Marie Chowdhury Clinical Scenario 50 yo man with a one day hx of a painful left ear Also some reduced hearing and creamy discharge in affected ear OE Apyrexial tender on pushing on tragus ID: 929917
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Slide1
Evidence Based Treatment of Otitis Externa
Marie Chowdhury
Slide2Clinical Scenario
50
yo man with a one day hx of a painful left ear.Also some reduced hearing and creamy discharge in affected ear.O/E: Apyrexialtender on pushing on tragus
erythematous but NOT swollen ear canal with small amount of creamy/yellow dischargeTM slightly pink but no evidence of perforation of otitis mediaTx: gentamicin only topical ear drop for 7-10 days and tcb if not improved or worse with next two days.Thought process: Ear canal not swollen and no perforation seen (or suspected) so decided against topical steroid drops and off licence ciprofloxacin drops.
Supervising GP said he would instead have prescribed a combination of antibiotics and steroid drops for any kind of otitis externa.
Slide3Local and National Guidelines
Oxfordshire Adult Antimicrobial Prescribing Guidelines For P
rimary Care:Aural toilet (if available) and analgesia1st line: Acetic acid 2% TDS for 7 days2nd line: Betnesol
-N (neomycin and corticosteroid) TDS for 7-14 daysCKS NICE Guidelines:Mild cases (mild pruritus and pain and no deafness or discharge): Acetic Acid 2%More severe cases (deafness and discharge present) or if acetic acid not successful: topical antibiotic with or without a topical steroid. Decision of which preparation will depend on risk of s/e, patient’s preferences and cost.
Slide4Three Part Question
Clinical problem: Are topical antibiotic/steroid drops the most effective way to treat acute otitis externa?
… In patients presenting to primary care with acute otitis externa …… are topical antibiotic/steroid ear drops better than topical antibiotic ear drops …… at reducing symptoms and treating acute otitis externa?
Slide5Search Strategy
PubMedS
teroid AND Antibiotics AND “otitis externa”: 6 relevant papers out of 15 resultsSteroid* AND Antibiotics* AND “external ear infection”: 0 relevant papers out of 1 result“primary care” AND “otitis externa”: 2 relevant papers out of 33 resultsTRIP:P: otitis externa I: antibiotic C: steroid O: left blank : 1 relevant paper out of 4 results.
“otitis externa” “antibiotics”: 7 relevant papers out of 192 resultsCochrane:“otitis externa”: 1 relevant paper out of 3 results
Slide6Search Strategy
After accounting for overlapping titles:11 papers found to be relevant
3 Systematic Reviews with meta-analyses6 RCTs ( 2 unable to access)1 Clinical guideline (USA)1 Survey (UK)
Slide7Search Outcome
After accounting for overlapping titles:11 papers found to be relevant
3 Systematic Reviews (meta-analyses in 2 of them)6 RCTs (2 unable to access)1 Clinical guideline (USA)1 Survey (UK)I decided to appraise the 3 systematic reviewsI found one RCT relevant to the question that had been recently published and thus not included in the systematic reviews.
Slide8Relevant Papers
Systematic Review: Kaushik
V, Malik T, Saeed S. Interventions for acute otitis externa. Cochrane Database of Systematic Reviews 2010Systematic Review: Rosenfeld R. Systematic review of topical antimicrobial therapy for acute otitis externa. (2006)
Systematic Review: Hajioff D, MackeithS. Clinical Evidence: Otitis externa. 2015
RCT: Lorente L. Ciprofloxacin plus
fluocinolone
acetonide
versus ciprofloxacin alone in the treatment of diffuse otitis externa.
(2014)
Slide9Cochrane SR
Rosenfeld
SRClinical Evidence SR
Clearly focused question?No “To determine the effectiveness of different methods of treating OE”Outcomes well definedYes/No “To determine the efficacy of topical antimicrobial for acute OE” (but included steroids in antibiotic arm)
Outcome: strived for binary outcome data only
No “what are the effects of empirical treatment for OE?”
Outcomes well defined
Appropriate papers?
Yes: 19
RCTs
Yes/No:
20 RCTs
Yes: 10 RCTs and 1 SR
Where the relevant
studies included?
Yes:
DB
and SB RCTs only
Very thorough search: contacted authors, reference list, included search strategy in appendices
Sample size 21 – 601
6 RCTs had pharmaceutical support
Yes but:
RCTs with binary data
50% of trials were DB
Included ‘open trials’
Sample size 28-842
Most studies did not declare financial support, 20% had pharmaceutical
support
Yes/No:
DB and SB RCTs
only with minimum 20 participants and 80% f/u (not less than 1 month)
Limited to English only papers
Was the quality of the studies assessed?
Yes:
based on sequence generation, allocation concealment and blinding.
Only 3 trials were of high quality.
Yes:
Jadad
score
50% had a low quality rating of 2 or below.
Only 4 studies were run with an
ITT
Yes: Grade analysis
9 trials very low or low quality
Slide10Cochrane SR
Rosenfeld
SRClinical Evidence SR
Was it reasonable to combine the results?Yes: 3 meta-analyses only combined outcome results which were collected at same time period No: pooled results from trials with different steroid, antiseptic and antibiotic active components
(Heterogenity was found to be due to different potency of steroids)
Unsure:
13 meta-analyses
Pooled trials with different active components so
No
meta-analysis as not enough trials with same intervention and control arms
What are the overall result?
Please see next slide
Please
see next slide
Please see next slide
Can the results be applied to the local population?
Yes:
Most studies from USA,
UK and EU so results applicable
No:
Most studies set in a secondary care setting
Majority of studies had micro-suction performed
Only 3 studies were run with an ITT protocol
Same concerns
as Cochrane SR
Same concerns
as Cochrane SR
Slide11Comparisons
Cochrane SR
Rosenfeld SRClinical Evidence SR
Antibiotic/steroid vs PlaceboSignificant difference in favour of antibiotic/steroid (1 RCT)OR 11 CI 95%
Significant difference in favour of antibiotic/steroid (2 RCTs)
P<0.001
No
significant effect (1RCT)
Quinolone vs
aminoglycoside
No significant
difference (1 RCT)
No significant
difference
(7 RCTs – contained steroids in some)
Antibiotic/steroid vs antiseptic
Significant effect in favour of antibiotic/steroid (1 RCT) at
3-6 weeks
(why 2 excluded?)
OR 3.12 CI 95%
Significant effect in favour of antibiotic/ steroid
OR 3.12
Antibiotic/steroid
vs antiseptic steroid
No significant
difference (1 RCT)
Antibiotic/steroid
vs antibiotic
No significant difference when 3 RCTs combined
No significant difference (3 RCTs)
Antiseptic/steroid vs
antiseptic
Significant difference in favour of antiseptic/steroid
(3 RCTs) OR 4.82 95% CI
No significant effect (1RCT)
Antibiotic/steroid
vs steroid
No significant difference (1RCT)
Significant difference in favour of steroid (2 RCTs)
P< 0.021
Slide12Relevant RCT not included in SRs
2014 Multi-centre, randomised, parallel group, double blinded clinical trial involving 590 patients
Comparison of clinical efficacy between ciprofloxacin/steroid drops and ciprofloxacin dropsDoes not set out if in secondary or primary care setting or if micro-suction was undertakenNo f/u beyond 8 daysNo mention of how participants were randomised, balanced or allocation sequence.Results: Significant difference in clinical efficacy at end of treatment, and total symptom score in favour of the ciprofloxacin/steroid drop. P=0.01
However no significance with regards to duration of otalgia
Slide13Clinical Bottom Line
3 systematic reviews based on predominantly low quality studies so effect size may be exaggerated.
With regards to my question: according the SRs no evidence that antibiotic/steroid drops have a better cure rate or prevents recurrence better than antibiotic drops.However:Causes of OE is varied and one should be mindful of clinical picture (a very swollen ear canal would probably require a steroid component)Multitude of treatment options so difficult to get enough evidence of a particular treatment in order to undertake a sound meta-analysis
Recent RCT suggests antibiotic/steroid combinations have a significant effect over antibiotic only drops on resolution of sx.It might be better to use anticeptic/steroid or antibacterial/steroid combinations drops rather than simple acetic acid drops in all cases but very mild OE.
Generability: poor due to nature of RCTs (based in secondary care, micro-suction undertaken introducing confounding and not available in primary care and scarce ITT analysis)
Adverse effect mild and few so choice of treatment should be one based on cost, minimising s/e and patient preference as set out in the CKS guidelines.
Slide14References
Kaushik V, Malik T, Saeed S. Interventions for acute otitis externa. Cochrane Database of Systematic Reviews 2010, Issue 1.
Rosenfeld R, Singer M, Wasserman J, Stinett S. Systematic review of topical antimicrobial therapy for acute otitis externa. Otolaryngology-Head and Neck Surgery (2006) 134, S24-S48.Hajioff
D, MackeithS. (2015) Clinical Evidence: Otitis externa. 2015;06:510.Lorente L, Sabater F, Rivas M, Fuste J, Risco
J, Gomez M. Ciprofloxacin plus fluocinolone acetonide
versus ciprofloxacin alone in the treatment of diffuse otitis externa. The Journal of Laryngology & Otology (2014), 128, 591-598.
https://www.bestbets.org
CASP checklist (Practice of Evidence Based Health Care – CEBM)