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Posts Tagged ‘acupuncture clinical trial’

Recommended by HealthPAIN RELIEF from http://www.prevention.com/health/health-concerns/acupunctures-effect-knee-pain
How Researchers Reached The Flawed Conclusion That Acupuncture Doesn’t Help With Knee Pain By MARYGRACE TAYLOR SEPTEMBER 30, 2014
The effects of acupuncture on knee pain

Picture this scenario: An adult plagued with chronic headaches seeks relief by popping ibuprofen a few times a week. The meds help. Then she decides to stop taking them. And when she does, the pain creeps back.

Surprised? Not exactly. The last thing you’d deduce from this imaginary experiment is that ibuprofen doesn’t help with headaches. But that’s basically what researchers suggested about needle and laser acupuncture’s effect on chronic knee pain in a new JAMA study.

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In the clinical trial, 282 adults age 50 and older with chronic knee pain were randomly assigned to needle or laser acupuncture treatments or a sham laser acupuncture treatment. After 12 weeks, participants who received the acupuncture reported modest improvements in pain. Then the treatments stopped, and nine months later, the participants had knee pain again. This, weirdly, led the researchers to conclude that acupuncture just doesn’t offer relief from chronic knee pain.

Sounds confusing, right? Save for undergoing surgery, most chronic pain problems can never really be permanently solved. Even for treatments that make the discomfort vanish, it tends to come back once said treatment stops. That’s sort of a given. “Acupuncture can be used as pain management, but it doesn’t necessarily heal the pain permanently,” says Michelle Goebel-Angel, licensed acupuncturist at Chicago’s Raby Institute for Integrative Medicine at Northwestern.

There’s more. The researchers of this small study posit that having a larger sample size might have yielded more significant results. Which is exactly what experts uncovered in 2012 meta-analysis of nearly 18,000 patients, which found that needle acupuncture does help with osteoarthritis, as well as other types of chronic pain.

Still, like many treatments, acupuncture doesn’t have the same effect on everyone. But it’s absolutely worth trying, and tends to be the type of thing where the benefits accumulate over time (as in, longer than 12 weeks). “When patients feel the relief, they believe it,” says Goebel-Angel. “And that opens a new level of healing—the spiritual aspect of healing.”

MORE: 12 Odd Pain Relief Tricks That Work

Tags: NEWSDOCTORS & MEDICINEHEALTH HABITS & MISTAKES

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Dr. Godwin and Dr. Fan’s article “Evidence based medicine skills for acupuncturist part I: The Hinman Trial on Chronic Knee Pain and the Importance of Critical Appraisal Skills.” was published recently in Journal of American Acupuncture 2015;71 (Summer): 22-29.(For the PDF file, please click the link below)

Godwin J, Fan AY. Evidence based medicine skills for acupuncturist part I- The Hinman Trial on Chronic Knee Pain and the Importance of Critical Appraisal Skills. J Am Acupunct 2015;71 Summer 22-29.

Abstract
Evidence-based medicine (EBM) skills are critical to clinical effectiveness and to developing and maintaining an effective intellectual ecosystem of clinicians, researchers, policy-makers, and academics. One important competency within the evidence-based medicine paradigm is the ability to appraise research papers critically. The authors first discuss the value of research literacy among acupuncturists and then demonstrate the importance of this skill by critically appraising a randomized controlled trial (RCT) on chronic knee pain published by Hinman et al. in
The Journal of the American Medical Association
(JAMA) in 2014.
Keywords: evidence-based medicine, Hinman trial, acupuncture, research literacy, acupuncture competencies

“ Research literacy is one of the most important issues facing the acupuncture profession in the United States and is a critical competency for all healthcare providers operating under a scientific evidence-based paradigm.”

“ From 2000 to 2006, the National Center for Complementary and Alternative Medicine (now the National Center for Complementary and Integrative Health, or NCCIH), of the National Institutes of Health (NIH), provided R25 funding to nine Complementary and Alternative Medicine (CAM) colleges to develop EBM programs. That the NIH is funding programs to improve EBM skills demonstrates how important these skills are in modern healthcare.”

“ No trial can conclude ‘acupuncture is ineffective’ for any condition. A trial can only demonstrate the efficacy of a particular acupuncture procedure. A trial tests a tightly controlled procedure, not an entire therapeutic intervention.”

“ The contemporary acupuncturist must have the skills to retrieve, critically appraise, and apply to his or her patients’ conditions the very best evidence available. Developing the skills demonstrated in this paper and by the many experts active in acupuncture research should be a priority for any clinician practicing acupuncture.”

Conclusion
The ability to critically appraise acupuncture research is crucial to the concept of fidelity described earlier. Patients, payers, regulatory agencies, and the public assume that clinicians are delivering the best available care based on the latest and highest-quality evidence. The contemporary acupuncturist must have the skills to retrieve, critically appraise, and apply to his or her patients’ conditions the very best evidence available. Developing the skills demonstrated in this paper and by the many experts active in acupuncture research should be a priority for any clinician practicing acupuncture.

Godwin J, Fan AY. Evidence based medicine skills for acupuncturist part I- The Hinman Trial on Chronic Knee Pain and the Importance of Critical Appraisal Skills. J Am Acupunct 2015;70 Summer 22-29.

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AcupunctureToday.com Interview Chinese-Doctors-Poke-Holes-in-Australian-Study 063015

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

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We thank Hinman and her colleagues for their considered reply to our letter. We accept that our approach was more informal than their response, but in our defence, we were writing originally for the audience of a general journal, rather than for methodologist and statisticians.

The main point we wished to make concerns the decision to power a study without any reference to previous literature or pilot data within the setting adopted. Of course it seems superficially justified to adopt a minimum change that you wish to measure (in this case a difference over sham of 1.8 on a 10 point scale), but if this difference has never been achieved in previous research it seems odd to invest so much unless the intention was to provide evidence of a lack of effect for acupuncture and laser acupuncture. More….http://acupmed.bmjjournals.com/content/33/1/86/reply

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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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http://www.acupuncturetoday.com/…/can_acu_treat_knee_pain.p…

Can Acupuncture Treat Knee Pain?

Ge Nan, PhD, Yong Ming Li, MD, PhD

Recently an article in Journal of the American Medical Association concluded that “neither laser nor needle acupuncture conferred benefit over sham for pain or function” among older chronic knee pain patients. (JAMA, 2014;312:1313)

We, the practitioners of acupuncture and more broadly Traditional Chinese Medicine (TCM), believe this conclusion is premature. There has been several thousand years of acupuncture practice in history. Acupuncturists’ observation, patients’ feedback, many previous clinical trials, as well as basic researches, all suggest that acupuncture could effectively treat knee pain.

There are several flaws in the design of this article, which we will itemize and address below. In general, the key reasons are 1) the lack of an appropriate sham needle control in the trial, 2) poorly designed protocol and insufficient power of test, and 3) exaggerated data interpretation.

This study demonstrates better effectiveness of needle acupuncture over no treatment control.
This is consistent with observations in previous clinical trials and real clinical practice. Logically, this does not argue against needle acupuncture as a potential therapy for treating chronic knee pain.
The primary goal of this trial is to determine the efficacy of laser treatment, not needle acupuncture, in treating chronic knee pain, as clearly evidenced by authors own trial protocols and publications.
A negative result is concluded from the data, that is, laser treatment was shown not to be better than sham laser treatment or needle acupuncture.
The final conclusion of this study states: both needle acupuncture and laser treatment are not better than sham laser treatment, thus acupuncture should not be recommended for patients with chronic knee pain.
This conclusion is ungrounded, and quite frankly does not make sense. Sham laser treatment is not a valid control for needle acupuncture, thus the comparison is invalid.
The acupuncture protocol in this trial is poorly designed and does not reflect real clinical practice and management of patients with knee pain.
Acupuncture point selection, acupuncture dose and frequency, time course, and evaluation points was not optimal.
Among 282 patients participated in this trial (about 70 per group), with variable health conditions, only 54 patients completed needle acupuncture treatment (less than 1 treatment per week, for 12 weeks).
This small sample of patients does not provide enough statistical power to test the difference between acupuncture and sham treatments.
Twelve months is too long a time-peirod for a second point of follow-up, considering the treatment concluded at the end of 12-week.
Moderate or severe chronic knee pain occurs naturally among older patients. A more appropriate follow up regimen would be frequent survey over a shorter time period.
The author over emphasized the strength of Zelen design and ignored its limitation.
Despite randomization in the beginning, the usage of Zelen design in this study is not appropriate. For example, different treatment groups are not equally blinded during the trial, which will exert variable placebo or even nocebo effects and eventually lead to unfair among-group comparisons. Furthermore, 19% of the patients that refused needle acupuncture were analyzed as receiving the treatment. This is not an accurate comparison by any means.
This trial includes patients older than 50 years with moderate or severe chromic knee pain and the potential benefit effect of acupuncture on younger patients or older patients with mild knee pain cannot be ruled out.
Since publication, there have been a lot of debates around the efficacy of needle acupuncture. The investigators of this trial appeared on several public interviews to promote their negative findings on acupuncture and recommend their physical therapies to the patients. However, based on above analysis, we think the conclusion of this trial is premature and editors of JAMA should re-evaluate this report.

Summary of 2014 Australian Acupuncture Trial
Figure 1: Summary of 2014 Australian Acupuncture Trial for Knee Pain: The trial was originally designed to test laser treatment using needle acupuncture as a positive control (reference treatment). However, after collecting undesired results that the needle did not work as they expected, the authors changed their research aims to test both needle and laser treatments in final report.

NIH Summary
Figure 2: A recent summary by National Center for Complementary and Integrative Health (NCCIH) of NIH states acupuncture may help to reduce pain and improve joint mobility for osteoarthritis. NCCIH analysis was based on data published prior to 2010. The quality of acupuncture trials is crucial, because flawed negative data may change this balance in the future.

Acupuncture Today is a leading provider of acupuncture and oriental medicine news, info and research information in the world
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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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Controlled trials, systematic reviews and meta-analyses: acupuncture effective for patients with knee osteoarthritis.

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The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions.

Click to access S2095-4964(15)60172-8.pdf

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The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med 2015; 13 (2) : 65–68.

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The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med 2015; 13 (2) : 65–68.

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There are several vedio online, posted by NCCIH, regarding to acupuncture research methodology.

    1. NCCIH

      • Active 1 month ago
      • 139 videos
      This is the official YouTube channel for the National Center for Complementary and Integrative Health (NCCIH) at the National …
      • CHANNEL

      1,408

    2. Acupuncture Studies

      • 7 months ago
      • 884 views
      In this clip (5 of 9), Dr. Deyo discusses some examples of studies on acupuncture. This clip is part of the lecture “Manipulating the …
      • HD
      • CC
    3. Comparative Effectiveness Research

      • 1 year ago
      • 675 views
      In this clip (8 of 9), how acupuncture can contribute to comparative effectivenessresearch is discussed. This clip is part of the lecture
      • HD
      • CC
    4. Data on Acupuncture’s Efficacy and Effectiveness

      • 1 year ago
      • 1,340 views
      In this clip (4 of 9), several recent studies on acupuncture’s efficacy and effectiveness are discussed. This clip is part of the lecture …
      • HD
      • CC
    5. Safety of Acupuncture

      • 1 year ago
      • 1,021 views
      In this clip (2 of 9): Results are presented from some large observational studies in the U.K. and Germany on the safety of …
      • HD
      • CC
    6. Acupuncture: Diverse Points of View

      • 1 year ago
      • 1,352 views
      In this clip (1 of 9): Acupuncture is a highly debated topic, as seen, for example, in the media. This clip is part of the lecture …
      • HD
      • CC
    7. Acupuncture Styles; Individual Treatment Response

      • 1 year ago
      • 676 views
      In this clip (6 of 9), the speaker addresses: (1) Do different acupuncture styles matter with respect to outcomes? (2) Are there …
      • HD
      • CC
    8. Neuroimaging and Stimulation Studies

      • 1 year ago
      • 834 views
      In this clip (5 of 9), the speaker addresses brain imaging with fMRI on acupunctureand then a controlled study on stimulated vs.
      • HD
      • CC
    9. Where Should We Go?

      • 1 year ago
      • 607 views
      In this clip (9 of 9), Dr. Witt discusses important areas for future acupuncture research. This clip is part of the lecture “International …
      • HD
      • CC
    10. Testing Hypotheses About Acupuncture

      • 1 year ago
      • 209 views
      In this clip (6 of 11), the speaker discusses some studies, including at the Martinos Center for Biomedical Imaging, on the …
      • CC
    11. Some Considerations in Clinical Studies

      • 1 year ago
      • 997 views
      In this clip (3 of 9), Dr. Witt discusses measuring benefit to patients, and matchingresearch questions with study types, in clinical …
      • HD
      • CC
    12. Dr. Rick Deyo discusses research for chronic low back pain

      • 5 months ago
      • 37 views
      Dr. Deyo explains why he began studying complementary therapies for chronic low back pain. To learn more about the research …
      • HD
    13. Where Do We Stand?

      • 1 year ago
      • 603 views
      In this clip (7 of 9), the speaker offers five summary points from the acupuncture research and discusses a paper on clinical …
      • HD
      • CC
    14. Historical Perspective on Chiropractic and Acupuncture

      • 7 months ago
      • 999 views
      In this clip (1 of 9): Dr. Deyo gives a brief history of chiropractic and acupuncture, especially as related to the mutual mistrust and …
      • HD
      • CC
    15. CAM Therapies: Neurostimulation and Acupuncture

      • 1 year ago
      • 1,026 views
      In this clip (7 of 10): Acupuncture and deep brain stimulation have strong placebo effects, and may do so through different brain …
      • CC
    16. Introduction to Neurobiological Correlates of Acupuncture

      • 1 year ago
      • 266 views
      In this clip (1 of 11): Acupuncture has been practiced for thousands of years in various parts of the world and has become popular …
      • CC
    17. How can we use functional imaging to look at the therapeutic effect of acupuncture?

      • 1 year ago
      • 128 views
      In this clip (8 of 11): Carpal tunnel syndrome is a condition for which acupuncture is used; this has been a research topic at the …
      • CC

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The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions .

Click to access S2095-4964(15)60172-8.pdf

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