Antisecretory therapy with no improvement in functional level in Ménière’s disease

Abstract

Conclusion Antisecretory factor-inducing (AF) specially processed cereals (SPC) were not shown to significantly improve the functional level in patients with MD. Objectives The aim of this study was to evaluate the effect of AF-inducing SPC in patients suffering from Ménière’s disease (MD). Methods A randomized double-blinded, placebo-controlled cross-over study was conducted. All patients had a 2 months intake of SPC and control cereal with a 2 months washout period in between. The severity of MD was classified according to the American Academy of Otolaryngology-Head and Neck Surgery (AOO-HNS) functional scale, and the frequency of attacks was registered. Results Thirty-two patients completed the study. No carryover effect was found. In both functional level and frequency of attacks no significant effect of SPC was found. Seventeen patients showed improvement in functional level when treated with SPC (mean improvement = 0.9 points) and 14 when treated with placebo (mean improvements = 0.7 points). No patients showed worsening in functional level during treatment with SPC, but three showed worsening when treated with placebo. Seventeen patients reported fewer attacks when treated with SPC, and 22 when treated with placebo. Three patients reported more frequent attacks when treated with SPC, and three when treated with placebo. A non-parametric comparison and a parametric analysis supported the findings.

Keywords:

• Antisecretory factor
• Ménière’s disease
• specially processed cereals

Acknowledgements

A special thanks to Lene Theil Skovgaard Associate professor, Department of Biostatistics, University of Copenhagen for preforming the statistical analyses. SPC and control cereals were kindly donated by Lantmännen AS-Faktor AB, Box 30192, 104 25 Stockholm, Sweden. Thank you to The Hearing Association in Denmark for their help in recruiting the patients and handling the distribution of SPC/placebo and questionnaires.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.