Acupuncture is often recommended for relieving symptoms of fibromyalgia syndrome (FMS). The aim of this systematic review was to ascertain whether verum acupuncture is more effective than sham acupuncture in FMS.
Ten RCTs with a total of 690 participants were eligible, and 8 RCTs were eventually included in the meta-analysis. Its results showed a sizable effect of verum acupuncture compared with sham acupuncture on pain relief, improving sleep quality and reforming general status. Its effect on fatigue was insignificant. When compared with a combination of simulation and improper location of needling, the effect of verum acupuncture for pain relief was the most obvious.
The authors concluded that verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS posttreatment. However, evidence that it reduces fatigue was not found.
I have a much more plausible conclusion for these findings: in (de-randomised) trials comparing real and sham acupuncture, patients are regularly de-blinded and therapists are invariably not blind. The resulting bias and not the alleged effectiveness of acupuncture explains the outcome.
And why do I think that this conclusion is much more plausible?
Firstly, because of Occam’s Razor.
Secondly, because this is roughly what my own systematic review of the subject found (The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia). This view is also shared by other critical reviews of the evidence (Current literature does not support the routine use of acupuncture for improving pain or quality of life in FM). Perhaps more crucially, the current Cochrane review seems to concur: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.
42 Responses to Acupuncture shown to be effective for fibromyalgia – so, why am I not convinced?
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1. What are your thoughts on sham acupuncture as an inaccurate placebo? Ie it may not actually be a placebo at all?
2. If EA has positive effects that last up to a month? Why not offer patients monthly EA if it is a safe low-cost alternative to conventional therapy?
This surely fits with preference-satisfaction utilitarianism (your More Good Than Harm book) and respects patient autonomy if we are honest and open about the inconclusion of whether it will have a sustained positive effect for them?
we developed one of the sham devices:
https://www.ncbi.nlm.nih.gov/pubmed/12512790
https://www.ncbi.nlm.nih.gov/pubmed/11268237
I think they are reasonably good placebos for trials.
EA = electroacupuncture?
I assume EA is electroacupuncture. I took it from your Cochrane quote above!
ok; if EA is proven to be effective and safe, it ought to be used. I am not sure, however, that the review proves that it is.
“Electro‐acupuncture is found to be consistently better than sham interventions in improving pain, global well‐being, sleep, stiffness and fatigue. The effect of acupuncture was not maintained at six to seven months after treatment. The same level of evidence supports acupuncture as an adjunct therapy to medication and exercise or acupuncture when compared with a medication and exercise control. When comparing acupuncture with medication or a wait list, there is low quality evidence in favour of acupuncture but this needs more rigorous and methodologically sound studies.”
This is from the same Cochrane review – https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD007070.pub2/full
Low-to-moderate evidence but evidence nonetheless
Seems as though the reviewers think EA is better than sham and safe too
do they?
and what do they say about the quality of the primary studies?
I tell a lie. “Implications for practice are limited due to weakness in evidence”
If they say this and then state my above quote about EA consistently performing better than sham acupuncture, what conclusion can we make?
Do we have to discard the positive effect due to the weakness of the evidence?
we need to take them with a pitch of salt or two.
More information on acupuncture study here;
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003317.pub3/full
@RG
Do you have a point[sic]?
he rarely has
Bjorn
Since you asked. The link I posted is of the same indication EE posted, just a wider test sampling, and better reporting information.
I’ll expand the conversation. The link that EE’s posted w/regard to acupuncture placebo trials using sham needles is nothing but a red herring. That specific trail had nothing to do with fibromyalgia. That trial was for the indication of acute stroke. So why provide that specific link in this blog post ? EE love to confuse the issues when if back his position.
First of all, trials involving acupuncture to treat acute stroke are likely to miss the mark, at best to be found inconclusive. Acute stroke is not an indication that will show up on most TCM indications for acupuncture recommendation. I could post various links as usual. Do some research and you will find that I am correct. At best, you might find recommendation of acupuncture for acute stroke near the bottom of the list… if at all. Does Pharma target treating stroke with diabetes meds ?
Beyond that, I am curious about the trial to which EE refers. The first group (study 1) were referred to as “acupuncture naïve”. Group 2 makes no claims about acupuncture naïve, or not acupuncture naïve. I’d be interested to know what was group 2 make up, and why if might be significant in group one but not group two. I think it’s important because this is precisely how in EBM, the data can be skewed to achieve the desired outcome.
@RG
You not only do not have a point, you do not have a clue about what is being discussed.
Next time you try to take part in a discussion about research and other complicated matters, try to read a few times slowly and deliberately through the discussion, take notes and get a grasp on what is being said and try to concentrate on what the subject is.
Don’t just get all fired up and rush to comment on the first thing that irritates you. Read the whole thing a few times and let your feelings pass. Just like drunk driving, excessive feelings make you loose your way and risk driving off the road, like you did now, in a way. Talking of drunk, I hope you are not commenting under the influence, that is a sure way to look stupid in a blog.
Then when you have written something, let it rest until the next day and go through it again, thoroughly, so you can check if you misunderstood what you are commenting on like you did now. Just like sobering up.
To be fair RG,
I think Edzard’s point was simply to show that they have made a valid non-invasive sham acupuncture to act as a placebo.
And by the looks of the results of the study (https://journals.sagepub.com/doi/abs/10.1136/aim.20.4.168) – I only seem to have access to the abstract annoyingly – it appears they’ve done this! For me, this would discount the argument that sham acupuncture has any [significant] physiological effect and so would be a perfectly valid placebo.
My next question is then is: Ernst and Bjorn, do you know if this non-invasive sham acupuncture has been used as the gold standard placebo for most studies since? Or have researchers generally continued to use invasive sham acupuncture as placebo?
Best,
Toby
Bjorn
You have no valid point, other than attacking me personally. If you have something to add to the conversation then by all means…. join the conversation.
Toby
Thanks for the reply
In my view it’s not a fair test for a placebo.
What if both groups of patients are aware that acupuncture is not a valid therapy for acute stroke ? When testing for a successful placebo, wouldn’t the subjects need to believe that the procedure can be a benefit ?
If a surgeon performs a knee surgery for a back patient, would you expect any placebo effect from giving a knee surgery ? I think not because there would be no expectation of a benefit.
This is what occurred in this forementioned trial, they used acupuncture on acute stroke and expected it to have results when TCM does not indicate acupuncture for stroke.
@RG
Interesting how you feebly imitate arguments you learn on the blog but do not understand how to use properly 🙂 No personal attack involved.
Only offering good advice to some incognito fool trolling this blog 😀
Toby wrote
I cannot give you figures, perhaps the professor can. But from reading scores of scum research I can tell you that subliminally or not, those who benefit from biased outcomes tend to use less strict approaches as they make it easier to obfuscate the outcome.
Bjorn
Again, you offer no answers, only personal attacks.
The fact remains that any placebo studies on acupuncture need to be done on an indication for which acupuncture is indicated, otherwise you have studied nothing.
The Kim systematic review does not address the fact that the sample sizes in the primary RCTs are very small. It’s impossible to base any firm conclusions on so many small studies.
true!
but this is one of the reasons to pool studies and to thus generate a more reliable overall result – at least in theory!
Yes, but surely pooling many small trials potentially allows publication bias to skew the final result?
that’s a danger; therefore one needs to also assess the rigor of the primary studies.
@Toby In my opinion, the ‘sham’ devices are ingenious, but only someone with little to no understanding of the actual clinical application of a needle in a traditional acupuncture treatment would consider them a good placebo. Happy to expand on that via email if you’re interested (I suspect others here won’t be, so I won’t waste my time).
look up Dr Park who was my PhD student developing it. then tell me whether he is acupuncture-naïve.
The majority of acupuncturists will select individualised points for treatment with a combination of the following:
1) careful analysis of signs and symptoms from a traditional perspective
2) physical palpation of various points and areas, weighing up what is felt as well as feedback from the patient
After this, the needling process involves:
1) inserting the needle to various depths and at various angles depending on the situation
2) carefully feeling the response of the tip of the needle to underlying tissues
3) listening to feedback from the patient
4) adjusting angle/depth/needling technique in order to stimulate specific sensations locally, or through propagation of sensation elsewhere
Very few placebo studies I have ever seen involve the above in the ‘real’ group, and I can’t imagine how sham needles could possibly allow for a realistic replication in the ‘sham’ arm. To me this means the vast majority of acupuncture RCTs are testing one type of skin poking versus another, and not traditional acupuncture at all.
… and if you are correct, it means that the proof for acupuncture is still missing – which means we have to consider it as unproven and should not use it in routine care.
Then we get back to the thorny subject of how many interventions are truly ‘proven’, especially complex manual ones. I had a migraine patient yesterday whose GP sent her along because he has found acupuncture to be the most useful option. I’m glad there’s still a place for clinical judgement and experience in a patient’s best interests.
you seem to think that only SCAM is complex. can you name a few interventions that are NOT complex?
I could easily outline that prescribing an Aspirin is at least as complex as your acupuncture.
So, what you seem to be saying Tom, is that traditional acupuncturists make it up as they go?
No Björn, a good acupuncturist will attempt to flexibly adapt to any given situation, whilst staying grounded in basic principles. I’d be happy to give more detailed examples if I felt there was genuine openness and interest.
Why do you doubt our intentions Tom? I am as interested as you in furthering medical knowledge and discovering better therapeutic options for those who rely upon our services i.e. the patients.
Your rather superficial description of how an accomplished acupuncturist approaches and plans his therapeutic intervention is intriguing. If AP were a useful therapeutic modality, then one would expect it to have developed a consistent, methodological approach, just as other medical techniques. What you describe is the opposite and is most consistent with the notion that there is no intrinsic efficacy in needling and the effect is non-specific and unrelated to the needling itseld. I would welcome any information to the contrary and I am, as you should know by now, genuinely interested in hearing more about the methodology you use and how you know where to stick, when and how.
Hello Tom,
I am interested in your point 2) as I really don’t know anything about acupuncture. Are the various points that you palpate, the same as Meridians?
@Peter, ‘ashi’ points (basically meaning points that are tender or reactive to pressure) can be almost anywhere, as opposed to channel/meridian points which are more specific.
whether this is true or not could easily be tested in a blinded experiment. are you aware of such a test? if not, you might be fooling yourself again.
@Edzard, sorry, whether what is true?
‘points that are tender or reactive to pressure’
this is a form of diagnostic method that needs validating; otherwise it is just fooling yourself.
@Edzard the decision making process behind prescribing aspirin may be complex, but administering it not. I’m talking about things like physiotherapy, which are harder to ‘prove’ with placebo controlled trials, are they not?
whenever placebo controlled trials are too difficult or impossible, one uses the next best design. no excuse for substituting evidence by creed.
Why do you keep referring to Aspirin? Its pro’s and con’s are well known and controlled. The myth about it killing scores of people every day is a tired old trope.
In my part of the world, aspirin is no longer widely used as an OTC medication. Its effect on platelets is used to prevent clotting but as an aches and pains remedy it is only used by few, who seem to get a better effect from it than from other mild analgesics, e.g. some migraine sufferers if I understand right.
@Björn I’m not certain who you were addressing, but it was Edzard that referred to Aspirin, not me.
true!