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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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.