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| |  Lansoprazole Superior to Placebo as Add-On to Behavioural Modification in Patients With Laryngopharyngeal Reflux: Presented at AAO-HNSF By Kristina Rebelo SAN DIEGO -- October 7, 2009 -- Patients with laryngopharyngeal reflux (LPR) prescribed lansoprazole 30 mg plus behavioural modifications show a greater improvement than patients prescribed similar behavioural modifications plus placebo, according to a study presented here at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting 2009. Results from a double-blind, placebo-controlled, randomised, 4-year study showed that lansoprazole and placebo groups actually felt better following their involvement in the 8-week trial. “It’s always a little tricky at the end of a trial when patients question why they got better with a sugar pill,” Peter C. Belafsky, MD, Surgical Head and Neck Oncological Surgery, and the Voice and Swallowing Center, University of California, Davis, Davis, California, told DocGuide on October 3. “Both groups were adhering to their modification program, but the twice-daily lansoprazole group enjoyed a 2-fold improvement.” In order to enrol in the trial, patients with symptoms suggestive of LPR were given the Reflux Symptom Index (RSI) and the 10-item Voice Handicap Index (VHI-10) and underwent strobovideolaryngoscopy to determine the Reflux Finding Score (RFS). In order to be admitted, patients had to have an RSI >=10 and those with an RFS of <6 were excluded. Behavioural modifications included nothing to eat or drink 3 hours before bed, the avoidance of caffeine, alcohol, carbonated beverages, and peppermint, and elevating one’s bed so the head rested at 30 degrees during sleep. All participants were required to be nonsmokers. A total of 41 patients (out of 60) with a mean age of 56 years completed the trial. Dr. Belafsky said it took more than 4 years to complete the study due to the challenge of finding patients to meet the inclusion criteria. “It’s rare to see people in my practice who have not been prescribed proton pump inhibitors.” The mean RSI value of patients on twice-daily lansoprazole improved 9.95 (7.40) in comparison with a mean improvement of 5.05 (8.39) on twice-daily placebo (P = .05). There were no significant changes between groups in the VHI (P = .46) or the RFS values (P = .33). “So we used the VHI and the RSI and found that on average on the symptom survey that the placebo group improved 5 points and patients given the lansoprazole improved nearly 10 points -- and that difference was significant,” said Dr. Belafsky, who noted that the differences in patient improvement were assessed with the independent samples t test. “So for reflux disease, twice-daily lansoprazole 30 mg for 8 weeks prescribed along with behavioural modification yielded a greater improvement in LPR symptoms than persons prescribed behavioural modifications for reflux disease and identical placebo,” he concluded. Funding for this study was provided by TAP Pharmaceuticals. [Presentation title: Treatment of Laryngopharyngeal Reflux With Twice-Daily Lansoprazole. Abstract SP244]
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