Management of endoscopy‐negative reflux disease: progress with short‐term treatment

Abstract

SUMMARYThe efficacy of omeprazole in the treatment of endoscopy‐negative reflux disease has been examined in five recently completed, multicentre, double‐blind, randomized, parallel group studies. A total of 1959 patients with endoscopy‐negative reflux disease took part in these trials in which 20 mg omeprazole once daily (n = 722) was compared with placebo (n = 304) and/or 10 mg omeprazole once daily (n = 624), 150 mg ranitidine twice daily (n = 213), or 10 mg cisapride four times daily (n = 96). In all studies, the primary outcome measures were assessed after 4 weeks of treatment.Absence of heartburn, defined as no episodes of heartburn during the fourth week of treatment, occurred in 14–29% of patients receiving placebo, 31% receiving cisapride, 35% receiving ranitidine, 31–60% receiving 10 mg omeprazole once daily, and 44–62% receiving 20 mg omeprazole once daily. Adequate control of heartburn, defined as only 1 day with episodes of mild heartburn during the seventh week of treatment, occurred in 24% of patients receiving placebo. 46% receiving cisapride, 46% receiving ranitidine, 49–60% receiving 10 mg omeprazole once daily, and 56–63% receiving 20 mg omeprazole once daily, on the basis of data from three of the studies. The differences between the two omeprazole doses and placebo, and between 20 mg omeprazole once daily, and either 10 mg omeprazole once daily, ranitidine or cisapride, were all statistically significant (P < 0.05). Diary cards for most patients who responded to omeprazole showed an absence of heartburn in the first week of treatment. Health‐related quality of life was measured at baseline and after 4 weeks of treatment, using validated questionnaires (i.e. the Psychological General Well‐Being Index and the Gastrointestinal Symptom Rating Scale). After 4 weeks of treatment, the general well‐being of patients taking 10 or 20 mg omeprazole once daily had improved significantly (P < 0.05) compared with those taking placebo.In conclusion, 10 and 20 mg omeprazole once daily provides effective and rapid control of heartburn in patients with endoscopy‐negative reflux disease. Absence of heartburn and adequate control of heartburn occur significantly more frequently in patients treated with 20 mg omeprazole once daily, compared with patients treated with 10 mg omeprazole once daily, 150 mg ranitidine twice daily, or 10 mg cisapride four times daily. Omeprazole also restores health‐related quality of life, in terms of enhanced well‐being, to the level observed in a healthy population.