Validation of a Single-Patient Drug Trial Methodology for Personalized Management of Gastroesophageal Reflux Disease

Wolfe, Barbara E.; Rio, Eve Del; Weiss, Sidney L; Mendelson, Avishai; Elbaga, Tamer A.; Huser, Frederic J.; Reitberg, Donald P.

doi:10.18553/jmcp.2002.8.6.459

Cited by 9 publications

(7 citation statements)

References 22 publications

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“…Of course, the pilot nature of this study and the sample size involved means that a full exploration of views is unlikely to have been achieved but the findings support and complement other similar research, which has found patient response to be very positive and established evidence of consumer demand for n-of-1 trials outside the UK[5,6,8,9,12]. Nickles et al recently published the results of a qualitative study conducted in Australia, where n-of-1 trials are more widely recognised and established[7].…”

Section: Discussionmentioning

confidence: 53%

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

Brookes

Biddle

Paterson

et al. 2007

Trials

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Section: Discussionmentioning

confidence: 53%

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

Brookes

Biddle

Paterson

et al. 2007

Trials

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“…A remarkable 40% of patients with gastroesophageal reflux disease (GERD) treated with proton pump inhibitors (PPIs) were found by the single-patient trial (SPT) method to achieve the same or better outcomes as these patients treated with ranitidine. 7 This work by Wolfe, del Rio, Weiss, et al suggests that spending on drug treatment for GERD could be reduced by more than one third since histamine-2 receptor antagonists such as ranitidine cost managed care organizations (MCOs) $.50 or less per day of therapy versus $4 or more per day of therapy with a PPI. All of the H2-antagonists (cimetidine, ranitidine, famotidine, and nizatidine) were available from generic manufacturers by mid-2002.…”

Section: ■■ Single-patient Trial (Spt) Method-substitute For Expert Omentioning

confidence: 99%

Effective Cholesterol Management With Fewer Dollars

Curtiss¹

2002

JMCP

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“…Patients with GERD usually require a continue therapy, either continuous, at demand, or intermittent [20]. Additionally, GERD has heterogeneous recurrent clinical expressions and many patients frequently experience symptomatic setbacks, which could be easily self-evaluated [21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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

Sierra-Arango

Castaño

Forero

et al. 2019

Canadian Journal of Gastroenterology and Hepatology

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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.

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Validation of a Single-Patient Drug Trial Methodology for Personalized Management of Gastroesophageal Reflux Disease

Cited by 9 publications

References 22 publications

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

Effective Cholesterol Management With Fewer Dollars

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

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