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Table 1 presents a summary of the available evidence supporting the efficacy of the CAM modalities reviewed here. Most of the CAM interventions reviewed fall in the promising category, with a few considered possibly efficacious and only one (self-hypnosis/relaxation for recurrent pediatric headaches) considered efficacious for a specific pain problem. Because self-hypnosis was reviewed as part of a package including other interventions (e.g., progressive muscle relaxation), its efficacy as stand-alone therapy remains unclear.

Our review clearly shows that the evidence for the efficacy of CAM interventions for pain in children is highly variable in strength and quality. Only two interventions, BFB and hypnosis, and for a limited set of pain conditions, are supported by a relatively substantial body of work, whereas the remaining modalities considered in this chapter have been evaluated in very few well-designed and controlled investigations. Even if there are several empirical reports of treatment outcomes following CAM interventions, the variations and flaws in methodological rigor of the studies make it impossible to reach definitive conclusions regarding the correct designation according to 1995 Task Force criteria. Moreover, some of the designations in Table 1 were based on the assessments of other reviewers; the application of the 1995 Task Force criteria may vary somewhat across reviewers and with our own conclusions.

In general, researchers have too often taken a haphazard and overly intuitive approach to demonstrating the efficacy of CAM interventions for pediatric pain, and a more systematic approach will be essential if EST status is to be established. As Wild and Espie (67) pointed out, many existing studies have leapfrogged through the EST process; rather than first demonstrating that an unproven intervention is superior to no treatment or standard medical care, the investigators have rushed to compare their modality to a well-established treatment (e.g., cognitive behavioral therapy). Large-scale randomized studies, perhaps

Table 1

Summary of Empirical Evidence for Efficacy of CAM Interventions for Pediatric Pain

Table 1

Summary of Empirical Evidence for Efficacy of CAM Interventions for Pediatric Pain

CAM modality

Definition

Condition

Designation

Acupuncture

Stimulation of anatomical points using needles that

Chronic pain (various)

Promising

may be accompanied by electrical stimulation

Pediatric migraine

Possibly efficacious

Biofeedback

Thermal biofeedback

Monitoring visual/auditory feedback based on skin

Pediatric migraine

Possibly efficacious"

temperature (e.g., via thermistor placed on the fingers)

Tension headaches

Promising

EMG-biofeedback

Monitoring visual/auditory feedback based on muscle

Tension headaches

Promising"

tension from the frontalis muscle

Music therapy

Use of live or recorded music; live interactive music

Injection pain

Promising

therapy is delivered by trained therapists using

voice, body language, and facial expression to

engage recipient

Herbal therapy

Use of herbs as supplements or tinctures either

Ear pain (AOM)

Possibly efficacious

singly or in mixtures

Hypnosis

Induction of hypnotic state using focused attention,

Procedural pain in

Possibly efficacious

deep relaxation, imagery, and suggestion

pediatric oncology

Procedural pain in

Unclear

pediatric burn injuries

Postoperative pain

Possibly efficacious

Recurrent pediatric

Efficacious6

headache

Massage therapy

Manual manipulation of muscle and

Juvenile rheumatoid

Promising

connective tissue

arthritis

Procedural pain in

Promising

pediatric burn injuries

"Recommendation in ref. 28.

^Recommendation in ref. 79 for the category of relaxation/self-hypnosis/guided imagery/autogenic training.

CAM, complementary and alternative medicine; AOM, acute otitis media; Designation, designation according to criteria for empirically supported therapies (ESTs) by American Psychological Association Division 12 Task Force on Promotion and Dissemination of Psychological Procedures.

"Recommendation in ref. 28.

^Recommendation in ref. 79 for the category of relaxation/self-hypnosis/guided imagery/autogenic training.

CAM, complementary and alternative medicine; AOM, acute otitis media; Designation, designation according to criteria for empirically supported therapies (ESTs) by American Psychological Association Division 12 Task Force on Promotion and Dissemination of Psychological Procedures.

drawing from multiple settings to ensure a sufficiently large number of subjects and comparing the CAM modality to "care as usual" or to nonintervention must be the initial step (67). If these investigations provide evidence of pain relief from the treatment of interest exceeding that to be expected from standard care or no treatment, then additional trials are justified to achieve EST status by comparing the CAM therapy with established treatments or to a well-chosen placebo condition. Also, because many CAM interventions have been tested as part of a multicomponent treatment package, further studies to dismantle the packages and test the efficacy of each individual component to isolate the effective, or most effective, therapeutic ingredient should also be conducted.

We offer these additional recommendations for future work. First, standardization of procedures through the use of a treatment manual or its equivalent is required for designation of an EST. Investigators have failed to employ such standardization in many existing studies, making comparison of results across studies extremely problematic. The use of a manual will also allow researchers to monitor therapists and ensure treatment protocol adherence, thus preserving treatment integrity. The failure to standardize techniques and procedures for therapeutic hypnosis, reflected in the profusion of terms employed (e.g., guided imagery, hypnotherapy), appears to be a particularly serious limitation in the literature on this CAM modality. On the other hand, certain CAM therapies (e.g., herbal medicine) do not necessarily require a manual for treatment administration. However, there may be problems of varying potency of preparations with herbal medicines.

Second, increased attention should be paid to the likelihood of methodological confounds if randomized assignment, blinding of participants and raters, appropriate control groups, and other parameters of good trial design are not employed. Lack of careful design increases the possibility that observed benefits may be erroneously attributed to the treatment itself rather than to other, nonspecific effects. Many of these potential confounds are specifically addressed in the 1995 Task Force criteria. CAM researchers should employ random group assignment, ensure that participants and experimenters/raters are unaware of group assignment (i.e., the equivalent of the double-blind pharmacological trial), use valid and reliable outcome measures, enroll sufficient sample sizes to achieve adequate statistical power to detect between-group differences, and devise an appropriate control group (e.g., standard medical care). For particular modalities, such as music therapy, inclusion of a truly comparative placebo group (e.g., other auditory stimuli) to control for nonspecific effects is especially important.

Third, the inadequate understanding of mechanisms of action in CAM interventions must be improved through the systematic testing of existing mechanistic models (67). For example, Hermann and Blanchard (28) make the argument that if it can be shown that the observed beneficial effects of BFB on pain are mediated by psychological (e.g., self-efficacy) rather than physiological (e.g., muscle tension) factors, such findings may encourage the application of BFB to other pain problems (e.g., recurrent abdominal pain).

Another important consideration is that the safety of CAM interventions for pediatric pain should be carefully monitored and detailed in published reports. With the exception of trials involving herbs/supplements and other similar substances that employ methodology analogous to that used in conventional drug trials, few studies on CAM appear to monitor safety or adverse side effects. Safety considerations should be specifically discussed in published research on CAM in children, and the number and nature of any adverse effects should be detailed.

Future efficacy studies of CAM should also consider the guidelines in the Consolidated Standards of Reporting Trials (CONSORT) statement, an evidence-based approach to improve the quality of reports of randomized clinical trials (http://www.consort-statement.org/). The CONSORT statement has been adopted by several prominent medical journals, and additional behavioral medicine-specific guidelines have been proposed (97). The five additional CONSORT requirements for reporting on behavioral medicine trials include detailed and specific information on (1) training of treatment providers; (2) supervision of treatment providers; (3) patient and provider treatment allegiance or preference; (4) manner of testing and success of treatment delivery by the provider; and (5) treatment adherence monitoring and reporting (97). Adoption of these additional behavioral medicine guidelines will help ensure the quality of reported findings for trials of CAM interventions in pediatric populations (98).

In sum, it is clear there is a paucity of high-quality empirical investigations supporting definitive conclusions regarding the efficacy of CAM therapies for pediatric pain. However, the studies to date have produced suggestive findings regarding several modalities that clinical researchers may use as guidance in conducting better-designed investigations. There remain a number of CAM interventions for pediatric pain, including movement therapies (yoga), creative arts interventions (art or dance therapy), meditation, aromatherapy, spiritual approaches, homeopathy, and folk remedies, for which no published, controlled studies exist and which were therefore not included in this review. One special group of CAM interventions often used in tertiary pediatric pain clinics but not studied systematically in children includes energy healing, such as Reiki and other therapies that purport to manipulate energy biofields within and around the human body, or bioelectromagnetic-based therapies involving the unconventional use of electromagnetic fields, such as pulsed fields, alternating current, or direct current fields. Many of these CAM treatments have shown encouraging results in case reports and uncontrolled studies; some may have great value; others may be of little more benefit than therapeutic attention and touch. It is our hope that future work may be directed at the systematic testing of all these unproven CAM modalities. The promise of safe and effective therapies that relieve pain in children and may replace or augment conventional medical approaches at low cost is a commendable goal that should be pursued with the highest degree of scientific rigor.

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