Benefits and risks of ear cleaning for people with chronic suppurative otitis media (persistent or recurring ear infection with discharge of pus)

Why this is important

Chronic suppurative otitis media (CSOM), also known as chronic otitis media (COM), is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent ear discharge – pus that leaks out from a hole in the eardrum – and hearing loss.

Different approaches can be used to clean the affected ears and remove discharge. These include:

- using cotton wool or tissue paper (dry mopping);
- sucking up material blocking the ear with a small device (usually done under a microscope); or
- washing out the ear (irrigation).

To find out how effective ear cleaning is in people with CSOM, and whether it causes unwanted effects, we reviewed the evidence from research studies. In particular, we wanted to know whether ear cleaning stopped ear discharge, and whether it affected health-related quality of life, or hearing. We also wanted to know if it caused pain, discomfort or irritation in the ear, unwanted effects such as dizziness or ear bleeding, or any serious complications.

How we identified and assessed the evidence

First, we searched for all relevant studies in the medical literature. We then compared the results, and summarised the evidence from all the studies. Finally, we assessed how certain the evidence was. We considered factors such as the way studies were conducted, study sizes and consistency of findings across studies. Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty.

What we found

We found three studies in 431 people with CSOM. People were followed for between six weeks and six months after treatment.

The studies compared:

- daily dry mopping versus no treatment (two studies, 351 people);
- daily suction combined with antibiotic ear drops administered in a clinic, versus one instance of suction only (in a clinic) followed by daily self-administered antibiotic ear drops (one study, 80 people).

Daily dry mopping compared against no treatment

- We do not know whether dry mopping stops ear discharge, because the evidence on whether people experienced discharge after four weeks was of very low certainty, and no studies looked at the presence of discharge earlier.

- One study reported serious complications, but it was not clear whether the people who reported complications had their ears cleaned with dry mopping or not, or whether the complications occurred before or after treatment. We therefore could not tell whether dry mopping caused serious complications, or how often these occurred.

- One study looked at hearing, but did not report the results in a way that could tell us whether or not dry mopping affects hearing.

- No studies investigated the impact of dry mopping on health-related quality of life, ear pain, dizziness or ear bleeding.

Daily suction compared against one instance of suction only, in addition to antibiotic ear drops

- We do not know whether suction stops ear discharge, because the evidence for between one and two weeks after treatment was of very low certainty, and the results for discharge after four weeks could not be interpreted.

- We do not know if suction affects hearing or dizziness, as the evidence was of very low certainty.

- No studies investigated the impact of suction on health-related quality of life, ear pain, serious complications or ear bleeding.

What this means

We do not know how effective ear cleaning is for people with CSOM, and whether it causes unwanted effects. There are very few studies in this area, and these provide very low-certainty evidence. Unwanted effects were not well reported in the studies we found. We need researchers to conduct future studies that compare ear cleaning to no cleaning, and compare different cleaning techniques and frequency, so that we can assess the benefits and risks of ear cleaning for people with CSOM.

How-up-to date is this review?

The evidence in this Cochrane Review is current to March 2020.

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.

Read the full abstract...
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 strategy: 

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).

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