Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia:A Randomized Clinical Trial in General Practice

Title: Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia: A Randomized Clinical Trial in General Practice. Purpose: To compare the clinical efficacy of two strategies for management of dyspepsia in general practice in a RCT design. Setting: June 2000 to August 2002, 41 GPs, Aarhus County, Denmark Methods: 368 people with dyspepsia (epigastric pain/discomfort, no alarm symptoms) were randomly assigned to treatment with omeprazol 40 mg/day for two weeks (PPI group, n:185) or endoscopy (endoscopy group, n:183). Due to migration, cancer, or death 25 were excluded.Outcome measures: Dyspeptic symptoms after 1 year and endoscopies in PPI group (GPs and patients' questionnaires). Use of PPI, sick leaves, visit to GPs and patients' satisfaction (patients' questionnaires).Results: We found no base line difference in age, symptoms, and use of PPI between the groups. The questionnaire response rates after 1 year were 91.3% for GPs and 86.9% for patients. After 1 year the GPs assessed whether the patients primary symptom at inclusion had improved, and 75.6% in the PPI group and 83.6% in the endoscopy group had improvement in their dyspeptic symptoms (2; P: 0.08). Pain/discomfort was the primary symptom at inclusion in 63.7% of the cases, and 74.1% in the PPI group, and after 1 year 85.7% in the endoscopy group had improvement in their pain/discomfort symptoms (2; P: 0.03). After 1 year the patients assessed whether they had of upper GI symptom regardless of the primary symptom at inclusion. The patients assessed 23.6% in the PPI group and 20.1% in the endoscopy group were free of symptoms after 1 year (2; P: 0.47). When pain/discomfort was the primary symptom at inclusion 20.4% in the PPI group and 35.4% in the endoscopy group were free of symptoms after 1 year (2; P: 0.05). The patients reported 31.8% in the PPI group and 42.6% in the endoscopy group used PPI after 1 year (2; P: 0.08). In the PPI group 35.7% had secondary endoscopy performed. We found no differences between the two strategies in respect to sick leaves, dyspeptic contacts to GP or patients' satisfaction. Conclusions: Prompt endoscopy was superior to proton pump inhibitor concerning symptom improvement in management of dyspepsia in general practice when pain/discomfort was the primary symptom. There were no differences between the two strategies in respect to sick leaves, dyspeptic contacts to GP or patients' satisfaction. Table1GPs and patients assessment of dyspeptic symptoms after 1 year. 20 of the GPs and 40 of the patients assessed other primary symptom than reflux or pain/discomfort at inclusion. All value in percentages. Chi-square used for all p-values Primary symptom at inclusionAll N(GP): 310N(pat): 298Pain/discomfortn(GP): 206n (pat): 154Reflux n(GP):84 n(pat):104PPIEndoscopyPPPIEndoscopyPPPIEndoscopyPGPs after 1 yearDyspepticsymptoms improved74.185.70.0479.277.10.9375.683.60.08Patientsafter 1 yearNo dyspepticsymptoms20.833.80.0717.914.60.6520.1 23.60.47