Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Abstract

We evaluated the efficacy over a short period of time of two ceruminolytic products, Otocerum (chlorobutanol, phenol, turpentine essence, ethyl alcohol; Reig Jofre Laboratories, Barcelona, Spain) and Taponoto (potassium carbonate, ethyl alcohol, glycerol, thymol; Teofarma Iberica SA, Barcelona), in adult subjects with complete occlusion of the ear canal due to cerumen. Ninety subjects with complete occlusion of the ear canal were enrolled in a randomized, subject- and observer-blinded, placebo-controlled clinical trial. The subjects were randomly assigned to one of three different treatments: Otocerum, Taponoto, or sterile saline solution (control group). The test medication was instilled into an occluded ear for 15 minutes. After this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes completely visualized after treatment. One subject among the 90 enrolled did not accept a second ear irrigation and was excluded from the study. Neither Otocerum nor Taponoto was superior to saline solution. Cerumen occlusion resolved in 21 of 32 subjects treated with Otocerum (65.6%), 16 of 29 treated with Taponoto (55.2%), and 12 of 28 treated with saline solution (42.9%). The use of Taponoto or Otocerum did not significantly improve the proportion of tympanic membranes that were completely visualized compared with saline solution when they were instilled 15 minutes before ear irrigation.