Samuel C Leong1, Surya Narayan, Tristram H Lesser. 1. Dept of Otorhinolaryngology-Head and Neck Surgery, Skull Base Surgery, University Hospital Aintree, Liverpool L9 7AL, United Kingdom.
Abstract
OBJECTIVES: The aim of this study was to evaluate the effectiveness of specially processed cereal (SPC) as a suitable adjunctive treatment for Meniere's disease. METHODS: We performed a randomized double-blinded, placebo-controlled, crossover study in a tertiary referral center of patients who had a diagnosis of Meniere's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). The main outcome measure was the AAO-HNS Functional Level Scale (FLS). RESULTS: Thirty-nine patients completed the study without any reported complications. The mean pretreatment FLS score for the entire study cohort was 3.8 (median, 4; range, 1 to 6). The overall FLS score improved significantly (p < 0.001), to 2.8 (median, 3), after SPC treatment. No patients showed worsening on the FLS during SPC or placebo treatment. Of the 39 patients, 23 showed improvement on the FLS, and no change was observed in the remaining 16. The median improvement on the FLS in these 23 patients was 2 points (mean, 1.7; range, 1 to 4). The mean FLS score after placebo cereal treatment was not significantly different from baseline (p = 0.452), but was significantly higher than that after SPC treatment (mean, 3.7; p < 0.001). The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that 5 patients reported 1-point improvements on the FLS after placebo treatment. Nevertheless, significantly fewer patients improved on placebo than on SPC (p < 0.001). CONCLUSIONS: Treatment with SPC appears to be well tolerated by most patients (91%) without any complications. More than half (59%) of the study cohort reported subjective improvement in functional level.
RCT Entities:
OBJECTIVES: The aim of this study was to evaluate the effectiveness of specially processed cereal (SPC) as a suitable adjunctive treatment for Meniere's disease. METHODS: We performed a randomized double-blinded, placebo-controlled, crossover study in a tertiary referral center of patients who had a diagnosis of Meniere's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). The main outcome measure was the AAO-HNS Functional Level Scale (FLS). RESULTS: Thirty-nine patients completed the study without any reported complications. The mean pretreatment FLS score for the entire study cohort was 3.8 (median, 4; range, 1 to 6). The overall FLS score improved significantly (p < 0.001), to 2.8 (median, 3), after SPC treatment. No patients showed worsening on the FLS during SPC or placebo treatment. Of the 39 patients, 23 showed improvement on the FLS, and no change was observed in the remaining 16. The median improvement on the FLS in these 23 patients was 2 points (mean, 1.7; range, 1 to 4). The mean FLS score after placebo cereal treatment was not significantly different from baseline (p = 0.452), but was significantly higher than that after SPC treatment (mean, 3.7; p < 0.001). The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that 5 patients reported 1-point improvements on the FLS after placebo treatment. Nevertheless, significantly fewer patients improved on placebo than on SPC (p < 0.001). CONCLUSIONS: Treatment with SPC appears to be well tolerated by most patients (91%) without any complications. More than half (59%) of the study cohort reported subjective improvement in functional level.