Segmental EA falls short in ovulation induction

…in women with polycystic ovarian syndrome (PCOS)

This blog was first published on 18th November 2017 on

affection beautiful blur couple
Photo by Pixabay on

Finally I have come to address this topic, some months following publication of an eagerly awaited (at least by me) large clinical trial.[1] I have been a colleague and friend of the second author (ES-V) since proofreading her PhD thesis over 20 years ago. In those days I focussed solely on muscle so any suggestion of acupuncture being used to influence visceral function or blood flow was a bit of a conceptual stretch for me. After all my needles were going directly into the target that I wanted to influence, and I was just about comfortable with the idea that the needle alone actually did something useful without the need for injecting a drug. So the idea that acupuncture or electroacupuncture could have any useful effect through indirect influences only really arose when I read Lisa’s thesis.

Her early work stimulated interest in the use of acupuncture in fertility and augmented reproduction,[2,3] although the subsequent plume of clinical research that occurred in this field seemed to go a little off course from a basic science perspective, with an unwarranted focus on embryo transfer as part of IVF.[4] Lisa observed this, but continued with her research path, which was by then on PCOS. She clearly showed that segmental electroacupuncture (EA) could have positive influences on the condition, both in terms of hormonal and metabolic markers, and apparently in terms of ovulation rates.[5,6]

Lisa regularly runs research updates for the BMAS, and we were all excited to hear of her involvement in this huge clinical trial in China on women with PCOS. With 1000 women to be randomised and treated the trial was a considerable undertaking, and several years passed with no news. Then on the 27th June 2017 the results were out… clomiphene was nearly twice as good as segmental EA, and segmental EA was no better than a very minimal non-segmental sham.

Figure from Wu et al JAMA 2017 [1]

It did not seem to make sense from the basic science perspective! The numbers were big enough to power the comparison with sham (assuming similar size effects to those we see in clinical trials of chronic pain). The intervention appeared sufficient in neurophysiological terms, to generate the effects that had been demonstrated in the basic science experiments that had led up to this trial. Yes it was a penetrating sham, but the physiological stimulus of the sham intervention would not have generated any effect in the laboratory in terms of somatovisceral reflexes. In the clinical realm, with conscious humans, sham always seems to have a substantial context effect, but still I would have expected some physiological effect from the segmental EA.

Well there was a difference between real and sham EA in terms of adverse events. In the segmental EA group the rate of diarrhoea was 3 times that in the sham EA group, perhaps indicating an excess effect in somatovisceral reflexes in a small proportion of women. It should be noted that the absolute rate of diarrhoea was low at 1.6 and 5%, in sham and real segmental EA respectively.

The primary outcome was live birth rate. This is the most valid outcome for trials of this nature, but it is not the same as ovulation induction of course, so it is not a direct measure of the putative physiological effect of segmental EA. This could add noise to the statistics, but even so, there was not even a trend in favour of segmental EA.

The slightly curious thing is that both acupuncture groups seemed to substantially outperform metformin, which, in a large comparative trial with clomiphene resulted in a live birth rate of just 7.2%.[7] The populations are not easily comparable though as there were notable differences in BMI that would favour acupuncture. The Chinese women were normal weight compared with an average BMI of about 35 in the metformin group in the prior comparative trial, and BMI is inversely related to outcome.[8] Could that explain the difference between 7.2 and 15.4%? Well frankly, I’m afraid it probably can!

So where does that leave the acupuncture in the fertility arena? There is little or no high quality clinical data to support its use, just a lot of experimental data that did seem encouraging, although the results of this trial should give pause to the assumptions of advocates that anything demonstrated at the bench should automatically imply useful effects at the bedside.

For now at least we must encourage women with PCOS to consider clomiphene before acupuncture for ovulation induction.


  1. Wu X-K, Stener-Victorin E, Kuang H-Y, et al. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome. JAMA 2017;317:2502. doi:10.1001/jama.2017.7217
  2. Stener-Victorin E, Waldenström U, Andersson SA, et al. Reduction of blood flow impedance in the uterine arteries of infertile women with electro-acupuncture. Hum Reprod 1996;11:1314–7.
  3. Stener-Victorin E. Reproductive medicine: Research projects in acupuncture. Acupunct Med 1998;16:80–2.
  4. Carr D. Somatosensory stimulation and assisted reproduction. Acupunct Med 2015;33:2–6. doi:10.1136/acupmed-2014-010739
  5. Stener-Victorin E, Maliqueo M, Soligo M, et al. Changes in HbA1c and circulating and adipose tissue androgen levels in overweight-obese women with polycystic ovary syndrome in response to electroacupuncture. Obes Sci Pract 2016;2:426–35. doi:10.1002/osp4.78
  6. Johansson J, Redman L, Veldhuis PP, et al. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab 2013;304:E934-43. doi:10.1152/ajpendo.00039.2013
  7. Legro RS, Barnhart HX, Schlaff WD, et al. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med 2007;356:551–66. doi:10.1056/NEJMoa063971
  8. Legro RS, Zhang H, Eunice Kennedy Shriver NICHD Reproductive Medicine Network. Letrozole or clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med 2014;371:1463–4. doi:10.1056/NEJMc1409550

Declaration of interests MC

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

This blog was first published on 27th July 2017 on

I subsequently attended the Spanish Pain Society conference (#SEDPalma2018) and there was a whole session devoted to this paper and why it did not apply to the way these specialists used the technique :-/.


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.

…at no time point did the addition of RFD reach clinical significance for the primary outcome

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.


  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. 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.
  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 MC

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

This blog was first published on 30th May 2017 on


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 push in fewer bugs from the skin…

…and there is no reason for them to go inside the joint

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).


  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–
  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;

Declaration of interests MC

TENS and acupuncture appear cost-effective in knee osteoarthritis


This blog was first published on 9th March 2017 on

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.

…when all non-pharmacological interventions are considered TENS and acupuncture are the two most cost effective, but NICE only recommends TENS


  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. 2014.

Declaration of interests MC

Precision needling in myofascial pain

This blog was first published on 9th February 2017 on

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.

I became less and less convinced that precision of trigger point needling would be validated

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!


  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 MC

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

This blog was first published on 26th January 2017 on At the time I was in Cape Town on holiday, trying to get a rapid response published to the NG59 summary in the BMJ. It was critical of NICE, and I was negotiating over content with a legal expert from BMJ! The response took three weeks to go up, by which time it was too late to be noticed. In the meantime I created a bit of a storm with this blog, and my use of the term ‘old sceptic blogger’ in the title. This is (mostly) the version edited by BMJ.


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 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 us had ever been in a position to try to help parents with a baby that 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)


  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 MC

Is acupuncture pseudoscience?

This blog was first published on 30th December 2016 on – on reviewing the Wikipedia page today, and the talk pages behind it, I see little has changed, but there has been a lot of talk behind the scenes ;-).


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 cyberbullying (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.

‘plain or scary looking bespectacled geeks and science nuts’

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.

Declaration of interests MC

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

This blog was first published on 30th Novenber 2016 on


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.


  1. NICE guideline on low back pain: early management of persistent non-specific low back pain. 2009.
  2. Low back pain and sciatica in over 16s: assessment and management. 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. 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]. 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. 2014.
  16. Percutaneous tibial nerve stimulation for faecal incontinence Interventional procedures 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. 2016.

Declaration of interests MC

Quality sham

This blog was first published on 13th October 2016 on

Saramago-F1-2016-1024x408Comments 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.


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’.


  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.
  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 MC


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

This blog was first published on 4th September 2016 on


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.

Madsen et al got away with pooling data from acute and chronic pain, from surgical pain to headache to arthritis…

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?


  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

Declaration of interests MC