While over on my post about the new NICE GUIDELINES on acupuncture for back pain, the acupuncturists’ assassination attempts of my character, competence, integrity and personality are in full swing, I have decided to employ my time more fruitfully and briefly comment on a new piece of acupuncture research.
This new Italian study was to determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer.
A total of 190 women with breast cancer were randomly assigned to two groups. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints.
The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses.
Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P < .05).
The authors concluded that acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.
This hardly needs a comment, as I have been going on about this study design many times before: the ‘A+B versus B’ design can only produce positive findings. Any such study concluding that ‘acupuncture (or whatever other intervention) is effective’ can therefore not be a legitimate test of a hypothesis and ought to be categorised as pseudo-science. Sadly, this problem seems more the rule than the exception in the realm of acupuncture research. That’s a pity really… because, if there is potential in acupuncture at all, this sort of thing can only distract from it.
I think the JOURNAL OF CLINICAL ONCOLOGY, its editors and reviewers, should be ashamed of having published such misleading rubbish.
11 Responses to “Acupuncture is effective” – more findings from the realm of pseudoscience
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Professor Ernst,
Finding a low quality study with A+B versus B design to critique – well, as you mention, “it hardly needs a comment” – while failing to answer embarrassingly simple questions about your support for NICEs recommendation to remove acupuncture from the guidelines, contrary to their methodological remit and their evidence, is unfortunate. You said you didn’t have time to answer my very simple, very basic questions, and then you post this, which adds nothing to anyone’s knowledge or understanding.
You have repeatedly claimed that acupuncture’s effectiveness is mediated through non-specific and placebo effects. When shown experimental evidence that contradicts this you have remained firm in your beliefs. When asked for any evidence to support your view point, you have come up completely empty. This is irrational. You have no evidence that acupuncture is merely a placebo and the overwhelming evidence supports the opposite conclusion.
Your behaviour is a masterclass in pseudoscience. You still have every opportunity to provide evidence for your position or admit that your conclusions are unsupported. Every comment that you make about acupuncture while avoiding this issue is a disgrace to your position, to academia, and to science.
did I not answer all you many, mostly nonsensical questions?
Mel, do you believe in the principle of ‘best evidence’? If yes, what do you say to the Cochrane reviews of acupuncture? if you read this [http://www.ncbi.nlm.nih.gov/pubmed/21359919] or this [http://www.ncbi.nlm.nih.gov/pubmed/18789644] you might even have to correct your misconception that I reject all the evidence that happens to be positive. how difficult is it for someone who seems to have a quasi-religious belief in something to do a ‘reality check’?
I think you missed the point here: acupuncture research is littered with studies of that kind!
please show me a few clinical trials that, in your mind, are rigorous and conclusive.
Dear Professor Ernst,
I suggest you refrain from speculating about my motives until such time as you have been able to provide a solid scientific argument for your position and against mine. Your attempt at rhetoric is oddly captivating but let’s stick to the research.
Your review of Cochrane reviews demonstrates a flawed understanding of basic clinical trial and review methodology. You have incorrectly characterised Cochrane reviews that demonstrate effectiveness of acupuncture but do not demonstrate efficacy as demonstrating lack of effectiveness e.g. IBS. This is quite a staggering and elementary error given your training and position. Do you know the difference between effectiveness and efficacy?
I was initially surprised that you found my questions “non-sensical” but now I’m beginning to understand that this is likely due to lack of familiarity with basic research terminology. So let me clear.
Systematic reviews of acupuncture largely evaluate acupuncture trials using two different types of comparator: either usual care or some sort of sham / acupuncture-like control. Reviews of acupuncture, including Cochrane Reviews, where sufficient research exists, largely find that acupuncture outperforms usual care for many conditions. In other words, they find that acupuncture is an effective treatment for these conditions. Very few argue with this conclusion. Even NICE agreed that acupuncture was effective for low back pain.
In an attempt to control for placebo and non-specific effects, researchers have attempted to create a control, the most common of which is some sort of sham control – this is an attempt to measure efficacy. In order to be fit for purpose, this sham control must not exert any of the specific physiological effects of the active arm. “acupuncture research is littered with studies of that kind!” Ok great, show me one!!! Show me a study that demonstrates that sham is biologically inert. Shouldn’t be hard since you’re aware of so many. The bottom line is, in order to accurately interpret “rigorous and conclusive clinical trials” you have to first understand the nature of the comparator. This is like Clinical Trial Interpretation for Dummies.
If sham acupuncture is an active control then a) you cannot conclude whether or not acupuncture has specific effects through comparison to sham and b) in order to demonstrate superiority of acupuncture, you need more people in your study than for an inactive control. Adequately powered studies of acupuncture demonstrate acupuncture’s superiority to sham.
To answer your question, I believe in the principle of ‘best evidence,’ of which Cochrane reviews form but one part of the picture. What you have finely demonstrated is that best-evidence is not idiot proof, the research still needs to be interpreted by people who understand the principles of clinical trial design.
I will ask again: where is your evidence that sham acupuncture is biologically inert? I have provided strong evidence that it is not. This question goes to the very heart of your argument. You can call me all the names in the book, I’m sure your readers find it a hoot, but I think we’d all still appreciate an answer to this foundational question on which your entire argument about the nature of acupuncture rests.
@Mel
You wrote: “Even NICE agreed that acupuncture was effective for low back pain.” In the Press release for the new NICE draft guidelines I read: “For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.” Errm do you have a different definition for the word ‘agreed’ from the normal one?
Hi Frank,
That would have been a great question, if I hadn’t answered it at length in the post you’re replying to. But I suppose a bit of repetition doesn’t hurt.
When the press release says that there wasn’t enough evidence that acupuncture more effective than sham treatment, they are saying that acupuncture did not demonstrate efficacy (a criteria that was not met by many treatments that they did recommend). Efficacy is the research term for “effectiveness compared to sham.” However, when evaluating effectiveness, which by definition is a comparison to usual care, “the GDG agreed that clinically important benefits in terms of improvements in quality of life were observed in evidence from a number of studies . . . Benefit was also observed in pain and function at <4 months." And indeed when we compare this benefit to other treatments recommended, acupuncture was actually the most effective treatment for pain relief that they evaluated.
Happy to answer any other questions, but certainly more interesting if they're ones that I didn't just finish answering. Cheers, Frank
@Mel
I apologize for reading your post as an essay about how Edzard Ernst doesn’t understand the disctinction between the terms ‘effectiveness’ and ‘efficacy’. I guess we had better add Professor Mark Baker, clinical practice director for NICE, to your list of those ignorant of the distinction, since the comment I quoted from the NICE Press Release is attributed to him, and — according to your response — he’s clearly confusing the two terms.
Perhaps, instead of taking your time responding to my comments here (they’re only blog comments, after all) you should write to NICE demanding an urgent correction to their Press Release, changing Baker’s remarks on ‘effectiveness’ to ‘efficacy’?
@Mel
You wrote: “Do you know the difference between effectiveness and efficacy?” ‘Effectiveness’ is usually used in medicine to explain why treatments that have been shown to be efficaceous in RCTs fail to live up to their promise in ‘real-world’ practice. In the world of Big Witchcraft it seems to be used the opposite way round.
You wrote: “I will ask again: where is your evidence that sham acupuncture is biologically inert? I have provided strong evidence that it is not.” In which case the whole, quasi-erudite nonsense about meridians, qi and acupuncture points collapses, to be replaced with “sticking fine needles into bodies may elicit some kind of physiological response.” That I can well believe, and in the right surroundings, can probably result in subjective symptom relief by a placebo effect.
Unfortunately for professional, highly-trained, certificated and board-registered acupuncturists, this does not elevate acupuncture from from its status as complementary or alternative medicine, aka witchcraft, aka Big Snakeoil, to the world of real medicine. Several comments on this blog have referred to “Minchin’s Law”: what do you call alternative medicine that works? Medicine. Much as I’m a fan of Tim Minchin, that remark dates back long before the gentleman was born. In all that time, acupuncture has not succeeded in demonstrating other than — at best — mild benefits in effectiveness and virtually none in efficacy.
In a separate, recent, acupuncture thread on this blog, Sciencemonkey commented: “Acupuncture successfully eliminated the boil on my shoulder so there’s that.” He was responded to by S. Cox, MD: “Good for popping pimples too.” Strange, considering the flak that has been generated on the other post about the NICE guidelines that these two (accurate!) comments are the only ones on that thread, in which Edzard praises the authors of a new Cochrane acupuncture review for their forthright and clear conclusions.
@Frank
“I apologize for reading your post as an essay about how Edzard Ernst doesn’t understand the disctinction between the terms ‘effectiveness’ and ‘efficacy’. I guess we had better add Professor Mark Baker, clinical practice director for NICE, to your list of those ignorant of the distinction, since the comment I quoted from the NICE Press Release is attributed to him, and — according to your response — he’s clearly confusing the two terms.”
Frank, a press release is a short communication typically written at a 5th grade reading level to provide a plain language summary of a development to a lay audience. Indeed, I was recently involved in the creation of a press release on this very subject where I did not to use the term “efficacy” because most of the lay public (and, it turns out, professors with PhDs who proclaim to have “superpowers” involving “rigorous scientific activity”) do not know what the word means.
However, Professor Mark Baker definitely knows what the word means. He clearly outlines this in a letter stating that the NICE GDG should use effectiveness, not efficacy, to make clinical decisions: http://www.abetterwaytohealth.com/wp-content/uploads/2016/04/17-July-2015-Letter-from-Mark-Baker.pdf
“Perhaps, instead of taking your time responding to my comments here (they’re only blog comments, after all) you should write to NICE demanding an urgent correction to their Press Release, changing Baker’s remarks on ‘effectiveness’ to ‘efficacy’?”
Actually, no need. I’ve just now come from a meeting of the NICE EC with Mark. He said to stop whining. If you don’t know what a word means, then look it up. If you get the meaning of a word wrong, then be an adult and admit you made a mistake and leave him out of it.
Word travels fast – many many practitioners from around the globe are following this exchange as well as the previous one. We see here in NZ that Prof Ernst’s work is frequently referenced by the local Society for Science Based Healthcare. Perhaps we should be thanking them for constantly drawing attention to all the things that acupuncture can help with – certainly that is what is happening here. Our clinics are getting busier as more and more people are becoming aware of the benefits of acupuncture treatment through reading the articles and seeing the items on TV. I’m sure that is not the aim but we are not minding the result.
Great! Congratulate yourself for conning the gullible and vulnerable patients with alternative fake care. People flock to voodoo and witch doctors too and throw money at faith healers.