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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Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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 -
Thorax Nov 2015Ototoxicity is a severe side effect of aminoglycoside antibiotics. Aminoglycosides are recommended for the treatment of multidrug-resistant TB (MDR-TB). N-Acetylcysteine... (Meta-Analysis)
Meta-Analysis Review
A systematic review and meta-analysis of the efficacy and safety of N-acetylcysteine in preventing aminoglycoside-induced ototoxicity: implications for the treatment of multidrug-resistant TB.
BACKGROUND
Ototoxicity is a severe side effect of aminoglycoside antibiotics. Aminoglycosides are recommended for the treatment of multidrug-resistant TB (MDR-TB). N-Acetylcysteine (NAC) appears to protect against drug- and noise-induced hearing loss. This review aimed to determine if coadministering NAC with aminoglycoside affected ototoxicity development, and to assess the safety and tolerability of prolonged NAC administration.
METHODS
Eligible studies reported on the efficacy of concomitant NAC and aminoglycoside administration for ototoxicity prevention or long-term (≥ 6 weeks) administration of NAC regardless of indication. Pooled estimates were calculated using a fixed-effects model. Heterogeneity was assessed using the I(2) statistic.
RESULTS
Three studies reported that NAC reduced ototoxicity in 146 patients with end-stage renal failure receiving aminoglycosides. Pooled relative risk for otoprotection at 4-6 weeks was 0.14 (95% CI 0.05 to 0.45), and the risk difference was -33.3% (95% CI 45.5% to 21.2%). Eighty-three studies (N=9988) described the administration of NAC for >6 weeks. Abdominal pain, nausea and vomiting, diarrhoea and arthralgia were increased 1.4-2.2 times.
DISCUSSION
This review provides evidence for the safety and otoprotective effect of NAC when coadministered with aminoglycoside. It represents a strong justification for a clinical trial to investigate the effect of concomitant NAC treatment in patients receiving aminoglycosides as part of MDR-TB treatment.
Topics: Acetylcysteine; Aminoglycosides; Ear Diseases; Free Radical Scavengers; Humans; Tuberculosis, Multidrug-Resistant
PubMed: 26347391
DOI: 10.1136/thoraxjnl-2015-207245 -
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 -
European Archives of... Jun 2017The objective of this study was to describe the occurrence, clinical manifestations, audiometric findings, pathogenesis and approach to sensorineural hearing loss (SNHL)... (Review)
Review
The objective of this study was to describe the occurrence, clinical manifestations, audiometric findings, pathogenesis and approach to sensorineural hearing loss (SNHL) among patients diagnosed with vitiligo with a review of the literature. We present a systematic review of the literature on cases of SNHL in patients diagnosed with vitiligo and studies conducted to investigate audiometric changes in such patients. Data on presentation, diagnosis and medical approach were reviewed. A total of 21 studies and case reports revealed at least 102 cases of SNHL in patients diagnosed with vitiligo. Arguments for a common causative etiology related to melanocyte function were mentioned in most of the literature. Evaluation of hearing function among all patients diagnosed with vitiligo seems to be an accepted approach; it should include audiometry, otoacoustic emissions (OAE) and ABR measurements. Extra precaution to prevent ototoxic or noise-induced hearing loss is strongly recommended. Further research is needed to better understand its pathogenesis.
Topics: Audiometry; Disease Management; Hearing Loss, Sensorineural; Humans; Otoacoustic Emissions, Spontaneous; Severity of Illness Index; Vitiligo
PubMed: 28197707
DOI: 10.1007/s00405-017-4452-8 -
The International Journal of... Jan 2021The use of injectable antibiotics to treat multidrug-resistant TB (MDR-TB) is associated with substantial morbidity due to long-term hearing loss. This systematic... (Meta-Analysis)
Meta-Analysis
The use of injectable antibiotics to treat multidrug-resistant TB (MDR-TB) is associated with substantial morbidity due to long-term hearing loss. This systematic review evaluates the incidence of ototoxicity among patients treated for MDR-TB, and the evidence for routine audiometric monitoring to mitigate its severity. Studies of ototoxicity among patients with MDR-TB were identified from six databases: PubMed, MEDLINE, Web of Science, Embase, SCOPUS and the Cochrane Library. Meta-analyses were performed to determine the overall incidence of hearing loss, tinnitus and vertigo. The incidence of hearing loss was further stratified by country income status and the injectable agent used during treatment. Among 64 studies from 25 countries including 12 793 patients, 28.3% (95%CI 23.4-33.1) of patients treated with injectables reported hearing loss. Tinnitus and vertigo were experienced by respectively 14.5% (95%CI 10.3-18.7) and 8.1% (95%CI 4.7-11.6) of patients. The incidence of hearing loss was highest among patients treated with amikacin (33.4%, 95%CI 18.2-48.6), and lowest among those treated with capreomycin (2.0%, 95%CI 0-5.5). We found that audiometry was widely used as a method of evaluating hearing loss, and was feasible in a wide range of settings. Injectable antibiotics contribute to significant morbidity in patients with MDR-TB. In settings where they are used, routine audiometric monitoring is recommended to prevent irreversible damage.
Topics: Amikacin; Antitubercular Agents; Capreomycin; Humans; Ototoxicity; Tuberculosis, Multidrug-Resistant
PubMed: 33384041
DOI: 10.5588/ijtld.20.0217 -
Current Molecular Medicine Aug 2023Aminoglycosides are among the first-choice antibiotics for routine clinical use. However, dose-limiting factors such as ototoxicity and nephrotoxicity are considered as...
INTRODUCTION
Aminoglycosides are among the first-choice antibiotics for routine clinical use. However, dose-limiting factors such as ototoxicity and nephrotoxicity are considered as serious complications of aminoglycosides.
OBJECTIVE
In this systematic review, the main goal was to investigate the efficacy and incidence of nephrotoxicity and ototoxicity of once-daily dosing (ODD) and multiple daily dosing (MDD) regimens of aminoglycosides through available randomized controlled trials (RCTs).
METHODS
We performed a literature-based research in relevant databases, including EMBASE, MEDLINE, and SCOPUS published between 1987 and 2023 using the keywords "aminoglycosides", "pharmacokinetics", "ODD", "MDD", "once daily", "multiple daily", "dosing regimen", "nephrotoxicity", "ototoxicity", "efficacy", "safety", and "toxicity". As so told, the results of this article were limited to papers available in English. Our initial search yielded 1124 results. After a review of the titles and abstracts of the articles, 803 articles were excluded from this study because they did not address the toxicity and effectiveness of ODD versus MDD of aminoglycosides. A total number of 21 studies on gentamicin, tobramycin, netilmicin, and amikacin met the inclusion criteria for the efficacy of aminoglycosides and their role in ototoxicity and nephrotoxicity were included in this review. Studies recruited different age classes, and the age of relevant cohorts varied from only a few days to more than 70 years.
RESULTS
The most common clinical condition in the included studies was cystic fibrosis.
CONCLUSION
In most studies, there were no significant differences between the two regimens regarding ototoxicity. In addition, the ODD regimens were safer than MDD concerning nephrotoxicity.
PubMed: 37533241
DOI: 10.2174/1566524023666230801160452 -
Travel Medicine and Infectious Disease 2021Drugs used in curative and prophylactic antimalarial treatment may be ototoxic and lead to permanent hearing loss, but there is no consensus regarding prevalence and... (Review)
Review
BACKGROUND
Drugs used in curative and prophylactic antimalarial treatment may be ototoxic and lead to permanent hearing loss, but there is no consensus regarding prevalence and permanence of ototoxic hearing loss caused by antimalarials. The purpose of this systematic narrative review was to synthesize current evidence on antimalarial ototoxicity in human populations.
METHOD
Studies published between 2005 and 2018 that reported prevalence of post-treatment hearing loss in individuals treated for malaria were included.
RESULTS
Twenty-two studies including data from 21 countries were included. Primary themes of the included studies were to evaluate drug safety and/or efficacy (n = 13) or ototoxic effects of drugs (n = 9). Hearing data were measured objectively in 9 studies. Five studies focused on quinine (or derivates), 10 focused on artemisinin combination therapies, and 7 considered multiple drug combinations. There is a paucity of evidence that thoroughly reports potentially permanent ototoxic effects of antimalarials.
CONCLUSIONS
Antimalarial drugs may be ototoxic in some cases. More research in human populations is needed to describe ototoxicity of current antimalarials and of future drugs that will be used/developed in response to antimalarial resistance. It is recommended that randomized trials evaluating drug safety objectively measure and report ototoxic hearing loss as an adverse event.
Topics: Antimalarials; Hearing Loss; Humans; Malaria; Quinine
PubMed: 34129960
DOI: 10.1016/j.tmaid.2021.102117 -
Pharmacogenetics and Genomics Jun 2017Cisplatin ototoxicity affects 42-88% of treated children. Catechol-O-methyltransferase (COMT), thiopurine methyltransferase (TPMT) and AYCP2 genetic variants have been... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Cisplatin ototoxicity affects 42-88% of treated children. Catechol-O-methyltransferase (COMT), thiopurine methyltransferase (TPMT) and AYCP2 genetic variants have been associated with ototoxicity, but the findings have been contradictory. The aims of the study were as follows: (a) to investigate these associations in a carefully phenotyped cohort of UK children and (b) to perform a systematic review and meta-analysis.
METHODS
We recruited 149 children from seven UK centres using a retrospective cohort study design. All participants were clinically phenotyped carefully. Genotyping was performed for one ACYP2 (rs1872328), three TPMT (rs12201199, rs1142345 and rs1800460) and two COMT (rs4646316 and rs9332377) variants.
RESULTS
For CTCAE grading, hearing loss was present in 91/120 (75.8%; worst ear) and 79/120 (65.8%; better ear). Using Chang grading, hearing loss was diagnosed in 85/119 (71.4%; worst ear) versus 75/119 (63.0%; better ear). No TPMT or COMT single-nucleotide polymorphisms (SNPs) were associated with ototoxicity. ACYP2 SNP rs1872328 was associated with ototoxicity (P=0.027; worst ear). Meta-analysis of our data with that reported in previous studies showed the pooled odds ratio (OR) to be statistically significant for both the COMT SNP rs4646316 (OR: 1.50; 95% confidence interval: 1.15-1.95) and the ACYP2 SNP rs1872328 (OR: 5.91; 95% confidence interval: 1.51-23.16).
CONCLUSION
We showed an association between the ACYP2 polymorphism and cisplatin-induced ototoxicity, but not with the TPMT and COMT. A meta-analysis was statistically significant for both the COMT rs4646316 and the ACYP2 rs1872328 SNPs. Grading the hearing of children with asymmetric hearing loss requires additional clarification.
Topics: Acid Anhydride Hydrolases; Adolescent; Antineoplastic Agents; Catechol O-Methyltransferase; Child; Child, Preschool; Cisplatin; Female; Genetic Association Studies; Hearing Loss; Humans; Infant; Male; Methyltransferases; Odds Ratio; Polymorphism, Single Nucleotide; Retrospective Studies; United Kingdom
PubMed: 28445188
DOI: 10.1097/FPC.0000000000000281 -
Research in Social & Administrative... Aug 2022Aminoglycosides are widely used, broad-spectrum antibiotics with significant potential for ototoxicity. Global efforts to prevent ototoxicity must account for... (Review)
Review
BACKGROUND
Aminoglycosides are widely used, broad-spectrum antibiotics with significant potential for ototoxicity. Global efforts to prevent ototoxicity must account for aminoglycoside overuse and non-prescription use.
OBJECTIVES
The goals of this study were to a) estimate the prevalence of aminoglycoside overuse by synthesizing evidence on self-medication, over the counter (OTC) availability, and household antibiotic storage for later use, and to report the specific aminoglycosides used and the predictors of overuse, and b) leverage this information to comment on potential risk of ototoxicity.
METHODS
Two systematic search strings were conducted to extract peer-reviewed articles published from 2005 to 2020. The first focused on overuse of aminoglycoside antibiotics. The second focused on potentially ototoxic effects of aminoglycosides related to drug overuse.
RESULTS
A total of 26 articles were included (first search string: n = 21; second search string: n = 5). The prevalence of aminoglycoside self-medication was high and household storage and OTC availability of aminoglycosides was common. Gentamicin was the most commonly overused aminoglycoside. No studies provided information on antibiotic dosing or resultant toxicities, including ototoxicity.
CONCLUSIONS
The limited available evidence indicates that antibiotic overuse (self-medication, home storage, and non-prescription availability) is relatively common, especially in low resource settings, and that aminoglycoside antibiotics comprise a variable, but concerning, proportion of non-prescribed antibiotics. Additional evidence is needed to evaluate the relationship between these dispensing patterns and ototoxicity.
Topics: Aminoglycosides; Anti-Bacterial Agents; Humans; Ototoxicity; Prescription Drug Overuse
PubMed: 34711521
DOI: 10.1016/j.sapharm.2021.10.004 -
The Cochrane Database of Systematic... Nov 2016The insertion of grommets (also known as ventilation or tympanostomy tubes) is one of the most common surgical procedures performed on children. Postoperative otorrhoea... (Review)
Review
BACKGROUND
The insertion of grommets (also known as ventilation or tympanostomy tubes) is one of the most common surgical procedures performed on children. Postoperative otorrhoea (discharge) is the most common complication with a reported incidence ranging from 10% to 50%. In the UK, many ENT surgeons treat with topical antibiotics/steroid combinations, but general practitioners, mainly through fears of ototoxicity, are unlikely to prescribe these and choose systemic broad-spectrum antibiotics.
OBJECTIVES
1. To identify the most effective non-surgical management of discharge from ears with grommets in place.2. To identify the risks of non-surgical management for this condition (e.g. ototoxicity), and to set benefits of treatment against these risks.
SEARCH METHODS
We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2005), MEDLINE (1966 to 2005) and EMBASE (1974 to 2005). We also searched the CINAHL, AMED, LILACS, ISI WEB OF KNOWLEDGE, ISI PROCEEDINGS, mRCT, NNR, ZETOC, KOREAMED, CSA, MEDCARIB, INDMED and SAMED databases. The date of the last search was February 2005.
SELECTION CRITERIA
Randomised controlled trials of adults or children, with any type of grommet and an ear with discharge were included. The trials compared treatment with placebo or one treatment with another. The primary outcome measure was the duration of the discharge.
DATA COLLECTION AND ANALYSIS
The trials were selected independently according to the above criteria by the four reviewers. Differences in opinion over the inclusion of studies were resolved by discussion. The studies were graded using the CASP critical appraisal tool. Analyses were based on the presence of discharge seven days from the onset of treatment.
MAIN RESULTS
There was very little good quality evidence. Four studies were included, all of them investigating different interventions and therefore a meta-analysis was not possible.Only one study demonstrated a significant difference. Oral amoxicillin clavulanate was compared to placebo in 79 patients. The odds of having a discharge persisting eight days after starting treatment was 0.19 (95% CI 0.07 to 0.49) . The number needed to treat to achieve that benefit is 2.5. Participants in both arms of this study also received daily aural toilet. The results will therefore not be applicable to most settings including primary care. No significant benefit was shown in the two studies investigating steroids (oral prednisolone with oral amoxicillin clavulanate and topical dexamethasone with topical ciprofloxacin ear drops), or the one study comparing an antibiotic-steroid combination (Otosporin®) drops versus spray (Otomize®) (although more patients preferred the spray form).
AUTHORS' CONCLUSIONS
The authors of this review have been unable to identify the most effective intervention or to assess the associated risks. Research is urgently needed into the effectiveness of oral versus topical antibiotics in this group of patients. Clinicians considering antibiotic treatment need to balance any potential benefit against the risks of side effects and antibiotic resistance.
Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cerebrospinal Fluid Otorrhea; Child; Ciprofloxacin; Dexamethasone; Drug Combinations; Humans; Hydrocortisone; Middle Ear Ventilation; Neomycin; Otitis Media, Suppurative; Polymyxin B; Randomized Controlled Trials as Topic; Tympanic Membrane Perforation
PubMed: 27845826
DOI: 10.1002/14651858.CD001933.pub3