A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Management for the children with otitis media with effusion in the tertiary hospital. Prophylactic ciprofloxacin drops after tympanostomy tube insertion. Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. Naturopathic treatment for ear pain in children. The use of antibiotic/steroid ear drops to reduce post-operative otorrhoea and blockage of ventilation tubes. A prospective study.
To determine the clinical effectiveness and cost-effectiveness of topical mometasone in children with bilateral otitis media with effusion (OME).
                A double-blind randomised placebo-controlled trial with an intention to treat analysis; the 10.6% of patients lost to follow-up at 1 month were censored in the analysis.
                76 Medical Research Council General Practice Research Framework practices throughout the UK between 2004 and 2007.
                A sample of 217 children aged 4-11 years was selected from those presenting to their GP with one or more episodes of otitis media or ear-related problems in the previous 12 months whom the research nurse confirmed had bilateral glue ear using microtympanometry (B B or B C2 types using a modified Jerger classification) at randomisation.
                Mometasone 50 micrograms in each nostril or placebo spray once daily for 3 months.
                The primary outcome was the proportions of children cleared of OME assessed by tympanometry at 1 month. Secondary outcomes included clearance at 3 months and 9 months; adverse events; OM8-30 scores (a functional health status responsive disease-specific measure); hearing loss; days with otalgia; cost-effectiveness; and health utilities.
                Of the topical steroid group, 40.6% (39/96) demonstrated tympanometric clearance (C1 or A type) in one or both ears at 1 month, compared with 44.9% (44/98) of the placebo group. The absolute risk reduction at 1 month was -4.3% (95% CI -18.05% to 9.26%); the odds ratio (OR) was 0.84 (95% CI 0.48 to 1.48). Four covariates were pre-specified for inclusion in logistic regression analysis: age as a continuous variable (p = 0.94), season (p = 0.70), atopy (p = 0.61) and clinical severity (p = 0.006). The adjusted OR (AOR) at 1 month for the main outcome was 0.93 (95% CI 0.50 to 1.75). Secondary analysis at 3 months showed 58.1% of the steroid group had resolved and 52.3% of the placebo group, AOR 1.45 (95% CI 0.74 to 2.84). At 9 months 55.6% of the treated group remained clear in at least one ear and 65.3% of the placebo group, AOR 0.82 (95% CI 0.39 to 1.75). Adverse events (although relatively minor) occurred in 7-22% of children and included nasal stinging, epistaxis, dry throat and cough. The OM8-30 scores (p = 0.55) reported hearing difficulty (p = 0.08), and days with otalgia (p = 0.46) were not significantly different between groups at 3 months. The economic evaluation found the active treatment arm to be dominated by placebo, accruing slightly (but not significantly) higher costs and fewer quality-adjusted life-years (QALYs), with a 24.2% probability that topical steroids are a cost-effective use of NHS resources at a ceiling ratio of 20,000 pounds per QALY gained.
                Use of topical intranasal corticosteroids is very unlikely to be a clinically effective treatment for OME (glue ear) in the primary care setting.
                Current Controlled Trials ISRCTN38988331. Acute otitis media (AOM) is the most common diagnosis for which antibiotics are prescribed for children. Previous trials that have evaluated a "wait-and-see prescription" (WASP) for antibiotics, with which parents are asked not to fill the prescription unless the child either is not better or is worse in 48 hours, have excluded children with severe AOM. None of these trials were conducted in an emergency department.
                To determine whether treatment of AOM using a WASP significantly reduces use of antibiotics compared with a "standard prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.
                A randomized controlled trial conducted between July 12, 2004, and July 11, 2005. Children with AOM aged 6 months to 12 years seen in an emergency department were randomly assigned to receive either a WASP or an SP. All patients received ibuprofen and otic analgesic drops for use at home. A research assistant, blinded to group assignment, conducted structured phone interviews 4 to 6, 11 to 14, and 30 to 40 days after enrollment to determine outcomes.
                Filling of the antibiotic prescription and clinical course.
                Overall, 283 patients were randomized either to the WASP group (n = 138) or the SP group (n = 145). Substantially more parents in the WASP group did not fill the antibiotic prescription (62% vs 13%; P<.001). There was no statistically significant difference between the groups in the frequency of subsequent fever, otalgia, or unscheduled visits for medical care. Within the WASP group, both fever (relative risk [RR], 2.95; 95% confidence interval [CI], 1.75 - 4.99; P<.001) and otalgia (RR, 1.62; 95% CI, 1.26 - 2.03; P<.001) were associated with filling the prescription.
                The WASP approach substantially reduced unnecessary use of antibiotics in children with AOM seen in an emergency department and may be an alternative to routine use of antimicrobials for treatment of such children.
                clinicaltrials.gov Identifier: NCT00250900. To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic acid, and steroid and antibiotic in acute otitis externa in primary care.
                Randomised controlled trial.
                79 general practices, Netherlands.
                213 adults with acute otitis externa.
                Primary outcome: duration of symptoms (days) according to patient diaries. Secondary outcome: cure rate according to general practitioner completed questionnaires and recurrence of symptoms between days 21 and 42.
                Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%, respectively. Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7, respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively). Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group (0.4, 0.2 to 1.0) than in the acetic acid group.
                Ear drops containing corticosteroids are more effective than acetic acid ear drops in the treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear drops are equally effective. To determine the efficacy and tolerance of Otikon Otic Solution (Healthy-On Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (containing Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum perforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical Ltd, Benyamina, Israel) ear drops (containing ametocaine and phenazone in glycerin) in the management of ear pain associated with acute otitis media (AOM).
                Children between the ages of 6 and 18 years who experienced ear pain (otalgia) and who were diagnosed with eardrum problems associated with AOM were randomly assigned to be treated with Otikon or Anaesthetic ear drops, which were instilled into the external canal(s) of the affected ear(s). Ear pain was assessed using 2 visual analog scales: a linear scale and a color scale. Pain assessment took place throughout the course of 3 days. The mean score of pain reduction was used to measure outcome.
                Primary pediatric community ambulatory centers.
                One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM.
                Each of the 2 treatment groups were comparable on the basis of age, sex, laterality of AOM, and the effectiveness of ameliorating symptoms of otalgia. The 2 groups were also comparable to each other in the initial ear pain score and in the scores at each application of Otikon or Anaesthetic drops. There was a statistically significant improvement in ear pain score throughout the course of the study period (P =.007).
                Otikon, an ear drop formulation of naturopathic origin, is as effective as Anaesthetic ear drops and was proven appropriate for the management of AOM-associated ear pain. 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. To evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of post-tympanostomy otorrhea, and the relation between middle ear content and post-tympanostomy otorrhea.
                One hundred and fifty patients aged 3-14 years underwent tympanostomy and tube insertion at the Prince Rashid Ben Al-Hasan Hospital, Al-Husn, Jordan during the interval between February 2000 to January 2003. The patients were randomized into 3 groups: group 1 (control group) received no antibiotic drops, group 2 received a single dose of ciprofloxacin drops intraoperatively and group 3 received an intraoperative dose followed by 5-day postoperative course.
                Application of topical ciprofloxacin after tympanostomy tube insertion was associated with a significantly lower incidence of early post-tympanostomy otorrhea. The rate of otorrhea for the control group was 16.5% and the treatment groups were (group 1) 8.4%, (group 2) 8.2% and p=0.011. A single dose of antibiotics was effective when patient's middle ears were dry or had serous effusions. For those whose ears had mucoid or purulent content a 5-day course was indicated.
                Topical administration of a single dose of ototopical ciprofloxacin after surgery is an effective treatment for the prevention of early post-tympanostomy otorrhea, and a prolonged course (5 days) may be indicated for those whose ears had purulent or thick mucoid contents, and the content of middle ear are important in predicating postoperative otorrhea. The widespread use of antibiotics for treatment of acute otitis media (AOM) has resulted in the emergence of multidrug-resistant pathogens that are difficult to treat. However, it has been shown that most children with nonsevere AOM recover without ABX. The objective of this study was to evaluate the safety, efficacy, acceptability, and costs of a non-ABX intervention for children with nonsevere AOM.
                Children 6 months to 12 years old with AOM were screened by using a novel AOM-severity screening index. Parents of children with nonsevere AOM received an educational intervention, and their children were randomized to receive either immediate antibiotics (ABX; amoxicillin plus symptom medication) or watchful waiting (WW; symptom medication only). The investigators, but not the parents, were blinded to enrollment status. Primary outcomes included parent satisfaction with AOM care, resolution of symptoms, AOM failure/recurrence, and nasopharyngeal carriage of Streptococcus pneumoniae strains resistant to ABX. Secondary outcomes included medication-related adverse events, serious adverse events, unanticipated AOM-related office and emergency department visits and telephone calls, the child's absence from day care or school resulting from AOM, the parent's absence from school or work because of their child's AOM, and costs of treatment. Subjects were defined as failing (days 0-12) or recurring (days 13-30) if they experienced a higher AOM-severity score on reexamination.
                A total of 223 subjects were recruited: 73% were nonwhite, 57% were <2 years old, 47% attended day care, 82% had experienced prior AOM, and 83% had not been fully immunized with heptavalent pneumococcal vaccine. One hundred twelve were randomized to ABX, and 111 were randomized to WW. Ninety-four percent of the subjects were followed to the 30-day end point. Parent satisfaction with AOM care was not different between the 2 treatment groups at either day 12 or 30. Compared with WW, symptom scores on days 1 to 10 resolved faster in subjects treated with immediate ABX. At day 12, among the immediate-ABX group, 69% of tympanic membranes and 25% of tympanograms were normal, compared with 51% of normal tympanic membranes and 10% of normal tympanograms in the WW group. Parents of children in the ABX group gave their children fewer doses of pain medication than did parents of children in the WW group. Subjects in the ABX group experienced 16% fewer failures than subjects in the WW group. Of the children in the WW group, 66% completed the study without needing ABX. Immediate ABX resulted in eradication of S pneumoniae carriage in the majority of children, but S pneumoniae strains cultured from children in the ABX group at day 12 were more likely to be multidrug-resistant than strains from children in the WW group. More ABX-related adverse events were noted in the ABX group, compared with the WW group. No serious AOM-related adverse events were observed in either group. Office and emergency department visits, phone calls, and days of work/school missed were not different between groups. Prescriptions for ABX were reduced by 73% in the WW group compared with the ABX group. Costs of ABX averaged $47.41 per subject in the ABX group and $11.43 in the WW group.
                Sixty-six percent of subjects in the WW group completed the study without ABX. Parent satisfaction was the same between groups regardless of treatment. Compared with WW, immediate ABX treatment was associated with decreased numbers of treatment failures and improved symptom control but increased ABX-related adverse events and a higher percent carriage of multidrug-resistant S pneumoniae strains in the nasopharynx at the day-12 visit. Key factors in implementing a WW strategy were (a) a method to classify AOM severity; (b) parent education; (c) management of AOM symptoms; (d) access to follow-up care; and (e) use of an effective ABX regimen, when needed. When these caveats are observed, WW may be an acceptable alternative to immediate ABX for some children with nonsevere AOM. Otitis media is 1 of the most frequent diseases of early infancy and childhood and 1 of the most common reasons for children to visit a physician. In the past 2 decades, there has been a substantial increase in the diagnosis of otitis media worldwide. In the United States, 93% of all children have had at least 1 episode of acute otitis media (AOM) by 7 years of age. Otalgia is the hallmark of AOM. Most affected children either complain of earache or manifest behavior that the parents interpret as indicating ear pain. Treatment of the ear pain early in the course of AOM decreases both parental anxiety and the child's discomfort and accelerates the healing process. The objective of this study was to determine the efficacy and tolerability of naturopathic versus traditional treatment for the management of otalgia commonly associated with AOM in children.
                The study was designed as a double-blind trial in an outpatient community clinic. A total of 171 children who were aged 5 to 18 years and had otalgia and clinical findings associated with middle-ear infection were studied. The children were randomly assigned to receive treatment with Naturopathic Herbal Extract Ear Drops (NHED) or anesthetic ear drops, with or without amoxicillin. On enrollment, the children were assigned by computer-numbered randomization to receive NHED (contents: allium sativum, verbascum thapsus, calendula flores, hypericum perfoliatum, lavender, and vitamin E in olive oil) 5 drops 3 times daily, alone (group A) or together with a topical anesthetic (amethocaine and phenazone in glycerin) 5 drops 3 times daily (group B), or oral amoxicillin 80 mg/kg/d (maximum 500 mg/dose) divided into 3 doses with either NHED 5 drops 3 times daily (group C) or topical anesthetic 5 drops 3 times daily (group D). A double-blind design was used, and all ear drops were placed in identical bottles. Treatment was initiated by the nurse in all cases. A single physician (M.S.) evaluated and treated all of the patients included in the study and recorded all of the data. The presence or absence of ear pain was assessed over 3 days with a visual analog scale. Ear pain was assessed by a specially devised observational instrument based on previous reports. One side of the instrument consisted of a linear numbered scale, from 1 (no pain) to 10 (worst possible pain), and a corresponding color scale, ranging from blue to dark red. The reverse side contained a scale of 5 facial expressions, ranging from broad smile (no pain) to a sad and crying face (worst possible pain), and a corresponding color scale, ranging from blue to dark red.
                There were no significant between-group differences in patient age or gender, degree of fever, main symptoms, associated symptoms, and severity or laterality of acute otitis media. Each group had a statistically significant improvement in ear pain over the course of the 3 days. Patients who were given ear drops alone had a better response than patients who were given ear drops together with amoxicillin. Results were better in the NHED group than in the controls. Nevertheless, the findings indicated that the pain was mostly (80%) self-limited and could be explained simply by the time elapsed. The American Academy of Otolaryngology-Head and Neck Surgery guidelines recommend topical medications as the first line of treatment for ear pain in the absence of systemic infection or serious underlying disease. Because no evidence was found that systemic antibiotics alone improved treatment outcome, if antibiotics do not change the natural course of otitis media, then the main goal of treatment, as in the present study, should be to alleviate the ear pain. The alternative, naturopathic herbal extract medications, may offer many new possibilities in the management of ear pain associated with AOM. Primary care physicians should be aware that at least 10% of their patients may have tried 1 or more forms of alternative/complementary medicine before presenting for consultation. As it was widely reported in the medical literature, these herb, these herbal extracts have the potential to meet all of the requirements of appropriate medication that could be routinely used in the pediatric patient, namely in vitro bacteriostatic and bacteriocidal activity against common pathogens, immunostimulation ability, antioxidant activity, and anti-inflammatory effects. They are also well-absorbed with good penetration into the tissue surrounding the tympanic membrane. They have been found to enhance local immunologic activity. Finally, herbal extracts are well-tolerated (owing to their long elimination time), easy to administer, and less expensive than the new antibiotics. There are no documented side effects. On the basis of our findings that the group with the most significant treatment effects (NHED with topical anesthetic) explained only 7.3% of the total pain reduction, we propose that sometimes the general practitioner or pediatrician needs to give the human body a chance to repair itself. Nevertheless, if the physician believes that there is an indication for some treatment, especially if the parents are anxious, then a local treatment such as one used in our study might be adequate.
                This study suggests that in cases of ear pain caused by AOM in children in which active treatment, besides a simple 2- to 3-day waiting period, is needed, an herbal extract solution may be beneficial. Concomitant antibiotic treatment is apparently not contributory. This prospective randomized study investigates whether the use of antibiotic/steroid ear drops (Betnesol-N) is effective in reducing early post-operative otorrhoea and blockage of ventilation tubes (VTs). The study included 162 children who had bilateral VT insertion and used Betnesol-N ear drops in one ear only for three days after surgery, the other ear was left as control. These children were reviewed two weeks later and their ears were examined for VT patency, presence of blood or of mucopus. Statistical analysis of our results showed that the use of Betnesol-N ear drops has significantly reduced the incidence of post-operative otorrhoea within two weeks of VTs insertion (p < 0.01). However, these drops did not have a significant effect on the blockage rates of VTs with dried blood (p > 0.05).
Evidence from five RCTs, only two of which addressed the most relevant question of primary effectiveness, provides limited evidence that ear drops are effective 30 minutes after administration in older children with AOM. Uncertainty exists as to the magnitude of this effect and more high-quality studies are needed.