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Precision needling in myofascial pain

9 Feb, 17 | by Dr Mike Cummings

Inspired by Wang et al Acupunct Med 2017[1]

Image taken from Cummings M Acupunct Med 2009.[2]

I got interested in swapping my hypodermic needles for filiform ones some 25 years ago, and was encouraged by my early success treating myofascial pain in a military population.[3] I became more and more expert at identifying these targets we call trigger points, touching them briskly with the tip of my fine filiform needle, and seeing them twitch with almost immediate relief of pain and tightness in the muscle. The twitch seemed to go along with immediate results, but it could be elusive, and other colleagues claimed similar success with less 3 dimensional accuracy – superficial needling or simply needling an acupuncture point nearby. As I have followed the clinical research in acupuncture I became less and less convinced that my accuracy, and the accuracy I tried to teach would be validated since there was so little difference between even real and sham needling.

My early research was a review of all both wet and dry needling in myofascial pain.[4] There was a strong suggestion that when injecting trigger points (wet needling), the substance in the syringe did not seem to matter, but all groups appeared to improve dramatically. At the time there were not many trials using filiform needles.

Now we have a selection of trials that can be combined in meta-analysis, and the tentative conclusion is that targeting trigger points seems to have some specific effect over sham, but that targeting acupuncture points is not clearly superior to sham.[1]

Figure 3 from Wang et al Acupunct Med 2017[1]

It is always worth having a careful look at Forest plots – so easy to miss the wood for the trees, so to speak, or even overlook some very strange trees! There are some issues to note here. The results of one trial (1.1.4 Tekin 2013) got included twice, albeit at different time points – they probably should have just decided on using one time point. Then there is a noticeable outlier in the lower plot (1.1.5 Chou 2009) – the effect size of this trial was huge in comparison to all the others. Under these circumstances it is always worth doing a sensitivity analysis excluding outliers. In this case it led me to check the original paper, and whilst the authors of this review classified it under acupuncture point treatment rather than trigger point treatment, the paper seems to suggest it used a trigger point needling technique to obtain multiple local twitch responses (LTRs) from remote trigger points that happened to be also at acupuncture point sites – in this case LI11 & TE5. Tricky to know how to classify this one then, but wait, there is another paper that used remote needling of a trigger point and measured an effect on upper trapezius myofascial pain (1.1.4 Tsai 2010). Maybe we should exclude that one as well in sensitivity analysis? Well I would have done all that for you, but given the small total number of total participants and the risk of bias, any conclusions would be unlikely to rise beyond a tentative suggestion.

So there you have it, perhaps the first meta-analysis of filiform needling in myofascial pain that points towards more accurate targeting of trigger points – but we have a long way to go!

References
1.   Wang R, Li X, Zhou S, et al. Manual acupuncture for myofascial pain syndrome: a systematic review and meta-analysis. Acupunct Med 2017. doi:10.1136/acupmed-2016-011176
2.   Cummings M. Myofascial trigger points: does recent research gives new insights into the pathophysiology? Acupunct Med 2009;27:148–9. doi:10.1136/aim.2009.001289
3.   Cummings TM. A computerised audit of acupuncture in two populations: civilian and forces. Acupunct Med 1996;14:37–9. doi:10.1136/aim.14.1.37
4.   Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil 2001;82:986–92. doi:10.1053/apmr.2001.24023

 


Declaration of interests

I am the salaried medical director of the British Medical Acupuncture Society (BMAS), a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit.

I am an associate editor for Acupuncture in Medicine.

I have a very modest private income from lecturing outside the UK, royalties from textbooks and a partnership teaching veterinary surgeons in Western veterinary acupuncture. I have no private income from clinical practice in acupuncture. My income is not directly affected by whether or not I recommend the intervention to patients or colleagues.

I have not chaired any NICE guideline development group with undeclared private income directly associated with the interventions under discussion. I have participated in a NICE GDG as an expert advisor discussing acupuncture.

I have used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989. My opinions are formed by data that spans the range of quality and reliability, much of which is in the public domain.

I have a logical mistrust of the motives of anyone who advertises an interest or hobby in being a ‘Skeptic’, as opposed to using appropriate scepticism within their primary profession, or indeed organisations that claim to promote generic ‘science’ as opposed to actually engaging in it.


 

Acupuncture for infantile colic – misdirection in the media or over-reaction from a sceptic blogger?

26 Jan, 17 | by Dr Mike Cummings

So there has been a big response to this paper press released by BMJ on behalf of the journal Acupuncture in Medicine. The response has been influenced by the usual characters – retired professors who are professional bloggers and vocal critics of anything in the realm of complementary medicine. They thrive on flexing their EBM muscles for a baying mob of fellow sceptics (see my ‘stereotypical mental image’ here). Their target in this instant is a relatively small trial on acupuncture for infantile colic.[1] Deserving of being press released by virtue of being the largest to date in the field, but by no means because it gave a definitive answer to the question of the efficacy of acupuncture in the condition. We need to wait for an SR where the data from the 4 trials to date can be combined.
On this occasion I had the pleasure of joining a short segment on the Today programme on BBC Radio 4 led by John Humphreys. My protagonist was David Colquhoun, who spent his short air-time complaining that the journal was even allowed to be published in the first place. Why would BBC Radio 4 invite a retired basic scientist and professional sceptic blogger to be interviewed alongside one of the journal editors – a clinician with expertise in acupuncture (WMA)? At no point was it made manifest that only one of the two had ever been in a position to try to help parents with a baby that they think cries excessively.
So what about the research itself? I have already said that the trial was not definitive, but it was not a bad trial. It suffered from under-recruiting, which meant that it was underpowered in terms of the statistical analysis. But it was prospectively registered, had ethical approval and the protocol was published. Primary and secondary outcomes were clearly defined, and the only change from the published protocol was to combine the two acupuncture groups in an attempt to improve the statistical power because of under recruitment. The fact that this decision was made after the trial had begun means that the results would have to be considered speculative. For this reason the editors of Acupuncture in Medicine insisted on alteration of the language in which the conclusions were framed to reflect this level of uncertainty.
David Colquhoun has focussed on multiple statistical testing and p values. These are important considerations, and we could have insisted on more clarity in the paper. P values are a guide and the 0.05 level commonly adopted must be interpreted appropriately in the circumstances. In this paper there are no definitive conclusions, so the p values recorded are there to guide future hypothesis generation and trial design. There were over 50 p values reported in this paper, so by chance alone you must expect some to be below 0.05. If one is to claim statistical significance of an outcome at the 0.05 level, ie a 1:20 likelihood of the event happening by chance alone, you can only perform the test once. If you perform the test twice you must reduce the p value to 0.025 if you want to claim statistical significance of one or other of the tests. So now we must come to the predefined outcomes. They were clearly stated, and the results of these are the only ones relevant to the conclusions of the paper. The primary outcome was the relative reduction in total crying time (TC) at 2 weeks. There were two significance tests at this point for relative TC. For a statistically significant result, the p values would need to be less than or equal to 0.025 – neither was this low, hence my comment on the Radio 4 Today programme that this was technically a negative trial (more correctly ‘not a positive trial’ – it failed to disprove the null hypothesis ie that the samples were drawn from the same population and the acupuncture intervention did not change the population treated). Finally to the secondary outcome – this was the number of infants in each group who continued to fulfil the criteria for colic at the end of each intervention week. There were four tests of significance so we need to divide 0.05 by 4 to maintain the 1:20 chance of a random event ie only draw conclusions regarding statistical significance if any of the tests resulted in a p value at or below 0.0125. Two of the 4 tests were below this figure, so we say that the result is unlikely to have been chance alone in this case. With hindsight it might have been good to include this explanation in the paper itself, but as editors we must constantly balance how much we push authors to adjust their papers, and in this case the editor focussed on reducing the conclusions to being speculative rather than definitive. A significant result in a secondary outcome leads to a speculative conclusion that acupuncture ‘may’ be an effective treatment option… but further research will be needed etc…
Now a final word on the 3000 plus acupuncture trials that David Colquhoun mentions. His point is that there is no consistent evidence for acupuncture after over 3000 RCTs, so it clearly doesn’t work. He first quoted this figure in an editorial after discussing the largest, most statistically reliable meta-analysis to date – the Vickers et al IPDM.[2] He admits that there is a small effect of acupuncture over sham, but follows the standard EBM mantra that it is too small to be clinically meaningful without ever considering the possibility that sham (gentle acupuncture plus context of acupuncture) can have clinically relevant effects when compared with conventional treatments. Perhaps now the best example of this is a network meta-analysis (NMA) using individual patient data (IPD), which clearly demonstrates benefits of sham acupuncture over usual care (a variety of best standard or usual care) in terms of health-related quality of life (HRQoL).[3]

Key to abbreviations
BMJ – British Medical Journal (company)
EBM – evidence-based medicine
HRQoL – health-related quality of life
IDP – individual patient data
IDPM – individual patient data meta-analysis
MCID – minimal clinically important difference
NMA – network meta-analysis
SR – systematic review
VAS – visual analogue scale (usually a 100mm line)

References
1.   Landgren K, Hallström I. Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL). Acupunct Med 2017: acupmed-2016-011208. doi:10.1136/acupmed-2016-011208
2.   Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012;172:1444–53. doi:10.1001/archinternmed.2012.3654
3.   Saramago P, Woods B, Weatherly H, et al. Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain. BMC Med Res Methodol 2016;16:131. doi:10.1186/s12874-016-0224-1

Addendum
This blog was edited on 26 January to remove some parts of the text to be in line with usual editorial standards.

Is acupuncture pseudoscience?

30 Dec, 16 | by Dr Mike Cummings

eyeballing

An eloquent and tenacious colleague has asked me to write about a cause she has taken up. It is certainly a just cause. She is mostly right I think. I have avoided these fights into which she dives headfirst. But if by being a bystander I silently condone the misdeed, then I have no choice but to join in…

Wikipedia has branded acupuncture as pseudoscience and its benefits as placebo. ‘Acupuncture’ is clearly is not pseudoscience; however, the way in which it is used or portrayed by some may on occasion meet that definition. Acupuncture is a technique that predates the development of the scientific method, introduced by Galileo Galilei among others, by well over a millennium, so it is hardly fair to classify this ancient medical technique within that framework. It would be better to use a less pejorative classification within the bracket of history when referring to acupuncture and other ancient East Asian medical techniques. The contemporary use of acupuncture within modern healthcare is another matter entirely, and the fact that it can be associated with pre-scientific medicine does not make it a pseudoscience.

The Wikipedia acupuncture page is extensive and currently runs to 302 references. But how do we judge the quality or reliability of a text or its references? When I was a medical student (well before the dawn of Wikipedia) I trusted in my textbooks, and I unconsciously judged the reliability by the weight and the cover. I am embarrassed to recount an episode at a big publishing event when I took a one such very large and heavy textbook to its senior editor and started pointing out what I thought were major errors. He laughed at me with a kindly wisdom and said “I’m sure there are lots of mistakes in there.” So now, some years later, as an author I have a different perspective on things, and a good deal more empathy with other authors and editors. I have submitted work for peer review and acted as a reviewer and editor, and with all its faults the peer review process may still be the best we have for assuring some degree of quality and veracity. So I would generally look down on blogs, such as this, because they lack the same hurdles prior to publication. Open peer review was introduced relatively recently associated with immediate publication. But all this involves researchers and senior academics publishing and reviewing within their own fields of expertise. Wikipedia has a slightly different model built on five pillars. The second of those pillars reads:


Wikipedia is written from a neutral point of view: We strive for articles that document and explain major points of view, giving due weight with respect to their prominence in an impartial tone. We avoid advocacy and we characterize information and issues rather than debate them. In some areas there may be just one well-recognized point of view; in others, we describe multiple points of view, presenting each accurately and in context rather than as “the truth” or “the best view”. All articles must strive for verifiable accuracy, citing reliable, authoritative sources, especially when the topic is controversial or is on living persons. Editors’ personal experiences, interpretations, or opinions do not belong.


Experts within a field may be seen to have a certain POV (point of view), and are discouraged from editing pages directly because they cannot have the desired NPOV (neutral POV). This is a rather unique publication model in my experience, although the editing and comments are all visible and traceable, so there is no hiding… apart from the fact that editors are allowed to be entirely anonymous. Have a look at the talk page behind the main acupuncture page on Wikipedia. You may be shocked by the tone of much of the commentary. It certainly does not seem to comply with the fourth of the five pillars, which urges respect and civility, and in my opinion results primarily from the security of anonymity. I object to the latter, but there is always a balance to be found between freedom of expression (enhanced for some by the safety of anonymity) and cyber bullying (almost certainly fuelled in part by anonymity). That balance requires good moderation, and whilst there was some evidence of moderation on the talk page, it was inadequate to my mind… I might move to drop anonymity from Wikipedia if moderation is wanting.

Anyway my impression, for what it’s worth, is that the acupuncture page on Wikipedia is not written from an NPOV, but rather it appears to be controlled by semi professional anti-CAM pseudosceptics, some of whom like to refer to acupuncture as “woo woo”. I have come across these characters regularly since I was introduced to the value of needling in military general practice some 25 years ago. I have a stereotypical mental image: plain or scary looking bespectacled geeks and science nuts, the worst are often particle physicists ;-). By the way, my first choice of career was astrophysics, so I may not be so different at my core :-/. Interacting with them is at first intense, but rapidly becomes tedious as they know little of the subject detail, fall back on the same rather simplistic arguments and ultimately appear to be motivated by eristic discourse rather than the truth.

Addendum
This is probably the first thing I have ever written without any references. Hey it is just an opinion piece, and this is a blog… and 3 clicks will get you here. It has been flagged as having no CI statement, my apologies for the oversight. I take conflicts of interest very seriously.


Declaration of interests

I am the salaried medical director of the British Medical Acupuncture Society (BMAS), a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. [2 clicks from this blog]

I am an associate editor for Acupuncture in Medicine. [3 & 1 click from this blog respectively]

I have a very modest private income from lecturing outside the UK, royalties from textbooks and a partnership teaching veterinary surgeons in Western veterinary acupuncture. I have no private income from clinical practice in acupuncture. My income is not directly affected by whether or not I recommend the intervention to patients or colleagues.

I have not chaired any NICE guideline development group with undeclared private income directly associated with the interventions under discussion. I have participated in a NICE GDG as an expert advisor discussing acupuncture.

I have used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989. My opinions are formed by data that spans the range of quality and reliability, much of which is in the public domain.

My point of view (POV) is clear, and can be read openly here and in other publications. My publications in this field span 20 years.

In Wikipedia editor terms I could be considered a potential ‘POV pusher’. It is hard to strike a neutral balance when you are an opinion leader in a field that faces inappropriate conventional bias driven perhaps ironically through a lack of exposure to a trusted expert POV. We try to provide peer reviewed data and associated POV via this journal, but this blog is not peer reviewed – it’s a blog.

I have a Wikipedia user account (Drmike001) and have made two suggestions for references on the Talk:Endorphins page (scroll to the bottom).

I have made several charitable donations to Wikipedia in recent years.

I have a logical mistrust of the motives of anyone who advertises an interest or hobby in being a ‘Skeptic’, as opposed to using appropriate scepticism within their primary profession.


 

Too NICE – there appears to be a glaring orthodox bias in NG59

30 Nov, 16 | by Dr Mike Cummings

When the draft clinical guideline for low back pain & sciatica was published in February 2016, it was with some resignation that I noted the 2009 recommendation in CG88 for acupuncture in low back pain (from 6 weeks to 1 year)[1] had been dropped. It was expected for a variety of off-radar reasons, from pre-guideline social media comments of anti-CAM Guideline Development Group (GDG) members to the professional activities and commercial interests of the GDG chair.

The 2009 guideline (CG88)[1] had a different scope from NG59,[2] the chair was an academic GP, and the vice chair was the president of the British Pain Society (BPS) and a professor of physiotherapy – the first president of the BPS who was not an anaesthetist. CG88 caused significant concern amongst the interventionist anaesthetists in the BPS because there was a recommendation to avoid spinal injections and positive recommendations for more conservative approaches: specifically exercise, spinal manipulation and acupuncture. The chair of the current guideline (NG59) is an interventionist. He did not call for an extraordinary general meeting of the BPS and a vote of no confidence in the president, but other interventionists did. Senior members of the BPS told me at the time of their embarrassment over this situation. Move on 3 years and we have an interventionist chair of NG59, and a recommendation for the interventionalists’ bread and butter procedure – radiofrequency denervation (RFD). Something that Cochrane suggests has no high quality evidence in chronic low back pain.[3] A coincidence perhaps… I will let the reader judge as the history unfolds.

Closer inspection of the draft guideline revealed that the situation for acupuncture was not as cut & dried as I had first thought. The evidence for acupuncture, examined in isolation, held no surprises. A clear statistical effect over sham in pain and functional outcomes, but the size of the benefit over sham (active sub-optimal needling) that did not meet the predefined required clinical relevance (in this case, for pain, 10mm on a 100mm VAS score). [I have always been puzzled by the nonsense of assessing clinical relevance over an active sham comparator (favoured by NICE) rather than usual care or the best current treatment available.]

The reason it did not appear so cut & dried this time was that very little else that was recommended (mostly conventional approaches) seemed to meet the requirements that were articulated for acupuncture (hence “Too NICE” in the title). Most notable was exercise and manual therapies. Not only did these interventions fail to show any clinically relevant benefit over shams, but exercise failed to show any benefit at all over sham. In the final guideline this has been managed by excluding the only sham controlled trial of exercise.[4] The explanation given was that the GDG decided that the sham exercises in question were not valid forms of sham exercise. Terribly convenient you might think, or you might agree with the GDG, it is difficult to conceive of what sham exercise might look like. Oh but wait a minute! What about sham acupuncture? It is equally difficult to conceive of a sham for acupuncture from a mechanistic neurophysiological (ie scientific) perspective.[5] Surely you just have to blind the patient? Since they are measuring the primary outcome in most trials of pain conditions. Or you just have to miss the point [;-) irony].[6] Modern explanations for the mechanisms of acupuncture clearly indicate that it is impossible to miss the point, as all target tissues are innervated, and can be stimulated with a needle. What about the non-penetrating needles? [You might cry]. Well in my first attempt using these for real I caused more pain and bleeding than with the real needles!

We are given a clue that sham acupuncture is an active intervention by the results of large three-armed clinical trials including a sham arm and a conventional care arm.[7] In back pain sham was 50% better than guideline based conventional care,[8] and in a large network meta-analysis sham acupuncture was significantly better than conventional care for chronic headache prophylaxis.[9] It seems strange then to be reminded that in CG150 we were told that topiramate was twice as good as acupuncture,[10] yet the data suggested that sham acupuncture exceeded the effect of the drug.[11] Now the biggest data set has confirmed this superiority of sham acupuncture.[9]

Now that we have this very large data set that has been subject to network meta-analysis,[9] we see that sham acupuncture consistently outperforms usual care (a mixture of trials including routine care and guideline-based conventional care comparators) in terms of health-related quality of life (HRQoL) – the outcome held up as most important to NG59’s GDG.

So in low back pain acupuncture outperforms an active sham comparator with a greater margin than any of the interventions recommended in NG59, but it is not recommended on the basis that the benefits may all be explained by context effects. This is because the effect beyond sham is not large, but I have already argued that sham acupuncture is better than conventional care comparators. Acupuncture is clearly disadvantaged by the standard NICE approach of looking only at its effect compared to an active sham, rather than comparisons with existing conventional interventions, and its insistence that all shams and placebos are equal – this is clearly wrong,[11,12] and I call on NICE to reconsider this assumption as a matter of urgency.

Medicine in the UK is facing a massive challenge through changing demographics (an aging population), chronic disease burden (musculoskeletal, metabolic & neurological) and relative underfunding. In this environment should we not be seeking low cost effective treatments, rather than expensive patented devices and products? It doesn’t seem as if our system has the right balance. The rigour applied to acupuncture is laudable, but only if the same rigour is equally applied to conventional interventions and particularly those that have strong commercial backing… but this does not seem to be the case.

In 2010 NICE approved a treatment for overactive bladder called posterior tibial nerve stimulation (PTNS).[13] PTNS has been set within the field of neuromodulation, and the majority of papers make no mention of acupuncture, yet the technique is performed with an acupuncture needle in a location frequently used by acupuncturists. The technique is effectively electroacupuncture to the S2 myotome in the leg, and it does work in overactive bladder. There is one large sham controlled trial of the technique,[14] and rather like some acupuncture trials it used the Streitberger placebo needle in the sham stimulation group. There was a clear statistical benefit for real PTNS over sham, and the paper displays impressive results in terms of responder rates; however, the effect size of changes in symptom severity scores and symptom diaries are well below a standardised mean difference (SMD) of 0.5 for every measure. The minimum important difference applied to acupuncture in CG177 was 0.5 SMD.[15] If PTNS was actually described as electroacupuncture to SP6 or KI7, would it have got the same treatment from NICE?

Subsequently, PTNS has been approved for faecal incontinence.[16] The evidence was based on a small non-randomised sham controlled trial, in which there was no effect in the sham group. The latter is unheard of in acupuncture research. A large prospective randomised clinical trial of PTNS in faecal incontinence recorded a responder rate of 31% in the sham group,[17] and this trial failed to demonstrate a significant benefit for real PTNS over the sham. I wonder if this patented intervention will survive in the eyes of NICE? If it is dealt with in the same way as acupuncture, it will surely not survive, but then it would never have been recommended in the first place of course.

Another patented device in the field of neuromodulation has been tentatively given a nod by NICE recently. It claims to stimulate the cervical branch of the vagus via surface stimulation.[18] But rather than stimulate skin innervated by the vagus nerve within the concha of the pinna, this device is held over the front of the neck, from where it is impossible to stimulate vagal afferents without picking up motor fibres in laryngeal nerves from the vagus. This would result in closure of the glottis (ie inability to breathe during stimulation – not ideal!). Anyway, the illogical premise of the device is not the point, it is the fact that it has been approved for further use and evaluation on the basis of a couple of small open trials in which the control group received no treatment. NICE have never approved acupuncture on the basis of such comparisons. The playing field is not level here, and medicine is becoming ever more expensive as a result…

A more worrying part of this picture is that the devices designed for these forms of neuromodulation (both PTNS and transcutaneous ‘vagal nerve’ stimulation) are created with an unnecessarily limited lifespan. The lead used for PTNS from one provider that supplies the NHS in England is a single use lead that costs over £30. The lead will only function for one treatment. Virtually identical electroacupuncture leads cost a few pounds and can last for years. A transcutaneous ‘vagal nerve’ stimulator called gammaCore is designed for home use by patients, but will only last for a limited number of uses and costs from around £150 for 50 episodes of use.

This is a call to us all in medicine to wake up and stop spending excessive funds on expensive patented drugs and devices that have not been shown to outperform simple cheap alternatives such as acupuncture that are easily taught to health professionals and have a very low inherent cost.

References
1.   NICE guideline on low back pain: early management of persistent non-specific low back pain. http://guidance.nice.org.uk/CG88. 2009.
2.   Low back pain and sciatica in over 16s: assessment and management. https://www.nice.org.uk/guidance/ng59. 2016.
3.   Maas ET, Ostelo RWJG, Niemisto L, et al. Radiofrequency denervation for chronic low back pain. Cochrane database Syst Rev 2015;:CD008572. doi:10.1002/14651858.CD008572.pub2
4.   Albert HB, Manniche C. The Efficacy of Systematic Active Conservative Treatment for Patients With Severe Sciatica. Spine (Phila Pa 1976) 2012;37:531–42. doi:10.1097/BRS.0b013e31821ace7f
5.   White AR, Filshie J, Cummings TM, et al. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med 2001;9:237–45.
6.   Cummings M. Commentary: Controls for acupuncture – can we finally see the light? BMJ 2001;322:1578.PM:11431299
7.   Cummings M. Modellvorhaben Akupunktur–a summary of the ART, ARC and GERAC trials. Acupunct Med 2009;27:26–30. doi:10.1136/aim.2008.000281
8.   Haake M, Müller H-H, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med 2007;167:1892–8. doi:10.1001/archinte.167.17.1892
9.   Saramago P, Woods B, Weatherly H, et al. Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain. BMC Med Res Methodol 2016;16:131. doi:10.1186/s12874-016-0224-1
10.   NICE guideline on headaches: diagnosis and management of headaches in young people and adults. http://guidance.nice.org.uk/CG150. 2012.
11.   White A, Cummings M. Inconsistent placebo effects in NICE’s network analysis. Acupunct Med 2012;30:364–5. doi:10.1136/acupmed-2012-010262
12.   Meissner K, Fässler M, Rücker G, et al. Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxis. JAMA Intern Med 2013;173:1941–51. doi:10.1001/jamainternmed.2013.10391
13.   Percutaneous posterior tibial nerve stimulation for overactive bladder syndrome Interventional procedures guidance [IPG362]. https://www.nice.org.uk/guidance/IPG362. 2010.
14.   Peters KM, Carrico DJ, Perez-Marrero R a, et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. J Urol 2010;183:1438–43. doi:10.1016/j.juro.2009.12.036
15.   NICE guideline update on osteoarthritis: the care and management of osteoarthritis in adults. http://guidance.nice.org.uk/CG177. 2014.
16.   Percutaneous tibial nerve stimulation for faecal incontinence Interventional procedures guidance [IPG395]. https://www.nice.org.uk/guidance/ipg395. 2011.
17.   Knowles CH, Horrocks EJ, Bremner SA, et al. Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial. Lancet (London, England) 2015;386:1640–8. doi:10.1016/S0140-6736(15)60314-2
18.   Transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. https://www.nice.org.uk/guidance/ipg552. 2016.

Quality sham – there appears to be a significantly greater improvement in health related quality of life (HRQoL) with sham acupuncture than with conventional care

13 Oct, 16 | by Dr Mike Cummings

saramago-f1-2016

Comments stimulated by: Saramago et al. BMC Med Res Methodol 2016

This week a new finding in the acupuncture field was published in rather unlikely journal. BMC Medical Research Methodology is one of the Biomed Central range of open access online journals, and the paper principally describes a new method within network meta-analysis for analyzing data from continuous variables using individual patient data.[1]

Briefly, meta-analysis allows summary data from different studies (two-way comparisons from randomized controlled trials – RCTs) to be combined in order to reduce statistical uncertainty, and assess other aspects of the data such as heterogeneity or the likelihood of publication bias. Combining summary data has limitations because the original trials may not report data in the same way, and may not use the most powerful statistical analysis in the first place. Hence there is value in using the raw (individual patient) data and reanalyzing with the same statistical method for each trial before combining the results (pooling).[2]

Network meta-analysis is a method for combining data from multiple two-way comparisons of interventions so that both direct and indirect comparisons between interventions can be performed. For indirect comparisons there must be a common node (or intervention). In CG150 a limited network meta-analysis used placebo as a common node to compare acupuncture directly with topiramate, and concluded that the latter was twice as good as the former.[3] For this to be a valid analysis, sham acupuncture would have had to be the same as placebo topiramate, yet the absolute data seemed to indicate that sham acupuncture was associated with a higher responder rate than the real drug itself, let alone the placebo version.[4] Subsequent analysis of shams in migraine clearly indicate that sham acupuncture and sham surgery significantly outperform all other shams and placebos.[5]

Enough of the sour grapes over the NICE view that topiramate is twice as good as acupuncture, and back to the new paper… This paper by Saramago et al used the data from the Acupuncture Trialists Collaboration that was reported in the first individual patient data meta-analysis (IDPM) in the field by Vickers et al.[2] But unlike the two-way comparisons of this first IPDM, which separately compared acupuncture with sham and acupuncture with no acupuncture controls, Saramago et al were able to simultaneously include all comparisons in a single network. This results in statistically robust data that for the first time compares sham acupuncture with usual care (or ‘no acupuncture’ control) as well as giving a higher degree of reliability to the main comparisons of acupuncture with sham and acupuncture with usual care.

So this brings us to the unexpected new insight that is alluded to in the title of this blog, and merely an incidental finding of the analysis. The results of the network meta-analysis demonstrate that acupuncture is superior to usual care for pain and health related quality of life (HRQoL) – the latter being measured with the EQ5D or converted from other measures such as the SF36, SF12, VAS pain, WOMAC etc. Acupuncture is also superior to sham acupuncture for pain (apart from the headache subset), but not unequivocally superior in terms of HRQoL (95% confidence intervals cross zero). The rather fascinating result is that sham acupuncture is unequivocally superior to usual care in terms of HRQoL, but not consistently superior in terms of pain – see Figure 2 from the paper below.

A rough and ready summary would be: acupuncture is superior to usual care in both outcomes; the difference between acupuncture and sham acupuncture appears greater in terms of pain than HRQoL; and the difference between sham acupuncture and usual care appears greater in terms of HRQoL than pain… Fascinating! This will give mechanistic advocates like me plenty to postulate over the differential effects of gentle versus standard acupuncture approaches in different circumstances.

saramago-f2-2016

Postscript note 1:

Usual care is a term used in the paper by Saramago et al, and it refers to the same data set labeled by Vickers et al as no acupuncture controls. This group includes a variety of interventions that could be described as standard or conventional care. Some involved quite intense treatment regimes, and others could be seen as more of a background usual care that might be common to all groups (ie including acupuncture and sham acupuncture groups).

Postscript note 2:

Sham acupuncture mostly involves needling superficial tissues and has similarities with gentle forms of acupuncture. Non-penetrating sham or ‘placebo’ needles are blunt ended, and often cause significant discomfort and can penetrate the skin. It seems clear that sham acupuncture is not synonymous with the term ‘placebo’.

References
1.   Saramago P, Woods B, Weatherly H, et al. Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain. BMC Med Res Methodol 2016;16:131. doi:10.1186/s12874-016-0224-1
2.   Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012;172:1444–53. doi:10.1001/archinternmed.2012.3654
3.   NICE guideline on headaches: diagnosis and management of headaches in young people and adults. 2012.http://guidance.nice.org.uk/CG150
4.   White A, Cummings M. Inconsistent placebo effects in NICE’s network analysis. Acupunct Med 2012;30:364–5. doi:10.1136/acupmed-2012-010262
5.   Meissner K, Fässler M, Rücker G, et al. Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxis. JAMA Intern Med 2013;173:1941–51. doi:10.1001/jamainternmed.2013.10391

Trust Me, I’m an acupuncture expert – but I have never actually had it or used it…

4 Sep, 16 | by Dr Mike Cummings

 

MC trust me 2016

On Thursday 1st September the first episode of series five of Trust Me I’m A Doctor aired on BBC2. I was keen to see how acupuncture was treated after spending a day engaged in trying to demonstrate a change in pressure pain threshold in the lead presenter about a month previously. The experiment went relatively well, and Michael’s pressure pain thresholds doubled from before to after the experiment. Sham acupuncture involved the use of ‘non-penetrating’ retractable needles. It was the first time I had used these in earnest and they succeeded in masking the subject – Michael could not tell which of the interventions involved real acupuncture. I did note that the sham needles could inadvertently penetrate the skin, particularly if the retractable shaft had an overly stiff sliding action. Michael found the sham needling created quite a strong sensation, and I had to work quite hard to create as strong a sensation with the real acupuncture – I found this very interesting as someone who has used acupuncture therapeutically for over 20 years, but never actually tried to perform sham acupuncture in a ‘trial’. Experienced acupuncture practitioners who then have to perform sham interventions have often remarked to me that the sham techniques do far more than they expect in terms of sensation, and in the case of the ‘so called’ non-penetrating needles, how often they cause bleeding.

So that brings us to the ‘acupuncture expert’, who, according to ‘Trust Me’, “…has spent much of his career studying the effect of acupuncture.” If you go to PubMed and insert in the search box: Hróbjartsson A [au] AND acup*; you will only get 4 papers, and only one of them will have acupuncture in the title. That is the infamous BMJ systematic review (Madsen et al BMJ 2009)[1] that got away with pooling data from trials of acute and chronic pain, from surgical pain to headache to arthritis. Yes I did say pooling. The clinical heterogeneity in this review was simply breathtaking, but I guess that the relevant BMJ editors were eclipsed by the home address of the authors – the esteemed Nordic Cochrane Centre. But this was not a review performed within the remit of the Cochrane Collaboration. As a Cochrane author I know the rigors of the process very well, and I can assure readers that Madsen et al would never pass muster in such an arena. Yet the authors of the review used this address, perhaps to their advantage in securing a prominent publication.

So we have an expert with one highly controversial review paper on acupuncture to his name. An expert who has never received acupuncture treatment let alone used it. An expert who thinks we do not know how it works, despite over 60 years of laboratory data investigating mechanisms from endogenous opioids to adenosine release.[2] Dare I say, a medical expert who has never touched a patient therapeutically?

So yes, I have to admit I am disappointed with the superficial way the subject was covered, and the lack of acknowledgement of the challenges of performing blinded trials of acupuncture. Challenges that are eminently illustrated by Haake et al (2007)[3] – the biggest ever sham controlled trial of acupuncture in low back pain, with over 1000 patients. In this trial, sham acupuncture performed twice as well as rather intensive German guideline-based conventional care. Can our acupuncture expert really propose that this is simply a placebo response?

References
1.   Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009;338:a3115. doi:10.1136/bmj.a3115
2.   Filshie J, White A, Cummings M. Medical Acupuncture – A Western Scientific Approach. 2nd ed. Elsevier 2016.
3.   Haake M, Müller H-H, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med 2007;167:1892–8. doi:10.1001/archinte.167.17.1892

Breathless…

18 May, 16 | by Dr Mike Cummings

…a career-defining symptom?

 

The Filshie files – breathlessness
JFJacky Filshie (JF) has devoted a medical career to symptom management in the cancer suffering population. Her early personal experience of acupuncture needling had a significant impression on her, probably because she happened to have the right genetic complement to maximise the central effects of the technique. Whatever the reason, she was driven to overcome the scepticism of her colleagues in a very prestigious medical institution, and she began to incorporate acupuncture treatment into her routine practice in the cancer pain population.[1] Her enthusiasm for the technique grew, and soon she was trying it on a variety of the more intractable symptoms of her patients. One of these was acute dyspnoea (breathlessness).[2] A key facet of the technique involved gentle periosteal tapping at two sites in the midline on the manubrium of the patient with 36 gauge acupuncture needles (0.16mm diameter). This technique has come to be known as ASAD, which stands for Anxiety, Sickness, And Dyspnoea, or fondly, to reflect JF’s enthusiasm, All Singing And Dancing. In practice this seems to result in a rapid reduction in anxiety and respiratory rate in at least 50% of patients – the figure comes from a conservative and independent palliative care physician who I asked for an honest and confidential opinion some years ago, because without personal experience of using it I admit to having been a little sceptical of JF’s seemingly miraculous results. In 1996 JF noted a marked symptomatic benefit in 70% of her pilot study population with cancer related breathlessness.

Well it is 20 years on since JF’s first published report, and I am pleased to relate that her observation has been confirmed in a subsequent large pragmatic comparative RCT against and in combination with morphine – the conventional treatment for cancer related breathlessness.[3] In fact the responder rate at 4 hours (primary outcome) in the acupuncture group was 76%, compared with 60% in the morphine group and 66% in the combined group (see Figure 3 below from the trial publication).[3] In statistical terms these were not different, but interestingly there was a highly significant benefit in terms of relaxation (secondary outcome) for acupuncture over morphine.

Fig 3 Minchom EJP 2016

For those interested, the acupuncture techniques used in the trial are illustrated in the photo below (with thanks to our model Dr Federico Campos): ASAD points; thoracic paraspinals T1 to T5; three trapezius trigger points on each side; and LI4 bilaterally.

6R0A4583

You could always come and she her demonstrate in person at the BMAS Palliative Care Day. Or if you are a BMAS member or an academic associate you can watch her in action from the comfort of your own armchair by logging in to watch the webcast of the BMAS Autumn Meeting 2015 held in the Royal College of Physicians, London.

References
1.   Filshie J. The non-drug treatment of neuralgic and neuropathic pain of malignancy. Cancer Surv 1988;7:161–93.
2.   Filshie J, Penn K, Ashley S, et al. Acupuncture for the relief of cancer-related breathlessness. Palliat Med 1996;10:145–50.
3.   Minchom A, Punwani R, Filshie J, et al. A randomised study comparing the effectiveness of acupuncture or morphine versus the combination for the relief of dyspnoea in patients with advanced non-small cell lung cancer and mesothelioma. Eur J Cancer 2016;61:102–10. doi:10.1016/j.ejca.2016.03.078

Musings on heterogeneity in quantitative outcomes of acupuncture trials in LBP

4 Apr, 16 | by Dr Mike Cummings

apple and pear pyramid pic

Further commentary:
Low back pain and sciatica: management of non-specific low back pain and sciatica
Draft clinical guideline February 2016

This commentary follows a previous blog post.

Late last Friday night I got around to dropping the pain VAS outcome figures from the trials of acupuncture versus sham into RevMan 5 – the software used for Cochrane Reviews. I was surprised to find that the high I2 value for the short-term outcome in the draft guideline did not drop substantially with the corrected data (incidentally there were errors in the data from both Brinkhaus and Leibing). Here is the corrected forest plot to replace Figure 667 [Appendix K, p 153].

Pain up to 4m +Haake

The total mean difference in pain now reaches clinical significance, and remember that is the difference over gentle needling, not an inactive placebo intervention. However, the heterogeneity remains unexpectedly high. The outlier now is Haake. This was a huge multicentre trial with some 300 different centres, where the participant clinicians did not meet for instruction on intervention procedures, as the 26 in Brinkhaus did. The primary outcome in Haake showed both real and sham acupuncture were twice as good as guideline based conventional care, so we might hypothesise that the sham was closer to real acupuncture than in Brinkhaus. Excluding Haake removes all heterogeneity.

Pain up to 4m -Haake

So one large trial where we suspect substantial differences in the comparator (sham acupuncture) creates all the heterogeneity. But large trials are usually held out to be more statistically reliable, so there does remain some uncertainty in interpretation. I should point out that within RevMan the pain results for Haake are positive, so whether you think the sum of the smaller trials (n=610) or Haake (n=749) are more reliable, both demonstrate a biological effect of average acupuncture over gentle acupuncture.

Moving to the long term analysis (pain VAS >4 month), there was a data entry error here too. Hard to spot, but glaring when noticed – the pain VAS outcome for Leibing was a negative value! How can a pain score be negative? The negative figure is clearly a change value, not an absolute value of pain at the relevant time point (this is the same data entry error made for the Brinkhaus data). Here is the corrected Figure 668 [Appendix K, p 153].

Pain over 4m

Statistically positive and no heterogeneity, this represents a clear long term biological effect of average acupuncture over gentle acupuncture, although the difference is not in the range that would be regarded as clinically significant by NICE, if indeed you can judge clinical significance in an explanatory (sham controlled) model. The heterogeneity result seems to be explained by a reduction in the mean difference between acupuncture and sham in the smaller trials, and no change in that of Haake, so in effect the smaller trial results got closer to the results of Haake. In terms of absolute pain scores, it seems that, on average, the patients in Haake continued to improve, whereas those in the smaller trials deteriorated slightly.

In summary, whilst there remains some uncertainty about interpretation of the clinical relevance of this data, it is clear that average acupuncture is superior to gentle acupuncture for low back pain in both the short and long term outcomes, and this data is clearly more convincing than the equivalent data for either the exercise or the manual therapies recommended in the draft NICE guideline for low back pain.

Exercise not acupuncture recommended by NICE for low back pain – balanced assessment, bias or error?

31 Mar, 16 | by Dr Mike Cummings

DSC_6271

Commentary:
Low back pain and sciatica: management of non-specific low back pain and sciatica
Draft clinical guideline February 2016

NICE clinical guidelines are very large pieces of work. This draft runs to over 1000 pages with the addition of around 2500 pages of appendices, and data extracted and analysed from nearly 600 RCTs. Having sat on the guideline development group (GDG) meetings for CG88 I had a firsthand view of the size and difficulty of the task, and the GDG in this case is to be congratulated for their work in completing this draft.

In this discussion I will focus on a very small section, and highlight key data entry errors within the analysis. I hope that a careful reconsideration of the data may result in a positive recommendation for acupuncture in low back pain.

Acupuncture techniques have been used in the UK for at least 200 years, but their strongest association is with traditional East Asian medicine, and therefore they can seem conceptually alien to our contemporary scientific medicine. Whilst the GDG recognised the modern interpretation of acupuncture, and its scientific basis, under the heading of Western medical acupuncture (WMA), they went on to apply an additional requirement to acupuncture that apparently was not applied to similar interventions (exercise & manual therapies).

The GDG first discussed the necessity of a body of evidence to show specific intervention effects, that is, over and above any contextual or placebo effects. [draft 1, p 493]

So this involves a focus on sham controlled trials of acupuncture, which nearly always compare two forms of needling – a gentle superficial form at sites away from the most common points used (minimal or sham), and an average style of routine acupuncture usually at muscle level. The comparison of normal and sham acupuncture certainly excludes contextual and placebo effects, but it also excludes the effect of gentle needling, and therefore underestimates the whole effect attributable to needle acupuncture. Consequently it would be inequitable to place too strong a reliance on the clinical relevance of this difference, but appropriate to focus on this for biological plausibility of the technique, before moving on to consider more pragmatic comparisons with usual care.

For the purposes of this discussion I will focus on the sham-controlled evidence for exercise, manual therapies and acupuncture, and compare and contrast the strength of evidence and the subsequent recommendations.

Exercise was recommended, and the GDG commented:

The GDG noted that there was some evidence of benefit for all exercise types compared to sham, usual care or other active comparators,… [draft 1, p 303]

By contrast I could not find any evidence of an effect of exercise over sham. Indeed there were only two trials that included data. Appendix K p 60 shows a forest plot (Fig 219) with data from Albert 2012 – this plot seems to demonstrate an effect of exercise over sham for pain ≤4 months, but the data in this plot is different from that extracted from the paper and included in the table of Appendix H p 146. Indeed the original paper reports no difference between exercise and sham in the primary outcomes, and the responder rate was actually slightly greater for sham. Only secondary outcomes of neurological signs relevant to sciatica were in favour of exercise over sham.

The second paper with data relevant to the comparison of exercise over sham reported no significant benefit in terms of the only outcome reported – psychological distress. [Appendix K, p 70]

So there is no sham-controlled data supporting exercise interventions, yet the GDG made a positve recommendation. This positive recommendation was therefore based either on error from faulty data entry, or on low quality data that could have been entirely attributable to contextual effects, those that the GDG insisted on excluding when considering data on acupuncture.

Manual therapies were also recommended. Two small trials tested massage against sham, and there was a borderline effect over sham for pain <4 months – the lower 95% confidence interval (CI) crossed the line of no effect by 0.02. [Appendix K, p 115] Five trials (533 patients) were combined for manipulation over sham for pain ≤4 months. The mean difference in VAS (0-10) was -0.26, and the lower 95% confidence interval (CI) reached zero. [Appendix K, p 122] There were no long-term effects >4 months. This is very weak data on which to base a positive recommendation.

The meta-analysis of acupuncture over sham (minimal needling) for pain ≤4 months included a major data entry error. [Appendix K, p 153] Brinkhaus 2006 data was entered as values representing a decrease in pain score from baseline rather than as the absolute value after treatment. This error flipped the point estimate for the mean difference to the wrong side of the zero effect line ie favouring sham instead of acupuncture. This resulted in a reduction in the total effect size, and more importantly an erroneously high heterogeneity (I2 = 76%). Both of these potentially resulted in a reduction in the ‘quality of evidence’ (GRADE) for this item, which was consequently presented as Low quality, rather than High or Moderate. It was this uncertainty that resulted in the GDG statement:

Heterogeneity was observed in the meta-analysis that was unexplained by pre-specified subgroup analysis of type of acupuncture or duration of pain. [draft 1, p 493]

Despite this error, the point estimate was -0.8, and the lower 95% CI was well clear of the zero effect line, resulting in a highly statistically significant result in favour of acupuncture over sham for pain ≤4 months. This analysis included 7 RCTs and a total of 1359 patients. Furthermore, the effect of acupuncture over sham in the long-term (>4 months) was also positive, with no heterogeneity, 4 RCTs and 1159 patients.

This data clearly demonstrates the biological plausibility of normal acupuncture over gentle needling. For clinically relevant effects we should look at the data compared with usual care. This analysis demonstrates clinically relevant effects for pain ≤4 months, but high heterogeneity. The latter is clearly related to the differences in the usual care comparisons in the larger trials: Brinkhaus 2006 used a waiting list control; and Haake 2007 used rather intensive guideline-based conventional care (physician visits, physiotherapy, NSAIDs). Despite this obvious clinical heterogeneity in the control groups, the GRADE category for quality was automatically reduced. The GDG stated that the benefits on pain were not sustained beyond 4 months; [draft 1, p 494] however, the forest plot for acupuncture compared with usual care for pain >4 months clearly demonstrates a statistically significant benefit. [Appendix K, p 159]

I note that the health economic data demonstrates a more favourable cost per quality adjusted life year (QALY) for acupuncture compared with the cost of either exercise or manual therapies. [Appendix I, p 29, p 18, p 27]

Taking all this together, I call for the GDG to look again at their data with the errors corrected, and invite them to consider a more equitable recommendation for acupuncture in low back pain.

Acupuncture & menopausal hot flushes

15 Mar, 16 | by Dr Mike Cummings

Pretty girl fanning herself

Comments on: Ee et al Ann Int Med 2016

A large rigorous trial published in a prestigious general medical journal, and the usual mantra rings out – acupuncture is no better than sham. In this case there was not a fraction of difference from a non-penetrating sham in a two-armed trial with over 300 women. Ok, so we have known for some time that we really need 400 in each arm to demonstrate the usual difference over sham seen in meta-analysis in pain conditions, but there really was not even a sniff of a difference here. So is that it for acupuncture in hot flushes? Well, we have a 40% symptom reduction in both groups, and a strong conviction from some practitioners that it really seems to work. Is 40% enough for a strong conviction? I have heard some dramatic stories from medical acupuncturist colleagues that really would be hard to dismiss as non-specific effects, and from others I have heard relative ambivalence about the effects in hot flushes.

Personally I always try to consider mechanisms, and I wish researchers in the field would do the same before embarking on their trials. That is not intended as a criticism of this trial, but some consideration of mechanisms might allow us to explain all our data, including the contribution of this trial.

Acupuncture has recognised effects that are local to the needle, in the spinal cord (mainly in the segments stimulated) and in the brain (as well as humoral effects in CSF and blood). The latter are probably the mildest of the three categories, and require the best group of patient responders for them to be observable in clinical practice.

Menopausal hot flushes are explained by the effects of reduced oestrogens on the thermoregulatory centre in the anterior hypothalamus. It is certainly plausible that the neuro-inhibitory effects of endogenous opioids such as beta-endorphin, which we know can be released by acupuncture stimulation in experimental settings, could stablise neurones in the anterior hypothalamus that have become irritable due to a sudden drop in oestrogens.

So are endogenous opioids always released by acupuncture? Well, they and their effects seem to be measurable in experiments that use what I call proper acupuncture. That is, strong stimulation to deep somatic tissue. In the laboratory, and indeed in the clinic, this is only usually achieved in a palatable manner by electroacupuncture to muscle, although repeated manual stimulation every few minutes may have similar effects.

Ee et al used a relatively gentle acupuncture protocol, so they may have only generated measurable effects, based on mechanistic speculation, in the most responsive patients, perhaps less than 10%.

What does all this tell us? Well this trial clearly demonstrates that gentle acupuncture protocols generate effects in women with hot flushes via context rather than penetrating needling. In conditions that rely on central effects, I think we still need to consider stronger stimulation protocols and enriched enrollment in trials, ie preselecting responders before randomisation.

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