WASHINGTON — Proton pump inhibitors do not improve most symptoms of supraesophageal reflux, according to a community-based study presented at the annual Digestive Disease Week meeting.
The study's aim was to determine which symptoms resolve completely with PPI therapy, and thus may be reflective of supraesophageal reflux, said Dr. Laura M. Iuga, an otolaryngologist at Mayo Clinic in Rochester, Minn., who presented the study on behalf of her colleagues.
She and her colleagues recruited study subjects from southern Minnesota through radio and print advertising, and also from Mayo's outpatient primary care and otolaryngology clinics. To be eligible, patients had to have at least one of the six chronic symptoms—chronic dry hacking cough, globus sensations, hoarseness, nocturnal cough, sore throat, and throat clearing. Patients were asked to complete the Supraesophageal Reflux Questionnaire and the Reflux Symptom Index.
After randomization, 302 patients received esomeprazole (Nexium) 40 mg twice daily, and 127 received a placebo for 6 months. The study ran from March 2005 until August 2006.
In the intent-to-treat analysis, the 112 patients who withdrew or stopped early (25% of those in each arm) were labeled as incomplete responders. A complete response was lack of symptoms at 3, 4, 5, and 6 months.
As expected, many subjects had complete resolution of their heartburn with PPI therapy, Dr. Iuga noted. About half those taking esomeprazole responded. Overall, patients with heartburn at baseline were 15 times more likely to achieve complete symptom response with esomeprazole than with placebo. “This symptom served as a positive control in the study, indicating enough power to detect a treatment effect,” she said.
There was also a statistically significant difference in throat clearing among patients with that symptom, but only 7% of those in the esomeprazole arm and 1% in the placebo group had improvement, “indicating that the majority of people with throat clearing did not achieve a response,” she said.
The study was supported by a grant from AstraZeneca's Investigator-Sponsored Study Program.