Understanding Acupuncture Research

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

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.

Unfortunately, the reporting of proof of efficacy for acupuncture in evidence-based medicine has largely relied on the relatively few human clinical trials that are held to standards that no other type of manual medicine has been held to, has been open to manipulation by study design, and has been discounted as insufficient when almost all of these studies show positive effect. The summary discounting of the effects of acupuncture is attributed to the small size of the acceptable studies, and because the manipulation of study design has compared a type of acupuncture needle stimulation that is performed without sufficient use of stimulation technique, and hence is designed to produce weaker results, with a so-called placebo or sham acupuncture stimulation that usually involves just alternate acupuncture points that are also needled without sufficient stimulation to insure that the so-called real and so-called sham needle insertions without sufficient stimulation are blinded to the physicians performing the treatment. Much thought has gone into this acupuncture study design to arrive at results that are positive but insufficient to prove efficacy. It is a shame, and shameful, that the field of medical research has not instead sought to just arrive at a better and more meaningful study of how acupuncture could be better utilized to help actual human patients with their health problems, rather than devote so much time and energy to insuring that there is insufficient proof of efficacy to pay for this therapy. Since the creation of the system of large human clinical trials that are double-blinded and placebo controlled was set up to insure public safety, comparing the health risks of new medicines with their actual efficacy in clinical treatment, and considering that acupuncture has been proven to be the safest medical treatment in human history, the application of these large RCTs in acupuncture is by its very nature a cynical means to discount and discourage the practice. At a time when there was still doubt as to the objective benefits of acupuncture stimulation, this seemed acceptable, yet today we have abundant objective scientific proof of the many benefits of this stimulation, verified by functional MRI, genetic testing, laboratory analysis, and in vivo as well as in vitro studies of the cascade of biological mechanisms that occur with specific types of acupuncture stimulation.

The objective scientific assessment of medical effectiveness of acupuncture stimulation, and its amazing safety, was completed in 1998 by the U.S. National Institutes of Health (NIH), the World Health Organization (WHO), and the Industrial Medical Council of California, perhaps the 3 most esteemed institutions regarding medical treatment guidelines. All 3 of these groups stated that the science of acupuncture was a medical treatment with proof of effectiveness and safety equivalent to any current medical treatment practice, and endorsed by these groups, despite the fact that they were comprised of Medical Doctors and research specialists from professions that had an intrinsic bias against the specialty of acupuncture and TCM. This had little actual effect on the perception of acupuncture efficacy and safety by the standard medical industry, the insurance industry, or the public, as it seemed to stimulate more publication of doubts of efficacy and safety rather than endorsement. Since large studies in Europe, China, Japan, Korea and other countries have proven acupuncture to be extremely safe, there is no obvious reason for it to be held to the same standards of trial as new synthetic pharmaceuticals, yet it still is. Why is this? There is no obvious answer. There is no governmental law or institutional decree that demanded this level of proof, and considering that the practice of acupuncture within the holistic framework of TCM specialty was very inexpensive and accessible, there would appear to be no objective reason not to utilize it, yet in 2015, it is still hardly accepted and utilized by the public, and is still not paid for by insurance and governmental healthcare for the most part. As we go forward in this vain attempt at satisfying the demands of scientific proof of acupuncture, we must consider a number of developments of the study design, though. Big Data Analysis, analysis of this treatment within the broader holistic framework of synergistic therapies, and analysis of acupuncture stimulation in the framework of integrative effects with standard medicine obviously need to be utilized. We may also see the application of new concepts in scientific study of biological effects, with measurement of quantum effects utilized, as they have been for decades in standard medical research to a small degree. While there is little funding available for a medical specialty that does not actually generate much profit, there is actual interest in this study from the academic world, as it is very interesting, and from public health experts, some of whom still see low-cost accessible medical practices as important, especially as standard medicine is pricing the poor, and even the lower middle class of the population, out of the medical system, and introducing more and more expensive treatments that cater to the wealthy.

How to Arrive at a Better Analysis of Medical Efficacy of the Manual Medicine of Needle Trigger-Point Stimulation that we Call Acupuncture and Electroacupuncture

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 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. We are not looking so much for the single allopathic effect as with pharmaceutical research, but rather for the quantum holistic effect on restoration of homeostasis, which requires a focus on a bigger data field. For this reason, analysis of the effects of acupuncture also requires a little more thought than the analysis of the allopathic effects of specific chemicals on specific cellular mechanisms, as complicated as that sometimes is. For example, 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. We are now measuring the modulation of receptor types in specific areas of the brain with acupuncture stimulation, and the modulatory feedback effects that result from specific stimulation as specific points. We are even able now able to measure the genetic expressions and epigenetic changes, and the effects of these modulations on the targeted gene expression, with either inhibition or stimulation of greater expression of specific gene proteins.

Acupuncture research is becoming complex. As research continues, we find the effects of acupuncture to be broad, not specific, and the early attempts at study design that narrowed the stimulation to ridiculously simple parameters is now recognized as perhaps designs that were meant to give the treatment a failing grade. On top of this, it is now widely recognized that design demands of so-called sham or placebo acupuncture that had to be blinded to both the patient and physician administering the treatment was clearly a design to discount acupuncture, not seriously study it. Research today, especially in China and South Korea, is using a single-blinded controlled design that also compares the effects to standard treatment in human clinical trials, and often measures a broader and more holistic field of effects. While the agreement internationally recognized by the STRICTA/CONSORT to reform the RCT design for acupuncture was adopted in 2001, implementation has been extremely slow in the West. One instance of a realistic reform of study design for acupuncture can be seen in this 2016 proposal published in the British Medical Journal (BMJ) with a human RCT conducted by the Emory University School of Medicine, in Atlanta, Georgia, and the Capital Medical University, in Beijing, China, where we see these realistic reforms finally enacted - just click here to read this proposed study design: http://bmjopen.bmj.com/content/6/3/e009594.full . This study blinds the patients and the administrators randomly assigning the patients to groups, but the physicians administering the acupuncture are using realistic point selection with real manipulation of the needles to achieve stimulation (de qi) and are aware that the so-called 'sham' points used are not meant to treat the studied insomnia and will not stimulate these needles in a meaningful way, to achieve a more honest comparative control. This realistically studies the effects of acupuncture as an integrated treatment protocol that often is combined with standard allopathic treatment as one of the controls.

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 the 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. As standard medicine progresses, we find that less allopathic, and more restorative approaches are being discovered as well, as in the case of pharmaceutical 'biologics', recombinant DNA, and other chemicals that mimic or are identical to genetic triggers or expressions. We are also seeing the use of pharmaceutical bioidentical therapies, such as the injection of hyaluronic acid and normal sugars, lipids and proteins into joint tissues to promote healing, as well as the extraction of growth factors from platelet-rich blood to inject into joint tissues to promote faster healing.

In the study and evaluation of acupuncture stimulation, we must consider that this manual therapy is restorative, triggering of homeostatic mechanism innate to the human organism, and achieving holistic effects. The point is, that acupuncture effects are usually modulating, and different techniques of stimulation, or even reaction to the needles by the individual patient, may produce opposite effects physiologically, and thus, the analysis 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.

This problem of evaluation of medical treatment approaches in Complementary and Integrative Medicine has a long history. Throughout history in China and Europe there has been a documentation of a fundamental disagreement in medical approach between schools of thought that advocate a typing of the patient based on theories of fundamental elements and biochemical parameters, and schools of thought that seek to fit all patients into a typing based on disease description and symptom presentation alone. Of course, this one-size-fits-all (or most of the patients) is easier to find treatment protocols and guidelines for, and is better for the business of medicine. Unfortunately, the greatest minds in medicine, even in the European tradition, suggest that we must have a broader and more holistic approach to achieve the greatest success. These ideas were fundamental to the medical science of Hippocrates, Galen, Aristotle, Democritus, Paracelsus, and many others in the development of European Medicine, yet ultimately rejected as unwieldy. In China, the great physicians that established the modern medical theories and many fundamental scientific discoveries adhered to a similar Daoist approach. Today, this fundamental binary schism between an allopathic guide for treatment that tries to find an altering treatment for the type of patient with any disease that makes up the majority of the patients, and the holistic approach of fundamental diagnostic typing and altering the therapeutic protocol for each type in a system, utilizing a homeostatic restoration when possible, continues, and is reflected in the problems with study design. Obviously, the randomized controlled study design devised for modern allopathic medicines does not work well with more holistic therapies that adheres to this fundamental typing in guiding therapy. The solution is to consider both approaches and integrate them, both in clinical treatment and in study design that seeks to truly find evidence of the best treatment approaches. Our present system has failed in this regard.

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 to provide a more accurate analysis of effectiveness, even in randomized controlled human clinical trials

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. 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 study cites 15 other small studies of positive physiological effects conducted between 1993 and 2003. 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. Once again, do we consider that measurable physiological effects are being discounted because of apriori assumptions and bias by the researchers?

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 fatigue 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, with some of this benefit possibly attributed to a placebo effect, but the study designed to show that this placebo effect was minimal since other acupuncture points massaged in the same manner showed little effect. 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, or allow the researchers to conclude that the acupuncture stimulation was not significantly more effective than so-called sham placebo.

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.

In recent years, these attempts to at least elucidate the parameters of the acupuncture study design to avoid easy design bias have achieved some success, and now the reasons for the choice of controls is elucidated, as well as the actual effects of so-called sham acupuncture if chosen, and the qualifications and experience of the physicians administering treatment are elucidated. This has led to many institutions designing human clinical trials that now compare actual acupuncture treatment to actual controls, and discuss the expected effects of these controls, as well as many institutions now using experienced and specialized Licensed Acupuncturists to administer the treatments studied, instead of practitioners with little of no experience, or even without real formal training. The result is that the positive findings of acupuncture in randomized controlled human clinical trials are now no longer discounted as unproven. The incorporation of the actual physiological effects into these controlled randomized human clinical trials also has led to greater acceptance of acupuncture as a proven integrative therapy. Other examples of physiological effects in acupuncture study are now numerous, although accessibility of the studies performed in China, Japan and Korea is still 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. As the practice of functional analysis and mapping of the brain in relation to acupuncture stimulation progresses, we are seeing more and more proof of not only efficacy, but positive effects even exceeding what was expected by the acupuncture profession.

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

The British Medical Association (BMA) 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. 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.

Many countries that now integrate acupuncture and Complementary Medicine into their standard health care system are providing randomized controlled human clinical trials that actually clarify the question of the placebo effect rather that allow study design to utilize a fake placebo with real effects to discount the efficacy of acupuncture. For instance, at the Fluminense Federal University Community Health Institute in Rio de Janeiro, Brazil, in 2012, a randomized study of the effects of electroacupuncture to resolve stress-related disorders in medical students compared the measurable effects of electroacupuncture professionally delivered to outcomes from medical students randomly assigned to a waiting list for this treatment. The outcome measures included 6 standard measures of sleep quality, depression, anxiety and quality of life parameters. The treatment involved just 8 treatments administered once a week, a relatively inexpensive and very safe protocol. The outcomes showed that 75 percent of students in the electroacupuncture group showed significant benefits in sleep quality, depression, energy, and quality of life. The students on the waiting list expecting the treatment showed significant benefits in 23 percent of the students (PMID: 22459648). This study showed proven benefits for a majority of patients over placebo, and if these outcomes were measured for a pharmaceutical medicine, the research summary would proclaim that this was a very effective drug, with widespread public demand and satisfaction. In the past, research design may have used other acupuncture points that also provided positive effects in the study to show that electroacupuncture did not show significantly higher effectiveness over this so-called placebo, and if the so-called real, or verum, showed a 12 percent greater effectiveness over the so-called sham placebo, the measure of significant effect over placebo may be set at 13 percent. The study summary would just say that the study did not demonstrate the effectiveness of acupuncture. In this study, a question persisted concerning the placebo effect, and so the study was repeated in 2014 with the addition of a TENS cutaneous electrical stimulation at the same acupuncture points. In this version of the study the electroacupuncture once again showed significant improvement in a majority of students for sleep quality and stress-related mental symptoms of depression and anxiety, with the TENS stimulation showing positive benefits that were much lower than that with electroacupuncture. The researchers concluded that the TENS cutaneous electrical stimulation confirmed that there was a placebo effect involved, but that the actual treatment produced significantly better outcome measures than placebo (PMID: 24113152). As stated above, the British Medical Association publicly stated that even this placebo effect should not be discounted as a positive measure of treatment effectiveness. In the past, the study summary would measure just one parameter of benefit, and despite these positive findings, would have stated simply that electroacupuncture did not perform better than placebo, and so electroacupuncture remained unproven.

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.

Even though, after decades of research publication, standard medicine is now eliminating study design bias to some extent, there remains an effective discouragement to this proven and inexpensive therapy of acupuncture trigger point stimulation. Decades of obvious widespread use, and even demand, of biased studies and study design in acupuncture studies have produced a widespread belief that acupuncture is not proven effective. This public belief will take decades of unbiased study publication to dispel. There is no acknowledgement that this obvious biased study design was systematically promoted, and no expression of regret. Hopefully, this is changing.

Quantum Mechanics, as measurable Quantum Chromodynamics and Quantum Entanglement are seen as the hope to finally explain the mysterious ways that acupuncture stimulation appears to work within the realm of Rational Design

While the use of quantum mechanics and related scientific methods in biomedicine is not expected to be immediately applied to the study of acupuncture and provide some new astounding proof of the practice in the near future, this realm is expected to finally uncover the answers to how acupuncture stimulation does indeed work. To understand how the same stimulation at a trigger point could actually produce the same set of biochemical reactions in the brain for all people, we need to assume that there is a field of reaction that is programmed into the organism. While such explanation seems farfetched, attempts to explain measurable reactions to acupuncture stimulation by simple electrochemical linear cascades have been very difficult, and yet there must be an explanation. Quantum entanglement is a phenomenon that has been measured and confirmed, where energetic particles that are created together respond together in the future with the same changes in spin and momentum for the whole quantum field that was created together. Such physical explanation explains a lot for scientists that are trying to deduce how the universe works. It also sets a framework for how reactions may occur in the brain, or any distal area of the body, to simple manual stimulation with a metal needle, and/or electrical charge and frequency, if the field of particles are related. Quantum entanglement was famously described by Albert Einstein as "spooky action at a distance", and this could accurately describe how modern scientists view the wealth of findings of acupuncture stimulation since the functional MRI studies revealed that indeed an instantaneous reaction seems to occur when stimulating an acupuncture trigger point and an appropriate response occurs in the designated area of the brain. This obvious effect of acupuncture stimulation has been viewed as "spooky" by most modern physicians. A relatively small sample of research has been conducted in this arena in the past decades, starting with the use of Superconductive Quantum Interference Device (SQUID) biomagnetometers to measure biomagnetic fields generated by the brain when stimulating specific acupuncture trigger points. This research confirmed that the areas of the bodies codified to be affected by the point, or the meridian system, was indeed real, and these meridian field effects have been confirmed by studies using thermography, ultrasound and other devices to measure the areas of immediate biological reactivity to the acupuncture stimulation at a distal point on the acupuncture meridian.

How is quantum entanglement measured? Initial experiments observed specific types of energetic particles that were created in a quanta, and noted that when one, separated from the others, was stimulated to change its spin and momentum, that the others in the quanta were affected instantaneously the same way. In June of 2015, researchers at UCLA, led by Zhenda Xie and Chee Wei Wong, showed that pairs of photons could be hyperentangled, carrying much more data, and that these photons could be separated by much time and space, and still respond the same, simultaneously. This research expands the potential for research and application of quantum entanglement, and already has applications that are being explored in communications and computing. Such research could produce a means of communication over very great distance in space as mankind sets forth into the galaxy. This research could also finally explain much of the phenomena that modern science has no explanation for, and often discounts for this reason. To finally achieve an objective explanation that is measurable and reproducible for the phenomena observed in acupuncture stimulation and even Qi gong therapy, an integral part of acupuncture, as well as the emerging recognition of mind-body medicine in standard practice, would be amazing, and this research, integrating an holistic set of values and parameters, could finally achieve these goals. For modern science, the explanations of the past, dumbing down the concepts of Qi and vitality, or vital energy, is surely inadequate, and the attempts to explain vital energy as bioelectric, biochemical or even electromagnetic phenomena is, of course, shown to be inadequate. Any serious researcher that explores the writings and concepts of ancient Daoist medicine sees that we must expand our modern perspective to truly understand their ideas.

Quantum Chromodynamics (QCD), or the study of energetic quantum fields which measures the strong nuclear interactions in fundamental particles, is finally finding a place in research of biophysics as well. Use of QCD is producing more accurate assessment of biochemical reactions in the body, and biochemical potential. This is merging with a Big Data approach in research, that computes a large field of data, rather than taking a large field and dumbing it down to a single parameter. Of course, such research design is applicable to herbal formulary, which involves a large array of chemicals and activities, not a single synthesized chemical and one activity. Quantum chromodynamics also has potential for explaining energetic phenomena that the present system of measurement with just one of the five fundamental forces, or energies, electromagnetic, does not. Even electromagnetic force, which we have used solely to measure energetic phenomena, is a bit insubstantial though, in regards to the purely objective modern scientific methods. Conceptually, electromagnetic energy and force is a measure of the elusive photon, a particle without mass, that determines our field of vision by defining the fundamental constant of movement and speed, the speed of light. Modern science, though, has proven that the photon is best explained by quantum mechanics and wave-particle duality, and the Heisenberg Uncertainty Principle showed us a century ago that it is in fact impossible to actually measure the photon movement and energetic force with a linear and non-quantum system. Currently, the Standard Model of physics shows us that photons and other elementary particles are described with a fundamental and universal law of Nature that assumes spacetime symmetry and a duality that exists for all particles described as patterns of movement and spin. These concepts, as their heart, are not different than the ancient Daoist concepts of Qi and Yin Yang duality, as well as micro-macro universality of patterns. Once modern science truly gets past its bias and quits calling these ancient concepts "quackery" we can finally get on with a more objective view.

There are other examples of the application of quantum measurements in biodmedicine as well. Another movement toward what is called rational design techniques is the use of a quantum assessment with alchemical free energy methods in biochemical drug discovery, which could be applied in the assessment of herbal formulas and specific herbal chemicals. Rational Design Techniques describe a type of research in which the medicine is engineered or assessed with the help of structural biology alongside traditional screening approaches, assessing the ability of the medicine as it metabolizes and interacts with other biochemicals and stimulates genetic modulation. This method is touted to achieve discovery of medicines that have unknown mechanisms of action, but are believed to demonstrate efficacy. Currently, rational design techniques have been used in pharmaceutical research to eliminate inactive compounds in assessment, to achieve allopathic focus, but with the advent of biologics, or chemicals that mimic natural homeostatic mechanisms, the use of rational design techniques has been expanded to identify compounds that may be contributing to the main focus of the medicine. Of course, this methodology holds much promise in assessing integrative medicine and adjunct therapies, even in designing better protocols that enhance the outcomes of pharmaceuticals. In the 1980s, free energy calculations, or the use of what was called alchemical free energy quantum fields, was incorporated into the research utilizing rational design techniques. While we see publication of opinions that we cannot apply these quantum biomechanical practices to the study of TCM, the rationale for this criticism generally involves assumptions that past attempts to scientifically explain TCM theories involved ideas labeled as vital energy, or Qi, and bioelectric forces from the metal needle. Such criticism is objectively absurd, though, as we obviously use whatever advances in science that are available to always evaluate what is still objectively unclear. Acupuncturists do not claim to have invented quantum mechanics, only realizing the application of this realm of physics to the traditional Daoist theories, which is an obvious application. Most practitioners of acupuncture and TCM will not tout this comparison, though, as there is also an unfortunate subjective bias in much of this medical field against explanations of the ancient science by "modern medicine". We must understand, though, that if the great minds of the past in China that wrote of TCM theory and practice were alive today, that they would surely utilize any and all scientific means to better understand the natural physics of acupuncture stimulation and all of the therapies in TCM.

Information Resources and Additional Information with Links to Scientific Studies

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. A 2015 report from research experts in China shows that a new era of "Big Data" evidence application is already having a significant effect on acupuncture and TCM research, affecting trial design, data collection, analysis and sharing of the huge amount of varied research findings: http://www.ncbi.nlm.nih.gov/pubmed/26721155
  4. Current research with fMRI technology is creating an objective mapping of the effects of specific acupuncture points, adding to the thousands of years of empirical data that guide acupuncture treatment and point selection. Here, a study in 2015, at the Southern Medical University, in Guangzhou, China, and the Zhaoqing Medical College, in Zhaoqing, China, used functional MRI to determine the effects of stimulation at the point KI3 on the ankle in healthy volunteers. This study showed with a randomized controlled clinical study that stimulation at this point with an acupuncture needle effected specific areas of the brain associated with perception, body movement, spirit and association, with clinical application to treatment of auditory and cognitive disorders, hypomnesis (impaired memory), loss of concentration, and deficits in learning ability. Such study clearly shows that the classic guidelines in TCM texts are fully supported by the modern evidence, to a remarkable degree: http://www.ncbi.nlm.nih.gov/pubmed/26467429
  5. The study designed in Britain to eliminate study design bias can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18054724
  6. The home page for STRICTA, or the Standards for Reporting Interventions in Controlled Trials of Acupuncture, which in 2010 adhered to the CONSORT Statement, or International Consolidated Standards for Reporting Trials, created to address widely accepted problems and issues in medical research with human clinical trials. From this current home page, links are provided to access an array of research guidelines and studies: http://www.stricta.info/
  7. A 2007 study by the Martinos Center for Biomedical Imaging and the Massachusetts 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 acupuncture, or superficial stimulation affected only the cortex sensation: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1997288/
  8. A 2012 study of the lasting effects of acupuncture stimulation, at the Southern Medical University, in Guangzhou, China, showed that electroacupuncture stimulation on 12 health volunteers, with effects measured with fMRI, noted that stimulation at the points Yintang and DU20, much studied in relation to psychiatric disorders, produced modulatory effects on key areas of the brain, with lasting effects greater after 15 minutes than after 5 minutes after the 30 minute treatment. The lasting effects produced changes n the frontal lobe, cingulate gyrus and cerebellum. Such study clearly shows that application for such treatment as part of a more holistic treatment protocol for diseases that affect the brain, and could significantly enhance the effects of herbal and nutrient chemicals, as well as pharmaceutical chemicals, in treatment, as well as being useful alone as a therapeutic protocol: http://www.ncbi.nlm.nih.gov/pubmed/22982941
  9. A study of the effects of a single acupuncture point, LI4, on the brain, utilizing functional MRI imaging, performed in 2002 at the China Academy of Traditional Chinese Medicine, in Beijing, China, showed that different types of stimulation at the same point in the same type of subjects, produced instantaneous activity in the same areas of the brain, and different ones, depending on whether the needle was stimulated manually or with electrical stimulation. Such study shows how the field of acupuncture is being clearly explained in modern terms, and does not rely purely on ancient theories of mystical energetic concept: http://www.ncbi.nlm.nih.gov/pubmed/12230901
  10. A further study in 2010 at the China Academy of Chinese Medical Sciences, in Beijing, utilized infrared thermography to show how similarly typed human subjects respond to 2 specific acupuncture points in relation to the body patterns assigned to the points, or the meridian system. Here, the measure of changes in tissue temperature that were immediately observed from stimulation of the trigger points matched the classic areas of treatment assigned to these points: http://www.ncbi.nlm.nih.gov/pubmed/20353116
  11. A 2013 study at Kyung Hee University, in Seoul, South Korea, compared the effects of acupuncture stimulation from 2 points on both healthy typed subjects, and similar patients who had suffered a stroke recently. The functional MRI imaging showed that the stimulation was broader in the healthy subjects, and more specific to areas of the brain in the stroke patients, showing the modulatory homeostatic effects induced by acupuncture, and elucidating the difference in effects for healthy and unhealthy subjects: http://www.ncbi.nlm.nih.gov/pubmed/23546630
  12. A 2013 study at Chongqing Medical University, in Chongqing, China, studied the difference in response between subjects with different constitutions regarding pain perception. The study showed that subjects in the normal and sensitive to pain perception showed significant increases in their pressure pain threshold (PPT) following stimulation at ST36, but patients in the insensitive parameter experienced no significant change, and that this correlated with measurement of the of the regional homogeneity (ReHo) with functional MRI in areas of the cerebrum as well as areas that process pain perception. Such studies explain the differences in the results of acupuncture treatment for different patients, as well as the importance of neuromuscular reeducation and mind-body medicine in pain management: http://www.ncbi.nlm.nih.gov/pubmed/24261302
  13. A 2014 study design for TCM manual therapies was introduced by the Beijing University of Chinese Medicine, in which patient preference was considered, taking into consideration the variation in measurable effects on different types of patients, many of which may gravitate to a particular treatment modality in TCM based in their sensitivity and individual bias toward a specific type of treatment: http://www.ncbi.nlm.nih.gov/pubmed/25012121
  14. A short description of the use of regional homogeneity (ReHo) in functional MRI study by San Diego State University experts, shows that such methodology may better elucidate the more holistic connectivity in regions of the brain observed with acupuncture stimulation: http://www.sci.sdsu.edu/bdil/web/lines_of_research/Entries/2008/8/27_Regional_Homogeneity_%28ReHo%29.html
  15. A description of current applications of regional homogeneity functional MRI studies, by experts at Hebei University, in China, shows how such holistic assessment reveals the differences in brain activity and coordination between areas of the brain in subjects with diseases such as mild cognitive impairment, or early Alzheimer's disease, as well as patients with ADHD, schizophrenia, Parkinsonism and depression. The obvious application of acupuncture and electroacupuncture to stimulation of the areas that show depressed activity in these diseases is apparent as an adjunct therapy: http://www.hindawi.com/journals/bmri/2015/807093/
  16. 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.pdfThis 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.
  17. 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/
  18. In the 21st century, we are finding that scientists are reexamining their views of acupuncture and Traditional Chinese Medicine in a new light, as current physics is finally being integrated into our biological sciences, over 100 years after the physical sciences found that our reality is best described as a quantum field of integrated energetic movements, not a static two dimensional picture of specific atoms combining into set molecules that perform set functions. The ancient Daoist scientists in fact saw this, as amazing as this sounds, and some interesting avenues of thought, such as quantum entanglement and quantum chromodynamics appear to mirror the ideas of these ancient scientists. For example: https://www.physicsforums.com/threads/carl-jungs-synchronicity-and-quantum-entanglement.518409/
  19. A June, 2015 experiment by experts at UCLA, MIT, Columbia University, and the University of Maryland showed that quantum entanglement could be seen in photon pairs that were hyperentangled, carrying a large amount of data that was instantaneously seen in the pair to the studied photon that was separated by space and time: http://newsroom.ucla.edu/releases/new-method-of-quantum-entanglement-vastly-increases-how-much-information-can-be-carried-in-a-photon
  20. Emerging research is just starting to design biophysics studies that could not just show what the effects of acupuncture stimulation are, but finally elucidate the complex mechanisms of acupuncture. Here, an independent physics researcher from California, Fred Thaheld, explains some of the astounding findings in the last 2 decades, which are just beginning to be accepted in standard scientific realms, as they are violating the apriori assumptions and religiosity of much of modern science. Such study will finally uncover the bias against ancient science as well: http://arxiv.org/vc/q-bio/papers/0605/0605027v1.pdf
  21. An early attempt to measure the meridian field of acupuncture stimulation in a quantum sense is seen here by this study at the Institute of Biomedical Engineering at South Central College in Wuhan, Hubei province, China: http://www.ncbi.nlm.nih.gov/pubmed/7572328
  22. A 2011 report on the state of rational design techniques and the use of alchemical free energy assessment in drug development, by experts at the University of California at Berkeley, the University of New Orleans, the University of Virginia, and Stanford University, explains how this more holistic and quantum research design holds much promise in new drug discovery, but has its limitations with the current pharmaceutical research perspective. The application of this research design for more complex integrated biochemical therapeutic protocols, including herbal medicine, is obvious, but the funding for such research will not come from the herbal industry itself, as there is relatively little money to be made with unpatented natural medicines: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3085996/