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Antisecretory therapy with no improvement in functional level in Ménière's disease
Charlotte J Ingvardsen1, Mads Klokker1
1a Department of Otorhinolaryngology, Head & Neck Surgery and Audiology , Rigshospitalet, University of Copenhagen , Denmark.
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.
Insights
Antisecretory factor-inducing specially processed cereals (SPC) did not significantly improve Ménière
Area of Science:
- Otolaryngology
- Nutrition Science
- Clinical Research
Background:
- Ménière's disease (MD) is a complex inner ear disorder.
- Current treatments for MD have limitations.
- AF-inducing SPC offers a novel therapeutic approach.
Purpose of the Study:
- To evaluate the efficacy of AF-inducing SPC in managing Ménière's disease.
- To assess the impact of SPC on functional levels and attack frequency in MD patients.
Main Methods:
- Randomized, double-blinded, placebo-controlled cross-over study design.
- Two-month intervention periods with SPC and control cereal, separated by a two-month washout.
- Severity assessed using the AOO-HNS functional scale; attack frequency was recorded.
Main Results:
- No significant improvement in functional level or attack frequency observed with SPC compared to placebo.
- Slight improvements in functional level were noted in both SPC and placebo groups.
- No worsening of functional level occurred with SPC, unlike with placebo.
Conclusions:
- AF-inducing SPC did not demonstrate significant therapeutic benefits for Ménière's disease.
- Further research may be needed to explore alternative applications or formulations of SPC.
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