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Archive for the ‘acupuncture clinical trial’ Category

In their recent report in the Annals of Internal Medicine, Ee et al1 state that Chinese medical acupuncture was no better than non-insertive sham acupuncture for women with moderately severe menopausal hot flashes in a randomised controlled trial. The authors conclude that they “cannot recommend skin-penetrating acupuncture as an efficacious treatment of this indication”.1 In my opinion, the authors might have misinterpreted the results.

The ‘sham acupuncture’ used in this clinical trial was the Park sham device, which is supposed to serve as a placebo treatment. It uses a 0.35×40 mm blunt needle supported by a plastic ring and guide tube (base unit) attached to the skin with a double-sided adhesive ring. The needle telescopes into itself and shortens on manipulation, giving the visual and physical impression of insertion into the skin.1 Although the blunt needle does not insert into the skin, it does cause considerable pressure and thereby mechanical stimulation, especially given the small diameter at its tip. This Park sham device should arguably be relabelled as an acupressure device, instead of a form of sham acupuncture treatment. Indeed, this type of device and needling method is historically recognised as an active form of treatment; it is otherwise known as a Di needle (鍉针 or Di Zhen, a style of pressing needle that does not penetrate the skin), as documented in The Spiritual Pivot: Nine Needles and Twelve Source Points (Ling Shu: Jiu Zhen Shi Er Yuan) in the second part of the Yellow Emperor’s Inner Classics, which was published 2000 years ago.2 For this reason, the trial design contained an obvious weakness; it compared acupuncture with acupressure, rather than acupuncture with truly inert sham acupuncture.

According to the trial’s results, hot flash scores decreased after both interventions by about 40% between baseline and the end of treatment (10 sessions, ending after 8 weeks) and these effects were sustained for 6 months. Statistically, there is no evidence that acupuncture was better than acupressure (called ‘sham acupuncture’ in the paper) in its impact on quality of life, anxiety or depression.1 This can equally be interpreted as evidence that both acupuncture and acupressure effectively decrease hot flashes and related symptoms, as well as quality of life, if we compare the results immediately after treatment (8 weeks) and at the 3- and 6-month follow-up, with baseline in the same group (self-control) or comparator group (as a waiting list-like control).

As regards the placebo effect, evidence from the literature3 and a review of multiple trials4 shows that patients receiving placebo interventions exhibit an average decrease of 21–25% in hot flash frequency and intensity. Therefore, a 40% decrease in hot flash symptom scores with either acupuncture or acupressure treatment is notably higher than that expected with a placebo and likely to be clinically significant. Further research with a more appropriate control group is needed. Meanwhile, however, if a patient declines or cannot tolerate conventional drug treatment, then it would not be unreasonable to offer either acupuncture or acupressure as an alternative treatment for this condition.

References 1. Ee C, Xue C, Chondros P, et al. Acupuncture for menopausal hot flashes: a randomized trial. Ann Intern Med 2016;164:146–54. doi:10.7326/M15-1380 [Medline] 2. Wu JN (translator). Ling Shu or The Spiritual Pivot. University of Hawaii Press, 2002. 3. Loprinzi CL, Michalak JC, Quella SK, et al. Megestrol acetate for the prevention of hot flashes. N Engl J Med 1994;331:347–52. doi:10.1056/NEJM199408113310602 [CrossRef][Medline][Web of Science] 4. Sloan JA, Loprinzi CL, Novotny PJ, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol 2001;19:4280–90. [Abstract/FREE Full text]

Fan AY. Trial suggests both acupuncture and acupressure are effective at reducing menopausal hot flashes. Acupunct Med doi:10.1136/acupmed-2016-011119.

http://aim.bmj.com/content/early/2016/04/19/acupmed-2016-011119.full

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Original article source: http://tcmaaa.org/JAMAresponse.shtml

In 2009, NHMRC funded a research grant (No. 566783; $687,239) to Dr. Rana S Hinman and her team as “ Laser acupuncture in patients with chronic knee pain: a randomised placebo-controlled trial ”. The grant resulted in a publication in the October 2014 issue of the Journal of American Medical Association (JAMA) titled “ Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial ”. The authors (Hinman and her colleagues) 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”. Following the publication, expert researchers called for explanations to study errors and inconsistencies. With unsatisfactory answers from Hinman and her colleagues, acupuncture organizations (23 organizations) filed three complaints with the University of Melbourne in May through July 2015, but in a letter dated 16 September 2015, the University denied all complaints without providing any reasonable supporting evidence and research documents…     Click here to read more …

Dr. Arthur Yin Fan published a series of articles poking the flaws in Hinman’s study:
► The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation
► The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions
► The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation

Article on Medical Acupuncture by Dr. Kehua Zhou:
► Acupuncture for Chronic Knee Pain: A Critical Appraisal of an Australian Randomized Controlled Trial

Response to JAMA by Dr. Qinhong Zhang et al:
► Acupuncture treatment for chronic knee pain: study by Hinman et al underestimates acupuncture efficacy

Commentary on Acupuncture in Medicine by White A and Cummings M.:
► Hinman’s Trial underestimated the acupuncture effectiveness

Article on The American Acupuncturist Summer 2015 by Jacob Godwin and Arthur Y Fan
► Evidence-Based Medicine Skills for Acupuncturists Part I: The Hinman Trial on Chronic Knee Pain…

Responses to JAMA:
► Responses to JAMA by Dr. Yong Ming Li, Lixing Lao, Hongjian He, etc.

Interview by Acupuncture Today:
► Chinese Doctors Poke Holes in Australian Study By Bill Reddy, LAc, Dipl. Ac.

Dr. Changzheng Gong’s article on International Journal of Clinical Acupuncture:
► Acupuncture Storms JAMA

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The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation
April 6, 2015 | Arthur Yin Fan | J Integr Med 2015; 13 (4) : 209–211
doi: 10.1016/S2095-4964(15)60184-4
ABSTRACT | FULL TEXT | PDF |

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Can Acupuncture Treat Knee Pain? Ge Nan, PhD, Yong Ming Li, MD, PhD.

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Chinese Doctors Poke Holes in Australian Acupuncture Trial for Chronic Knee Pain by Rana Hinman- By Bill Reddy, LAc, Dipl. Ac..

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Hinman Acupuncture Trial

Chinese Doctors Poke Holes in Australian Study

By Bill Reddy, LAc, Dipl. Ac.

http://www.acupuncturetoday.com/mpacms/at/article.php?id=33043

Editor’s Note: In addition to this interview, you can find several resources regarding this study atwww.acupuncturetoday.com, including a PDF of the Australian study published in JAMA, an article in response to the flaws seen in this study, the Letter to the Editor of JAMA referenced in this interview and a complaint letter from the Traditional Chinese Medicine American Alumni Association (TCMAAA).

For more information about the TCMAAA, contact: Selene Hausman, LAc at 480-510-2259 or via email at seleneph@gmail.com.


A recent Australian clinical trial, published in theJournal of the American Medical Association (JAMA) in 2014 by Rana Hinman, et el., evaluating the effectiveness of both needle and laser acupuncture for chronic knee pain, caught the attention of Dr.’s Hongjian He, AP, MD, PhD; Lixing Lao, PhD, MB; Wing-Fai Yeung, BCM, PhD; and Yong Ming Li, MD, PhD. They were astonished to read that the conclusions of the study stated, “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.” Obviously, that statement didn’t reflect their combined clinical experience. Upon further investigation, they felt there were serious design flaws in the study and wrote letters to the editor ofJAMA expressing their concerns that were published in February 2015 along with the Australian researchers’ responses.

more detail at: http://www.acupuncturetoday.com/mpacms/at/article.php?id=33043

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  1. POSTED OCTOBER 13TH, 2014 AT 7:07 PM 
    From Harvard medical school-Harvard Health Publications.
    http://www.health.harvard.edu/blog/acupuncture-knee-arthritis-fails-one-test-may-still-worth-try-201410017470

    Quick Care Walk-In Medical Clinic
    Although acupuncture is indeed not endorsed by the medical community, some of our patients do report successful treatments. Thank you for an informative article.
    • POSTED OCTOBER 15TH, 2014 AT 2:23 AM

      Kino
      This is silly! many doctors ‘work’ with Acupuncture, Kinesiology, Chiropractic and more. Many in the medical profession are disillusioned by the ‘a pill for every ill and hide the symptoms’ attitude to disease which the AMA forces them to work with.
      In an editorial in the highly esteemed ‘British Medical Journal’, titled ‘Where is the Wisdom? The Poverty of Medical Evidence, BMJ’s editor Dr. Richard Smith recounts a lecture he attended with renowned health policy consultant Dr. David Eddy.Eddy found, after doing significant research, that only about 13% of medical interventions are supported by solid scientific evidence and that only 1% of the articles in medical journals are scientifically sound.Why is that? Because most of those articles quote from other articles which make unsupported and unfounded claims.

      The High Risks of the Medical Approach

      Dr. Lucian Leape, researcher at the Harvard Medical School of Public Health, also states that only 13% of medical procedures have ever been tested for appropriateness by randomized trials.
      He noted that adverse events occurred in 3.7 percent of all hospitalizations. Worse yet, 13.6 percent of those adverse events led to death!
      He is quoted as saying, “Medicine is now a high risk industry, like aviation.
      But, the chance of dying in an aviation accident is one in 2 million, while the risk of dying from a medical accident is one in 200!”
      I think I’ll take acupuncture anytime!

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