Therapeutic strategies in the treatment of Menière's disease: the Italian experience.

PURPOSE: Ménière's disease (MD) is an inner ear disorder of unknown etiology, whose pathological substrate is the endolymphatic hydrops. Different treatments have been proposed; however, evidence of their effectiveness is lacking. The aim of this study was to evaluate by a questionnaire which medical and surgical treatments are used in Italy for the treatment of MD and to compare them with those proposed in other countries. METHODS: An electronic questionnaire of 40 questions was formulated and sent to Italian otolaryngologist (ENT) divided into two groups: Group 1 ("generalists" 60.8%) and Group 2 ("neurotologist- NO" 39.2%). RESULTS: One hundred and twenty five ENT replied. Treatment of the acute phase, apart from symptomatics, was based on diuretics that are prescribed by 83.5% of respondents, steroids, prescribed by 66.7%, and vasodilators, prescribed by 22%. In the intercritical phase, 87.2% of respondents recommended low-salt diet, 78.4% of respondents prescribed betahistine, and 52.8% diuretics. Statistical analysis did not show correlation neither with the declared specialization nor with the number of patients treated. In case of failure of medical treatment, IT gentamicin was suggested by 48.8% of the respondents and IT steroids by 40.8%. Statistical analysis showed that generalists prefer IT steroids and NO IT gentamicin (p 0.019). In case of failure of both medical treatment and IT treatment, vestibular neurectomy was indicated by 58.4% of the respondents, 6.4% indicated endolymphatic sac surgery, and 2.4% surgical labyrinthectomy. CONCLUSION: In Italy, the treatment of MD stand on a gradual approach that starts from the dietary-behavioral changes and a pharmacological therapy based on betahistine. In refractory cases, IT treatment initially with steroids and, therefore, with gentamicin allows the control in vertigo in the majority of cases. In case of failure of IT treatment, VNS is the surgery of choice.

Treatment of Meniere's disease with intratympanic dexamethazone plus high dosage of betahistine.

PURPOSE: The aim of the present study was to assess if the combined therapy of intratympanic dexamethasone (ITD) and high dosage of betahistine (HDBH) is able to provide increased vertigo control compared to ITD alone in patients suffering from definite unilateral Meniere's disease (MD). MATERIALS AND METHODS: Consecutive MD patients were enrolled and randomly divided in two groups, each comprising 33 cases. Group A received a combination of ITD and identical-appearing placebo pills while Group B received a combination of ITD and HDBH. ITD protocol consisted of three consecutive daily injections. HDBH comprised 144mg/day (48mg tid). The main outcome measures were: 1) vertigo class, pure tone average (PTA), speech discrimination score (SDS) and Functional Level Score (FLS) according to the American Academy of Otolaryngology-Head and Neck Surgery criteria; 2) complete and substantial vertigo control according to the Kaplan-Meier survival method. RESULTS: Sixty two patients completed the 24-month follow-up. A complete vertigo control was achieved in 14 patients (44%) from Group A and in 22 patients (73.3%) from Group B, statistically significant (p=0.01). Complete vertigo relief is also significant according to the Kaplan-Meier method: p=0.027, log rank test. Substantial vertigo control was obtained in 21 patients (65.6%) in Group A and 27 patients (90%) in Group B. The difference is statistically significant, p=0.02. The difference is significant according to the Kaplan-Meier method: p=0.035, log rank test. No significant differences between hearing levels and tinnitus scores were demonstrated between the groups. CONCLUSIONS: Our preliminary results demonstrate that complete and substantial vertigo control is significantly higher in patients treated with a combination of HDBH and ITD.

Antisecretory therapy with no improvement in functional level in Ménière's disease.

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.

Antisecretory factor-inducing therapy improves patient-reported functional levels in Meniere's disease.

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.

Ménière disease and gluten sensitivity: recovery after a gluten-free diet.

We report the case of a 63-year-old female with definite unilateral Ménière disease, osteoarthritis of the distal finger joints with mucous cysts and Heberden's nodes, and constipation with recurrent abdominal pain whose symptoms remitted after 6months of a restrictive gluten-free diet.

Antisecretory factor-inducing therapy improves the clinical outcome in patients with Ménière's disease.

CONCLUSION: Intake of antisecretory factor (AF)-inducing SPC-flakes significantly reduced vertigo in patients suffering from Ménière's disease (MD). The positive effect may be due to a modulation of the transport of water and ions in the endolymphatic space. OBJECTIVE: To evaluate the effects of a 3-month treatment period with SPC-flakes in patients suffering from MD. PATIENTS AND METHODS: A prospective, double-blind, placebo-controlled study was performed. A total of 51 adult patients with MD were included in the study: 27 subjects treated with SPC-flakes and 24 subjects with control cereals. The patients received SPC-flakes or control cereals (1 g per kg body weight per 24 h in two servings) for 3 months. Otoneurological examinations were carried out before and after this period. RESULTS: The severity of MD was classified according to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) grading system. Fourteen of the 27 patients randomized to intake of the AF-inducing SPC-flakes reported decreased vertigo, compared with 2 of 24 in the control group (p < 0.001). No consistent change in the otoneurological examinations could be demonstrated in any of the groups of patients.

The antisecretory factor: synthesis, anatomical and cellular distribution, and biological action in experimental and clinical studies.

The antisecretory factor (AF) is a 41-kDa protein that provides protection against diarrheal diseases and intestinal inflammation. Its cDNA has been cloned and sequenced. AF is highly potent, with 10(-12) mol of recombinant AF being sufficient to counteract experimentally induced diarrhea in rat. The antisecretory activity is exerted by a peptide located between positions 35 and 50 of the AF sequence. Synthetic peptides based on this sequence are promising candidates for drugs to counteract intestinal hypersecretion, as well as imbalances of fluid transport in other body compartments. AF probably exerts its effects via nerves; AF immediately and potently inhibits ion transport across isolated nerve membranes from Deiters' cells. Immunocytochemistry has shown that AF is present in most tissues in the body, and in situ nucleic acid hybridization has shown that cells that store AF are also capable of AF synthesis. The endogenous plasma level of AF is increased by enterotoxins and by certain food constituents such as hydrothermally processed cereals. These cereals significantly improve clinical performance in patients suffering from inflammatory bowel diseases. AF-enhancing food also protects domestic animals against diarrheal diseases, and such feed has been used successfully in Swedish swine farming for the past 10 years. Increased understanding of AF action might result in expanded clinical applications and confirm that AF is an important regulator of homeostasis.