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Our clinical study “Effect of Two Acupuncture Protocols on Vulvodynia” starts to recruit patients. Please contact Dr.Sarah Alemi or Dr. Arthur Yin Fan. Tel: 703-547-8197, 703-499-4428. Email: ArthurFan@ChineseMedicineDoctor.US.

Clinical Trial ID is: NCT03481621

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Rana Hinman’s Acupuncture Clinical Trial has too many methodology Flaws (III)-There is a crucial mistake in interpreting the Hypothesis testing – What means? if P>0.05..

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There is a crucial mistake in interpreting the Hypothesis testing – What means? if P>0.05.

Hinman said :”in……chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function (Dr. Fan notes: Her statement was based on P>0.05). Our findings do not support acupuncture for these patients”

From the perspective of hypothesis testing in Statistics, if acupuncture has better results and with significant difference over the primary control (no-treatment group), p<0.05, we can conclude that “acupuncture is effective”- no matter what the result get from the comparing to the secondary control, such as “sham laser acupuncture”, but Hinman intentionally does not report this effectiveness in her conclusion; if acupuncture has better results over “laser acupuncture” and “sham laser acupuncture”, without significant in statistics, p>0.05, we can conclude that “acupuncture is better than the laser acupuncture, and sham laser acupuncture, but need more studies to confirm”. We can’t conclude that “acupuncture is not effective” because that there are no significant difference in statistics between acupuncture and “laser acupuncture”, or between acupuncture and “sham acupuncture” does not mean there is no difference between these treatments clinically. Hinman et al mis-interpreter the results and violates the basic principle of Statistics.

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TCMAAA Fan AY Hinman Trial’s Flaws Part I-design and results interpretation
February 27, 2015 | Arthur Yin Fan | J Integr Med 2015; 13 (2) : 65–68
doi: 10.1016/S2095-4964(15)60170-4
ABSTRACT | FULL TEXT | PDF

In the October 2014 edition of JAMA, Dr. Hinman and her colleagues published an acupuncture clinical trial entitled “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial” and concluded that “in patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients”. The author strongly disagrees with this conclusion, as there were serious flaws in the trial design, the statistical analysis of the data and in the interpretation of the results of this study.

Hinman’s acupuncture RCT has too many methodology flaws and misleading

As an independent researcher and practitioner in Acupuncture and Chinese medicine for thirty years, I strongly disagrees with Hinman’s conclusion, as there were serious flaws in the trial design, the statistical analysis of the data and in the interpretation of the results of this study. I published a commentary recently [Fan A. The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med. 2015; 13(2): 65–68.]http://www.jcimjournal.com/articles/publishArticles/pdf/S2095-4964(15)60170-4.pdf

The major concerns are:

(1)There is a major mistake in the primary testing factor in this RCT: the laser acupuncture should be the primary testing factor, not the needle acupuncture;

(2)The interpretation of the results was misleading;

(3)The “under-dosed” acupuncture treatments diluted the potential real effectiveness of acupuncture;

(4)Laser acupuncture and acupuncture would be effective in Hinman’s RCT, if the statistics were re-analyzed after re-adjusting the data.

(5)It is improper to test two different testing factors in one RCT with so small sample size;

(6)Laser acupuncture is not one kind of acupuncture, the author intentionally mixes it with acupuncture;

(7)Acupuncture did have significant effectiveness (p<0.05 in week 12), compared to the control (this is a primary control). However, the author intentionally does not interpreter this important result into the conclusion, instead, she concludes acupuncture is not effective and says her findings do not support acupuncture for patients.

I feel the author, somehow, intentionally misleads readers by testing acupuncture as a major intervention in this RCT-There was no significance between the positive control and the naïve control (i.e., acupuncture and control groups). Therefore, we can only conclude that the positive control, acupuncture was under-dosed or the study was otherwise flawed. That the positive control shows significance is a basic sign of the success of a clinical trial. From this perspective, Hinman’s trial was a failed clinical trial for laser acupuncture. As it would be unethical to publish an astonishing article, with a group of almost scrapped data and confusing logic, that misleads the readers, including the general public, medical society and policy makers, the researchers should have re-adjusted or re-designed their study instead of publishing it.

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Letters to JAMA Exposing Acupuncture Research Flaws Applauded by TCMAAA

http://www.marketwatch.com/story/letters-to-jama-exposing-acupuncture-research-flaws-applauded-by-tcmaaa-2015-02-19

Published: Feb 19, 2015 8:01 a.m. ET

TCMAAA calls for stricter adherence to research ethics and well-designed acupuncture studies among the integrative medicine community

TAMPA, Fla., Feb 19, 2015 (BUSINESS WIRE) — In five letters to the editor published in the latest issue of JAMA, the Journal of the American Medical Association, acupuncture clinicians and researchers around the world point to key flaws that call into question the validity and research methods used in a randomized clinical trial published in JAMA in October of 2014. The Australian study, Acupuncture for chronic knee pain: a randomized clinical trial, by Hinman, et al., concluded, “In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients.” Many American acupuncturists were outraged when the October 2014 article was published in JAMA and have called for a review of the study’s design and protocols.

Yong Ming Li, MD, Ph.D., of New Jersey challenges that the researchers altered the aims and hypotheses of the study after the data was collected and the trial was closed. According to the original aims and hypotheses submitted to the official clinical trials registry in 2009 the objective of the study was not to evaluate the effectiveness of traditional needle acupuncture against sham laser acupuncture, but to evaluate laser acupuncture against sham laser acupuncture with needle acupuncture serving as a positive control for laser acupuncture. Protocols originally filed with the registry as well as the authors’ baseline publication do not describe sham laser acupuncture as being a control for needle acupuncture. Dr. Li’s letter furthermore debates the validity of using sham laser acupuncture as a control for needle acupuncture, as it is not generally accepted as a valid control for needle acupuncture.

Hongjian He, AP, Ph.D., of Florida also questions design choices: she specifically points to the use of non-standardized point selection for chronic knee pain. Also some patients received treatments once a week, while others got treated twice a week. This lack of consistency throws into question the validity of the statistics extrapolated from the data collected during the study.

David Baxter, TD, DPhil, MBA, and Steve Tumilty, Ph.D., questioned in their letters why the researchers chose to use laser dosages below the threshold necessary to have a therapeutic effect and why they failed to specify wavelength used in the study and why those levels were chosen.

Lixing Lao, Ph.D., MB, and Dr. Wing-Fai Yeung, BCM, Ph.D., point out in their letter that patients were assessed after 12 weeks and then again after one year, but that without treatment for chronic knee pain after one year, the condition naturally will deteriorate, so that the findings after a year are irrelevant. With these key flaws revealed the conclusion of this randomized clinical trial is clearly undermined.

No group has been more involved in this issue than the Traditional Chinese Medicine American Alumni Association (TCMAAA). Through its broad social media in the USA and around the world, TCMAAA has orchestrated a series of professional forums and discussions on research ethics and design for acupuncture studies after the Australian study was published in JAMA.

“This collection of letters represents a merging of licensed acupuncturists and integrative medicine practitioners who demand the same gold standards of ethics and design quality for clinical acupuncture research as conventional medical studies,” stated Haihe Tian, Ph.D., AP., the President of TCMAAA.

Even with the challenges acupuncture poses in gold-standard randomized clinical trials this valuable treatment method should not be overlooked. With properly designed and well-thought-out studies acupuncture can be evaluated fairly and thoroughly, with conclusions founded upon careful reasoning, accepted controls, and irrefutable evidence.

About TCMAAA:

Registered in Florida, TCMAAA (website: http://www.tcmaaa.org) is a nonprofit organization with one thousand members of licensed acupuncture practitioners formally trained in accredited medical education institutions in China. As a leading organization among Chinese Medicine practitioners, TCMAAA continues to support its members’ professional growth across the United States.

SOURCE: TCMAAA

For TCMAAA
Selene Hausman, L.Ac., 480-510-2259
seleneph@gmail.com

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Acupuncture Today, April, 2012, Vol. 13, Issue 04      http://www.acupuncturetoday.com/mpacms/at/article.php?id=32551

Real Acupuncture or Real World Acupuncture? Deciphering Acupuncture Studies in the News .  By Matthew Bauer, LAc

Recent studies have concluded that acupuncture is no more effective than various forms of sham or placebo acupuncture, and these conclusions have been reported in the media and used by skeptics to discredit acupuncture.

The Oriental medical (OM) community’s response to these reports has been ineffective, perhaps counterproductive. These studies, and the resulting media coverage, can serve was a wake-up call to the OM community, alerting us that we need to be more proactive in our public education efforts and rethink some long-held beliefs regarding the efficacy of traditional theories.

In the News 

In the last few years, several studies sought to measure the effectiveness of acupuncture in treating common conditions.1,2,3 The findings of these studies were widely reported within the media.4,5,6 The good news for the Oriental medicine (OM) profession is that these studies found that acupuncture was not only effective, but often more effective than conventional therapies. The bad news is that these studies also found that traditional acupuncture techniques – based on the point/channel theories taught inOMschools – were no more effective than what is termed “sham” or “placebo” acupuncture.

The most recent of these studies, published in the May 11, 2009 issue of the Archives of Internal Medicine and sometimes referred to as the “Seattle” study, built on other recent studies and is a good example of current acupuncture research. One of the conclusions this study’s authors reached is particularly striking:

“Collectively, these recent trials provide strong and consistent evidence that real acupuncture needling using the Chinese Meridian system is not more effective for chronic low back pain than various purported forms of sham acupuncture.”

As someone who has treated thousands of people with chronic low back pain using the Chinese meridian system, my first reaction to this statement was to feel the researchers were mistaken. But, I also respect scientific research and feel it would be a great mistake for those of us in the OM profession to criticize these studies just because they tell us something we don’t want to hear, without looking critically at both the studies and our own beliefs.

Real Vs. Real World 

The only evidence these studies actually provide is that so-called “real” acupuncture is not more effective than sham acupuncture in a controlled, clinical trial environment. I believe this detail is of critical importance. But, before I explain why this detail is of such importance, I want to critique the response to these studies from within the OM profession.

Up to this point, the sparse response from theOMfield to these studies has been limited to pointing out that there are many acupuncture points including hundreds of extra points, so “sham” acupuncture is still hitting acupuncture points. Regarding studies that use “placebo” techniques in which acupuncture is simulated with the skin unbroken, some acupuncturists have pointed to tapping techniques, common in Japanese acupuncture, that never pierce the skin. While there is some merit to these arguments, they ignore the greater problem with these studies and make theOMprofession sound to the public like we are grasping at straws and making excuses. If researchers can’t help but hit useful points no matter how hard they try to avoid them, why should anyone bother seeking treatment from people trained in the complex traditional theories that stress diagnosing qi imbalances to identify the best point prescriptions?

The primary problem with these studies is not that researchers inadvertently performed real acupuncture when they attempted to do sham or placebo acupuncture, but that the real acupuncture seriously underperformed. Most of these studies show the real acupuncture groups to be somewhere in the 45-60% effective range. Only 45-60%? If I was only getting 45-60% positive effect for my patients, I would never have been able to build my practice and support my family for the last 23 years. Ask any clinically successful acupuncturist, and they will tell you for common pain problems like low back pain, the average range of effectiveness is somewhere between 75-85%.

Obviously, something about the design of these studies does not capture what happens in the real world when using acupuncture to treat these conditions. Unfortunately, we don’t have enough studies that reflect what happens in the real world because most of the money for research has gone to the “controlled” studies using sham and placebo controls, and the type of patient contact that happens in real world treatment is not allowed. None of these recent studies allowed the acupuncturist who did the needling to consult with the patient and choose points and techniques.

In most of these studies, a set of points were prescribed and used repeatedly regardless of the patient’s progress, or lack thereof. TheSeattlestudy was the only study that attempted to mimic actual practice by having a diagnostic acupuncturist see one group of patients before each treatment. This diagnostician chose the points to be used based on traditional diagnostic rationale, but then these points were passed along to the treating acupuncturist who did the actual needling.

Qi Interaction

Will it affect the outcome if the acupuncturist who inserts the needles is not allowed to interact with the patient and choose what points and techniques to use? It shouldn’t matter, if acupuncture only stimulates specific nerve endings, causing mechanical neuro-chemical responses within the body. But, if acupuncture actually works by manipulating qi, as its founders and supporters have claimed for more than 2,000 years, then there is very good reason to believe that the qi dynamic between the acupuncturist and the patient is an important factor that must be considered.

The first day I interned in the private practice of my school’s clinic director, he asked me to take charge of treating a very difficult case. When I balked and said I thought I was too inexperienced to manage such a difficult case, my teacher told me that my sincere enthusiasm created a positive qi that helped to offset my lack of experience. Over the years, I have come to believe the acupuncturist’s qi can be as important as the points themselves. Points do matter, but the effect these points elicit is influenced by the qi of the one stimulating them. Like yin and yang, there is a combination of both factors at play: different points have different tendencies regarding how they influence a patient’s qi dynamics, but that tendency is influenced by the qi of the person manipulating the points. Because this fact is rarely discussed in acupuncture circles, researchers have not taken this into account in their studies.

Skeptics have long contended that acupuncture only works if the patient believes in it (ignoring the effects of veterinary acupuncture or animal studies), but it may be more important that acupuncturists believe in what they are doing. The best practitioners with the highest success rates put everything they have into every treatment – into every needle or patient contact. We choose points and techniques because we believe they are very best for our patients, and that belief influences the effects of the points. Any acupuncturist who puts needles in a patient not believing it to be the very best they can do is inserting those needles with less than optimal qi.

Unlike administering drugs or performing surgery, which manipulates the body in a more mechanical fashion, influencing qi dynamics is more dependant on subtle factors, including the qi of the one doing the manipulating. This may sound like what skeptics call “woo-woo” – irrational, new age mysticism — but it is a key part of acupuncture’s traditional foundation and deserves consideration. Before jumping to conclusions about traditional concepts, we should encourage studies using acupuncture in a way that reflects what takes place in the real world. Let’s study what happens to patients when treated in actual clinic conditions with no blinding or controls, in which the acupuncturist does whatever their years of training and experience leads them to believe is the best they can do for each patient. Don’t limit them in their techniques and communication with the patient, because such limits are not imposed in real world practice. And don’t refer to acupuncture being done under research constrained controls as “real” acupuncture, because it does not resemble the manner in which acupuncture is done in actual practice.

These studies point to sobering realities theOMprofession needs to face. We cannot ignore the fact that in study after study in which researchers stimulated points in a manner that seemed incompatible with traditional Chinese medicine protocols, a respectable percentage of test subjects experienced significant improvement. So while it may be fact that the best trained and most experienced acupuncturists will obtain 75-85% effectiveness rates for their patients, it may also be a fact that poking some needles virtually anywhere will get 40%-50%, sometimes even 60% effectiveness. (See sidebar.) If that is the case, then the value of comprehensive traditional training and years of experience may be in getting that extra 20-30% of successful outcomes.

I am not surprised that poking needles anywhere can help a decent percentage of pain-related cases because I believe any acupuncture stimulates the body to produce anti-trauma chemistry such as pain modifiers and anti-inflammatory compounds. That is why I was never strongly opposed to other health care professionals being able to legally do some acupuncture. I have long felt that rather than fighting to prevent other health care professionals from having the right to perform acupuncture, theOMprofession should be trying to educate these other professions that the more comprehensive training allows for that additional 20-30% effectiveness. In a spirit of mutual respect, we could encourage other health care professionals to refer their more difficult cases to us. This suggestion may not be welcomed by some, but theOMprofession must be open to evolve with the times.

Regardless of how we approach the issue of other health care professionals using acupuncture in their practices, the recent studies and media reporting of their findings should make one thing very clear: The OM profession needs to be much more proactive both in encouraging research that better reflects real-world acupuncture and in educating the public and media about OM and the OM profession. TheOMprofession has never mounted a comprehensive, multi-year, public education campaign. We have never seen fit to make such a campaign a priority. This must change. We cannot continue to leave the manner in whichOMis perceived by the public and portrayed within the media to outside forces. For too many years, our profession has acted as if all we have to do is raise education standards and do the good work of helping people and the rest would take care of itself. The conclusions of these studies and the media reports that followed should be making it clear that this is not the case.

Conclusion

If it were true that getting successful results does not depend on where one puts the needles, then every first-year acupuncture intern would get the same results as their most experienced teachers, which is not the case. While it seems to be true that having positive qi can make up for lack of experience, almost any acupuncturist will tell you that they get better results with experience. After training and licensure, acupuncturists typically spend the next several years of their careers learning more techniques and theories to add to their arsenal. Why do we do this? Because we learn that sometimes your Plan A or Plan B does not get results, so you better have a Plan C, D, and E as back-up if you want to get the highest degree of success. If it did not matter where you put the needles, no one would bother to keep learning additional techniques and the robust continuing education offerings out there would cease to exist.

We OM professionals, who work our tails off helping our patients, know how valuable our services are and we know that points do matter. We are buoyed by the gratitude of our patients, even as they tell us how they wished they had known aboutOMsooner and wonder why more people don’t take advantage of this safe healing resource. We don’t have to manipulate the facts to educate the public, media, and policymakers about what we have to offer, but we do have to guard against allowing the facts to be manipulated against us. There are acupuncture researchers who have a greater grasp of the subtle dynamics of clinical acupuncture, including the Society for Acupuncture Research, and the OM profession should do more to familiarize ourselves with their work and to encourage that the real-world effects of OM is given its just due.

References

  1. Haake M, Mueller HH, Schade-Brittinger C, et al. German acupuncture trials (GERAC) for chronic low back pain. Arch Intern Med. 2007;167(17):1892-1898.
  2. Cherkin D, Sherman K, Avins A, et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169(9):858-866.
  3. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: A systematic review of clinical trials. J Altern Complement Med. 2009;15(3):213-6.
  4. Bankhead C. Acupuncture tops conventional therapy for low-back pain. MedPage Today, 2007. www.medpagetoday.com/PrimaryCare/AlternativeMedicine/6770. Accessed October 11, 2009.
  5. Doheny K. Acupuncture may ease chronic back pain. WebMD Health News, 2009.www.webmd.com/back-pain/news/20090511/acupuncture-may-ease-chronic-back-pain. Accessed October 11, 2009.
  6. Park A. Acupuncture for bad backs: Even sham therapy works. Time.Com, 2009.www.time.com/time/health/article/0,8599,1897636,00.html. Accessed October 11, 2009.
  7. Amaro J. Is most of acupuncture research a “sham?” Acupuncture Today. August 2009;10(8).www.acupuncturetoday.com/mpacms/at/article.php?id=32013. Accessed October 11, 2009.

About the Studies 

The two main trials referenced in this article are the German Acupuncture Trails (GERAC) for chronic low back pain and that carried out in both the Center for Health Studies,Seattle,Wash.and the Division of Research, Northern California Kaiser Permanente,Oakland,Calif.that is sometimes called the “Seattle Study.”

In the German trails, 1,162 patients were randomized into groups receiving “real” acupuncture, “sham” acupuncture, or conventional therapy. Participants underwent 10 30-minute sessions usually at 2 treatments a week for 5 weeks. An additional five treatments were offered to those who had partial response to treatment. The “real” acupuncture groups were needled at points traditionally believed to be beneficial for lower back pain while the sham acupuncture involved superficial needling at non-traditional points. At 6 months, positive response rate was 47.6% in the real acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group.

In theSeattlestudy, 638 adults with uncomplicated low back pain of 3-12 months duration were randomized into four groups: individualized acupuncture, standardized acupuncture, simulated acupuncture, and conventional care. In the individualized acupuncture groups, a “diagnostic acupuncturist” considered the patient’s progress and prescribed points according to traditional theory. The prescribed points were then needled by the treating acupuncturist. The standardized group employed a set of points traditionally considered helpful in treating low back pain that were used throughout the treatment series. The simulated group had the same points as used in the standardized group but toothpicks were used to simulate the feeling of acupuncture. The treatments were done using back points so subjects could not see the needles. Treatments in the first three groups were done by experienced acupuncturists and consisted of two treatments a week for three weeks then once a week for four weeks.

At eight weeks, mean dysfunction scores for the first three groups were 4.5, 4.5, and 4.4 points compared to 2.1 points for conventional care. Symptoms improved by 1.6 to 1.9 points in the first three groups and 0.7 in the conventional care group.

While I emphasize the need to distinguish what both of these studies refer to as “real” acupuncture from that which is practiced in the real world of clinical acupuncture settings, the Seattle Study did make note that its design had limitations, including restricting treatment to a single component of TCM (needling), pre-specification of the number and duration of treatment, and limited communication between the patient and acupuncturist. While I applaud this study’s authors for mentioning these limitations, the conclusions they reached regarding the “strong and consistent evidence” that real acupuncture is not more effective than sham acupuncture indicate they did not consider these limitations too significant.


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