Complementary, Holistic, and Integrative Medicine: Therapies for Acute Otitis Media

Abstract

1. Cecilia Bukutu, PhD* 2. Janjeevan Deol* 3. Sunita Vohra, MD, FRCPC, MSc* 1. *Complementary and Alternative Research and Education (CARE) Program, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada Acute otitis media (AOM) is diagnosed frequently in early childhood; its peak incidence is between 6 and 15 months of age. (1) Streptococcus pneumoniae, Haemophilus influenzae , and Moraxella catarrhalis are the leading bacterial causes. Eighty percent of AOM cases resolve without treatment within 3 days. (2)(3) This high rate of spontaneous resolution along with variations in diagnostic criteria complicate studies of otitis media. Most cases of AOM are treated with antibiotics and pain relievers, but antibiotics may contribute to antimicrobial resistance or produce adverse effects (AEs) such as diarrhea. (4) These concerns, in part, have led some parents to turn to the use of complementary and alternative medicine (CAM) to treat childhood AOM. This review of published scientific literature examines some commonly used CAM therapies in the prevention and treatment of childhood AOM. ### Naturopathic Herbal Ear Drops (NHEDs) A Cochrane systematic review conducted in 2004 (4) assessed the effectiveness of NHEDs in the management of ear pain associated with AOM in two randomized, controlled trials (RCTs) (Table 1). The first study compared an NHED comprised of Calendula flores (marigold), garlic ( Allium sativum ), mullein ( Verbascum thapsus ), and St. John's wort ( Hypericum perfoliatum ) in olive oil with anesthetic eardrops. (5) The second study compared NHED (garlic, mullein, marigold, St John's wort, lavender, and vitamin E in olive oil) to anesthetic eardrops with and without antibiotics. (6) Findings from these trials point to NHEDs being modestly therapeutic for pain associated with AOM compared with anesthetic eardrops. However, the trials have some methodologic problems: lack of allocation concealment, power calculation, and intention-to-treat analysis. Two children dropped out of the first study because of the odor of NHED; no other AEs were documented. (5) The evidence regarding safety and efficacy of NHEDs seems promising. | Citation | Study Type | Population | Intervention | Outcomes | Results | Comments | |:-------------------------:| ---------------- | ---------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | Sarrell et al. (2001) (5) | Double-blind RCT | 103 children ages 6 to 18 y who had otalgia associated with AOM (Israel) | Group A: Naturopathic drops ( Allium sativum, Verbascum thapsus, Calendula flores, Hypericum perforatum in olive oil) Group B: Anesthetic ear drops (amethocaine, phenazone, glycerine) In both groups, drops instilled 3 times daily for 3 days At start, all children given a single dose of acetaminophen (15 mg/kg) | Severity and duration of pain Two visual (linear and color) analog scales used Ear pain assessed prior to treatment and at 15 and 30 min after treatment | NHED reduced pain as effectively as anesthetic ear drops Pain score improved throughout the course of the study period ( P =0.007) | Children older than the age group in which peak AOM incidence occurs (6 to 15 mo) 7 dropouts (2 did not like odor of the NHED, 5 for noncompliance) Randomization method not described | | Sarrell et al. (2003) (6) | Double-blind RCT | Ambulatory clinic, 171 children (5 to 18 y) who had otalgia associated with AOM (Israel) | Children randomized into 1 of 4 treatments and received eardrops 3 times daily for 3 days Group A: NHED alone ( Allium sativum, Verbascum thapsus, Calendula flores, Hypericum perfoliatum , lavender, and vitamin E in olive oil) Group B: NHED with oral amoxicillin (antibiotic) Group C: Anesthetic eardrops alone Group D: Anesthetic eardrops with oral amoxicillin (antibiotic) | As in Sarrell, 2001 | After 3 days, rate of pain reduction: Group A=95.9%, Group B=90.9%, Group C=84.0%, Group D=77.8% Pain was mostly (80%) self-limited and explained by the passage of time | Children older than the age group in which peak AOM incidence occurs (6 to 15 mo); thus, likely greater chance of spontaneous recovery | * AOM=acute otitis media, NHED= naturopathic herbal ear drops. RCT=randomized, controlled trial. Table 1. Clinical Trials of Naturopathic …