A new guideline on the care and management of osteoarthritis has recently been published by the National Institute for Health and Clinical Excellence, and makes wide-ranging and authoritative recommendations. The guideline states that there is insufficient evidence to recommend acupuncture. There appears to be three areas where the guidelines may have not used the available evidence in the most appropriate manner. First, data on the long-term effectiveness of acupuncture may have been misinterpreted. Second, the specific rejection of electroacupuncture indicates a restricted understanding of acupuncture as a treatment, and is based on a cost-effectiveness analysis which may not be ideal. Third, the cost-effectiveness calculations used comparisons with sham acupuncture (“placebo”) when comparison with standard care would have been more appropriate. The guideline may therefore lead some patients with osteoarthritis to miss out on a treatment that may be effective for them.
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The National Institute for Health and Clinical Excellence (NICE) guideline on osteoarthritis (OA) grapples with a mammoth task, reviewing not only current opinion on the aetiology and epidemiology of OA but also summarising the literature on 16 different interventions.1 It achieves major success in drawing together the diverse evidence and interpreting it with common sense. The guideline contains much wisdom, particularly a recognition of the role of self-care and the need to take a broad approach to the management of pain, as well as tailoring advice to the individual. There is little doubt that the changes in the “bottom line” treatment recommendations deserve to influence practice: exercise should be routinely recommended for early management; the safety of paracetamol is confirmed; topical non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for the first time; and treatment with NSAIDs or cyclo-oxygenase-2 inhibitors should be reserved for second-line care.
In view of the down to earth approach of the authors, it is disappointing that acupuncture finally gets a “thumbs down”. The guideline interprets the available evidence on acupuncture with surprising caution, and expresses considerable doubts about its cost-effectiveness. It is argued here that the evidence has not been interpreted in a manner that is appropriate for acupuncture. Since the guideline could influence patients’ choices for self-care, and is likely to influence the direction of future clinical studies, it seems important to discuss those aspects of the guideline that are contentious.
The author writes from the perspective of an acupuncturist and researcher familiar with the literature on acupuncture for knee OA23 who was invited to attend a meeting of the Guideline Development Group. This paper discusses three of the NICE conclusions that could be open to different interpretations, and a response is published in the accompanying paper.4
THE LONG-TERM EFFECTIVENESS OF ACUPUNCTURE
The NICE guideline summary of the evidence on long-term effectiveness states: “At 26 weeks, there are few studies and overall they do not support a benefit over placebo”.
It is true that there are few long-term studies — only three, in fact, all for OA knee.5–7 But their results combined in a meta-analysis do show that acupuncture has a significant effect over placebo: “Acupuncture remained significantly superior to sham acupuncture at long-term outcome for both pain and function in three studies which are all higher quality”.2 In fact, the guideline actually includes those results: WOMAC pain long term p<0.05 in Table 6.57, and WOMAC function long term p<0.05 in Table 6.59; which seems to contradict their statement.
It is worth noting, in passing, how few interventions for OA do have evidence on their long-term effectiveness, including some of those they are recommended. Although there is long-term evidence for exercise (though not exercise against placebo), the evidence for NSAIDs is deficient. For topical NSAIDs (recommended as “core treatment”) the longest study period was 12 weeks, and not a single study followed up patients after the end of treatment. For oral NSAIDs, only two studies used study periods as long as 6 months. And of course, drugs have the disadvantage that patients have to continue to take their medication, whereas two of the three acupuncture studies only gave the initial course of treatment.
So it seems that the evidence on acupuncture is interpreted rather more conservatively than for other interventions.
THE CONCLUSION ON ELECTROACUPUNCTURE
The single, main conclusion of the section on acupuncture is this: “Electroacupuncture should not be used to treat people with osteoarthritis”.
This statement comes as a surprise for anyone who knows the literature: the studies of Vas8 and Berman5 suggest that electroacupuncture (EA) is highly effective, and indeed likely to be rather more effective than the manual acupuncture used in other studies.
The guideline group considered acupuncture and EA as separate treatments, which is odd. In practice, many acupuncturists progress to using electrical stimulation of needles for patients who have not responded to manual acupuncture. The only sensible approach is to regard acupuncture and EA as part of the same therapy. The reviewers may have been diverted by different descriptions in the titles of papers — some of which state acupuncture whereas others specify EA.
The conclusion against EA was based on a single study — that of Sangdee et al. This was a four-arm study comparing all possible combinations of EA, diclofenac, sham transcutaneous electric nerve stimulation and placebo drug.9 The conclusion of that paper reads: “EA is significantly more effective than placebo and diclofenac in the symptomatic treatment of OA of the knee in some circumstances. However, the combination of EA and diclofenac treatment was no more effective than EA alone”.
That seems a fairly convincing conclusion to the study, so how did that turn into the negative conclusion in the guideline? The answer is that the conclusion was based on the cost-effectiveness analysis; and the study by Sangdee was the only one included under the banner “electroacupuncture”. The study by Berman should also have been included here. This brings us to the discussion on the various other deficiencies in the economic analysis.
COST-EFFECTIVENESS OF ACUPUNCTURE AGAINST “PLACEBO”
There are two main problems with the economic analysis, and both seem to arise from a lack of flexibility in applying the standard NICE procedures. The first problem is the choice of placebo for the comparison, and the second is the inappropriate manner of considering the available evidence.
It is usual to compare the cost-effectiveness of drugs against a placebo drug. It is easy to understand the rationale behind this, because this takes into account the “non-specific” or “context” (placebo) effects of the regular medical consultation — mainly expectation and conditioning. But it is not logical to extend the same reasoning to any kind of manual therapy, because this involves extensive contact and interaction between the practitioner and the patient, which are well known to enhance the effect of the actual intervention itself.
Economic evaluations are all about making practical decisions on use of resources, that is, which treatment is most cost-effective for patients. The choice faced by service managers is: “Should we provide acupuncture or continue with usual care alone?” Nobody wants the answer to the question: “Shall we provide a service of acupuncture or placebo acupuncture?” It seems clear, then, that it is best to compare acupuncture with some form of standard care, not with placebo.
The arguments used to justify the use of the placebo arm as the control in economic evaluations of acupuncture were as follows (p. 339):
“The comparator should be placebo rather than the next best alternative because often data comparing the next best alternative are not available, and it is not always clear what the next best alternative is.” In fact, there are good-quality data from studies that compare acupuncture with education alone,5 with usual care,6 or with guideline-based optimal conservative care7 — all of which are realistic alternatives to acupuncture.
“… because these interventions are secondary treatments for osteoarthritis rather than core treatments, and because these treatments generally have very small effect sizes, it may be that a comparison to placebo is optimal.” The first part of this sentence involves circular reasoning — acupuncture is being designated as “secondary” on the results of this economic analysis. And there is evidence to suggest that the effect size of acupuncture for knee OA may be the largest of any conservative intervention for that condition.3
By limiting the economic analysis to placebo-controlled studies, the NICE group seems to have overlooked another piece of standard advice: “All relevant comparators for the technology being appraised need to be included in the analysis”.10
There is one clinical trial of the cost-effectiveness of acupuncture for OA that seems ideal for the purpose.11 It investigates acupuncture compared with a waiting list of primary care patients with knee or hip pain. It is a good-quality pragmatic study with an extensive economic analysis, and although it had not been formally published at the time of the report, the data were provided by the authors.
This study was rejected as evidence for two reasons. (1) It is NICE policy not to use cost-effectiveness data generated outside the NHS. In fact, the patients, setting, and treatment costs in the study seem remarkably similar to primary care in the UK. (2) It is NICE policy to consider only the health service perspective, not the societal perspective, on costs. This is understandable, but the health service costs are given separately in the published report.11 In fact, the separated data indicate that the figure for cost-effectiveness is conservative — non-treatment costs were actually higher, by chance, in the acupuncture group. The study is also conservative in only assessing the effect over 3 months; if some of the effects lasted a year — and there is evidence that they do — the cost-effectiveness would be correspondingly higher.
For all these reasons, then, there are good reasons to give this study considerable weight in drawing conclusions about acupuncture. The cost-effectiveness of acupuncture was estimated to be €17 845 per additional quality-adjusted life-year (QALY), which is within the limit of normally acceptable costs. The NICE guideline summarises the study: “This suggests that acupuncture along with usual care is cost effective compared with usual care alone for 3-month time period, from the societal perspective. The cost year was not reported in the study”.
But instead of using the actual measured costs from this study, the guideline relied more on estimates made using formulae for converting WOMAC scores into QALYs, and “guesstimates” of costs, and restricted to studies of acupuncture against sham acupuncture. The guideline stated: “The incremental cost-effectiveness ratio for acupuncture is often higher than the threshold of £20–30K per QALY that is typically quoted as what the NHS can afford. However, there is considerable uncertainty about this estimate because of the limitations in the data. However, electro-acupuncture was consistently above the threshold of cost effectiveness”.
Apparently forgetting about the single reliable study from Germany, the conclusions of this section are: “The results for acupuncture are varied with the intervention appearing possibly cost effective compared with placebo. However, electroacupuncture appears unlikely to be cost effective”.
The OA guideline has been rather a “test case” for NICE, as it includes a specific section on acupuncture. Some sentences suggest that the details of acupuncture research had not been fully grasped — which is hardly surprising considering its intricacies, but nevertheless disappointing for patients who want guidance on whether to use acupuncture.
For example, “The studies … mostly using a comparison of sham acupuncture where a needle does not pierce the skin” (actually, only three of 15 studies), and “Trial participants cannot feel a difference between acupuncture and electro-acupuncture so this comparison should be well controlled” [sic].
The discussion in this paper does not amount to a total rejection of the main conclusion of the guideline about the place of acupuncture in the NHS: “There is not enough consistent evidence of clinical or cost-effectiveness to allow a firm recommendation on the use of acupuncture for the treatment of osteoarthritis”. When given with the usual 20- to 30-minute appointments, acupuncture will be of borderline value to the NHS. However, recent reports of clinics that treat several patients simultaneously suggest that acupuncture can be delivered more efficiently within the NHS,12–14 and this is an important area for research.
Box 1 Suggested revised conclusion and recommendation
The evidence on effectiveness of acupuncture for osteoarthritis is promising though not conclusive. The evidence also suggests that it is safe, and marginally cost-effective for the NHS in comparison with other available treatments. Patients who wish to use acupuncture as part of their self-care strategy should be encouraged to do so.
Unfortunately, the NICE guideline gives the reader a distinctly negative impression of acupuncture. This could be against patients’ best interests if, as a result, they choose to avoid a treatment which may be effective for them. The current balance of evidence is that acupuncture is effective for knee pain and patients should not be discouraged from trying it if other treatment has failed. A more appropriate overall conclusion and recommendation is suggested in Box 1.
Competing interests: The author is employed by the British Medical Acupuncture Society, a not-for-profit organisation, as editor of this journal.
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