Trial reportBMC gastroenterology2009
Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.
Trial report in BMC gastroenterology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00241501 (A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease), which is not on this map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.
Who cites it
5 citing papers in PubMed, 13 citations in OpenAlex.
- Sleep patterns and problems among children with 22q11 deletion syndrome.Molecular genetics & genomic medicine · 2020Article
- Efficacy and tolerability of hydrogen carbonate-rich water for heartburn.World journal of gastrointestinal pathophysiology · 2016Article
- Use of the Montreal global definition as an assessment of quality of life in reflux disease.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2012Article
- Clinical utility of esomeprazole for treatment of gastroesophageal reflux disease in pediatric and adolescent patients.Adolescent health, medicine and therapeutics · 2012Review
- Rabeprazole and esomeprazole in mild-to-moderate erosive gastroesophageal reflux disease: A comparative study of efficacy and safety.Journal of pharmacology & pharmacotherapeutics · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.
methodsThis international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.
resultsOf the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.
conclusionGERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.
trial registrationD9614C00098; ClinicalTrials.gov Identifier NCT00241501.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.