“First, do no… Placebo? How NICE got it Wrong on the Ethics and the Science.

Last April, I wrote a blog post reporting on how a committee under the UK’s National Institute for Health and Care Excellence (NICE) had released a draft of a review they had done on treatments for low back pain. They had decided they were going to recommend reversing the decision they made in 2009 to add acupuncture to the list of therapies paid for under the U.K.’s national healthcare insurance system (NHS). They were doing this, they said, because the evidence did not support keeping acupuncture on that list.

The ANF registered as a stakeholder organization and, together with others in the acupuncture community, sent in an extensive list of mistakes the NICE committee had made in their review of research and asked them to reconsider their findings. On November 30, 2016, NICE released the final recommendations standing by their draft report and recommending that NHS doctors do not offer acupuncture for managing low back pain with or without sciatica.

If the impact of this committee’s recommendations weren’t so serious, it might be funny; a comedy of errors by a committee clearly without a clue about how to review acupuncture’s value. Instead of actually studying how effective or ineffective acupuncture had been for low back pain patients treated under the NHS since 2009, they decided instead to review research from various, unrelated sources.

This committee then made an ethically and scientifically bad decision about what they would consider in making their recommendation. They actually decided that they could ignore all evidence of acupuncture’s clinical effectiveness if they did not believe the studies they selected showed “real’ acupuncture to consistently outperform “sham” acupuncture. You read that right: All evidence of acupuncture’s clinical effectiveness and cost effectiveness meant nothing to them if they did not find real acupuncture’s efficacy being above a level they had established.

The ANF is in the process of putting together several resources that go into detail about this development including a fact-filled video by ANF VP Mel Hopper Koppelman. However, I wanted to emphasize a few things here to put this new recommendation into perspective. At the end of this post you will find materials to support all the points I make here. Keep checking our website for more updates.

1. NICE found acupuncture to be more effective for pain and function as well as quality of life than conventional care in treating low back pain with or without sciatica:

2. NICE found acupuncture for low back pain to be cost effective.

3. A top U.S. research agency found real acupuncture clearly did outperform sham for low back pain in contradiction to NICE’s findings. They also found no other therapy outperformed acupuncture for chronic low back pain and that acupuncture was more effective than drugs.

Why NICE’s Decision to Ignore Clinical and Cost Effectiveness Violates Medical Ethics.

The most common treatments for low back pain are drugs that have a relatively high rate of side-effects. When we consider the potential harms of “conventional care” for low back pain, we are talking about drugs that literally kill many thousands of people a year and cause harm to millions more. If a therapy is shown to provide greater improvements in pain and/or quality of life while also causing less harm than these higher risk drugs, it is an ethical imperative to promote the safer therapy.

The original idea behind sham studies in acupuncture was to try to provide a placebo-like control for the active acupuncture therapy to see what degree of the clinical benefits people experience with acupuncture were due to real effects vs. placebo. But over time, it has become clear that the vast majority of attempts at placebo controls in acupuncture trials were not at all like giving a placebo in a drug trial but more like doing another type of acupuncture or acupressure. That is why experts for years now have been saying these trials should no longer be considered.

The evidence is clear that acupuncture has a better benefit to harm ratio for treating low back pain than conventional therapy. The principal of striving for the best benefit to harm ratio is found in the popular medical saying to “First, do no harm”. There is no similar saying that says “First, do no placebo”. The NICE committee that recommended against acupuncture was more concerned about preventing the possibility of placebo than of providing a more effective and less harmful treatment. Shame on them.

Supporting materials:

Quotes from February NICE 2016 draft: “Low back pain and sciatica: Management of non-specific low back pain and sciatica. Assessment and non-invasive treatments”

Recommendation 13. “ Do not offer acupuncture for managing non-specific low back pain with or without sciatica” page 493

M.B. – The quote below is the rational they gave for ignoring clinical effectiveness evidence if they did not find real acupuncture to outperform sham.

“The GDC first discussed the necessity of the body of evidence to show specific intervention effects, that is, over and above any contextual or placebo effects. It was therefore agreed that if placebo-controlled evidence (or sham acupuncture) is available, this should inform decision making in preference to contextual effects, but that the effect sizes compared with usual care would be important to consider if effectiveness relative to placebo, or sham, has been demonstrated.” page 493

M.B – This next quote shows that NICE did indeed find clear evidence that acupuncture caused “important benefits” from “a number of studies”.

“For the usual care comparison in people with low back pain without sciatica, the GDG agreed that clinically important benefits in terms of improvements in quality of life were observed in evidence from a number of studies.” And further: “The results were similar for the mixed population of low back pain with or without sciatica, with clinically important benefits were demonstrated for quality of life (EQ5D and most of the SF-36 domains) as well as for pain and function (RMDQ) in the short term, but not for EQ-5D and pain in the longer-term. “ page 493

M.B. – This following quote references the cost per QALY (quality adjusted life year). NICE sets a threshold for the cost of a QALY at £20,000 to £30,000. If a therapy can provide 1 QALY for less than £20,000 to £30,000, it is considered cost effective. Acupuncture was found to provide 1 QALY at £3,598, more than 5 times below that threshold in all measurements at no worse than a 97% probability. Now, of course, the only way a therapy could be found to be cost effective is if it is also clinically effective but, again, this committee decided from the onset that clinical effectiveness could be ignored.

“This within-trial analysis found that the addition of acupuncture to usual care increased costs and improved health (increased QALYs) with an incremental cost-effectiveness ratio of £3,598 per QALY gained. Uncertainty was not reported in the analysis using EQ-5D but in the analysis using SF-6D (which had a similar ICER) the probability of acupuncture being cost effective was around 97%”. page 495

M.B. – Here is a link to my blog post about the review published by the AHRQ whose findings contradict those of the NICE committee. This post also contains a link to the full review.

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