Objective: To determine the efficacy and tolerance of Otikon Otic Solution (Healthy-On Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (containing Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum perforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical Ltd, Benyamina, Israel) ear drops (containing ametocaine and phenazone in glycerin) in the management of ear pain associated with acute otitis media (AOM).
Design: Children between the ages of 6 and 18 years who experienced ear pain (otalgia) and who were diagnosed with eardrum problems associated with AOM were randomly assigned to be treated with Otikon or Anaesthetic ear drops, which were instilled into the external canal(s) of the affected ear(s). Ear pain was assessed using 2 visual analog scales: a linear scale and a color scale. Pain assessment took place throughout the course of 3 days. The mean score of pain reduction was used to measure outcome.
Setting: Primary pediatric community ambulatory centers.
Participants: One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM.
Results: Each of the 2 treatment groups were comparable on the basis of age, sex, laterality of AOM, and the effectiveness of ameliorating symptoms of otalgia. The 2 groups were also comparable to each other in the initial ear pain score and in the scores at each application of Otikon or Anaesthetic drops. There was a statistically significant improvement in ear pain score throughout the course of the study period (P =.007).
Conclusions: Otikon, an ear drop formulation of naturopathic origin, is as effective as Anaesthetic ear drops and was proven appropriate for the management of AOM-associated ear pain.