Naturopathic Drops for Otalgia
With Comments from Russell H. Greenfield, MD
Source: Sarrell EM, et al. Naturopathic treatment for ear pain in children. Pediatrics 2003;111:e574-e579.
Goal: To compare the effectiveness of a specific naturopathic remedy vs. conventional therapy in the management of ear pain associated with acute otitis media (AOM) in children, both with and without antibiotics.
Design: Double-blind, randomized trial.
Subjects: Of the 180 children aged 5-18 years presenting with ear pain secondary to AOM, nine subjects were excluded due to noncompliance with protocol.
Methods: Subjects were randomly assigned to one of four treatment regimens. Group A received Naturopathic Herbal Extract Ear Drops (NHED) 5 drops three times daily; Group B received NHED along with oral amoxicillin 80 mg/kg/d; Group C received topical anesthetic drops (amethocaine plus phenazone in glycerin); Group D received the topical anesthetic drops plus oral amoxicillin 80 mg/kg/d. Treatment was initiated by a nurse. The presence or absence of pain was evaluated at specified times over the course of three days using a child-appropriate Visual Analog Scale (VAS). Physician follow-up with the children’s parents occurred 24 and 48 hours after initiation of treatment.
Results: Subjects in all four groups experienced an improvement in pain over the course of three days (no subject had clinically significant ear pain after the third day of follow-up). Rates of pain reduction for each group were: Group A (NHED) 95.9%; Group B (NHED plus amoxicillin) 90.9%; Group C (anesthetic drops) 84.7%; Group D (anesthetic drops plus amoxicillin) 77.8%. The NHED group experienced less pain than the group receiving anesthetic drops on days 2 and 3.
Conclusion: A specific naturopathic herbal extract solution can provide pain relief to children with AOM. Concomitant antibiotic therapy does not contribute to pain relief.
Study strengths: Use of child appropriate VAS; close follow-up.
Study weaknesses: One physician (the lead author) evaluated and treated all subjects, instructed children in the use of the VAS, and recorded all data; mean age of patients was almost 7 years; no mention of duration of symptoms at time of presentation, or means of ensuring adherence to protocol.
Of note: The NHED contained Verbascum thapsus, Calendula officinalis, Hypericum perforatum, olive oil, vitamin E oil, and essential oils of garlic and lavender; those who received either set of ear drops alone fared better than when amoxicillin was added.
We knew that: Nearly all U.S. children (93%) have been diagnosed with at least one episode of AOM by the time they reach age 7.
Clinical import: As has come to light in recent years, children with AOM often do not require antibiotic therapy, provided close follow-up is secured. Any parent who has witnessed their son or daughter holding their ear and crying in pain, however, knows the first order of business is to make their child comfortable. Although this study contains significant flaws, it does suggest that NHED may be of use in relieving the pain of AOM for some children. The study also supports the widely held belief, based on experience, that ear pain associated with AOM most often is self-limited.
What to do with this article: Keep a copy of the abstract on your computer.
Dr. Greenfield, Medical Director, Carolinas Integrative Health, Carolinas HealthCare System, Charlotte, NC, is Executive Editor of Alternative Medicine Alert.
Greenfield RH. Naturopathic Drops for Otalgia. Altern Med Alert 2003;6(8):95-96.
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