Homeopathy for acute otitis media—time for a definitive trial

This issue of Homeopathy contains yet another study which adds to the evidence base regarding the effectiveness of homeopathy in treating acute otitis media (AOM).[ ¹ ] In a well-designed investigation, Sinha and colleagues from two Indian research institutions found that homeopathic treatment alone is as effective as the delayed antibiotic strategy in treating AOM. More importantly, their results confirmed those of two previous studies which found faster symptom relief in those receiving homeopathic treatment.[ ^2,3 ]

Although there was no placebo control group, the Sinha study had several strengths. The most important was the involvement of an ENT specialist, who evaluated the tympanic membrane (TM) of all subjects to determine eligibility for inclusion. This adds a greater degree of rigor to the study results, since the diagnosis of AOM is difficult for most general physicians. This specialist, who was blinded as to treatment allocation, also evaluated the TMs at each of the 3, 7, 10, and 21 day follow-ups. While the AOM symptom scores might be seen as subjective and could be reported differently by parents of those who received homeopathy versus conventional treatment, the objective analysis of the TM by a blinded (no pun intended) ENT specialist cannot be questioned.

Other strengths of the study include individualized homeopathic treatment, an intention-to-treat analysis with last value carried forward in those lost to follow-up, and a stringent definition of “cure”. The lack of a placebo control group means that this study will not be taken seriously by those who question the efficacy of homeopathy. However, the finding of an equivalent “cure” rate in patients treated with homeopathy compared to those receiving antibiotics is an important first step. I suspect that if comparable results were found using an allopathic alternative to antibiotics for AOM, a study such as this would be published in a top-ranked peer-review medical journal and we might be reading about it in the popular press.

The overuse of antibiotics for AOM, comprising 60% of all antibiotic prescriptions in pediatric patients, is a major public health problem.[ ⁴ ] While the majority of cases of AOM are viral in nature, antibiotics continue to be prescribed by many physicians for this illness, often to allay parental anxiety. Studies suggest that AOM recurs more frequently in those treated with antibiotics.[ ⁵ ] This also leads to increased antibiotic resistance.[ ⁶ ] While the American Academy of Pediatrics (AAP) urges its members to delay treatment with antibiotics and to treat ear pain conservatively with analgesics, ear drops, etc., only 15% of pediatricians have been found to utilize this strategy.[ ⁷ ]

We now have evidence from three separate studies that homeopathic treatment gives relief from AOM symptoms, including pain, and that this symptom relief is most significant during the first three days of the illness.[ ^1–3 ] The AAP watch-and-wait strategy recommends that antibiotics be delayed for the first 48h of the illness. If homeopathy were utilized on a large scale during this two-day period, it could lead to a dramatic decrease in the use of antibiotics for AOM in the pediatric population.

In order to achieve legitimacy for these claims in the greater scientific community, a large-scale placebo-controlled trial of homeopathy for AOM needs to be done, as suggested by Rutten et al. [ ⁸ ] The Sinha study offers an interesting design that could be used as a model for such an investigation. India might be an appropriate venue for further research in this area, as the research infrastructure and experience there grows. While the costs of such a study would be high, its impact could reach far beyond the homeopathic community.

• References

• 1 Sinha MN, Siddiqui VA, Nayak C. Randomized controlled pilot study to compare homeopathy to conventional therapy in acute otitis media, doi:10.1016/j.homp.2011.08.003.
• 2 Jacobs J., Springer D.A. Homoeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001; 20: 177-183.
• 3 Taylor J.A., Jacobs J. Homeopathic ear drops as an adjunct to standard therapy in children with acute otitis media. Homeopathy 2011; 100: 109-115.
• 4 Diagnosis and management of acute otitis media. Pediatrics 2004; 113: 1451-1465.
• 5 Bezáková N., Damoiseaux R.A., Hoes A.W., Schilder A.G., Rovers M.M. Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants. BMJ 2009; 338: b2525.
• 6 Costelloe C., Metcalfe C., Lovering A., Mant D., Hay A.D. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ 2010; 340: c2096.
• 7 Coco A., Vernacchio L., Horst M., Anderson A. Management of acute otitis media after publication of the 2004 AAP and AAFP clinical practice guideline. Pediatrics 2010; 125: 214-220.
• 8 Rutten L., Lewith G., Mathie R., Fisher P. Homeopathy in upper respiratory tract infections? The impact of plausibility bias. WebmedCentral 2010; 1 (11) WMC001126.