NG59 used different levels of evidence for conventional interventions compared with those for acupuncture and may not have adequately address personal financial COIs of the GDG chair
Readers of this guideline summary may not be aware of some of the factors affecting the decisions made by the GDG (guideline development group) of NG59. I would like to draw attention to two issues:
1. Different levels of evidence were used for different interventions, with a perceived bias favouring conventional practice
2. Personal financial conflicts of interests of interventionists on the GDG (chair SW and one other member CW) may not have been adequately addressed from the public perspective.
My own declaration of interests is below. I am openly an advocate of the appropriate evidence-based use of acupuncture techniques within conventional medicine after orthodox medical diagnosis. The evidence-based medicine (EBM) approach I take follows the broader description of Sacket et al in this journal 20 years ago.
So what are the different levels of evidence used in NG59? Acupuncture was required to show a clinically relevant benefit over the context of receiving acupuncture. In reality this means standard needling plus context over gentle needling plus context, not needling versus context of needling. Exercise was compared to no exercise with no context control, which is described as usual care. Exercise improved pain over usual care by 0.74 on a 0-10 VAS (visual analogue scale) of pain at 4 months or less – so it did not reach clinical relevance (1 on a 0-10 VAS), but achieved a positive recommendation. Acupuncture improved pain compared with usual care by 1.61 on the same scale at the same time point but received a negative recommendation.
Exercise was compared to sham exercise in the draft of NG59. Exercise versus the context of exercise achieved no benefit whatsoever, whereas acupuncture (standard needling plus context) achieved a very highly statistically significant benefit over sham (gentle needling plus context) that measured 0.80 on the 1-10 VAS pain. The data on exercise versus sham exercise was subsequently excluded from the analysis, leaving only the comparisons with usual care.
The best data on the efficacy of acupuncture comes from the IPD (individual patient data) meta-analysis of Vickers et al. There are very highly significant benefits of standard acupuncture plus context over gentle needling plus context, although the effect size of this comparison is small. This data was used for one trial in the final guideline, but the analysts used the SMD (standardised mean difference) instead of the MD (mean difference). The GDG put a very negative over interpretation on this error in their summary of evidence. The error is easy to spot. The IDP meta-analysis used ANCOVA which generally increases confidence in the MD. This would increase weighting on Brinkhaus in the meta-analysis and therefore improve the point estimate, rather than reduce it. The error resulted in a reduction, which was interpreted in a negative manner by the GDG.
Now to the COIs (conflicts of interest) in NG59. Two members of the GDG have private practices offering interventional procedures in low back pain,[6,7] but they engaged fully with the GDG discussions over whether or not to recommend these interventions.[2,8–12] When this was specifically questioned NICE responded by saying that both individuals had adequately declared their interests, that Dr Ward's leadership of guideline discussions was unlikely to be influenced by his private work, and that in any event their guidelines were for the NHS and not private practice. The latter point implies that national guidelines issued by NICE have no influence on what patients seek as interventions for back pain in the private sector. I find this hard to believe, and the chair of the GDG for NG59 (Dr Ward) even advertises this position on his private practice website. In addition to this, the reaction of interventionists from the BPS (British pain Society) to CG88 would suggest a perceived link between NICE guidelines and private income – they forced the then president of the BPS, and vice chair of CG88 to resign through a vote of no confidence. CG88 had made a negative recommendation for spinal injections in back pain from 6 weeks to 1 year, and a positive recommendation for less interventional procedures.
1 Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71–2.
2 NICE guideline on low back pain and sciatica in over 16s: assessment and management. https://www.nice.org.uk/guidance/ng59. 2016.
3 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
4 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
5 Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in Patients With Chronic Low Back Pain. Arch Intern Med 2006;166:450. doi:10.1001/archinte.166.4.450
8 NG59 GDG Meeting Minutes 12. https://www.nice.org.uk/guidance/NG59/documents/low-back-pain-and-sciati...
9 NG59 GDG Meeting Minutes 13. https://www.nice.org.uk/guidance/NG59/documents/minutes
10 NG59 GDG Meeting Minutes 17. https://www.nice.org.uk/guidance/NG59/documents/minutes-5
11 NG59 GDG Meeting Minutes 18. https://www.nice.org.uk/guidance/NG59/documents/minutes-6
12 NG59 GDG Meeting Minutes 19. https://www.nice.org.uk/guidance/NG59/documents/minutes-7
13 Price C, Pither C, Stannard C, et al. Members shocked and saddened. BMJ. 2009. http://www.bmj.com/rapid-response/2011/11/02/members-shocked-and-saddened
Competing interests: I am the salaried medical director of the British Medical Acupuncture Society (BMAS), a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. I am an associate editor for Acupuncture in Medicine. I have a very modest private income from lecturing outside the UK, royalties from textbooks and a partnership teaching veterinary surgeons in Western veterinary acupuncture. I have no private income from clinical practice in acupuncture. My income is not directly affected by whether or not I recommend the intervention to patients or colleagues. I have not chaired any NICE guideline development group with undeclared private income directly associated with the interventions under discussion. I have participated in a NICE GDG as an expert advisor discussing acupuncture. I have used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989. My opinions are formed by data that spans the range of quality and reliability, much of which is in the public domain. I have a logical mistrust of the motives of anyone who advertises an interest or hobby in being a ‘Skeptic’, as opposed to using appropriate scepticism within their primary profession, or indeed organisations that claim to promote generic ‘science’ as opposed to actually engaging in it.