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Of the subjects with NAB, only 7 (21%) had pathologic nocturnal integrated esophageal acidity and 18 (53%) had pathologic nocturnal time esophageal pH < 4. In the 3rd study, 140 of 156 subjects (90%) had NAB.
Also, in the 3rd study, 26 GERD subjects with esophageal pH < 4 for at least 10% of the 24-hour baseline recording period were randomized to receive 8 consecutive daily doses of 20 mg omeprazole or 20 mg rabeprazole in a crossover fashion with a 14-day washout between treatment periods.
In the index and 3rd study, 47% of subjects had pathologic time esophageal pH < 4 and Table 2 indicates that the probability that the prevalence of 24-hour pathologic esophageal reflux is greater than the corresponding prevalence of false-positive values is 0.985.
Table 4 also indicates that if NAB is absent there is a high probability that integrated nocturnal esophageal acidity will be normal, because of the subjects without NAB 0 of 12 subjects in the index study and 1 of 16 subjects in the 3rd study had pathologic integrated esophageal acidity.
The 3rd study involved 57 adults with a history of GERD who experienced heartburn at least 4 times per week for at least 6 months [ 4].
Analyses of data from Day 8 in the 3rd study were used to attempt to confirm results from the index study that compared pathologic esophageal reflux defined by time pH < 4 to that defined by integrated acidity.
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