Homeopathy for Acute and Chronic Otitis Media

April 2000; Volume 3; 37-40

By E-P. Barrette, MD, FACP

Placement of tympanostomy tubes for otitis media is the most commonly performed surgery in children, except circumcision. In the United States, routine care for acute otitis media (AOM) usually includes antibiotics. In Europe, antipyretics and frequent early follow-up are common, with antibiotics reserved for children who fail to improve. Cost estimates for treatment of childhood otitis media are $5 billion annually.

Homeopathic practitioners have long advocated their remedies for otitis media. In a member survey of the American Institute of Homeopathy, which has an M.D. and D.O. membership, otitis media was tied for second place among the principal diagnoses of patients seeking care.1 What is the evidence that homeopathy provides benefit for this common ailment?

History

More than 200 years ago, Samuel Hahnemann developed the medical system of homeopathy.2 Based on the law of similars, homeopathic remedies are based on "provings," which are experiments in healthy subjects. This "like-cures-like" philosophy proposes that an agent which causes a symptom or group of symptoms in a healthy subject will serve as a remedy for someone suffering from the same symptom or group of symptoms.3

Homeopathy continues to maintain a unique position in the field of complementary medicine. It has a long and rich tradition in both Europe and the United States and competed with allopathic medicine until the opening of the 20th century. However, basing its practices on medicines, some of which have been diluted to the point of containing none of the original agent, has led to significant skepticism within the mainstream.

Current Practice

Both the United States and Europe are experiencing a resurgence of homeopathy. In the United States, sales of homeopathic remedies increased from $100 million in 1988 to $250 million in 1996. The National Center for Homeopathy claims 6,000 members. The number of homeopathy training programs increased from three in 1990 to 20 in 1996.

Current practitioners of homeopathy utilize various styles, e.g., classical when a single remedy is matched to the totality of symptoms, clinical when one or more remedies is matched to a conventional diagnosis, and complex when several remedies are combined to treat all the symptoms. Eighteenth century homeopaths referred to vitalism while contemporary practitioners refer to chaos theory and memory of water crystals.

Practitioners of homeopathy describe clinical homeopathy as:

a. when a single remedy is matched to the totality of symptoms.

b. when one or more remedies is matched to a conventional diagnosis.

c. when several remedies are combined to treat all symptoms.

d. None of the above.


Mechanism of Action

The major controversy over homeopathy involves "potentization" and serial dilutions. The substance is diluted one part in 10 to produce a D1 solution; one part in 100 makes a C1 solution. The solution is then shaken ("succussed"). A C2 solution results when one part of a C1 solution is mixed with 99 parts of solute and then agitated. Theoretically, dilutions greater than D24 or C12 (10-24) contain no molecules of the original agent.

Dilutions are referred to as low potencies for C1 to C4, medium potencies for C5 to C11, and high potencies for greater than C11. No adequate explanation accounts for the success claimed with high-potency dilutions, i.e., very low concentrations.

Pathophysiology of Otitis

Most children will suffer at least one bout of otitis by age three. The peak incidence is between six and 24 months of age. Infants’ eustachian tubes are shorter and more horizontal than adults’, thus facilitating reflux of fluid, viruses, and bacteria into the middle ear. Risk factors for otitis media include second-hand cigarette smoke, male sex, exposure to large numbers of children (e.g., day care), lack of breast feeding, and family history.

The most common pathogens are Streptococcus pneumoniae, Moraxella catarrhalis, and Hemophilus influenzae4 and up to one-third of infections may be viral in origin.

Disease Course—Otitis

Although uncommon, severe complications of inadequately treated or untreated otitis media may occur. The introduction of antibiotics resulted in the dramatic reduction in the rate of otomastoiditis and intracranial complications of AOM.

AOM resolves spontaneously in 75% of cases.4 This rate reflects bacterial infections that the immune system is able to clear, viral infections, and misdiagnosed cases. Antibiotics given early will improve the cure rate and decrease the complication rate. Since it is difficult to predict which children will improve without treatment, U.S. physicians routinely prescribe antibiotics for AOM.

Chronic otitis media with effusion (COME) often follows AOM and is the most common cause of hearing loss in children. Evidence suggests that a 20 dB or greater hearing loss will temporarily interfere with language development. COME with hearing loss for three or more months that fails to resolve with medical therapy may be treated with tympanostomy tubes with or without adenoidectomy. (See Table 1 for estimated costs associated with treating otitis media.)


Table 1-Estimated costs for treating otitis media
Homeopath
$45-75 for initial visit (1 hour or longer); subsequent visits would cost considerably less
Pediatric Otolaryngologist
$100-250 for initial visit; $70-120 for audiogram
Pediatric Otolaryngologist
(for Tympanostomy Tube Placement)
$300-1,000 for surgeon fees; total cost approximately $3,500
Sources: National Center for Homeopathy, telephone surveys



Clinical Studies—Otitis

An extensive search for all trials of homeopathy and otitis media resulted in finding only two studies. A German prospective study of AOM compared treatment by one homeopathic and four conventional otolaryngologists. This data set has been reported twice.5,6 The study was neither randomized nor blinded.

Single homeopathic remedies were compared to usual care with antipyretics, decongestants, secretolytics, and antibiotics. One hundred three children were enrolled by the homeopathic physician and 28 by the conventional physicians. The duration of pain was longer in the conventional group (median 3 vs. 2 days, P = 0.12), as was the duration of therapy (median 10 vs. 4 days, P = 0.0001). Of note, the duration of antibiotics generally prescribed is 10 days; homeopathic treatments are stopped when improvement is noted. Audiograms were abnormal in an equal percentage of children. A greater number of children treated by homeopathy were free of recurrences at one year (70.7% vs. 56.5%, P not reported).

Selection bias complicates this study, as children treated conventionally were likely more difficult cases, since routine care for acute otitis media in Germany is by pediatricians, not by otolaryngologists. The children in the conventional group also had a higher rate of previous adenoidectomy (32.1% vs. 15.5%). Although the indication for adenoidectomy was not provided, this surgery is most often performed in children with recurrent AOM and COME. These children with prior adenoidectomy may have had infections refractory to usual treatments.

A non-blind randomized control trial for COME compared homeopathy to routine care by general practitioners.7 Children with COME, > 20 dB hearing loss, and an abnormal tympanogram ages 1.5 to 9 years were included. Only 33 children were enrolled. Exclusion criteria included history of adenoidectomy, tonsillectomy, tympanostomy tubes, tympanic membrane disease, or craniofacial anomaly. One center randomized children by an alternate basis, a potential source of bias. Routine care involved watchful waiting, low-dose antibiotics, and tympanostomy tube insertion if no improvement was seen by 6-12 months.

More children in the homeopathy-treated group had improved hearing with < 20 dB loss at 12 months (64% vs. 56%, P > 0.2). More children four or younger were seen in the homeopathy group (10/17) than in the routine care group (5/16). Since children who will have difficulties with otitis generally present by age four, the older children in the routine care may have included children with more longstanding and difficult-to-resolve COME.

A related study compared homeopathy vs. placebo in a randomized, double-blind controlled format in children aged 1.5 to 10 years who had at least three upper respiratory infections in the past year or had two upper respiratory infections and otitis media with effusion at entry.8 Exclusion criteria included history of adenoidectomy, tonsillectomy, and homeopathic treatment in the prior six months, chronic medical condition, or congenital malformation.

The children continued to receive routine care by their general practitioner. They also received either individualized homeopathic medicine or placebo for the entire one-year study. One hundred seventy-five children were enrolled. The groups were well balanced. Eighty-nine percent in each group had a history of AOM, while 58% had a history of COME. The mean daily symptom score was lower in the treatment group (2.61 vs. 2.21, difference 0.41, 95% confidence interval -0.02 to 0.83).

The authors felt the clinical relevance of this degree of difference was questionable. Antibiotic use decreased in both groups. Multiple outcomes, including measures of symptom scores during infections, episodes of upper respiratory infections, antibiotic use, antibiotic duration, adenoidectomies, and other measures all failed to reach statistical significance.

Adverse Effects

With the exception of contamination, homeopathic medications have been free of significant side effects.

Conclusion

AOM is a very common illness. Most cases will resolve spontaneously. Practitioners of homeopathy frequently treat children with otitis and claim success with this problem. However, there is no published evidence to support this claim.

In a condition that has such a high rate of spontaneous resolution, the experience of homeopathic practitioners may reflect only the natural history of this condition, recall bias, and selective follow-up. The greatest danger may be relying on an unproven therapy for COME with associated hearing loss, since speech may be delayed.

Recommendation

For AOM, homeopathy during the first 2-3 days may be analogous to the watchful waiting practiced by European physicians. However, COME that persists needs more careful evaluation and clinical treatment.

High-potency homeopathic preparations:

a. contain one part substance diluted in 10 parts solute.

b. contain one part substance diluted in 5 parts solute.

c. contain high concentrations of the original agent.

d. contain low concentrations of the original agent.

References

1. Jacobs J, et al. Patient characteristics and practice patterns of physicians using homeopathy. Arch Fam Med 1998;7:537-540.

2. Ernst E, Kaptchuk TJ. Homeopathy revisited. Arch Intern Med 1996;156:2162-2164.

3. Kratz AM. Contemporary homeopathy. In: Pizzorno JE, Murray MT, eds. Textbook of Natural Medicine. 2nd ed. Edinburgh: Churchill Livingstone; 1999:
281-285.

4. Kenna MA. Diagnosis and management of acute otitis media and otitis media with effusion. In: Wetmore RF, et al, eds. Pediatric Otolaryngology: Principles and Practice Pathways. New York: Thieme Medical Pub.; 2000:263-279.

5. Friese KH, et al. The homoeopathic treatment of otitis media in children—comparisons with conventional therapy. Int J Clin Pharmacol Ther 1997;35:296-301.

6. Friese KH, et al. Otitis media acuta bei Kindern. Vergleich zwischen konventioneller und homöopathischer therapie. [Acute otitis media in children. Comparison between conventional and homeopathic therapy] HNO 1996;44:462-466.

7. Harrison H, et al. A randomized comparison of homoeopathic and standard care for the treatment of glue ear in children. Complement Ther Med 1999;7:132-135.

8. de Lange de Klerk ES, et al. Effect of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. BMJ 1994;309:1329-1332.