A randomised controlled trial of four management strategies for dyspepsia:relationships between symptom subgroups and strategy outcome

Background: The first step in the management of uncomplicated dyspepsia in primary care often consists of prescribing empirical therapy, bite in certa in cases prompt endoscopy might be preferred. Any decision is usually based on the patient's symptoms and the presumed underlying pathology that cause s these symptoms. Aim: To assess the relationship between symptom subgroups and the effect of management strategies on primary care patients with dyspepsia. Design of study: Randomised controlled trial. Setting. All patients presenting successively with a new episode of dyspeps ia between January 1995 and November 1997. Method. The results of four management strategies in dyspeptic primary care patients were compared and the value of subgrouping within this trial was estimated. Patients were allocated to one of either (a) empirical treatment in which therapy was based on the presented symptoms, or empirical treatme nt with (b) omeprazole or (c) cisapride regardless of the presented symptom s, or (d) prompt endoscopy followed by the appropriate treatment. Patients were retrospectively classified into the subgroups for each strategy using baseline data. The yield of each strategy was measured by counting the numb er of strategy failures in the first year. Results: Of the 349 included patients, 326 were analysed No statistically s ignificant difference could be demonstrated between the strategies or betwe en the symptom subgroups. However, patients in the reflux-like subgroup sho wed a trend towards a better outcome in all empirical strategies. Ulcer-lik e dyspepsia seemed to benefit from omeprazole. The non-specific subgroup se emed to benefit from cisapride but also had the highest proportion of strat egy failure. Prompt endoscopy did not appear especially useful in any subgr oup. Conclusion: Although this study has relatively low power we conclude that t he use of symptom subgroups seems to he a sensible approach when choosing e mpirical therapy in dyspepsia. Patients with reflux-like symptoms seem to h ave the best prognosis in the first year in every strategy.