Cerumenolytic Efficacy of 2.5% Sodium Bicarbonate Versus Docusate Sodium: A Randomized, Controlled Trial

Abstract

Objectives: To evaluate the efficacy of 2.5% sodium bicarbonate and docusate sodium in patients with complete occlusion of the ear canal from impacted cerumen. Study Design: Randomized controlled trial. Method: We enrolled patients with unilateral complete cerumen occlusion of the ear canal that was unable to be removed using suction. Either 2.5% sodium bicarbonate or docusate sodium was applied and allowed to sit for 15 minutes. The ear canal was then cleaned under a microscope for up to 3 minutes until the tympanic membrane was completely visible. A second attempt with the same agent was performed in subjects in whom the first application was unsuccessful. The outcomes were compared between the two groups in terms of cleaning, the success rate, time taken to clean the canal, and adverse events. Results: There were 91 participants enrolled in this study. The mean age of the participants was 48.0 years. The patients’ demographic did not differ between the two groups. At the end of the treatment, the tympanic membrane was completely visible in 41 (91.11%) subjects treated with 2.5% sodium bicarbonate and 38 (82.61%) subjects treated with docusate sodium, with a 1.10 success ratio between the two groups (95% CI: 0.94–1.29, p = 0.23). The mean successful suctioning time was 103.61 seconds using 2.5% sodium bicarbonate and 124.13 using docusate sodium. The mean difference was 20.52 seconds (95% CI: –10.55–51.59). Conclusion: 2.5% sodium bicarbonate demonstrated non-inferior efficacy and safety compared with docusate sodium. We recommend using this agent in clinical practice. Trial Registration: Clinicaltrials.in.th/TCTR20160803001.

Cerumenolytics with or without manual extraction for impacted earwax: A network meta‐analysis of randomised clinical trials

“…Six hundred and thirteen articles were retrieved using the search strategy of which finally 26 17‐42 were included in the systematic review and 25 in the meta‐analysis (Figure 1) encompassing 3419 patients in total. One study could not be included in the meta‐analysis as the authors did not provide the exact numbers of patients with complete wax clearance after intervention.…”

Searching for the Holy Grail among ear drops

“…Studies compared the efficacy in unblocking impacted earwax or the effectiveness of ear syringing performed after administration of cerumenolytics. Docusate sodium appears to give better results than no treatment (OR 1.87; 95% CI: 0.79-4.42) 25 , while compared to 2.5% sodium bicarbonate it shows slightly less effectiveness (SR 1.10; 95% CI: 0.94-1.29) 30 . In contrast, a comparison of docusate sodium (presented under the trade name Colace®) to triethanolamine polypeptide (trade name Ceruminex®) shows that Ceruminex® might be slightly more effective than Colace® (RR 0.81; 95% CI: 0.38-1.72) 5,26,27,29 .…”

Novel In Vitro Intestinal Microbiome Model to Study Lipidomic and Metabolomic Adaptations Due to Exposure to Glyphosate, Perfluorooctanoic Acid, and Docusate Sodium

“…29,30 Finally, DOSS has been used for decades as an emulsifier in dairy products and salad dressings 31 as well as an effective dispersant in oil spills. 32 Additionally, DOSS is often prescribed in order to facilitate the removal of earwax 33 and as a stool softener when peristaltic stimulants are contraindicated due to safety (e.g., during pregnancy), 34−36 but evidence of its clinical efficacy is weak. Recently, adverse effects have been observed in in vivo laboratory models, 37−39 and it has been highlighted as a probable obesogen.…”

“…Nevertheless, their high thermal stability, long half-lives, novel alternative fluorinated replacements, and continued manufacture in other countries pose a high global contamination risk, with significant efforts being made to characterize the kinetics and potential routes of exposure, , profile new and legacy PFAS structures, , and reduce the continued PFAS influx from the waste stream into the environment. , Finally, DOSS has been used for decades as an emulsifier in dairy products and salad dressings as well as an effective dispersant in oil spills . Additionally, DOSS is often prescribed in order to facilitate the removal of earwax and as a stool softener when peristaltic stimulants are contraindicated due to safety (e.g., during pregnancy), − but evidence of its clinical efficacy is weak. Recently, adverse effects have been observed in in vivo laboratory models, − and it has been highlighted as a probable obesogen …”