CAM: no recommendation is made regarding CAM as a treatment for OME

There is no recommendation based on lack of scientific evidence documenting efficacy and an uncertain balance of harm and benefit.

The 1994 OME guideline1 made no recommendation regarding CAM as a treatment for OME, and no subsequent controlled studies have been published to change this conclusion. The current statement of “no recommendation” is based on the lack of scientific evidence documenting efficacy plus the balance of benefit and harm.

Evidence concerning CAM is insufficient to determine whether the outcomes achieved for OME differ from those achieved by watchful waiting and spontaneous resolution. There are no randomized, con-trolled trials with adequate sample sizes on the efficacy of CAM for OME. Although many case reports and subjective reviews on CAM treatment of AOM were found, little is published on OME treatment or prevention. Homeopathy and chiropractic treatments were assessed in pilot studies with small numbers of patients that failed to show clinically or statistically significant benefits. Consequently, there is no research base on which to develop a recommendation concerning CAM for OME.

The natural history of OME in childhood (discussed previously) is such that almost any intervention can be “shown” to have helped in an anecdotal, uncontrolled report or case series. The efficacy of CAM or any other intervention for OME can only be shown with parallel-group, randomized, controlled trials with valid diagnostic methods and adequate sample sizes. Unproved modalities that have been claimed to provide benefit in middle-ear disease include osteopathic and chiropractic manipulation, dietary exclusions (such as dairy), herbal and other dietary supplements, acupuncture, traditional Chinese medicine, and homeopathy. None of these modalities, however, have been subjected yet to a published, peer-reviewed, clinical trial.

The absence of any published clinical trials also means that all reports of CAM adverse effects are anecdotal. A systematic review of recent evidence found significant serious adverse effects of unconventional therapies for children, most of which were associated with inadequately regulated herbal medicines. One report on malpractice liability associated with CAM therapies did not address childhood issues specifically. Allergic reactions to echinacea occur but seem to be rare in children. A general concern about herbal products is the lack of any governmental oversight into product quality or purity. Additionally, herbal products may alter blood levels of allopathic medications, including anticoagulants. A possible concern with homeopathy is the worsening of symptoms, which is viewed as a positive, early sign of homeopathic efficacy. The adverse effects of manipulative therapies (such as chiropractic treatments and osteopathy) in children are difficult to assess because of scant evidence, but a case series of 332 children treated for AOM or OME with chiropractic manipulation did not mention any side effects. Quadriplegia has been reported, however, after spinal manipulation in an infant with torticollis.