Trial reportClinical drug investigation2011
Effects of structured follow-up and of more effective acid inhibitory treatment in the management of GORD patients in a Swedish primary-care setting: a randomized, open-label study.
Trial report in Clinical drug investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00272701 (A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease), which is not on this map. Cited by 1 paper.
What it found
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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 Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks.
Who cites it
1 citing paper in PubMed, 4 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite the high prevalence of gastro-oesophageal reflux disease (GORD) and the documented impact of GORD symptoms on individual health-related quality of life (HR-QOL) and on socioeconomic factors, structured management of GORD has had a low priority in Swedish routine primary health care.
objectiveThe primary objective of this study (IMPROVE) was to evaluate the effects of a structured follow-up and management regimen for primary-care GORD patients with symptomatic breakthrough despite standard proton pump inhibitor (PPI) treatment. Patients received either an increased dose of current PPI treatment or were switched to the more effective acid inhibitor esomeprazole.
methodsGORD patients with symptomatic breakthrough despite standard PPI treatment were identified through medical records and by a postal survey using the GERD Impact Scale (GIS) questionnaire. Patients rated the severity and frequency of GORD symptoms, general health status (EuroQol Group 5-Dimension Self-Report Questionnaire) and the impact of GORD symptoms on work productivity (Work Productivity and Activity Impairment) before and 4 weeks following randomization to open-label treatment with either increased acid suppressive therapy or an adjusted, higher dosage of the PPI previously used. The patients' valuation, in monetary terms, of the treatment they received pre-study versus the treatment given during the study was documented through willingness-to-pay (WTP) questions.
resultsFollowing more effective acid suppression, 66.3% of the study population experienced complete relief of heartburn, with no difference between the groups; HR-QOL was restored to a level comparable to that of a normal Swedish population and ability to work efficiently was significantly improved. Access to a better acid suppressive treatment was highly valuable to the patients in terms of WTP.
conclusionAn improved GORD management strategy including structured follow-up of treatment given and initiation of more effective acid inhibitor therapy when symptoms persist will be of great benefit to GORD patients. [ClinicalTrials.gov Identifier: NCT00272701].
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