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The Cochrane Database of Systematic... Jan 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. Topical antibiotics, the most common treatment for CSOM, 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 antiseptics or ear cleaning (aural toileting).
OBJECTIVES
To assess the effects of topical antibiotics (without steroids) 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Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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 1 April 2019.
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 single, or combination of, topical antibiotic agent(s) 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 compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B). Within each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting 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; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
MAIN RESULTS
We included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears. A: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that "no medical side-effects and worsening of audiological measurements related to this topical medication were detected" (very low-certainty evidence). B: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms) Four studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation. C: Comparisons of different topical antibiotics The certainty of evidence for all outcomes in these comparisons is very low. Quinolones versus aminoglycosides Seven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups. Quinolones versus aminoglycosides/polymyxin B combination ±gramicidin We identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A "few" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated). Others Other studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain.
AUTHORS' CONCLUSIONS
We are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. 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.
Topics: Administration, Topical; Anti-Bacterial Agents; Chronic Disease; Humans; Otitis Media, Suppurative; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31896168
DOI: 10.1002/14651858.CD013051.pub2 -
The Turkish Journal of Pediatrics 2023Acute mastoiditis (AM) is a severe infection of the mastoid air cells that occurs in cases of acute, sub-acute, or chronic middle ear infections. No definitive consensus... (Review)
Review
BACKGROUND
Acute mastoiditis (AM) is a severe infection of the mastoid air cells that occurs in cases of acute, sub-acute, or chronic middle ear infections. No definitive consensus regarding the management of AM has been identified. The current guidelines include a conservative approach (parenteral antibiotics alone, antibiotics plus minor surgical procedures such as myringotomy with a ventilation tube inserted or drainage of the subperiosteal abscess through retro-auricolar incision or needle aspiration) or surgical treatment (mastoidectomy). The main aim of this review was to evaluate and summarize the current knowledge about the management of pediatric AM by analyzing the current evidence in the literature.
METHODS
We examined the following bibliographic electronic databases: Pubmed and the Cochrane Library, from the inception date until February 2023. The search was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISM). The key words used for the search across electronic databases were: `mastoiditis` and `management`; `mastoiditis` and `surgery`; `mastoiditis` and `conservative`; `mastoiditis` and `antibiotics`; `mastoiditis` and `myringotomy`; `mastoiditis` and `grommet`; `mastoiditis` and `drainage`; and `mastoiditis` and `mastoidectomy`.
RESULTS
We selected 12 articles involving 1124 episodes of mastoiditis. Some of these studies considered medical therapy alone as a valid first step, whereas others considered a minor surgical intervention as an initial approach along with antibiotic therapy. Considering the studies that evaluated medical therapy as the initial sole treatment option, the success rate of antibiotics alone was 24.6%. Overall, the success rate of minor surgical procedures, excluding mastoidectomy, was 87.7%, whereas the mastoidectomy success rate was 97%.
CONCLUSIONS
Overall, there is no shared consensus on the diagnostic or therapeutic approach to mastoiditis. Conservative therapy has gained considerable ground in recent times, quite limiting the predominant role of mastoidectomy. Further studies will be necessary to definitely develop standardized protocols shared in the scientific community.
Topics: Humans; Child; Mastoiditis; Abscess; Anti-Bacterial Agents; Conservative Treatment
PubMed: 38204305
DOI: 10.24953/turkjped.2023.320 -
Otolaryngology--head and Neck Surgery :... Jan 2017Objective The aim of this report is to provide a review of the current literature for assessment of performance for mastoidectomy, to identify the current assessment... (Review)
Review
Objective The aim of this report is to provide a review of the current literature for assessment of performance for mastoidectomy, to identify the current assessment tools available in the literature, and to summarize the evidence for their validity. Data Sources The MEDLINE database was accessed via PubMed. Review Methods Inclusion criteria consisted of English-language published articles that reported use of a mastoidectomy performance assessment tool. Studies ranged from 2007 to November 2015 and were divided into 2 groups: intraoperative assessments and those performed with simulation (cadaveric laboratory or virtual reality). Studies that contained specific reliability analyses were also highlighted. For each publication, validity evidence data were analyzed and interpreted according to conceptual definitions provided in a recent systematic review on the modern framework of validity evidence. Conclusions Twenty-three studies were identified that met our inclusion criteria for review, including 4 intraoperative objective assessment studies, 5 cadaveric studies, 10 virtual reality simulation studies, and 4 that used both cadaveric assessment and virtual reality. Implications for Practice A review of the literature revealed a wide variety of mastoidectomy assessment tools and varying levels of reliability and validity evidence. The assessment tool developed at Johns Hopkins possesses the most validity evidence of those reviewed. However, a number of agreed-on specific metrics could be integrated into a standardized assessment instrument to be used nationally. A universally agreed-on assessment tool will provide a means for developing standardized benchmarks for performing mastoid surgery.
Topics: Clinical Competence; Humans; Mastoid; Osteotomy; Quality Assurance, Health Care
PubMed: 27677598
DOI: 10.1177/0194599816670886 -
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 -
Tomography (Ann Arbor, Mich.) Apr 2022Bezold's abscess is a deep neck abscess related to otomastoiditis. Due to the insidious clinical presentation, diagnosis can be extremely challenging, leading to delays... (Review)
Review
Bezold's abscess is a deep neck abscess related to otomastoiditis. Due to the insidious clinical presentation, diagnosis can be extremely challenging, leading to delays in treatment and possible life-threatening complications. The literature currently provides a fragmented picture, presenting only single or small number of cases. The present study aims at examining our experience and the literature findings (based on PRISMA criteria) of 97 patients with Bezold's abscess, summarizing their epidemiology, pathogenesis, clinical presentation, imaging findings, and treatments. Bezold's abscess is found at any age, with overt male prevalence among adults. The clinical presentation, as well as the causative pathogens, are strikingly heterogeneous. Otomastoiditis and cholesteatoma are major risk factors. A clinical history of otitis is commonly reported (43%). CT and MRI are the main diagnostic tools, proving the erosion of the mastoid tip in 53% of patients and the presence of a concomitant cholesteatoma in 40%. Intracranial vascular (24%) or infectious (9%) complications have also been reported. Diagnosis might be easily achieved when imaging (CT) is properly applied. MRI has a limited diagnostic role, but it might be crucial whenever intracranial complications or the coexistence of cholesteatoma are suspected, helping to develop proper treatment (prompt antibiotic therapy and surgery).
Topics: Abscess; Adult; Cholesteatoma; Humans; Male; Mastoid; Mastoiditis; Neck
PubMed: 35448708
DOI: 10.3390/tomography8020074 -
Journal of Clinical Medicine Sep 2023This systematic review was aimed at gathering the clinical and technical applications of CAD/CAM technology for craniofacial implant placement and processing of... (Review)
Review
This systematic review was aimed at gathering the clinical and technical applications of CAD/CAM technology for craniofacial implant placement and processing of auricular prostheses based on clinical cases. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, an electronic data search was performed. Human clinical studies utilizing digital planning, designing, and printing systems for craniofacial implant placement and processing of auricular prostheses for prosthetic rehabilitation of auricular defects were included. Following a data search, a total of 36 clinical human studies were included, which were digitally planned and executed through various virtual software to rehabilitate auricular defects. Preoperative data were collected mainly through computed tomography scans (CT scans) (55 cases); meanwhile, the most common laser scanners were the 3dMDface System (3dMD LLC, Atlanta, Georgia, USA) (6 cases) and the 3 Shape scanner (3 Shape, Copenhagen, Denmark) (6 cases). The most common digital design software are Mimics Software (Mimics Innovation Suite, Materialize, Leuven, Belgium) (18 cases), Freeform software (Freeform, NC, USA) (13 cases), and 3 Shape software (3 Shape, Copenhagen, Denmark) (12 cases). Surgical templates were designed and utilized in 35 cases to place 88 craniofacial implants in auricular defect areas. The most common craniofacial implants were Vistafix craniofacial implants (Entific Medical Systems, Goteborg, Sweden) in 22 cases. A surgical navigation system was used to place 20 craniofacial implants in the mastoid bone. Digital applications of CAD/CAM technology include, but are not limited to, study models, mirrored replicas of intact ears, molds, retentive attachments, customized implants, substructures, and silicone prostheses. The included studies demonstrated a predictable clinical outcome, reduced the patient's visits, and completed the prosthetic rehabilitation in reasonable time and at reasonable cost. However, equipment costs and trained technical staff were highlighted as possible limitations to the use of CAD/CAM systems.
PubMed: 37762891
DOI: 10.3390/jcm12185950 -
The Cochrane Database of Systematic... Feb 2021Chronic 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. Antibiotics are the most common treatment for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be administered both topically and systemically, and can be used alone or in addition to other treatments for CSOM such as ear cleaning (aural toileting).
OBJECTIVES
To assess the effects of topical versus systemic antibiotics 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 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 studies compared topical antibiotics against systemic (oral, injection) antibiotics. We separated studies according to whether they compared the same type of antibiotic in both treatment groups, or different types of antibiotics. For each comparison we considered whether there was background treatment for both treatment groups, for example aural toileting (ear cleaning).
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 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
Six studies (445 participants), all with high risk of bias, were included. All but two studies included patients with confirmed CSOM, where perforation of the ear drum was clearly documented. None of the studies reported results for resolution of ear discharge after four weeks or health-related quality of life. 1. Topical versus systemic administration of the same type of antibiotics (quinolones) Four studies (325 participants) compared topical versus systemic (oral) administration of ciprofloxacin. Three studies reported resolution of ear discharge at one to two weeks and found that the topical administration may slightly increase resolution (risk ratio (RR) 1.48, 95% confidence interval (CI) 1.24 to 1.76; 285 participants; 3 studies; I = 0%; low-certainty evidence). In these studies, aural toileting was either not mentioned, or limited to the first visit. Three studies (265 participants) reported that they did not suspect ototoxicity in any participants, but it is unclear how this was measured (very low-certainty evidence). No studies reported the outcomes of ear pain or serious complications. No studies reported results for hearing, despite it being measured in three studies. 2. Topical versus systemic administration of different types of antibiotics (quinolones versus aminoglycosides) One study (60 participants) compared topical ciprofloxacin versus gentamicin injected intramuscularly. No aural toileting was reported. Resolution of ear discharge was not measured at one to two weeks. The study did not report any 'side effects' from which we assumed that no ear pain, suspected ototoxicity or serious complications occurred (very low-certainty evidence). The study stated that "no worsening of the audiometric function related to local or parenteral therapy was observed". 3. Topical versus systemic administration of different types of antibiotics (quinolones versus amoxicillin-clavulanic acid) One study compared topical ofloxacin with amoxicillin-clavulanic acid with all participants receiving suction ear cleaning at the first visit. It is uncertain if there is a difference between the two groups in resolution of ear discharge at one to two weeks due to study limitations and the very small sample size (RR 2.93, 95% CI 1.50 to 5.72; 56 participants; very low-certainty evidence). It is unclear if there is a difference between topical quinolone compared with oral amoxicillin-clavulanic acid with regards to ear pain, hearing or suspected ototoxicity (very low-certainty evidence). No studies reported the outcome of serious complications.
AUTHORS' CONCLUSIONS
There was a limited amount of low-quality evidence available, from studies completed over 15 years ago, to examine whether topical or systemic antibiotics are more effective in achieving resolution of ear discharge for people with CSOM. However, amongst this uncertainty there is some evidence to suggest that the topical administration of antibiotics may be more effective than systemic administration of antibiotics in achieving resolution of ear discharge (dry ear). There is limited evidence available regarding different types of antibiotics. It is not possible to determine with any certainty whether or not topical quinolones are better or worse than systemic 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.
Topics: Administration, Topical; Adult; Aminoglycosides; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bias; Child; Chronic Disease; Humans; Ofloxacin; Otitis Media, Suppurative; Quinolones; Randomized Controlled Trials as Topic; Time Factors
PubMed: 33561891
DOI: 10.1002/14651858.CD013053.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 -
The Cochrane Database of Systematic... Feb 2021Chronic suppurative otitis media (CSOM) is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic suppurative otitis media (CSOM) 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. Systemic antibiotics are a commonly used treatment option for CSOM, which 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.
OBJECTIVES
To assess the effects of systemic antibiotics 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 comparing systemic antibiotics (oral, injection) against placebo/no treatment or other systemic antibiotics with at least a one-week follow-up period, involving patients with chronic (at least two weeks) ear discharge of unknown cause or due to CSOM. Other treatments were allowed if both treatment and control arms also received it.
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
We included 18 studies (2135 participants) with unclear or high risk of bias. 1. Systemic antibiotics versus no treatment/placebo It is very uncertain if there is a difference between systemic (intravenous) antibiotics and placebo in the resolution of ear discharge at between one and two weeks (risk ratio (RR) 8.47, 95% confidence interval (CI) 1.88 to 38.21; 33 participants; 1 study; very low-certainty evidence). The study did not report results for resolution of ear discharge after two weeks. Health-related quality of life was not reported. The evidence is very uncertain for hearing and serious (intracranial) complications. Ear pain and suspected ototoxicity were not reported. 2. Systemic antibiotics versus no treatment/placebo (both study arms received topical antibiotics) Six studies were included of which five presented useable data. There may be little or no difference in the resolution of ear discharge at between one to two weeks for oral ciprofloxacin compared to placebo or no treatment when ciprofloxacin ear drops were used in both intervention arms (RR 1.02, 95% CI 0.93 to 1.12; 390 participants; low-certainty evidence). No results after two weeks were reported. Health-related quality of life was not reported. The evidence is very uncertain for ear pain, serious complications and suspected ototoxicity. 3. Systemic antibiotics versus no treatment/placebo (both study arms received other background treatments) Two studies used topical antibiotics plus steroids as background treatment in both arms. It is very uncertain if there is a difference in resolution of ear discharge between metronidazole and placebo at four weeks (RR 0.91, 95% CI 0.51 to 1.65; 40 participants; 1 study; very low-certainty evidence). This study did not report other outcomes. It is also very uncertain if resolution of ear discharge at six weeks was improved with co-trimoxazole compared to placebo (RR 1.54, 95% CI 1.09 to 2.16; 98 participants; 1 study; very low-certainty evidence). Resolution of ear discharge was not reported at other time points. From the narrative report there was no evidence of a difference between groups for health-related quality of life, hearing or serious complications (very low-certainty evidence). One study (136 participants) used topical antiseptics as background treatment in both arms and found similar resolution of ear discharge between the amoxicillin and no treatment groups at three to four months (RR 1.03, 95% CI 0.75 to 1.41; 136 participants; 1 study; very low-certainty evidence). The narrative report indicated no evidence of differences in hearing or suspected ototoxicity (both very low-certainty evidence). No other outcomes were reported. 4. Different types of systemic antibiotics This is a summary of four comparisons, where different antibiotics were compared to each other. Eight studies compared different types of systemic antibiotics against each other: quinolones against beta-lactams (four studies), lincosamides against nitroimidazoles (one study) and comparisons of different types of beta-lactams (three studies). It was not possible to conclude if there was one class or type of systemic antibiotic that was better in terms of resolution of ear discharge. The studies did not report adverse events well.
AUTHORS' CONCLUSIONS
There was a limited amount of evidence available to examine whether systemic antibiotics are effective in achieving resolution of ear discharge for people with CSOM. When used alone (with or without aural toileting), we are very uncertain if systemic antibiotics are more effective than placebo or no treatment. When added to an effective intervention such as topical antibiotics, there seems to be little or no difference in resolution of ear discharge (low-certainty evidence). Data were only available for certain classes of antibiotics and it is very uncertain whether one class of systemic antibiotic may be more effective than another. Adverse effects of systemic antibiotics were poorly reported in the studies included. As we found very sparse evidence for their efficacy, the possibility of adverse events may detract from their use for CSOM.
Topics: Amoxicillin; Anti-Bacterial Agents; Ciprofloxacin; Humans; Otitis Media, Suppurative; Ototoxicity; Pain; Persistent Infection
PubMed: 35819801
DOI: 10.1002/14651858.CD013052.pub2 -
Public Health Reviews 2021Anterior fontanel is an integral element of an infant craniofacial system. There are six fontanels in the newborn skull, namely anterior, posterior, two mastoid, and...
Anterior fontanel is an integral element of an infant craniofacial system. There are six fontanels in the newborn skull, namely anterior, posterior, two mastoid, and two sphenoid fontanels. The anterior fontanel is the largest, prominent, and most important for clinical evaluation. Sex, race, genetics, gestational age, and region are the principal factors that influence anterior fontanel size. There exist inconclusive findings on the size of anterior fontanel in newborns. Therefore, this systematic review and meta-analysis aimed to determine the pooled mean size of anterior fontanel among term newborns and to identify the pooled mean difference of anterior fontanel size between males and females. PubMed/Medline, Google Scholar, Science Direct, JBI Library, embase, and Cochrane Library databases were systematically searched. All essential data were extracted using a standardized data extraction format. The heterogeneity across studies was assessed using the Cochrane Q test statistic, I test statistic, and -values. A fixed-effect model and random effect model were used to estimate the pooled mean size of anterior fontanel and the pooled mean difference between male newborns and female newborns, respectively. To deal with heterogeneity, sub-group analysis, meta-regression analysis, and sensitivity analysis were considered. JBI quality appraisal checklist was used to evaluate the quality of studies. In this meta-analysis, 8, 661 newborns were involved in twenty-six studies. Among studies, 13 conducted in Asia, 7 in Africa, 5 in America, and 1 in Europe. The pooled mean size of anterior fontanel was 2.58 cm (95% CI: 2.31, 2.85 cm). The pooled mean size of anterior fontanel for Asia, Africa, America, and Europe region was 2.49, 3.15, 2.35, and 2.01 cm, respectively. A statistically significant mean difference was detected between male and female newborns (D + L pooled MD = 0.15 cm, 95% CI: 0.02, 0.29 cm). The pooled estimate of this review does provide the mean value of the anterior fontanel size in the newborns. There was a statistically significant mean fontanel size difference between male and female newborns. Therefore, male newborns had a significantly larger mean size than female newborns.
PubMed: 34692179
DOI: 10.3389/phrs.2021.1604044