A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease
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-...
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| Format: | Article |
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Wiley
2019-01-01
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| Series: | Canadian Journal of Gastroenterology and Hepatology |
| Online Access: | http://dx.doi.org/10.1155/2019/3926051 |
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| author | Fernando Sierra-Arango D. M. Castaño Jennifer D. Forero Erika D. Pérez-Riveros Gerardo Ardila Duarte Maria L. Botero Andres Cárdenas Jose De la Hoz-Valle |
| author_facet | Fernando Sierra-Arango D. M. Castaño Jennifer D. Forero Erika D. Pérez-Riveros Gerardo Ardila Duarte Maria L. Botero Andres Cárdenas Jose De la Hoz-Valle |
| author_sort | Fernando Sierra-Arango |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-717d454f657e437aab315163352260cd |
| institution | Kabale University |
| issn | 2291-2789 2291-2797 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Canadian Journal of Gastroenterology and Hepatology |
| spelling | doaj-art-717d454f657e437aab315163352260cd2025-02-03T01:12:30ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27892291-27972019-01-01201910.1155/2019/39260513926051A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux DiseaseFernando Sierra-Arango0D. M. Castaño1Jennifer D. Forero2Erika D. Pérez-Riveros3Gerardo Ardila Duarte4Maria L. Botero5Andres Cárdenas6Jose De la Hoz-Valle7Gastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, ColombiaGastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, ColombiaGastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, ColombiaFundación Santa Fe de Bogotá, Bogotá, ColombiaFundación Santa Fe de Bogotá, Bogotá, ColombiaPathology Department, Hospital Universitari Vall de Hebron, Barcelona, SpainGI/Endoscopy Unit, Institut de Malalties Digestives Metaboliques, Hospital Clinic, University of Barcelona, Barcelona, SpainHead of Subdirección de Estudios Clínicos y Epidemiología Clínica (SECEC), Fundación Santa Fe de Bogotá, Bogotá, ColombiaBackground. 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.http://dx.doi.org/10.1155/2019/3926051 |
| spellingShingle | Fernando Sierra-Arango D. M. Castaño Jennifer D. Forero Erika D. Pérez-Riveros Gerardo Ardila Duarte Maria L. Botero Andres Cárdenas Jose De la Hoz-Valle A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease Canadian Journal of Gastroenterology and Hepatology |
| title | A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease |
| title_full | A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease |
| title_fullStr | A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease |
| title_full_unstemmed | A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease |
| title_short | A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease |
| title_sort | randomized placebo controlled n of 1 trial the effect of proton pump inhibitor in the management of gastroesophageal reflux disease |
| url | http://dx.doi.org/10.1155/2019/3926051 |
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