Em. Sarrell et al., Efficacy of naturopathic extracts in the management of ear pain associatedwith acute otitis media, ARCH PED AD, 155(7), 2001, pp. 796-799
Objective: To determine the efficacy and tolerance of Otikon Otic Solution
(Healthy-On Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (cont
aining Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum p
erforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical
Ltd, Benyamina, Israel) ear drops (containing ametocaine and phenazone in g
lycerin) 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 pai
n (otalgia) and who were diagnosed with eardrum problems associated with AO
M 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). E
ar pain was assessed using 2 visual analog scales: a linear scale and a col
or scale. Pain assessment took place throughout the course of 3 days. The m
ean 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 diagno
sed 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 ea
r 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 manag
ement AOM-associated ear pain.