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

Abstract

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.

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

“…In the Roland and colleagues 62 RCT, rates of related AEs were low in all groups. One participant in the TP group and two in the Murine group had ear pruritis.…”

“…a Control arm with no treatment not included. 46 Whatley and colleagues, 47 Singer and colleagues, 49 Pavlidis and Pickering, 42 Amjad and Scheer, 51 Lyndon and colleagues, 45 Saloranta and colleagues a , 58 Roland and colleagues, 62 Fraser, 60 Dubow, the arms in the trial was a self-syringing group and this may also explain the higher number of AEs in the study. If this study was excluded then the probability of minor AEs would fall to 3.05% for the remaining included studies.…”

“…In some studies the overall population sample size was not reported, rather the numbers of ears were presented. 42,43,60 Seventeen studies were two-arm comparisons, [41][42][43][44][45][48][49][50][51][52][53][54]56,58,59,63,64 five were three-arm studies, 46,47,55,57,62 and there was one study each with four, 4 five 61 and six 60 intervention arms.…”

“…One RCT 62 was undertaken in a corporate research clinic in adult volunteers with excessive or impacted cerumen on examination ( Table 15). The study compared TP, Murine and placebo with saline, and follow-up was immediate.…”

“…63 The higher incidence of AEs in this study, especially for discomfort and dizziness suggest a more sensitive inclusion of AEs than the other studies. 63 One of 76 Coppin and colleagues, 63 Meehan and colleagues, 46 Whatley and colleagues, 47 Singer and colleagues, 49 Pavlidis and Pickering, 42 Amjad and Scheer, 51 Lyndon and colleagues, 45 Saloranta and colleagues a , 58 Roland and colleagues, 62 Fraser, 60 Dubow, 57 Harris 64 AEs, adverse events. a Control arm with no treatment not included.…”