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Otology & Neurotology : Official... Feb 2021To systematically review the available medical literature to investigate the viral load in the middle ear and mastoid cavity and the potential risk of exposure to... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To systematically review the available medical literature to investigate the viral load in the middle ear and mastoid cavity and the potential risk of exposure to airborne viruses during otologic surgery.
DATA SOURCES
PubMed, MEDLINE, and Cochrane databases.
STUDY SELECTION
This review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol.
DATA EXTRACTION
Using the Boolean method and relevant search term combinations for terms "mastoid," "middle ear," "virus," "exposure" "COVID-19" "SARS-CoV-2." PubMed, MEDLINE, and Cochrane databases were queried. A total of 57 abstracts were identified and screened by two independent reviewers. Following inclusion and exclusion criteria, 18 studies were selected for the final analysis.
DATA SYNTHESIS
Due to the heterogeneity of clinical data, a meta-analysis was not feasible.
RESULTS
Rhinovirus, followed by respiratory syncytial virus are reported to be the most prevalent viruses in MEF samples but formal statistical analysis is precluded by the heterogeneity of the studies. Drilling was identified to have the highest risk for aerosol generation and therefore viral exposure during otologic Surgery.
CONCLUSIONS
The medical literature has consistently demonstrated the presence of nucleic acids of respiratory viruses involving the middle ear, including SARS-CoV2 in a recent postmortem study. Although no in vivo studies have been conducted, due to the likely risk of transmission, middle ear and mastoid procedures, particularly involving the use of a drill should be deferred, if possible, during the pandemic and enhanced personal protective equipment (PPE) used if surgery is necessary.
Topics: COVID-19; Ear, Middle; Humans; Mastoid; Otologic Surgical Procedures; Pandemics; Viral Load
PubMed: 33201081
DOI: 10.1097/MAO.0000000000002986 -
JAMA Otolaryngology-- Head & Neck... Oct 2020Subtotal petrosectomy (STP) has been more frequently performed to prepare ears with unfavorable conditions for cochlear implantation.
IMPORTANCE
Subtotal petrosectomy (STP) has been more frequently performed to prepare ears with unfavorable conditions for cochlear implantation.
OBJECTIVES
To provide an overview of indications for and complications of STP and cochlear implantation and to compare outcomes between single vs multistage procedures and between pediatric vs adult populations.
DATA SOURCES
A search of PubMed, Scopus, Ovid, and the Cochrane Library was performed from the databases' inception to January 23, 2020, for studies evaluating STP for cochlear implantation.
STUDY SELECTION
Studies with a minimum follow-up of 3 months and no missing data regarding postoperative outcomes were included. Of the initial 570 studies identified, 27 (4.7%) met selection criteria.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently assessed study eligibility according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines; discrepancies were resolved by a third reviewer. Extracted data included patient demographics, indications for STP, rates of complications, and cholesteatoma recidivism when applicable. Data were pooled using a random- or a fixed-effects model when appropriate.
MAIN OUTCOMES AND MEASURES
The primary study outcome was rate of global complications stratified by patient- and surgery-level characteristics.
RESULTS
Twenty-seven unique studies with 377 unique patients (54.2% male; mean age, 50.6 [range, 1-99] years) undergoing 397 STP procedures and cochlear implantation were included. Of these procedures, 299 of 394 cases with the information reported (75.9%) were single procedures and 95 (24.1%) were multistage procedures. Of the total 397 STP procedures, most common indications included chronic otitis media (220 cases [55.4%]), previous open mastoid cavity (141 [35.5%]), cholesteatoma (74 [18.6%]), and cochlear ossification (29 [7.3%]). The overall complication rate was 12.4% (95% CI, 9.4%-15.9%); overall cholesteatoma recidivism rate was 9.3% (95% CI, 4.3%-17.1%). Complication rates did not significantly differ based on stage or age of patients. Cases with cholesteatoma more often underwent multistage vs single-stage procedures (23 of 54 [42.6%] vs 35 of 174 [20.1%]).
CONCLUSIONS AND RELEVANCE
Across all age groups, STP has been shown to be an effective surgical operation in preparing an ear with unfavorable conditions for cochlear implantation. The potential indications for which cochlear implantation can be performed have expanded with the use of STP. Presence of cholesteatoma might indicate that a multistage procedure should be performed. Lastly, with complication rates comparable to those in adult patients, STP can be considered in children requiring cochlear implantation to minimize ear-related issues and allow benefit from cochlear implantation.
PubMed: 33057602
DOI: 10.1001/jamaoto.2020.3380 -
Journal of Drugs in Dermatology : JDD Sep 2020An approach to the reconstruction of the ear requires consideration of gross anatomy, blood supply, and size of the defect to select the repair. While skin grafts...
BACKGROUND
An approach to the reconstruction of the ear requires consideration of gross anatomy, blood supply, and size of the defect to select the repair. While skin grafts provide a convenient option for many helical and conchal defects, using posterior auricular reservoir can preserve ear contour and hide the scar for an aesthetic closure.
PURPOSE
To illustrate the versatility of the post-auricular and mastoid skin reservoir for auricular repairs after surgical removal of a cutaneous malignancy.
DATA SOURCES
MEDLINE, EMBASE, and Cochrane Databases were searched for all techniques using a post-auricular approach for auricular repair of surgical defects in the context of cutaneous oncology until November 2019.
DATA SYNTHESIS
The most well-described techniques of pull-through, post-auricular pedicle and Banner flaps were selected for in-depth review. Illustrative cases and a summary of the spectrum of techniques from case reports are provided.
LIMITATIONS
Few randomized trials exist to compare the outcomes of the flaps to determine a preferred flap technique.
CONCLUSIONS
A post-auricular approach for repair of auricular defects can provide a reasonable option for single and multi-staged closure to create an excellent aesthetic outcome while hiding the donor site. More prospective data is required to determine the overall best approach. J Drugs Dermatol. 2020;19(9):883-888. doi:10.36849/JDD.2020.5106.
Topics: Ear Auricle; Ear Neoplasms; Esthetics; Humans; Plastic Surgery Procedures; Skin Neoplasms; Surgical Flaps; Surgical Wound; Treatment Outcome
PubMed: 33026744
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5106 -
The Annals of Otology, Rhinology, and... Apr 2021In tissue engineering, biomaterials create a 3D scaffold for cell-to-cell adhesion, proliferation and tissue formation. Because of their similarity to extracellular...
OBJECTIVE
In tissue engineering, biomaterials create a 3D scaffold for cell-to-cell adhesion, proliferation and tissue formation. Because of their similarity to extracellular matrix and architectural adaptability, nanofibers are of particular interest in tissue engineering. Electrospinning is a well-documented technique for nanofiber production for tissue engineering scaffolds. Here we present literature on the applications of electrospinning in the field of otolaryngology.
REVIEW METHODS
A PubMed database search was performed to isolate articles published about applications of electrospun nanofibers for tissue engineering in otolaryngology. Study design, size, material tested, site of application within the head and neck, and outcomes were obtained for each study.
RESULTS
Almost all data on electrospinning in otolaryngology was published in the last 6 years (84%), highlighting its novelty. A total of 25 pre-clinical studies were identified: 9 in vitro studies, 5 in vivo animal studies, and 11 combination studies. Sites of application included: tracheal reconstruction (n = 16), tympanic membrane repair (n = 3), cranial nerve regeneration (n = 3), mastoid osteogenesis (n = 1) and ear/nose chondrogenesis (n = 2).
IMPLICATIONS FOR PRACTICE
Tissue engineering is a burgeoning field, with recent innovative applications in the field of otolaryngology. Electrospun nanofibers specifically have relevant applications in the field of otolaryngology, due in part to their similarity to native extracellular matrix, with emerging areas of interest being tympanic membrane repair, cranial nerve regeneration and tracheal reconstruction.
Topics: Biocompatible Materials; Electrochemical Techniques; Humans; Materials Testing; Nanofibers; Otolaryngology; Tissue Engineering; Tissue Scaffolds
PubMed: 32975429
DOI: 10.1177/0003489420959692 -
The Cochrane Database of Systematic... Sep 2020Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Aural toileting is a term describing a number of processes for manually cleaning the ear. Techniques used may include dry mopping (with cotton wool or tissue paper), suction clearance (typically under a microscope) or irrigation (using manual or automated syringing). Dry mopping may be effective in removing mucopurulent discharge. Compared to irrigation or microsuction it is less effective in removing epithelial debris or thick pus. Aural toileting can be used alone or in addition to other treatments for CSOM, such as antibiotics or topical antiseptics.
OBJECTIVES
To assess the effects of aural toilet procedures for people with CSOM.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving people (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. We included any aural toileting method as the intervention, at any frequency and for any duration. The comparisons were aural toileting compared with a) placebo or no intervention, and b) any other aural toileting method. We analysed trials in which background treatments were used in both arms (e.g. topical antiseptics or topical antibiotics) separately.
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and the adverse events of ear bleeding and dizziness/vertigo/balance problems.
MAIN RESULTS
We included three studies with a total of 431 participants (465 ears), reporting on two comparisons. Two studies included only children with CSOM in the community (351 participants) and the other study (80 participants) included children and adults with chronic ear discharge for at least six weeks. None of the included studies reported the outcomes of health-related quality of life, ear pain or the adverse event of ear bleeding. Daily aural toileting (dry mopping) versus no treatment Two studies (351 children; 370 ears) compared daily dry mopping with no treatment. Neither study presented results for resolution of ear discharge at between one and up to two weeks or between two to four weeks. For resolution of ear discharge after four weeks, one study reported the results per person. We are very uncertain whether there is a difference at 16 weeks (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.60 to 1.72; 1 study; 217 participants) because the certainty of the evidence is very low. No results were reported for the adverse events of dizziness, vertigo or balance problems. Only one study reported serious complications, but it was not clear which group these patients were from, or whether the complications occurred pre- or post-treatment. One study reported hearing, but the results were presented by treatment outcome rather than by treatment group so it is not possible to determine whether there is a difference between the two groups. Daily aural toileting versus single aural toileting on top of topical ciprofloxacin One study (80 participants; 95 ears) compared daily aural toileting (suction) with administration of topical antibiotic (ciprofloxacin) ear drops in a clinic, to a single aural toileting (suction) episode followed by daily self-administered topical antibiotic drops, in participants of all ages. We are unsure whether there is a difference in resolution of ear discharge at between one and up to two weeks (RR 1.09, 95% CI 0.91 to 1.30; 1 study; 80 participants) because the certainty of the evidence is very low. There were no results reported for resolution of ear discharge at between two to four weeks. The results for resolution of ear discharge after four weeks were presented by ear, not person, and could not be adjusted to by person. One patient in the group with single aural toileting and self administration of topical antibiotic ear drops reported the adverse event of dizziness, which the authors attributed to the use of cold topical ciprofloxacin. It is very uncertain whether there is a difference between the groups (RR 0.33, 95% CI 0.01 to 7.95; 1 study; 80 participants, very low-certainty). No results were reported for the other adverse events of vertigo or balance problems, or for serious complications. The authors only reported qualitatively that there was no difference between the two groups in hearing results (very low-certainty).
AUTHORS' CONCLUSIONS
We are very uncertain whether or not treatment with aural toileting is effective in resolving ear discharge in people with CSOM, due to a lack of data and the poor quality of the available evidence. We also remain uncertain about other outcomes, including adverse events, as these were not well reported. Similarly, we are very uncertain whether daily suction clearance, followed by antibiotic ear drops administered at a clinic, is better than a single episode of suction clearance followed by self-administration of topical antibiotic ear drops.
Topics: Adult; Anti-Bacterial Agents; Bias; Child; Chronic Disease; Ciprofloxacin; Humans; Hygiene; Otitis Media, Suppurative; Randomized Controlled Trials as Topic; Suction; Time Factors
PubMed: 32926406
DOI: 10.1002/14651858.CD013057.pub2 -
The Cochrane Database of Systematic... Aug 2020Chronic suppurative otitis media (CSOM) is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic suppurative otitis media (CSOM) is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as steroids, antiseptics or ear cleaning (aural toileting). Antibiotics are commonly prescribed in combined preparations with steroids.
OBJECTIVES
To assess the effects of adding a topical steroid to topical antibiotics in the treatment of people with chronic suppurative otitis media (CSOM).
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any combination of a topical antibiotic agent(s) of any class and a topical corticosteroid (steroid) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic and steroid compared to a) placebo or no intervention and b) another topical antibiotic.
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity.
MAIN RESULTS
We included 17 studies addressing 11 treatment comparisons. A total of 1901 participants were included, with one study (40 ears) not reporting the number of participants recruited, which we therefore could not account for. No studies reported health-related quality of life. The main comparisons were: 1. Topical antibiotics with steroids versus placebo or no treatment Three studies (210 participants) compared a topical antibiotic-steroid to saline or no treatment. Resolution of discharge was not reported at between one to two weeks. One study (50 'high-risk' children) reported results at more than four weeks by ear and we could not adjust the results to by person. The study reported that 58% (of 41 ears) resolved with topical antibiotics compared with 50% (of 26 ears) with no treatment, but the evidence is very uncertain. One study (123 participants) noted minor side effects in 16% of participants in both the intervention and placebo groups (very low-certainty evidence). One study (123 participants) reported no change in bone-conduction hearing thresholds and reported no difference in tinnitus or balance problems between groups (very low-certainty evidence). One study (50 participants) reported serious complications, but it was not clear which group these patients were from, or whether the complications occurred pre- or post-treatment. One study (123 participants) reported that no side effects occurred in any participants (very low-certainty evidence). 2. Topical antibiotics with steroids versus topical antibiotics (same antibiotics) only Four studies (475 participants) were included in this comparison. Three studies (340 participants) compared topical antibiotic-steroid combinations to topical antibiotics alone. The evidence suggests little or no difference in resolution of discharge at one to two weeks: 82.7% versus 76.6% (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.21; 335 participants; 3 studies (4 study arms); low-certainty evidence). No results for resolution of discharge after four weeks were reported. One study (110 participants) reported local itchiness but as there was only one episode in each group it is uncertain whether there is a difference (very low-certainty evidence). Three studies (395 participants) investigated suspected ototoxicity but it was not possible to determine whether there were differences between the groups for this outcome (very low-certainty evidence). No study reported serious complications. 3. Topical antibiotics with steroids compared to topical antibiotics alone (different antibiotics) Nine studies (981 participants plus 40 ears) evaluated a range of comparisons of topical non-quinolone antibiotic-steroid combinations versus topical quinolone antibiotics alone. Resolution of discharge may be greater with quinolone topical antibiotics alone at between one to two weeks compared with non-quinolone topical antibiotics with steroids: 82.1% versus 63.2% (RR 0.77, 95% CI 0.71 to 0.84; 7 studies; 903 participants, low-certainty evidence). Results for resolution of ear discharge after four weeks were not reported. One study (52 participants) reported usable data on ear pain, two studies (419 participants) reported hearing outcomes and one study (52 participants) reported balance problems. It was not possible to determine whether there were significant differences between the groups for these outcomes (very low-certainty evidence). Two studies (149 participants) reported no serious complications (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain about the effectiveness of topical antibiotics with steroids in improving the resolution of ear discharge in patients with CSOM because of the limited amount of low-certainty evidence available. Amongst this uncertainty, we found no evidence that the addition of steroids to topical antibiotics affects the resolution of ear discharge. There is also low-certainty evidence that some types of topical antibiotics (without steroids) may be better than topical antibiotic/steroid combinations in improving resolution of discharge. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.
PubMed: 35659673
DOI: 10.1002/14651858.CD013054.pub2 -
Ear, Nose, & Throat Journal Feb 2021The mainstay of cholesteatoma treatment is surgical and requires the removal of all squamous epithelium from the underlying normal structure. The application of laser...
OBJECTIVES
The mainstay of cholesteatoma treatment is surgical and requires the removal of all squamous epithelium from the underlying normal structure. The application of laser technology in middle ear and mastoid surgery has shown promise in achieving both disease eradication and hearing preservation. This systematic review aims to include studies that have assessed the application of laser to the treatment of cholesteatoma and to review its outcomes in terms of disease eradication as well as hearing results.
METHOD
Two independent researchers conducted a systematic review of the literature on MEDLINE and Cochrane library, according to PRISMA guidance.
RESULT
The search resulted in 12 papers, reporting on 536 participants that fulfilled the inclusion criteria. The hearing results did not show that using laser surgery improved hearing in cholesteatoma surgery, but neither has the use of laser shown to deteriorate hearing. With regards to the prevention of residual/recurrent cholesteatoma, the current literature reports a residual/recurrent rate of 0% to 33%. The complication rate of facial palsy is 0.6%.
CONCLUSION
While there is certainly a role for future studies especially randomised large-cohort prospective comparative studies, the current literature suggests that laser may have a role in prevention or minimizing of residual cholesteatoma and generally have a safe hearing outcome profile.
Topics: Adolescent; Adult; Child; Cholesteatoma, Middle Ear; Female; Hearing; Hearing Loss; Humans; Laser Therapy; Male; Middle Aged; Postoperative Period; Treatment Outcome; Young Adult
PubMed: 32809846
DOI: 10.1177/0145561320948772 -
European Archives of... Apr 2020Congenital cholesteatoma (CC) presents as a white pearl-like lesion behind a normal tympanic membrane (TM), without a history of otorrhea, infection, perforation or... (Meta-Analysis)
Meta-Analysis
PURPOSE
Congenital cholesteatoma (CC) presents as a white pearl-like lesion behind a normal tympanic membrane (TM), without a history of otorrhea, infection, perforation or previous otologic surgery. Several recent studies provided new data improving this pathology characterization. The aim of this paper is to expand the knowledge about CC and to provide new insights on its pathogenesis.
METHODS
The study consisted of two main research parts: (1) systematic review and meta-analysis; (2) medical literature review englobing anatomy, histology, embryology and congenital pathology of the ear.
RESULTS
The search strategy identified a total of 636 papers. Seventy retrospective studies were included. A total of 1497 cases were studied and the mean age was 6.58 years, with a male-female ratio of 3:1, 34% were asymptomatic, 26% had hearing loss and 2% had facial dysfunction/paralysis. The overall estimate for antero-superior quadrant involvement was 0.70 [95% confident interval (CI) 0.64-0.76], in the postero-superior quadrant was 0.60 (95% CI 0.52-0.69), in the antero-inferior quadrant was 0.32 (95% CI 0.23-0.41), in the postero-inferior quadrant was 0.38 (95% CI 0.29-0.47), in the attic was 0.53 (95% CI 0.43-0.63) and in the mastoid was 0.33 (95% CI 0.26-0.41). More advanced Potsic stages were present in older patients. The most likely inclusion place seems to be between the pars flaccida and the upper quadrants of the pars tensa.
CONCLUSIONS
During the last decades, a substantial improvement in CC diagnosis and management had been achieved. The presented mechanism seems to explain most of middle ear CC.
Topics: Cholesteatoma, Middle Ear; Ear, Middle; Humans; Mastoid; Tympanic Membrane
PubMed: 31955213
DOI: 10.1007/s00405-020-05792-4 -
The Cochrane Database of Systematic... Jan 2020Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antiseptics, one of the possible treatments for CSOM, inhibit the micro-organisms that may be responsible for the infection. Antiseptics can be used alone or in addition to other treatments for CSOM, such as antibiotics or ear cleaning (aural toileting). Antiseptics or their application can cause irritation of the skin of the outer ear, manifesting as discomfort, pain or itching. Some antiseptics (such as alcohol) may have the potential to be toxic to the inner ear (ototoxicity), with a possible increased risk of causing sensorineural hearing loss, dizziness or tinnitus.
OBJECTIVES
To assess the effects of topical antiseptics for people with chronic suppurative otitis media.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antiseptic agent of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. Two main comparisons were topical antiseptics compared to: a) placebo or no intervention; and b) another topical antiseptic (e.g. topical antiseptic A versus topical antiseptic B). Within each comparison we separated studies where both groups of patients had received topical antiseptics a) alone or with aural toileting and b) on top of antibiotic treatment.
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
MAIN RESULTS
Five studies were included. It was not possible to calculate the total number of participants as two studies only provided the number of ears included in the study. A. Topical antiseptic (boric acid) versus placebo or no treatment (all patients had aural toileting) Three studies compared topical antiseptics with no treatment, with one study reporting results we could use (254 children; cluster-RCT). This compared the instillation of boric acid in alcohol drops versus no ear drops for one month (both arms used daily dry mopping). We made adjustments to the data to account for the intra-cluster correlation. The very low certainty of the evidence means it is uncertain whether or not treatment with an antiseptic leads to an increase in resolution of ear discharge at both four weeks (risk ratio (RR) 1.94, 95% confidence interval (CI) 1.20 to 3.16; 174 participants) and at three to four months (RR 1.73, 95% CI 1.21 to 2.47; 180 participants). This study narratively described no differences in suspected ototoxicity or hearing outcomes between the arms (very low-certainty evidence). None of the studies reported results for health-related quality of life, adverse effects or serious complications. B. Topical antiseptic A versus topical antiseptic B Two studies compared different antiseptics but only one (93 participants), comparing a single instillation of boric acid powder with daily acetic acid ear drops, provided any information for this comparison. The very low certainty of the evidence means that it is uncertain whether more patients had resolution of ear discharge with boric acid powder compared to acetic acid at four weeks (RR 2.61, 95% CI 1.51 to 4.53; 93 participants), or whether there was a difference between the arms with respect to ear discomfort due to the low number of reported events (RR 0.10, 95% CI 0.01 to 1.81; 93 participants). Narratively, the study reported no difference in hearing outcomes between the groups. None of the included studies reported any of the other primary or secondary outcomes.
AUTHORS' CONCLUSIONS
Due to paucity of the evidence and the very low certainty of that which is available the effectiveness and safety profile of antiseptics in the treatment of CSOM is uncertain.
Topics: Administration, Topical; Anti-Infective Agents, Local; Chronic Disease; Humans; Otitis Media, Suppurative; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31902140
DOI: 10.1002/14651858.CD013055.pub2 -
The Cochrane Database of Systematic... Jan 2020Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics and antiseptics kill or inhibit the micro-organisms that may be responsible for the infection. Antibiotics can be applied topically or administered systemically via the oral or injection route. Antiseptics are always directly applied to the ear (topically).
OBJECTIVES
To assess the effectiveness of antibiotics versus antiseptics for people with chronic suppurative otitis media (CSOM).
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where ear discharge had continued for more than two weeks. The intervention was any single, or combination of, antibiotic agent, whether applied topically (without steroids) or systemically. The comparison was any single, or combination of, topical antiseptic agent, applied as ear drops, powders or irrigations, or as part of an aural toileting procedure. Two comparisons were topical antiseptics compared to: a) topical antibiotics or b) systemic antibiotics. Within each comparison we separated where both groups of patients had received topical antibiotic a) alone or with aural toilet and b) on top of background treatment (such as systemic antibiotics).
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
MAIN RESULTS
We identified seven studies (935 participants) across four comparisons with antibiotics compared against acetic acid, aluminium acetate, boric acid and povidone-iodine. None of the included studies reported the outcomes of quality of life or serious complications. A. Topical antiseptic (acetic acid) versus topical antibiotics (quinolones or aminoglycosides) It is very uncertain if there is a difference in resolution of ear discharge with acetic acid compared with aminoglycosides at one to two weeks (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.72 to 1.08; 1 study; 100 participants; very low-certainty evidence). No study reported results for ear discharge after four weeks. It was very uncertain if there was more ear pain, discomfort or local irritation with acetic acid or topical antibiotics due to the low numbers of participants reporting events (RR 0.16, 95% CI 0.02 to 1.34; 2 RCTs; 189 participants; very low-certainty evidence). No differences between groups were reported narratively for hearing (quinolones) or suspected ototoxicity (aminoglycosides) (very low-certainty evidence). B. Topical antiseptic (aluminium acetate) versus topical antibiotics No results for the one study comparing topical antibiotics with aluminium acetate could be used in the review. C. Topical antiseptic (boric acid) versus topical antibiotics (quinolones) One study reported more participants with resolution of ear discharge when using topical antibiotics (quinolones) compared with boric acid ear drops at between one to two weeks (risk ratio (RR) 1.56, 95% confidence interval (CI) 1.27 to 1.92; 1 study; 409 participants; moderate-certainty evidence). This means that one additional person will have resolution of ear discharge for every five people receiving topical antibiotics (compared with boric acid) at two weeks. No study reported results for ear discharge after four weeks. There was a bigger improvement in hearing in the topical antibiotic group compared to the topical antiseptic group (mean difference (MD) 2.79 decibels (dB), 95% CI 0.48 to 5.10; 1 study; 390 participants; low-certainty evidence) but this difference may not be clinically significant. There may be more ear pain, discomfort or irritation with boric acid compared with quinolones (RR 0.56, 95% CI 0.32 to 0.98; 2 studies; 510 participants; low-certainty evidence). Suspected ototoxicity was not reported. D. Topical antiseptic (povidone-iodine) versus topical antibiotics (quinolones) It is uncertain if there is a difference between quinolones and povidone-iodine with respect to resolution of ear discharge at one to two weeks (RR 1.02, 95% CI 0.82 to 1.26; 1 RCT, 39 participants; very low-certainty evidence). The study reported qualitatively that there were no differences between the groups for hearing and no patients developed ototoxic effects (very low-certainty evidence). No results for resolution of ear discharge beyond four weeks, or ear pain, discomfort or irritation, were reported. E. Topical antiseptic (acetic acid) + aural toileting versus topical + systemic antibiotics (quinolones) One study reported that participants receiving topical and oral antibiotics had less resolution of ear discharge compared with acetic acid ear drops and aural toileting (suction clearance every two days) at one month (RR 0.69, 95% CI 0.53 to 0.90; 100 participants). The study did not report results for resolution of ear discharge at between one to two weeks, ear pain, discomfort or irritation, hearing or suspected ototoxicity.
AUTHORS' CONCLUSIONS
Treatment of CSOM with topical antibiotics (quinolones) probably results in an increase in resolution of ear discharge compared with boric acid at up to two weeks. There was limited evidence for the efficacy of other topical antibiotics or topical antiseptics and so we are unable to draw conclusions. Adverse events were not well reported.
Topics: Administration, Topical; Anti-Bacterial Agents; Anti-Infective Agents, Local; Humans; Otitis Media, Suppurative; Quinolones; Randomized Controlled Trials as Topic
PubMed: 31902139
DOI: 10.1002/14651858.CD013056.pub2