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Acupuncture: Does the Evidence Support

its Efficacy? A Systematic Review of the

Literature

SARAH LYNLEY RADER, D.O., Community Westview Family Medicine Residency,

Indianapolis, Indiana

Introduction

From the beginning, medicine has been fraught with ideas that were initially met with skepticism. Some of these preposterous ideas eventually turned out to be groundbreaking scientific discoveries that changed the world. For example, in the 16th century no one could believe that illness could be caused by invisible organisms that invaded the body. But then Antoine van Leeuwenhoek perfected the microscope and discovered bacteria, becoming known as “the father of microbiology.” Edward Jenner, “the father of immunology,” was a country doctor who became fascinated by the old wives’ tale that milkmaids could not get smallpox. He had a difficult time convincing people that

deliberately infecting them with extremely mild cases of a disease could protect them from ever actually catching that disease until he pioneered the smallpox vaccine. Barry Marshall, an obscure Australian physician, was reportedly booed off the stage at ground rounds for theorizing that peptic ulcer disease was caused by an infectious agent.1 Establishment doctors and scientists did not believe that bacteria

could possibly live in the acidic environment of the stomach. He later went on to win the Nobel Prize when he demonstrated that the bacterium Helicobacter Pylori causes most peptic ulcers.

Today, acupuncture, although having a long and robust history, is considered outside the mainstream and thus labeled “alternative.” Alternative therapies are grouped under the wide umbrella of “complementary and alternative medicine,” or “CAM,” a term that arose in the 1990s to give name to such diverse healing modalities as acupuncture, yoga, meditation, massage, and herbal medicine. No matter how one defines CAM modalities, there is no denying they are rapidly becoming more main stream and are actively being sought out by patients.

Americans have been seeking out non-conventional therapy for over 20 years. In fact, about one fourth of the American public is skeptical of conventional medical explanations for disease and efficacy of conventional medicine. In 1990, Americans made 425 million visits to providers of alternative medicine. What is more remarkable is that this number actually exceeded the 388 million visits to physicians who provided conventional primary care.2 According to the National Center for

Complementary and Alternative Medicine (NCCAM) and the National Center for Health Statistics (NCHS) the U.S. public spent $40 billion on CAM. In 2002, 8 million adults reported having used acupuncture in their lifetime, and greater than 2 million adults reported using it the previous year. 2007 National Institute of Health (NIH) statistics show 3.1 million American adults and 150,000 American children underwent acupuncture in 2006.3 In 2009 the U.S. Air force became a believer, implementing battlefield

acupuncture in Iraq and Afghanistan. Acupuncture is increasingly being used by the military to treat post-traumatic stress disorder. Currently NATO forces are considering following the Americans’ lead .4

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Why do patients turn to acupuncture? For the most part, people use acupuncture for chronic, painful conditions. Back pain and arthritis are the most common conditions treated by acupuncture, followed by chronic headache and migraine.5 This makes sense when one considers that osteoarthritis,

joint disorders, and back problems are among the most prevalent conditions for which Americans seek health care. 6 Although most people believe there to be a substantial amount of research backing

conventional medical practices, many times this is far from the truth. Can the same be said for

alternative therapies such as acupuncture? According to the NIH Consensus Statement on acupuncture the data and supporting evidence behind acupuncture is just as robust as that for many accepted western therapies.7 Nevertheless, in spite of its usefulness, and perhaps because of its popularity, there

remains among some a sense that these approaches lack sufficient evidence basis. This then raises the question as to what differentiates CAM from mainstream medicine. There is hardly a narrower, more limiting term than “alternative,” an idea defined by that which it is not. “From the word alone, you have no idea what you’re getting, only what is being left out,” says Brent Bauer, M.D.1 If a natural substance

is studied in an appropriately designed clinical trial, is it no longer an “alternative medicine?” Once the medication becomes “mainstream” and is recommended by allopathic physicians, is it no longer “complementary?” This paper will attempt to determine whether there is a sufficient body of scientific experimental evidence to support acupuncture as a therapeutic modality equal to or superior to other traditional or “mainstream” treatments.

Defining the Review Criteria

The objective of this review is to determine the quality of scientific evidence behind the practice of acupuncture in treating common medical conditions in the primary care setting. There are no

uniformly accepted criteria by which one can evaluate the validity or quality of a study. In fact more than 100 grading scales are in use by various medical publications according to the Agency for

Healthcare Research and Quality. 8 In an effort to create a standardized approach, the editors of the U.S.

family medicine and primary care journals (i.e., American Family Physician, Family Medicine, Journal of Family Practice, Journal of the American Board of Family Practice, and BMJ-USA) and the Family Practice Inquiries Network (FPIN) came together to develop a unified taxonomy (SORT) for the Strength of recommendations based on a body of evidence. For the purposes of this study, patient oriented, rather than disease oriented, outcomes will be considered. Patient oriented outcomes that matter, also referred to as “POEMS,” are those that matter to patients, in this case providing symptomatic relief and improved quality of life. This can be contrasted with disease oriented outcomes which incorporate histopathologic, physiologic, or surrogate results, such as blood sugar and blood pressure.

The essential goal is to evaluate the strength of various acupuncture modalities using patient oriented evidence. Although this would allow us to establish practice guidelines based upon levels of evidence and SORT, this is beyond scope of this review.* As mentioned above, the goal of this treatise is

to determine whether there is sufficient evidence to support the use of acupuncture in the practice of family medicine. That is, can the clinician offering acupuncture to his/her patients be confident that *In March 2002, the Agency for Healthcare Research and Quality (AHRQ) published a report that summarized the state-of-the-art methods of rating the strength of evidence. The report identified a large number of systems for rating the quality of individual studies: 20 for systematic reviews, 49 for randomized controlled trials, 19 for observational studies, and 18 for diagnostic test studies. It also identified 40 scales that graded the strength of a body of evidence consisting of one or more studies.7

JUNE 4, 2014: Acupuncture: Does the Evidence Support its Efficacy? Page 2

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there is a high level strength of recommendation? The following diagram (figure 1) aligns well with the goals of this review article and will form the basis of the SORT ranking. In making this determination, reliance on meta analyses provided by the Cochrane database was significant.

Figure 1

THIS ALGORITHM IS MOST ALIGNED WITH THE GOALS OF THIS REVIEW ARTICLE AND WILL FORM THE BASIS OF THE SORT RANKING.

Acupuncture

Acupuncture is one of the oldest healing modalities in the world. Although the Chinese practice of acupuncture can be traced back at least 2500 years2, less than 50 years have passed since its

“introduction” to the west following President Nixon’s visit to China in 1971. Since then the interest in both the U.S. and Europe has grown rapidly.

When we view acupuncture through the lens of traditional Chinese medicine, it soon becomes apparent that its mechanism of action is based on theories that are unfamiliar to those trained in western medicine. It is perhaps because of this unfamiliarity that there remains skepticism regarding the

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usefulness of acupuncture. With the traditional scientific community increasingly calling for evidence based studies to support the value of any therapeutic intervention, the goal through this review is to determine if and what evidence exists to validate acupuncture’s therapeutic efficacy relative to other modalities.

Traditional Chinese Medicine theorizes that pain and disease result from either the blockage or stagnation of normal movement of the body’s vital energy, or “qi.”9 Qi flows through invisible tracts or

channels throughout the body. These channels are called meridians. The meridians are distinct from other anatomical networks such as nerves or blood vessels.10 Several hundred specific points on the

body, called acupoints or acupuncture points, are used as sites for insertion of fine, solid, metallic needles into the skin.7 Placing the acupuncture needles at specific acupuncture points is believed to

restore the proper flow of qi. The needles are typically inserted to a certain depth and left in place for 15-30 minutes. The needles may be manually stimulated to produce “de qi” (a dull, localized ache) and “needle grasp” a tugging sensation noted by the physician as the needle moves against connective tissue. Frequently additional needle stimulation with electrical current, or electroacupuncture, is used.11 The standard amount and duration of treatment varies based on patient specific condition and

physician practices, but on average 12 treatments, once to twice a week, would be considered sufficient to treat most conditions. Acupuncture is considered safe, with relatively few side effects and extremely rare adverse events. Additionally, acupuncture has a favorable cost profile.

Although it is not the goal of this study to elucidate how acupuncture exerts its therapeutic effects, in recent years significant efforts have focused on identifying the physiologic mechanism of acupuncture. Western friendly theories have proposed a link between the anti-nociceptive actions of acupuncture and the release of endogenous endorphins. That the opioid antagonist naloxone reverses the analgesic effects of acupuncture further strengthens this hypothesis. Other studies have linked pain relief of acupuncture from a needle evoked release of adenosine and adenosine triphosphate. Local accumulations of these transmitters can lead to adenosine receptor activation on nearby afferent nerves, likely responsible for local analgesia.10 It has been shown to have multiple effects on the central

and peripheral nervous systems which are presumed to change pain perception through an unknown mechanism.9 Acupuncture may also activate the hypothalamic-pituitary axis thus resulting in a broad

spectrum of systemic effects. Alteration in neurotransmitter and neurohormone secretion and change in regulation of blood flow both centrally and peripherally have been documented.

Analysis of Relevant Studies:

The World Health Organization declared acupuncture a useful adjunct for more than 50 medical conditions. The NIH agrees, endorsing acupuncture’s potential in the treatment of addiction, migraines, menstrual cramps, abdominal pain, tennis elbow, nausea resulting from chemotherapy and more. Using key words and phrases such as acupuncture, pain management, complementary and alternative

medicine, and specific disease entities such as “back pain,” the English language literature was searched for clinical studies, review articles and other information relating to acupuncture. The Cochrane

database was particularly useful in that its reviewers also accessed the Chinese literature. Of greatest interest were studies relating to conditions frequently encountered by the family physician. The results of these studies were then evaluated to determine the relative strength of each recommendation based upon SORT criteria.

When studying acupuncture there are a number of limitations. Outcomes measured are often subjective, which are more difficult to quantitate than objective outcomes, such as physiological parameters (i.e. blood pressure). It is difficult to appropriately blind patients in the sham treatment

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group of a study protocol involving a procedure, particularly one that may involve a small degree of discomfort. It is also difficult to account for the placebo affect associated with studies involving procedures or the “laying on of hands.”

Analysis

Back Pain:

Pain, with low back pain number one on the list, is the most common cause of physician visits.4 It is a major reason for absenteeism and disability. Chronic musculoskeletal pain syndromes are

the most common reasons people try acupuncture and of these, chronic low back pain is most prevalent.12 A 2005 Cochrane database systematic review article comprising thirty-five randomized

controlled trials with 2,861 patients concluded that there is insufficient evidence to recommend

acupuncture for acute low back pain. For chronic low back pain however, the results demonstrated that acupuncture is more effective for pain relief than either no treatment or sham treatment in

measurements taken up to 3 months. The results also demonstrated that for chronic low back pain, acupuncture is more effective for improving function in the short term than no treatment. Acupuncture alone is not more effective than other conventional or “alternative” treatments, but when added to other conventional therapies it relieves pain and improves function better than conventional therapies alone. Overall the effects were small and more research is needed. The Royal College of Surgeons in Ireland performed a systematic literature search without date or language restrictions up to May 2012. Studies were randomized controlled trials that examined all forms of acupuncture that adhered to traditional acupuncture theory for the treatment of chronic low back pain. The quality of the studies was examined using the Cochrane risk of bias tool. They concluded “acupuncture may have a favorable effect on self-reported pain and functional limitations on non-specific chronic low back pain.” 13

A large well designed German acupuncture trial showed statistically and clinically significant benefit of true acupuncture and a sham procedure compared with usual care; the 2 acupuncture groups showed approximately a 50% response rate at 6 months.14 Acupuncture may be more effective than

medication for symptom improvement or relieve pain better than sham acupuncture in acute low back pain according to a study done by the department of oriental rehabilitation medicine, college of Korean medicine, Seoul, Korea and published in the Clinical Journal of Pain in 2013.15

Assessment: based upon multiple systematic meta-analyses noted above, the body of evidence supports a SORT rating of A for the use of acupuncture in the treatment of chronic low back pain. That is, there is relatively consistent and good-quality patient-oriented evidence. In the case of acute low back pain, the evidence is less consistent and inadequate to conclusively recommend acupuncture. Nevertheless, for the treatment of acute low back pain the body of evidence supports a SORT ranking of B.

Neck pain

Neck pain is one of the most frequent complaints of the musculoskeletal system. In a review performed for the Cochrane library that included the database TCMLARS in China, the authors were unable to find any trials that examined acupuncture for acute or sub-acute neck pain. Ten trials (661 participants) addressing chronic neck pain were included in this review and acupuncture was compared to sham acupuncture, a waiting list, laser sham treatments (sham laser, sham TENS unit) or other treatments (mobilization, massage, traction).16 The trials were of moderate methodological quality but

the number of participants in each trial was relatively low. Only limited conclusions could be drawn

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because of the range of individuals studied, acupuncture techniques used and outcomes measured. The results of the trials to get an overall picture of acupuncture effectiveness were limited because the results could not be combined. Individuals with chronic neck pain who received acupuncture reported, on average, better pain relief immediately after treatment and in the short term than those who received sham treatments.

Assessment: although the Cochrane review found moderate evidence that acupuncture provides superior pain relief when compared to other modalities, the individual trials had relatively low number of participants making it difficult to provide a strong recommendation of efficacy. For neck pain, the body of evidence supports a SORT rating of B.

Migraine Prophylaxis:

An intervention review by the Cochrane Pain Palliative and Supportive Care Group searched CENTRAL, MEDLINE, EMBASE, and the Cochrane Complementary Medicine Field Trials Register through January 2008. This review was an updated version of a similar review performed in 2001 but included 12 additional reviews done in the interim. They included randomized trials with post randomization

observation periods of no less than 8 weeks that compared effects of acupuncture with a control, a sham acupuncture intervention, or another intervention in patients with migraines. Twenty-two of these trials met inclusion criteria and contained 4,419 participants. Six trials compared acupuncture to routine care only. Participants in the acupuncture group had higher response rates and fewer headaches after 3-4 months. Fourteen trials comparing true acupuncture with various sham acupuncture

treatments showed no statistically significant difference between the interventions in migraine response rates. When comparing acupuncture with proven prophylactic drug treatment, four trials showed that acupuncture was associated with better outcomes at 2, 4, and 6 months after randomization and had fewer adverse effects than prophylactic drug treatment.17

The same Cochrane editorial group that reviewed acupuncture for migraine prophylaxis also conducted an intervention review of acupuncture for the treatment of tension-type headaches. This review was also an updated version of a previous one with 6 additional trials included. The Cochrane Pain, Palliative, and Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE, and the Cochrane Complementary Medicine Field Trials Register were searched through January of 2008. Eleven trials (2317 participants) met inclusion criteria. Two trials investigated whether acupuncture added to basic care was superior to acute care alone. Significant short term benefits (up to 3 months) were associated with the acupuncture adjunct group. Six trials comparing acupuncture with sham treatments found a small, but significant, reduction in number of headache days in the true acupuncture group. The authors concluded that the available studies found acupuncture to be at least as effective as, or possibly more effective than prophylactic drug treatment with fewer adverse effects. They also concluded that acupuncture should be considered a treatment option for patients desiring migraine prophylaxis.

In treatment of tension or episodic like headaches, acupuncture was shown to be beneficial for response (i.e. at least 50% reduction in headache frequency) and several other outcomes compared with sham treatment.18

Assessment: based upon the clear Cochrane recommendation and consistent findings from other studies, acupuncture is effective in the prophylactic treatment of migraine headaches as well as treatment of tension-type headache. The body of evidence supports a SORT rating of A.

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Rheumatoid and joint arthritis:

Acupuncture has been studied in both rheumatoid and joint arthritis. Acupuncture has not been found to have any effect on serum markers, pain, medication use or disease activity in rheumatoid arthritis. Sham controlled trials showed a small, statistically significant benefit that was of questionable clinical relevance. When acupuncture is compared with a wait list control, beneficial effect is more robust, possibly due to a placebo effect .19 Cost of treatment, coupled with lack of coverage for

acupuncture by most insurance companies limits utility of this option.

A review shows that in people with osteoarthritis, acupuncture may lead to small improvements in pain and physical function after 8 weeks with small improvements in pain and physical function after 26 weeks.19 A large high quality randomized controlled trial showed improvement in function and pain

relief when acupuncture was compared with sham acupuncture or patient education. Systematic reviews and meta-analyses have also been published. The Cochrane Musculoskeletal Group reviewed sixteen trials (3498 participants) and found statically significant, short-term improvements in

osteoarthritis pain when compared to sham, but the benefits did not meet their predetermined thresholds for clinical relevance. When compared to no treatment, the results were both statistically significant and clinically relevant.20

Assessment: although acupuncture does not seem to demonstrate any clear-cut evidence of efficacy in the treatment of rheumatoid arthritis, the meta-analysis of its efficacy in osteoarthritis is more compelling. Acupuncture appears to be clearly superior to no treatment and statistically superior to sham treatment. The question is whether the benefit is clinically relevant. Until that question is answered, the body of evidence supports a SORT rating of B.

Irritable Bowel Syndrome:

Irritable bowel syndrome is a chronic gastrointestinal condition characterized by altered bowel habits and abdominal pain and discomfort. Cochrane attempted to assess efficacy and safety of using acupuncture for irritable bowel syndrome.21 A review of 17 randomized controlled trials including 1806

patients and 5 randomized controlled trials including 411 patients compared acupuncture to sham acupuncture for the treatment of irritable bowel syndrome. These studies tested the effects of acupuncture on symptom severity or health-related quality of life. None of these trials found acupuncture to be better than sham acupuncture. Evidence from 4 Chinese language comparative effectiveness trials showed acupuncture to be superior to two antispasmodic drugs, both of which provide a modest benefit for the treatment of irritable bowel syndrome although neither is approved for treatment of irritable bowel syndrome in the United States.

Assessment: the current body of evidence does not clearly support the efficacy of acupuncture for the treatment of irritable bowel syndrome resulting in a SORT rating of C.

Asthma

The objective of a 2003 Cochrane review was to assess whether there is evidence from randomized controlled trials that asthma or asthma-like symptoms benefit from acupuncture.22 The

study authors concluded that there was not sufficient evidence to make recommendations about the value of acupuncture as a treatment for asthma. The studies used were of variable quality with inconsistent results. The reviewing authors suggested that future research should concentrate on whether there is a non-specific component of acupuncture which benefits recipients of treatment. There should be an assessment not merely of placebo treatment, but of also, “no treatment” as well.

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Assessment: the current body of evidence does not clearly support the efficacy of acupuncture in the treatment of asthma mandating a SORT rating of C.

Chemotherapy induced nausea and vomiting:

In 2011 the Cochrane Pain, Palliative and Support Group looked at whether stimulating

acupuncture points could reduce nausea and vomiting caused by chemotherapy. The authors reviewed eleven studies (1247 participants) and found that electroacupuncture reduced first day vomiting

whereas manual acupuncture did not. Acupressure also reduced nausea, but was not effective on later days and acupressure showed no benefit for vomiting. Electrical stimulation on the skin showed no benefit. All trials also gave anti-vomiting drugs, but the drugs used in the electroacupuncture trials were not the most modern drugs, so it is not known if the benefits of electroacupuncture have clinical relevance. The authors concluded that additional studies of electroacupuncture with modern anti-emetic drugs are needed.23

Assessment: the current body of evidence shows a small benefit of acupuncture in the treatment of chemotherapy induced nausea and vomiting but the clinical relevance remains

unanswered due to a lack of trials comparing acupuncture to modern anti-emetics. Until that time the use of acupuncture for the treatment of chemotherapy induced nausea and vomiting earns a SORT rating of B.

Cancer pain

Three randomized controlled trials with 204 patients were included. One study comparing acupuncture with medication concluded that both methods were effective in controlling pain, although acupuncture was the most effective. Long-term pain relief was reported for both acupuncture and point injection compared with medication during the last 10 days of treatment.24 Although both studies have

positive results in favor of acupuncture, they should be viewed with caution due to methodological limitations, small sample sizes, poor reporting and inadequate analysis. The conclusion is that there is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults. Nevertheless, the use of acupuncture for the treatment of cancer pain is endorsed by the Society of Integrative Oncology.25

Assessment: although acupuncture seems to be effective in the treatment of cancer pain, at this point there is not enough evidence to support a SORT rating above B. Given the relatively strong

evidence of acupuncture’s benefit in treating other types of pain, this is an area that should benefit from additional studies.

Psychological distress

The purpose of this study was to evaluate and compare the effects of an integrative treatment (IT) therapeutic acupuncture (TA), conventional treatment (CT) in alleviating symptoms of anxiety and depression in psychologically distressed primary care patients. An open pragmatic randomized

controlled trial consisting of 120 adults was used in the study. The study concluded that both integrative treatment and therapeutic acupuncture appeared to be beneficial in reducing anxiety and depression in primary care patients referred for psychological distress whereas CT does not. These results need to be confirmed in larger, longer-term studies addressing potentially confounding design issues in the present study.26

Assessment: due to a lack of sufficient number of studies it is not possible to assign a SORT rating above C at this time.

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Allergic Rhinitis

The Department of Medical Research of the Korean Institute of Oriental Medicine designed a study to evaluate the efficacy and safety of acupuncture in the treatment of allergic rhinitis. The study, which was published in 2013, was a multicenter randomized parallel-controlled study in which there were three groups comprising 238 participants. The authors found that acupuncture showed a

significantly greater effect on the nasal symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The results were statistically significant with a 95% confidence interval. Acupuncture also significantly reduced the total non-nasal symptom score, but so did sham treatment. The authors concluded that acupuncture appears to be an effective and safe treatment for allergic rhinitis.27

In 2013 Lee reviewed 115 possibly relevant studies and found 12 RCTs that met their inclusion criteria. Of those, 7 trials were deemed high quality based on their methodological rigor. The results were mixed, suggesting no specific effects of acupuncture for the treatment of seasonal allergic rhinitis with a possible effectiveness for perennial allergic rhinitis. Two RTCs favored acupuncture over oral pharmacological medications.28 In another systematic review, Roberts concluded that there is currently

insufficient evidence to support or refute the use of acupuncture in patients with allergic rhinitis.29

Assessment: The efficacy of acupuncture in the treatment of allergic rhinitis has been investigated through multiple studies without definitive conclusion. Absent consistent findings in multiple RTCs and with no Cochrane review recommendation, the use of acupuncture for the treatment of allergic rhinitis requires a SORT rating of B-.

Fibromyalgia

Fibromyalgia is a complex disorder with many manifestations as defined by the American College of Rheumatology. Patients most often suffer from pain involving joints and muscles, fatigue, sleep disorders and memory problems. Symptoms can vary in intensity over time and may be worsened by stress. In addition, some patients also suffer from depression, migraine, irritable bowel syndrome, GERD and temporomandibular joint dysfunction. The physiologic cause of fibromyalgia is unclear, but there may be a genetic component as well as trigger factors (trauma, physical or emotional stress). Some believe that fibromyalgia causes a change in the way the body “talks “ with the spinal cord and brain, possibly causing changes in levels of brain chemicals and proteins. There are no specific diagnostic tests for fibromyalgia and the diagnosis is generally based on signs and symptoms of tenderness and pain.

There is no cure for fibromyalgia and treatment is largely symptomatic with both medication and non-drug therapy such as Tai Chi, yoga, cognitive behavioral therapy and acupuncture. Currently, one in five fibromyalgia patients uses acupuncture within two years of diagnosis.30

Lack of specific diagnostic tests makes the assessment of acupuncture’s efficacy difficult. For instance, in 2006, Laurie Barkley, MD reported a prospective, partially blinded, randomized study in the Mayo Clinical Proceedings.31 In that relatively small study, 25 patients, all having failed other

conservative symptomatic treatments, were measured with the Fibromyalgia Impact Questionnaire and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 and 7 months. The authors found that acupuncture “significantly improved symptoms of fibromyalgia,” particularly for fatigue and anxiety.

In 2013, the Cochrane Musculoskeletal Group examined nine randomized and quasi-randomized trials involving any type of invasive acupuncture for fibromyalgia that reported any main outcome such as pain, physical function, fatigue, sleep, total well-being, stiffness or adverse events. The authors

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concluded that although acupuncture without electrical stimulation probably does not reduce pain, improve fatigue, improve overall well-being or improve sleep quality, acupuncture with electrical

stimulation is probably better than non-acupuncture treatment in those areas. They also concluded that acupuncture probably enhances the effect of drugs and exercise on pain. They considered the

supportive evidence low to moderate and suggested larger studies were warranted.

Assessment: Based upon the lack of a clear Cochrane recommendation but with consistent findings from several moderate quality diagnostic cohort studies, the use of acupuncture in fibromyalgia requires a SORT rating of B+.

Discussion and Conclusion:

Medicine has a well-documented history of ideas and treatment modalities that, while initially ridiculed or criticized, eventually turned out to be proven correct. The question then arises; how does one know whether a treatment is truly beneficial or nothing more than a passing fad? One potential solution to the problem might be the recent incorporation of evidence-based medicine (EBM) into the clinical decision process. Even the term “evidence-based medicine” is a relative newcomer to medicine. In their 2005 review article, Claridge and Fabian found that investigators from McMaster’s University first began using the term during the 1990s. In 1996, Sackett et al. defined the term further as “the conscientious and judicial use of current best evidence from clinical care research in the management if individual patients.”32

Although EBM provides a useful tool for the clinician, there remain certain limitations. For example, clinicians currently lack a uniform agreement as to what constitutes adequate evidence or how to best determine the quality of a given study. As noted previously, the taxonomy for the strength of recommendations (SORT) is one such effort. Along with the Cochrane Review, it provides clinicians with a reasonable framework with which to evaluate various therapeutic modalities. These will form the basis of my assessment of acupuncture as a therapeutic tool.

As I researched my topic two issues arose immediately. First, it became apparent that the terms complementary medicine, alternative medicine, and traditional medicine were being used

inconsistently. Further, in order to put my findings for acupuncture into perspective, I would need to subject several common traditional medicine therapies to similar scrutiny.

According to the World Health Organization, “traditional medicine is the sum total of the knowledge, skills and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.”33 Although the terms

“complementary medicine” or “alternative medicine” are used interchangeably in some countries, they in actuality refer to a broad set of health care practices that are not part of that country’s own tradition and are not integrated into the dominant health care system. This is why even the National Center for Complementary and Alternative Medicine (NCCAM) admits that the terms are “actually hard to define and mean different things to different people.” It appears that the differences among these three types of medicine are cultural rather than efficacy based. That is, traditional medicine has no greater claim to effectiveness than alternative medicine. Each must stand on its own unique merits, and currently our best gauge of effectiveness is the use of EBM noted above.

To address the second issue and put my findings into perspective, I investigated several concepts generally associated with traditional medicine to determine whether they had the same level

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EBM support being asked of acupuncture. Not surprisingly, many had either not been studied or were in fact found to lack robust evidence based support. For example, Prochazka et al pointed out in the Archives of Internal Medicine that although the evidence does not support the value of annual screening physical exams in asymptomatic adults, most primary care physicians continue to perform such

exams.34 One might conclude that alternative medical practices are held to a more robust burden of

proof in demonstrating efficacy than traditional medicine.

Study Protocol

Using key words and phrases such as acupuncture, pain management, and complementary and alternative medicine, the English language literature was searched for clinical studies, review articles and other information relating to acupuncture. The Cochrane Review was particularly useful in that its reviewers also accessed the Chinese literature. Of greatest interest were studies relating to conditions frequently encountered by a family physician. The results of these studies were then evaluated to determine the relative strength of each recommendation based upon SORT ranking criteria as noted above.

Conclusions

As shown above in the “Review of Studies” section, the evidence based support for acupuncture is varied and in many instances insufficient to provide a strong recommendation for efficacy. In some cases there were conflicting results when comparing the English language and Chinese studies. For example, 17 English language randomized controlled trials including 1,806 participants found

acupuncture to be ineffective in the treatment of irritable bowel syndrome whereas 4 Chinese language studies demonstrated superior results with acupuncture compared to antispasmodic drugs.

Although acupuncture has its proponents, I found insufficient evidence basis to recommend it in the treatment of irritable bowel syndrome, asthma or for the treatment of anxiety or depression. That in no way suggests that acupuncture should be abandoned in these areas, it simply means that

additional or higher quality studies are needed.

In some areas the evidence-based support is rather strong, particularly in the area of pain management where the results showed acupuncture to be statistically superior to control in all analyses when treating back pain, neck pain, shoulder pain, headache and osteoarthritis. Frequently, as in the treatment of fibromyalgia, allergic rhinitis, osteoarthritis pain and chemotherapy induced nausea and vomiting the efficacy of acupuncture is less clear with mixed evidence based results. In these situations acupuncture may be a viable modality.

Anecdotally, there appears to be somewhat of a cultural bias in traditional medicine against acupuncture. I would propose several possible factors. In some groups there can exist an inherent bias against ideas not emanating from within its ranks – the “not invented here” syndrome. A second factor might be the early proposed mechanisms of action for acupuncture. These early theories describe concepts such as meridians and “qi” that are not familiar to western medicine. Those trained in western medicine are likely much more comfortable with more recent theories rooted in physiology and

biochemistry. Lack of consistent reimbursement from insurance carriers and a paucity of formal training opportunities may also play a role. Lastly, some physicians favor traditional therapeutic modalities and are off-put by treatments that they view as consumer driven.

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This may soon change, particularly in light of a new law passed by the Indiana legislature to comply with a federal mandate. The law requires physicians to perform certain protocols when

prescribing narcotic medications for the treatment of chronic pain. If the protocols are not followed, the physician could face licensure actions or potential criminal prosecution. In order to prescribe opioid narcotics for pain, the law requires the physician to perform a detailed history and physical exam, obtain mental health, opiate-addiction risk and pain management questionnaires, develop an individualized treatment plan, initially and annually review the patient’s INSPECT report, obtain urine drug screens and have the patient sign a controlled substance agreement. Additionally, the physician must discuss with the patient alternative treatments.

Richard Feldman, M.D., director of medical education and the family medicine residency at Franciscan St. Francis Health in Beech Grove, Indiana points out it is difficult to predict “how this new law will affect drug abuse and how many primary-care physicians will opt to no longer prescribe opioid narcotics.”35 Given the relatively strong evidence based support for the effectiveness of acupuncture in

the treatment of pain, it would not be surprising to see the increasing use of acupuncture by primary care physicians as an alternative to narcotics in the treatment of chronic pain. The skills and training needed to perform acupuncture are well within the reach of the family physician. In the opinion of this author acupuncture training will become a key component of family medicine post graduate training. As proposed by McKee, et al in the November-December 2013 Journal of the American Board of Family Medicine, “bringing acupuncturists in training directly into the primary care setting…is an effective and viable way to deliver a non-pharmacological approach to the management of chronic pain.”36

In conclusion, based upon the currently available evidence, a strong recommendation can be made for the use of acupuncture in the treatment of several conditions frequently encountered by a family physician. Although additional efforts to clarify acupuncture’s role are needed, I believe that there is sufficient evidence to transition acupuncture from the vague category of alternative medicine to the equally vague but more generally accepted descriptor of traditional medicine.

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References

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