Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products

Peter S. Roland, Debbie Anderson Eaton, Robert D. Gross, G. Michael Wall, Peter J. Conroy, Rekha Garadi, Laura LaFontaine, Susan Potts, Gail Hogg

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objective: 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. Design: Randomized, subject- and observer-blind, placebo-controlled, clinical trial. Setting: Corporate research clinic. Participants: 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. Interventions: 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. Results: 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. Conclusion: The currently marketed ceruminolytic products, Cerumenex and Murine, are no more effective than a saline placebo in removing earwax.

Original languageEnglish (US)
Pages (from-to)1175-1177
Number of pages3
JournalArchives of Otolaryngology - Head and Neck Surgery
Volume130
Issue number10
DOIs
StatePublished - Oct 2004

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Placebos
Cerumen
Ear
Tympanic Membrane
Ear Canal
Controlled Clinical Trials
Volunteers
Therapeutics
Outcome Assessment (Health Care)
trolamine polypeptide oleate-condensate
Pressure
Water
Research

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

Roland, P. S., Eaton, D. A., Gross, R. D., Wall, G. M., Conroy, P. J., Garadi, R., ... Hogg, G. (2004). Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. Archives of Otolaryngology - Head and Neck Surgery, 130(10), 1175-1177. https://doi.org/10.1001/archotol.130.10.1175

Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. / Roland, Peter S.; Eaton, Debbie Anderson; Gross, Robert D.; Wall, G. Michael; Conroy, Peter J.; Garadi, Rekha; LaFontaine, Laura; Potts, Susan; Hogg, Gail.

In: Archives of Otolaryngology - Head and Neck Surgery, Vol. 130, No. 10, 10.2004, p. 1175-1177.

Research output: Contribution to journalArticle

Roland, PS, Eaton, DA, Gross, RD, Wall, GM, Conroy, PJ, Garadi, R, LaFontaine, L, Potts, S & Hogg, G 2004, 'Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products', Archives of Otolaryngology - Head and Neck Surgery, vol. 130, no. 10, pp. 1175-1177. https://doi.org/10.1001/archotol.130.10.1175
Roland, Peter S. ; Eaton, Debbie Anderson ; Gross, Robert D. ; Wall, G. Michael ; Conroy, Peter J. ; Garadi, Rekha ; LaFontaine, Laura ; Potts, Susan ; Hogg, Gail. / Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. In: Archives of Otolaryngology - Head and Neck Surgery. 2004 ; Vol. 130, No. 10. pp. 1175-1177.
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abstract = "Objective: 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. Design: Randomized, subject- and observer-blind, placebo-controlled, clinical trial. Setting: Corporate research clinic. Participants: 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. Interventions: 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. Results: 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. Conclusion: The currently marketed ceruminolytic products, Cerumenex and Murine, are no more effective than a saline placebo in removing earwax.",
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AU - Garadi, Rekha

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