Evidence-based Medicine and Acupuncture Research

Paul Reller, L.Ac.

Evidence-Based Medical Practice is defined by its main promoter, the National Institutes of Health (NIH), as: “A way of providing health care that is guided by a thoughtful integration of the best available scientific knowledge with clinical expertise. This approach allows the practitioner to critically assess research data, clinical guidelines, and other information resources in order to correctly identify the clinical problem, apply the most high-quality intervention, and re-evaluate the outcome for future improvement.” Evidence-based medicine has been adopted by the health industry, though, as a means of denying or altering care, altering the way that the physician chooses the best available treatment protocol, and undermining the thoughtful integration of scientific data with clinical expertise. The patient population is starting to understand the nuances of evidence-based medicine.

The patient today has a vast array of scientific study available, publically assessable, to help make the right patient choices, together with their physicians, but the manipulation of scientific data has become a topic of much concern, as well as the misuse of evidence-based medicine by the insurance industry to control patient-doctor choices. The health industry in the United States now accounts for nearly 19 percent of the total economy, and is growing by more than a percentage point of GDP per year, with spending per person exceeding 8000 dollars per person per year. With this enormous largely unquestioned spending, there has arisen a system of manipulation of healthcare spending that supersedes the physician-patient choice in patient care, and it is not the federal government. Healthcare spending as a percentage of GDP in the United States is almost double that of the United Kingdom, Japan, and Spain, and about 65 percent of this healthcare spending comes from the government. With even this government healthcare spending largely controlled by the private insurance industry, manipulation of the spending is a matter of concern regarding the federal deficit and taxpayer responsibility. The manipulation of the well-meaning system of evidence-based medicine by big business to control practice guidelines and promote more lucrative drugs and technology has become a topic of great concern even by our most conservative politicians.

With the array of confusing and often contradictory information from medical studies now highly publicized in the form of research summaries, or worse, superficial headlines, the public is justifiably stressed when trying to make sense of their health problem based on evidence. The scientific evidence reaching your doctor is, of course, more refined, coming from professional sources, but even this data is now the realm of phone apps and controlled superficial presentation of the vast array of scientific study. Scientific medical evidence has been largely coopted by private business. Evidence-based medicine is thus a strongly adopted, but very complex issue, today. Manipulation of the field of evidence-based medicine is the focus of concern of a very conservative Republican senator from Iowa, Charles Grassley, whose commerce committee panel has uncovered massive fraud from numerous sources in the last 13 years. Since 2006, at least 15 drug and medical device companies have paid over 6.5 billion dollars to settle accusations of marketing fraud or kickbacks, and underscoring these fraudulent marketing scams are scores of physicians, professors, and researchers taking large sums of money to falsify research evidence and make sure that “evidence” is published. The thoughtful patient and physician today must look more carefully at the specifics involved in “evidence-based medicine” to find what is truly proven, significant, and presents greater benefits than risks.

Senator Grassley has successfully investigated a list of prominent academic physicians who failed to report large payments from drug companies whose product was being researched by these same academic physicians, most of whom were overseeing the research, often paid for by the NIH, meaning the taxpayer. This list includes Dr. Charlie Nemeroff, chair of the Department of Psychiatry at Emory University, who was forced to resign, but was hired to chair this same department at the University of Miami. It also includes Dr. Alan Schatzberg, former chair of the Department of Psychiatry at Stanford University, who oversaw a research study of a drug that was seeking FDA approval from a company that he was given partial ownership in. Dr. Joseph Biederman from Harvard University was also investigated, as he and two colleagues failed to report almost a million dollars each in consulting fees from pharmaceuticals that had interest in NIH research that they were overseeing. These are just some of the examples of conflict of interest in accumulation of evidence supporting medical practice. The NIH reported that a study showed that financial relationships between academic researchers and the medical industry nearly doubled between 1996 and 2007, as evidence-based medicine was adopted as the basis for approving payment in insurance and govermental health agencies.

Of course, these same academic research physicians, and the big pharmaceutical and medical equipment companies, as well as the big insurance and medical service corporations, all state that the routine payment of “consultant” fees of fantastic amounts, as well as the numerous smaller fees to physicians to disseminate this information in provider education and published reports, is all perfectly innocent. Paying billions of dollars and accepting billions of dollars to affect research, publication of research, and dissemination of the research findings is just an innocent way to help the public with “evidence-based medicine”. Everyone wants to believe that this scenario of manipulation just isn’t so, but any objective person can see that in a world where making profits is the key to success, this type of behavior is bound to happen.

How widespread is the manipulation of medical “evidence”? In 2005, the National Institutes of Health (NIH), a government funded research institute that thought it was independent of corporate manipulation, did an anonymous survey of their researchers, and found that over 40 percent admitted to adjusting data because of their financial ties to pharmaceutical companies and other medical corporations. In 2006, a new set of ethics rules were implemented that banned taking money from companies that had an interest in the research an individual was conducting. As a result, 40 percent of these academic researchers went looking for other jobs (Associated Press; Rita Beamish, SF Chronicle, Oct 29, 2006). In 2011, the U.S. Department of Health and Human Services issued an updated 144 page Final Rule on conflict of interest, lowering the monetary threshold at which significant financial interests require disclosure from NIH researchers from 10,000 dollars to 5000 dollars, and required ethics investigators at universities to disclose all of their significant financial interests related to their ethics investigations. This was in response to the industry adaptations to the current ethics rules and the way that money was distributed to more individuals under the 10,000 dollar disclosure limit.

In 2009, 200 Harvard medical students organized to demand a change in ethics behavior after the American Medical Student Association rated Harvard with an F for failure to monitor and control the influence of drug industry money on research and teaching. As the flow of endowment money decreases, and after the endowment trusts lost money in the economic meltdown of 2008, dependence on corporate “support” for faculty and research has increased. The situation at Harvard in not unique. At Stanford University Medical School, Dr. Alan Schatzberg, former chair of the Psychiatry Department, along with Dr. Charles Nemeroff of the University of Miami Medical School, were accused of authoring a prominent textbook with guidelines for pharmaceutical prescription for pediatric psychiatry that was apparently written and researched by a company tied to the pharmaceutical giant SmithKline Beecham, Scientific Therapeutics Information. A New York Times article outlined how the information and research in this proposed medical school textbook was prepared for the authors, who in effect, ghost wrote the text. Stanford University only established a policy against such ghostwriting in 2006, after this event became public in a trial of malpractice and harm from a common pharmaceutical psych drug. Senator Charles Grassley&rsuo;s investigations found that several controversial new pharmaceuticals benefitted enormously from ghostwritten articles in medical journals, citing this as apparently common practice. A New York Times journalist interviewed such an academic researcher who signed onto ghostwritten scientific studies, who replied that with decreases in academic funding he felt compelled to take money for this ghostwriting of scientific research published articles to supplement his income. The manipulation of “evidence” is apparently widespread.

Real change in the reliability of evidence-based medicine may only come when the patient population becomes knowledgeable on this subject and voices concern. Real change may only come when the actual individuals at our pharmaceutical, medical device, and insurance companies improve their ethical behavior, and when our academic researchers, physicians, teachers and administrators take individual responsibility to fix this problem, which is a threat to public health. The days of passive participation in such a widespread violation of the rules of civilization need to come to an end. The students in the American Medical Student Organization set an example for us all.

Defining Evidence-based Medicine

The Dartmouth College Biomedical Libraries defines evidence-based medicine as “the integration of best research with clinical expertise and patient values”, according to a medical textbook entitled Evidence-based Medicine: how to practice and teach EBM by DL Sackett, SE Strauss, and WS Richardson, published in 2000. These authors established a pyramid of evidence sources, starting with the foundation of expert opinion, proceeding to case studies, cohort studies, randomized controlled trials (RCTs), and then to published article synopses, evidence syntheses, and finally to systematic reviews of published articles on these RCTs, cohort studies and case studies. Today, the top of the pyramid, systematic reviews, dominate the field of evidence-based medicine, yet there are only a few acknowledged databases of these meta-analyses. The Cochrane Database, DARE (database of abstracts), PubMed (the U.S. National Institutes of Health database), and Ovid MEDLINE dominate the field of systematic reviews of published medical evidence. When just two systems, Cochrane and Medline, become the benchmark for deciding what medical care should be paid for, the possibility of manipulation of evidence-based medicine obviously becomes a concern.

So, instead of creating a real integration of best research with clinical expertise, and most importantly, patient values, we have instead created another tool for corporate medicine to control and manipulate how money is spent, how medical guidelines are written, and which pharmaceuticals and medical devices are authorized in treatment, not by the treating phsycians, but by the insurance companies and accounting experts. Today, the interpretations of all of our scientific knowledge by a few companies, in the form of meta-analyses of published research, dominates the question of what type of treatment the patient will receive. This is not an indictment of evidence-based medicine, but an indictment of how this wonderful concept has been transformed into another tool of financial manipulation. Much work is needed to reverse this trend and reestablish evidence-based practice as a truly ethical and workable tool.

Evidence-based research supporting acupuncture has also been manipulated, not to promote acupuncture, but to discourage it, yet despite these economic hurdles, research has persisted that has consistently shown the benefits

Acupuncture and its physiological effects and specific benefits has perhaps been the most studied manual medical therapy in world history. Not only does acupuncture have a rich history of thousands of years of data accumulation on clinical effectiveness, modern science has sought to understand and measure the effects of acupuncture objectively, not only with outcome measures, but also with the metabolic and physiological effects evident from acupuncture stimulation. These effects may be very important to the outcome in specific diseases and injuries, often serving as adjuncts or complements to the eventual cure or management of the disease. The evidence of benefit may not be apparent in many cases from the study of immediate outcomes from short courses of acupuncture, but the physiological effects of the treatment may contribute greatly within the overall protocol. In holistic medicine, the goals of treatment often fit within an integrated framework, where a number of treatments work synergistically to produce the desired outcome. This is difficult to assess with the current system, which is designed to discover if a single allopathic drug produces a significant benefit over a placebo pill.

The present system of randomized placebo-controlled double-blinded human clinical trials used to support evidence-based medicine as not intended to assess outcomes in manual medicine, such as acupuncture, physical therapy, and surgery. The Office of Technology Assessment, a branch of the United States Congress, utilized an advisory board in 1978 to study the subject of scientific proof of efficacy in standard medical procedures. This panel concluded that: “only 10-20 percent of all procedures (manual medicine) currently used in medical practice have been shown to be efficacious by controlled trial.” This was because the system of controlled trials was set up to primarily assess the safety, not the efficacy, of new pharmaceuticals. Of all medical procedures, acupuncture was the subject of most controlled trials to assess efficacy, and this was purely because the evidence of effectiveness was highly questioned by standard medicine, and standard medicine has cynically proposed that acupuncture must meet the standards of controlled human trials that new pharmaceuticals were subjected to, despite the fact that very few medical procedures, or manual medicine, had been shown to be effective with such trials. This was mainly due to the problem of designing a placebo for a manual procedure. The subject of the placebo effect was also a legitimate scientific issue, as numerous studies showed that when a patient received a placebo that there was significant and measurable medical benefit. In fact, most pharmaceuticals outperformed placebos by only a small percentage. This outperforming of the placebo in controlled trials, often by as little as 5 percent, was proof that the drug was effective. The degree of effectiveness was not important in these studies, only the binary outcome, yes or no. On the other hand, the patient was more concerned by how effective the drug was, not just is it or isn’t it, especially when the measured potential side effects took pages to list, and the long-term adverse effects were sometimes devastating to the overall health.

When analyzing the evidence of needle trigger point stimulation, as well as electrical stimulation, and other more high tech types of stimulation, notably cold laser, at the trigger points, what is perhaps most important are the physiological effects, rather than the specific immediate outcomes. The reason for this is that trigger point stimulation with metal needles is not strictly a type of allopathic approach to medicine, but rather a modulating effect that is holistic and systemic. Often the benefit of this treatment is not just the effects produced by one or two needle stimulations, but the synergistic effects of a full prescription of needle stimulations combined with other therapies, such as herbal formulas, nutrient medicine, physiotherapies, cognitive and behavioral changes, and even short courses of pharmaceutical drugs. For this reason, analysis of the effects of acupuncture requires a little more thought than the analysis of the allopathic effects of specific chemicals on specific cellular mechanisms. Research in recent years has found that electroacupuncture stimulation affects pain modulation and promotes tissue healing by stimulating hypothalamic function and prompting a metabolic cascade, and in the past, endorphin and other enkaphlins were found to be increased in central and peripheral nervous system pain pathways in response to acupuncture stimulation. In fact, seminal research at the Massachusetts General Hospital in coordination with the Harvard University School of Medicine showed that the acupuncture stimulation provided a modulatory effect between the hypothalamus and amygdala, which was very important to both sensory and motor effects related to pain and injury. As research continues, we find the physiological effects of acupuncture to be broad, and often both local and systemic, affecting specific mechanisms, as well as a cascade of homeostatic events in healing. A truthful assessment of this evidence of benefit needs to take many parameters of outcome into consideration.

So the evidence of benefit for a manual therapy, or procedure, that is normally part of a holistic interdisciplinary protocol, cannot be fully assessed by simplistic and narrow outcome measures as in allopathic medicine. What do I mean by allopathic approach? Of course, this term has been used in a number of contexts throughout the years, and this can lead to controversy. In modern terms, allopathic approach would signify the use of therapy that is not biodientical or stimulating of normal physiological responses to cure a disease. Use of pharmaceutical chemicals that are not identical to the body's own chemistry to effect specific changes, and use of surgical or other devices to alter the anatomy or physiology rather than restore it may be used as examples of allopathic approach. The use of benign needle stimulation at trigger points, and the use of bioidentical chemicals from plants, animals or even minerals, to stimulate normalization of homeostatic mechanisms is not allopathic. Research findings must take this difference into consideration when analyzing the significance of positive findings, as well as in the design of acupuncture studies.

The point is, that acupuncture effects are modulating, and different techniques of stimulation, or even reaction to the needles by the individual patient, may produce opposite effects physiologically, and thus, the anaylysis of acupuncture must incorporate these variables in order to make a thorough and competent evaluation of the effects of acupuncture. The present scientific method controls for variables by reducing these variables and extraneous effects on outcome, but this is inadequate to fully produce an unbiased result with acupuncture. Typing of the patient and consistency with physiological effects should be controlled. The problems with setting up the scientific study to effectively measure results is difficult, but studies that measured both objective physiological effects as well as outcomes would be an improvement.

In analyzing the outcomes of past and present study of acupuncture it may be helpful to actually take a look at the details of the study and use your own knowledge of the problems with double-blinded studies of acupuncture, as well as the knowledge of physiological effects and the modulating holistic effects expected to adequately form an opinion, especially when the outcome measures are significantly positive.

Understanding the physiological effects of acupuncture

One way to better understand the actual potential benefits from acupuncture is to incorporate measures of physiological effects into the study of a particular type of needle stimulation on a particular type of patient group. For this reason, the subject of actual physiological effects of needle stimulation is the subject of much scientific interest.

The study of actual physiological effects has also elucidated the subject of placebo effect in acupuncture. Since there has been a high degree of difficulty in setting up a placebo effect that is blinded to both the patient and the physician performing the treatment, studies have relied on so-called sham acupuncture stimulation that is either actual stimulation with acupuncture needles at alternate points, or use of alternate methods of stimulation at the same points. The alternative method is to use a type of device that seems like a needle stimulation to the blinded patient, but not to the physician, resulting in a single-blinded study. All of these studies have generally shown remarkable beneficial outcomes for both the actual needle selection and the so-called sham, or alternate selection or sham device stimulation at the same points. The difference in outcome measures between the studies of acupuncture stimulation and these so-called sham techniques has been used to determine proof of beneficial effect greater than placebo. Any rational scientist can see the problem with this type of outcome measurement, since the potential for beneficial effects from the so-called sham methods is great. In England, a study was set up in 2007 to measure physiological differences between real needle stimulation and placebo stimulation. The patients were blinded to the difference, but the outcome measures were dramatically different in terms of physiological effects. This study, at the University College of London and Southhamptom College, proved with PET scan study that a placebo stimulation mimicking acupuncture, excited areas of the brain associated with touch, while the real acupuncture stimulation with needles excited areas of the brain associated with endorphin and dynorphin release and pain modulation (insular). This was proof that the effects of real acupuncture needle stimulation had a physiological effect different from placebo, even though the placebo stimulation had potential for positive CNS response.

In 2007, a unique study of acupuncture effects was conducted at the Martinos Center for Biomedical Imaging, Massachusetts General Hospital (Pain 130 (2007) 254-6). Here, functional MRI was used to evaluate real (verum) and sham acupuncture stimulation at a single point (LI4) on chronic carpal tunnel patients and health controls. The researchers found that chronic pain patients responded differently in the brain from healthy controls, and that real acupuncture stimulation in these patients exerted a beneficial modulating activity in the hypothalamus balance with amygdala activity, whereas such response did not occur in healthy controls. This response was measured immediately and in follow-up, demonstrating the long-lasting effects of this beneficial hypothalamus and amygdala stimulation. The modulation of these pain centers produced not only a change in sensed pain, but measurable functional changes in the inter-digit separation distance of the hand affected. Since this seminal study, the researchers, working with Harvard Medical University, have proven that there is a measurable difference in response to superficial point stimulation and real acupuncture stimulation. The real acupuncture affects the brain stem and centers, while the superficial, or sham, acupuncture stimulated the cortex, affecting only a temporary sensation of pain relief. Placebo effects were thoroughly studied as well, by Professor Ted Kaptchuk, who proved in a randomized single-blinded controlled trial of IBS patients receiving placebo acupuncture, in 2008, that the placebo effect of a caring confident physician-patient relationship, typically delivered in a clinical setting with acupuncture, produced a significant outcome benefit over placebo acupuncture alone, or the outcome on a patient waiting list with no treatment. Such research has expanded the objective assessment of the acupuncture treatment outcome. The use of double-blinded “placebo” controlled clinical trials, where the patients received only limited superficial acupuncture, without an actual treatment utilizing the physician-patient relationship, were designed to find failure of the acupuncture over placebo and deny care. We see now that this study design did not adequately assess the real acupuncture treatment outcomes. The remarkable outcome, though, is that even with this biased study design, acupuncture proved itself in human clinical trials.

To elucidate, let us take a recent study set up to measure the outcome of acupuncture stimulation at a single point to reduce post-operative nausea and vomiting. A 2004 study at the University of Heidelberg, Germany, measured the outcomes of acupuncture stimulation at the point P6 on the wrist with so-called placebo acupuncture stimulation at the same point. Nausea in post-operative patients with gynaecological surgery, within 24 hours after surgery, was measured by the need for antiemetic medication as well as the secondary outcome of reduced incidence of vomiting. The acupuncture group showed a reduction to 48.9% of the usual need for medication, while the so-called placebo stimulation of the point showed a reduction to 67.6% from normal need for medication. The incidence of vomiting, a secondary measurement, was reduced from normal statistics of 39.6% of paitents, to just 24.8%. The study included two subgroups that received the acupuncture stimulation before surgery, with one group receiving the stimulation before anesthesia, and the other after the start of anesthesia. The study outcome reported no significant effect over placebo for the acupuncture stimulation. This article was published in Anaesthesia Vol. 59;(2);142-149; 2004 Blackwell Publishing Ltd; Wiley Interscience. With such a significant reduction in need for antiemetic medication and vomiting, and considering the limitations of the strength of stimulation and lack of individual adjustment by a physician post-operatively, the summation of findings seems rather harsh. When looking at the so-called placebo and realizing that it too was a significant form of acupuncture trigger point stimulation, comparison to placebo with about a 20% greater effect for the real acupuncture, and P = 0.07, and a reduction in incidence of vomiting by about 15%, P = 0.03, seems to be a rather impressive outcome. The study authors suggested that this study showed no significant benefit over placebo. When comparing this to pharmaceutical research, where the placebo is a pill with zero positive effect expected, and considering that one may look in any pharmacological clinical physician's guide and see many standard medications outperforming placebo by less than 6%, the outcome judgement seems unrealistic. This shows that the current state of research does not value realistic understanding of the parameters of acupuncture research compared to pharmaceutical research when publishing research summaries.

The British Medical Association went so far as to state that even the placebo effects of acupuncture should not be discounted, and stated: "The placebo effect in itself should not be a reason for discounting complementary therapy research, as the usefulness of a medical intervention in practice is different from asesssing formal efficacy." In fact, many expensive pharmaceuticals in clinical study barely outperform the placebo pills, and meta-analysis has revealed that the placebo effects overall in clinical studies has nearly doubled since 1960. While the implications of this fact are complex, it nevertheless implies that evaluation of acupuncture compared to placebo is not as simple and straightforward at some would have us believe.

When looking at the above study, one should realize that in actual medical practice, the physician performing the acupuncture could increase the positive benefit of the treatment considerably by adding other acupuncture points, by individualizing the treatment, and by responding to the individual patient during the treatment time. Experience and ability of the individual acupuncturist would also play a part in improving the outcome clinically. When this is compared to pharmaceutical outcomes, there is no chance that the outcome could be improved from the study parameters when using medication, if the study is using the optimal dosage and type of drug. Positive outcomes in acupuncture research should be viewed with greater respect rather than less respect, and this is not currently the case.

The study of physiological effects of acupuncture reached a new plateau in 1998 with the fMRI studies of neurological effects from distal acupuncture point stimulation at the University of California Irvine, Susan Samueli Center for Integrative Medicine. Here, Michael E. Phelps, creator of the PET scanner and UCLA pharmacology chair and Norton Simon Professor, (NOTE: Edward J. Hoffman (deceased July 9, 2004), UCLA professor and co-inventor of the PET scan with Dr. Gordon L Brownell (deceased Nov. 23, 2008, are distinguished from the creator of the device), sponsored a collaboration study between the UC Irvine Departments of Radiology, Psychiatry, Human Behavior and Opthamology, and three prestigious South Korean Colleges, including the College of Medicine at Kyung Hee University, Seoul, Korea. This study was in response to positive benefits of treatment that Professor Phelps observed on himself when treated in South Korea with acupuncture. Prior to this experience, Professor Phelps did not believe in the scientific efficacy of acupuncture. This study used points associated with the treatment of ocular diseases on the side of the foot, Taiyang channel, and measured effects of stimulation on the corresponding brain cortices using functional MRI to map brain activity. The points used are typically called UB67, UB66, UB65, and UB60. The Korean researchers divided the study participants into Yin type and Yang type to explain differences in measurable outcomes with the same type of stimulation. The controls used were visual light stimulation previously used in fMRI studies of the occipital visual cortex, and an atypical acupuncture point stimulation on the same foot, but away from the meridian. In this case, the so-called placebo control was not the same point, or a nearby point on the same meridian, but an acupuncture point well off of the area deemed to affect the same pathway and CNS responses. The conclusions reached were that acupuncture stimulation could work by stimulating a corresponding brain cortex area via the CNS, and thereby stimulating a homeostatic chemical or hormonal release via the CNS to a diseased or disordered tissue. The stimulation by the acupuncture needling was very similar to stimulation with methods of visual stimulation previously studied. The study was published in Proc. Natl. Academy of Science, USA; Vol. 95, pp. 2670-2673, March 1998, Physiology. Much criticism of this study was engendered by standard medicine, and a partial retraction of findings was published due to this criticism on June 21, 2006, but the bulk of the research findings remained, and the researchers at UC Irvine went on to conduct a number of well designed studies to examine the cardiovascular metabolic cascade stimulated by acupuncture.

Smaller pilot studies of the physiological effects of acupuncture, such as the 2004 Portland State University collaboration with Kaiser-Permanente Center for Health Research, D. Tsunami, A. Colbert et al, study of electrocardiogram and electrodermal responses to needle stimulation, were conducted, and also showed significant physiological effects. In this study, significant effects were also noted at the so-called control point, but the authors conceded that the point selected was close enough to the point studied, called ST36, that stimulation may have also elicited the normal point response. In TCM literature, past Chinese physicians have noted that stimulation of a point in the approximate area of the exact point location will have a beneficial effect, albeit smaller. There is also significant debate in TCM history as to the exact location of the points in many instances. It does seem historically, that the response to the needle stimulation is more determinant of point location than a standard skin charting and measurement. Frequently, study design does not take this into consideration, or perhaps uses this fact to bias the study outcome against acupuncture by choosing a placebo point that is also active. This type of study design manipulation has been found to be widespread in large studies funded by the standard medical industries, or when conflicts of interest affect the academic study design. This Portland State University study cites 15 other small studies of positive physiological effects conducted between 1993 and 2003 that support their positive findings. The researchers conclude that the significant physiological effects measured on heart response from stimulation of points below the knee could be attributed to psychological responses of the patient, or placebo effect, though. Once again, do we consider that measurable physiological effects are being discounted because of apriori assumptions and bias by the researchers? Why does the study summary appear to discount the measurable effects of the acupuncture stimulation?

There are examples of quality acupuncture study by researchers that are not biased against the profession, and that choose placebo points that are not as likely to produce similar reactions to that of the chosen study points. An example would be a study entitled: The management of cancer-related fatique after chemotherapy with acupuncture and acupressure: A randomised controlled trial, published in Complementary Therapies in Medicine, Vol. 15;(4):228-237, conducted at the University of Manchester, School of Nursing, Manchester, UK; Nov 13, 2006. Forty-seven patients with post-chemotherapy moderate to severe fatique were randomised to an acupuncture group receiving 6 20-minute treatments over 2 weeks, a second group that was taught to massage the points and did so daily, and a third group that was taught to massage points not considered effective. The measured outcomes showed a 36% improvement in the acupuncture group, a 19% improvement in the acupressure group, and a 0.6% improvement in the sham acupressure group. Here we see that even manual stimulation near the acupuncture point produced good results, but not as good as needle stimulation, but that the same manual stimulation at points not considered viable produced almost no results. Scientific observation should show you that acupuncture was shown to be effective, but that sham treatment at the points was also proven beneficial. This finding should help you to analyze the aforementioned ECG study at Portland, and see that the researchers used a needle stimulation very close to the actual point, resulting in positive results lower than the study point. This should be expected and should not discount the study.

Other examples of physiological effects in acupuncture study are now numerous, although accessibility of the studies performed in China, Japan and Korea is often problematic. An example of recent study of note in the West is a study aired on BBC TV Alternative Medicine showed that deep needle acupuncture therapy can actually deactivate the brain's limbic system, or pain sensitization, making this medical practice anesthaetic. Evidence was derived from fMRI study in this study also.

Towards a better understanding of outcome measures in clinical trials of acupuncture

The British Medical Association in 2007 stated that the adherence to trial standards set for pharmaceutical research is unfair to the study of acupuncture. It stated that: "trials of acupuncture must be single blind", and that randomized controlled trials of patients must provide evidence "only in an experimental setting on a selected group of patients", in order to decrease the unfair manipulation of acupuncture trial data. Single blind refers to the patient being blinded to the choice of so-called real acupuncture versus the so-called placebo or sham acupuncture stimulation, without blinding the physician administering the needle manipulation to this choice. Of course, if a study is to utilize real acupuncture stimulation, the administering physician must really manipulate the needle, and this is not accomplished in studies where the treating physician is blinded to the therapy choice, and a device is used that does not really involve actual needle technique. In trying to understand whether acupuncture is truly evidence-based, one must be able to distinguish biased study design from unbiased, and be able to consider the physiological benefits along with the symptom outcome measures. Often, the study itself needs to be examined to see if evidence of proven benefit exists even though the study authors state in summary that the results are inconclusive or that benefit is not proven over placebo.

Is there a systemic bias in our medical system that undermines our understanding of the evidence of benefit from acupuncture? To examine such bias, let's look at a recent meta-analysis conducted in China, where there is still much criticism by standard medicine of TCM. This University of Hong Kong study examined 12 research databases for clinical trials of acupuncture to treat insomnia. Randomised, controlled trials were chosen, with acupuncture compared to placebo, sham acupuncture, or no treatment, or acupunucture combined with another standard therapy compared to that standard therapy without acupuncture added. Studies that compared acupuncture to other treatment, without comparison to placebo, sham or no treatment in a blinded setting were excluded. Because of this, only 7 trials were included. The meta-analysis found that acupuncture and acupressure may help to improve sleep quality score compared to placebo (p = 0.006) or no treatment (p = 0.002). The study authors concluded that the small number of acceptable randomised controlled trials, together with poor methodological quality and significant clinical heterogeneity, means that current evidence is not sufficiently extensive or rigorous to support the use of any form of acupuncture for the treatment of insomnia. Because these trials deemed acceptable were not standardized, numbered only 7, and because the authors felt that variances in outcome measurements must imply poor methodological quality, the meta-analysis was negative to support acupuncture, even though the trials that met inclusion all proved significant benefit. The problems inherent in study design with double-blinded trials was not considered, and hence the available studies in 12 databases were limited to 7 trials. Inherent problems with standardized outcome measures in a field where study design problems are still not solved, and funding is poor, are not considered. The end result is that by standards of large clinical trials designed for pharmaceuticals, and paid for with megabucks of pharmaceutical companies, that acupuncture study does not compare well. This is the criteria with which such meta-analysis is prepared for Cochrane Database Systems Review. No mention of funding for this meta-analysis at the University of Hong Kong Pediatrics and Adolescent Medicine is mentioned.

The history of evidence and the acupuncture profession

The acupuncture profession was not officially licensed until 1972 in the United States, despite widespread acknowlegment of its efficacy and worldwide popularity, long history, and legal practice in many countries. The actual licensing to practice legally occurred in California, mainly in response to support from the Nixon administration, which publicized the use of acupuncture on a member of the Nixon staff on a visit to China, especially the use of acupuncture as an effective form of surgical anesthesia. The notoriety in the press prompted public support and the California legislature approved medical licensing and the establishment of a regulatory board and medical school standards. This was all accomplished after years of committee study to verify the scientific evidence of actual effectiveness of acupuncture and related therapies. The original medical degree was a doctorate in Oriental medicine. After much lobbying on the part of the California Medical Association, the legislature gave in to pressure and money and changed this degree to a Master of Science. The title of the TCM physician was changed from a doctor or Oriental medicine to a business license called a Licensed Acupuncturist, even though the practice of needle stimulation was just one part of the total medical treatment protocol and constituted just a part of the medical training. The actual TCM practice was an integration of modern medicine with the long history of the medical specialty, and involved modern diagnosis, and treatment with complex herbal formulas and preparations, nutrient medicines, dietary medicine, various direct physiotherapies, pateint counseling, patient instruction in therapeutic techniques, and energetic medicine, or a mind-body therapy.

By the late 1970s, the acupuncture profession was acknowledged as scientifically evidenced and the acupuncturist was approved for therapy in the Workers’ Compensation system under Title 8 law. By 1978, the legislature enacted Workers’ Compensation reforms that reversed this approved use of acupuncture in the system. A committee was established to again review the scientific evidence to see if it warranted the qualification of acupuncture as a scientifically proven therapy required by law if the patient or physician chose it. This commission delayed its findings for nearly ten years. In 1986, the California Industrial Medical Council, now considered the benchmark for evaluation of musculoskeletal treatment guidelines, released a report that stated that the evidence not only supported acupunture and related therapies of myofascial release and soft tissue mobilization, but recommended that this safe and effective therapy be used as a first-line treatment in most industrial injuries, unless surgical intervention was warranted. The commission also found that a significant benefit occurred in the reduction of the dependence on pain medication, espcially addictive narcotic pain medication, which had a number of associated adverse effects.

This commission report, from the most respected Medical Doctors and research specialists, with little input from the acupuncture profession itself, coincided with a report from commissions set up by the World Health Organization and the National Institutes of Health, both of which, after thorough review of all scientific evidence, declared that the TCM practice and specifically acupuncture met strict standards of evidence in scientific study and was apparently as evidenced as standard medical practice now. After this, the California legislature declared that the Licensed Acupuncturist was considered a legal primary care physician within the Workers’ Compensation system.

By 2004, the acupuncture-supporting governor of the state of California, Gray Davis, was removed from office with a recall vote funded heavily by the medical corporations, and Governor Arnold Schwarenegger was elected, again with much funding from the medical corporations. Immediately, the industry composed Workers’ Compensation Reform Act was again enacted, and again the practice of acupuncture was ousted from the system and a special commission to evaluate current scientific evidence was supposed to be set up immediately to form acupuncture evidence-based treatment guidelines that would supersed the temporarily adopted ACOEM treatment guidelines, which did not address acupuncture, and cited almost not scientific studies of acupuncture in thes guidelines. Of course, deja vu, the adoption of the proposed new acupuncture evidence-based guidelines was delayed until late 2007. Again, acupuncture was not paid for, or compensated, due to the legal requirement of new “evidence” assessment, which was already published and acknowledged. In fact, finally an acupuncture organization again assembled this high-quality scientific evidence, separating only the peer-reviewed controlled human trials of sufficient size and design integrity, from the plethora of thousands of smaller studies and clinical trials. These FAR guidelines were accepted by the RAND corporation and the AHRQ, a branch of the NIH sponsored health research assessment of our federal government. Again, this scientific evidence was not accepted by the Workers’ Compensation commission until late 2007, despite much interest by the legislature in adopting the guidelines that supported acupuncture. The reason cited for delay was that Governor Schwarzenegger fired the administrative director, appointed a temporary AD, failed to approve a new AD supported by the legislature, and appointed a special commission on specialty guidelines that stated in committee that acupuncture guidelines were not being considered for years because acupuncture was not a cost driver in the system, and hence, not a priority. In other words, a simple acceptance of recognized scientific evidence and guidelines into law was not being performed because the acupuncture treatments were inexpensive, as well as effective, and not a significant cost-driver. Judge for yourself whether this was merely duplicitous politics with complete negative logic, a bizarro world type of decision.

These legal manipulations of the evidence-based practice of acupuncture were then adopted by standard insurance to restrict what diagnoses were paid for even when the patient paid for a plan with acupuncture benefits, and most diagnoses were rejected, with most insurance companies picking and choosing the evidence that they accepted and stating that in their opinion, only a handful of health problems was justified for insurance compensation with the treatment of acupuncture. The complexity of this whole evidence-based approach to acupuncture is overly complex, unbelievable, persistent, and discouraging to both patients and practitioners, with most Licensed Acupuncturists opting now to not take on insurance claims. The patient has the option, often in today’s practice, to pay out of pocket and perhaps get reimbursed if they pursue the coverage benefits. This is how evidence-based practice has impacted the TCM medical specialty and hindered the benefits for the public of this effective, extremely safe, and relatively inexpensive medical practice. The equation of utilizing current scientific evidence and clinical experience to provide the best evidence-based practice continues to progress with the Licensed Acupuncturist, but the system also is used to destroy the practice and deny compensation.

Information Resources

The purpose of this article is not to present acupuncture research, but merely to point out the problems with the industry bias and manipulation of the positive research in acupuncture. A few links below help to illustrate how specific and detailed the scientific proofs are, as well as to illustrate how study design, understatement, and summary bias has created an atmosphere of negativity toward acupuncture research that is blatantly used to deny coverage and care, not to promote greater scientific understanding and successful utilization for the public good.

1. Harvard Medical School study on the CNS modulatory effects of acupuncture stimulation. http://www3.interscience.wiley.com/journal/70000102/abstract?CRETRY=1&RETRY=0
2. 1998 fMRI study of distal acupuncture stimulation and physiological effects in the brain at the University of California Irvine can be seen at http://www.pnas.org/content/95/5/2670.full.pdf?ck=nck
3. The study designed in Britain to eliminate study design bias can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18054724
4. A 2007 study by the Martinos Center for Biomedical Imaging and the Massacusetts General Hospital in coordination with Harvard Medical University, proved that real acupuncture has modulating and long-term effects on the brain centers, the hypothalamus and amygdala, while sham acupucture, or superficial stimulation affected on the cortex sensation: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1997288/
5. A German journal article discussing problems with acupuncture trials is very illuminating from a number of perspectives: http://www.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=110416&Ausgabe=234157&ProduktNr=224242&filename=110416.pdf This article is titled Forschende Komplementarmedizin 2007;14:371-375 Journal Club - Acupuncture for Hypertension: A Tale of Two Trials, and you may need to scroll down the page to Further Sections 371 Journal Club and click on the Article PDF Free Access. If this link fails, you may try searching under this title.
6. An August 24, 2010 article in the New York Times Health section, finally presents a truthful outlook at how acupuncture research is designed by the medical industry to achieve outcome headlines that are negative. This article focuses on an industry study of knee pain which utilizes a supposedly sham acupuncture comparison that is so close to the so-called real acupuncture therapy in the study as to be laughable, with the study summary stating that the so-called real acupuncture was not proven to significantly outperform the so-called sham acupuncture, but failing again to report the positive medical effects of both treatments: http://well.blogs.nytimes.com/2010/08/23/studying-acupuncture-one-needle-prick-at-a-time/