OBJECTIVES: This open cross-over study compared the effects on esophageal pH of omeprazole (O) (20 mg once a day) and famotidine (F) (40 mg b.i.d.) in 19 patients with proven acid gastroesophageal reflux (GER) complicated by erosive or ulcerated esophagitis. METHODS: Each drug was taken for 7 days. A wash-out interval of at least 3 days separated the two treatment periods in each subject. Twenty-four-hour pH measurements were performed in similar standardized conditions at 7 +/- 2 days, at the end of each period of treatment. RESULTS: Compared with the pretreatment results, both O and F reduced the following pH parameters: percent of time with esophageal pH < 4, total number of GER episodes, number of nocturnal GER episodes, and duration of the longest GER episodes. O was more effective than F except for the percent of time esophageal pH < 4 and the number of nocturnal GER episodes, not different between the two treatments. With O, GER was reduced to physiological value in 19 of the 19 patients and abolished in 13. With F, GER was normalized in 13 and abolished in four. The effects of both drugs and grading of esophagitis were not correlated. Both treatments were well-tolerated. CONCLUSIONS: In patients with acid GER complicated by ulcerative esophagitis, O, 20 mg daily, and F, 40 mg b.i.d. significantly reduced acid exposure. O was superior to F, but the latter drug improved significantly two important prognostic variables: the total percent of time pH < 4 and the nocturnal GER.
RCT Entities:
OBJECTIVES: This open cross-over study compared the effects on esophageal pH of omeprazole (O) (20 mg once a day) and famotidine (F) (40 mg b.i.d.) in 19 patients with proven acid gastroesophageal reflux (GER) complicated by erosive or ulcerated esophagitis. METHODS: Each drug was taken for 7 days. A wash-out interval of at least 3 days separated the two treatment periods in each subject. Twenty-four-hour pH measurements were performed in similar standardized conditions at 7 +/- 2 days, at the end of each period of treatment. RESULTS: Compared with the pretreatment results, both O and F reduced the following pH parameters: percent of time with esophageal pH < 4, total number of GER episodes, number of nocturnal GER episodes, and duration of the longest GER episodes. O was more effective than F except for the percent of time esophageal pH < 4 and the number of nocturnal GER episodes, not different between the two treatments. With O, GER was reduced to physiological value in 19 of the 19 patients and abolished in 13. With F, GER was normalized in 13 and abolished in four. The effects of both drugs and grading of esophagitis were not correlated. Both treatments were well-tolerated. CONCLUSIONS: In patients with acid GER complicated by ulcerative esophagitis, O, 20 mg daily, and F, 40 mg b.i.d. significantly reduced acid exposure. O was superior to F, but the latter drug improved significantly two important prognostic variables: the total percent of time pH < 4 and the nocturnal GER.