Meta AnalysisID 1463

局部唑类药物治疗耳真菌病[Cochrane方案]

CRD42019146266

To assess the effects of topical azole treatments for otomycosis.

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Meta Analysis Id: 1463
Evidence Id: 10021
Core Evidence Id: 10021
Source Meta Analysis Id: 1417
Herb2 Meta Analysis Id: HBMA001417
Crd Id: CRD42019146266
Title: Topical azole treatments for otomycosis [Cochrane protocol]
Review Question: To assess the effects of topical azole treatments for otomycosis.
Study Type Included: Randomised controlled trials with a minimum follow-up duration of two weeks from the start of treatment. We will exclude the following study designs: Cross-over studies (because uncomplicated otomycosis is a self-limiting condition). Furthermore, it is anticipated that the carry-over effect of clotrimazole treatment may be prolonged as this drug is typically administered for over two weeks. Cluster-randomised studies. Within-patient controlled studies (where the unit of randomisation is the ear) because it is difficult to determine with confidence whether the outcomes of interest can clearly be attributed to one side as reported by either the participant or the study investigator.</ul>
Condition Being Studied: The Cochrane ENT Group
Participant: Participants over the age of 16 with a diagnosis of otomycosis. Diagnosis of otomycosis will be based on presentation with symptoms including: ear pain, itchiness, discharge, fullness or hearing impairment with findings of ear discharge. Studies should describe the mycological criteria for confirmation using either direct microscopy or culture showing fungal spores or hyphae. We will exclude studies that focus primarily on otitis externa (see <link tag=SUBGROUP_ANALYSIS type=SECTION/>Subgroup analysis and investigation of heterogeneity) and those with skull base osteomyelitis (also known as malignant otitis externa).
Animal
Human Disease Modelled
Intervention: Intervention Topical azole antifungals. Control Placebo or no intervention. Adjunctive treatment Aural toileting is considered routine in the treatment of discharging ears in an outpatient clinic. It may consist of dry mopping, syringing or microsuction. The main comparisons will be: topical azoles versus placebo; topical azoles versus no treatment; one type of topical azole versus another type of topical azole.</ul> We include studies using aural toileting if this adjunctive treatment is administered equally in both the intervention and comparator groups. We will exclude other agents used for treating otomycosis as a comparison as we expect that the majority of these studies would use a heterogeneous mixture of agents and concentrations. Pooling of data under these circumstances would be problematic. We will record details of the interventions including treatment concentration, mode of administration (cream, drops, powder), dose (milligrams, millilitres or other) and number of administrations per day. We will include studies using an azole dosage of 1% with a minimal duration of therapy of 14 days. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
Comparator Control: Intervention Topical azole antifungals. Control Placebo or no intervention. Adjunctive treatment Aural toileting is considered routine in the treatment of discharging ears in an outpatient clinic. It may consist of dry mopping, syringing or microsuction. The main comparisons will be: topical azoles versus placebo; topical azoles versus no treatment; one type of topical azole versus another type of topical azole.</ul> We include studies using aural toileting if this adjunctive treatment is administered equally in both the intervention and comparator groups. We will exclude other agents used for treating otomycosis as a comparison as we expect that the majority of these studies would use a heterogeneous mixture of agents and concentrations. Pooling of data under these circumstances would be problematic. We will record details of the interventions including treatment concentration, mode of administration (cream, drops, powder), dose (milligrams, millilitres or other) and number of administrations per day. We will include studies using an azole dosage of 1% with a minimal duration of therapy of 14 days. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
Main Outcome: Clinical resolution as measured by the proportion of participants with complete resolution, however defined by the authors of the studies. Significant adverse events: severe topical allergic reaction.</ul>
Outcome Measure
Additional Outcome: Mycological resolution: eradication of pathogenic ear canal fungi as determined by mycological means (e.g. KOH smear or fungal culture). Other adverse effects: local irritation, hearing loss, mild allergic reaction.</ul> The time point for outcome assessment will be final follow-up, as defined by the study authors.
Study Method: Intervention, Systematic review
Keyword: Antifungal Agents; Aspergillosis; Azoles; Humans; Otomycosis
Contact: Ambrose Lee [email protected]
Organisational Affiliation: The Cochrane Collaboration http://www.cochrane.org/
Funding Source: National Institute for Health Research
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009289/abstract
Review Type
Language: English
Country: Canada
Review Stage: Review Ongoing
First Submission Date
Registration Date: 2019-08-06
Anticipated Start Date: 2011-09-15
Anticipated Completion Date: 2020-03-22
Title Cn: 局部唑类药物治疗耳真菌病[Cochrane方案]
Title En: Topical azole treatments for otomycosis [Cochrane protocol]
Bilingual Status: complete