MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

acupuncture

1 2 3 14

I have often cautioned my readers about the ‘evidence’ supporting acupuncture (and other alternative therapies). Rightly so, I think. Here is yet another warning.

This systematic review assessed the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Nine trials involving 653 women were selected. A meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group. Regarding the HAMD and EPDS scores, no difference was found between the two groups. The Chinese authors concluded that acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

What a conclusion!

What a review!

What a journal!

What evidence!

Let’s start with the conclusion: if the authors feel that the evidence is ‘inconclusive’, why do they state that ‘acupuncture appears to be effective for postpartum depression‘. To me this does simply not make sense!

Such oddities are abundant in the review. The abstract does not mention the fact that all trials were from China (published in Chinese which means that people who cannot read Chinese are unable to check any of the reported findings), and their majority was of very poor quality – two good reasons to discard the lot without further ado and conclude that there is no reliable evidence at all.

The authors also tell us very little about the treatments used in the control groups. In the paper, they state that “the control group needed to have received a placebo or any type of herb, drug and psychological intervention”. But was acupuncture better than all or any of these treatments? I could not find sufficient data in the paper to answer this question.

Moreover, only three trials seem to have bothered to mention adverse effects. Thus the majority of the studies were in breach of research ethics. No mention is made of this in the discussion.

In the paper, the authors re-state that “this meta-analysis showed that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group.” This is, I think, highly misleading (see above).

Finally, let’s have a quick look at the journal ‘Acupuncture in Medicine’ (AiM). Even though it is published by the BMJ group (the reason for this phenomenon can be found here: “AiM is owned by the British Medical Acupuncture Society and published by BMJ“; this means that all BMAS-members automatically receive the journal which thus is a resounding commercial success), it is little more than a cult-newsletter. The editorial board is full of acupuncture enthusiasts, and the journal hardly ever publishes anything that is remotely critical of the wonderous myths of acupuncture.

My conclusion considering all this is as follows: we ought to be very careful before accepting any ‘evidence’ that is currently being published about the benefits of acupuncture, even if it superficially looks ok. More often than not, it turns out to be profoundly misleading, utterly useless and potentially harmful pseudo-evidence.


Reference

Acupunct Med. 2018 Jun 15. pii: acupmed-2017-011530. doi: 10.1136/acupmed-2017-011530. [Epub ahead of print]

Effectiveness of acupuncture in postpartum depression: a systematic review and meta-analysis.

Li S, Zhong W, Peng W, Jiang G.

They say that minds are like parachutes – they function only when open. Having an open mind means being receptive to new and different ideas or the opinions of others.

I am regularly accused of lacking this quality. Most recently, an acupuncturist questioned whether acupuncture-sceptics, and I in particular, have an open mind. Subsequently, an interesting dialogue ensued:

___________________________________________________________

Tom Kennedy on Wednesday 01 August 2018 at 19:27

@Rich It sounds to me as if you are at least partly open-minded, and take a more genuinely scientific approach than most here – i.e. rather than dismissing something with a lot of intriguing evidence behind it (even if much of this evidence is still hotly debated) mainly on the grounds that it ‘sounds a bit silly’, you understand that it’s possible to look at something like acupuncture objectively without being put off by the strange terminology associated with it. I strongly urge you to consult various other outlets as well as this one before coming to any final judgement. http://www.evidencebasedacupuncture.org/ for example is run by intelligent people genuinely trying to present the facts as they see them. Yes, they have an ‘agenda’ in that they are acupuncturists, but I can assure you, having had detailed discussions with some of them, that they are motivated by the urge to see acupuncture help more people rather than anything sinister, and they are trying to present an honest appraisal of the evidence. No doubt virtually everyone here will dismiss everything there with (or without) a cursory glance, but perhaps you won’t fall into that category. I hope you find something of interest there, and come to a balanced opinion.

the EVIDENCEBASEDACUPUNCTURE site you recommend quotes the Vickers meta-analysis thus:
“A meta-analysis of 17,922 patients from randomized trials concluded, “Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo.”
Pity that they forgot a bit. The full conclusion reads:
“Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
AND YOU TRY TO LECTURE US ABOUT AN OPEN MIND?

@Edzard I’m not sure I understand your point. ‘However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.’ Perhaps the full conclusion should always be quoted, but I don’t think that addendum changes the context significantly. Acupuncture has been shown to be more than a placebo in a large meta-analysis (when compared to arguably active sham controls). The authors put it well I think, in the ‘Interpretation’ section:

‘Our finding that acupuncture has effects over and above sham acupuncture is therefore of major importance for clinical practice. Even though on average these effects are small, the clinical decision made by doctors and patients is not between true and sham acupuncture, but between a referral to an acupuncturist or avoiding such a referral. The total effects of acupuncture, as experienced by the patient in routine practice, include both the specific effects associated with correct needle insertion according to acupuncture theory, non-specific physiologic effects of needling, and non-specific psychological (placebo) effects related to the patient’s belief that treatment will be effective.’

Compare this to Richard’s comment here, for example: ‘Of course the effects of ‘acupuncture’ (if any) are due to placebo responses (and perhaps nocebo responses in some cases). What else?’. And your post tile includes the line ‘the effects of acupuncture are due to placebo’. These are the kinds of comment that to me seem closed-minded in the face of some significant evidence.

edzard on Thursday 02 August 2018 at 12:46

“Perhaps the full conclusion should always be quoted…”

YES, IF NOT, IT’S CALLED ‘BEING ECONOMICAL WITH THE TRUTH’

“…I don’t think that addendum changes the context significantly.”
IT’S NOT AN ADDENDUM, BUT PART OF THE CONCLUSION; AND YOU ARE WRONG, FOR ME, IT CHANGES A LOT.
“…your post tile includes the line ‘the effects of acupuncture are due to placebo’.”
BECAUSE THIS IS WHAT THE PAPER DISCUSSED IN THAT PARTICULAR POST IMPLIED.

I think you need a new keyboard – the caps key seems to be stuck.

‘IT’S CALLED ‘BEING ECONOMICAL WITH THE TRUTH’’

The title of this post is: ‘Yet another confirmation: the effects of acupuncture are due to placebo’. That’s also being economical with the truth I think. You argue ‘BECAUSE THIS IS WHAT THE PAPER DISCUSSED IN THAT PARTICULAR POST IMPLIED’, but is it? The authors state ‘Future studies are needed to confirm or refute any effects of acupuncture in acute stroke’, and that would have been a much more balanced headline. You clearly imply here that it has been CONFIRMED that the effects of acupuncture are due to placebo, and that this trial is further confirmation. This is misleading at best. Yes, you add in brackets ‘(for acute stroke)’ at the end of the post, but why not in the title, unless you want to give the impression this is true for acupuncture in general

Edzard on Thursday 02 August 2018 at 14:09

my post is about critical evaluation of the published literature.
and this is what follows from a critical evaluation of this particular article.
I am not surprised that you cannot follow this line of reasoning.
could it be that the lack of an open mind is not my but your problem

Tom Kennedy on Thursday 02 August 2018 at 14:43

‘could it be that the lack of an open mind is not my but your problem?’

Who knows, maybe the problem is both of ours? I’m open to all possibilities!

VERY GOOD!
ok, let’s have a look.
you 1st: learnt acupuncture [a therapy that relies on a 2000 year old dogma], never published anything negative about it, never used any other therapeutic modality, even treated my own daughter with acupuncture when she suffered from infant colic, earn my livelihood by doing acupuncture.
[I MIGHT BE WRONG HERE, AS I DON’T KNOW ALL THAT MUCH ABOUT YOU, SO PLEASE CORRECT ME] me next: studied acupuncture during my time in med school, used it occasionally, learnt to use dozens of other therapeutic modalities, published lots about acupuncture based on the current evidence [this means that some conclusions – even of my Cochrane reviews – were positive but have since changed], worked with acupuncturists from across the globe, published one book about acupuncture together with several acupuncture fans, now dedicate my time to the critical analysis of the literature and bogus claims, have no conflicts of interest.
[IN CASE YOU KNOW MORE RELEVANT THINGS ABOUT ME, PLEASE ADD]

@Edzard Your summaries seem to be more or less accurate. However, a) I wouldn’t agree with your use of the term ‘dogma’; b) I haven’t published any scientific papers, but I’ve acknowledged various problems in the acupuncture field through informal pieces; c) I’ve used other CAM modalities, and I’ve directly or indirectly experienced many conventional modalities; d) I only earn part of my livelihood by doing acupuncture. Yes, my background makes it more likely that I’ll be biased in favour of acupuncture. But your credentials in no way guarantee open-mindedness on the subject, and personally I don’t see that displayed often on this blog. It still makes for interesting and stimulating reading though.

what problems in the acupuncture field have you acknowledged through informal pieces?
can you provide links?
I want to get a feel for the openness of your mind.
“…your credentials in no way guarantee open-mindedness on the subject, and personally I don’t see that displayed often on this blog.”
1) you seem to forget that blog-posts are not scientific papers, not even close.
2) you also forget that my blog is dedicated to the CRITICAL assessment of alt med.
finally, what would make you think that someone has an open mind towards acupuncture, if not the fact that someone has a track record of publishing positive conclusions about it when the evidence allows?
remember: an open mind should not be so open that your brain falls out!

Tom Kennedy on Friday 03 August 2018 at 11:20

Here’s one example: https://www.tomtheacupuncturist.com/blog/2017/2/24/does-acupuncture-really-work

‘what would make you think that someone has an open mind towards acupuncture, if not the fact that someone has a track record of publishing positive conclusions about it when the evidence allows?’

I think there’s plenty of evidence that allows for positive conclusions about acupuncture, but you don’t report these. I understand the slant of this blog, but I’d say it comes across as ‘negative assessment’ rather than ‘critical assessment’. Perhaps you’ll argue that your critical assessment has led you to a negative assessment? I’ll just have to disagree that that’s a fair and open-minded summary of the evidence.

Out of interest, can I ask what your acupuncture training involved (hours, theory, clinic time etc.)?

I am sorry to say that I see no critical evaluation in the post you linked to.
” I’d say it comes across as ‘negative assessment’ rather than ‘critical assessment’.
have you noticed that criticism is often experienced as negative to the person(s) it is aimed at?

Tom Kennedy on Friday 03 August 2018 at 12:55

‘I am sorry to say that I see no critical evaluation in the post you linked to’

I’ll just have to live with that. I feel as though it acknowledges some of the problems in the acupuncture world, in an attempt at balance. I don’t feel your posts aim for balance, but as you said, a blog isn’t a scientific paper so it’s your prerogative to skew things as you see fit

Edzard on Friday 03 August 2018 at 13:18

it seems to me that the ‘screwing things as you see fit’ is your game.

____________________________________________________________________

This exchange shows how easily I can be provoked to get stroppy and even impolite – I do apologise.

But it also made me wonder: how can anyone be sure to have an open mind?

And how can we decide that a person has a closed mind?

We probably all think we are open minded, but are we correct?

I am not at all sure that I know the answer. It obviously depends a lot on the subject. There are subjects where one hardly needs to keep an open mind and some where it might be advisable to have a closed mind:

  • the notion that the earth is flat,
  • flying carpets,
  • iridology,
  • reflexology,
  • chiropractic subluxation,
  • the vital force,
  • detox,
  • homeopathy.

No doubt, there will be people who even disagree with this short list.

Something that intrigues me – and I am here main ly talking about alternative medicine – is the fact that I often get praised by people who say, “I do appreciate your critical stance on therapy X, but on my treatment Y you are clearly biased and unfairly negative!” To me, it is an indication of a closed mind, if criticism is applauded as long as it does not tackle someone’s own belief system.

On the subject of homeopathy, Prof M Baum and I once published a paper entitled ‘Should we maintain an open mind about homeopathy?’ Its introduction explains the problem quite well, I think:

Once upon a time, doctors had little patience with the claims made for alternative medicines. In recent years the climate has changed dramatically. It is now politically correct to have an open mind about such matters; “the patient knows best” and “it worked for me” seem to be the new mantras. Although this may be a reasonable approach to some of the more plausible aspects of alternative medicine, such as herbal medicine or physical therapies that require manipulation, we believe it cannot apply across the board. Some of these alternatives are based on obsolete or metaphysical concepts of human biology and physiology that have to be described as absurd with proponents who will not subject their interventions to scientific scrutiny or if they do, and are found wanting, suggest that the mere fact of critical evaluation is sufficient to chase the healing process away. These individuals have a conflict of interest more powerful than the requirement for scientific integrity and yet defend themselves by claiming that those wanting to carry out the trials are in the pocket of the pharmaceutical industry and are part of a conspiracy to deny their patients tried and tested palliatives….

END OF QUOTE

And this leads me to try to define 10 criteria indicative for an open mind.

  1. to be free of conflicts of interest,
  2. integrity,
  3. honesty,
  4. to resist the temptation of applying double standards,
  5. to have a track record of having changed one’s views in line with the evidence,
  6. to not cling to overt absurdities,
  7. to reject conspiracy theories,
  8. to be able to engage in a meaningful dialogue with people who have different views,
  9. to avoid fallacious thinking,
  10. to be willing to learn more on the subject in question.

I would be truly interested to hear, if you have further criteria, or indeed any other thoughts on the subject.

Needle acupuncture in small children is controversial, not least because the evidence that it works is negative or weak, and because small children are unable to consent to the treatment. Yet it is recommended by some acupuncturists for infant colic. This, of course, begs the questions:

  1. Does the best evidence tell us that acupuncture is effective for infant colic?
  2. Are acupuncturists who recommend acupuncture for this condition responsible and ethical?

This systematic review and a blinding-test validation based on individual patient data from randomised controlled trials was aimed to assess its efficacy for treating infantile colic. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents].

The investigators included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min at mid-treatment, -11.4 min at the end of treatment and -11.8 min at the 4-week follow-up. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min. The registration of crying during treatment suggested more crying during acupuncture.

The authors concluded that percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis.

The authors also provide this further comment: “Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.”

So, returning to the two questions that I listed above – what are the answers?

I think they must be:

  1. No.
  2. No.

Most people probably think of acupuncture as being used mainly as a therapy for pain control. But acupuncture is currently being promoted (and has traditionally been used) for all sorts of conditions. One of them is stroke. It is said to speed up recovery and even improve survival rates after such an event. There are plenty of studies on this subject, but their results are far from uniform. What is needed in this situation, is a rigorous summary of the evidence.

The authors of this Cochrane review wanted to assess whether acupuncture could reduce the proportion of people suffering death or dependency after acute ischaemic or haemorrhagic stroke. They included all randomized clinical trials (RCTs) of acupuncture started within 30 days after stroke onset. Acupuncture had to be compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischaemic or haemorrhagic stroke, or both. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

The investigators included 33 RCTs with 3946 participants. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only 6 trials (668 participants) comparing acupuncture with sham acupuncture.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain and were not confirmed by trials comparing acupuncture with sham acupuncture. In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain. These findings were not confirmed in trials comparing acupuncture with sham acupuncture.Trials comparing acupuncture with any control showed little or no difference in death or institutional care or death at the end of follow-up.The incidence of adverse events (eg, pain, dizziness, faint) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these patients (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain.

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

This Cochrane review seems to be thorough, but it is badly written (Cochrane reviewers: please don’t let this become the norm!). It contains some interesting facts. The majority of the studies came from China. This review confirmed the often very poor methodological quality of acupuncture trials which I have frequently mentioned before.

In particular, the RCTs originating from China were amongst those that most overtly lacked rigor, also a fact that has been discussed regularly on this blog.

For me, by far the most important finding of this review is that studies which at least partly control for placebo effects fail to show positive results. Depending on where you stand in the never-ending debate about acupuncture, this could lead to two dramatically different conclusions:

  1. If you are a believer in or earn your living from acupuncture, you might say that these results suggest that the trials were in some way insufficient and therefore they produced false-negative results.
  2. If you are a more reasonable observer, you might feel that these results show that acupuncture (for acute stroke) is a placebo therapy.

Regardless to which camp you belong, one thing seems to be certain: acupuncture for stroke (and other indications) is not supported by sound evidence. And that means, I think, that it is not responsible to use it in routine care.

Can I tempt you to run a little (hopefully instructive) thought-experiment with you? It is quite simple: I will tell you about the design of a clinical trial, and you will tell me what the likely outcome of this study would be.

Are you game?

Here we go:

_____________________________________________________________________________

Imagine we conduct a trial of acupuncture for persistent pain (any type of pain really). We want to find out whether acupuncture is more than a placebo when it comes to pain-control. Of course, we want our trial to look as rigorous as possible. So, we design it as a randomised, sham-controlled, partially-blinded study. To be really ‘cutting edge’, our study will not have two but three parallel groups:

1. Standard needle acupuncture administered according to a protocol recommended by a team of expert acupuncturists.

2. Minimally invasive sham-acupuncture employing shallow needle insertion using short needles at non-acupuncture points. Patients in groups 1 and 2 are blinded, i. e. they are not supposed to know whether they receive the sham or real acupuncture.

3. No treatment at all.

We apply the treatments for a sufficiently long time, say 12 weeks. Before we start, after 6 and 12 weeks, we measure our patients’ pain with a validated method. We use sound statistical methods to compare the outcomes between the three groups.

WHAT DO YOU THINK THE RESULT WOULD BE?

You are not sure?

Well, let me give you some hints:

Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.

Group 2 will be pleased to receive some treatment. However, during the course of the 6 weeks, they will get more and more suspicious. As they were told during the process of obtaining informed consent that the trial entails treating some patients with a sham/placebo, they are bound to ask themselves whether they ended up in this group. They will see the short needles and the shallow needling, and a percentage of patients from this group will doubtlessly suspect that they are getting the sham treatment. The doubters will not show a powerful placebo response. Therefore, the average pain scores in this group will decrease – but only a little.

Group 1 will also be pleased to receive some treatment. As the therapists cannot be blinded, they will do their best to meet the high expectations of their patients. Consequently, they will benefit fully from the placebo effect of the intervention and the pain score of this group will decrease significantly.

So, now we can surely predict the most likely result of this trial without even conducting it. Assuming that acupuncture is a placebo-therapy, as many people do, we now see that group 3 will suffer the most pain. In comparison, groups 1 and 2 will show better outcomes.

Of course, the main question is, how do groups 1 and 2 compare to each other? After all, we designed our sham-controlled trial in order to answer exactly this issue: is acupuncture more than a placebo? As pointed out above, some patients in group 2 would have become suspicious and therefore would not have experienced the full placebo-response. This means that, provided the sample sizes are sufficiently large, there should be a significant difference between these two groups favouring real acupuncture over sham. In other words, our trial will conclude that acupuncture is better than placebo, even if acupuncture is a placebo.

THANK YOU FOR DOING THIS THOUGHT EXPERIMENT WITH ME.

Now I can tell you that it has a very real basis. The leading medical journal, JAMA, just published such a study and, to make matters worse, the trial was even sponsored by one of the most prestigious funding agencies: the NIH.

Here is the abstract:

___________________________________________________________________________

Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.

Objective:

To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.

Design, Setting, and Patients:

Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).

Interventions:

Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures:

The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).

Results:

Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).

Conclusions and Relevance:

Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.

__________________________________________________________________________

Do you see how easy it is to deceive (almost) everyone with a trial that looks rigorous to (almost) everyone?

My lesson from all this is as follows: whether consciously or unconsciously, SCAM-researchers often build into their trials more or less well-hidden little loopholes that ensure they generate a positive outcome. Thus even a placebo can appear to be effective. They are true masters of producing false-positive findings which later become part of a meta-analysis which is, of course, equally false-positive. It is a great shame, in my view, that even top journals (in the above case JAMA) and prestigious funders (in the above case the NIH) cannot (or want not to?) see behind this type of trickery.

Alternative practitioners practise highly diverse therapies. They seem to have nothing in common – except perhaps that ALL of them are allegedly stimulating our self-healing powers (and except that most proponents are latently or openly against vaccinations). And it is through these self-healing powers that the treatments in question cure anything and become a true panacea. When questioned what these incredible powers really are, most practitioners would (somewhat vaguely) name the immune system as the responsible mechanism. With this post, I intend to provide a short summary of the evidence on this issue:

Acupuncture: no good evidence to show stimulation of self-healing powers.

Aromatherapy: no good evidence to show stimulation of self-healing powers.

Bioresonance: no good evidence to show stimulation of self-healing powers.

Chiropractic: no good evidence to show stimulation of self-healing powers.

Detox: no good evidence to show stimulation of self-healing powers.

Energy healing: no good evidence to show stimulation of self-healing powers.

Feldenkrais: no good evidence to show stimulation of self-healing powers.

Gua sha: no good evidence to show stimulation of self-healing powers.

Herbal medicine: no good evidence to show stimulation of self-healing powers.

Homeopathy: no good evidence to show stimulation of self-healing powers.

Macrobiotics: no good evidence to show stimulation of self-healing powers.

Naturopathy: no good evidence to show stimulation of self-healing powers.

Osteopathy: no good evidence to show stimulation of self-healing powers.

Power bands: no good evidence to show stimulation of self-healing powers.

Reiki: no good evidence to show stimulation of self-healing powers.

Reflexology: no good evidence to show stimulation of self-healing powers.

Shiatsu: no good evidence to show stimulation of self-healing powers.

Tai chi: no good evidence to show stimulation of self-healing powers.

TCM: no good evidence to show stimulation of self-healing powers.

Vibrational therapy: no good evidence to show stimulation of self-healing powers.


Vaccinations: very good evidence to show stimulation of self-healing powers.


THE END

Why  do most alternative practitioners  show such dogged determination not to change their view of the efficacy of their therapy, even if  good evidence shows that it is a placebo? This is the question that I have been pondering for some time. I have seen many doctors change their mind about this or that treatment in the light of new evidence. In fact, I have not seen one who has not done so at some stage. Yet I have never seen an alternative therapist change his/her mind about his/her alternative therapy. Why is that?

You might say that the answers are obvious:

  • because they have heavily invested in their therapy, both emotionally and financially;
  • because their therapy has ‘stood the test of time’;
  • because they believe what they were taught;
  • because they are deluded, not very bright, etc.;
  • because they need to earn a living.

All of these reasons may apply. But do they really tell the whole story? While contemplating about this question, I thought of something that had previously not been entirely clear to me: they simply KNOW that the evidence MUST be wrong.

Let me try to explain.

Consider an acupuncturist (I could have chosen almost any other type of alternative practitioner) who has many years of experience. He has grown to be a well-respected expert in the world of acupuncture. He sits on various committees and has advised important institutions. He knows the literature and has treated thousands of patients.

This experience has taught him one thing for sure: his patients do benefit from his treatment. He has seen it happening too many times; it cannot be a coincidence. Acupuncture works, no question about it.

And this is also what the studies tell him. Even the most sceptical scientist cannot deny the fact that patients do get better after acupuncture. So, what is the problem?

The problem is that sceptics say that this is due to a placebo effect, and many studies seem to confirm this to be true. Yet, our acupuncturist completely dismisses the placebo explanation.

Why?

  • Because he has heavily invested in their therapy? Perhaps.
  • Because acupuncture has ‘stood the test of time’? Perhaps.
  • Because he believes what he has been taught? Perhaps.
  • Because he is deluded, not very bright, etc.? Perhaps.
  • Because he needs to earn a living? Perhaps.

But there is something else.

He has only ever treated his patients with acupuncture. He has therefore no experience of real medicine, or other therapeutic options. He has no perspective. Therefore, he does not know that patients often get better, even if they receive an ineffective treatment, even if they receive no treatment, and even if they receive a harmful treatment. Every improvement he notes in his patients, he relates to his acupuncture. Our acupuncturist never had the opportunity to learn to doubt cause and effect in his clinical routine. He never had to question the benefits of acupuncture. He never had to select from a pool of therapies the optimal one, because he only ever used acupuncture.

It is this lack of experience that never led him to think critically about acupuncture. He is in a similar situation as physicians were 200 years ago; they only (mainly) had blood-letting, and because some patients improved with it, they had no reason to doubt it. He only ever saw his successes (not that all his patients improved, but those who did not, did not return). He simply KNOWS that acupuncture works, because his own, very limited experience never forced him to consider anything else. And because he KNOWS, the evidence that does not agree with his knowledge MUST be wrong.

I am of course exaggerating and simplifying in order to make a point. And please don’t get me wrong.

I am not saying that doctors cannot be stubborn. And I am not saying that all alternative practitioners have such limited experience and are unable to change their mind in the light of new evidence. However, I am trying to say that many alternative practitioners have a limited perspective and therefore find it impossible to be critical about their own practice.

If I am right, there would be an easy (and entirely alternative) cure to remedy this situation. We should sent our acupuncturist to a homeopath (or any other alternative practitioner whose practice he assumes to be entirely bogus) and ask him to watch what kind of therapeutic success the homeopath is generating. The acupuncturist would soon see that it is very similar to his own. He would then have the choice to agree that highly diluted homeopathic remedies are effective in curing illness, or that the homeopath relies on the same phenomenon as his own practice: placebo.

Sadly, this is not going to happen, is it?

 

My previous post praised the validity and trustworthiness of Cochrane reviews. This post continues in the same line.

Like osteoarthritis, acute stroke has been a condition for which acupuncture-fans prided themselves of being able to produce fairly good evidence. A Cochrane review of 2005, however, was inconclusive and concluded that the number of patients is too small to be certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke. Larger, methodologically-sound trials are required.

So, 13 years later, we do have more evidence, and it would be interesting to know what the best evidence tells us today. This new review will tell us because it is the update of the previous Cochrane Review originally published in 2005.

The authors sought randomized clinical trials (RCTs) of acupuncture started within 30 days from stroke onset compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischemic or haemorrhagic stroke, or both. Needling into the skin was required for acupuncture. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

Two review authors applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data independently. They contacted study authors to ask for missing data and assessed the quality of the evidence by using the GRADE approach. The primary outcome was defined as death or dependency at the end of follow-up.

In total, 33 RCTs with 3946 participants were included. Twenty new trials with 2780 participants had been completed since the previous review. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only six trials (668 participants) that compared acupuncture with sham acupuncture control. The authors downgraded the evidence to low or very low quality because of risk of bias in included studies, inconsistency in the acupuncture intervention and outcome measures, and imprecision in effect estimates.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.46 to 0.79; very low-quality evidence; and OR 0.67, 95% CI 0.53 to 0.85; eight trials with 1436 participants; very low-quality evidence, respectively) and were not confirmed by trials comparing acupuncture with sham acupuncture (OR 0.71, 95% CI 0.43 to 1.18; low-quality evidence; and OR 0.67, 95% CI 0.40 to 1.12; low-quality evidence, respectively).In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain (standardized mean difference [SMD] 0.84, 95% CI 0.36 to 1.32; 12 trials with 1086 participants; very low-quality evidence; and SMD 1.08, 95% CI 0.45 to 1.71; 11 trials with 895 participants; very low-quality evidence).

These findings were not confirmed in trials comparing acupuncture with sham acupuncture (SMD 0.01, 95% CI -0.55 to 0.57; low-quality evidence; and SMD 0.10, 95% CI -0.38 to 0.17; low-quality evidence, respectively).Trials comparing acupuncture with any control reported little or no difference in death or institutional care at the end of follow-up (OR 0.78, 95% CI 0.54 to 1.12; five trials with 1120 participants; low-quality evidence), death within the first two weeks (OR 0.91, 95% CI 0.33 to 2.55; 18 trials with 1612 participants; low-quality evidence), or death at the end of follow-up (OR 1.08, 95% CI 0.74 to 1.58; 22 trials with 2865 participants; low-quality evidence).

The incidence of adverse events (eg, pain, dizziness, fainting) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain (OR 0.58, 95% CI 0.29 to 1.16; five trials with 576 participants; low-quality evidence).

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

These cautious conclusions might be explained by the fact that Chinese researchers are reluctant to state anything overtly negative about any TCM therapy. Recently, one expert who spoke out was even imprisoned for criticising a TCM product! But in truth, this review really shows that acupuncture has no convincing effect in acute stroke.

And for me, this conclusion is fascinating. I have been involved in acupuncture/stroke research since the early 1990s.

Our RCT produced a resounding negative result concluding that acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.

Our 1996 systematic review concluded that the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling.

By 2001, more data had become available but the conclusion became even less encouraging: there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation.

Finally, by 2010, there were 10 RCT and we were able to do a meta-analysis of the data. We concluded that our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke.

Yes, my reviews were on slightly different research questions. Yet, they do reveal how a critical assessment of the slowly emerging evidence had to arrive at more and more negative conclusions about the role of acupuncture in the management of stroke patients. For a long time, this message was in stark contrast to what acupuncture-fans were claiming. I wonder whether they will now finally change their mind.

I have said it often, and I say it again: I do like well-conducted systematic reviews; and Cochrane reviews are usually the best, i. e. most transparent, most thorough and least biased. Thus, I was pleased to see a new Cochrane review of acupuncture aimed at assessing the benefits and harms of acupuncture in patients with hip OA.

The authors included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short-term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. The authors are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in 4 RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites.

The authors concluded that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

This is an excellent review of data that (because of contradictions, methodological limitations, heterogeneity etc.) are not easy to evaluate fairly. The review shows that previous verdicts about acupuncture for osteoarthritis might have been too optimistic. Acupuncture has no or only very small specific therapeutic effects. As we have much better therapeutic options for this condition, it means that acupuncture can no longer be recommended as an effective therapy.

That surely must be big news in the little world of acupuncture!

I have been personally involved in several similar reviews:

In 1997, I concluded that the most rigorous studies suggest that acupuncture is not superior to sham-needling in reducing pain of osteoarthritis: both alleviate symptoms to roughly the same degree.

In 2006, the balance of evidence seemed to have shifted and more positive data had emerged; consequently our review concluded that sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Now, it seems that my initial conclusion of 1996 was more realistic. To me this is a fascinating highlight on the fact that in EBM, we change our minds based on the current best evidence. By contrast, in alternative medicine, as we have often lamented on this blog, minds do not easily change and all too often dogma seems to reign.

The new Cochrane review is important in several ways. Firstly, it affirms an appropriately high standard for such reviews. Secondly, it originates from a research team that has, in the past, been outspokenly pro-acupuncture; it is therefore unlikely that the largely negative findings were due to an anti-acupuncture bias. Thirdly – and most importantly – osteoarthritis has been THE condition for which even critical reviewers had to admit that there was at least some good, positive evidence.

It seems therefore, that yet again a beautiful theory has been slain by an ugly fact.

Does acupuncture increase birth rates after IVF?

You might be correct when pointing out that this is a rhetorical question.

Why should acupuncture increase the live birth rates after in vitro fertilization (IVF)?

Because it re-balances yin and yang?

Give me a break!!!

Yet acupuncture is widely used by women undergoing IVF, and therefore, we perhaps ought to know whether it works.

Laudably someone has conducted a trial so that we know the answer.

This study determined the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births. It was designed as a single-blind, parallel-group RCT, including 848 women undergoing a fresh IVF cycle, and conducted at 16 IVF centres in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016.

The women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and two treatments were administered prior to and following embryo transfer. The sham control used a non-invasive needle placed away from acupuncture points. The primary outcome was live birth, defined as the delivery of one or more living infants at greater than 20 weeks’ gestation or birth weight of at least 400 g.

Among the 848 women, 24 withdrew consent, and 824 were included in the study, 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control.

The authors concluded that among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF.

This is a clear result and technically a fairly decent study. I say ‘fairly decent’ because, had the result been positive, one would have to question the efficacy blinding as well as the fact that the acupuncturists might have (inadvertently?) influenced their verum-patients such that they were less anxious and thus produced better outcomes. Moreover, the trial was under-powered, and its publication so long after the end of the study is odd, in my view.

There have, of course, been plenty of trials and even systematic reviews of this topic. Here are the conclusions of the three most recent reviews:

Yet the authors state that “the evidence for efficacy is conflicting”.

Why?

The above conclusions seem crystal clear and not at all conflicting!

Is it because the authors needed to justify the no doubt huge costs for their study?

Is it because conducting such a trial while the evidence is already clear (and negative) is arguably not ethical?

Is it because the authors needed this alleged ‘uncertainty’ for getting their trial in a major journal?

I am, of course, not sure – but I am quite sure of one thing: the evidence that acupuncture is useless for IVF was already pretty clear when they started their study.

And pretending otherwise amounts to telling porkies, doesn’t it?

And telling porkies is unethical, isn’t it?

1 2 3 14
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories