V Meineche-Schmidt1, E Christensen. 1. Department of General Practice, The Panum Institute, University of Copenhagen, Denmark.
Abstract
OBJECTIVE: The effect of omeprazole therapy in dyspepsia is unpredictable. The aim of this study was to identify patient characteristics and symptoms associated with the omeprazole response to improve selection of patients for empirical treatment with omeprazole. METHODS: Data from a randomized controlled trial of 471 patients with ulcer-like or reflux-like dyspepsia treated withomeprazole20 mg daily (243 patients) orplacebo (228 patients) for 2 wk were studied using logistic regression analysis. The patients were randomly divided into a model sample (N = 236) for modeling the association between the omeprazole response and descriptive variables, and a test sample (N = 235) for testing the obtained model. RESULTS: In the model sample a high body mass index, the use of antacids or H2-blockers within the last month, or pain at night time were independently associated with a good omeprazole response, whereas the presence of nausea was associated with a poor omeprazole response. Using these variables combined into a therapeutic index, the independent test sample patients could be classified into predicted good (N = 56), medium (N = 88), and poor omeprazole responders (N = 91). In these groups the observed therapeutic gain of omeprazole (omeprazole response minus placebo response) was 39.4%, 19.3%, and 4.6%, respectively (p = 0.013). For clinical use, an easy-to-use pocket chart to obtain the therapeutic index in a given patient has been devised. CONCLUSIONS: In dyspepsia the identification of potential responders to omeprazole can be improved by considering certain patient characteristics and symptoms associated with the omeprazole response. Applying these data using a simple pocket chart may assist decision about empirical omeprazole therapy in patients with dyspepsia in general practice.
RCT Entities:
OBJECTIVE: The effect of omeprazole therapy in dyspepsia is unpredictable. The aim of this study was to identify patient characteristics and symptoms associated with the omeprazole response to improve selection of patients for empirical treatment with omeprazole. METHODS: Data from a randomized controlled trial of 471 patients with ulcer-like or reflux-like dyspepsia treated with omeprazole 20 mg daily (243 patients) or placebo (228 patients) for 2 wk were studied using logistic regression analysis. The patients were randomly divided into a model sample (N = 236) for modeling the association between the omeprazole response and descriptive variables, and a test sample (N = 235) for testing the obtained model. RESULTS: In the model sample a high body mass index, the use of antacids or H2-blockers within the last month, or pain at night time were independently associated with a good omeprazole response, whereas the presence of nausea was associated with a poor omeprazole response. Using these variables combined into a therapeutic index, the independent test sample patients could be classified into predicted good (N = 56), medium (N = 88), and poor omeprazole responders (N = 91). In these groups the observed therapeutic gain of omeprazole (omeprazole response minus placebo response) was 39.4%, 19.3%, and 4.6%, respectively (p = 0.013). For clinical use, an easy-to-use pocket chart to obtain the therapeutic index in a given patient has been devised. CONCLUSIONS: In dyspepsia the identification of potential responders to omeprazole can be improved by considering certain patient characteristics and symptoms associated with the omeprazole response. Applying these data using a simple pocket chart may assist decision about empirical omeprazole therapy in patients with dyspepsia in general practice.