mometasone-furoate and Otitis-Media-with-Effusion

To investigate the statistical relationship between the OM8-30 health-related quality of life measure for children with otitis media with effusion (OME) and measures of health utility (Health Utilities Index [HUI] Mark 3 and Mark 2) and to develop models to estimate HUI3 and HUI2 health utilities from OM8-30 scores.. A placebo-controlled, randomised trial (GNOME) evaluating intranasal mometasone in 217 children with OME provided concurrent responses to OM8-30 and HUI at three time points. Ordinary least squares (OLS), generalised linear models and two-step regression analyses were used to predict HUI3 and HUI2 utilities based on OM8-30 facet and domain scores.. OLS models including all nine OM8-30 facets with or without predicted hearing level (HL) produced the best predictions of HUI3 utilities (mean absolute error: 0.134 with HL and 0.132 without; R(2): 0.63 with HL and 0.596 without). An OLS model predicting HUI3 utilities based on the two OM8-30 domain scores, reported hearing difficulties, predicted HL, age and sex also produced accurate predictions.. Regression equations predicting HUI3 and HUI2 utilities based on OM8-30 facet and domain scores have been developed. These provide an empirical basis for estimating quality-adjusted life years (QALYs) for interventions in children with OME.

Topics: Administration, Intranasal; Analysis of Variance; Anti-Inflammatory Agents; Child; Child, Preschool; Double-Blind Method; Female; Health Status Indicators; Humans; Male; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Psychometrics; Quality-Adjusted Life Years; Reference Values; Severity of Illness Index; Sickness Impact Profile; Surveys and Questionnaires

To estimate the cost-effectiveness of topical intranasal steroids for the treatment of otitis media with effusion (OME) in primary care from the perspective of the UK National Health Service.. An economic evaluation was conducted based on evidence from the double-blind, randomized, placebo-controlled GPRF [General Practice Research Framework] Nasal Steroids for Otitis Media with Effusion (GNOME) trial. Participants comprised 217 children aged 4-11 years who had at least one episode of otitis media or related ear problem in the previous 12 months and had tympanometrically confirmed bilateral OME. Children were randomly allocated to receive either mometasone furoate 50 microg or placebo spray once daily into each nostril for 3 months. The main outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained for topical steroids compared with placebo. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative willingness to pay thresholds.. Children receiving topical steroids accrued nonsignificantly higher costs (incremental cost/child: pound11, 95% confidence interval [CI]: - pound199 to pound222) and nonsignificantly fewer QALYs (incremental QALY gain/child: -0.0166, 95% CI: -0.0652 to 0.0320) than those receiving placebo. Topical steroids had a 24.19% probability of being cost-effective at a pound20,000 per QALY gained threshold, a 23.82% probability of being more effective and a 46.25% probability of being less costly. Sensitivity and subgroup analyses showed incremental costs and benefits to be highly sensitive to the methods used and the patient group considered, although differences between groups did not reach statistical significance in any analysis.. Topical steroids are unlikely to be a cost-effective treatment for OME in general practice.

Topics: Acoustic Impedance Tests; Administration, Intranasal; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Child; Child, Preschool; Confidence Intervals; Cost-Benefit Analysis; Evidence-Based Medicine; Female; Humans; Male; Mometasone Furoate; Odds Ratio; Otitis Media with Effusion; Pregnadienediols; Quality of Life; Quality-Adjusted Life Years; State Medicine; Statistics, Nonparametric; Surveys and Questionnaires; Treatment Outcome; United Kingdom

To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion.. Double blind randomised placebo controlled trial.. 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007.. 217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types).. Mometasone furoate 50 microg or placebo spray given once daily into each nostril for three months.. Proportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported.. Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months.. Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Double-Blind Method; Female; Humans; Male; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Treatment Outcome

Topical steroid treatment can be a powerful alternative to surgery in controlling adenoid hypertrophy and otitis media with effusion (OME).. A prospective, controlled, randomized, clinical study in an academic tertiary care center. A total of 122 children (3-15-year-old) on the waiting list for an adenoidectomy and/or ventilation tube placement were enrolled into the study and control groups. The study group (67 patients with adenoid hypertrophy, 34 of them with otitis media with effusion) received intranasal mometasone furoate monohydrate 100 mcg/day, and the control group (55 patients with adenoid hypertrophy, 29 of them with otitis media with effusion) was followed up without any treatment. All patients were evaluated at 0 and 6 weeks. The assessment of each patient included history, a symptom questionnaire, a skin prick test, a tympanogram, if possible a pure tone audiogram, and otoscopic and endoscopic examinations. The size of adenoid tissue was graded as a percentage according to obliteration of the choanae. The adenoid/choana ratio (A/C) was recorded for each patient. Symptoms were scored as 0 (absent), 1 (intermittent/periodic), or 2 (continuous). The data were analyzed with the "Statistical Package for the Social Sciences" (SPSS 9.0) using the appropriate nonparametric tests for nominal and ordinal data.. Resolution of otitis media with effusion in the study group (42.2%) was significantly higher than that in the control group (14.5%) (p<0.001). Forty-five patients (67.2%) with adenoid hypertrophy in the study group showed a significant decrease in adenoid size according to the endoscopic evaluation compared to the control group (p<0.001). A significant improvement in obstructive symptoms was seen in the study group (p<0.001). The endoscopically measured adenoid/choana ratio and degree of obstructive symptoms showed a significant correlation (r=0.838 p<0.001, r=0.879 p<0.001, r=0.838 p<0.001, r=0.879 p<0.001). The adenoid/choana ratio improved significantly in atopic patients in the study group (p<0.05), whereas in atopic patients in the control group there was no change (p=0.221).. Nasal mometasone furoate monohydrate treatment can significantly reduce adenoid hypertrophy and eliminate obstructive symptoms. It is a useful alternative to surgery, at least in the short term, for otitis media with effusion.

Topics: Academic Medical Centers; Adenoids; Administration, Topical; Adolescent; Anti-Inflammatory Agents; Child; Child, Preschool; Female; Hearing Tests; Humans; Hypertrophy; Male; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Turkey

The objective of the present study was to improve the effectiveness of medicamental therapy of exudative otitis media in the children with recurrent and chronic adenoiditis. It was shown that the use of fluifort (carbocysteine lysine salt) for the treatment of exudative otitis media in the children presenting with chronic adenoiditis is a more effective approach in comparison with the expectant management. It is concluded that the application of carbocysteine lysine salt in combination with the mometasone furoate nasal spray ensures the rapid elimination of the symptoms of adenoiditis and significantly accelerates the resolution of exudative otitis media compared with the monotherapeutic treatment.. Цель исследования - повышение эффективности медикаментозной терапии экссудативного среднего отита у детей с рецидивирующими и хроническими аденоидитами. Показано, что использование карбоцистеина лизиновой соли (флуифорт) в терапии экссудативного среднего отита у детей с рецидивирующим и хроническим аденоидитом является более эффективным методом лечения по сравнению с выжидательной тактикой. Применение карбоцистеина лизиновой соли в комбинации с назальным спреем мометазона фуроата позволяет достичь быстрого купирования симптомов аденоидита и значительно ускоряет разрешение экссудативного среднего отита по сравнению с монотерапевтическим подходом.

Topics: Adenoids; Anti-Infective Agents, Local; Anti-Inflammatory Agents; Carbocysteine; Child; Child, Preschool; Chronic Disease; Comorbidity; Drug Therapy, Combination; Humans; Mometasone Furoate; Nasopharyngitis; Otitis Media with Effusion; Pregnadienediols; Treatment Outcome

We undertook comparative analysis of ciliotoxic effect of glucocorticosteroids frequently used for catheterization of the eustachian tube in patients presenting with exudative otitis media and concomitant allergic rhinitis. It was shown that the recovery of transport function of ciliary epithelium and appreciable clinical effect of the treatment were achieved by the application of mometasone furoate. Dexamethasone was next to mometasone in terms of efficiency whereas hydrocortisone produced much lower beneficial effect. It is concluded that, taking into account high bioavailability of dexametasone and hydrocortisone (> 80%) and contraindications to their intranasal administration, the preference should be given to medications with lower bioavailability.

Topics: Adolescent; Adult; Catheterization; Cilia; Dexamethasone; Epithelium; Eustachian Tube; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult