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.

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.

Advertisement

Read Full Post »

Chinese-Doctors-Poke-Holes-in-Australian-Study

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

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

Read Full Post »

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

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.

Can Acupuncture Treat Knee Pain?

Acupuncture Today is a leading provider of acupuncture and oriental medicine news, info and research information in the world

ACUPUNCTURETODAY.COM

Read Full Post »

Chinese Doctors Poke Holes in Australian Study- By Bill Reddy, LAc, Dipl. Ac.

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

Read Full Post »

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 II: Zelen design and effectiveness dilutions.

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

Read Full Post »

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 II: Zelen design and effectiveness dilutions .

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

Read Full Post »

Rana Hinman’s Acupuncture Clinical Trial has methodology flaws (IV)-The sham laser acupuncture is not a valid negative control for acupuncture

The sham laser acupuncture is not a valid negative control for acupuncture

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”(Hinman RS,et al. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014; 312(13): 1313–1322.).

I strongly disagrees with such a 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 do agree acupuncture should have a real sham control in a vigorous RCT; however, in Hinman’s acupuncture RCT, the sham laser acupuncture is only fit to the laser acupuncture, not to real acupuncture. Because Acupuncture and Sham laser acupuncture, these two interventions do not have comparability in both characteristics and form (i.e., not matched). Furthermore, there was no blinding method performed between these two groups-both the patients and the administrators who performed the interventions knew the difference between the groups, such as needling acupuncture and sham laser acupuncture.

Read Full Post »

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.

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.

Read Full Post »