The NICE Sham-bles

Dr. Carl Clarkson • April 25, 2020

For at least 18 months the rumours had circulated; acupuncture was to be removed from the LBP NICE guidelines. Sure enough, March 2016 saw the draft guidelines confirm it. We were given an opportunity to make comments on the recommendations put forward, and after duly obliging, it was disappointing but fully expected that the definitive guidelines, published late in 2016, persisted with the assertion that not only should acupuncture be removed, but future research in the area should not continue. The fallout from this decision has inevitably led to passionate arguments for and against; a whole village was razed to the ground in protest, whilst those in support of the recommendations built an underground network of small, but well maintained, garden projects.

Worryingly, health professionals have frequently failed to question the findings, and in several incidences, health managers have failed to scrutinise these controversial instructions before attempting to implement the NICE recommendations. Given the potential detriment to LBP services, and in an attempt to see more over-ground garden projects, I felt it was time to put forward some points which should be considered before omitting acupuncture from a service. Whilst my thoughts on whether it should be included are obvious, I thought it pertinent to put forward why the exclusion of acupuncture is completely bizarre. As usual, my approach will be respectful, and I welcome any comments that you may have, so please feel free to get in touch without the fear of being ridiculed, belittled or given short shrift (however if you are looking for humiliation, I do provide a service, but you have to head to my OTHER website). I have put page numbers for the full guideline for ease of cross-reference throughout this blog! To begin, let us look at why acupuncture has been removed, before we do a simple compare and contrast to the non-invasive interventions that have been included (SPOILER ALERT: There is less consistency in the inclusion and exclusion criteria than there is in a Labour Party election campaign).

Acupuncture exclusion rationale

‘The GDG discussed that despite a large number of trials reporting pain as an outcome and the inclusion of trials with large numbers of patients for these and other outcomes, there was still not compelling and consistent evidence of a treatment-specific effect for acupuncture (p.497).’

As the guideline puts forward (p.497-498), out of the 32 studies included (p.459), literature consistently shows acupuncture groups to outperform non-acupuncture groups, but not better than sham/placebo arms (check this meta-analysis for a different take on chronic pain data). NICE conclude that because there is a failure to consistently demonstrate acupuncture to be better than placebo approaches, acupuncture should be omitted. Put simply, if a three-armed study demonstrated that two groups outperformed a third, but there was no difference between the two higher performing groups, these findings should be interpreted as the intervention is inappropriate for inclusion. That’s right, even if this observation is noted numerous times, in numerous studies, with numerous groups, it was considered inappropriate. Essentially this guideline is saying, we know there is an intervention that consistently performs better than others, but we are going to INSIST YOU NEVER EVER DO IT, because its mechanism of action is unclear. But, as our grandmothers and theirs before them have handed down in wise words, an inclusion criteria is an inclusion criteria. If a guideline wants to include / exclude interventions based on a specific thing, then we can accept that. And in any case, an inclusion criterion is there specifically so we know that everything that is included in that study has the same characteristic. I mean, it’s not as if people are applying one rule for acupuncture, and then different rules for other interventions….

Included interventions

If the excluding of acupuncture is based purely on that it has not been shown to be more effective than a placebo, it is logical to assume that the authors of the LBP NICE guideline are not saying it is ineffective, but that the effects are down to an unknown variable, or as the panel put it, contextual factors. This means that they do not consider contextual factors as a good basis in which to base recommendations, and therefore, any intervention that cannot show benefits above and beyond contextual factors, should not be recommended. It goes without saying this approach should be applied to every intervention that is reviewed. The inclusion / exclusion criteria should not resemble the subjective views of a nightclub bouncer, letting the fashionable ones in and throwing out the ones who don’t fit in with the crowd because their dancing ‘is disturbing other people’ (DISCLAIMER: I don’t know anyone who has been in that situation………)

Strangely, in the eyes of this NICE panel, acupuncture appears to be the enthusiastic dancer. For self-management, exercise, psychological interventions, return to work and MBR, there were either no studies that compared the intervention against a placebo, or, found no difference when compared to a placebo. In other words, there was no way to demonstrate that the above interventions relied upon anything other than placebo to demonstrate benefit. For manual therapy, it’s even better ‘The GDG were aware of the difficulties with providing adequate patient blinding to manual therapy treatments as sham or placebo interventions may have contextual or primary therapeutic effects, which may reduce the differences between groups (p. 456).’ Of course, when they looked at the acupuncture studies, they made sure they looked at the difficulty of blinding……

For exercise, where no studies included in their review were considered to have a placebo arm, the panel make the point that no one exercise approach was considered superior to another. It is also noted that ‘the effect of exercise compared with usual care or self-management could be due, at least in part, to an imbalance of therapeutic attention inherent to such trials and may not necessarily or solely reflect a specific effect (p.306).’ That’s EXACTLY what was reported in several of the included acupuncture studies, and yet, it has been removed from the recommended list. For the MBR recommendation, and what is now likely to be expected by you my avid reader, contradiction reigns supreme: ‘It was consequently not possible to determine exactly which element in this study was responsible for the effects, however, it was considered that tailoring the approach would be reflective of how the treatment would be delivered in clinical practice (p.732).’

In summary, it would appear a significant number (though clearly not all) of the GDG panel considered it essential that an independent variable was responsible for benefits to the patient. Not only does this raise questions around the arrogance of our current understanding of back pain / how interventions work, it completely ignores the glaring evidence that when acupuncture is added to a treatment regime, patients report better outcomes than when acupuncture is not included. To make matters worse, most of the other interventions included in this guideline have not been subjected to the same exclusion criteria, and thus contradiction runs riot. I would put forward that, if we look purely at the placebo argument, acupuncture has just as much merit as all of the other inventions proposed, and given the strength and breadth of literature to support it, clinicians would be well within reason to continue to use it. So, please, take the needle and dance!

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