montelukast and Otitis-Media-with-Effusion

This study demonstrated that treatment with montelukast in combination with levocetirizine may have a beneficial effect on clinical improvement of middle ear fluid in children with otitis media with effusion (OME).. To evaluate the effect of the combination of montelukast and levocetirizine on shortening the duration of effusion in successfully treated OME in children.. This was a randomized, prospective, double-blind, placebo-controlled trial. The study group consisted of 120 children (age range 2-6 years), who were diagnosed with OME of at least 2 months duration. The children were randomized into one of four groups. The treatment packs containing montelukast 4 mg (tablet) and/or levocetirizine 2.5 mg/5 ml as the active drug or placebo were prepared, numbered, and distributed by the second author.. The amelioration of bilateral otoscopic sign scores in the combination therapy group was statistically significantly greater than in all the other groups (p < 0.05). Improvement in bilateral tympanometric findings in the combination therapy group and montelukast group was greater than in the other groups. However, this difference was not statistically significant (p > 0.05). When we compared the difference between otoscopic sign scores before and after treatment we found that it was statistically significant in every group (p > 0.05). However, the significant improvement in tympanometric findings occurred in all groups except the levocetirizine group (p > 0.05).

Topics: Acetates; Administration, Oral; Cetirizine; Child; Child, Preschool; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Follow-Up Studies; Histamine H1 Antagonists, Non-Sedating; Humans; Leukotriene Antagonists; Male; Otitis Media with Effusion; Otoscopy; Prospective Studies; Quinolines; Sulfides; Treatment Outcome

We conducted a prospective, randomized, placebo-controlled, double-blind study to determine if the leukotriene inhibitor montelukast is effective in eliminating persistent middle ear drainage in patients with otitis media with effusion (OME). Our study population was made up of patients aged 2 to 6 years who had had confirmed OME in one or both ears for at least 2 months. Patients were randomized to receive either placebo or 4 mg of montelukast daily for 1 month. The main outcome measure was clearance of middle ear effusion as demonstrated by otoscopy and tympanometry 1 month after the initiation of treatment. Our goal was to recruit 120 patients; however, an interim analysis was conducted after 38 patients had completed their regimen (19 patients in each group) when it became apparent that montelukast was not having any effect in clearing the effusions. Indeed, the OME had cleared in only 3 montelukast patients (15.8%) and 4 controls (21.1%); the difference was not statistically significant (p > 0.90). Based on this early trend, the study was terminated at this point. We conclude that montelukast appears to be no more effective than placebo in eliminating persistent middle ear effusion.

Topics: Acetates; Child; Child, Preschool; Chronic Disease; Cyclopropanes; Double-Blind Method; Humans; Leukotriene Antagonists; Otitis Media with Effusion; Quinolines; Sulfides; Treatment Failure

Otitis media with effusion (OME) is a common pediatric disease and there is great controversy concerning its management. Mechanical, medical and surgical treatments have not proven adequate in resolving the disease and serve mainly to manage complications. Leukotriene inhibitors are new drugs that have been approved recently for the treatment of asthma in children. The aim of this study was to evaluate the impact of leukotriene inhibitor therapy for asthma on the clinical course of OME in children with co-existing disease. Fifty children with bilateral OME and asthma, divided equally into two groups, were studied. The children in the first group were treated with budesonide and terbutaline inhalers together with the leukotriene inhibitor montelukast, whereas the children in the second group were treated with the inhalers alone. Duration of treatment was 30 days. Pneumatic otoscopy, tympanometry and pure-tone audiometry were performed at the beginning and at the end of treatment. Fifteen (60%) of the children receiving inhalers and montelukast and nine (36%) of those receiving only inhalers were found free of OME after 30 days of therapy. Thus, it may be concluded that a statistically significant beneficial effect on the clinical course of OME resulted from the addition of montelukast to the treatment of children with co-existing asthma and OME. Given that no medication has been shown to be effective in OME therapy, further investigation of the possible effects of leukotriene inhibitors is warranted.

Topics: Acetates; Administration, Inhalation; Adolescent; Asthma; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Otitis Media with Effusion; Quinolines; Sulfides; Terbutaline

The present study aimed to investigate the effects of indomethacine, montelukast and methylprednisolone in management of experimental otitis media with effusion.. Forty Wistar albino rats of which the weights ranged between 310 and 370 g were included in this study. Middle ear effusion was created by transtympanic histamine injection. The presence of effusion was confirmed by otomicroscopic examination. Thirty-seven rats with effusion were divided into 4 groups (methylprednisolone, montelukast, indomethacine and saline-control groups). All agents were administered for a period of consecutive 10 days. At the 11th days of administration, the recovery of effusion was confirmed by otomicroscopic examination. Tympanic bullae of the rats were removed and histopathological examinations were carried out. In the histopathological examination, the neutrophil leukocytes accumulated in the middle ear submucosa were counted.. The mean numbers of submucosal neutrophils in the methylprednisolone, montelukast, indomethacine, and saline groups were 24.6±8.1, 54.1±6.2, 52.3±7.3, 55.7±8.3, respectively. The otomicroscopic recovery rates of effusion in the methylprednisolone, montelukast, indomethacine, and saline groups were 18/18 (100%), 8/18 (44%), 2/14 (14%), 2/18 (11%) respectively.. Methylprednisolone and montelukast ameliorate the middle ear effusion. However, only methylprednisolone reduces the submucosal infiltration of the neutrophil leukocytes which are the most evident cell of inflammatory process. Montelukast is effective in the resolution of experimental otitis media with effusion.

Topics: Acetates; Administration, Oral; Animals; Biopsy, Needle; Cyclopropanes; Disease Models, Animal; Dose-Response Relationship, Drug; Drug Administration Schedule; Immunohistochemistry; Indomethacin; Injections, Intraperitoneal; Male; Methylprednisolone; Otitis Media with Effusion; Otoscopy; Quinolines; Random Allocation; Rats; Rats, Wistar; Reference Values; Statistics, Nonparametric; Sulfides; Treatment Outcome