Is upper gastrointestinal radiography necessary in the initial management of uncomplicated dyspepsia? - A randomized controlled trial comparing empiric antacid therapy plus patient reassurance with traditional care

Study objective: To compare two strategies for the evaluation and management of patients who have had acute dyspepsia for four days or more: empiric high-dose antacid therapy combined with patient reassurance (empiric care) versus therapy based on prompt upper gastrointestinal radiography (traditional care). Design: Prospective, randomized trial. The patients in the empiric care group were reassured that upper gastrointestinal radiography was not necessary and were subsequently treated with high-dose empiric antacid therapy (15-30 ml of high-potency antacid one and three hours after meals and at bedtime). The traditional care group received upper gastrointestinal radiography as part of the initial evaluation. Subsequent treatment was determined by individual physicians based on test results. Settings: Fee-for-service, hospital-based primary care practice and Veteran's Administration medical center outpatient clinic. Patients: All patients were less than 70 years of age and without gastrointestinal bleeding, anemia, significant weight loss, or other specified symptoms of severe acid peptic disease. Fifty patients were randomized to traditional care, and 51 to empiric care. Pre-randomization clinical features were identical with the exception of sex distribution and baseline disability. Measurements and main results: After six months of follow-up, there were no significant differences in symptom scores, disability, satisfaction, and quality of life measures (as measured by the Sickness Impact Profile scores) between the two groups. Findings were unchanged when adjusted for sex, study site, alcohol consumption, and cigarette smoking. Of the radiographs obtained in the traditional care group, 13 (27%) showed duodenal ulcer disease, gastritis, or duodenitis. There were no serious complications of ulcer disease or therapy noted in either group. The average costs per patient associated with traditional care at one study site were greater, $286 versus $116 (p<0.0001). Conclusions: Select patients with dyspepsia receiving a combination of reassurance and empiric antacid therapy do as well as patients whose initial management strategy includes upper gastrointestinal radiography, at a substantially lower cost.