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BMJ Clin Evid. 2008; 2008: 0504.
Published online 2008 January 25.
PMCID: PMC2907972

Ear wax

George GG Browning, Professor of Otorhinolaryngology

Abstract

Introduction

Ear wax only becomes a problem if it causes a hearing impairment or other ear-related symptoms. Ear wax is more likely to accumulate and cause a hearing impairment when normal extrusion is prevented — for example, by the use of hearing aids, or by the use of cotton buds to clean the ears. Ear wax can visually obscure the ear drum, and may need to be removed for diagnostic purposes.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical question: What are the effects of methods to remove ear wax? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found nine systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review, we present information relating to the effectiveness and safety of the following interventions: ear syringing; manual removal (other than ear syringing); and wax softeners (alone or prior to syringing).

Key Points

Ear wax only becomes a problem if it causes a hearing impairment, or other ear-related symptoms.

  • Ear wax is more likely to accumulate and cause a hearing impairment when normal extrusion is prevented — for example, by hearing aids, or by the use of cotton buds to clean the ears.
  • Ear wax can visually obscure the ear drum, and may need to be removed for diagnostic purposes.

For such a commonly occurring condition, there is little high-quality evidence available to guide practice.

Ear syringing is generally considered to be effective, but evidence is limited.

  • Syringing can clear wax from the ear canal in up to 100% of ears when performed alone, or after the use of wax softeners.
  • Ear syringing may be associated with vertigo and tympanic membrane perforation in some people. Pain, damage to the skin of the ear canal, and otitis externa are other possible adverse effects.

Other mechanical methods of removing ear wax by trained staff using instruments — such as microsuction — are probably effective, although the evidence is limited.

  • Mechanical removal of wax with suction, probes, or forceps is considered effective, but can cause trauma to the ear canal, depending on the experience and training of the operator, and the adequacy of visualisation.

Benefits of wax softeners are unknown when used prior to syringing or alone.

  • The use of wax softeners prior to syringing may increase clearance rate, but the evidence is limited.
  • Evidence is too limited to show whether wax softeners alone are effective in clearing wax, or whether one type of softener is more effective than another.

Clinical context

About this condition

Definition

Ear wax is normal and becomes a problem only if it produces hearing impairment, pain, or other ear-related symptoms. Ear wax may also need to be removed if it prevents inspection of the ear drum. The term ”impacted wax” is used in different ways, and can merely imply the coexistence of wax obscuring the ear drum with symptoms in that ear.

Incidence/ Prevalence

We found four surveys of the prevalence of impacted wax. The studies were carried out in a variety of populations, and used a variety of definitions of impacted wax. Prevalence ranged from 7% to 35%. It is unclear how these figures relate to prevalence in the general population.

Aetiology/ Risk factors

Factors that prevent the normal extrusion of wax from the ear canal (e.g., wearing a hearing aid, using cotton buds to clean ears) increase the chance of ear wax accumulating.

Prognosis

Most ear wax emerges from the external canal spontaneously; one small RCT that included a no-treatment group found that 32% of ears with impacted wax showed some degree of spontaneous resolution after 5 days (26% described as moderately clear; 5% described as completely clear). Without impaction or adherence to the drum, there is likely to be minimal, if any, hearing loss.

Aims of intervention

To relieve symptoms or to allow examination, especially of the tympanic membrane, by completely removing impacted wax or visually obstructing wax; and to ease wax removal.

Outcomes

Treatment success: proportion of people (or ears) with relief of hearing loss or discomfort; subjective assessment of amount of wax remaining; after use of wax softeners prior to cleansing: proportion of people requiring mechanical removal to improve symptoms; degree of visualisation of the tympanic membrane; perceived ease of mechanical removal (measured, for example, by the volume of water used to accomplish successful syringing).

Methods

Clinical Evidence search and appraisal June 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2007, Embase 1980 to June 2007, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2007, Issue 2. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and NICE. We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as “open”, “open label”, or not blinded, unless blinding was impossible. We also searched for prospective and retrospective cohort studies on the manual removal methods, and on harms of included interventions. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table
GRADE Evaluation of interventions for Ear wax.

Glossary

Impacted wax
Wax that has been compressed in the ear canal, completely obstructing the lumen. In practice, many RCTs define impaction as the presence of symptoms associated with wax obscuring the ear drum.
Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Obstructing wax
Wax that obscures direct vision of the ear drum.
Very low-quality evidence
Any estimate of effect is very uncertain.

Notes

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

References

1. Keane EM, Wilson H, McGrane D, et al. Use of solvents to disperse ear wax. Br J Clin Pract 1995;49:7–12. [PubMed]
2. Kalantan KA, Abdulghani H, Al-Taweel AA, et al. Use of cotton tipped swab and cerumen impaction. Ind J Otol 1999;5:27–31.
3. Minja BM, Machemba A. Prevalence of otitis media, hearing impairment and cerumen impaction among school children in rural and urban Dar es Salaam, Tanzania. Int J Pediatr Otorhinolaryngol 1996;37:29–34. [PubMed]
4. Swart SM, Lemmer R, Parbhoo JN, et al. A survey of ear and hearing disorders amongst a representative sample of Grade 1 school children in Swaziland. Int J Pediatr Otorhinolaryngol 1995;32:23–34. [PubMed]
5. Lewis-Cullinan C, Janken JK. Effect of cerumen removal on the hearing ability of geriatric patients. J Adv Nurs 1990;15:594–600. [PubMed]
6. Pavlidis C, Pickering JA. Water as a fast acting wax softening agent before ear syringing. Australian Family Physician 2005;34:303–304. [PubMed]
7. Ogunleye AOA, Awobem AA. Trends in ear syringing in Ibadan, Nigeria. Afr J Med Sci 2004;33:35–37. [PubMed]
8. Sharp JF, Wilson JA, Ross L, et al. Ear wax removal: a survey of current practice. BMJ 1990;301:1251–1252. [PMC free article] [PubMed]
9. Pothier DD, Hall C, Gillett S. A comparison of endoscopic and microscopic removal of wax: A randomised clinical trial. Clin Otolaryngol 2006;31:375–380. [PubMed]
10. Hand C, Harvey I. The effectiveness of topical preparations for the treatment of earwax: a systematic review. Br J Gen Pract 2004;54:862–867. Search date 2003. Primary sources Medline, Cinahl, Cochrane Controlled Trials Register, National Research Register, Clinical Evidence, references and review articles, contact with experts in the field, authors of identified trials and pharmaceutical companies. [PMC free article] [PubMed]
11. Burton MJ, Doree CJ. Ear drops for the removal of ear wax (Cochrane Review). In: The Cochrane Library, Issue 2, 2007. Chichester, UK: John Wiley & Sons, Ltd. Search date 2003, primary sources Cochrane ENT Group Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and hand searches of reference lists of all trials retrieved.
12. Roland PS, Eaton EA, Gross RD, et al. Randomized placebo-controlled evaluation of cerumenex and murine earwax removal products. Arch Otolaryngol Head Neck Surg 2004;130:1175–1177. [PubMed]
13. Memel D, Langley C, Watkins C, et al. Effectiveness of ear syringing in general practice: a randomised controlled trial and patients' experiences. Br J Gen Pract 2002;52:906–911. [PMC free article] [PubMed]
2008; 2008: 0504.
Published online 2008 January 25.

Ear syringing

Summary

Ear syringing is generally considered to be effective, but evidence is limited.

Syringing can clear wax from the ear canal in up to 100% of ears when performed alone, or after the use of wax softeners.

Ear syringing may be associated with vertigo and tympanic membrane perforation in some people. Pain, damage to the skin of the ear canal, and otitis externa are other possible adverse effects.

Benefits and harms

Ear syringing versus no treatment:

We found no RCTs comparing ear syringing alone versus no treatment. However, there is consensus that ear syringing is effective at removing wax. Visualisation of the tympanic membrane in up to 100% of ears has been reported after syringing (see comment).

Ear syringing with prior water instillation versus ear syringing without prior water instillation:

We found one RCT.

Treatment success

Ear syringing with prior water installation compared with ear syringing without prior water instillation Water instilled in the ear 15 minutes before syringing may be more effective at reducing the volume of water needed to syringe the ear clear of wax compared with no treatment (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Volume of water needed to clear the ear

RCT
26 people, 39 ears Mean volume of water needed to clear the ear
187 mL with water instillation (ear filled with warm tap water for 15 minutes) prior to syringing
635 mL with no treatment

P = 0.043
Possible bias; for full details see further information about studies
Effect size not calculatedprior water instillation

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
26 people, 39 ears Adverse effects
with water instillation (ear filled with warm tap water for 15 minutes) prior to syringing
with no treatment

Further information on studies

The RCT was not blinded, which may have introduced bias, as the outcome reported depended on the visual subjective assessment of when the ear was clear of wax, and syringing was done manually rather than by a standardised electronic device.

Comment

Ear syringing versus no treatment:

Although we found no RCTs, there is consensus that ear syringing is effective at clearing wax. In RCTs comparing wax softeners versus no wax softeners prior to syringing, subsequent syringing was effective at clearing wax from the ear canal in up to 100% of ears. One large prospective observational study (952 ears in 622 subjects) of all people attending an Ear, Nose, and Throat clinic for ear syringing between December 1999 to June 2001 found that the most common complications were vertigo, and perforation of the tympanic membrane (vertigo: 1 [0.2%]; tympanic membrane perforation: 1 [0.2%]; further details, including details of denominators for adverse effects, not reported; other adverse effects not reported). This study was undertaken in an Ear, Nose, and Throat clinic, and adverse-event rates may not be generalisable to other settings. Other reported complications of ear syringing include pain, damage to the skin of the external canal with haemorrhage, and otitis externa.

Substantive changes

No new evidence

2008; 2008: 0504.
Published online 2008 January 25.

Manual removal (other than ear syringing)

Summary

Other mechanical methods of removing ear wax by trained staff using instruments — such as microsuction — are probably effective, although the evidence is limited.

Mechanical removal of wax with suction, probes, or forceps is considered effective, but can cause trauma to the ear canal, depending on the experience and training of the operator, and the adequacy of visualisation.

We found no clinically important results about mechanical methods compared with no treatment or alternative treatments in removal of ear wax.

Benefits and harms

Mechanical methods alone versus no treatment or alternative treatment:

We found no systematic review or RCTs comparing mechanical methods alone versus no treatment or alternative treatment (see comment ).

Endoscopic vision versus microscopic vision to assist mechanical dewaxing:

We found one RCT that compared using an endoscope versus using a microscope to aid vision in mechanical dewaxing.

Treatment success

Endoscopic vision compared with microscopic vision We don't know how endoscopic vision and microscopic vision compare at increasing treatment success rates in mechanical dewaxing in people with a build-up of wax which prevents inspection of the tympanic membrane (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful dewaxing

RCT
100 people in secondary care with ear wax preventing inspection of the tympanic membrane Proportion of people successfully dewaxed after one procedure
45/50 (90%) with endoscopic vision
48/50 (96%) with microscopic vision

Significance not assessed
Possible bias; for full details see further information about studies

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
100 people in secondary care with ear wax preventing inspection of the tympanic membrane Median pain score on a 100 mm visual analogue scale from 0 (no pain) to 100 (very painful)
5 with endoscopic vision
25 with microscopic vision

P = 0.002
Possible bias; for full details see further information about studies
Effect size not calculatedendoscopy

RCT
100 people in secondary care with ear wax preventing inspection of the tympanic membrane Median discomfort score on a 100 mm visual analogue scale from 0 (no discomfort) to 100 (very uncomfortable)
3.5 with endoscopic vision
10 with microscopic vision

P = 0.075
Possible bias; for full details see further information about studies
Not significant

RCT
100 people in secondary care with ear wax preventing inspection of the tympanic membrane Traumatisation to the skin of the canal causing a minor bleed
1/50 (2%) with endoscopic vision
1/50 (2%) with microscopic vision

Possible bias; for full details see further information about studies

Mechanical methods after use of wax softeners:

See option on wax softeners.

Further information on studies

People who failed with initial treatment were crossed over to the other group; after second dewaxing, intention-to-treat analysis found that only 2/50 (4%) of people in the endoscopic vision group and 1/50 (2%) of people in the microscopic vision group required ceremunolytics before subsequent dewaxing. Potential bias: The study was open label, which may have introduced bias into the results of the levels of discomfort and pain experienced by the participants. Randomisation was by opaque envelope.

Comment

Mechanical techniques other than syringing include manual removal under direct vision, with or without a microscope, using suction, probes, or forceps. These methods require specific training and access to appropriate equipment. The incidence of trauma is likely to be related to the experience of the operator, and the availability of appropriate equipment, particularly that for adequate visualisation.

Substantive changes

Manual removal (other than ear syringing) One RCT added comparing different visual aids to assist with manual dewaxing; categorisation unchanged (Unknown effectiveness).

2008; 2008: 0504.
Published online 2008 January 25.

Wax softeners prior to syringing

Summary

Benefits of wax softeners are unknown when used prior to syringing or alone.

The use of wax softeners prior to syringing may increase clearance rate, but the evidence is limited.

Benefits and harms

Water-based wax softeners prior to syringing versus no treatment:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water-based, oil-based, or non-water and non-oil-based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The later review identified one small RCT comparing water-based softeners versus no treatment. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Water-based wax-softeners compared with no treatment Water-based proprietary wax-softeners may be more effective than no treatment at facilitating removal of ear wax by syringing (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
45 people
Data from 1 RCT
Successful syringing
75% with triethanolamine polypeptide/propylene glycol/chlorbutol/water (water base)-based proprietary preparation
5% with no treatment
Absolute numbers not reported

OR 60
95% CI 6.6 to 547.3
The confidence limits are wide, and blinding in the RCT was inadequate
Large effect sizewater-based proprietary preparation

Water-based wax softeners prior to syringing versus saline:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water-based, oil-based, or non-water and non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The later review included four small RCTs which compared water-based proprietary preparations containing triethanolamine polypeptide (2 RCTs) or docusate sodium (2 RCTs) versus normal saline. We found one subsequent RCT. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Water-based wax-softeners compared with saline We don't know how water-based wax softeners and saline compare at facilitating removal of ear wax by syringing (low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
91 people
2 RCTs in this analysis
Successful syringing
21/47 (45%) with triethanolamine polypeptide-based proprietary preparation
27/44 (61%) with normal saline

OR 0.5
95% CI 0.2 to 1.2
Not significant

Systematic review
93 people
2 RCTs in this analysis
Successful syringing
23/49 (47%) with docusate-based proprietary preparation
27/44 (61%) with normal saline

OR 0.5
95% CI 0.2 to 1.2
Not significant

RCT
3-armed trial
74 people Wax clearance after syringing
with triethanolamine polypeptide-based proprietary preparation
with saline
Absolute results not reported

P = 0.37
Not significant

RCT
3-armed trial
74 people Wax clearance after syringing
with carbamide peroxide-based proprietary preparation
with saline
Absolute results not reported

P = 0.06
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
3-armed trial
74 people Pruritus
1/24 (4%) with triethanolamine polypeptide-based proprietary preparation
2/26 (8%) with carbamide peroxide-based proprietary preparation
0/24 (0%) with saline

Significance not assessed

RCT
3-armed trial
74 people Discomfort
0/24 (0%) with triethanolamine polypeptide-based proprietary preparation
0/26 (0%) with carbamide peroxide-based proprietary preparation
1/24 (4%) with saline

Significance not assessed

RCT
3-armed trial
74 people Contact dermatitis
1/24 (4%) with triethanolamine polypeptide-based proprietary preparation
0/26 (0%) with carbamide peroxide-based proprietary preparation
0/24 (0%) with saline

Significance not assessed

Water-based wax softeners versus oil-based wax softeners prior to syringing:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water and non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The review with the later search date found five RCTs comparing various proprietary water-based preparations (including plain water) and oil-based preparations. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Water-based wax-softeners compared with oil-based wax-softeners Water-based wax-softeners and oil-based wax-softeners seem to be equally effective at facilitating removal of ear wax by syringing (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
523 people
5 RCTs in this analysis
Successful syringing
249/318 (78%) with water-based preparations
161/205 (79%) with oil-based preparations

OR 1.0
95% CI 0.6 to 1.6
Not significant

Water-based wax softeners versus each other prior to syringing:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water and non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The review with the later search date found four RCTs comparing two proprietary water-based preparations. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Water-based wax-softeners compared with each other We don't know how water-based wax softeners compare with each other at facilitating removal of ear wax by syringing (low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
190 people
4 RCTs in this analysis
Successful syringing
63/98 (64%) with docusate sodium
46/92 (50%) with triethanolamine polypeptide

OR 1.9
95% CI 0.7 to 5.0
Not significant

Oil-based wax softeners versus each other prior to syringing:

We found two systematic reviews (search date 2004; search date 2003; see comment), which between them identified four RCTs. The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water and non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The later review included four RCTs included in the earlier review, two additional RCTs, eight RCTs excluded by the earlier review, excluded three RCTs included by the earlier review, and found one RCT subsequent to the earlier review. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Oil-based wax softeners compared with each other We don't know how oil-based wax-softeners compare with each other at facilitating removal of ear wax by syringing (low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
106 people, number of ears not stated
Data from 1 RCT
Successful syringing
with oil-based preparations
with oil-based preparations
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
275 people
3 RCTs in this analysis
Successful syringing
93/136 (68%) with dioctyl sodium sulphosuccinate-based softener
98/139 (70%) with maize oil base or olive oil-based softener

OR 0.6
95% CI 0.2 to 2.4
Not significant

Non-water, non-oil based wax softeners versus water-based or oil-based preparations prior to syringing:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews had slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water and non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity among included RCTs. The later review found two RCTs. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Non-water, non-oil based wax softeners compared with water-based or oil-based preparations Non-water, non-oil based wax softeners may be more effective than oil-based proprietary preparations at facilitating ear wax removal by syringing but may be less effective than water-based preparations (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Successful syringing

Systematic review
36 people, 72 ears
Data from 1 RCT
Successful syringing
with arachis oil/almond oil/rectified camphor oil (oil base)-based preparation
with choline salicylate/glycerol/ethyleneoxide-polyoxypropylene glycol (non-water, non-oil base)-based proprietary preparation given over 4 days
Absolute results not reported

OR 21.4
95% CI 2.6 to 178.6
Large effect sizenon-water, non-oil based proprietary preparation
Wax removal

Systematic review
80 ears, number of people not reported
Data from 1 RCT
Removal of wax
with triethanolamine polypeptide (water base)-based proprietary preparation (applied 30 minutes prior to syringing)
with carbamide peroxide (non-water, non-oil base)-based proprietary preparation
Absolute results not reported

OR 33.0
95% CI 9.5 to 114.3
Large effect sizewater-based proprietary preparation

Wax softeners alone versus wax softeners plus syringing:

We found one RCT which compared oily drops versus oily drops plus syringing, and assessed improvement in hearing. For adverse effects of wax softeners, see option on wax softeners alone.

Treatment success

Wax softeners plus syringing compared with wax softeners alone Wax softeners plus syringing may be more effective than wax softeners alone at improving hearing after removal of wax (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Improvement in hearing

RCT
Population details not reported Improvement in hearing
with oily drops (not further defined) plus syringing
with oily drops (not further defined) alone
Absolute results not reported

Reported as significant
P value not reported
Possible bias; for full details see further information about studies
Effect size not calculatedoily drops plus syringing

Adverse effects

No data from the following reference on this outcome.

Further information on studies

Oily drops may impair baseline hearing level, which may have biased the results in favour of intervention. This makes the RCT difficult to interpret.

Comment

The later review categorised ear drops into three groups — water based; oil based; and non-water, non-oil based — in order to pool data, and both reviews noted that the included RCTs were of poor methodological quality. See comment for wax softeners alone.

Substantive changes

No new evidence

2008; 2008: 0504.
Published online 2008 January 25.

Wax softeners alone

Summary

Benefits of wax softeners are unknown when used prior to syringing or alone.

Evidence is too limited to show whether wax softeners alone are effective in clearing wax, or whether one type of softener is more effective than another.

Benefits and harms

Wax softeners versus no treatment:

We found two systematic reviews (search date 2004; search date 2003; see comment) which used slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity between included RCTs. The later review included five RCTs included in the earlier review, and two RCTs excluded by the earlier review, excluded three RCTs included by the earlier review, and found one RCT subsequent to the earlier review. The reviews identified three RCTs in total. Both included the same two RCTs, and the later review included one RCT subsequent to the earlier review.

Treatment success

Water-based and oil-based wax softeners compared with no treatment Water-based and oil-based wax softeners may be more effective at completely clearing wax compared with no treatment (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Wax clearance

RCT
4-armed trial
97 people, 155 ears, older people in hospital with impacted wax
In review
Proportion of ears with complete wax clearance
9/40 (22%) with arachis oil/chlorbutol/p-dichlorobenzene (oil-based) wax softener
2/38 (5%) with no treatment

P <0.05 for oil-based wax softener versus no treatment
Result was of borderline significance
Effect size not calculatedwax softener

RCT
4-armed trial
97 people, 155 ears, older people in hospital with impacted wax
In review
Proportion of ears with complete wax clearance
8/39 (21%) with sodium bicarbonate/glycerol/sterile water (water-based) wax softener
2/38 (5%) with no treatment

P <0.05 for water-based wax softener versus no treatment
Result was of borderline significance
Effect size not calculatedwax softeners

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
Population details not reported Adverse effects
with wax softeners
with

Systematic review
Population details not reported Adverse effects
with wax softeners
with

Wax softeners versus sterile water:

We found two systematic reviews (search date 2004; search date 2003; see comment) which used slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity between included RCTs. The later review included five RCTs included in the earlier review, and two RCTs excluded by the earlier review, excluded three RCTs included by the earlier review, and found one RCT subsequent to the earlier review. The reviews identified three RCTs in total. Both included the same two RCTs, and the later review included one RCT subsequent to the earlier review.

Treatment success

Wax softeners compared with sterile water We don't know whether water-based and oil-based wax softeners are more effective than sterile water at clearing wax (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Wax clearance

RCT
4-armed trial
97 people, 155 ears, older people in hospital with impacted wax
In review
Proportion of ears with complete wax clearance
9/40 (22%) with arachis oil/chlorbutol/p-dichlorobenzene (oil-based) wax softener
8/39 (21%) with sodium bicarbonate/glycerol/sterile water (water-based) wax softener
8/38 (21%) with sterile water alone

Among group difference reported as not significant
P value not reported
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
Population details not reported Adverse effects
with wax softeners
with

Systematic review
Population details not reported Adverse effects
with
with

Water-based wax-softener versus saline:

We found one systematic review (search date 2004), which included two small RCTs comparing proprietary preparations containing docusate sodium (water based) or triethanolamine polypeptide (water based) versus normal saline in children.

Treatment success

Water-based softeners compared with normal saline Water-based proprietary preparations containing triethanolamine polypeptide may be more effective at clearing wax compared with saline, but we don't know whether softeners containing sodium docusate are more effective than saline at clearing wax (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Wax clearance

Systematic review
91 children
2 RCTs in this analysis
Proportion of children whose ears were completely clear
11/47 (23%) with triethanolamine polypeptide (water base)-based softener
3/44 (7%) with normal saline

OR 4.6
95% CI 1.1 to 18.5
Potential bias: see further information on studies for full details
Moderate effect sizewater-based wax softener

Systematic review
91 children
2 RCTs in this analysis
Proportion of children whose ears were completely clear
6/49 (12%) with sodium docusate (water base)-based softener
3/44 (7%) with normal saline

OR 1.9
95% CI 0.4 to 8.8
Potential bias: see further information on studies for full details
Not significant

Water-based wax softeners versus each other:

We found two systematic reviews (search date 2004; search date 2003; see comment). The review used slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity between included RCTs. The later review included five RCTs included in the earlier review, and two RCTs excluded by the earlier review, excluded three RCTs included by the earlier review, and found one RCT subsequent to the earlier review. The reviews found no consistent differences between different agents.

Treatment success

Water-based wax softeners compared with each other We don't know how water-based wax softeners (docusate sodium, triethanolamine polypeptide, aqueous sodium bicarbonate, and acetic acid) compare with each other at clearing wax (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Wax clearance

Systematic review
146 ears (number of people not clear)
3 RCTs in this analysis
Proportion of ears clear of wax 15 minutes
11/76 (14%) with docusate sodium (water based)
13/70 (19%) with triethanolamine polypeptide (water based)

OR 0.8
95% CI 0.2 to 2.8
Not significant

Systematic review
69 people, 138 ears
Data from 1 RCT
Wax clearance
with aqueous sodium bicarbonate (water based)
with acetic acid (water based)
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
Number of people/ears not clear Adverse effects
with water-based softeners
with

Non-water, non-oil wax-softener versus oil-based wax softener:

We found one systematic review (search date 2004). The review identified two RCTs comparing non-water non-oil based softeners versus oil based softeners.

Treatment success

Non-water, non-oil based softeners compared with oil-based softeners We don't know how non-water, non-oil based proprietary preparations and oil-based preparations compare at clearing wax (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Wax clearance

Systematic review
50 people, 100 ears
Data from 1 RCT
Wax clearance
with choline salicylate/glycerol/ethyleneoxide-polyoxypropylene glycol (non-water non-oil based)
with arachis oil/chlorbutol/p-dichlorobenzene (oil based)
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
36 people, 72 ears
Data from 1 RCT
Wax clearance
with choline salicylate/glycerol/ethyleneoxide-polyoxypropylene glycol (non-water non-oil based)-based softener
with arachis oil/almond oil/rectified camphor oil (oil based)-based softener
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
Number of people/ears not clear Adverse effects
with water-based softeners
with

Oil-based wax softeners versus each other:

We found two systematic reviews (search date 2004; search date 2003; see comment). The reviews used slightly different inclusion criteria. The later review categorised ear drops as being water based, oil based, or non-water non-oil based, and pooled data on this basis (see comment). The earlier review did not use this categorisation, and did not pool data because of clinical heterogeneity between included RCTs. The later review included five RCTs included in the earlier review, and two RCTs excluded by the earlier review, excluded three RCTs included by the earlier review, and found one RCT subsequent to the earlier review. The later review identified one RCT comparing oil-based preparations versus each other.

Treatment success

Oil-based softeners compared with each other Oil-based preparations containing arachis oil/almond oil/rectified camphor oil may be more effective at reducing the need for syringing compared with an oil-based preparation containing arachis oil/chlorobutol/p-dichlorobenzene (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Need for syringing

Systematic review
106 people
Data from 1 RCT
Proportion of people not requiring syringing
26% with arachis oil/almond oil/rectified camphor oil (oil based)-based softener
11% with arachis oil/chlorobutol/p-dichlorobenzene (oil based)-based softener
Absolute numbers not reported

OR 2.8
95% CI 1.0 to 8.0
Moderate effect sizearachis oil/almond oil/rectified camphor oil-based softener

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
106 people Adverse effects ("mainly pain/irritation"; no further details reported)
7 people with arachis oil/almond oil/rectified camphor oil (oil-based)-based softener
10 people with arachis oil/chlorbutol/p-dichlorobenzene (oil-based)-based softener
Absolute results not reported

Significance not assessed

Further information on studies

Sterile water versus no treatment The RCT that sterile water improved rate of wax clearance compared with no treatment (complete clearance of ears: 8/38 [21%] with sterile water v 2/38 [5%] with no treatment; P <0.05; result was of borderline significance). Analysis Of 113 people initially randomised, data were only presented for the 97 (86%) people who completed the trial. The analysis was not by intention to treat.

In one RCT (48 children) included the analysis for water-based wax-softener versus saline, not all ears were completely occluded at baseline, which may have introduced bias if the proportion with partial obstruction was different between groups.

Comment

The later review categorised ear drops into three groups — water based; oil based; and non-water non-oil based — in order to pool data. The rationale was that the mechanism of action between these three groups is different, and those with similar properties or constituents have a similar mechanism of action. Some RCTs reported water or saline as control or placebo. However, water or saline may or may not be inert in these circumstances. Where water or saline has been used as a comparator, we have stated this and not used the term control or placebo. Both reviews noted that, overall, the included RCTs were of poor methodological quality. Most included trials did not use rigorous methods of randomisation, and did not control for degree of ear canal occlusion at randomisation. In many, blinding was unclear or inadequate. Many trials were sponsored by companies that manufactured only one of the products being tested, but the possibility of publication bias (failure to publish unfavourable results) has not been assessed. The inclusion criteria for the RCTs were not always clear: many stated that the participants had impacted wax, without defining this. We found no good evidence about the optimal duration of treatment. The earlier review concluded that, because of the heterogeneous, poor-quality trials, it was difficult to offer any definitive recommendations on cerumenolytics for the removal of symptomatic ear wax.

Substantive changes

No new evidence


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