How effective is docusate as a cerumenolytic agent?
David F. McAuley, Pharm.D.
GlobalRPh Inc.

     Cerumen composition is based primarily on the combination of secretions of both the sebaceous and ceruminous glands located in the external ear canal and the subsequent mixing with desquamated skin.1 Cerumen also mixes with water that is trapped in the ear canal. Its consistency and appearance varies widely depending upon the percentage of its different components and the time spent in the ear canal. Usually, harder cerumen is more likely to accumulate, however, does not warrant removal unless the patient has a specific complaint.1 
  
     Problems attributed to the accumulation of ear wax are one of the most common reasons for patients with ear trouble to present to their physician.2 In children, cerumen obstructing the ear canal can make visualization of the tympanic membrane difficult, if not impossible and represents a significant problem with the examination of children with febrile illnesses.3,4  In addition, impacted cerumen can cause ear canal irritation, vertigo, hearing loss and may contribute to infection.4,5 Various methods have been used to remove cerumen, including irrigation, suction, and manual removal with a curette.6 Several studies have assessed the effectiveness of softening the cerumen with agents such as olive oil, sodium bicarbonate, docusate sodium, para-dichlorobenzene, hydrogen peroxide, and triethanolamine polypeptide. Many of these studies had limited strength due to lack of a comparison group or limited patient enrollment.The treatment of this condition often involves the use of a wax softening or cerumenolytic before syringing. Use of a cerumenolytic reduces or eliminates the need for syringing.5 
  
     Several studies have found docusate sodium to be very effective as a cerumenolytic and in some cases superior to other agents. Here is a summary of the findings: 

     S. Wilson reported in 2002 that the best treatment for impacted cerumen based on the available evidence is docusate sodium given 15 minutes before irrigation. He stated that this particular intervention: “Is the most effective for facilitating cerumen removal during a single office visit based on head-to-head trials that lacked irrigation only arms.” Triethanolamine polypeptide (Cerumenex®) and olive oil were the next most effective treatments. Carbamide peroxide (Debrox®) was the least effective. The author also stated that until more placebo-controlled data are generated, recommendations should be based on relative safety and on the direct comparison trials. Complications of irrigations may include otitis externa, perforation, canal trauma, pain, tinntus, vertigo, otitis media, and treatment failure. Injury or harm due to wax softeners is minimal.7   

     Singer and associates compared the ceruminolytic effects of a single application of docusate sodium +/- irrigation, with the application of the commonly used triethanolamine polypeptide (Cerumenex®) in a randomized, double-blind test (n=50 adult and pediatric patients).4,8,9 The physician instilled 1 mL of either docusate sodium or triethanolamine polypeptide in the affected ear and the patient remained on his or her side with the affected ear upward for 10 to 15 minutes. The ceruminolytic agent was allowed to drain by gravity. If the tympanic membrane was still obscured, irrigation with normal saline was performed and repeated x 1 if necessary. The tympanic membrane was visualized immediately in 5 (19 %) of the 27 patients who received docusate sodium and in 2 (9 %) of the 23 who received triethanolamine polypeptide. Although this difference was not significant, the added number of tympanic membranes that were visible after the first or second irrigation was significantly higher in the docusate sodium group. No adverse events were reported with either group. Authors’ conclusion: docusate sodium is superior to triethanolamine polypeptide as a ceruminolytic agent.8 Docusate was approximately twice as effective.9 This finding was even more pronounced in study subjects who were younger than five years.8 Masterson E and Seaton TL stated that this study was not designed to evaluate the efficacy of ceruminolytics on a chronic basis. They also stated that generic docusate liquid is less expensive than triethanolamine polypeptide. One pint (480 doses) of docusate sodium costs approximately $7.00 compared with $2.50 for 15 ml of generic triethanolamine polypeptide.10   
     
     G. Somerville performed a mini-review in 2002 of the available literature to find out what was the best preparation to use before syringing to facilitate cerumen removal. 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 were found along with seven in vitro studies that focused on efficacy of a range of products. The author stated that the randomized controlled trials did not show any one product to be more effective. Many of the studies suffered from a lack of information such as side effect reporting, or impact of syringing. Three randomized controlled trials found that docusate sodium was more effective than Cerumol and triethanolamine polypeptide. Implications: The author states that the evidence was not adequate to determine the most effective preparation.5 
  
     Whatley et al evaluated the efficacy of docusate sodium, triethanolamine polypeptide, and normal saline as a control, +/- irrigation in removing cerumen obstruction in children. Study design:  randomized, controlled, double blind trial. (n=92) aged 6 months through 5 years. One ml of docusate sodium, triethanolamine polypeptide, or normal saline as control was placed into the patient's ear canal. If the tympanic membrane was not completely visualized after 15 minutes, the ear was irrigated with 50 mL of tepid water. Irrigation was repeated a second time if needed. Results: Of 92 patients, 34 received docusate sodium; 30, triethanolamine polypeptide; and 28, saline. Groups were similar in age, race, sex, earwax consistency, and degree of obstruction. There was no significant difference in the proportion of tympanic membranes completely visualized after treatment with docusate (18/34; 53%), triethanolamine polypeptide (13/30; 43%), or saline (19/28; 68%). Study conclusion: None of the agents significantly improved the proportion of tympanic membranes that were completely visualized versus application of the saline control.3



Conclusion
     Docusate sodium represents a very cost effective alternative to facilitate the removal of cerumen, although more studies are needed to determine the best approach to treatment. Available evidence supports the use of a cerumunolytic over multiple irrigations in order to help reduce potential complications such as perforation, canal trauma, pain, tinntus, vertigo, or otitis media.7 However, Ceruminolytics should be avoided if the status of the tympanic membrane is unknown.
  

References
1) Dinces EA. Cerumen. UptoDate in Otolaryngology. 2005:13(2). 
  
2) Burton MJ, Doree CJ. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2003;(3):CD004400. 
  
3) Whatley VN, Dodds CL, Paul RI. Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1177-80. 
  
4) Sadovsky R. Docusate Sodium for Use as a Ceruminolytic Agent. Amer Fam Phys. 2001 Mar;63(5):947. 
  
5) Somerville G. The most effective products available to facilitate ear syringing. Br J Community Nurs. 2002 Feb;7(2):94-101. 
  
6) Miller KE. What Is the Best Way to Remove Cerumen in Children? Amer Fam Phys. 2004 Jul;70(1):p188-89. 
  
7) Wilson, SA. What is the best treatment for impacted cerumen? Jour of Fam Pract. 2002 Feb;51(2):117. 
  
8) Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann Emerg Med. 2000 Sep;36(3):228-32. 
  
9) Klasco RK (Ed): DRUGDEX® System. Thomson Micromedex, Greenwood Village, Colorado (Edition expires [Nov 2005]).


10) Masterson E, Seaton TL. How does liquid docusate sodium (Colace) compare with triethanolamine polypeptide as a ceruminolytic for acute earwax removal? Journ of Fam Pract. 2000 Dec;49(12):1076.

 

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