Study Question: Are naturopathic herbal extract ear drops effective in the treatment of ear pain in children?

Setting: Outpatient (primary care)

Study Design: Randomized controlled trial (double-blinded)

Synopsis: Most cases of otitis media in children resolve without treatment. The main issue is pain management. Children five to 18 years of age who had ear pain were randomized (allocation concealed) to one of four treatment groups: (1) naturopathic herbal extract ear drops (n = 44); (2) naturopathic herbal extract ear drops plus amoxicillin (n = 42); (3) anesthetic ear drops (n = 42); or (4) anesthetic drops plus amoxicillin (n = 43). Ear drop assignment was double-blinded, but use of amoxicillin was open label.

A diagnosis of acute otitis media was a criterion for study entry. The methodology for making the diagnosis was not too convincing but was similar to what happens in usual primary care practice. The outcome of interest was pain, which was measured adequately.

Drops and oral medications were used three times daily for three days. Patients assessed their own pain using a 10-point visual analog scale three times each day of the study, before instilling the drops and 15 and 30 minutes after. All groups experienced at least a 3-point mean decrease in pain 30 minutes after the first instillation of ear drops. All groups had similar improvement, with resolution of pain within three days.

Bottom Line: Naturopathic ear drops work as well as anesthetic ear drops in the treatment of ear pain in children. Antibiotic treatment provides no additional reduction in pain. It would be interesting to see the results of a well-designed, placebo-controlled trial of acetaminophen versus ear drops for pain management. (Level of Evidence: 1b)