Naturopathic ear drops minimally effective for acute otitis media

Journal of Family Practice, Sept, 2003 by David L. Fay, Kenneth G. Schellhase

Sarrell EM, Cohen HA, Kahan E. Naturopathic treatment for ear pain in children. Pediatrics 2003; 111:e574-579.

* PRACTICE RECOMMENDATIONS

In children aged 5 to 18 years with acute otitis media, naturopathic herbal ear drops accounted for a small change in reported otalgia over 48 hours.

This study does not provide strong evidence for using naturopathic herbal ear drops in the studied population, let alone the population we most often see with otalgia due to acute otitis media: infants aged 6 to 24 months. Since no adverse events were reported, it seems reasonable to allow parents this option if they desire a nonpharmacologic analgesic--although the study does, once again, point out that time is often the best treatment for acute otitis media.

* 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).

The investigators excluded patients who had been treated with any ear drop or analgesic within 4 hours of the exam; children with otorrhea, ear drum rupture, or ventilation tubes; or complications of ear disease in the past 2 weeks.

* 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 off 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.

This study had several weaknesses. Though the study was performed in children aged 5 to 18 years, the vast majority of acute otitis media occurs in children aged 6 to 24 months, and these results may not apply to younger children. The study was not truly double-blinded, as children were not given an oral placebo. This might lead to overestimating the effect of the drops in those receiving antibiotics, since this group may believe more strongly that they were improving.

The authors did hot use an intention-to-treat analysis, as only 171 of 180 enrollees were analyzed; 9 children were removed from analysis after randomization due to noncompliance. Intention-to-treat analysis is important because it preserves the baseline comparability between groups at randomization, and more realistically reflects the performance of a given treatment in actual practice, where compliance is never 100%.

Pain was assessed with an unvalidated visual analog scale. The major finding of the study--that those given ear drops alone had statistically significantly greater pain relief than those receiving drops and antibiotics--was reported in the discussion; the actual results were hot presented.

* 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).

David L. Fay, MD, Kenneth G. Schellhase, MD, MPH, and Daniel Wujek, MD, Department of Family and Community Medicine, Medical College of Wisconsin, Milwaukee. E-mail: david.fay@phci.org.