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A placebo-controlled, randomized, double-blind, single-patient trial was carried out to compare the efficacy of standard dose (40 mg/day) with double dosage (40 mg/bid) of esomeprazole to mitigate the GERD symptoms in a single patient.
In this 6 month study it was found that in gastroesophageal reflux disease (GERD)
patients, increasing the dose of oral esomeprazole did not substantially improve the GERD symptoms. In chronic
pathologies including GERD, N-of-1
clinical trials are advocated due to their valuable relevance as systematic
methods that assess therapies without significant scientific evidence.
A
placebo-controlled, randomized, double-blind, single-patient trial was carried
out to compare the efficacy of standard dose (40 mg/day) with double dosage (40
mg/bid) of esomeprazole to mitigate the GERD symptoms in single patient.
From 25 September 2012 to 26 April 2013, the study was performed and included one outpatient (non-obese male without any tobacco or alcohol usage) at the gastroenterology service in a fourth-level hospital, diagnosed with non-erosive reflux disease (NERD). Yet, the participant depicted symptoms of reflux and heartburn, and his endoscopic results illustrated normal esophageal mucosa, without hiatal hernia, though pathological pH values.
For 24 weeks, the patient was given esomeprazole 40 mg/day and 40 mg/bid. The symptom frequency and severity was weekly determined by a standardized gastroesophageal reflux disease questionnaire (GerdQ).
Adequate treatment adherence was the consumption of 90% of the capsules. To determine the normal or non-normal distribution and compare both therapies with a significant statistical difference the D'agostino-Pearson, and Wilcoxon test used.
The study was successfully completed by the patient with 96% of adherence. Compared with the standard dosage, the double dosage of esomeprazole did not improve the GERD symptoms. The mean symptomatic score for treatment with the standard dose and double dose of esomeprazole is depicted in the following table:
No significant improvement in the average frequency and
severity of symptoms was witnessed during the 6 months of study.
In GERD patients, elevating oral esomeprazole dose does not
improve GERD symptoms.
Canadian Journal of Gastroenterology and Hepatology
A Randomized Placebo-Controlled N-of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease
Fernando Sierra-Arango et al.
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