How Researchers Reached The Flawed Conclusion That Acupuncture Doesn’t Help With Knee Pain

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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Acupuncture for knee osteoarthritis: reply by Hinman et al still denies real benefits for patients

• Adrian R White, Honorary University Fellow ; Mike Cummings,Plymouth University

http://acupmed.bmjjournals.com/content/33/1/86/reply

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

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

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-reported by AcupunctureToday

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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Controlled trials, systematic reviews and meta-analyses: acupuncture effective for patients with knee osteoarthritis

Controlled trials, systematic reviews and meta-analyses: acupuncture effective for patients with knee osteoarthritis.

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Acupuncture is effective for Chronic Knee Pain , or say, patients with knee osteoarthritis, supported by multiple studies

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

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 II: Zelen design and effectiveness dilutions

Click to access S2095-4964%2815%2960172-8.pdf

In the October 2014 publication of JAMA, Dr. Hinman and colleagues published the study “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial,” which 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[1].” As pointed out in my former article, Part I[2], there were serious flaws in the trial design and statistics, as well as in the interpretation of the results. This article attempts to address problems in the Zelen design used by Hinman et al[1]. There are some advantages to using a Zelen design for a randomized controlled trial (RCT). First, a Zelen design has a post-randomization consent design, which means that consent is only sought for one treatment each time, without the uncertainty of randomization. Researchers can be more comfortable knowing that they have the participants’ consent each time they undergo a treatment. Patients can also be more comfortable with this design because they know which type of treatment they are receiving; unlike traditional RCTs, patients are not ignorant of whether they are receiving the placebo or experimental treatment. Effects such as resentful demoralization and what is known as the “Hawthorne effect” (altered behavior or performance resulting from awareness of being a part of an experimental study) become less of an issue as patients are not weary of being part of a new alternative group, only the “standard” therapy will applies to them. However, it does have some disadvantages, and therefore can cause biases.

1 High drop-out rate:

The drop-out rates were 2.82% (2/71) in the control group; 22.86% (16/70) in the acupuncture group; 18.31% (13/71) in the laser acupuncture group; and 22.86% (16/70) for the sham laser acupuncture group. According to the acceptable standards for an RCT, dropout rates less than 10% are acceptable, drop-out rates between 10% and 20% mean that the resulting data quality is poor, and drop-out rates of more than 20% mean that the data quality is considered very poor and should not be used in analysis. In this trial analysis, the data quality in the acupuncture and sham laser acupuncture groups are very poor as the drop-out rates are over 20%; the authors should not have directly used them in any statistical analysis, unless they had re-adjusted and re-balanced the sample among the groups during the study. As outlined by the National Institutes of Health, if there is a differential drop-out rate of 15% or higher between study arms, such as between the control group and the treatment group in this clinical trial, then there is a very high potential for bias. This is a flaw that can decrease the quality of the study results.

2 The effectiveness in intervention groups was diluted by various factors

The dilution rates should then be 21.87% in the laser acupuncture group, 13.80% in the sham laser acupuncture group, and 31.27% in the acupuncture group (the dilution rate calculations were shown in Tables 1–3). The dilution rate was very significant in the acupuncture group, which causes the effectiveness to be undervalued in the acupuncture group, by almost 1/3.

The effective significance was masked by limited sample size due to the Zelen design of this study.

3.The sample size calculation in this study is questionable.

4 Conclusion The effectiveness of the acupuncture group was diluted 31.27%, and its drop-out rate was 22.86%, much higher than that of the other groups in Hinman’s clinical trial, which constitutes major flaws in how this study is analyzed and interpreted[8]. Based on the bias of Zelen design used in the study, and incorrect sample size calculation, the conclusions drawn from this study are of poor quality, inaccurate, and invalid.

Click to access S2095-4964%2815%2960172-8.pdf

Reference:

1 Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, Harris A, Reddy P, Conaghan PG, Bennell KL. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014; 312(13): 1313–1322.

2 Fan AY. 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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Acupuncture treatment for chronic knee pain: study by Hinman et al underestimates acupuncture efficacy

Acupuncture treatment for chronic knee pain: study by Hinman et al underestimates acupuncture efficacy.

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

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

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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.

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

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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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.

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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.

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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