Triethanolamine Polypeptide Research Articles

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MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials.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.

WITHDRAWN: Ear drops for the removal of ear wax.

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. To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. 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. 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. The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. 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. 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.

The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation

Build-up of earwax is a common reason for attendance in primary care. Current practice for earwax removal generally involves the use of a softening agent, followed by irrigation of the ear if required. However, the safety and benefits of the different methods of removal are not known for certain. To conduct evidence synthesis of the clinical effectiveness and cost-effectiveness of the interventions currently available for softening and/or removing earwax and any adverse events (AEs) associated with the interventions. Eleven electronic resources were searched from inception to November 2008, including: The Cochrane Library; MEDLINE (OVID), PREMEDLINE In-Process & Other Non-Indexed Citations (OVID), EMBASE (OVID); and CINAHL. Two reviewers screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text or retrieved papers and data were extracted by two reviewers using data extraction forms developed a priori. Any differences were resolved by discussion or by a third reviewer. Study criteria included: interventions - all methods of earwax removal available and combinations of these methods; participants - adults/children presenting requiring earwax removal; outcomes - measures of hearing, adequacy of clearance of wax, quality of life, time to recurrence or further treatment, AEs and measures of cost-effectiveness; design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) for clinical effectiveness, cohort studies for AEs and cost-effectiveness, and costing studies for cost-effectiveness. For the economic evaluation, a deterministic decision tree model was developed to evaluate three options: (1) the use of softeners followed by irrigation in primary care; (2) softeners followed by self-irrigation; and (3) a 'no treatment' option. Outcomes were assessed in terms of benefits to patients and costs incurred, with costs presented by exploratory cost-utility analysis. Twenty-six clinical trials conducted in primary care (14 studies), secondary care (8 studies) or other care settings (4 studies), met the inclusion criteria for the review - 22 RCTs and 4 CCTs. The range of interventions included 16 different softeners, with or without irrigation, and in various different comparisons. Participants, outcomes, timing of intervention, follow-up and methodological quality varied between studies. On measures of wax clearance Cerumol, sodium bicarbonate, olive oil and water are all more effective than no treatment; triethanolamine polypeptide (TP) is better than olive oil; wet irrigation is better than dry irrigation; sodium bicarbonate drops followed by irrigation by nurse is more effective than sodium bicarbonate drops followed by self-irrigation; softening with TP and self-irrigation is more effective than self-irrigation only; and endoscopic de-waxing is better than microscopic de-waxing. AEs appeared to be minor and of limited extent. Resuts of the exploratory economic model found that softeners followed by self-irrigation were more likely to be cost-effective [24,433 pounds per quality-adjusted life-year (QALY)] than softeners followed by irrigation at primary care (32,130 pounds per QALY) when compared with no treatment. Comparison of the two active treatments showed that the additional gain associated with softeners followed by irrigation at primary care over softeners followed by self-irrigation was at a cost of 340,000 pounds per QALY. When compared over a lifetime horizon to the 'no treatment' option, the ICERs for softeners followed by self-irrigation and of softeners followed by irrigation at primary care were 24,450 pounds per QALY and 32,136 pounds per QALY, respectively. The systematic review found limited good-quality evidence of the safety, benefits and costs of the different strategies, making it difficult to differentiate between the various methods for removing earwax and rendering the economic evaluation as speculative. Although softeners are effective, which specific softeners are most effective remains uncertain. Evidence on the effectiveness of methods of irrigation or mechanical removal was equivocal. Further research is required to improve the evidence base, such as a RCT incorporating an economic evaluation to assess the different ways of providing the service, the effectiveness of the different methods of removal and the acceptability of the different approaches to patients and practitioners.

Ear drops for the removal of ear wax

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. To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. 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. 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. The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. 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. 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.

Ototoxicity of Triethanolamine Polypeptide (Cerumenex) in the Chinchilla

The use of earwax softeners and cerumenolytics to unblock the external auditory canal is increasing. Although reports on their effectiveness are available, data about their effect on hearing are limited. To assess the effect of ototopic triethanolamine polypeptide oleate condensate 10% (Cerumenex) on hearing. Prospective, randomized, controlled trial in a chinchilla animal model. Tympanostomy tubes were inserted in five chinchillas, and hearing was assessed with distortion product otoacoustic emissions (DPOAE) between 1 and 9 kHz prior to application and at days 1, 4, 30, and 100 postototopic application of Cerumenex. One ear received Cerumenex; the other ear served as control. Postmortem scanning electron microscopy was performed to assess the cochlear hair cells. A reduction in the mean DPOAE signal was shown in the ears treated with Cerumenex from the first day after treatment and throughout the study. Almost all tested frequencies were affected. Swelling, crusting, and fluid were observed in four of the five experimental ears. One animal also developed facial paralysis in the experimental side. Electron microscopy showed damage of the outer and inner hair cells in the Cerumenex-treated ears. In the chinchilla, when a tympanic perforation is present, Cerumenex causes a reduction in DPOAE signal and damage to the cochlear hair cells. Caution should be observed when prescribing this agent if the status of the tympanic membrane is unknown. Furthermore, its use without medical prescription should be discouraged because of the risk of ototoxicity and severe inflammatory reaction.

Randomized, Placebo-Controlled Evaluation of Cerumenex and Murine Earwax Removal Products

To evaluate the efficacy of 2 ceruminolytic products, Cerumenex Eardrops (Purdue Frederick Company, Norwalk, Conn) and Murine Ear Drops (Abbott Laboratories, Abbott Park, Ill), in subjects with partial or complete occlusion of the ear canal due to cerumen. Randomized, subject- and observer-blind, placebo-controlled, clinical trial. Corporate research clinic. From among 230 volunteers screened, 74 subjects (age, 22-66 [mean, 45] years) were enrolled in the study. Participants had baseline occlusion levels of mild (n = 10), moderate (n = 26), or complete (n = 38) impairment of tympanic membrane visualization. Subjects were randomly assigned to 1 of 3 treatments: Cerumenex (10% triethanolamine polypeptide oleate-condensate), Murine (6.5% carbamide peroxide), and a placebo, BSS Sterile Irrigating Solution (Alcon Laboratories Inc, Ft Worth, Tex). The test medication was instilled into 1 occluded ear for up to two 15-minute applications. Following the treatment, the subject's ear was irrigated with 50 mL of lukewarm water delivered at low pressure via a WaterPik irrigator equipped with a Grossan irrigator tip. Main Outcome Measure The degree of occlusion, measured against a previously established 4-point scale, was assessed and recorded at baseline and after each instillation and irrigation procedure. Neither Cerumenex nor Murine was superior to saline placebo. By the end of treatment, 29.2%, 15.4%, and 41.7% of subjects treated with Cerumenex, Murine, and placebo, respectively, experienced resolution of cerumen occlusion. These values were not statistically significantly different from one another. The currently marketed ceruminolytic products, Cerumenex and Murine, are no more effective than a saline placebo in removing earwax.

Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children

Context The efficacy of the variety of ceruminolytic agents used in clinical practice in children is not very well studied. Objectives To evaluate the efficacy of triethanolamine polypeptide and docusate as ceruminolytic agents in children with cerumen impaction. Design Randomized controlled trial. Setting Urban tertiary care children's hospital emergency department and general pediatric clinic. Participants 92 children aged 6 months to 5 years who presented as a convenience sample to either of the study sites with cerumen impaction. Intervention Children were computer randomized to receive 1-mL instillation of triethanolamine polypeptide, docusate, or saline placebo. The study drug was left in place for 15 minutes, then flushed with a standardized amount and technique of warm tap water up to two times. Main outcome measures Percentage of children in each group that had complete visualization of the tympanic membrane (light reflex, ossicles, and mobility). Results Groups were similar in age, race, sex, ear enrolled, wax consistency, and degree of obstruction. There was no statistical difference in the percentage of children who had complete resolution of cerumen impaction (docusate 53%, triethanolamine polypeptide 43%, and placebo 68%). Conclusion There was no difference between either of the two drugs used or placebo in alleviating cerumen impaction in children. Comment Earache is the fourth most common complaint of children who present to a pediatrician. The diagnosis of the various ear disorders requires careful history and examination of the ear canal and tympanic membrane. All too often, the pediatrician is frustrated by the inability to adequately examine the ear due to cerumen impaction. There are several studies of the agents used commonly in practice to alleviate cerumen obstruction,1.Jaffe G. Grimshaw J. A multicentric clinical trial comparing Otocerol® with Cerumol® as cerumenolytics.J Int Med Res. 1978; 6: 241-244Crossref PubMed Scopus (13) Google Scholar, 2.Fahmy S. Whitefield M. Multicentre clinical trial of Exterol® as a cerumenolytic.Br J Clin Pract. 1982; 36: 197-204PubMed Google Scholar, 3.Keane E.M. Wilson H. McGrane D. Coakley D. Walsh J.B. Use of solvents to disperse ear wax.Br J Clin Pract. 1995; 49: 7-12PubMed Google Scholar, 4.Lyndon S. Roy P. Grillage M.G. Miller A.J. A comparison of the efficacy of two ear drop preparations (Audax® and Earex®) in the softening and removal of impacted ear wax.Curr Med Res Opin. 1992; 13: 21-25Crossref PubMed Scopus (19) Google Scholar, 5.Meehan P. Isenhour J.L. Reeves R. Wrenn K. Ceruminolysis in the pediatric patient: a prospective, double-blinded, randomized controlled trial.Acad Emerg Med. 2002; 9: 521-522Crossref Google Scholar, 6.Singer A.J. Sauris E. Viccellio A.W. Ceruminolytic effects of docusate sodium: a randomized, controlled trial.Ann Emerg Med. 2000; 36: 228-232Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar but they include very few children. There is even a meta-analysis on the topic7.Burton M.J. Doree C.J. Ear drops for the removal of ear wax.The Cochrane Database of Systematic Reviews. 2003; Vol 1Google Scholar that shows heterogeneous effects based on the studies of low quality that existed before this study. This study sought to identify any differences in efficacy of the most commonly used agents, docusate, and triethanolamine polypeptide (Cerumenex). Their study design was sound, but found no difference between the two drugs studied, and even had a trend toward the saline control being more effective. Unfortunately, it was relatively underpowered with an 80% chance of finding a 40% difference between groups. Perhaps pediatricians would be happy deciding between the two alternatives if only a 10% to 20% difference existed. Detecting this difference would have required a much larger sample size to achieve (>300 in each group). In the meantime, pediatricians are left with their clinical judgment and experience in selecting from the variety of agents and procedures to clear ear wax for a good view.

Docusate sodium with irrigation was better than triethanolamine polypeptide with irrigation for dissolving earwax

Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann Emerg Med2000 Sep; 36 : 228 –32 [OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] QUESTION: Is a single...

Ceruminolytic Effects of Docusate Sodium: A Randomized, Controlled Trial

Study Objective: Assessment of the tympanic membrane is often impeded by the presence of cerumen. We compared the ceruminolytic effects of triethanolamine polypeptide and docusate sodium in patients with cerumen. Methods: We conducted a prospective, randomized, controlled, double-blind trial on a convenience sample of cooperative adult and pediatric patients presenting to a university-based emergency department who required removal of cerumen to visualize the tympanic membrane. Structured data collection was performed, and the physician determined whether visualization of the tympanic membrane was partially or totally obscured by cerumen (interobserver agreement, ρ=0.79). Patients received intra-aural instillation of 1mL of either docusate sodium or triethanolamine polypeptide in a liquid form. If not completely cleared within 15 minutes, the external ear canal was irrigated with 50 or 100 mL of normal saline solution and additional attempts to visualize the tympanic membrane were made. The main outcome was the proportion of ears in which the tympanic membrane could be totally visualized after ceruminolytic instillation with or without irrigation. This study had 80% power to detect a 40% difference between groups in the proportion of totally visualized tympanic membranes (χ2 test, α=.05). Results: Of 50 enrolled patients, 23 received triethanolamine polypeptide and 27 received docusate sodium. Mean patient age was 40 years (range 1 to 81 years); 35% were female. Groups were similar in age, sex, and proportion of completely obscured tympanic membranes at presentation (78%). The ability to completely visualize the tympanic membrane was significantly greater after treatment with docusate sodium versus triethanolamine polypeptide (81% versus 35%; difference in proportions 47%; 95% confidence interval [CI], 22 to 71) particularly in children aged 5 or less (90% versus 0%; difference in proportions 89%; 95% CI 50 to 100). Conclusion: Docusate sodium solution is a more effective ceruminolytic than triethanolamine polypeptide, allowing complete or partial visualization of the tympanic membrane in most patients after a single application when followed with irrigation. Use of docusate sodium as a ceruminolytic should be encouraged, particularly in children. [Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann Emerg Med. September 2000;36:228-232.]

A Better Way to Get the Wax Out

A number of solvents ranging from olive oil to hydrogen peroxide have been used to clear cerumen from the external auditory canal so that the tympanic membrane can be visualized in the ED. One of the most commonly used solvents is triethanolamine polypeptide (Cerumenex), …

A Clinical Comparison of Triethanolamine polypeptide oleate‐condensate Ear Drops with Olive Oil for the Removal of Impacted Wax

A Clinical Comparison of Triethanolamine polypeptide oleate‐condensate Ear Drops with Olive Oil for the Removal of Impacted Wax

Dermatitis venenata from cerumenex, a new otic solution.

Cerumenex is a cerumenolytic agent recently introduced for the softening and removal of ear wax. Its use has been recommended for routine aural hygiene of the infant and child, as well as for the removal of amniotic debris from the auditory canal of infants. 1,2 It is hoped that traumatic injury to the ear and its parts may be avoided by precluding instrumentation of the ear for this procedure. Cerumenex is composed of 10% cerapon in propylene glycol, with 0.5% chlorbutanol added as an antibacterial preservative. Cerapon is a triethanolamine polypeptide oleate condensate made by adding triethanolamine to the polypeptide oleate. 3 The otic solution is applied by instillation into the external auditory canal. A cotton plug then is inserted into the canal to keep the drops in place overnight. The next morning the ear canal is rinsed gently with lukewarm water from a soft rubber syringe. As little as