Participation in a clinical trial influences the future management of patients with gastro-oesophageal reflux disease in general practice
Article first published online: 12 SEP 2006
Alimentary Pharmacology & Therapeutics
Volume 24, Issue 7, pages 1117–1125, October 2006
How to Cite
MEINECHE-SCHMIDT, V., HVENEGAARD, A. and JUHL, H. H. (2006), Participation in a clinical trial influences the future management of patients with gastro-oesophageal reflux disease in general practice. Alimentary Pharmacology & Therapeutics, 24: 1117–1125. doi: 10.1111/j.1365-2036.2006.03046.x
- Issue published online: 12 SEP 2006
- Article first published online: 12 SEP 2006
- Publication data Submitted 25 March 2006 First decision 9 April 2006 Resubmitted 23 June 2006 Accepted 26 June 2006
Background The long-term effects of participation in trials has not been reported. A randomized-controlled trial (the ONE study) reported on the management of gastro-oesophageal reflux disease with esomeprazole in primary care, testing on-demand treatment vs. treatment courses.
Aim To evaluate the impact of participation in a trial on General Practitioners management and patient behaviour.
Methods Management of gastro-oesophageal reflux disease was compared between General Practitioners who participated in ONE (ONE-GPs) and a random sample of General Practitioners who did not participate in ONE (Other-GPs). Symptom presentation and satisfaction with treatment was compared between patients who had participated in ONE (ONE-patients) and patients who had not (Other-patients).
Results ONE-GPs prescribed on-demand treatment with proton-pump inhibitors to 47% of the patients, Other-GPs to 27%. ONE-patients consulted for significantly less symptoms compared with Other-patients. ONE-patients reported significantly higher patient satisfaction compared with Other-patients. ONE-patients used 98 doses during 6 months whereas Other-patients used 76 doses.
Conclusions Participation in a clinical trial influenced both doctors and patients. Treatment modalities introduced by the trial were used in daily practice by the General Practitioners. Patients who had participated in the trial consulted for less symptoms and used more medication, compared with patients who did not participate.