A summary of the evidence supporting the CAM modalities discussed above is displayed in . In general, most of the CAM interventions reviewed are included in the promising or possibly efficacious categories. The only intervention (self-hypnosis/relaxation/guided imagery for recurrent pediatric headaches) that may be considered efficacious is actually a combined package of interventions. Thus, the efficacy of self-hypnosis/guided imagery in isolation remains unclear. As is evident from the preceding discussion, the quality of the studies examining the efficacy of CAM interventions for pain in children varies widely. Only two of the interventions, BFB and hypnosis, have a relatively substantial body of work supporting their application, although these are limited to a relatively circumscribed set of pain problems. The remaining interventions reviewed have been the subject of very few controlled investigations. Even within those CAM modalities that have amassed a number of empirical reports examining treatment outcome, the quality of the methodology across studies varied a great deal. Thus, conclusions regarding designations according to APA Task Force criteria in this review may not be considered definitive. It should also be noted that some of the designations in were derived from other reviews, and interpretation of the APA Task Force criteria may have varied slightly across reviewers.
Summary of empirical evidence for efficacy of CAM interventions for pediatric pain
Generally speaking, research on CAM interventions for pediatric pain would benefit from a more systematic approach to achieving EST status. As discussed by Wild and Espie (54
), many studies have skipped several steps in the EST process by comparing an unproven intervention with an already established treatment (e.g. cognitivebehavioral approaches) without first showing that the intervention is superior to a no-treatment control or standard medical care. Thus, they recommend that the first step in securing EST status might involve large-scale, randomized studies, perhaps drawing from multiple settings in order to provide sufficient sample sizes, comparing the CAM intervention with a no-intervention or ‘care as usual’ condition (54
). Only if the results of such studies show that the intervention yields benefits exceeding that of standard care or no-intervention should further work be undertaken to compare the intervention with established therapies and/or an attention control/placebo condition. Another important consideration is isolating the therapeutic ingredient(s) that lead to change. Given that many CAM interventions have been studied within the context of an overall treatment package that includes many different treatment components, careful treatment dismantling studies testing the efficacy of each individual component should also be conducted if the overall package is shown to be efficacious.
Several additional recommendations may be incorporated into future work. First, for interventions that do not easily lend themselves to testing against a ‘pill placebo’ or equivalent placebo formulation or placebo procedure (e.g. acupuncture), standardization of the intervention procedures using a treatment manual or its equivalent is a requirement for EST designation. The majority of studies have not used a manual, making it difficult to compare results across studies and to replicate results by independent research groups. Use of a manual will also allow assessments of the degree of adherence to the treatment protocol on the part of therapists. The lack of standardization appears to be particularly problematic in the hypnosis literature, which has a relatively large body of studies dating back >20 years; this lack of standardization is reflected in the disparate terms used to describe hypnotic procedures (e.g. guided imagery and hypnotherapy). Secondly, increased attention should be paid to methodological confounds that may lead positive findings to be attributable to non-specific effects, rather than specific effects of the intervention. Among the most important considerations include: (i) random group assignment; (ii) ensuring that both researchers and patients are kept unaware of group assignment (i.e. the equivalent of the ‘double-blind’ pharmacological trial); (iii) use of valid and reliable outcome measures; (iv) including sufficient sample sizes to achieve adequate statistical power to detect between-group differences; and (v) use of an appropriate control condition. For certain interventions such as music therapy, inclusion of a placebo group (e.g. other auditory stimuli) to control for non-specific effects is particularly important. Finally, even though mechanisms of action in CAM interventions may not be well understood, systematic testing of existing mechanistic models should be pursued (54
). Hermann and Blanchard (22
) pointed out that if the beneficial effects of BFB on pain are found to be mediated by psychological (e.g. self-efficacy) rather than physiological (e.g. muscle tension) factors, this would increase the likelihood that BFB will be studied in relation to other pain problems (e.g. RAP) rather than headache alone.
In sum, there are few high-quality empirical investigations that permit definitive conclusions to be drawn regarding the efficacy of CAM interventions for pediatric pain. The studies to date do, however, provide many useful findings that may guide researchers in conducting more carefully controlled investigations. It should be noted that several CAM interventions for pediatric pain were not included in this review due to a lack of published, controlled studies. These interventions include movement therapies such as yoga, other interventions involving the creative arts such as art or dance therapy, as well as meditation, energy healing, aromatherapy, folk remedies and spiritual approaches. This list is not exhaustive. Notably, many of these CAM treatments have shown encouraging findings in case reports and uncontrolled studies. It is our hope that future work may be directed at the careful testing of these unproven but potentially therapeutic CAM modalities. The pursuit of safe, efficacious and cost-effective interventions for pain in children that may be used in place of, or in concert with, conventional medical approaches is a worthy goal that should be undertaken with the highest degree of scientific rigor.