Reviewed: Sarrell EM, Mandelberg A, Cohen HA. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Arch Pediatr Adolesc Med. 2001 155:796-9.

Summary: Children ages 6-18 years with a diagnosis of acute otitis media (middle ear infection) and associated ear pain (otalgia) were recruited for a study comparing the effects of a "naturopathic" herbal ear drop product (Otikon Otic Solution, Healthy-On Ltd., Petach-Tivka, Israel) with standard anesthetic ear drops (Vitamed Pharmaceutical Ltd., Benyamina, Israel) for the symptomatic treatment of the ear pain. The herbal ear drops contained a combination of garlic (Allium sativum L., Liliaceae), mullein (Verbascum thapsus L., Scrophulariaceae), calendula (aka marigold, Calendula officinalis L., Asteraceae), and St. John’s wort (Hypericum perforatum L., Clusiaceae) in a base of olive oil (Olea europaea L., Oleaceae) (the part of the plant used is not listed in the paper, so it is not clear whether mullein leaf or flower was used; traditionally, mullein flower is used for earache and related ailments, the leaf for pulmonary indications). The anesthetic drops were a combination of the drugs ametocain and phenazone in glycerin. One hundred and ten children were randomized to treatment with either the herbal drops or anesthetic drops — five drops to the external canal of the affected ear three times per day. Children in the study received no antibiotic treatment. A single dose (15 mg) of acetaminophen was administered at the beginning of the trial, but parents were instructed to use no other analgesics for the remainder of the study.

The first data point (pain scores) was assessed at the diagnosis of acute otitis media (AOM). After instillation of either the herbal or anesthetic ear drops, the patients and parents, under the guidance of the physician, recorded the pain scores at 15 and 30 minutes following administration. At days 2 and 3, pain scores were recorded at home. Pain scores were completed prior to the first daily administration of the eardrops and at 15 and 30 minutes after the eardrops were administered. Ear pain was assessed using the Observational Scale of Behavioral Distress (the Pain-O-Meter). On one side of the Pain-O-Meter are a linear scale (1–10) and a color scale ranging from blue (indicating no pain) to red (indicating the most pain). On the reverse side of the card is a face scale that is composed of five facial representations ranging from a broad smile (no pain) to a sad and crying child (indicating the worst pain). Entry in the study required a pain score of at least 3 out of 10 on the linear scale. Success was determined if the child had a reduction in ear pain of at least 75 percent after 48 hours and there was improvement in the child’s appearance, activity, and quality of sleep.

One hundred and three children completed the study. Five children were excluded due to noncompliance and two who did not like the smell of the eardrops and refused to have them administered. Sixty-one children (59.3 percent) received the herbal ear drops and 42 children (40.7 percent) the anesthetic ear drops. Compared to baseline, children in both groups had a statistically significant (p = 0.007) reduction in ear pain scores. The difference in the mean pain levels between the two groups was not statistically significant, although there was less pain at the 30-minute evaluation on day 1 in the group using the herbal ear drops. All children were effectively treated with the eardrops and there were no observed complications even though systemic antibiotics were not used.

Comments/Opinions: With an estimated 31 million physician visits reported each year, otitis media is the most common condition in children seen by health care professionals in the United States.¹ AOM has a peak incidence in children between the ages of 6 and 18 months and, by 7 years, 93 percent of all U.S. children will have had at least one diagnosed episode of AOM.² The majority of children with AOM experience an earache.

While antibiotic therapy has become a standard approach to treating AOM, many pediatricians will recommend acetaminophen and/or anesthetic eardrops to reduce ear pain during the first few days of the infection. These eardrops (such as the standard mixture used in this clinical trial) have a localized anesthetic, anti-inflammatory, and analgesic action on the tympanic membrane (the eardrum). Additionally, glycerin may decrease middle ear pressure by reducing fluid build-up via osmosis.

Completed by clinical researchers at Tel-Aviv University and the Edith Wolfson Medical Center in Holon, Israel, this study indicates that a traditional combination of herbs in an olive oil base is as effective as standard anesthetic ear drops in the symptomatic treatment of ear pain associated with AOM. While the results of the study suggest that the herbal ear drops may have been more effective at the 30-minute evaluation on day 1 of the study, readers should note that acetaminophen absorption rates range from 23 to 60 minutes.³ Considering the initial timing of the single acetaminophen dose, this comparison becomes somewhat cloudy.

While subjective evaluation of pain was the clear focus of the study, it is unclear how the investigators determined there were no complications due to the infection. The researchers correctly point out that children older than 6 years old have a greater chance of spontaneous recovery from AOM without using antibiotics. However, any practitioner would expect that this be based on follow-up evaluation of the child’s affected ear and not based solely on subjective feedback of patients or parents. In addition to evaluation at 3 days, follow-up evaluation of the tympanic membrane to rule out fluid build-up in the middle ear (otitis media with effusion) would be critical to determining success with or without antibiotic therapy.

Concerns with study design aside, the clinical trial does provide some support for a clinical tool used widely by practitioners of herbal medicine (including naturopathic physicians and medical doctors using complementary and alternative therapies) for the management of pain associated with AOM. During my seven years of pediatric practice, I frequently recommended that parents administer a similar herbal eardrop preparation (Mullein Garlic Compound, HerbPharm, Williams, Oregon) for children during the first 48 hours of an AOM episode. In addition to the older age group in the Israeli trial, I found the drops to be equally effective for pain reduction in younger children. The upside of the pain reduction was not only happier kids, but also reduced use of acetaminophen (not to mention more relaxed parents).

The herbs used in the Israeli product and similar products in the U.S. are based on traditional use. Calendula (marigold) flowers have been traditionally used topically as an anti-inflammatory and for wound healing.⁴ Mullein flowers and leaves, because of high mucilage content, act as a demulcent to soothe irritated mucous membranes internally and as an emollient topically to treat skin irritations and minor burns.⁵ Although more commonly associated with its use as an antidepressant, St. John’s wort flowering tops have also been used topically to reduce "nerve pain" and inflammation.⁶ Garlic bulbs are thought to have topical antimicrobial effects — an action that has been demonstrated in vitro.⁷

While the herbal combination used in this trial apparently provides symptomatic relief of ear pain associated with AOM, the investigators in the discussion section of the paper fuel the controversy surrounding the rampant use of antibiotics for AOM. The authors of the study suggest that in children older than 6 years, initial antibiotic treatment at the diagnosis of AOM be withheld until follow-up (exact amount of time is not given). If no improvement is noted, they suggest then using antibiotics.

Practice Implications: Herbal ear drops containing a combination of mullein, calendula (marigold), St. John’s wort, and garlic in an olive oil base may reduce ear pain associated with AOM as effectively as standard anesthetic ear drops. However, recommendation of these drops should be made only following otoscopic examination of the tympanic membrane and the absence of any rupture that would allow the drops to enter the middle ear. It should be noted that these drops are only for symptomatic treatment and do not exclude the potential need for antibiotic treatment and/or other supportive therapies.

Reference:

1. Fliss DM, Leiberman A, Dragan R. Medical sequelae and complications of acute otitis media. Pediatr Infect Dis 1994;13(suppl1):S34-S40.

2. Klein JO, Teele DW, Pelton SI. New concepts in otitis media: results of the Greater Boston Otitis Media Study Group. Adv Pediatr 1992;39:127-56.

3. Watson PD, Mortensen ME. Pharmacokinetics of common analgesics, anti-inflammatories and antipyretics in children. Clin Pharmacokinet 1989;17(suppl 1):116-37.

4. Leung A, Foster S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics, 2nd ed. New York: John Wiley & Sons; 1996. p. 113-4.

5. Hoffmann D. The Herbal Handbook: A User’s Guide to Medical Herbalism. Rochester, VT: Healing Arts Press; 1998. p. 67.

6. Hobbs C. St. John’s wort (Hypericum perforatum L.): A review. HerbalGram 1988/1989;18/19:24-33.

7. Hughes BG, Lawson LD. Antimicrobial effects of Allium sativum L. (garlic), Allium ampeloprasum L. (elephant garlic) and Allium cepa L. (onion), garlic compounds and commercial garlic supplement products. Phytother Res 1991;5:154-8.

Clinical Updates are reproduced from HerbalGram, the Journal of the American Botanical Council (ABC) (www.herbalgram.org). ABC, based in Austin, Texas, is an independent, member-based, nonprofit, herbal medicine education and research organization serving the public, researchers, and the herbal community since 1988.