Naturopathic ear drops minimally effective for acute otitis media

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Naturopathic ear drops minimally effective for acute otitis media

J Fam Pract. 2003 September;52(9):664-688

By

David L. Fay, MD

Kenneth G. Schellhase, MD, MPH

Daniel Wujek, MD

BACKGROUND: Given evidence suggesting that antibiotics provide little benefit for most children with acute otitis media, recent studies have focused on effective, safe analgesics to ease pain while awaiting spontaneous resolution. This study examined the effectiveness of naturopathic herbal ear drops for relieving otalgia as compared with traditional analgesics, with and without antibiotics.
POPULATION STUDIED: The study enrolled 180 children in Israel aged 5 to 18 years who presented with ear pain and were found to have acute otitis media. Acute otitis media was diagnosed if middle-ear effusion was present (decreased mobility with pneumatic otoscopy or tympanogram, or visible bubbles or air-fluid level) with at least 1 other marker of inflammation (marked redness, distinct fullness, or bulging of the tympanic membrane).
STUDY DESIGN AND VALIDITY: Subjects were randomly assigned to 1 of 4 groups. Group A received naturopathic herbal ear drops (abstracts of Calendula officinalis [marigold] flores, Hypericum perforatum [St. John’s wort] herba tota, and Verbascum thapsus [mullein] flores in olive oil and the essential oils Allium sativum [garlic], Lavandula officinalis [lavender], and tocopherol acetate [vitamin E]), 5 drops 3 times daily. Group B received herbal ear drops with amoxicillin 80 mg/kg/d, divided into 3 doses. Group C received a topical anesthetic (amethocaine and phenazone) 5 drops 3 times daily. Group D received topical anesthetic with amoxicillin. Herbal ear drops and anesthetic drops were given at the time of diagnosis and then in the morning of 2 subsequent days.
OUTCOMES MEASURED: Ear pain was assessed using the Pain-O-Meter, a visual analog scale devised by the authors. Pain measurements were taken each day at the time drops were instilled, then 15 and 30 minutes later.
RESULTS: Otalgia was reduced by 93% in the groups using naturopathic herbal ear drops with or without antibiotics, and 81% in the groups using anesthetic drops with or without antibiotics; the authors don’t indicate whether this difference was statistically significant. Linear regression analysis showed that time alone accounted for 78% of the pain reduction, whereas naturopathic herbal ear drops accounted for 7.3% (P=.0001).

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Naturopathic ear drops minimally effective for acute otitis media

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