Pharmacological and conservative interventions for ear discharge associated with grommets (ventilation tubes) outside the postoperative period

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness and safety of various treatment strategies in patients with grommets who developed ear discharge

Interventions for children with ear discharge occurring at least two weeks following grommet (ventilation tube) insertion

BACKGROUND: Ear discharge (otorrhoea) is common in children with grommets (ventilation/tympanostomy tubes); the proportion of children developing discharge ranges from 25% to 75%. The most common treatment strategies include oral broad-spectrum antibiotics, antibiotic eardrops or those containing a combination of antibiotic(s) and a corticosteroid, and initial observation. Important drivers for one strategy over the other are concerns over the side effects of oral antibiotics and the potential ototoxicity of antibiotic eardrops. OBJECTIVES: To assess the benefits and harms of current treatment strategies for children with ear discharge occurring at least two weeks following grommet (ventilation tube) insertion. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register, CENTRAL (2016, Issue 5), multiple databases and additional sources for published and unpublished trials (search date 23 June 2016). SELECTION CRITERIA: Randomised controlled trials comparing at least two of the following: oral antibiotics, oral corticosteroids, antibiotic eardrops (with or without corticosteroid), corticosteroid eardrops, microsuction cleaning of the ear canal, saline rinsing of the ear canal, placebo or no treatment. The main comparison of interest was antibiotic eardrops (with or without corticosteroid) versus oral antibiotics. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Primary outcomes were: proportion of children with resolution of ear discharge at short-term follow-up (less than two weeks), adverse events and serious complications. Secondary outcomes were: proportion of children with resolution of ear discharge at intermediate- (two to four weeks) and long-term (four to 12 weeks) follow-up, proportion of children with resolution of ear pain and fever at short-term follow-up, duration of ear discharge, proportion of children with chronic ear discharge, ear discharge recurrences, tube blockage, tube extrusion, health-related quality of life and hearing. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included nine studies, evaluating a range of treatments, with 2132 children who developed acute ear discharge beyond the immediate postoperative period. We judged the risk of bias to be low to moderate in most studies. Antibiotic eardrops (with or without corticosteroid) versus oral antibioticsAntibiotic eardrops with or without corticosteroid were more effective than oral antibiotics in terms of:- resolution of discharge at one week (one study, 42 children, ciprofloxacin eardrops versus amoxicillin: 77% versus 30%; risk ratio (RR) 2.58, 95% confidence interval (CI) 1.27 to 5.22; moderate-quality evidence);- resolution of discharge at two weeks (one study, 153 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 95% versus 56%; RR 1.70, 95% CI 1.38 to 2.08; moderate-quality evidence);- duration of discharge (two studies, 233 children, ciprofloxacin eardrops versus amoxicillin: median 4 days versus 7 days and bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 4 days versus 5 days; moderate-quality evidence);- ear discharge recurrences (one study, 148 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 0 versus 1 episode at six months; low-quality evidence); and- disease-specific quality of life (one study, 153 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: difference in change in median Otitis Media-6 total score (range 6 to 42) at two weeks: -2; low-quality evidence).We found no evidence that antibiotic eardrops were more effective in terms of the proportion of children developing chronic ear discharge or tube blockage, generic quality of life or hearing.Adverse events occurred at similar rates in children treated with antibiotic eardrops and those treated with oral antibiotics, while no serious complications occurred in either of the groups. Other comparisons(a) Antibiotic eardrops with or without corticosteroid were more effective thancorticosteroid eardrops in terms of:- duration of ear discharge (one study, 331 children, ciprofloxacin versus ciprofloxacin-fluocinolone acetonide versus fluocinolone acetonide eardrops: median 5 days versus 7 days versus 22 days; moderate-quality evidence).(b) Antibiotic eardrops were more effective than saline rinsing of the ear canal in terms of:- resolution of ear discharge at one week (one study, 48 children, ciprofloxacin eardrops versus saline rinsing: 77% versus 46%; RR 1.67, 95% CI 1.04 to 2.69; moderate-quality evidence);but not in terms of tube blockage. Since the lower limit of the 95% CI for the effect size for resolution of ear discharge at one week approaches unity, a trivial or clinically irrelevant difference cannot be excluded.(c) Eardrops containing two antibiotics and a corticosteroid (bacitracin-colistin-hydrocortisone) were more effective than no treatment in terms of:- resolution of discharge at two weeks (one study; 151 children: 95% versus 45%; RR 2.09, 95% CI 1.62 to 2.69; moderate-quality evidence);- duration of discharge (one study; 147 children, median 4 days versus 12 days; moderate-quality evidence);- chronic discharge (one study; 147 children; RR 0.08, 95% CI 0.01 to 0.62; low-quality evidence); and- disease-specific quality of life (one study, 153 children, difference in change in median Otitis Media-6 total score (range 6 to 42) between groups at two weeks: -1.5; low-quality evidence).We found no evidence that antibiotic eardrops were more effective in terms of ear discharge recurrences or generic quality of life.(d) Eardrops containing a combination of an antibiotic and a corticosteroid were more effective than eardrops containing antibiotics (low-quality evidence) in terms of:- resolution of ear discharge at short-term follow-up (two studies, 590 children: 35% versus 20%; RR 1.76, 95% CI 1.33 to 2.31); and- duration of discharge (three studies, 813 children);but not in terms of resolution of discharge at intermediate-term follow-up or proportion of children with tube blockage. However, there is a substantial risk of publication bias, therefore these findings should be interpreted with caution. AUTHORS' CONCLUSIONS: We found moderate to low-quality evidence that antibiotic eardrops (with or without corticosteroid) are more effective than oral antibiotics, corticosteroid eardrops and no treatment in children with ear discharge occurring at least two weeks following grommet insertion. There is some limited, inconclusive evidence that antibiotic eardrops are more effective than saline rinsing. There is uncertainty whether antibiotic-corticosteroid eardrops are more effective than eardrops containing antibiotics only

Otitis media

Otitis media (OM) or middle ear inflammation is a spectrum of diseases, including acute otitis media (AOM), otitis media with effusion (OME; ‘glue ear’) and chronic suppurative otitis media (CSOM). OM is among the most common diseases in young children worldwide. Although OM may resolve spontaneously without complications, it can be associated with hearing loss and life-long sequelae. In developing countries, CSOM is a leading cause of hearing loss. OM can be of bacterial or viral origin; during ‘colds’, viruses can ascend through the Eustachian tube to the middle ear and pave the way for bacterial otopathogens that reside in the nasopharynx. Diagnosis depends on typical signs and symptoms, such as acute ear pain and bulging of the tympanic membrane (eardrum) for AOM and hearing loss for OME; diagnostic modalities include (pneumatic) otoscopy, tympanometry and audiometry. Symptomatic management of ear pain and fever is the mainstay of AOM treatment, reserving antibiotics for children with severe, persistent or recurrent infections. Management of OME largely consists of watchful waiting, with ventilation (tympanostomy) tubes primarily for children with chronic effusions and hearing loss, developmental delays or learning difficulties. The role of hearing aids to alleviate symptoms of hearing loss in the management of OME needs further study. Insertion of ventilation tubes and adenoidectomy are common operations for recurrent AOM to prevent recurrences, but their effectiveness is still debated. Despite reports of a decline in the incidence of OM over the past decade, attributed to the implementation of clinical guidelines that promote accurate diagnosis and judicious use of antibiotics and to pneumococcal conjugate vaccination, OM continues to be a leading cause for medical consultation, antibiotic prescription and surgery in high-income countries

Antibiotics for otitis media with effusion (OME) in children

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects (benefits and harms) of oral antibiotics for otitis media with effusion (OME) in children

Incidence and management of acute otitis media in adults: a primary care-based cohort study

BACKGROUND: Although primarily considered a childhood disease, acute otitis media (AOM) also occurs in adults. Data on the burden of this condition in adults are, however, scarce. OBJECTIVE: To explore the primary care incidence and current management of AOM in adults. METHODS: All patients aged 15 and older included in the routine health care database of the Julius General Practitioners' Network were followed from 2015 to 2018 (contributing to a total of 1 261 575 person-years). We extracted data on AOM episodes, AOM-related consultations, comorbidities, and antibiotic and analgesic prescriptions. RESULTS: Five thousand three hundred and fifty-eight patients experienced one or more AOM episodes (total number of AOM episodes: 6667; mean 1.2 per patient). The overall AOM incidence was 5.3/1000 person-years and was fairly stable over the study period. Incidence was particularly high in atopic patients (7.3/1000 person-years) and declined with age (from 7.1 in patients 15-39 years of age to 2.7/1000 person-years in those aged 64 years and older). Oral antibiotics, predominantly amoxicillin, were prescribed in 46%, and topical antibiotics in 21% of all episodes. CONCLUSION: Over the past years, the incidence of AOM in adults in primary care has been stable. Oral antibiotic prescription rates resemble those in children with AOM, whereas a remarkably high topical antibiotic prescription rate was observed. Future prognostic research should inform on the need and feasibility of prospective studies into the best management strategy in this condition

Adenoidectomy for otitis media with effusion (OME) in children

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the effects (benefits and harms) of adenoidectomy, either alone or in combination with ventilation tubes (grommets), for otitis media with effusion (OME) in children

Topical and oral steroids for otitis media with effusion (OME) in children

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the effects (benefits and harms) of topical and oral steroids for otitis media with effusion (OME) in children

Impact of acute otitis media clinical practice guidelines on antibiotic and analgesic prescriptions: a systematic review

BACKGROUND: Clinical practice guidelines focusing on judicious use of antibiotics for childhood acute otitis media (AOM) have been introduced in many countries around the world. OBJECTIVE: To systematically review the effects of these guidelines on the prescription of antibiotics and analgesics for children with AOM. METHODS: Systematic searches of PubMed, Embase and Cochrane Library from inception to 6 June 2017 using broad search terms. Studies specifically aimed at evaluating the effects of introduction of national AOM practice guidelines on type of antibiotic and/or analgesic prescriptions were included, irrespective of design, setting or language. The Risk Of Bias In Non-randomized Studies of Interventions tool was used to assess risk of bias. RESULTS: Of 411 unique records retrieved, seven studies conducted in six different countries (France, Italy, Spain, Sweden, UK and USA (twice)) compared data before and after guideline introduction. All studies had an observational design, using longitudinal data of children aged under 15 years (n=200-4.6 million) from either routine care, insurance databases or electronic surveys. Risk of bias of all studies was judged serious to critical.Of the five studies reporting on antibiotic prescription rates, three showed a decline of 5%-12% up to 3 years after guideline introduction and two found no or negligible effect. In one US study, the initial 9% decline decreased to 5% after 4-6 years. The recommended first choice antibiotic was prescribed more frequently (9%-58% increase) after guideline introduction in four out of five studies reporting on this outcome. Analgesic prescription rates for AOM were reported in one US study and increased from 14% to 24% after guideline introduction. CONCLUSION: Based upon what is published, the effects of introduction of national clinical practice guidelines on antibiotic and analgesic prescribing for children with AOM seem modest at the most. REGISTRATION: PROSPERO: CRD42016050976

Autoinflation for otitis media with effusion (OME) in children

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects (benefits and harms) of autoinflation for otitis media with effusion (OME) in children