Current Problems with Acupuncture Research

Paul L. Reller L.Ac. / Last Updated: August 03, 2017

To fully understand the current problems with acupuncture research, it is necessary to understand the historical challenges that the profession of Traditional Chinese Medicine (TCM), or Oriental Medicine, has faced. The universal competitive bias in standard medicine of course fueled a biased clinical study design intended to discourage the practice. Only after decades of pointing this out did the research community finally adopt reform in the design of human clinical trials, as the combined STRICTA/CONSORT were officially adopted. We are now seeing a widespread integration of acupuncture and TCM in standard medical practice.

Acupuncture and TCM have been perhaps the most challenged medical protocol in history. In the United States, the profession and practice was recognized and licensed as a medical practice in the state of California in 1972, after considerable research to determine whether needle stimulation and the related physiotherapies and herbal nutrient medicine was indeed a valid medical practice. Enough proof was presented to the legislative committee that the practice was licensed and regulated like the practices of the medical doctor, chiropractor and osteopath. The original title granted to the profession was Oriental Medical Doctor, or OMD, but this was quickly changed to a title of Licensed Acupuncturist, or LAc, and the profession placed under the business and professions code, rather than the medical license code, because of intense lobbying efforts by the California Medical Association (CMA).

Of course, this form of medical practice was already recognized in China, Japan, Korea, Russia, Europe etc. In the United States, organizations such as the American Medical Association (AMA) have lobbied to consolidate standard medical practice to those physicians with a degree from a University medical college. Of course, the practice of TCM was opposed in the U.S., just as the practice of traditional medicines such as herbology and naturopathy were opposed within the field of the medical doctor earlier in the century. The last group of Medical Doctors that practiced herbal and nutrient medicine were the Eclectic School, who promoted a holistic and integrated model of care in standard medicine initiated in the 19th century, and who were finally driven from practice in the 1940s, at the same time that government support of synthetic chemical pharmaceuticals expanded because of the Second World War. Prior to this time, most of the pharmaceuticals were at least based on chemicals naturally occurring in herbs, algaes, fungi, minerals or animals. The Eclectic School was a very popular school of medicine that promoted an Integrative approach, with the physician Constantine Samuel Rafinesque and botanist Samuel Thompson, the founder of Thomsonian Medicine, creating a medical practice that combined Native American herbalism and healing methods with European technology, and supported both traditional and modern medicine. The term 'eclectic' comes from a Greek word that is close to the concept of Complementary and Integrative Medicine, and refers to integrating diverse medical disciplines and being open minded and not doctrinal in the medical approach. Despite strong opposition to traditional medicine in the twentieth century, formal medical colleges were finally created, though, to provide standard medical education to Licensed Acupuncturists (L.Ac.), originally designated as Doctors of Oriental Medicine (DOM), or Oriental Medical Doctors (OMD). In the United States, unlike the rest of the world, medical schools were created specifically to train Licensed Acupuncturists, and these approved medical colleges were completely separate from the University medical colleges that trained M.D.s. It was thought that training in specialized medical colleges, rather than as a specialty in the M.D. profession, would provide more accessible and lower cost care, by decreasing the need to complete the standard MD degree and then proceed to specialized medical training the TCM specialty, which generates enormous cost. Of course, the long history in the United States to control the designation of the M.D. and exclude competing models of medical care by the AMA was also involved. Fifty years after the recognition of specialized TCM medical colleges, we are still struggling with the promise of fulfilling these goals in Complementary and Integrative Medicine.

The practice of TCM and acupuncture continued to be challenged as a medical practice that was not sufficiently proven after its California recognition in 1972. Only in the 1980s was the practice recognized by the Federal Government and Medicare, after the creation of the first viable acupuncture professional groups in 1982, who worked to gain recognition of the profession. The practice of acupuncture was still listed as a recognized unproven medical practice, though. A panel was created to research whether the profession was a medically proven practice, and finally, in 1997, the National Institutes of Health (NIH), concurrent with the reports of the panels from the California Industrial Medical Council and the World Health Organization (WHO), released statements that confirmed that scientific evidence concerning acupuncture was sufficient to fully validate it as a proven science on a par with standard medical practice.

Despite this recognition, the practice of acupuncture is not covered by Medicare, although it is recognized as a proven science, and a Medicare fee schedule exists. The necessary legislation, the Federal Acupuncture Coverage Act, sponsored each year by Representative Maurice Hinchey, has failed to emerge from committee since 1992, due to intense lobbying efforts. Today, the acupuncture and TCM practice is licensed in at least 43 states, yet the federal government still does not recognize the practice as a separate profession, and lists it as a therapeutic technique under the professions of Chiropractor and Registered Nurse. This listing exists despite the fact that in most states, only Licensed Acupuncturists and Medical Doctors, not Chiropractors and Registered Nurses without a degree and separate license as an acupuncturist, are legally validated to practice acupuncture.

The result of this long delay in full recognition of the profession is that there is still no Medicare coverage, and thus the insurance industry does not have to provide coverage for legitimate medical bills from a physician who is a Licensed Acupuncturist. Of course, to placate the public, which is now very supportive of the profession, insurance companies offer optional coverage of acupuncture. After 1997, the state of California, upon advice from the California Industrial Medical Council, created laws that declared that the acupuncture profession, and care from a Licensed Acupuncturist, was mandated by the Labor Code in Workers' Compensaton claims, and that the Licensed Acupuncturist should officially be recognized as a primary care physician, along with the Medical Doctor, Chiropractor and Osteopath. To counter these laws, the medical industry came up with so-called Workers' Compensation Reform in 2004, which strengthened the industry ability to challenge payment for acupuncture therapy in specific cases because there was insufficient evidence to support its use. The term evidence-based medicine was touted, and a set of medical guidelines supported by current evidence was adopted temporarily, in lieu of specific evidence-based guidelines accepted legally for the practice of acupuncture within the system. These temporary guidelines were from the small American College of Occupational and Environmental Medicine (ACOEM), based in San Francisco.

Unfortunately, the ACOEM did not have Licensed Acupuncturists within its ranks, and did not utilize the wealth of scientific study available on acupuncture in its guidelines. The only evidence cited in these studies were two small studies of acupuncture effects performed by a chiropractor on less than 12 patients. There was considerable opinion from medical doctors in ACOEM that acupuncture was not a proven science in most cases of industrial or occupational injury. In 2005, ACOEM admitted in hearings before the California Workers’ Compensation Commission that they did not present evidence to support these opinions in the ACOEM temporary evidence guidelines. A set of guidelines based upon the meta-analysis of acupuncture clinical trials in the United States was assembled by a group called Foundation for Acupuncture Research (FAR), and used only clinical evidence held to strictest standards, and published in medical journals in the United States and Europe. These guidelines were approved by the NIH, AHRQ, National Guideline Clearinghouse, and RAND, yet were not adopted by the Schwarzenegger administration until 2007, and then in an altered form. In the meantime, the AHRQ, a federal commission under the NIH (National Institutes of Health) that reports on health research quality, found that almost no manual medicines in the United States were evidence-based when applying the standard of double-blinded placebo-controlled clinical trials on humans that were consistently used in approving pharmaceutical medicines. In fact, acupuncture was perhaps the only manual medicine proven with such double-blinded placebo-controlled studies. Surgical procedures, standard physical therapies, and other common manual procedures were not evidence-based according to this standard, yet these manual medicines were not challenged for lack of evidence. The FAR studies of acupuncture trials were approved by AHRQ as the only comprehensive acceptable guidelines for the practice of acupuncture.

A logical examination of acupuncture research methodology

An almost religious zeal has been applied to the opposition to the acupuncture profession in the United States. To counter this professional opposition, and denial of payment for practice by the insurance industry, the acupuncture profession has had to produce evidence of efficacy. Of course, there was a wealth of scientific study and evidence from China, Japan, Korea and Russia. Unfortunately, this evidence was not recognized because it was not performed as clinical study compared to placebo, and administered as a double-blinded procedure, meaning that the procedure deemed a placebo and the procedure being studied was not identified as real or placebo to the administering physician, or the patient. This was a type of clinical trial set up to confirm unbiased study of pharmaceutical pills and injections, and by its very design is difficult to apply to any manual medical technique. Of course, any logical person can see that this type of study would be difficult to set up in the study of acupuncture. How does one create a viable acupuncture placebo treatment that the administrator of the treatment and the patient receiving treatment cannot distinguish from the actual acupuncture needling? This is easy with a pill or injection, but when being stuck with a needle that needs to produce a stimulation, how is this possible?

The application of the double-blinded placebo-controlled human clinical trial ends up measuring the difference in specific outcomes between this so-called "placebo" acupuncture that the real thing, but when studying pharmaceuticals this way, the placebo has no actual real effect, whereas the "placebo" acupuncture stimulation is a real stimulation of acupuncture points and obviously would have some effect, just not the same effect as the chosen "real", or verum, acupuncture stimulation. The measurable difference between a drug and a sugar pill should be large, but the measurable difference between inserting a needle at an acupuncture point, and inserting a "placebo" needle at another acupuncture point, which is needed to insure 'blinding' to the treating physician, is obviously not going to be so large of a difference. Nevertheless, this measurable difference was used to discount the "real" acupuncture stimulation, even though by study design of uniformity and blinding, the needles could not be properly manipulated to achieve optimal stimulation in the trial. These two obstacles to objective analysis, the use of a comparative "placebo" that has to have a significant effect, and the denial of the ability to properly perform the techniques of stimulation, or to individually design the treatment protocol for each patient, present enormous design obstacles to achieving fair and objective analysis of efficacy. In almost all of these trials, both the "real" and the "placebo" acupuncture worked quite well, but the study summaries all merely stated that the "real" or verum acupuncture did not outperform the so-called "placebo" acupuncture by a significant enough margin. Any person with an objective and pragmatic mind could see the blatant study design manipulation and the inherent bias in the reporting, but this was widely acceptable in the field of medical research, until recently.

Of course, in China, experts deemed this sort of double-blinded placebo-controlled study illogical and unpractical, and performed many acupuncture trials on humans, measuring the results, sometimes compared to other standard treatments, but not with a so-called "placebo" acupuncture. All of this data was rejected by medical journals in the United States which were run by medical doctors, and professional organizations such as the American Medical Association (AMA), and their journal (JAMA). Acupuncture had become the most studied medical practice in world history, with detailed proof of what effects were stimulated, and large studies demonstrating benefit for specific diseases and injuries. All of this evidence was not accepted in the United States, which called for the standard of double-blinded placebo-controlled human clinical trials, despite the overwhelming problems of study design.

Despite this seemingly insurmountable obstacle, a great number of researchers devised trials over time that met these standards. This was the only way that the profession could survive, and patients reimbursed for the therapy. Besides, acupuncture effects were a source of considerable scientific curiosity, and increasing funding from the NIH was available, due to the legal challenges to the profession. At first, fake needling devices were created to mimic the feel of a needle insertion. Unfortunately, this required that the real needle insertion also be applied with this device for it to be blinded to the physician administering treatment. Since this was of course difficult to achieve and still call it an acupuncture treatment, finally, the physician was given a set of points, some called real and some fake, or placebo. Once again, a logical person can see that choosing points near a designated acupuncture point, and arbitrarily calling these placebo points, even though they are needled, will probably produce a real acupuncture effect. In fact, in acupuncture literature, it is clear that in the treatment of musculoskeletal pain especially, that needle trigger points may be found anywhere on the body. The main 365 points on the 12 meridians reflect points applicable to the organ systems and internal medicine, although they are also very useful to the treatment of pain and musculoskeletal injury or disease. The trigger points for pain that could be located anywhere were called A shi, a Chinese term indicating that's it, with the patient designating the point as a trigger point for pain.

These strict standards requiring double-blinded placebo clinical trials in acupuncture, called RCT, or randomized clinical trials, of course, left open the distinct possibility that the trial could be designed in a way that presented bias. The so-called placebo points could be selected that were themselves effective for the health problem being treated. In fact, this was often the case. Most RCT trial of acupuncture show that the real acupuncture points produced significant benefit over a short period of time, often less than 10 treatments. The effects generally are recorded as about a 50-70% improvement in measurable symptom relief. Yet the placebo treatments created positive effects that were only slightly lower, generally about 5-13% less effective. The study designers usually deemed this statistically inadequate to state that evidence showed significant benefit compared to placebo. The summary of the study usually was worded to state that no evidence, or unclear evidence of acupuncture benefits were found. This, of course, was printed in medical journals and used to deny payment for acupuncture. Of course, it does not take a research scientist to understand that merely by selecting beneficial acupuncture points as the "sham" or "placebo" in the study that this measure of success could be diminished. It is obvious that the words "sham" and "placebo" do not apply to the use of other acupuncture points that also achieve healthy measurable effects. This absurd design was universally accepted.

By 2013, health research authorities finally admitted that this standard pharmaceutical study design with the RCT (randomized controlled human clinical trials) was not appropriate for the study of acupuncture stimulation, and changes were recommended to avoid study design bias. An example of such changes is this human clinical trial announced in 2015 by the University of Melbourne, in Australia, which can be accessed by clicking here: http://www.ncbi.nlm.nih.gov/pubmed/24925094. We see here that in a study of acupuncture to treat menopausal vasomotor symptoms of hot flush and sweating episodes, that the study design only blinds the selection of studied points and sham acupuncture achieved with blunt non-inserting needles, to the patients, and insures that the acupuncture stimulation is performed by acupuncturists who have received specific training in this type of manipulation. In the past, the insertion of the so-called "real" acupuncture needles could be performed by any type of medical practitioner, and often the professional manipulation of the needles were not allowed, while the so-called "sham" acupuncture was just the insertion of needles at nearby points which the performing practitioner could not distinguish from the actual acupuncture points. Such design was obviously designed to limit benefits of the acupuncture stimulation and increase the benefits of the selected "placebo" treatment controls. In this new study design we also see a typing of the patient that corresponds to the selection of points, not just an inclusion of any patent with the disease. The outcome measures are not just narrowed to a particular effect, but inclusive of a related set of effects, as is appropriate when evaluating holistic modulatory medicine, including quality of life measures and mood regulation, and measures of the patient expectations and beliefs about acupuncture, with a consideration of the real placebo mind-body benefits that are obviously a part of acupuncture stimulation of homeostatic regulation. Such study design will give us more realistic measures of just how acupuncture could be integrated in standard care to provide real benefits for patients.

Another problem inherent in these studies was the poor funding, and thus the number of participation patients was low, generally under 50. The pharmaceutical industry, with trillions of dollars at their disposal, had no problem paying for large clinical trials, but the acupuncture profession had almost no funds available. In fact, most of the acupuncture RCT clinical trials were funded by medical groups or the NIH, even when performed with cooperation of acupuncture medical colleges. The large number of RCTs, or randomized clinical trials, of acupuncture, that showed proof of positive benefits, were criticized as being too small to prove efficacy. The requirement of size of a randomized controlled human clinical trial has prevented the publication in standard medical journals of nearly a third of all RCTs presently, denying what is considered "evidence" of many valuable therapies, not only in the TCM realm, and has limited the acceptance of "evidence-based medicine" to those treatments supported by large sums of money and backing only, not focused on what is just good for public health. Almost none of the numerous studies of benefits from acupuncture were published in accepted journals until the U.S. PubMed database became more inclusive.

By 2009, a government committee in the United States that reviewed the practice of health research, led by a very conservative Senator Charles Grassley from Iowa, found that there was much manipulation of scientific research by the pharmaceutical companies in the United States. The committee found that millions of dollars had been paid to persons overseeing research and study design at the most prestigious medical colleges in the United States by pharmaceutical companies. This occurred despite prohibitions and limits on accepting these funds due to conflict of interest. Top medical doctors and researchers had failed to report phenomenal sums of money given to them as consultants to pharmaceutical companies, often when the research involved drugs from these companies, or rival drugs and therapies. The committee also found the in an anonymous survey to NIH researchers at colleges and universities, that over 40% admitted to taking money from pharmaceutical companies that affected outcomes or design of scientific study. For one class of drug, unopposed estrogen, the committee found that 270 studies were ghost-written. One research company that published medical research was given false research data but published that clinical trial without investigating its legitimacy. We see from this that there is no longer any doubt about the manipulation of research evidence in the United States. The long history of manipulation to deny the evidence of acupuncture benefits is not hard to see.

Many people may ask why were these obstacles to the proof of acupuncture benefit, and the means to manipulate the studies to discount them created? The obvious reason would be to deny payments from the insurance industry and government programs to save money. Yet this is not the real answer. The real answer lies mainly in two parts. One, the insurance industry determines the price of your policy by accounting for the costs of standard treatment and its use each year. If such a low cost treatment as acupuncture became the norm in certain pathologies and care, the cost of your policy would have to be greatly reduced according to this formula. Two, the pharmaceutical industry converted to synthetic chemical, rather than plant-based medicines, after World War II, in order to utilize the patenting system to increase profits. The primary group of Licensed physicians certified in herbal medicine are Licensed Acupuncturists. In the 1960's, years of patent holding on a new synthetic drug was extended and linked to the amount spent on research and clinical trials. A plant-based medicine cannot be patented. If plant-based medicines become popular, this means huge losses for the big pharmaceuticals on new patented drugs. Herbal prescription is linked to the practice of acupuncture within the legal scope of practice. Of course, the AMA has alway been competitively opposed to health professions outside of the M.D. realm, and this is a third reason, although much less important to the specific economics that we refer to here. The American Medical Association, it must be kept in mind, was created to insure that the business of medicine, and the enormous chunk of GDP naturally devoted to health care, was focused on new technology. Hence, AMA propaganda has always sought to undermine the popularity of traditional medicines.

Fortunately, these simple changes to the study design, the adopting of single-blinding, meaning that the physician administering the trial protocol did no longer have to be blind to whether they were administering the so-called "placebo" treatment, and the use of an increased field of outcome measures to judge efficacy, were finally adopted after decades of this bad practice. The question of safety, which the RCT was designed for in the field of pharmaceuticals, is not even a serious question, as thousands and thousands of studies of acupuncture on humans have been conducted and no significant risk of injury or adverse effects have been noted, while on the other hand, the list of adverse effects of pharmaceutical medicines seen in RCTs continues to grow, often times requiring pages of listing of all the adverse health effects seen in the trials, euphemistically still called "side effects", as though these adverse health effects just occur 'on the side' and need not be taken seriously. The field of medical research is thankfully also adopting the 'Big Data' approach, and this will insure that a more objective analysis of the true benefits and proof of efficacy of acupuncture stimulation is recorded as well. With a Big Data approach, the sum of measurable benefits in studies will be able to be considered in evaluation, not just the chosen study parameter, which is easily manipulated to imply that the treatment is ineffective, and the combining of data so that we may see actual integrative effects, with acupuncture stimulation improving the effects of other treatments, will be evident.

Scientific study that validates both the efficacy and the sensible cost effectiveness of acupuncture - an important consideration in the era of unaffordable medicine

Acupuncture has been shown to be the safest manual medical treatment in history. A review of 50,000 treatments in the European Union after the adoption of mandated coverage showed only a small number (about 15) of mild cases of reported injury, such as a bruise, surprising the researchers. Generally, malpractice insurance rates are less than $1300 per year and reflect administrative costs only. When compared to standard medicine and malpractice rates we see objectively that TCM is the safe or conservative approach to your healthcare.

Acupuncture is also proven to be a cost effective treatment. In Great Britain, an NHS study showed that not only was acupuncture effective for treatment of chronic low back pain with 10 treatments, but that the cost per quality of adjusted life years (QALY) of the addition of acupuncture to standard care was nearly one-fifth of the this cost with use of standard treatment alone. Of course, this assessment required that a statistical model of some complexity be devised to measure this cost-benefit, and I am not able to explain this statistical model in simple terms in this web page. The study, by Canter, Coon and Ernst, was published in the British Medical Journal: 2005;331;880-881. Another study of cost effectiveness in 2004 had concluded that in a randomized trial of acupuncture for chronic headache therapy, that addition of acupuncture therapy to the normal protocol significantly improves health related quality of life at a small additional cost, and is "relatively cost effective compared with a number of other interventions provided by the NHS." BMJ, 2004;328(7442);747(27 March). Countries that have adopted Complementary Medicine have noted large decreases in total health care costs, especially Brazil.

Many critics state that the effects of acupuncture stimulation must be a pure placebo effect, since they disbelieve that a small needle stimulation could have such dramatic results. This has also been disproven. A study in 2007 by 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 (opioid neurotransmitters) release and pain modulation (insular). This confirmed previous study at the University of California Irvine, where the inventor of the PET scan used functional MRI studies to show that distal limb point stimulation in acupuncture actually stimulated appropriate parts of the brain to effect the healing mechanisms that it was supposed to effect. 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.

The British Medical Association in 2007 also stated that the adherence to trial standards set for pharmacuetical 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. These changes to the evidence-based clinical trials of acupuncture were an admittance that evidence of acupuncture efficacy was manipulated by study design to deny the actual efficacy of this treatment.

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. Why is all of this proof generated in the European Union, instead of the United States? The answer is that acupuncture and Complementary Medicine was recognized officially by the European Union in 2006, yet in the United States we still wait for the Federal Acupuncture Coverage Act to get out of committee since 1997. The act was first introduced in 1993, and was instrumental in formation of the expert panel of the NIH to validate acupuncture as a proven medical science. This failure to get the Act out of committee is of course due to heavy lobbying to discourage the votes needed, and each year our legislators allow the vote on this act to fall a few votes short to get it to the floor, where it would be passed. Once it is passed, this would allow for much more government study and confirmation of medical necessity in the United States, as well as increased coverage on insurance policies. The manipulation by big business against the interests of the public, and the cooperation by our legislators is no surprise to most Americans.

Fairness and Objectivity in Acupuncture Research

Ultimately, how fair are these standards of randomized, controlled clinical trials to the proof of medical efficacy for acupuncture? These standards were set up to insure safety in the pharmaceutical industry. When applied to pharmaceutical pills, the outcome measured is the greatest possible difference in real medical application. There is no possibility of improved treatment outcome over the administration of the standard dose and quality of the chemical medications being studied. With acupuncture, the treatment is inherently limited to insure uniformity of study treatments. In actual treatment, the individual acupuncturist selects a treatment that is individualized to the patient. In addition, the quality of the acupuncturist and experience is an important variable, as well as the choice and skill of needle manipulation techniques, and the use of these techniques in response to the individual patient and reactivity. The acupuncture treatment is also combined in actual application with a host of other complementary treatment modalities, insuring a greater chance of success. In randomized, controlled trials these variations that improve the chance of success are eliminated in favor of a required uniformity of study treatment. Therefore, unlike pharmaceuticals, we can assume that acupuncture trials are actually evaluating the low end of the potential gradient of treatment success.

How objective are the published systematic reviews of clinical trials and research concerning acupuncture? The medical community relies on a few companies to publish systematic reviews of evidence, and this too is an area where statistical bias is evident, and methodology is used to portray results and analysis differently than with standard medicine. To see a 2003 anaylysis of systematic reviews by Technische University Medical School in Munich, Germany, click here: http://www.ncbi.nlm.nih.gov/pubmed/12519797

By 2014, various study guidelines were suggested to get past study design bias in acupuncture research. STRICTA and CONSORT are 2 organizational approaches created to overcome this now widely accepted study design bias in acupuncture.

STRICTA, or the Standards for Reporting Interventions in Controlled Trials of Acupuncture, was started in 2008 at Exeter University in the United Kingdom, to overcome obvious problems with the use of double blinding and placebos in acupuncture trials. By blinding the physician to which is the real and which is the placebo or sham in acupuncture, this not only severely limits the type of needle stimulation, but tends to create either a fake acupuncture treatment utilizing a box to insert the needle or produce a similar feeling for the patient, or utilizing actual needle points that the physician recognizes as actual treatment points for the problem, called a "sham", but which obviously produce a meaningful treatment response as well. These limitations also create a treatment where not only the study points are limited and standardized, ignoring the essential typing of the patient so critical to TCM, but also limits the treatment to a superficial insertion of the needle without actual stimulation, or technique, which is also individualized to the point and to the patient, and other parameters. Finally, these considerations were taken seriously. In 2010, these STRICTA guidelines were finally accepted by the international CONSORT group. The CONSORT, or Consolidated Standards of Reporting Trials, began in 1993, in Ottawa, Canada, to address problems in design bias and manipulation of human clinical trials in medical research, and was eventually accepted by most medical journals. Since many of these expert guidelines and parameters suggested by CONSORT were not routinely reported in clinical trial study summaries by the authors, this made CONSORT somewhat irrelevant until about 2001. In 2010, these experts, again in Canada, revised the 2001 CONSORT statement again to resolve issues that hampered universal acceptance, and here the STRICTA guidelines were incorporated. After the STRICTA/CONSORT standards were finally implemented, there has at least been an elucidation of these study design elements noted, reducing the ability of a blatant design bias.

Why is the vast body of research and meta-analysis in China concerning acupuncture and herbal medicine not included in the review of evidence in the United States and Europe? The West has set technical standards of methodology that the Chinese are working to incorporate into their system. The Chinese data is sound for the most part, and Universities are working to achieve compatibility with their Western counterparts. One problem is the disagreement early in collection of scientific data over the use of double-blind placebo studies to analyze manual therapies like acupuncture, and the issue of specificity in chemical analysis of herbal formulas. These problems are also becoming a hot topic in the West. To see how the Chinese are objectively working to conform to International, or Western, standards, click here to see the 2007 report by Beijing University of Chinese Medicine: http://www.ncbi.nlm.nih.gov/pubmed/17526167

The Current State of Clinical Evidence of the Benefits of Acupuncture and its Related Therapies of Soft Tissue Physiotherapy and Herbal Medicine

Much of the specific study results and evidence on this website will be categorized for easy use and study on separate pages. Here we will talk about the research and cite ways to access it. Access is a problem with acupuncture research. Most of the serious study is not published in standard medical journals, a criteria for research in the United States, and even when published, much of the research is not listed in standard meta-analysis of medical research, or one needs to pay a significant sum to access the medical journals.

To date, most of the research confirming the efficacy of acupuncture has centered on the relief of pain. The literature of 6000 years in China shows that acupuncture is used for a much wider variety of illnesses, diseases and syndromes, though. Common sense dictates that if the needle stimulation does indeed induce healing responses throughout the body, neurological and biochemical, that proof of one type of efficacy would support the others, especially as the empirical use, technique and exact nature of the trigger points is so well documented over such a long period of time. We need to finally admit that acupuncture stimulation improves natural homeostatic mechanisms and is thus applicable to any disease or injury, not just pain relief, and is a viable integrative treatment for any disease or injury, not an alternative to standard care. As the era of Big Data analysis begins, we will also realize the acupuncture stimulation is symbiotic with other treatment protocols, enhancing effectiveness and creating a more quantum and holistic response, and study design and analysis should seek to find out how best to utilize this safe and inexpensive treatment protocol, not how to discourage it and deny patients care.

Medical research should serve the public, not just the richest corporations. This is not the way modern research is used, though. Clinical research in pharmaceuticals is used to justify the use of potentially harmful chemicals by the FDA, proving that benefit outweighs risk. The FDA was created for this purpose. Franklin Delano Roosevelt in 1938, signed the new Food, Drug and Cosmetic Act that created federal regulation and enforcement over drugs by mandating a pre-market review of safety of all drugs, in response to the increasing number of tragic deaths from new, unknown chemicals. Today, we have expanded this arena of research to justify the denial of care, or payment for care, by insurers, under the need to prove medical necessity. There is little research of substance performed that is not tied to pharmaceutical chemicals or justification for payment. This commercialization of most research does not, perhaps, work in the best interests of the public at large. It has made the subject of acupuncture research not revelatory, but rather necessary to survive; a sort of guilty until proven innocent approach, with a twisted standard of scientific proof.

Since most payment for acupuncture therapies by the insurance industry to date concern the treatment of pain, this is where most of the research has gone. This has produced a limited public view of the benefits of acupuncture. Most of the public is unaware of the vast benefits of acupuncture stimulation, which promotes healthier function in the body to help cure disease through natural processes. Since the healthiest people have the fewest health problems and the greatest survival and outcome when illness, disease and injury occur, this is an excellent approach. Improving homeostasis improves the body's ability to affect a cure. Let us look now, though, at the evidence for success in treating musculoskeletal, rheumatological, neurological and vascular pathologies of pain, since this constitutes most of the research available.

Modern research has promoted the use of acupuncture as the most effective means of correcting myofascial referred pain syndromes. Dr. Janet Travell pioneered research and treatment of trigger points in muscle and fascia and showed that there was a measurable correlation between the main trigger points in the innervation sites of muscles, or sarcolemma, and the common acupuncture points. She ultimately recommended dry needling, or omission of injected chemicals, into the trigger points. Since acupuncture needles are so much thinner than common hypodermic needles, this became the most comfortable way to needle the trigger points. An article in the New York Times, Health section, Sept. 16, 2008, reveals the new attitude on the part of medical doctors to referred pain syndromes and treatment, utilizing acupuncture. Experts such as Dr. Lars Arendt-Nielsen at the Center for Sensory Motor Interaction in Aalborg, state that new evidence ’has changed the way we treat pain to a multifaceted approach‘, utilizing trigger point needling in a complimentary protocol. Research conducted in 2003 at the University of Bath in England showed that the intensity of referred pain diminished when the patient saw that the distal trigger points being treated were actually the cause of their pain. Patient belief that chronic pain was caused at the site that they felt the pain, which was inexplicable, hindered the body's ability to cope with pain. By utilizing the time and attention of the acupuncture trigger point needling, not only was the cause of the pain treated, but also the complicated mechanisms of hyperalgesia, or exaggerated pain sensation, that we commonly see in chronic syndromes, resolved.

Trigger point needling has been utilized for centuries in China. It was referred to in ancient texts as A Shi needling. A Shi translates loosely as ’that's it‘. This signified the identification of trigger points by the patient, especially satellite trigger points. Modern study of the main myofascial trigger points by the famed Dr. Janet Travell with Dr. David Simons showed that there is a remarkable correspondence between the main measurable myofascial trigger points and the main 365 meridian acupuncture points as well. The foundation text of the organized practice of acupuncture, the Nei Jing de Huang Di, clearly explains the use of trigger point needling techniques, in the book entitled the Ling Shu. New research in the last 50 years has helped acupuncturists refine the techniques for increased effectiveness. Besides trigger point needling, a variety of needling strategies are used in the treatment of pain and injured tissue, and these are also reflected in the scientific study of acupuncture.

Most of the quality research published in the United States prior to 2004 was included in the CAOMA/FAR Acupuncture and Electroacupuncture: Evidence-based Treatment Guidelines 2004, which was RAND approved and cited as the only quality comprehensive guidelines for the profession by the NIH/NGC/AHRQ (National Institute of Health/ National Guideline Clearinghouse/ Association of Health Research Quality). To see an overview of these guidelines, go to: http://www.guideline.gov/summary/ A complete copy of the guidelines is more helpful as a citation reference, and is available from CAOMA, if you try hard. Since 2004, the quality and quantity of such studies has increased exponentially, and the sheer success of these studies is propelling the time and expense devoted to them. If the findings were truly negative, and scientists found that acupuncture stimulation does not work, this enormous amount of research would not exist.

These CAOMA/FAR guidelines were created in response to Workers' Compensation reform signed into law by California Governor Arnold Swarzenegger, which actually called for specific acupuncture guidelines to replace the temporary ACOEM guidelines. A RAND study on the ACOEM guidelines described them as inadequate to address the subject of acupuncture, yet, despite public protest over the virtual elimination of acupuncture from California Workers' Compensation, the temporary administrative director of WC under Governor Swarzenegger delayed implementation of these guidelines for over 3 years, eventually applying them in a watered down form as Labor Code 9792.20-2 of the California Code of Regulations Title 8. This delay prompted the legislators to vote for AB2287, adopting these guidelines, in 2005, which was vetoed by the Governor. The reason cited by the committee appointed to assemble practice guidelines for the long delay was that "acupuncture was not considered a priority area since it is not a cost driver" (Dr. Nuckols-Scott and Christine Baker). Since acupuncture was considered inexpensive and proven effective in RTC studies, this delay in implementation not only hurt the profession and denied patient care, but also cost the state Workers' Compensation system money. One can easily see the scope of politics involved in the adoption of scientific study into law.

Serious proof of the scientific validity of effectiveness of acupuncture in the United States dates back at least to 1983. Petrie 1983 and Loy 1983 RCT studies (randomized controlled trials) of acupuncture versus placebo and electroacupuncture versus traction combined with short-wave diathermy showed that acupuncture and electroacupuncture demonstrated a remarkable benefit of an over 80 percent decrease in pain in studies of patients with mechanical neck disorders (spondylosis). The outcome measures included range of motion and improvement on standard pain scales, and were authored and peer-reviewed by M.D.s. These studies were discounted because of the problems with establishing a credible placebo, though, as there is no viable way to achieve an acupuncture "placebo" that the administering physician does not realize is a "sham" procedure. The study design of double-blinding made this virtually impossible. The discounting of these early acupuncture RCTs was for this reason was absurd, and pointed out the absurdity of demanding large human clinical trials with randomized choices and blinding between these choices of acupuncture stimulation and so-called "placebo" acupuncture. Prior to 1983, a large body of scientific evidence of measurable effects from acupuncture stimulation, usually compared to standard treatments, existed, yet these were discounted by standard medicine because they simply were not RCTs. This was a true catch-22.

Nevertheless, the implementation of the RCT to assess efficacy of acupuncture continued as the gold standard, or in fact, the only acceptable standard for "evidence-based" medicine, now required by payment. By 2007, studies in Germany, which were large-scale and met the most stringent standards, such as the Ruhr University study of acupuncture for chronic low back pain, showed that acupuncture was proven effective for the treatment of low back injury, migraines, tension headaches, arthritis and neck pain. The Ruhr study of Dr. Heinrich Endres (Archives of Internal Medicine September 2007) showed that 47% of patients with chronic low back pain felt significant relief over time compared to only 27% of patients receiving standard drugs and other standard therapies. The Charite University study in Berlin in 2005 demonstrated that patients with chronic osteoarthritis of the knee improved after 8 weeks with acupuncture more than with no acupuncture (Lancet, 2005 Jul12;366(9480):136-43). A University of Essen study of migraine patients concluded that acupuncture was just as effective as standard drug therapy in preventing or reducing incidence of migraine headache over a 26 week study period (Lancet; March2, 2006).

Since acupuncture exerts a homeostatic effect on the body, stimulating normalization of physiological mechanisms to produce improved healing and tissue maintenance, the study of acupuncture has been expanded to measuring these effects. Studies at the University of California at Irvine pioneered the use of functional MRI imaging to show that acupuncture did indeed stimulate homeostatic mechanisms in the central nervous system that had appropriate cascade responses throughout the body. Study on human subjects at the Massachusetts General Hospital, Martinos Center for Biomedical Imaging, in 2007, and published online, with access at PubMed Central, NIH Public Access (PMC1997288), showed that acupuncture stimulated an appropriate Hypothalamic and Amygdala response that improved carpal tunnel symptoms. Such studies were not accepted, and still are not, by the standard AMA controlled medical journals in the United States. Fortunately, the U.S. government, and the NIH, have opened access to published sound studies on their website. This will significantly affect the amount of accepted medical proof of acupuncture effectiveness in the United States. The study authors concluded that acupuncture stimulation in the brains of patients with carpal tunnel syndrome was different than that of control subjects, and that this functional connectivity between the amygdala and hypothalamus suggested a coordinated limbic response to acupuncture stimuli that could underlie the efficacy of this treatment as a healing modality.

In the United States, a 2006 Mayo Clinic study concluded that evidence suggests that acupuncture reduces the symptoms of fibromyalgia (Science Daily; 6/13/2006). This syndrome of systemic neurological pain is very difficult to treat in modern medicine, and is now called encephalomyelitis. The fact that acupuncture is proven effective supports evidence-based acupuncture in pain syndromes immensely. Prior to this study, the United States government Centers for Medicare and Medicaid Services published a report from AHRQ on June 5, 2003, stating that in a meta-analysis of all available studies of acupuncture for the treatment of fibromyalgia, that on study met the criteria for a large-scale RCT. This was the Deluze et al study, which showed that 70 patients found statistically significant benefits with acupuncture using several methods of outcome measurement. Ingenta reported that it concluded that acupuncture is effective for fibromyalgia and chronic pain based on this Ezzo, Berman et al 2000 study. The CAOMA/FAR guidelines cite numerous large-scale studies with statistically positive results for acupuncture in the treatment of chronic pain and a variety of pain syndromes and injuries.

Recent studies also point to the benefits of including acupuncture in a treatment protocol to reduce side effects of harmful therapies in the treatment of cancer and AIDS. In 2004, the AIDS Care Project in Boston demonstrated efficacy in managing side effects of the HAART drug cocktail. Since gastrointestinal side effects could potentially decrease the effectiveness of this drug regimen, patients were enrolled in a blinded randomized study and record of GI complaints and compliance with medication use were measured. The acupuncture group showed significant benefit (International Conference AIDS, 2004, July 11-16; abstract B10402). A study of reduction of chemotherapy induced nausea and vomiting conducted at the Memorial Sloan-Kettering Cancer Center in New York in 2005 also showed significant benefit from acupuncture, electroacupuncture and acupressure in randomized controlled trials (Journal of Clinical Oncology, Vol 23, No 28; October 1, 2005; pp7188-98). In addition, a number of quality studies show benefit in reducing side effects in breast cancer hormonal therapy, and increasing the quality of life with cancer protocol. Refer to the UCLA David Geffen School of Medicine, Center for East-West Medicine, the American Society for Therapeutic Radiology and Oncology (Nicole Napoli; nicolen@astro.org), and other organizations that have published the results of these studies.

Research into the effects of herbal chemicals has expanded exponentially in recent years. It is no longer difficult to access a wide variety of studies showing remarkable effects from specific herbal extractions. A small percentage of these studies is available by accessing the United States government's research database PubMed. Unfortunately, much of this research is also driven by profit rather than public benefit, as is the sparse news articles on this remarkable research. Consequently, the public is steered toward miracle herbal cures with billions of dollars spent currently instead of using their money wisely to access professional herbalists with clinically real cures.

It is no longer difficult to find information on the corruption of medical health research. In 2006, the NIH did an anonymous survey of medical researchers engaged in public health research, mainly at public universities, and found that over 40% admitted to taking money from pharmaceutical companies and other big business to alter study outcomes. This was beyond alarming. Minnesota passed a law in 2007 finally requiring disclosure from drug companies on money given to researchers, and subsequently, many key medical experts in charge of our medical associations and research have been found to be under-reporting millions of dollars in income from major drug companies. Why would they have been paid so much money under the table? Surely it is not hard to imagine the benefits in profits associated with manipulation of scientific study outcome, design and opinion. Senator Charles Grassley of Iowa has uncovered amazing payments of money to top medical researchers. He found that Dr. Melissa DelBello of the University of Cincinnati earned fantastic sums from 8 drug companies from 2005 to 2007, with AstraZeneca alone paying her $238,000. He found that a top expert in child psychiatry and research at Harvard, Dr. Joseph Biederman, and a colleaque, Dr. Timothy Wilens, had each earned at least $1.6 million dollars in drug company consulting fees from 2000 to 2007. He found that a Stanford medical doctor, Dr. Alan F. Schatzberg, president-elect of the American Psychiatric Association, had $4.8 million dollars in stock holdings in drug companies. Dr. Charles Nemeroff of Emory University was the principal researcher for a 5 year study funded with $3.9 million from the National Institute of Mental Health for which GlaxoKlineSmith provided drugs, and he accepted at least $1.2 million in consulting income from drug makers. The culture of corruption is taken for granted, and it appears that these medical doctors and teachers no longer find this to be unusual or wrong.

A March 3, 2009 article in the Business Day section of the New York Times highlighted the evolution of realization among Medical Doctors that this dark time of scientific manipulation and indoctrination must end. Students in the American Medical Student Association at Harvard University were shocked to find that Harvard medical faculty were routinely and ubiquitously paid large sums of money by the pharmaceutical industry as consultants. Students were alarmed years ago when professors would not address the subject of scientific research into side effects of standard medications, and the possibility that alternative medicine and conservative care should be considered in treatment strategy when these findings of increased risk versus benefit emerged. The professors seemed to belittle students with this frame of mind. Student research found that these same professors were being paid large sums of money as consultants for the drug companies making the pharmaceuticals in question. Today, more than 200 concerned students and faculty at Harvard have joined together to try to change this culture of scientific bias that is being taught as a philosophy of sorts to the brightest young minds in medicine. The national American Medical Student Association continues to give Harvard and F in rating how well the school monitors and controls drug industry money, highlighting how rooted in econonomics is the manipulation of not only medical research, but the very mindset of the researchers themselves.

Hopefully, a new generation of Medical Doctors will shed this history of blind adherence to Big Medicine, and will become more open-minded toward the history of small medicine, for the good of the public. It was not that long ago that a large group of medical doctors in the United States, the Eclectics, were hounded out of practice by the AMA and its influence on government regulation. Eclectic Medicine taught both modern pharmaceutical principles and the science of modern botanical medicine, and were the victims of the Flexner Report and the Carnegie Institute in 1910, where certain schools adhering to teaching of herbal medicine were denied accredidation because they refused to adhere to strict standards of mainstream science in their teaching and research. While on the surface this seems to be a way to simply undermine Eclectic Medicine, it was also a means to deny access to the medical field to minorities and lower class students. These students, particularly African Americans, Native Americans and Chinese, were not able to afford the tuition, and were often outright denied admission to the universities where standard medical science was taught. Eclectic Medicine was also more open to female students. The debate on validity of Eclectic Medicine was used as a shield for those in a wealthy white male dominated society to insure that the practice of medicine, and its economic benefits, were consolidated. This was successful in part because of the racial backlash in society after the riots related to the question of Jack Johnson, and the rising sense of equality and power in the non-white population.

The last schools of Eclectic Medicine closed in 1939, in part because of a new notion that synthetic medicines were necessary to insure sufficient supply of materials in times of war, and in part because of the economic struggle of the 1930s and the vast economic support for modern medicine by the government and the insurance industry. Even after 1910, the majority of Americans still favored Eclectic and Native American Medicine in polls, as a personal choice in standard health care, but a broad publicity campaign characterizing herbal medicine and other traditional practices as dangerous and unscientific eventually eroded support. The first schools of Eclectic Medicine were established in response to research by the physician Constantine Rafinesque around 1800 with his investigation of medicinal planst used by Native Americans. The schools grew to emphasize a multifaceted conservative approach to treatment, combining botanical apothecary with standardized extracts, and a host of physical therapy practices, which became very popular in the late 19th century. Standard European medicine was still emphasizing harsh medicines based on mercury and calomel, purgatives, bloodletting, and crude surgeries, often with insufficient anesthesia, as well as a post-Civil War emphasis on opiates. Crude surgeries, especially the emphasis on amputation that was promoted during the Civil War, frightened the public.

In this light, how are we to assess the reality of research into the positive effects of Complementary Medicine? Of course, we must step back and see that big money has supported the suppression of research findings that could reduce the profitability of synthetic drugs and expensive medical technology. Once we adopt a realistic attitude when assessing the research on Complementary Medicine, we might be able to pick out the facts that benefit the public health, rather than merely utilize the scientific evidence to deny patient care.

Information Resources and Links to Studies

A lot of published medical research confirming the efficacy of acupuncture is available on the numerous other articles on this website, with links to the research summaries, most from PubMed. By now, there should be no debate concerning the evidence that acupuncture therapies are based on. Below is just a sampling of some of the studies that elucidate the problem of study design bias with acupuncture.

  1. The U.S. government maintains a research database website for the public that can be quickly found at http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&itool=toolbar If you have trouble accessing this database by clicking on this address, Google PubMed or NCBI.
  2. A 2007 study of the effects of acupuncture stimulation on the brain, using functional MRI imaging, and measuring differences and outcomes with carpal tunnel patients, is presented here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1997288/ If you have trouble accessing this database by clicking on this address, Google PubMed or NCBI.
  3. A 2001 study of the effects of acupuncture stimulation on the brain, using PET scans, performed at the Integrated Brain Research Unit at Taipei General Hospital with the help of National Yang-Ming University Institute of Neuroscience, showed that simple electroacupuncture stimulation affected the hypothalamus to exert analgesic effects: http://www.sciencedirect.com/ If you have trouble accessing this database by clicking on this address, Google PubMed or NCBI.
  4. Harvard Medical School study on the CNS modulatory effects of acupuncture stimulation. http://www3.interscience.wiley.com/journal/70000102/abstract?CRETRY=1&RETRY=0
  5. 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
  6. The study designed in Britain to eliminate study design bias can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18054724
  7. A multicenter meta-review of study design bias in clinical randomized controlled human clinical trials of acupuncture, by the University of York, UK, Memorial Sloan-Kettering Cancer Research Center, NY, USA, the University of Southampton, UK< the Technische Universtat Munchen, Germany, the Group Health Research Institute, Seattle, USA, and Charite Universitatmedizin, Berlin, Germany, found that while true acupuncture is found to be superior to control types in all sizes of clinical human trials for chronic pain, the use of a so-called sham acupuncture stimulation of alternate acupuncture points as the control comes with much potential for study design bias, as these alternate acupuncture point stimulations blinded to the practitioner present obvious and important physiological activity and benefit, making them an unreal placebo. These experts at 6 renowned medical schools and research centers recommended that the practice of using these so-called sham acupuncture points be avoided in acupuncture studies to stop the practice of design bias that has negated acupuncture benefits in the past literature: http://www.ncbi.nlm.nih.gov/pubmed/24705624
  8. 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.
  9. A 2015 randomized controlled human clinical trial of acupuncture for the treatment of asthma, by the University of Sao Paolo School of Medicine, in Sao Paolo, Brazil, found that both the studied acupuncture stimulations and the so-called "sham" acupuncture points chosen as the control, or "placebo" in these studies, showed significant benefits, yet these benefits were decidedly different in the measurable physiological responses. The conclusion was that such so-called "sham" acupuncture was not a good choice for the control, or "placebo", in such studies. While this may seem obvious to an objective scientific researcher upon reflection, this conclusion has taken decades to finally be acknowledged: http://www.ncbi.nlm.nih.gov/pubmed/26598077
  10. A 2010 study at the Oregon College of Oriental Medicine, the Helfgott Research Institute of the National College of Natural Medicine, and the Oregon Health Science University, all in Portland, Oregon, U.S.A. provides a comprehensive analysis and guidelines for achieving fairness in study design and reporting of acupuncture randomized controlled human clinical trials, now that the agreement internationally to use a CONSORT and STRICTA model of the acupuncture RCT has been agreed to after decades of acknowledged manipulation of study design and reporting. This multicenter panel describes a tool to actually assess and monitor the improved standards of RCTs in acupuncture, although such measures will be complex to administer and assess, and it is certain that there will be competing arguments in standard medicine:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952291/