The proton pump inhibitor rabeprazole had a small, but significant effect in reducing laryngopharyngeal reflux symptoms after 12 weeks of treatment, Dr. Paul K.Y. Lam and colleagues reported in an article appearing in the September issue of Clinical Gastroenterology and Hepatology.
The results are in contrast to those of previous, smaller studies that did not find PPIs to be of benefit in laryngopharyngeal reflux (LPR), wrote the authors.
This study also was one of the first to use both the nine-item Reflux Symptom Index questionnaire (J. Voice 2002;16:274-7) and the Reflux Finding Score to measure both laryngopharyngeal reflux (LPR) symptoms and physical findings.
According to Dr. Lam, of the department of surgery at the University of Hong Kong, the researchers looked at patients referred to the Voice & Laryngeal Pathology Laboratory at his institution between November 2004 and June 2007. To be included in the prospective, double-blind, placebo-controlled, randomized study, patients needed to have either hoarseness, globus (a feeling of a lump in the throat), persistent throat discomfort, or frequent throat clearing for at least 1 month in the preceding year, as well as videostroboscopic evidence of LPR with a corresponding “reflux finding score” above 7.
The reflux finding score, or RFS, is “an 8-item clinical severity scale based on findings during fiberoptic laryngoscopy” that ranges from 0, indicating no abnormal findings, to 26 (Laryngoscope 2001;111:1313-7).
Participants also had to have a negative history for any upper respiratory tract infection or allergic laryngitis in the 4 weeks prior to evaluation, and could not be younger than age 18 years, have any other laryngeal pathology, or have a history of gastroesophageal x-ray or surgery. Patients who had been taking an acid suppressive drug any time during the month prior to enrollment were also excluded.
A total of 82 patients were randomized and completed the study at 6, 12, and 18 weeks follow-up. Overall, 42 patients took rabeprazole 20 mg twice daily for 12 weeks, 30 minutes prior to lunch and dinner (mean age, 46 years; 15 males), while the remaining 40 subjects were given placebo (mean age, 47 years; 8 males).
All patients also were taught to abstain from caffeine, alcohol, smoking, spicy food, and other potential triggers of reflux. They were advised to avoid eating less than 3 hours before bedtime and to drink plenty of water.
“Patients in the rabeprazole group had a significantly reduced total RSI score at week 6 (-3.03 +/-1.05, p = 0.003) and at week 12 (-3.73 +/- 1.18, p = 0.002) compared to the placebo group,” wrote the authors.
However, the improvement on the RSI did not persist at week 18, which was 6 weeks following conclusion of the PPI regimen (-1.48 +/- 1.26, p = 0.124).
In contrast, when looking at physical improvement as measured on the RFS, there was no significant difference between groups at weeks 6, 12, or 18, with significance set at the 0.01 level.
Rather, both groups showed improvement, possibly due to the effects of education regarding abstinence from smoking, alcohol, and caffeine, although “this did not translate into significant improvement in RSI in the placebo patient group.”
Indeed, within the rabeprazole group, Dr. Lam did find improvement from baseline at both week 12 (-2.21 +/- 0.64. p = 0.002) and week 18 (-3.21 +/- 0.57, p = 0.0001), especially relating to laryngeal and vocal cord edema.
Dr. Lam and colleagues conceded that “Despite the improvement in both RSI and RFS in the rabeprazole group at week 12, the actual change was not much (only 2.81 and 2.21, respectively).”
Furthermore, total average scores for both the RSI and the RFS were still high even after 12 weeks of therapy with rabeprazole, “with RSI score well above 10 and RFS more than 7” which was positive for a laryngopharyngeal reflux condition.
The authors disclosed that the study was partially sponsored by the developer of rabeprazole, Esai Co. Ltd. The researchers reported having no conflicts to disclose in relation to the study.