The long-term outcome of nonsuppurative otitis media with effusion. [Effects and adverse effects of decongestants in otosalpingitis]. Secretory otitis media, oral decongestant and antihistamine. Clinical trial with Lunerin mixture and Lunerin mite in children with secretory otitis media. Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial. Childhood serous otitis media: fifteen months' observations of children untreated compared with those receiving an antihistamine-adrenergic combination. Management for the children with otitis media with effusion in the tertiary hospital. Secretory otitis media. Aspects on treatment and control. Topical phenylephrine for the treatment of middle ear effusion. Management of middle-ear effusions in children. Antimicrobial therapy for otitis media with effusion ('secretory' otitis media). The medical treatment of secretory otitis media. A clinical trial of three commonly used regimes. Diagnostic and therapeutic studies in childhood serous otitis media. Results of treatment with an antihistamine-adrenergic combination. S-carboxymethylcysteine in otitis media with effusion. (A double-blind study). Efficacy of medical treatment as an adjunct to surgery in the treatment of secretory otitis media. Prevention and therapy of serous otitis media by oral decongestant: a double-blind study in pediatric practice.
Seventy-four children were enrolled in a double-blind placebo-controlled study to define the outcome of nonsuppurative otitis media with effusion (OME) over a 12-week period. Participants were randomly assigned to one of three treatment groups: pseudoephedrine (4 mg/kg/day), chlorpheniramine (0.35 mg/kg/day), or placebo. The children were reexamined at 2, 4, 8, and 12 weeks after enrollment unless earlier dismissed from the study because OME resolved or acute suppurative otitis media developed. Of the 66 children completing the study protocol, 44 percent had resolved OME, 38 percent developed acute suppurative otitis media, 14 percent had unresolved OME, and 4 percent developed severe hearing loss or medication side effects by the end of 12 weeks. The greatest incidence of both suppurative otitis media and resolution of OME occurred by 2 weeks of follow-up. There was no significant difference in resolution of effusion between treatment groups. Children who were 18 months of age or older with unilateral effusion had the best likelihood of resolution. nan nan A double-blind comparison between a combined antihistaminc and vasoconstricting preparation (Lunerin Mixture, Lunerin Mite) and placebo was performed in children with secretory otitis media. It was shown that the children given the active drug reacted more favourably on every investigated parameter (hearing threshold, appearance and mobility of the ear drum, number of myringotomies and observation time) than the patients who were given placebo. The incidence of side-effects was low. In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children. Of 55 patients who had received, in a previously reported double-blind study, either an antihistamine-adrenergic combination or a placebo for three months for serous otitis media, 48 were followed without drug therapy for an additional year. During the follow-up period no differences were detected between the patients who had initially been treated with drugs and those who had received the placebo, as detected by audiometry, tympanometry, parental concern about hearing loss (as detected by the parents themselves or by their children's teachers or primary health care providers), school performance, or recurrences of serous otitis media. Recently, new evidence-based recommendations have been introduced for diagnosing and managing otitis media with effusion (OME) in children. However, there are some difficulties to follow the general guidelines in the tertiary hospitals. The purpose is to evaluate the efficiency of antibiotics or antihistamines for treatment of children with OME in the tertiary hospital with a randomized prospective clinical study.
                Eighty-four children with OME who had been diagnosed in the tertiary hospital were randomized to receive 5 different medications for 2 weeks. We prescribed antibiotics (amoxicillin-clavulanate syrup) in Group I (n=16), antibiotics/steroids (prednisolone) in Group II (n=18), antibiotics/antihistamines (ebastine) in Group III (n=15), antibiotics/steroids/antihistamines in Group IV (n=17), and mucolytics (ivy leaf extract) in Group V (n=17) for control. We followed-up children every 2 weeks and evaluated the state of OME at 3 months.
                Thirty six (42.9%) of 84 children were resolved within average 6.9 weeks after the treatments. Thirty-six (42.9%) were treated with ventilation tube insertion and 12 patients (14.3%) were observed. There was no difference in the resolution rates of OME among the five different protocols (P>0.05). There was no difference in the resolution rates among groups who used steroids, antihistamines, steroids and antihistamines, or other medications to manage 42 children with allergies (P>0.05).
                In the tertiary hospital, the cure rate of children with OME was not as high as well-known, and antibiotics or anti-allergic medications were not more effective than control. We may, therefore, need any other guidelines which are different from the previous evidence-based recommendations, including early operation in the tertiary hospitals. In a double-blind study, 228 secretory otitis media patients were evaluated according to mucolytic and decongestive treatment. No definite difference comparing with the placebo group was registered. About 50% of all patients were cured within 4 weeks after the diagnosis was established. Those patients who earlier had been treated with antibiotics because of a preceding acute otitis media had a better cure rate than the untreated group. Suggestions on treatment and control of secretory otitis media are given. One hundred fifty-two children were enrolled in a randomized, controlled clinical trial of the efficacy of phenylephrine hydrochloride nose drops or nasal spray in hastening the resolution of middle ear effusion. Children with persistent effusion were recruited for the study during a return visit two weeks after an episode of acute otitis media. Forty-six patients (30%) dropped out of the study, many because they failed to tolerate the medication, especially the nose drops. Another 27 (18%) had to be excluded because of intercurrent illness or systemic drug therapy. Among those children completing the study, rates of clinical and tympanometric cure during the following four weeks were similar in the drug and placebo groups. In view of the absence of documented clinical efficacy and the practical difficulties inherent in their administration, topical decongestants appear to have a limited role, if any, in treating children with persistent effusion. A double-blind placebo controlled trial of Mucodyne (carbocisteine, Berk Pharmaceuticals), Actifed (triprolidine HC1 and pseudoephedrine HC1, Wellcome) and combined Mucodyne and Actifed in the treatment of middle-ear effusions is reported. The trial was undertaken to assess whether either preparation, alone or in combination, would reduce the number of children requiring surgical treatment for this condition. No statistical difference between the various groups in avoiding surgical treatment was detected. In those patients undergoing surgery, pre-operative treatment with Mucodyne was associated with a significantly greater number of ears restored to a normal appearance and middle ear function as measured by tympanometry. All patients relapsing after surgery belonged to the groups receiving placebo, Actifed or the combination of Mucodyne and Actifed prior to the operation. To determine the effectiveness of antimicrobial treatment for otitis media with effusion ("secretory" otitis media) in children.
                We report the reexamination of a previously published study by Mandel et al that evaluated the efficacy of a 2-week course of antimicrobials (amoxicillin trihydrate) with and without a 4-week course of an oral decongestant-antihistamine combination in a double-blind, placebo-controlled, randomized trial involving 518 infants and children with otitis media with effusion.
                At 4 weeks, amoxicillin efficacy as determined by a tympanometric criterion (P = .121) or by a measure of improvement in hearing (P = .311) was insignificant. Only by otoscopic judgment, which is shown to contain a systematic bias as used in this clinical trial, could an argument be made for a marginal efficacy of amoxicillin at the 4-week end point. Logistic regression analyses of the combined effects of treatment and prognostic factors showed no significant differences between placebo- and antibiotic-treated groups for unilateral effusions and for bilateral effusions. When subjects with unilateral and bilateral effusions were combined, the estimated efficacy of antibiotic treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry (P = .171). We also demonstrate the sensitivity of outcome to diagnostic measures used and provide statistical evidence questioning the validity of otoscopic observations in this study. Six weeks after the termination of amoxicillin therapy, the recurrence of effusion was two to six times higher in the amoxicillin-treated children than in those treated with placebo (P = .001), and resolution of effusion was not significantly different among antibiotic and placebo groups (13.6% and 11.3%, respectively; P = .477).
                Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children. A clinical trial was undertaken to evaluate three medical treatments commonly used for chronic secretory otitis media. The treatments compared were Ephedrine nose drops, an oral antihistamine and decongestant (Dimotapp) and autoinflation of the middle ear. Changes in middle ear compliance and pressure were used as objective criteria of the efficacy of treatment in addition to changes in pure-tone threshold and to clinical assessment. Symptoms and abnormal signs tended to remit during the trial but there was no evidence from pure-tone audiometry and tympanometry that any of the treatments was beneficial. The period of observation enabled 28% of the children to avoid surgical treatment. Good and bad prognostic features are described which should help in deciding whether to manage a case conservatively or whether to proceed directly to surgery. Fifty-five children with their first recognized episodes of serous otitis media were followed over a three-month period. The efficacy of an antihistamine-adrenergic combination (diphenhydramine and pseudoephedrine), the comparative value of various diagnostic studies of middle ear function, and the prognostic importance of information obtained at the first visit were assessed. Compared double-blindly to a placebo, the pharmaceutical preparations did not appear to influence the clinical course, although more drug patients experienced lethargy or relief of symptoms not directly concerned with middle ear function (mainly upper respiratory congestion). The color and extent of motility of the tympanic membrane, but no other pneumatic otoscopic findings, were related to audiometry, whereas tympanometry correlated with the amount of motility and the presence or absence of visible fluid behind the membrane. The patients with the most severe hearing losses or with visible middle ear fluid at their initial visits improved the most, and those who began to be followed in the summer the least. The last finding may be due to a general but unexplained deterioration of childhood serous otitis media during the fall. S-carboxymethylcysteine syrup (SCMC); brompheniramine, phenylephrine with phenylpropanolamine elixir (BPP); and a placebo were compared in a double-blind trial in 58 children with otitis media with effusion (OME). All patients underwent myringotomies after an initial period of medical treatment. SCMC, but not BPP, was significantly better than the placebo in speeding up resolution of the effusion after surgery, as judged by pure tone audiometry, showing this drug to be a useful adjunct to the surgical management of OME. It should also be considered as an alternative to surgery. In a pilot controlled randomised trial of 38 children who had bilateral secretory otitis media, with effusion demonstrated at operation, we compared the efficacy of a six-week course of an oral decongestant--antihistamine combination and a mucolytic preparation with a control group in preventing the presence of middle-ear effusion six weeks after myringotomy and adenoidectomy. The mucolytic preparation decreased the presence of middle-ear effusion when compared to the decongestant-antihistamine combination and the control group (p = 0.06). We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no siginificant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM.
The pooled data demonstrate no benefit and some harm from the use of antihistamines or decongestants alone or in combination in the management of OME, therefore we recommend against their use.