Abstract

Study background: The objective of this study was to make a Randomized Controlled Trial (RCT) of laryngopharyngeal reflux treatment based on a sufficient number of patients (referring to our Cochrane review 2009).

Material and methods: In order to detect differences prospectively of treatment effect in a randomized controlled trial, the following treatments of Laryngopharyngeal Reflux (LPR) were compared: lifestyle advice, lifestyle advice combined with proton pump inhibitor, and life style advice combined with proton pump inhibitor and alginate. Subjective complaints of LPR were stored and the objective evaluation of interarytenoids oedema of the larynx was evaluated visually on high speed films, with minimum of 2000 frames per second, a supplement of routine acoustical measures were made.

Results: A total of 237 patients were randomized based on the planned statistical power calculation of 90% to detect a difference of 20%, under the assumption that the true difference was 5% and that the standard deviation was 25%. The differences between the three groups were found not to be statistically significant, but there was a general positive effect of treatment.

Conclusion: Lifestyle guidance, lifestyle guidance added with esomeprazole and lifestyle guidance added with esomeprazole and alginate were all effective in this RCT for treatment effect of laryngopharyngeal reflux based on subjective complaints and documented with high speed films with minimum 2000 frames per second.

Keywords: Alginate, Esomeprazole, High speed films, Laryngopharyngeal reflux