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Research commentaries

Burning nerves with needles in back pain – stop the burning, just use the needles!

27 Jul, 17 | by Dr Mike Cummings

This piece has also been stimulated by a publication in JAMA, this time evaluating the use of denervation of joints in spinal pain.[1] It is a set of three large (n=251, n=228, n=202), probably definitive, pragmatic trials that evaluate the use of radiofrequency denervation (RFD) as an addition to a 3 month standardised exercise programme. The design is such that the intervention was given the greatest possible opportunity to demonstrate an effect, that is both the specific effect of the intervention plus the context in which it is provided. This is rather similar to the Acupuncture in Routine Care (ARC) trials performed as part of the German Modellvorhaben Akupunktur;[2] all of which were markedly positive for acupuncture.

The results seem clear – at no time point did the difference been intervention and control reach clinical significance in terms of pain intensity (the primary outcome); and in only one of 18 time points across the three trials did the difference reach statistical significance (the 3 week outcome in the sacroiliac joint trial). The measure used for clinical significance here was 2 points on a 0-10 scale of pain, or 20mm on a 100mm visual analogue scale, but at no point did RFD achieve the lower level of 1 point set by NICE in NG59.[3]

The data from NG59 comparing acupuncture with no acupuncture controls (the closest equivalent comparison to the current trials of RFD) gave a pooled result at less than 4 months of more than 60% greater than the best outcome recorded in these trials of RFD. A result that was both statistically significant and clinically relevant by the standards used in NG59, although it would not have reached the standard set in these trials.

So what is RFD, and why am I drawing attention to this? RFD is a method of burning nerves, and the idea is that by denervating a pain source in the spine you might achieve sustained pain relief in chronic back pain. The typical targets are facet joints, sacroiliac joints and intervertebral joints. The radiofrequency term is unnecessarily confusing since the method uses electrical pulses at about 5000Hz rather than electromagnetic radiation in the radiowave spectrum. The latter stretches roughly from 3×103Hz to 3×109Hz equating respectively to wavelengths from 100km to 1mm, but that’s enough physics for now. Basically the high frequency electrical pulses cause a heating effect at the tip of the RFD probe and it typically reaches 80 degrees C, which coagulates the tissues at the tip.

Isn’t burning nerves a bit of an archaic technique? Yes it is, and in principle modern pain medicine tends to try to avoid neurolytic treatments. Damaging nerves can cause neuropathic pain in some individuals, and the nerves can grow back anyway.

Why was it recommended in NG59? This decision was controversial because the guideline development group (GDG) for NG59 recommended RFD based on quite limited data from very small trials, and the current Cochrane review clearly concluded that the evidence was insufficient to recommend it.[4] The decision to recommend RFD and recommend against acupuncture was also controversial because of potential conflicts of interests of interventionists on the GDG and how these were addressed.[5]

In reviewing the data on RFD used by NG59, I discovered that there was quite disproportionate weighting given to one particular trial despite it only having 20 patients per group (Tekin 2007 [6]). The reason for this is the meta-analytic software favours trials with low standard errors.


K.16.1 from Appendices K-Q of NG59

Anyway, I thought I would take a closer look at this paper, and discovered that the control group dropped from 6.8 to 4.3 on a 0 to 10 pain score from pre- to post-procedure. The slightly funny thing about this was that the control procedure involved exactly the same intervention as was used to determine eligibility for the trial – a diagnostic medial branch block ie a local anaesthetic block to the nerve that would then be coagulated or burnt in the active (CRF) group. In order to get in the trial the patients had to have a reduction in pain score of 50% or more, yet the control group who went on to have the same procedure again only dropped by about 37% (see Table 2 from Tekin 2007 below).


Table 2 from Tekin 2007

Well it all just goes to show that small trials are unreliable, but what should we do now? We should ask the centre that conducted the guideline (the National Guideline Centre hosted by the RCP) to perform an urgent review on the grounds of safety. As it stands NG59 has all but stopped NHS acupuncture for back pain and is likely to result in a vast increase in the use of RFD, which now we see doesn’t actually do anything worthwhile for patients, but may boost the Maserati-purchasing power of certain interventionists.

References
1.   Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA 2017;318:68–81. doi:10.1001/jama.2017.7918
2.   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
3.   NICE guideline on low back pain and sciatica in over 16s: assessment and management. https://www.nice.org.uk/guidance/ng59. 2016.
4.   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
5.   Cummings M. NG59 used different levels of evidence for conventional interventions compared with those for acupuncture and may not have adequately addressed personal financial COIs of the GDG chair. BMJ. 2017;356. http://www.bmj.com/content/356/bmj.i6748/rr-6
6.   Tekin I, Mirzai H, Ok G, et al. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain;23:524–9. doi:10.1097/AJP.0b013e318074c99c


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, or by whether or not it is recommended in national guidelines.

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.


Why not needles for OA – no steroid, just the needles!

30 May, 17 | by Dr Mike Cummings

This piece has been stimulated by a recent publication in JAMA evaluating the use of regular intra-articular corticosteroid injections for symptom management and cartilage volume in osteoarthritis (OA) of the knee.[1] Previous research had suggested that the inflammatory process in the knee was associated with both pain and progression of cartilage loss, however, this trial clearly demonstrated a greater loss of cartilage after two years of 3 monthly intra-articular triamcinolone injections compared with the same frequency of saline injections.

It seems pretty clear then that we should avoid long-term use of intra-articular steroid within the knee and probably other synovial joints. Previous research, also published in JAMA, indicates that steroid can also have a negative impact in the long term on lateral epicondylalgia.[2] Furthermore, a systematic review of the effects of local corticosteroid on tendon clearly concluded that the impact was negative both in vitro and in vivo.[3]

In shoulder pain it does not seem to matter whether or not the steroid is injected into the presumed target based on imaging, or whether it is injected into the buttock.[4] Moreover, given the anatomical vulnerability of the human supraspinatus tendon and its propensity for self destruction with age,[5] combined with the known negative effects of steroid on tendon, it looks as though we should avoid steroid in the shoulder too.

So what do we do if we do not inject steroid into our peripheral sources of musculoskeletal pain? We can try injecting other things I guess. Diclofenac, botulinum toxin or maybe normal saline – the latter seems to do very well when used as a control procedure in trials, in terms of the change from baseline. Having been brought up to accept steroid injection as a standard conventional procedure, it was a major surprise to find that needles alone (dry needling or local acupuncture) in tender muscle appeared to be highly effective.[6] Having got over this surprise I was guided through the process of my first systematic review to find that virtually none of the trials of needling and injection therapies in myofascial trigger point pain demonstrated superiority for any individual technique.[7] Indeed, saline injection (the intended control procedure) proved superior in most outcomes of one particularly good quality trial.[8]

Despite saline injection being no less effective in terms of pain relief than an ‘active’ comparator, and being associated with clinically meaningful changes from baseline in trials, we do not use it in practice. Well it has not been tested in a double blind randomised controlled trial… but what would we use in the control group of such a trial? Perhaps the needle without an injection. Then we have the challenge of blinding the practitioner, and we are getting closer to the dilemma of acupuncture research.

Acupuncture needles are less traumatic than hypodermic needles, and carry no risk related to the injected substance. They also carry less from the outside of the organism (skin flora and contaminants) into the internal environment because they lack the hollow bore of a needle for injection. In general we avoid needling into joint spaces with acupuncture needles despite the reduced theoretical risk of carrying in bugs from the outside. The best quality evidence for acupuncture in chronic pain related to osteoarthritis demonstrates and effect size (standardised mean difference) of 0.26 over sham acupuncture (minimal needling in the biggest trials) and an effect size of 0.57 over no acupuncture controls (waiting list, usual care, or guideline-based conventional care).[9] For comparison, topical non-steroidal anti-inflammatory drugs have an effect size of 0.4 over placebo and oral preparations range from 0.29 to 0.44.[10] So 0.57 looks pretty good if you don’t mind buying a bit of the relatively safe context of acupuncture, or if you prefer something more potent you might go for oral opiates which come in at 0.78… but we all know the path from there on, and it does not look so rosey!

Well I would go for the needles, probably with a little umph added from electrical impulses as Jorge Vas did in 2004,[11] with an effect size of 1.21 (this was an outlier in the Vickers IPDM,[9] but the only trial to use electroacupuncture (EA) to muscles around the knee compared with non-penetrating sham EA).

References
1.   McAlindon TE, LaValley MP, Harvey WF, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA 2017;317:1967–75. doi:10.1001/jama.2017.5283
2.   Coombes BK, Bisset L, Brooks P, et al. Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial. JAMA 2013;309:461–9. doi:10.1001/jama.2013.129
3.   Dean BJF, Lostis E, Oakley T, et al. The risks and benefits of glucocorticoid treatment for tendinopathy: a systematic review of the effects of local glucocorticoid on tendon. Semin Arthritis Rheum 2014;43:570–6. doi:10.1016/j.semarthrit.2013.08.006
4.   Ekeberg OM, Bautz-Holter E, Tveitå EK, et al. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ 2009;338:a3112. doi:10.1136/bmj.a3112
5.   Vincent K, Leboeuf-Yde C, Gagey O. Are degenerative rotator cuff disorders a cause of shoulder pain? Comparison of prevalence of degenerative rotator cuff disease to prevalence of nontraumatic shoulder pain through three systematic and critical reviews. J shoulder Elb Surg 2017;26:766–73. doi:10.1016/j.jse.2016.09.060
6.   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
7.   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
8.   Frost FA, Jessen B, Siggaard-Andersen J. A control, double-blind comparison of mepivacaine injection versus saline injection for myofascial pain. Lancet 1980;1:499–500.pm:0006102230
9.   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
10.   Birch S, Lee MS, Robinson N, et al. The U.K. NICE 2014 Guidelines for Osteoarthritis of the Knee: Lessons Learned in a Narrative Review Addressing Inadvertent Limitations and Bias. J Altern Complement Med 2017;23:242–6. doi:10.1089/acm.2016.0385
11.   Vas J, Mendez C, Perea-Milla E, et al. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ 2004;329:1216.pm:15494348


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, or by whether or not it is recommended in national guidelines.

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.


 

TENS and acupuncture appear cost-effective in knee osteoarthritis

9 Mar, 17 | by Dr Mike Cummings

Figure 3 from Woods B et al PLoS One 2017[1]

This figure may seem familiar to some who follow big data in the acupuncture field. It comes from another big project at the Centre for Health Economics, University of York.[1] It is effectively a repeat of their first large network meta-analysis (NMA) that included acupuncture and sham acupuncture in knee osteoarthritis (OA),[2] but this time replacing pain outcomes with health-related quality of life in the form of the EQ-5D aka Euroqol.

There are also overlaps with Saramago et al from 2016,[3] which I wrote about on this blog under the title Quality sham. This paper by Woods et al narrows the view from chronic pain to OA knee alone and extends the analysis to a full cost comparison of non-pharmacological interventions.

This is a thorough piece of work from a well-recognised centre. Whilst data for some interventions was limited, the data for acupuncture and muscle strengthening exercise for example appears fairly reliable; that is, the confidence intervals are tight and the point estimate consistent in both analyses illustrated in the figure above. In total the NMA included 88 RCTs (randomised controlled trials) and 7507 patients.

I suppose the major limitation of this analysis is that there was only data available to calculate outcomes at 8 weeks ie after a course of treatment rather than in the long term. Woods et al cover this aspect in their discussion and put forward an argument for positive commissioning decisions rather than waiting for more evidence.

In terms of EQ-5D outcomes, acupuncture appears to do well, but costs of performing a course of treatment must also be taken into account. When this is done, TENS is the most cost effective intervention, coming in at £2690 per QALY (quality adjusted life year) versus usual care. When only trials with a low risk of selection bias were considered the effect size of TENS dropped and it then came in at £6142 per QALY versus usual care. In this analysis acupuncture then became cost effective at £13 502 versus TENS.

I should note that when all non-pharmacological interventions are considered TENS and acupuncture are the two most cost effective. In the latest clinical guideline from NICE on osteoarthritis (CG177)[4] TENS is recommended, but acupuncture is not.

References
1.   Woods B, Manca A, Weatherly H, et al. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One 2017;12:e0172749. doi:10.1371/journal.pone.0172749
2.   Corbett MS, Rice SJC, Madurasinghe V, et al. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage 2013;21:1290–8. doi:10.1016/j.joca.2013.05.007
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
4.   NICE guideline update on osteoarthritis: the care and management of osteoarthritis in adults. http://guidance.nice.org.uk/CG177. 2014.


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, or by whether or not it is recommended in national guidelines.

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.


 

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, or by whether or not it is recommended in national guidelines.

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


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, or by whether or not it is recommended in national guidelines.

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.


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

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


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, or by whether or not it is recommended in national guidelines.

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.


 

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


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, or by whether or not it is recommended in national guidelines.

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.


 

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.


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, or by whether or not it is recommended in national guidelines.

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.


 

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.


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, or by whether or not it is recommended in national guidelines.

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 & 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.


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, or by whether or not it is recommended in national guidelines.

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.


 

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