• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  
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• Explain to interested patients that treatment with a PPI improved nocturnal gastroesophageal reflux symptoms, associated sleep disturbance, and performance on a simulated driving test.
  
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• Note also that the study involved only 11 patients.
  

SAN ANTONIO -- Nighttime dyspepsia and associated sleep disturbance improved significantly during treatment with a proton pump inhibitor (PPI), which in turn improved alertness on a simulated driving test, results of a small pilot study showed.

The 11 patients treated with esomeprazole (Nexium) had an 85% decrease in the frequency of disordered sleep, which was associated with an identical improvement in symptom scores for gastroesophageal reflux disease (GERD).

Patients' performance on the simulated driving test deteriorated significantly over two weeks without PPI therapy; the therapy reversed the trend and led to significant improvement on the test, David A. Johnson, MD, reported at the American College of Gastroenterology meeting.

"We have the potential for tying a simple -- what some might consider a lifestyle -- disease to a fairly significant impact with a meaningful endpoint of major driving dysfunction," said Johnson, of Eastern Virginia Medical School in Norfolk. "People need to expand their thoughts on what reflux means and target their endpoints appropriately."

GERD has an established association with impaired sleep quality and next-day performance. Unrelated studies have shown that sleep disturbance associated with sleep apnea and other conditions leads to impaired performance on tests of psychomotor functioning, including simulated driving tests.

Johnson and colleagues hypothesized that treatment with a PPI would improve nocturnal GERD symptoms, associated sleep disturbance, and performance on a simulated driving test.

The study involved otherwise healthy adults with longstanding GERD. Nine of the patients were women; the average age was 49.

Each patient completed six consecutive 10-minute driving tests after a 14-day period off PPI therapy and after four weeks of treatment with the PPI.

Each test was performed by use of a validated commercial driving simulator that generates realistic roadway images in response to driver input (steering, throttle, brake, etc.). The test's primary metric was standard deviation of lane variation, assessed every 0.5 second during each test period.

During the 14 days off treatment, the proportion of nights with disordered sleep averaged 62.5% and decreased to an average of 9.5% during esomeprazole therapy (P<0.001). The GERD symptom score averaged 2.10 off PPI therapy and 0.33 on therapy (P<0.001).

The measure of lane variation increased significantly over time when the patients were off PPI therapy (P=0.002) and then decreased significantly during treatment with esomeprazole (P=0.004). The mean score of the Epworth Sleepiness Scale declined from 7.9 to 5.9, but the difference did not quite reach statistical significance (P=0.056).

Johnson expressed hope that findings from studies such as his would open more eyes to the potential impact of effectively treating GERD and sleep disturbance. As an example, he noted that 6.5 million motor-vehicle accidents occur each year, 3.5 million of which result in injuries, and more than 400,000 people die each year as a result of auto accidents.

"I would ask that people start to expand their horizons in talking about reflux disease and talking about next-day function," said Johnson. "But also recognize that the ability to adequately and appropriately treat reflux disease really has a lot more global implications."