436 Pediatric acupuncture and duration of needling. Therefore, the variability inherent to the implementation of acupuncture makes it difficult to examine through standard methodological approaches. Likewise, most acupuncture literature is generated in adult populations in China under a more lenient methodological framework. Reports tend to be descrip- tive in nature with unclear outcome measures often reported as ‘cured’, ‘greatly improved’, or ‘slightly improved’ (98–100). In addition, most studies are retro- spective, do not include control groups, employ unde- fined inclusion and exclusion criteria, and do not report statistical analyses. While this research may provide a qualitative review of acupuncture, it is difficult to rely on these reports as an unbiased endorsement of effectiveness. Future acupuncture research should be based on rigorous study methodology and comparison with a randomized control group, such as a wait list, standard care, alternative treatment, or sham acupuncture group. Alternatively, investigators in pain management have discussed the utility of practical controlled trials (PCTs) versus randomized controlled trials (RCTs). PCTs are designed to answer specific questions faced by health care providers and decision makers, such as those regarding the costs, benefits, safety, or feasibility of a particular intervention (101). They are particularly well suited for the study of complex interventions, such as CAM therapies, as they assess traditional outcome measures as well as the environment in which a therapy is delivered and its influences on broad health outcomes, such as quality of life (102). While the RCT is often limited by strict inclusion/exclusion criteria, the PCT assesses a broad range of health outcomes across diverse popula- tions and practice settings. An example of a PCT may be a natural comparison of yoga, acupuncture and pharma- ceutical management for low back pain in participants from diverse backgrounds (103). This PCT study would examine pain outcomes as well as quality of life outcomes and outside healing influences. In addition to understanding the methodological limitations associated with the pediatric acupuncture literature base, one must address concerns related to potential side effects, and the acceptability of this treatment among parents and children. Research has consistently shown that the occurrence of adverse events in the practice of acupuncture is rare (44). Although there have been case reports of acupuncture-associated fatal pneumothoraces (104), cardiac tamponade (105) and serious infections (106), the reported incidence of serious side effects from acupuncture therapy performed by a licensed acupuncturist ranges from 1 in 10 000 to 1 in 100 000 (15,107,108). In a review of first-hand accounts of acupuncture-related complications and adverse effects, Lao and colleagues (109) identified only 202 reported cases in 35 years of literature. While serious consequences of acupuncture are rare, adverse effects can occur (110). Several studies report injuries to the central nervous system, including direct injury to the spinal cord and the spinal nerve roots, as well as indirect injury by needle fragments (111,112). A Swedish study observed bleeding in 1371 of 9277 (14.8%) acupuncture treatments, as well as transient symptoms, including faintness, sweating and fatigue (113). A large Australian survey demonstrated that local skin infections occurred after acupuncture in 128 of 3222 cases (114). Likewise, though the chances of serious infection are quite low, there are several case reports suggesting that hepatitis, HIV and sub acute bacterial endocarditis may develop after acupuncture treatment (115–117). Improper handling of the acupuncture needles or reuse without proper sterilization can increase the risk of infections (108). Consequently, the NIH Consensus Developmental Panel on Acupuncture (96) calls for appropriate safeguards to be implemented for the protection of patients. Acupuncture needle use must also follow FDA regulations, including the use of sterile, single-use needles. In addition, access to licensed and certified acupuncture professionals should be ensured for all patients. In contrast to conventional thought that children are afraid of needles, studies suggest that most children tolerate acupuncture therapies well and view acupuncture as a positive experience (37–39). However, as some children may still be wary of acupuncture treatment, many pediatric acupuncturists use gentle or non-invasive treatments such as low-level electrical stimulation, mag- nets, press balls, indirect moxabustion and warming skin salve to stimulate acupuncture points without penetrating the skin (1). As the scientific literature investigating the role of acupuncture in pediatric populations continues to grow, health care professionals must be prepared to discuss complementary and alternative interventions with families. However, a significant amount of additional research is still needed in order to establish a sound empirical basis for the incorporation of acupuncture into standard care. Given the promising trends in the current research, the relative willingness of families to engage in acupuncture and the low risk of deleterious side effects, acupuncture may serve to harmonize Traditional Western Medicine and Traditional Chinese Medicine as a means of promoting preventive care and symptom management for children. References 1. Lee AC, Highfield ES, Berde CB, Kemper KJ. Survey of acupuncturists: practice characteristics and pediatric care. West J Med 1999;171:153–7. 2. Bellas A, Lafferty WE, Lind B, Tyree PT. Frequency, predictors, and expenditures for pediatric insurance claims for complementary