WITHDRAWN: Ear drops for the removal of ear wax.

BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble. Treatment for this condition often involves use of a wax softening agent (cerumenolytic) to disperse the cerumen, reduce the need for, or facilitate syringing, but there is no consensus on the effectiveness of the variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008 issue 2); MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was April 2008. SELECTION CRITERIA: We identified all randomised controlled trials in which a cerumenolytic was compared with no treatment, a placebo, or other cerumenolytics in participants with obstructing or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable. DATA COLLECTION AND ANALYSIS: The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. MAIN RESULTS: Nine trials satisfied the inclusion criteria. In all, 679 participants received one of 11 different cerumenolytics. One trial compared active treatments with no treatment, three compared active treatments with water or a saline 'placebo', and all nine trials compared two or more active treatments. Eight trials included syringing as a secondary intervention.Overall, results were inconclusive. The majority of comparisons showed no difference between treatments.  Meta-analysis of two high quality trials produced a statistical difference in favour of triethanolamine polypeptide over saline in preventing the need for syringing, but no other significant differences between treatments.In three trials of high to moderate quality, no difference was found between the effectiveness of either sodium bicarbonate ear drops, chlorbutanol, triethanolamine polypeptide oleate condensate or docusate sodium liquid versus a sterile water or saline 'placebo'.One trial of moderate methodological quality found all three treatments - sodium bicarbonate ear drops, chlorbutanol and sterile water - to be significantly better than no treatment at preventing the need for syringing.None of the higher quality trials demonstrated superiority of one agent over another in direct comparisons. AUTHORS' CONCLUSIONS: Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.

A guide to managing disorders of the ear pinna and canal.

This review will help you troubleshoot everything from infections and foreign bodies to trauma and neoplasm.

Ear drops for the removal of ear wax.

BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble. Treatment for this condition often involves use of a wax softening agent (cerumenolytic) to disperse the cerumen, reduce the need for, or facilitate syringing, but there is no consensus on the effectiveness of the variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008 issue 2); MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was April 2008. SELECTION CRITERIA: We identified all randomised controlled trials in which a cerumenolytic was compared with no treatment, a placebo, or other cerumenolytics in participants with obstructing or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable. DATA COLLECTION AND ANALYSIS: The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. MAIN RESULTS: Nine trials satisfied the inclusion criteria. In all, 679 participants received one of 11 different cerumenolytics. One trial compared active treatments with no treatment, three compared active treatments with water or a saline 'placebo', and all nine trials compared two or more active treatments. Eight trials included syringing as a secondary intervention.Overall, results were inconclusive. The majority of comparisons showed no difference between treatments. Meta-analysis of two high quality trials produced a statistical difference in favour of triethanolamine polypeptide over saline in preventing the need for syringing, but no other significant differences between treatments.In three trials of high to moderate quality, no difference was found between the effectiveness of either sodium bicarbonate ear drops, chlorbutanol, triethanolamine polypeptide oleate condensate or docusate sodium liquid versus a sterile water or saline 'placebo'.One trial of moderate methodological quality found all three treatments - sodium bicarbonate ear drops, chlorbutanol and sterile water - to be significantly better than no treatment at preventing the need for syringing.None of the higher quality trials demonstrated superiority of one agent over another in direct comparisons. AUTHORS' CONCLUSIONS: Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.

Back to basics: finding an optimal cerumenolytic (earwax solvent).

An in vitro study was conducted to assess the effectiveness of the commonly used aqueous and organic cerumenolytic (earwax solvent). Three agents were included in the study: olive oil, sodium bicarbonate and urea-hydrogen peroxide complex 5% in glycerol. Distilled water was used as a control. The disintegration of preformed wax plug was noted at specific intervals. The test tube containing distilled water as a control was found to be most effective and fastest in completely disintegrating the wax. This was closely followed by sodium bicarbonate. In contrast, the organic products, namely urea-hydrogen peroxide complex 5% in glycerol showed very little cerumenolytic effect. Olive oil, the most commonly used solution, was ineffective in disintegrating the wax plug even after 24 hours. The study shows aqueous cerumenolytics are more effective than organic agents.

Topical pimecrolimus 1% for the treatment of pruritic external auditory canals.

OBJECTIVES/HYPOTHESIS: To understand the role and efficacy of topical pimecrolimus in the treatment of refractory pruritus of the external auditory canals (EACs). STUDY DESIGN: Retrospective chart review. METHODS: Thirty-six patients with pruritic EACs who had failed conventional therapy with topical and systemic medications were treated with topical pimecrolimus 1% for a period of 3 months. Baseline and follow-up evaluation of the degree of pruritus among other variables was performed. A control group of 19 patients was instructed on aural toilet alone and was not treated with topical pimecrolimus 1%. RESULTS: Of the 36 patients who were treated with topical pimecrolimus for their pruritic EACs, 34 patients had resolution of their symptoms. There was evidence of return of cerumen production in 86% of patients. In the control group, 16% of patients had improvement of their symptoms with aural toilet. This difference was statistically significant (chi, P < .0001). CONCLUSIONS: Topical pimecrolimus appears to be more efficacious than aural toilet in the treatment of pruritic ears for chronic use without side effects.

Safety and efficacy of Sofenz ceruminolytic solution.

We conducted an open-label study of 109 untreated patients who had excessive or impacted cerumen. Our goal was to evaluate the safety and efficacy of Sofenz Cerumenolytic Solution, a methyltrypsin-containing earwax removal solution. Each patient's external auditory canal was filled with Sofenz for 15 minutes. The primary measure of efficacy--visibility of the tympanic membrane--was assessed after the solution had been drained from the canal and again after the canal had been irrigated with lukewarm water. If the tympanic membrane was not completely visible following either application, the procedure was repeated. A safety examination was conducted 1 to 3 days after treatment. Secondary outcomes measures included relief of otologic symptoms (e.g., hearing loss, tinnitus, etc.) and patients'overall satisfaction with treatment. Immediately after treatment, we found that the external auditory canal was completely visible in 81 patients (74.3%) after 1 application of Sofenz and subsequent irrigation, and in 98 patients (89.9%) after 2 applications of each. At the safety follow-up visit, we determined that the number of otologic symptoms had declined by 93.2%. A self-reported assessment completed by each patient following the procedure revealed a high degree of satisfaction with treatment. A total of 58 adverse events were reported, but only 16 were directly related to treatment, and all were transient and either mild or moderate. We conclude that 1 or 2 applications of Sofenz followed by irrigation with lukewarm water is a safe, well-tolerated, and effective treatment for excessive or impacted cerumen in the external auditory canal.

Water as a fast acting wax softening agent before ear syringing.

BACKGROUND: Dispute exists over the best treatment for softening occlusive earwax. Some require the patient to go away for days before returning for syringing. Some syringe immediately with no preparation. METHODS: An open, nonblinded, randomised controlled trial was conducted in one rural general practice. Effects of instillation of water into the ear canal for 15 minutes before syringing were compared to effects of syringing immediately. RESULTS: Thirty-nine ears (of 26 patients) were randomised. Ear wax was removed entirely by syringing in all ears. Prior instillation of water required a mean 7.5 (+/- 7.3) attempts at syringing versus a mean 25.4 (+/- 39.4) attempts for ears that were syringed immediately (p=0.043). DISCUSSION: Prior installation of water before syringing seems to be an effective and simple method of reducing the number of attempts required to clear the ear of occlusive wax.

A new approach for cerumenolytic treatment in children: In vivo and in vitro study.

OBJECTIVES: To demonstrate the effects of various cerumenolytic solutions in vivo and in vitro and to measure the change in pain following treatment. METHODS: The study was done as a single-centre, prospective and double-blind study. Among 1243 paediatric patients with total or nearly total occlusive plug in 4 years period, those who accepted endoscopic ear examination and cleaning via aspiration after a follow-up period of at least 10 days following treatment were included in the study. Day of total TM visualisation was noted and removal co-efficient was calculated. The pre and post-treatment pain levels of the patients were assessed using analogue chromatic continuous scale (ACCS). In the in vitro part, cerumen samples collected at equal amounts from 20 patients were treated at 36-400°C in 6 different tubes with the same solutions and their dissolution degrees were assessed over a period of 5 days (Hour 6, Hour 12, Hour 48, Hour 72, Hour 92, Hour 120). Additionally, the degree of resolution in the tube treated with distilled water was considered to be the control reference. RESULTS: In the in vivo part of the study, total TM visualisation was observed in Group 1 at 50.2% (Day 3), in Group at 57.1%, in Group at 62.3%, in Group at 44.3% and in Group 5 at 73.5%. The group with the lowest removal co-efficient was Group 5 (removal co-efficient=1.623). In reference to the ACCS pain scores of the patients, the intra-group change pre-post treatment was found statistically significant for all groups (p=0.008; p=0.0222; p=0.005; p=0.026; p=0.018). After statistical analysis between the groups the difference between Group 5 and other groups was found statistically significant (p=0.002; p=0.026; p=0.044; p=0.034). In the in vitro part of the study, the best dissolution was observed in Group 2. CONCLUSIONS: In our study, the best cerumenolytic solutions were identified to be glycerine 10cc+3% hydrogen peroxide 10cc+10% sodium bicarbonate 10cc+distilled water 10cc. Especially the use of this mixture ease in terms of pain for the patient and in terms of time and comfort for the physician during the removal procedure.

A comparison of the efficacy of two ear drop preparations ('Audax' and 'Earex') in the softening and removal of impacted ear wax.

Thirty-six patients with symptoms of impacted ear wax were recruited to an open, randomized, parallel group study of 'Audax' ear drops and 'Earex' ear drops. Patients had had their symptoms for several weeks and they were assessed on entry for the degree of impaction in each ear. After using the drops, morning and evening for 4 days, they were assessed on the fifth day for degree of impaction, ease of syringing, side-effects or discomfort, and the investigator's and patient's own global impression of efficacy of the ear drops. A trend was seen showing less impaction post-treatment in the 'Audax' group than in the 'Earex' group although the difference did not reach statistical significance. A significant difference was seen in favour of 'Audax' for the frequency and ease of syringing (p < 0.005). No patients in the 'Audax' group reported any side-effect or discomfort although 1 patient using 'Earex' reported slight irritation whilst another found the smell unacceptable. The results of the investigators' and patients' own global impression of efficacy were significantly in favour of 'Audax' ear drops (p < 0.01).

A single-blind, randomized study to compare the efficacy of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax.

A parallel group, single-blind, randomized study was carried out in a general practice to compare the effectiveness and tolerability of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax in 50 adult patients with impacted or hardened ear wax. Assessments were made on entry of the amount, colour and consistency of the ear wax, symptoms, and objective hearing. Patients were then allocated at random to receive one or other preparation and instructed to use the drops, morning and evening, for 4 days after which they were reassessed. Details were recorded of any side-effects or discomfort caused by the study medication and both physician and patients were asked to give their overall opinion of treatment efficacy. Both treatments were shown to be effective in the softening of ear wax and were well tolerated, there being no significant difference between the two groups in these parameters. However, patients who had abnormal hearing before treatment had a significantly greater improvement in objective hearing after treatment with 'Audax' ear drops compared to those patients treated with 'Cerumol' ear drops. There were no between-treatment differences in either either the physician's or patient's overall assessments of effectiveness.

A technique for measuring the rate of cerumen production.

A technique is described for quantitatively measuring the rate of cerumen production. Two different washing solutions were tried. A mixture of alcohol/ether (3:1 v/v) appeared to be the best extracting solution yielding 2.05 +/- 0.22 versus 0.73 +/- 0.14 mg/week per ear obtained with Triton X-100 solution. In addition, reproducibility was definitely better. Triton X-100 may be useful whenever microbiologic evaluations are requested. Total lipids accounted for 73.3% of cerumen extracted with the former solution, triglycerides being 19.5%, and cholesterol 7.2%. Our extracting technique appears to be a good estimate of the cerumen global output and may supply important information about cerumen in several biologic conditions.

The effectiveness of topical preparations for the treatment of earwax: a systematic review.

BACKGROUND: Earwax is a common problem in both primary and secondary care. There is uncertainty as to the most effective topical treatment. AIM: To assess the evidence concerning the efficacy of topical preparations used for treating earwax. DESIGN OF STUDY: Systematic review and meta-analysis. METHOD: Searching for randomised controlled trials (RCTs) of relevant studies. Classification of preparations into three groups, enabling pooling of data and meta-analysis. RESULTS: Of the 18 RCTs included in the review, four were judged to be of high quality. Fifteen preparations including saline and plain water were studied. Oil-based and water-based preparations were equally effective at clearing earwax without syringing (odds ratio [OR] = 0.9, 95% confidence interval [CI] = 0.4 to 2.3) and facilitating successful syringing (OR = 1.0, 95% CI = 0.6 to 1.6). A non-water-, non-oil-based preparation appeared more effective than an oil-based preparation at both clearing earwax without syringing, and facilitating successful syringing. Immediate syringing after application of a preparation may be as effective as using eardrops for several days and delaying syringing. CONCLUSIONS: On current evidence, there is little to choose between water-based and oil-based preparations; non-water-, non-oil-based preparations appear promising at both clearing earwax and facilitating successful syringing, but further large trials are needed. Although immediate ear syringing is effective and convenient for patients, it may be less cost-effective than using eardrops and perhaps avoiding syringing. Most of the evidence regarding such a common and time-consuming problem is not of high quality.

Ear drops for the removal of ear wax.

BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are one of the most common reasons for people to present to their general practitioners with ear trouble (Sharp 1990). Treatment for this condition often involves use of a wax softening agent (cerumenolytic) in order to disperse the cerumen and reduce the need for syringing, or to facilitate syringing should it prove necessary, but there is no consensus on the effectiveness of the wide variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH STRATEGY: We searched the Cochrane ENT Group Register, the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1, 2003), and MEDLINE and EMBASE up to March 2003. Reference lists of all trials were also manually searched. SELECTION CRITERIA: We identified all randomised controlled trials (with or without blinding) in which a cerumenolytic was evaluated in comparison with either no treatment, a placebo, or other cerumenolytics in participants with hard or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable. The full text articles of all the retrieved trials of possible relevance were reviewed by the two reviewers and the inclusion criteria applied independently. Any differences in opinion about which studies to include in the review were resolved by discussion. DATA COLLECTION AND ANALYSIS: Trials were graded for methodological quality using the Cochrane approach. Data extraction was performed in a standardised manner by one reviewer and rechecked by the other reviewer, and where necessary investigators were contacted to obtain missing information. Meta-analysis was neither possible nor considered appropriate because of the heterogeneity of the treatments, treatment amounts and durations, trial procedures, and scoring systems. A narrative overview of the results is therefore presented. MAIN RESULTS: Eight trials satisfied the inclusion criteria, the majority of which were of poor quality. In all, 587 participants received one of nine different cerumenolytics. One trial compared active treatments with no treatment, two trials compared active treatments with water or a saline 'placebo', and all eight trials placed two or more active treatments in head-to-head comparisons. Seven trials included syringing as a secondary treatment where necessary.Overall, results were inconclusive. One trial found a significant difference between one of three active agents (Cerumol) in comparison to no treatment, but no statistically significant difference was found between these three agents (sodium bicarbonate ear drops; Cerumol; sterile water). In two trials no statistical difference was found between the effectiveness of either sodium bicarbonate ear drops, Cerumol, Cerumenex or Colace versus a sterile water or saline 'placebo'. Three trials (from the same source) found statistically significant differences in favour of the same active agent (Exterol) in comparison to glycerol and Cerumol. Three trials found no statistically significant difference between two or more cerumenolytics (Otocerol versus Cerumol; Audax versus Earex; sodium bicarbonate ear drops versus Cerumol). Two trials comparing the same two cerumenolytics (Cerumenex versus Colace) also failed to show any significant benefit of one over the other. No serious adverse effects were reported from any of the interventions. REVIEWER'S CONCLUSIONS: Trials to date have been heterogeneous and of poor quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo and/or no treatment.

A multicentric clinical trial comparing Otocerol with Cerumol as cerumenolytics.

Fifteen general practitioners conducted a randomized, double-blind comparative trial of two cerumenolytics, namely, Otocerol and Cerumol. A total of 106 patients were entered into the study (fifty-three in each group). Otocerol was shown to be marginally better than Cerumol in all parameters evaluated.

Ear wax removal: a survey of current practice.

OBJECTIVE: To determine the methods of removing ear wax used by local general practitioners and the incidence of associated complications. DESIGN: Postal survey of 312 general practitioners serving a population of about 650,000; supplementary study of ear, nose, and throat outpatients to quantify the improvement in aural acuity after wax removal. SETTING: Catchment area of the Edinburgh otolaryngological unit. PARTICIPANTS: 289 General practitioners who responded to the survey; 21 outpatients in the ear, nose, and throat department with occlusive wax. RESULTS: 274 General practitioners removed wax by syringing, but only 53 (19%) always performed the procedure themselves; the remainder routinely delegated the task to practice nurses, some of whom had received no instruction. Ears were rarely examined again after the procedure. Complications had been experienced by 105 practitioners (38%) and included perforation, canal lacerations, and failure of wax removal. The removal of occlusive wax improved hearing by a mean of 5 dB over the frequencies analysed. CONCLUSIONS: About 44,000 ears are syringed each year in the area and complications requiring specialist referral are estimated to occur in 1/1000 ears syringed. The incidence of complications could be reduced by a greater awareness of the potential hazards, increased instruction of personnel, and more careful selection of patients.

Practice tip. Which cerumenolytic?

AIM: To test the in vitro dispersion of ear wax by four commonly used cerumenolytics. METHOD: Equal parts of the same piece of ear wax were covered with 10 mL of each preparation and observed for up to 30 days. RESULTS: Sodium bicarbonate and Waxsol dispersed wax within 2 hours, Cerumol was much slower and olive oil had no effect. CONCLUSIONS: The cheapest and most effective cerumenolytic is a solution of sodium bicarbonate.

The most effective products available to facilitate ear syringing.

Loss of hearing from accumulation of cerumen (ear wax) is a commonly seen problem. Treatment for this condition often involves use of a wax softening or dispersing agent (cerumenolytic) before syringing. A mini-review was undertaken to find out what is the best preparation to use before syringing to facilitate the procedure. Five databases were searched using subject searches combined with methodological filters to find the highest level of evidence to answer the question. Nine randomized controlled trials (RCTs) were found and seven in vitro studies that researched the efficacy or effectiveness of a range of products. The RCTs do not show any one product to be more effective. The in vitro studies show Waxsol to be better at dispersing wax followed by sodium bicarbonate. This needs to be demonstrated with in vivo testing comparing all products for effectiveness. Many of the studies suffered from a lack of information. Side effects were not adequately investigated.