A comparative study of azithromycin and pseudoephedrine hydrochloride for otitis media with effusion in children. Efficacy of oral antibiotics for the treatment of persistent otitis media with effusion. Epidemiology and treatment of otitis media with effusion in children in the first year of primary school. Cefaclor in the treatment of otitis media with effusion. Otitis media with effusion: can erythromycin reduce the need for ventilating tubes? A controlled trial of cotrimoxazole therapy in serous otitis media. Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice. Trimethoprim-sulfamethoxazole treatment of persistent otitis media with effusion. Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children. Antibiotic treatment of children with secretory otitis media. A randomized, double-blind, placebo-controlled study. Resolution of otitis media with effusion with the use of a stepped treatment regimen of trimethoprim-sulfamethoxazole and prednisone. Otitis media with effusion and chronic upper respiratory tract infection in children: a randomized, placebo-controlled clinical study. Prophylaxis of recurrent acute otitis media and middle-ear effusion. Comparison of amoxicillin with sulfamethoxazole and trimethoprim. Single dose of betamethasone in combined medical treatment of secretory otitis media. Serous otitis media. A double-blind trial with sulfisoxazole. The efficacy of oral steroids in the treatment of persistent otitis media with effusion. Management for the children with otitis media with effusion in the tertiary hospital. A controlled trial comparing three treatments for chronic otitis media with effusion. Antimicrobial therapy of chronic otitis media with effusion. Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial.
We compared the outcomes of two different regimens--azithromycin and pseudoephedrine hydrochloride (PHCl)--for the treatment of otitis media with effusion (OME) in children. In a double-blind randomized clinical study, a total of 90 children aged between 2 and 13 years with persistent OME were randomly assigned to one of 3 treatment groups. The first group received azithromycin at a dose of 10 mg/kg once daily for 3 days and this regimen was repeated weekly for up to 12 weeks according to the results of tympanometry and pneumatic otoscopy. The second group received azithromycin at a dose of 10 mg/kg once daily for 3 days for the first week, and this regimen was repeated for 1 day a week for the following 11 weeks. The third group received PHCl, 4 mg/kg, 3 times daily for up to 12 weeks. Each patient underwent pneumatic otoscopic and tympanometric investigations at baseline and at Weeks 4, 8 and 12. The outcomes in the azithromycin-treated groups were superior to that in the decongestant group. However, the difference between the outcomes in the azithromycin groups according to the treatment protocol was not statistically significant. Azithromycin therapy, particularly a once-weekly regimen, helps patients to comply with treatment and also helps us to achieve good results with minimal therapy. We followed 137 children who were found to have persistent otitis media with effusion (POME) one month after the diagnosis of acute otitis media. Subjects were randomly assigned to either treatment with erythromycin ethylsuccinate and sulfisoxizole or to no treatment. Follow-up utilizing pneumatic otoscopy and tympanometry showed that treated patients were more likely to have normal findings, and less likely to develop acute otitis media during the month following treatment. These data indicate that children with POME one month following acute otitis media may benefit from an additional course of antibiotics. In this multicentre study we evaluated the prevalence and risk factors of otitis media with effusion (OME) in Italian school-children and the effectiveness of medical treatment of chronic OME with a new cephalosporin, ceftibuten. During two winter periods, 3413 children, aged 5 to 7 years, were examined for the presence of OME by means of pneumotoscopy and a portable, hand-held tympanometer. The prevalence of asymptomatic OME was 14.2%, with no difference as regards sex, age, month of examination or geographic area. Younger children had significantly more bilateral than unilateral effusion. A recent episode of acute otitis media and previous tonsillectomy or adenoidectomy were associated with an increased risk of OME in multivariate logistic regression models. The presence of OME was unrelated to such factors as birthweight, prematurity, sibling or parental history of allergy, duration of daycare attendance, family history of ear infections. After 12 weeks, 26.6% of children with OME still had middle-ear fluid: 52 were randomized to ceftibuten (9 mg/kg q.d. for 14 days) and 59 to no treatment (nasal saline drops allowed). Children treated with ceftibuten had a significantly better resolution of middle-ear effusion after 4 and 8 weeks. As mass screening programmes for OME in the year of school entry are questioned, a focus only on children with known risk factors seems advisable. Ceftibuten can be useful in reducing the duration of middle-ear effusion. A randomized clinical trial in which 91 children with chronic OME participated was performed. Cefaclor 20 mg/kg body weight b.i.d. was given to the treated group (n = 46) during 10 days preceding the day appointed for surgery. The control group (n = 45) remained untreated. On the day scheduled for surgery 24 (52%) of the treated cases had healed, compared to 5 (11%) of the untreated cases, a significant difference (p less than 0.001). The long term effects showed that in the treated group 18 of the 24 primarily healed remained unoperated at a median follow-up period of 20 months. In the untreated group two of the five that originally resolved later relapsed and were subjected to surgery. Otitis media with effusion (OME) is a common condition among children and is characterized by nonpurulent fluid in the middle ear and fluctuating conductive hearing loss. Most children will spontaneously regain normal air-filled middle ears, but a certain number will have persistent problems. In our department we will treat annually about 500 children on an outpatient basis, with the insertion of ventilating tubes in the eardrum. The reason for this study was to evaluate the effect of erythromycin, instead of inserting a ventilation tube, in children with bilateral OME of longer duration than three months (double blind/placebo). The study comprises 147 children, 1-15 years of age, 83 boys and 64 girls, all with OME for more than three months. All the patients were candidates for tube insertion. In the group treated with erythromycin, 12 patients out of 69 had bilaterally air-filled middle ears after one month, as compared to 19 out of 72 in the group treated with the placebo. No difference was noted due to sex or age. The results support our indication and timing for ventilation tube insertion. nan The treatment of persistent otitis media with effusion (OME) remains controversial, but this condition is the commonest reason for children to require ear, nose, and throat (ENT) surgery. Trials of antibiotics are inconclusive, are often weak methodologically, and have not been done in general practice. Our aim was a trial of an antibiotic for OME in such a population.
                433 children, aged 6 months to 6 years, with OME from 57 general practices entered a 3-month watchful waiting period. Of 223 (52%) with persistent bilateral OME, 162 were randomised double-blind to receive co-amoxiclav suspension (20 mg/kg amoxicillin, 5 mg/kg clavulanate potassium) or matching placebo, orally three times a day for 14 days. All cases also received xylometazoline 0.25% decongestant nosedrops thrice daily. Of the 61 not randomised, 13 children were referred to an ENT surgeon and parents refused consent in 48 cases. The main outcome measures were persistent OME in both ears and in one or both ears, as assessed clinically and by tympanometry. Analysis was by intention-to-treat.
                79 children in the treatment group and 70 in the placebo group were analysed for efficacy. 3 withdrew in the co-amoxiclav group (2 lost to follow-up, 1 due to side-effects); 6 withdrew in the placebo group (5 and 1, respectively). In addition, 4 tympanograms were uninterpretable in the controls. Compliance was over 90% in both groups. Persistent OME in both ears and in one or both ears were found at significantly lower rates in the co-amoxiclav group than in the controls at the 2-week follow-up: 53 vs 84% and 77 vs 93%, respectively. Odds ratios adjusted for sex, history of adenoidectomy, and upper respiratory tract infection at follow-up were 0.25 (95% CI 0.11, 0.58, p = 0.001) and 0.30 (0.10, 0.89, p = 0.03), respectively. Parents of children in the co-amoxiclav group reported significantly more side-effects than those of control children (44 vs 22%, p = 0.03). Side-effects were mostly gastrointestinal and mild.
                Our study in a general-practice setting confirmed the positive short-term effect of antibiotic treatment for persistent middle-ear infection. Before referral to an ENT surgeon, children with persistent OME presenting to general practitioners could be considered for such treatment, depending on the individual child and possible adverse sequelae. Persistent otitis media with effusion (POME) is found in 50% of young children after 10 days of antimicrobial therapy for acute otitis media. Pathogenic bacteria are present in at least 25% of such effusions. We studied the effect of a 2-week course of trimethoprim-sulfamethoxazole (TMP-SMX) administered to 33 children who had POME and compared the results obtained to those of a similar group of children with POME who did not receive drug therapy. This study was designed to answer two questions: (1) Would TMP-SMX promote the resolution of POME? (2) Would TMP-SMX prevent an attack of acute otitis media (AOM) superimposed on POME? The diagnosis of POME was validated by obtaining a type B tympanogram, and AOM was diagnosed according to strict criteria. Each child was randomly assigned either to a treatment group that received a 14-day course of TMP-SMX or to a control group that received no medication. TMP-SMX failed to promote resolution of POME but did prevent recurrent AOM. During the second 2-week (follow-up) phase of the study, when no antimicrobial was given to either subject group, the incidence of AOM was similar in both groups. We randomly assigned children with otitis media with effusion to receive either erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for a 2-week period, primarily to determine whether either erythromycin-sulfisoxazole or cefaclor would have greater short term efficacy than that found previously for amoxicillin, and secondarily to supplement earlier data on outcomes in placebo-treated subjects. Interim analyses showed no statistically significant (P less than 0.05) differences between the three antimicrobial treatment groups in the primary outcome measures, i.e. the prevalence of middle-ear effusion 2 and 4 weeks after entry, and indicated that postulated differences favoring the erythromycin-sulfisoxazole and cefaclor groups over the amoxicillin group were unlikely to be found even if the originally calculated sample size were attained. Subject accrual was therefore terminated. Final analysis showed no significant between-group differences in other outcome measures as well. In antimicrobial vs. placebo comparisons neither erythromycin-sulfisoxazole nor cefaclor gave more favorable outcomes than placebo, whereas more children were effusion-free in the amoxicillin group than in the placebo group at 2 weeks (31.6% vs. 14.1%, P = 0.007), but not at 4 weeks. We conclude that when antimicrobial treatment for otitis media with effusion is deemed advisable, neither erythromycin-sulfisoxazole nor cefaclor should replace amoxicillin as first line treatment. A double-blind, randomized, placebo-controlled clinical trial was conducted to evaluate one month of amoxicillin-clavulanate potassium treatment of children with secretory otitis media. In total, 264 children, aged 1 to 10 years, were randomly assigned to either antibiotic or placebo treatment; 43 patients were excluded during treatment, equally distributed in both groups, leaving 221 patients completing the trial. The inclusion criterion was a type C2 and type B tympanometry result of at least three months' duration. Tympanometry was performed every month for 12 additional months. At the end of the treatment period, the disease was reversed in 61% in the antibiotic-treated group compared with 30% in the placebo-treated group (P less than .0001), and the improvement was persistently significant in favor of antibiotic for eight months. The effect was present in all age groups and independent of laterality of disease. The middle-ear status at the end of treatment was the determining factor for the outcome of tympanometry the year following treatment. From the end of treatment, there was no difference between tympanometry in a patient having been treated with the antibiotic and a patient having been treated with placebo. Antibiotic treatment shifts the individual patient from poor to better tympanometric conditions, so antibiotics can be recommended in the treatment of secretory otitis media before inserting ventilating tubes. This double blind, placebo-controlled trial was designed to determine whether intervention with a stepped regimen of trimethoprim-sulfamethoxazole (TMP-SMX) and prednisone would prevent high risk children from developing chronic otitis media with effusion (OME) and recurrent acute otitis media. Forty-two children were enrolled, assigned to treatment with active drug or placebo and then examined at 2-week intervals. They received TMP-SMX (or placebo) during the first 2 weeks, TMP-SMX and prednisone (or placebo) during Weeks 3 and 4 for persistent OME and TMP-SMX (or placebo) for Weeks 5 and 6 if OME was still unresolved. After treatment 48% of active drug and 14% of placebo subjects resolved OME bilaterally (P less than 0.05). Active drug subjects also had fewer acute otitis media episodes than placebo subjects while receiving study treatment (P less than 0.01). Although this treatment regimen produced short term OME resolution, long term benefits were not demonstrated. This study was performed to investigate the course of spontaneous recovery from otitis media with effusion in children with chronic rhinosinusitis treated in various ways. One hundred forty-one children between 3 and 10 years of age were selected for the presence of chronic rhinosinusitis and unilateral or bilateral otitis media with effusion. The children were assigned at random to one of four treatment groups, i.e., placebo, amoxicillin combined with xylometazoline hydrochloride nose drops, maxillary sinus drainage, or a combination of the latter two forms of therapy. The follow-up period was 6 months. Drainage of the maxillary sinus had no effect on either the recovery of the chronic upper respiratory tract infection or otitis media with effusion. Amoxicillin combined with xylometazoline nose drops had no significant effect on recovery from the upper respiratory tract infection, but did have a small but significant effect on recovery from otitis media with effusion. However, the general tendency of the upper respiratory tract and ears to recover was poor. Persistence of the chronic upper respiratory tract infection during the follow-up period proved to be a negative prognostic factor with respect to cure of otitis media with effusion. Children with chronic rhinosinusitis as defined in this study appear to have a high risk of developing chronic otitis media with effusion. The results of the study are discussed. We compared the efficacy of amoxicillin with that of the combination drug sulfamethoxazole and trimethoprim in reducing recurrences of acute otitis media (AOM) in a single-blind, randomized, placebo-controlled trial involving 96 children. Each of the children had had three or more episodes of AOM in the preceding 6 months, and 97% (93/96) of them still had unilateral or bilateral effusion at the beginning of the study. During the 6-month study period, 9 (27%) of 33 of the children in the amoxicillin group developed 9 episodes of AOM, 9 (27%) of 33 of the children in the sulfamethoxazole and trimethoprim group experienced 11 episodes of AOM, and 19 (63%) of 30 of the children in the placebo group developed 25 episodes. Young age and day-care attendance characterized children for whom prophylaxis was more efficacious. Overall persistence of middle-ear effusion was shorter in treated children only as a consequence of the reduced number of new episodes of AOM. With the objective of evaluating the efficacy of cefixime and the combination of cefixime and betamethasone in the treatment of secretory otitis media (SOM), we enrolled 142 children 2 to 12 years old in a randomized, double-blind, placebo-controlled study. All children suffered from SOM, verified by otomicroscopy and tympanometry, of at least 3 months' duration. Active treatment was a 10-day course of cefixime with and without a single dose of 6 mg betamethasone. On hundred forty children were available for efficacy evaluation 14 to 23 days after the start of treatment. A statistically significant treatment effect was found in the group treated with cefixime plus betamethasone (n = 59), with a 44.1% cure rate as compared to 19.7% in the cefixime-treated group (n = 61; p < .005) and 5% in the placebo group (n = 20; p < .005). Relapse rates were high and no statistically differences between groups remained at last valid visit. Adverse events possibly or probably associated with active treatment were reported in 11 cases (9.2%). One patient reported a severe adverse event. No serious events occurred. The study did not show any significant long-term effect of cefixime treatment or any long-term treatment benefit with the addition of betamethasone to the antibiotic. nan One hundred thirty-six children with otitis media with effusion of at least 2 months' duration were investigated in a strict, double-blind, randomized prospective study to evaluate the efficacy of oral steroids in the treatment of this disease. The results of our study showed a significant complete and partial recovery from otitis media with effusion in the group treated by a combination of antibiotics (amoxicillin) and oral steroids (prednisone), compared with an amoxicillin-treated group and a placebo-treated group. We believe that this treatment mostly benefits children aged 4 to 10 years without oversized adenoids. The findings of our study imply that a combined course of antibiotics and oral steroids deserves its place as a routine conservative trial before surgery. 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. A randomized, controlled clinical trial was conducted in 76 children to evaluate the efficacy of trimethoprim-sulfamethoxazole for 4 weeks, prednisone for 2 weeks and aluminum ibuprofen suspension for 2 weeks in resolving chronic otitis media with effusion which had persisted for more than 8 weeks. After 2 weeks of treatment resolution rates of chronic otitis media with effusion in the prednisone and trimethoprim-sulfamethoxazole groups were significantly greater than those in the control (no treatment) and ibuprofen groups. After 4 weeks the differences in resolution rates between the control, trimethoprim-sulfamethoxazole and prednisone groups became smaller. After 12 months of follow-up, differences in hearing sensitivity among study groups were not statistically significant, although 83% of patients had a 15-dB or greater hearing loss. Therefore short term antimicrobial and antiinflammatory treatment did not appear to have a long lasting effect on chronic middle ear inflammation. Otitis media with effusion is the most common cause of hearing loss in children. Prior studies have indicated that viable bacteria may be present in this process. A controlled clinical trial was therefore undertaken to assess the efficacy of antimicrobial agents in the treatment of this disease entity over a four week period. It appears that the use of antibiotics significantly improves the outcome in patients treated for four weeks when compared with patients observed over the same time period. In a randomized, double-blind, placebo-controlled trial involving 518 infants and children who had otitis media with effusion ("secretory" otitis media), we evaluated the efficacy of a two-week course of amoxicillin (40 mg per kilogram of body weight per day) with and without a four-week course of an oral decongestant-antihistamine combination. Among the 474 subjects who were evaluated at the four-week end point, the rate of resolution of middle-ear effusion was twice as high in those treated with amoxicillin, either with or without the decongestant-antihistamine, as in those who received placebo (P less than 0.001), but 69.8 percent of the amoxicillin-treated subjects still had effusion. Among both the amoxicillin-treated subjects and the placebo-treated subjects, resolution was more likely in those with initially unilateral effusion, in those who had had effusion for eight weeks or less, and in those without an upper respiratory tract infection at the four-week end point. Side effects were reported more often in subjects who received decongestant-antihistamine than in those who did not. Among the subjects without effusion at the four-week end point, recurrent effusion developed in approximately half those in both the amoxicillin and placebo groups during the subsequent three months. We conclude that in infants and children with otitis media with effusion, amoxicillin treatment increases to some extent the likelihood of resolution.
The results of our review do not support the routine use of antibiotics for children up to 18 years with otitis media with effusion. The largest effects of antibiotics were seen in children treated continuously for four weeks and three months. Even when clear and relevant benefits of antibiotics have been demonstrated, these must be balanced against the potential adverse effects when making treatment decisions. Immediate adverse effects of antibiotics are common and the emergence of bacterial resistance has been causally linked to the widespread use of antibiotics for common conditions such as otitis media.