Consensus Statement on Acupuncture

Government report excerpt

By: David J. Ramsay, et. al.

Date: 1997

Source: D. J. Ramsay, et al. "National Institutes of Health Consensus Statement on Acupuncture." 15, no. 5 (November 3-5, 1997). Available online at: 〈http://www.healthy.net/LIBRARY/Articles/NIH/Report.htm〉 (accessed January 20, 2006).

About the Author: At the time that the NIH Consensus Panel issued its finding on acupuncture, David J. Ramsay, a physiologist, was President of the University of Maryland and chairman of the twelve-member panel.

INTRODUCTION

In November, 1997 a National Institutes of Health (NIH) consensus panel concluded that there was clear evidence that acupuncture treatment shows effectiveness in treating postoperative nausea, nausea and vomiting due to chemotherapy, nausea of pregnancy, and postoperative dental pain.

The NIH panel also concluded that there are other pain-related conditions for which acupuncture may be effective as an adjunct therapy, an acceptable alternative, or as part of a comprehensive treatment program. These conditions include, among others, addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia (general muscle pain), low back pain, carpal tunnel syndrome, and asthma.

The consensus panel called for further research to validate the findings with respect to acupuncture, and to explore ways in which traditional Chinese medical practice might be integrated into Western medicine, for example by elucidating the biological mechanisms that might account for acupuncture's efficacy. Although some of the panel members are reported to have dissented from the findings, the consensus statement conveyed the opinions of the majority of the panel members.

Acupuncture, which originated in China more than 2,500 years ago, involves stimulation of certain points on or under the skin, mostly with ultra-fine needles that are manipulated manually or electrically. Although there are other forms of acupuncture, the NIH panel focused particularly on needle acupuncture because this was the form most widely researched and practiced in the United States.

PRIMARY SOURCE

1. What is the efficacy of acupuncture, compared with placebo or sham acupuncture, in the conditions for which sufficient data are available to evaluate?

Acupuncture is a complex intervention that may vary for different patients with similar chief complaints. The number and length of treatments and the specific points used may vary among individuals and during the course of treatment. Given this reality, it is perhaps encouraging that there exist a number of studies of sufficient quality to assess the efficacy of acupuncture for certain conditions.

According to contemporary research standards, there is a paucity of high-quality research assessing efficacy of acupuncture compared with placebo or sham acupuncture. The vast majority of papers studying acupuncture in the biomedical literature consist of case reports, case series, or intervention studies with designs inadequate to assess efficacy.

This discussion of efficacy refers to needle acupuncture (manual or electroacupuncture) because the published research is primarily on needle acupuncture and often does not encompass the full breadth of acupuncture techniques and practices. The controlled trials usually have only involved adults and did not involve long-term (i.e., years) acupuncture treatment.

Efficacy of a treatment assesses the differential effect of a treatment when compared with placebo or another treatment modality using a double blind controlled trial and a rigidly defined protocol. Papers should describe enrollment procedures, eligibility criteria, description of the clinical characteristics of the subjects, methods for diagnosis, and a description of the protocol (i.e., randomization method, specific definition of treatment, and control conditions, including length of treatment, and number of acupuncture sessions). Optimal trials should also use standardized outcomes and appropriate statistical analyses. This assessment of efficacy focuses on high-quality trials comparing acupuncture with sham acupuncture or placebo.

Response Rate. As with other interventions, some individuals are poor responders to specific acupuncture protocols. Both animal and human laboratory and clinical experience suggest that the majority of subjects respond to acupuncture, with a minority not responding. Some of the clinical research outcomes, however, suggest that a larger percentage may not respond. The reason for this paradox is unclear and may reflect the current state of the research.

Efficacy for Specific Disorders. There is clear evidence that needle acupuncture is efficacious for adult post-operative and chemotherapy nausea and vomiting and probably for the nausea of pregnancy.

Much of the research is on various pain problems. There is evidence of efficacy for postoperative dental pain. There are reasonable studies (although sometimes only single studies) showing relief of pain with acupuncture on diverse pain conditions such as menstrual cramps, tennis elbow, and fibromyalgia. This suggests that acupuncture may have a more general effect on pain. However, there are also studies that do not find efficacy for acupuncture in pain.

There is evidence that acupuncture does not demonstrate efficacy for cessation of smoking and may not be efficacious for some other conditions.

While many other conditions have received some attention in the literature and, in fact, the research suggests some exciting potential areas for the use of acupuncture, the quality or quantity of the research evidence is not sufficient to provide firm evidence of efficacy at this time.

Sham Acupuncture. A commonly used control group is sham acupuncture, using techniques that are not intended to stimulate known acupuncture points. However, there is disagreement on correct needle placement. Also, particularly in the studies on pain, sham acupuncture often seems to have either intermediate effects between the placebo and 'real' acupuncture points or effects similar to those of the 'real' acupuncture points. Placement of a needle in any position elicits a biological response that complicates the interpretation of studies involving sham acupuncture.

Thus, there is substantial controversy over the use of sham acupuncture as control groups. This may be less of a problem in studies not involving pain.

2. What is the place of acupuncture in the treatment of various conditions for which sufficient data are available, in comparison with or in combination with other interventions (including no intervention)?

Assessing the usefulness of a medical intervention in practice differs from assessing formal efficacy. In conventional practice, clinicians make decisions based on the characteristics of the patient, clinical experience, potential for harm, and information from colleagues and the medical literature. In addition, when more than one treatment is possible, the clinician may make the choice taking into account the patient's preferences. While it is often thought that there is substantial research evidence to support conventional medical practices; this is frequently not that case. This does not mean that these treatments are ineffective. The data in support of acupuncture are as strong as those for many accepted Western medical therapies.

One of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions. As an example, musculoskeletal conditions, such as fibromyalgia, myofascial pain, and "tennis elbow," or epicondylitis, are conditions for which acupuncture may be beneficial. These painful conditions are often treated with, among other things, anti-inflammatory medications (aspirin, ibuprofen, etc.) or with steroid injections. Both medical interventions have a potential for deleterious side effects, but are still widely used, and are considered acceptable treatment. The evidence supporting these therapies is no better than that for acupuncture.

In addition, ample clinical experience, supported by some research data, suggests that acupuncture may be a reasonable option for a number of clinical conditions. Examples are postoperative pain and myofascial and low back pain. Examples of disorders for which the research evidence is less convincing but for which there are some positive clinical reports include addiction, stroke rehabilitation, carpal tunnel syndrome, osteoarthritis, and headache. Acupuncture treatment for many conditions such as asthma, addiction, or smoking cessation should be part of a comprehensive management program.

Many other conditions have been treated by acupuncture; the World Health Organization, for example, has listed more than forty for which the technique may be indicated.

3. What is known about the biological effects of acupuncture that helps us understand how it works?

Many studies in animals and humans have demonstrated that acupuncture can cause multiple biological responses.

These responses can occur locally, i.e., at or close to the site of application, or at a distance, mediated mainly by sensory neurons to many structures within the central nervous system. This can lead to activation of pathways affecting various physiological systems in the brain as well as in the periphery. A focus of attention has been the role of endogenous opioids in acupuncture analgesia. Considerable evidence supports the claim that opioid peptides are released during acupuncture and that the analgesic effects of acupuncture are at least partially explained by their actions. That opioid antagonists such as naloxone reverse the analgesic effects of acupuncture further strengthens this hypothesis. Stimulation by acupuncture may also activate the hypothalamus and the pituitary gland, resulting in a broad spectrum of systemic effects. Alteration in the secretion of neurotransmitters and neurohormones and changes in the regulation of blood flow, both centrally and peripherally, have been documented. There is also evidence that there are alterations in immune functions produced by acupuncture. Which of these and other physiological changes mediate clinical effects is at present unclear.

Despite considerable efforts to understand the anatomy and physiology of the "acupuncture points," the definition and characterization of these points remains controversial. Even more elusive is the scientific basis of some of the key traditional Eastern medical concepts such as the circulation of Qi, the meridian system, and the five phases theory, which are difficult to reconcile with contemporary biomedical information but continue to play an important role in the evaluation of patients and the formulation of treatment in acupuncture.

Some of the biological effects of acupuncture have also been observed when "sham" acupuncture points are stimulated, highlighting the importance of defining appropriate control groups in assessing biological changes purported to be due to acupuncture. Such findings raise questions regarding the specificity of these biological changes. In addition, similar biological alterations including the release of endogenous opioids and changes in blood pressure have been observed after painful stimuli, vigorous exercise, and/or relaxation training; it is at present unclear to what extent acupuncture shares similar biological mechanisms.

It should be noted also that for any therapeutic intervention, including acupuncture, the so-called "non-specific" effects account for a substantial proportion of its effectiveness, and thus should not be casually discounted. Many factors may profoundly determine therapeutic outcome including the quality of the relationship between the clinician and the patient, the degree of trust, the expectations of the patient, the compatibility of the backgrounds and belief systems of the clinician and the patient, as well as a myriad of factors that together define the therapeutic milieu.

Although much remains unknown regarding the mechanism(s) that might mediate the therapeutic effect of acupuncture, the panel is encouraged that a number of significant acupuncture-related biological changes can be identified and carefully delineated. Further research in this direction not only is important for elucidating the phenomena associated with acupuncture, but also has the potential for exploring new pathways in human physiology not previously examined in a systematic manner.

4. What issues need to be addressed so that acupuncture may be appropriately incorporated into today's health care system?

The integration of acupuncture into today's health care system will be facilitated by a better understanding among providers of the language and practices of both the Eastern and Western health care communities. Acupuncture focuses on a holistic, energy-based approach to the patient rather than a disease-oriented diagnostic and treatment model.

An important factor for the integration of acupuncture into the health care system is the training and credentialing of acupuncture practitioners by the appropriate state agencies. This is necessary to allow the public and other health practitioners to identify qualified acupuncture practitioners. The acupuncture educational community has made substantial progress in this area and is encouraged to continue along this path. Educational standards have been established for training of physician and non-physician acupuncturists. Many acupuncture educational programs are accredited by an agency that is recognized by the U.S. Department of Education. A national credentialing agency exists that is recognized by some of the major professional acupuncture organizations and provides examinations for entry-level competency in the field.

A majority of States provide licensure or registration for acupuncture practitioners. Because some acupuncture practitioners have limited English proficiency, credentialing and licensing examinations should be provided in languages other than English where necessary. There is variation in the titles that are conferred through these processes, and the requirements to obtain licensure vary widely. The scope of practice allowed under these State requirements varies as well. While States have the individual prerogative to set standards for licensing professions, harmonization in these areas will provide greater confidence in the qualifications of acupuncture practitioners. For example, not all States recognize the same credentialing examination, thus making reciprocity difficult.

The occurrence of adverse events in the practice of acupuncture has been documented to be extremely low. However, these events have occurred in rare occasions, some of which are life threatening (e.g., pneumothorax). Therefore, appropriate safeguards for the protection of patients and consumers need to be in place. Patients should be fully informed of their treatment options, expected prognosis, relative risk, and safety practices to minimize these risks prior to their receipt of acupuncture. This information must be provided in a manner that is linguistically and culturally appropriate to the patient. Use of acupuncture needles should always follow FDA regulations, including use of sterile, single-use needles. It is noted that these practices are already being done by many acupuncture practitioners; however, these practices should be uniform. Recourse for patient grievance and professional censure are provided through credentialing and licensing procedures and are available through appropriate State jurisdictions.

It has been reported that more than one million Americans currently receive acupuncture each year. Continued access to qualified acupuncture professionals for appropriate conditions should be ensured. Because many individuals seek health care treatment from both acupuncturists and physicians, communication between these providers should be strengthened and improved. If a patient is under the care of an acupuncturist and a physician, both practitioners should be informed. Care should be taken so that important medical problems are not overlooked. Patients and providers have a responsibility to facilitate this communication.

There is evidence that some patients have limited access to acupuncture services because of inability to pay. Insurance companies can decrease or remove financial barriers to access depending on their willingness to provide coverage for appropriate acupuncture services. An increasing number of insurance companies are either considering this possibility or now provide coverage for acupuncture services. Where there are State health insurance plans, and for populations served by Medicare or Medicaid, expansion of coverage to include appropriate acupuncture services would also help remove financial barriers to access.

As acupuncture is incorporated into today's health care system, and further research clarifies the role of acupuncture for various health conditions, it is expected that dissemination of this information to health care practitioners, insurance providers, policymakers, and the general public will lead to more informed decisions in regard to the appropriate use of acupuncture.

Conclusions and Recommendations Acupuncture as a therapeutic intervention is widely practiced in the United States. There have been many studies of its potential usefulness. However, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebo and sham acupuncture groups.

However, promising results have emerged, for example, efficacy of acupuncture in adult post-operative and chemotherapy nausea and vomiting and in post-operative dental pain. There are other situations such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma where acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful.

Findings from basic research have begun to elucidate the mechanisms of action of acupuncture, including the release of opioids and other peptides in the central nervous system and the periphery and changes in neuroendocrine function. Although much needs to be accomplished, the emergence of plausible mechanisms for the therapeutic effects of acupuncture is encouraging.

The introduction of acupuncture into the choice of treatment modalities that are readily available to the public is in its early stages. Issues of training, licensure, and reimbursement remain to be clarified. There is sufficient evidence, however, of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value.

SIGNIFICANCE

News spread quickly in the final months of 1997 when the NIH panel of experts concluded that acupuncture was an effective therapy for certain medical conditions, particularly for nausea and pain. The idea that physicians should try to integrate traditional Chinese medicine into standard medical practice for these problems was simultaneously considered both remarkable and unlikely by many health care professionals, even when they were inclined to accept the panel findings.

In the spirit of Herodotus' admonition to "do no harm," the panel emphasized that acupuncture was comparatively safe, with fewer side effects than many well-established pain therapies, including opioids (medicines with opiate compounds such as codeine) and nonsteroidal anti-inflammatory medications. Current estimates of acupuncture use are that more than a million Americans rely on acupuncture to treat ailments ranging from headache and bowel disorders to arthritis and stroke.

The panel's findings encouraged more patients and physicians to consider acupuncture as an alternative or complementary treatment for some common health problems, including nausea associated with pregnancy and cancer chemotherapy, and pain following dental surgery. The report has fostered the use of acupuncture to treat chronic problems, like low back pain and asthma, for which standard treatments are inadequate or costly or may entail serious side effects. It also encouraged some medical doctors to become certified as medical acupuncturists and augment their practices by treating acupuncture patients themselves.

The report prompted health insurers, including Medicare and Medicaid, to begin covering the costs of acupuncture for conditions where the panel identified clear evidence of its benefits.

The positive recommendation of the panel came as a surprise to many health care providers and medical scholars. The medical establishment had been slow to accept acupuncture because the traditional Chinese explanations for its observed effects were based on unproved concepts of opposing forces called yin and yang, which, when out of balance, disrupt the natural flow of qi in the body.

However, the panel cited growing evidence of biological effects induced by acupuncture that might help to explain the benefits observed in scores of studies and in medical practice. For example, acupuncture is associated with the release of natural pain-relieving endorphins. Acupuncture also appears to alter the functioning of the immune system.

Thus, after evaluating seventeen presentations summarizing hundreds of studies conducted in recent years, primarily in Western countries, the panel recommended that acupuncture be integrated into medical practice. However, acupuncture critics said that the presentations were biased in favor of acupuncture's effectiveness and that experts wanting to testify against its efficacy were not invited to present their views. Wallace Sampson, a researcher who prepared the National Council Against Health Fraud's position paper on acupuncture (1991) pointed out that the best-designed studies of acupuncture tended to show the poorest efficacy results. This fact was also mentioned in several of the panel presentations.

Nevertheless, the panel represented multiple scientific disciplines and included some physicians who practice acupuncture or have been treated by it. The panel based its conclusions almost entirely on studies that meet criteria for well-designed research. It did not issue a forceful endorsement of acupuncture, but did find the procedure to be particularly effective for treating painful disorders of the musculoskeletal systems, such as fibromyalgia and tennis elbow, and possibly safer than currently accepted remedies for those disorders. Also, acupuncture might be a reasonable option for low back and post-operative pain, and showed some potential for use in drug addiction, stroke rehabilitation, carpal tunnel syndrome, osteoarthritis, headache, and asthma.

Although the panel cited the lack of well-designed clinical studies of acupuncture, it found that in many cases "the data supporting acupuncture are as strong as those for many accepted Western medical therapies." Many of these therapies are simply palliative. The long-term use of non-steroidal anti-inflammatory painkillers is known to have risk for deleterious effects, including hemorrhagic stroke and gastrointestinal bleeding. Still, the panel called for larger, better, and longer studies to properly establish acupuncture's therapeutic benefits and limitations. This is unlikely to happen independently of government funding, as the private sector is unlikely to support research on a technique that cannot be patented.

Although the panel focused on clinical studies that represented the gold standard of efficacy research, randomized placebo-controlled double-blind trials, these studies often had small numbers of patients. There is also controversy over whether "sham acupuncture," in which needles are placed in spots that are not recommended in traditional acupuncture, is a true placebo control. Sham acupuncture is also associated with some of the neurohormonal changes that have been found to result from regular acupuncture, so it is unclear whether sham acupuncture truly qualifies as "no treatment." This makes it difficult to determine the true benefit of real acupuncture.

The dependency of medical research on the economic incentives involved in patent protection is perhaps the most significant observation coming out of the consensus panel review process. This dependency has consequences far beyond the question of the efficacy of acupuncture. Private enterprise has been a huge source of dramatic and profound innovation in health care. However, the area of research pertaining to older and traditional therapies such as acupuncture that could potentially show as much effectiveness as some expensive innovations, is one in which the current research funding system is weak. Consequently, certain areas such as pain in which true innovations have been hard to achieve suffer from a paucity of well-designed, well-funded studies that could either usher in a new era of "high-touch" medical practice with less use of potentially harmful drug treatment, or finally put to rest contentions that this form of traditional medicine can really benefit people who desperately seek better quality of life.

The NIH National Center for Complementary and Alternative Medicine is an attempt in the United States to address the underfunding of rigorous research in important alternative health care areas that do not promise large financial returns to private investors. The center is currently pursuing research in the efficacy and safety of herbal medicines; biologically based practices such as dietary supplements, some of which (e.g. quinine) have proved to be effective medical treatments; manipulation and body-based practices such as chiropractic; mind-body medicine; and whole medical systems such as traditional Chinese medicine, acupuncture, and homeopathy. Some of research could produce useful treatments that otherwise would be discarded or overlooked because they would not reward significant financial investment.

FURTHER RESOURCES

Books

Kidsin, Ruth. Acupuncture for Everyone. Rochester, VT: Healing Arts Press, 1991.

Periodicals

Cassileth, B. R. and G. Deng. "Complementary and Alternative Therapies for Cancer." The Oncologist 9 no. 1 (February 2004): 80-89.

Web sites

National Center for Complementary and Alternative Medicine. "Whole Medical Systems: An Overview." 〈http://nccam.nih.gov/health/backgrounds/wholemed.htm#tcm〉 (accessed January 31, 2006).