Archive for the ‘acupuncture study’ Category

Auricular Interventions in Neurology: the Vascular Autonomic Signal challenge

Quah-Smith, Im M.D. PhD



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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.


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

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How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

Klaus Linde1*, Karin Niemann1, Antonius Schneider1 and Karin Meissner12

Author Affiliations

1Institute of General Practice, Technische Universität München, Orleansstrasse 47, D-81667 Munich, Germany

2Institute of Medical Psychology, Ludwig-Maximilians-University, Goethestrasse 31, D-80336 Munich, Germany

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BMC Medicine 2010, 8:75  doi:10.1186/1741-7015-8-75

The electronic version of this article is the complete one and can be found online at:http://www.biomedcentral.com/1741-7015/8/75



While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham) acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions.


MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method.


Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger’s test for funnel plot asymmetry, P= 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029).


Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials.

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BMJ Editors Hit–and Hit Hard–Over Careless Interpretation of Acupuncture for Chronic Knee Pain Study (JAMA 10/1/2014)

Let’s start with the conclusion, lest I lose you between here and the end.

Acupuncture is more likely to provide relief for chronic knee pain due to osteoarthritisthan any other modality. Pooled studies (a meta analysis) that compared physical interventions for chronic knee pain showed the following “effect sizes:”

(Electro-) Acupuncture: ES of 0.89
Warm baths: ES 0.65
Exercise: ES 0.55

To put this in perspective, the “Minimum Clinically Important Difference” or minimally significant Effect Size, according to patients suffering from chronic knee pain, is 0.39. And the Effect Size threshold the UK’s National Institute for Health and Care Excellence (NICE) uses to determine reimbursement is 0.50.

Call them acupuncture activists. And really brainy ones.

When an Australian group published (in October 1st JAMA) an impressively large (N=282, but there were 4 groups) clinical trial of 12 weeks of acupuncture for chronic (moderate to severe) knee pain in persons 50 years and older, they concluded no difference between the sham control and actual acupuncture. Editors of the premier acupuncture journal in the world (the BMJ group’s Acupuncture In Medicine), however, cried foul. And lamented the lost opportunity to help millions of chronic knee pain suffers. There were determined to set the record straight.

Their protest and clarification letter to JAMA was summarily rejected.

But guess what? They just happen to have their own journal. (Take that, AMA.) And not one of the enumerable, embarrassing American titles. As noted above, we’re talking The British Medical Journal (Even if the quality of the studies AIM publishes sometimes causes a cringe here and there, the White and his staff are doing the best with what they have to work with.) And so AIM editor and British Medical Acupuncture Society chief Mike Cummings proceeded to publish their quibbles today for inclusion, I imagine, in the January 2015 print edition, and set about to educate folks about how to consider clinically relevant results.

For expediency’s sake, I will extract the key arguments from their brilliantly prepared letter today. Then over the next week or so I will work on paraphrasing and whittling it down.

1. BACKGROUND OF THE CLINICAL PROBLEM. Patients with OA knee pain are suffering the commonest cause of pain and disability in older people. More than half have inadequate pain relief.2 They face a choice between ineffective paracetamol, non-steroidal drugs that can harm the heart, (kidneys) and gastrointestinal tract, gels that scarcely work, physiotherapy, opioids that cause dependency and lose effectiveness, arthroscopic washouts that do nothing or surgery.3 They deserve a fuller, more considered answer to their question: “Is it worth trying acupuncture?”

2. NIFTY DESIGN OF TRIAL. The neat part of the Zelen design that Hinman et al used was that the control group, who were not given acupuncture, were not even aware that their pain scores were used in a trial of acupuncture so disappointment could not influence their scores, as was claimed for other studies. This ‘no acupuncture’ group was compared with acupuncture (manual) and with sham laser (and with real laser, which is not considered here, to keep things simple).

3. WHERE THE ANALYSIS BEGINS TO STUMBLE. The problems started with the trialists’ choice of the threshold minimum clinically important difference (MCID) to estimate sample size. They chose a value based on one chosen by six self-styled ‘expert’ physicians,4 namely a 35% fall in baseline pain score (1.8/sample mean baseline 5.1). This is equivalent to an effect size (ES) of 0.6, calculated using their assumed baseline SD of 30 (the actual SD was 21, giving a higher threshold ES of 0.86). A different figure for MCID was generated by 192 patients with OA, who registered improvement scores as well as changes in pain.5 This showed a more modest MCID, equivalent to an ES of 0.39 (shown in figure 1). The National Institute for Health and Care Excellence (NICE) did not regard any value for MCID as valid6 and chose a generic value of 0.5 (see figure 1). Hinman et al chose a high threshold and also failed to discuss the effect that alternative threshold MCID values would have on the interpretation of their findings. We also note that the MCID for any treatment should be chosen to take account of acceptability, safety and cost-effectiveness,7 which would argue for a lower threshold for acupuncture for knee pain.

4. THE OLD “BETA ERROR” BUGABOO: SHORT ON STATISTICAL POWER. Hinman et alapplied this ‘clinically important’ difference to a ‘clinically irrelevant’ comparison–acupuncture versus sham laser. Sham laser is not an available therapy. The only reason for comparing acupuncture with sham would be to estimate the effects of the needles themselves, but this is already well known from the Cochrane review8 and an individual patient data meta-analysis (figure 1).9 It is known that the effect of needles alone is small, and so is unlikely to be identifiable reliably with sample sizes of less than about 800.10 The sample size in the study by Hinman et al (n=70) clearly appears to be inadequate for the question, according to the existing evidence, and not best use of resources. The resulting ES of acupuncture against sham that was actually found by Hinman is similar to that shown by the best evidence8 (see figure 1), although the wide CI means the data can only be of any importance when they are included in a meta-analysis in the future.

5. WHO DECIDES WHAT TREATMENT EFFECT IS MEANINGFUL? Hinman et al found that, after 12 weeks, knee pain was significantly reduced by acupuncture compared with no acupuncture control, with an ES of 0.6 (data from their table 2; see figure 1). The difference did not quite meet the MCID they had postulated–although the estimated ES is the same size as the MCID–but it more than meets the MCID chosen by patients themselves (ES 0.39) and that selected by NICE (ES 0.5). In interpreting this result, the secondary outcomes should also have been brought into thoughtful consideration: there were significant differences in favour of acupuncture for six out of eight secondary outcomes (see eTable 5 in their paper) and the response rate, which is the most patient-orientated measure of success,7 was 76% in the acupuncture group compared with 32% in the no acupuncture control group.

6. TO MAKE MATTERS WORSE, THE AUSTRALIANS STUDIED THE LEAST EFFECTIVE ACUPUNCTURE TECHNIQUE. Hinman et al did not apply optimal acupuncture. Use of electroacupuncture has been shown superior to manual stimulation for knee pain in 2010.8

A couple of weeks ago, I also came across a study of “needle-less” acupuncture, also for chronic knee pain of the OA variety. Basically it involved warming the knee with these stick on cones of burning mugwort–sort of like (very carefully) burning incense around your knee cap. That too showed clinical effectiveness, although now I am prompted to dig up the original study and see if we can fit that “effect size” into our acupuncture, warm baths, exercise line-up above. Stay tuned.

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