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MAY / JUNE 2013 :: 74(3)
Chronic Pain

This issue focuses on the challenge of managing chronic pain. Commentaries present various treatment options, including opioids, nonopioid medications, surgery, and alternative therapies. Authors also address the problems of opioid misuse and abuse and discuss ways to lessen these risks. Original articles examine health professionals’ communication with adolescents about smoking, as well as children's immunization status as verified by practice records and by the North Carolina Immunization Registry.

INVITED COMMENTARY

Acupuncture for the Treatment or Management of Chronic Pain

Remy R. Coeytaux, Eric Garland

N C Med J. 2013;74(3):221-225.PDF | TABLE OF CONTENTS



Evidence supports the safety and efficacy of acupuncture compared with no treatment, but it is unclear what role the placebo effect plays in acupuncture’s efficacy. In determining whether acupuncture is indicated for a given individual or patient population, clinicians should consider acupuncture’s effectiveness compared with no acupuncture—as well as the effectiveness, safety, and cost of alternative types of treatment.

Pain is a complex biopsychosocial phenomenon that arises from the interaction of neuroanatomical and neurochemical systems with cognitive, affective, and physiological processes. In contrast to acute pain, which is most often evoked by noxious stimuli or damage to bodily tissues, chronic pain does not necessarily correlate with tissue damage. In patients with chronic pain, the magnitude of the reported pain may be out of proportion to the degree of tissue damage. Thus, clinical interventions that focus on repairing injured tissue may not adequately alleviate chronic pain, and multimodal treatment approaches may be warranted. In this paper, we summarize the evidence regarding the use of acupuncture for the treatment or management of chronic pain.

The published literature includes hundreds of randomized controlled trials (RCTs) designed to evaluate the efficacy and safety of acupuncture for a wide variety of clinical indications. Chronic or recurrent pain conditions are well represented in the acupuncture literature. Since 2000, there have been at least 14 systematic reviews of acupuncture for back or neck pain [1-14], 12 systematic reviews of acupuncture for peripheral joint pain [13, 15-26], and 8 systematic reviews of acupuncture for headache [13, 27-33] (Table 1).

The majority of RCTs of acupuncture that have been published to date have evaluated the effectiveness of an “active” or “true” acupuncture protocol compared either to a no-treatment group or to a “sham” acupuncture intervention. Most sham acupuncture protocols involve penetration of the skin by acupuncture needles, but these needles are applied to bodily locations that are not thought to correspond to therapeutic acupuncture points. Many recent, larger studies are 3-arm RCTs that compare true acupuncture both to a sham intervention and to a no-treatment, waitlist, or usual-care-only control group. A relatively small proportion of clinical trials have directly compared acupuncture with 1 or more other potentially active interventions.

There are enough published RCTs of acupuncture to conduct meta-analyses on individual patient-level data. Vickers and colleagues [13] recently published a meta-analysis of patient data from 29 high-quality RCTs (involving a total of 17,922 patients) that evaluated acupuncture for chronic pain. This analysis demonstrated that acupuncture was associated with significant alleviation of pain relative both to no treatment and to sham acupuncture for all 4 chronic pain conditions studied: back and neck pain, chronic headache, shoulder pain, and osteoarthritis.

Effectiveness, Safety, and Cost
Whether acupuncture is found to be effective for the treatment or management of chronic pain depends in large part on the comparison group used in clinical trials. The available evidence strongly suggests that acupuncture is effective for most of the pain conditions that have been studied to date when the alternative is not undergoing a course of acupuncture treatment. When compared with a sham intervention that is intended to serve as a placebo control, however, some trials demonstrate the superiority of true acupuncture, whereas others do not. The observation that true acupuncture is not always superior to sham acupuncture in the context of RCTs is consistent with 2 different—but not necessarily mutually exclusive—explanations: The first possible explanation is that acupuncture’s clinical effects are attributable to the placebo effect. The second possibility is that sham acupuncture treatments are not physiologically inert and thus may influence clinical outcomes.

Our interpretation of the existing evidence is that the placebo effect probably accounts for a not-insignificant proportion of acupuncture’s observed efficacy in the context of both clinical trials and clinical practice. Even if acupuncture is associated with a relatively strong placebo effect, the clinical benefits associated with acupuncture—which have been demonstrated by findings from RCTs and have been reaffirmed by systematic reviews and meta-analyses—should not be discounted. Other factors should also be taken into consideration, including the safety and cost of acupuncture as a treatment option, as well as the comparative effectiveness and safety of alternative treatment options. Patient choice and preference should also be considered.

Acupuncture’s safety profile is characterized by a low incidence of a variety of different adverse events, including transient pain associated with the needling, dizziness, feelings of disorientation, bruising, or exacerbation of the symptoms for which treatment was sought. A prospective survey of 574 acupuncturists in the United Kingdom revealed 43 adverse events identified by practitioners as being “significant” out of a total of 34,407 acupuncture treatments, which corresponds to a rate of 1.3 events per 1,000 treatments. None of the events was considered to be “major” or “serious.” Of the 43 reported adverse events, 5 were severe nausea, 4 involved fainting, and 3 were local pain at the site of the needling. A variety of other adverse events were reported with an incidence of 1 or 2 events per 34,407 treatments [34].

Acupuncture’s cost effectiveness has been studied in the United Kingdom, Germany, and Italy, but it has not been studied in the United States. Ambrosio and colleagues [35] included 7 cost-utility analyses and 1 cost effectiveness analysis in a systematic review of the literature evaluating acupuncture as a treatment for lower back pain, neck pain, dysmenorrhea, migraine, and osteoporosis. They found that, although acupuncture was clinically effective, it added to the overall cost of care. The cost per quality-adjusted life-year gained ranged from £2,527 to £14,976, which is below the typical willingness-to-pay threshold estimated by the UK National Institute for Health and Clinical Excellence. The authors concluded, “acupuncture appears to be a cost-effective intervention for some chronic pain conditions” [35]. However, cost effectiveness analyses and conclusions from European studies may not be readily applicable to the United States.

Currently, Medicare, Medicaid, and most private health insurance plans in North Carolina do not cover the costs of acupuncture services. Instead, acupuncture is typically rendered on a fee-for-service basis. The direct, out-of-pocket cost to the patient for each acupuncture treatment is typically in the range of $50 to $120. For most chronic pain conditions, multiple treatments may be needed, thereby resulting in direct costs of more than $700 for a course of treatment. In addition, there may be indirect costs associated with time lost from work and travel expenses, and there may be opportunity costs if the time and resources spent on a course of acupuncture treatment preclude the use of an alternative approach that might have resulted in lower costs or greater benefit.

Acupuncture as Adjunctive Therapy
Most of the studies cited above evaluated the efficacy or effectiveness of acupuncture as a stand-alone treatment for defined symptoms or clinical conditions. In addition, acupuncture could also play a role as an adjunct to other treatments for individuals with chronic pain. In the management of opioid withdrawal symptoms, for example, the use of acupuncture plus opioid agonists is associated with a lower reported incidence of side effects than when opioid agonists are used alone; the relapse rates of these 2 approaches do not differ after 6 months, however [36]. Acupuncture has also been shown to reduce the incidence of opioid-related side effects such as nausea, dizziness, sedation, pruritus, and urinary retention in the setting of postoperative pain management [37]. This evidence suggests that acupuncture might be useful in alleviating opioid-related side effects associated with medical management of chronic pain.

Licensing, Certification, and Availability of Acupuncturists
In North Carolina, 4 licensing boards play a role in overseeing the practice of acupuncture: First, the North Carolina Acupuncture Licensing Board is charged with issuing, denying, suspending, and revoking licenses of licensed acupuncturists who have successfully completed an approved, 3-year postgraduate acupuncture college or training program. Second, the American Board of Medical Acupuncture (ABMA) oversees board certification for medical acupuncture for physicians who are already licensed to practice medicine by the state’s medical board. Board certification requirements for physician medical acupuncturists include graduation from an accredited medical school; possession of a valid, unrestricted license to practice medicine in a state or jurisdiction of the United States or Canada; and completion of a minimum of 300 hours of board-approved acupuncture training and education. Third, the North Carolina Medical Board is responsible for licensure of physicians, nurse practitioners, and physician assistants. The use of medical devices (including acupuncture needles) falls under the scope of care of these health care professionals. Licensed physicians and physician extenders may therefore administer acupuncture treatments without acupuncture-specific board certification. Finally, the North Carolina Board of Chiropractic Examiners (NCBE) is responsible for licensing individuals who are qualified to practice chiropractic in the state of North Carolina. The NCBE requires a licensed chiropractor to complete a minimum of 200 hours of board-approved acupuncture training and education in order to be eligible to provide acupuncture as part of his or her practice.

In February 2013, approximately 400 licensed acupuncturists, 6 board-certified physician acupuncturists, and 348 chiropractors were eligible to provide acupuncture in North Carolina. These figures do not include licensed physicians who include acupuncture as part of their medical practice but who have not sought board certification from the ABMA. Licensed acupuncturists, medical acupuncturists, and acupuncture-trained chiropractors practice in a variety of different clinical settings, including hospitals, clinics or centers within medical centers, private practices, community health centers, and free clinics. Third-party payer reimbursement issues and hospital credentialing requirements make it relatively difficult for hospitals to offer acupuncture to inpatients; consequently, most acupuncture services in North Carolina are provided in ambulatory care settings.

Future Research
The question of how much of acupuncture’s clinical benefit is attributable to the placebo effect is likely to remain unanswered. Hundreds of RCTs—many of them with high-quality methodologies—and dozens of meta-analyses have already been published on this topic. In our opinion, more research of the same type (in terms of study design and research questions) is not likely to be particularly illuminating. We believe that progress is more likely to be made by asking a different set of questions: How does acupuncture compare with alternative approaches, taking into account comparative effectiveness, safety, and cost? Which of the many acupuncture traditions or approaches is most effective for a particular clinical indication? Is there a role for acupuncture as an adjunct to other treatment modalities for chronic pain? If a course of acupuncture adds to the net cost of treatment (after factoring in possible savings from decreased health care resource utilization elsewhere), is the additional cost “worth it” from the perspective of patients, payers, and policymakers?

Conclusion
Strong evidence supports the safety and efficacy of acupuncture relative to no acupuncture treatment for a variety of chronic pain conditions. However, there is insufficient evidence to clarify the potential role of the placebo effect. In the absence of clear evidence that all of acupuncture’s clinical benefits are solely attributable to the placebo effect, we conclude that factors such as acupuncture’s effectiveness relative to no acupuncture for treatment of certain pain conditions—as well as the effectiveness, safety, and cost of alternative treatment options—should be considered when determining whether a course of acupuncture treatment is indicated for a given individual or patient population.

Acknowledgments
We thank Leila Ledbetter for her assistance with the review of the published literature.

Potential conflicts of interest. R.R.C. is a board-certified medical acupuncturist who owns a private medical practice that employs licensed acupuncturists. He serves on the Board of Directors for the Society for Acupuncture Research. E.G. has no relevant conflicts of interest.

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Remy R. Coeytaux, MD, PhDB associate professor, Doctor of Physical Therapy Division, Department of Community and Family Medicine, Duke University, Durham, North Carolina.
Eric Garland, PhD associate professor, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.

Address correspondence to Dr. Remy R. Coeytaux, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715 (remy.coeytaux@duke.edu).