enfermedades gastrointestinales::enfermedades del esófago::trastornos de la deglución::trastornos de la motilidad esofágica::reflujo gastroesofágico [ENFERMEDADES]
Esomeprazole
law.invention
Hiatal hernia
Randomized controlled trial
law
Internal medicine
medicine
lcsh:RC799-869
Medicaments gastrointestinals
Hepatology
business.industry
Reflux gastroesofàgic
Heartburn
General Medicine
medicine.disease
digestive system diseases
Gastrointestinal disorder
Organic Chemicals::Sulfur Compounds::Sulfoxides::2-Pyridinylmethylsulfinylbenzimidazoles::Omeprazole::Esomeprazole [CHEMICALS AND DRUGS]
GERD
compuestos orgánicos::compuestos de azufre::sulfóxidos::2-piridinilmetilsulfinilbencimidazoles::omeprazol::esomeprazol [COMPUESTOS QUÍMICOS Y DROGAS]
lcsh:Diseases of the digestive system. Gastroenterology
medicine.symptom
business
medicine.drug
Assaigs clínics
Zdroj: Canadian Journal of Gastroenterology and Hepatology, Vol 2019 (2019)
Scientia
ISSN: 2291-2797
2291-2789
Popis: Background. Gastroesophageal reflux disease (GERD) is the most frequent chronic gastrointestinal disorder. It is defined as a condition developed when the reflux of gastric contents causes troublesome symptoms (heartburn and regurgitation). This requires adequate treatment since it can lead to long-term complications including esophagus adenocarcinoma. Proton pump inhibitors (PPI) are generally used to treat GERD due to their high-security profile and efficiency on most patients. However, recurrent reflux despite initial treatment is frequent. N-of-1 trial is a study that allows the identification of the best treatment for each patient. The objective of this study is to compare the efficacy of standard dose with double dosage of esomeprazole, to improve the GERD symptoms in a single patient. Methods. A single-patient trial, placebo-controlled, randomized, double-blind, was carried out from September 25th, 2012, to April 26th, 2013. It included one outpatient at the gastroenterology service in a fourth-level hospital, diagnosed with nonerosive reflux disease (NERD). Yet, his symptoms were heartburn and reflux, and his endoscopic results were normal esophageal mucosa, without hiatal hernia, though pathological pH values. A no-obese male without any tobacco or alcohol usage received esomeprazole 40 mg/day and 40 mg/bid for 24 weeks. A standardized gastroesophageal reflux disease questionnaire (GerdQ) was used weekly to evaluate symptom frequency and severity. The consumption of 90% of the capsules was considered as an adequate treatment adherence. D’agostino–Pearson and Wilcoxon test were used to determine normal or nonnormal distribution and compare both treatments, respectively, both with a significant statistical difference of p<0.05. Results. The patient completed the study with 96% of adherence. The double dosage of esomeprazole did not improve the control of symptoms compared with the standard dosage. Mean symptomatic score was 9.5±0.5 and 10.2±0.6 for each treatment, respectively (p>0.05). Conclusion. There was no significant improvement in the patient GERD symptoms increasing the dose of oral esomeprazole during the 6 months of study. N-of-1 trials in chronic pathologies including GERD are recommended due to their potential value as systematic methods that evaluate therapies without strong scientific evidence.
Databáze: OpenAIRE
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