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Efficacy of Naturopathic Extracts in the Management of Ear Pain Associated With Acute Otitis Media
E. Michael Sarrell, MD;
Avigdor Mandelberg, MD;
Herman Avner Cohen, MD
Arch Pediatr Adolesc Med. 2001;155:796-799.
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.
From the Pediatric and Adolescent Ambulatory Community Clinic of General
Health Services (Drs Sarrell and Cohen) and the Department of Family Medicine
(Drs Sarrell, Mandelberg, and Cohen), Sackler School of Medicine, Tel-Aviv
University, Tel-Aviv, Israel; and the Department of Pulmonary Medicine and
Pediatrics, Edith Wolfson Medical Center, Holon, Israel (Dr Mandelberg).
Corresponding author: E. Michael Sarrell, MD, Hairis 7 Moshav Gan-Haim,
44910 Israel (e-mail: sarrell{at}netvision.net.il).
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