Heartburn is one of the most common problems presented to family physicians. The symptom usually indicates gastroesophageal reflux disease, but most patients are treated empirically without undergoing extensive radiologic or endoscopic investigations. Of the many treatment possibilities, omeprazole has become widely used and has established a reputation for efficacy. Recently, medications that target gastroesophageal motility rather than acid production have been advocated as effective treatments. Hatlebakk and colleagues compared the efficacy of omeprazole and cisapride in treating primary care patients with heartburn.
They recruited more than 573 adults who had heartburn for at least three months. Symptoms were required to be present at least three days per week. All patients underwent endoscopy before randomization, and those with severe esophagitis, peptic ulcer disease, Barrett's esophagus or other serious conditions were excluded from the study. Other exclusions included recent use of the study medications and concomitant serious illness, including misuse of alcohol or drugs. Patients (453) who met study criteria were tested for Helicobacter pylori infection by a rapid urease breath test before randomization. The patients were randomly assigned to receive placebo (159 patients), omeprazole at 20 mg daily (161 patients), or cisapride at 20 mg twice daily (163 patients). Placebo tablets were used so that all patients took two tablets twice daily regardless of assigned treatment. Patients were reassessed after two, four and eight weeks of treatment. Adequate control of heartburn was defined as no more than mild symptoms limited to one day in the week before the assessment. Patients kept a record of symptoms and any adverse effects attributable to the medications.
After four weeks, 71 percent of those taking omeprazole reported adequate symptom control compared with 22 percent of those taking cisapride and 18 percent of those taking placebo. All aspects of symptom control, including severity of heartburn, use of antacids and number of symptom-free days, were significantly improved by omeprazole therapy. Symptom control was greater in patients taking omeprazole who were positive for H. pylori infection.
All three groups reported improvement in other gastrointestinal symptoms such as epigastric discomfort, belching, dysphagia and nausea, but the improvement in the omeprazole group was significantly greater than that reported for placebo or cisapride. No significant difference in symptom control was reported between the cisapride and placebo groups. Adverse effects were uncommon, but slightly more patients taking cisapride reported adverse effects than patients in the other two groups.
The authors conclude that 20 mg of omeprazole daily was highly effective in relieving heartburn symptoms in more than 70 percent of patients. Conversely, cisapride in dosages of 20 mg twice daily was no more effective than placebo.