Lay Summary

What is Middle Ear Infection (Acute Otitis Media)?
Acute Otitis Media (AOM) is the medical term for middle ear infection. It is one of the most common infections in children, especially those under 3 years old. It usually occurs as a complication of viral infections such as colds. Symptoms include severe pain inside the ear, irritability, and sometimes fever. On examination, the eardrum is seen to be red, opaque and bulging with pus.

How is Middle Ear Infection (Acute Otitis Media) treated conventionally?
More than 80% of middle ear infections gets better within 48 hours using only medications to treat pain, such as acetaminophen and ibuprofen. Occasionally, various types of ear drops are used if the pain is severe or if the eardrum ruptures and pus drains out. Children should be taken to see their physician and antibiotics may be prescribed in some situations:
- the child is younger than 6 months to 2 years old (depending on the country and local recommendations)
- the child looks sick
- the child has certain underlying medical conditions
- the pain is severe
- the pain lasts more than 48 hours
- the eardrum ruptures.
Other ways to help a child with ear infections include keeping the head of the bed propped up in order to promote drainage of the pus, and eliminating exposure to cigarette smoke which can prolong congestion and recovery from respiratory problems including colds. Repeated and frequent infections may require consultation with an ear-nose-and-throat (ENT) specialist to consider insertion of ear tubes.

What is Complementary and Alternative Medicine (CAM)?
Complementary and alternative medicine (CAM) is a group of diverse health care systems, practices and products that are not presently considered to be part of conventional medicine. (NCCAM. What is Complementary and Alternative Medicine. Health Information. 2002) Examples of CAM practices include massage therapy and acupuncture. Examples of CAM products (also known as natural health products) include Echinacea and St. John's wort.

What kinds of CAM are used to treat Middle Ear Infections (Acute Otitis Media)?
There are many CAM therapies used to treat ear infections. Many treatments have not been well studied in children, especially regarding effectiveness and safety. There are very few high-quality studies, and this can make it difficult to give good evidence-based advice. The information presented here is based on published research. In particular, randomized, controlled trials (RCTs) of commonly used CAM and studies involving children were searched. For AOM, the focus will be on 4 kinds of CAM:
- Natural health products (NHPs)
- Homeopathy
- Chiropractic
- Osteopathy

Natural Health Products (NHPs)
NHPs are widely used for prevention and treatment of various conditions and to maintain health. Examples include herbals, homeopathic remedies, vitamins, minerals, probiotics, amino acids, and traditional medicines. Dosing and quality of products can vary significantly. Herbal ear drops are used to relieve pain in AOM.

2 studies published in 2001 and 2003 looked at herbal ear drops containing different combinations of herbs, including Allium sativum (garlic), Verbascum thapsus (mullein leaf), Calendula officinalis (calendula flowers), Hypericum perforatum (St. John's wort flowers), and Lavandula officinalis (lavender) in olive oil. The herbal ear drops were found to be more effective in relieving pain compared to anaesthetic drops. However, both studies lacked information that was important for quality assessment and one of the studies was supported by the manufacturer of the product. These studies were included in a 2006 Cochrane systematic review that concluded there was insufficient evidence to determine effectiveness of the herbal ear drops.

Safety of herbal ear drops
Safety of the herbal ear drops is unknown. No side effects were reported in the above studies.

Homeopathy
The principle that "like cures like" means that substances that cause symptoms at normal or high doses can cure them when given in small, highly diluted amounts.

Homeopathic preparations for treatment of ear infections may include Aconitum napellus (monkshood), Belladonna, Capsicum, Chamomilla, Lycopodium, Okoubaka, Pulsatilla nigrans, silicea, sulphur, Calcarea carbonic, Mercuris solubilis, Kalium bichromium and lachesis, among many others. 4 studies published between 1997 and 2001 used individualized homeopathic medicine, and one study in 2004 used a proprietary product. The preparations were compared to a variety of conventional treatments and showed benefits in some areas such as better pain relief, better results on hearing tests and fewer recurrences of infection, but the results were not consistent between the studies, and there were several concerns about the quality of the studies.

Safety of homeopathy
Homeopathy is considered to be very safe since the preparations are very dilute, but it may be possible to trigger a reaction in an allergic person. Temporary worsening of symptoms, called "aggravation", can last a few hours and happens in 10-20% of patients.

Chiropractic
The World Federation of Chiropractic (WFC) defines chiropractic care as the diagnosis, treatment and prevention of mechanical disorders of the musculoskeletal system, and the effects of these disorders on the function of the nervous system and general health. It uses manipulation of the spine, joints and soft tissues to treat various conditions and to maintain and restore health.

No randomized controlled trials of chiropractic treatment of middle ear infection were found. 2 American studies published in 1996 and 1997 had significant design flaws that limited interpretation of results, which showed improvement of ear infection over several days. There were no comparison groups. Because most ear infections clear up without antibiotic treatment, it is not possible to conclude whether or not chiropractic manipulations had any effect on the natural course of the illness.

Safety of chiropractic
Safety of chiropractic therapy in children is not known due to limited research. Children's bodies and spines are immature and they are more vulnerable to potential injury from rapid and forceful manipulations, especially young children and infants. Less forceful techniques may be less likely to cause spinal injuries. Serious events requiring hospitalization or resulting in permanent loss of function seem to be rare. Financial costs may be a barrier for some families.

Osteopathy
The World Osteopathy Health Organization defines osteopathy as a health care system that relies on manual contact for diagnosis and treatment. Osteopathic medicine varies according to the country. For instance, osteopathy in the United States is similar to conventional medicine in training and practice, and in Canada it has more in common with chiropractic. Various manipulative techniques are generally less forceful than chiropractic. Osteopathy emphasizes the structural and functional integrity of the body and the body's intrinsic tendency for self-healing.

Osteopathy was used in a small 2003 randomized controlled trial of ear infection that compared it to standard care that included antibiotics. Patients receiving osteopathy had fewer recurrent infections and surgeries for ear tubes, but no differences in use of antibiotics, hearing tests or parental satisfaction.

Safety of osteopathy
Safety of osteopathic therapy in children is not known due to limited research. Adverse events have generally not been reported, but spinal manipulation may cause injury. Financial costs may be a barrier for some families.

Conclusions

There is research showing that CAM may help children with ear infections. However, many of the studies have significant limitations that make it difficult to offer advice with confidence based on their conclusions, whether positive or negative. These limitations include lack of safety information (especially long-term side effects), flaws in methodology, and small numbers of patients recruited. Evidence from a single trial of any specific CAM should encourage further study and confirmation of conclusions, and the use of such therapies should be supervised with caution by health care providers. Pediatric dosing is often unknown and the quality of some natural health products is unreliable, making safety a further concern. Adults respond to therapies in ways that children may not, therefore assumptions based on adult experience can be inaccurate or even harmful. Also, some therapies and products can be costly and add financial stress for families.

The following figure shows how the evidence for each CAM can be organized according to safety and effectiveness.

Green
Osteopathy

Blue
Herbal ear drops
Homeopathy

Yellow
Chiropractic

The CAM therapies are organized into colour-coded categories for clarity. Conventional medications can also be categorized similarly. For instance, many over-the-counter medications would fall into the blue area, and many prescription medications would fall into the yellow area. Some pediatric health issues can be potentially serious, especially if the condition is chronic, or multiple therapies, NHPs and medications are used together. The decision to use CAM should be based on each child's health and include discussion with the child's physician.

The natural course of ear infections is that more than 80% of children will get better within 48 hours without antibiotics, and will only require pain medications. Each child is unique, and families must weigh the risks and benefits of all interventions as objectively as possible. This is especially important for therapies and products in which good evidence is limited or unknown. The information provided here is intended to promote discussion among parents and health care providers of children with middle ear infections and is not meant to replace medical advice. More high-quality studies are needed to guide recommendations about effectiveness and safety of CAM for treatment of middle ear infections, and to assist caregivers and families in making informed decisions about treatment options.

Funding: Partial funding support for this review was received from Passeport Santé.

Lay summaries: For more information in French, please see Passeport Santé.

Clinician summaries: Full scientific review article will be published in Pediatrics in Review.

Disclaimer: The information available on this website is intended to provide general information about complementary and alternative medicine (CAM). This website does not provide specific medical advice and the information provided should not be used as a substitute for seeking medical advice from a registered health practitioner. The opinions expressed on this website are not necessarily reflective of the opinion of the Stollery Children's Hospital, Capital Health Authority, Passeport Santé, or Pediatrics in Review.