This article reports on a highly significant, high-quality randomised controlled trial to determine whether GP referral to a short course (up to 10 individualised sessions) of traditional acupuncture might improve longer term outcomes for patients with chronic low back pain in primary care, and at a cost that would be affordable by the NHS. 241 patients were recruited to the trial with 160 being randomised to the acupuncture group and 81 to the control group which received usual GP care alone. The results indicate that when patients in primary care with low back pain are referred to a BAcC acupuncturist for a short course of treatment, they will, on average, improve over time and show greater improvement than if they had received usual GP care alone. Although the course of acupuncture only lasted around 3 months, their situation improved over time, and continued to improve between 12 and 24 months. The authors' recommendation from this study is that GPs should consider referring patients with low back pain to a qualified acupuncturist.
Introduction As acupuncturists we often see people with low back pain getting better relatively quickly. Yet if you look at the evidence from systematic reviews you could be forgiven for thinking that the evidence just does not make sense. For example, a Cochrane review is relatively equivocal about the benefits of acupuncture. Commentators who compare acupuncture to other interventions for low back pain tend not to rate acupuncture as highly as practitioner experience would indicate. So what is happening here? One possibility is that acupuncturists are simply observing the natural recovery that most patients would be expected to experience after an episode of back pain. Another possibility is that sub-optimal acupuncture is being delivered in the trials that are reviewed. In a systematic review of acupuncture for low back pain, the highest trial quality in methodological terms involved one acupuncture needle inserted once! The ecological validity, a measure of the extent that acupuncture reflects routine practice, of this could be said to be low because very few acupuncturists would treat low back pain at a single session with only a single needle!
Having these concerns in mind and with several colleagues based in York, we set out to discover what would happen if we allowed acupuncturists in a trial to treat in their normal fashion. Our aim was to develop the highest quality of evidence possible while maximising the ecological validity, in order to ensure a fair comparison between acupuncture based on traditional principles and a control group. Moreover, we wanted to follow up patients over a reasonably long time period, we were interested in cost-effectiveness and we wanted to monitor safety and the acceptability of acupuncture to patients. This article describes our endeavours to develop evidence at a high quality level and brings together results from previously published papers in order to tell this story.
The research processes Our first challenge was to conduct some pilot research to get a feel for the area, develop good tools for measuring outcomes and building the basis for a strong collaboration in anticipation of applying for serious funding. First our small group in York conducted a case series with four patients. This was a useful exploratory exercise and we found it possible to work with a local GP who referred patients. We tested out measurement tools, specifically the Short Form (SF)-36 which has a sub-scale for measuring bodily pain. The next step was recruitment of a larger cohort of patients (n=20) and the explicit goal of exploring the feasibility of a large-scale randomised controlled trial. As in the case series of four patients, we allowed the acupuncturists to carry out treatment for these 20 patients in an individualised way, much as they would in their routine practice.
We then experienced a rare stroke of luck. While we were analysing the data in 1999, the Health Technology Assessment (HTA) Programme asked for bids for clinical trials to evaluate acupuncture for chronic pain in primary care. At this stage we had initiated this research activity as a small charity (the Foundation for Traditional Chinese Medicine) but with a big mission. We were in need of a key partner based at a university in order to develop a successful proposal for a major study. Kate Thomas, who was then at Sheffield University, joined our team as Principal Investigator, with the support of specialists in statistics and health economics from her department. This expanded team, which included the local GP, put together a carefully crafted application, with the aim of determining whether GP referral to a short course (10 sessions) of traditional acupuncture might improve longer term outcomes for patients with chronic low back pain in primary care, and at a cost that would be affordable by the NHS. To answer this very practical question, the methodology of choice was a pragmatic, open, randomised controlled trial, as this design was one with high ecological validity. Rather than dictating acupuncturists’ treatment methods, we supported what they considered to be their optimal practice and at the same time collected data on actual treatments for future reference.
Later that year we heard that we had been successful in our application for funding, and the hard work began. We first appointed a trial co-ordinator, Lucy Thorpe, who then spent the next four years managing many of the aspects of running the trial. We sought the requisite approvals for the trial, in particular ethics approval. Over a period of 18 months we recruited to our study 241 patients aged between 18 and 65, all with low back pain of at least four weeks duration but no longer than a year. Certain patients were excluded: those who were receiving current acupuncture treatment; those who had possible spinal disease (for example, carcinoma); severe or progressive motor weakness; prolapsed central disc; past spinal surgery; bleeding disorders (for example, haemophilia); or pending litigation. In the recruitment process, we received referrals from 39 general practitioners who worked at 16 different GP practices in the York area.
After patients consented to enter the trial, various baseline measures were obtained. We had pre-specified our primary outcome measure, which was to be the bodily pain dimension of the SF-36. This yields a pain score of 0 (worst possible) to 100 (best possible), where the self-assessment is of back pain experienced over the previous four weeks. Initially we planned an end-point at 12 months, but after a progress review and analysis of some of the three months’ data, the HTA agreed to fund us to collect data at 24 months. The extra year was designed to explore longer term outcomes and cost-effectiveness, on the basis that potential savings might take time to accrue. For each patient, we recorded whether they believed acupuncture would work for them prior to knowing which treatment they were to receive (more on this later). We also had various secondary outcome measures. At three months, satisfaction with treatment was assessed, including questions on worry about back pain, and about current use of analgesics over the previous month. At 12 and 24 months we collected patient reports of back pain in the previous year. Follow-up was carried out by post, and when this was unsuccessful we sought main outcome data by telephone. We assessed safety by monitoring adverse events reported at each acupuncture session.
As this was to be a randomised controlled trial, we aimed, with the analysis, to estimate the differences between the group randomised to acupuncture and the group randomised to normal GP care. Unusually, the patients were randomised in a ratio of 2:1, and with a required sample of 240 patients, 160 were offered acupuncture and 80 offered normal GP care. The reason for this was to ensure sufficient numbers of patients treated by acupuncture to determine whether there were significant differences in outcome between acupuncturists (more on this later). As this was an open trial, neither participants nor researchers were blind to treatment assignment.
The short course of acupuncture consisted of up to 10 individualised sessions, usually provided within a three-month period. Six acupuncturists, registered with the British Acupuncture Council and with at least three years’ experience, provided the treatment. The first appointments were held in one of three private clinics in York, usually within two weeks of randomisation. All patients remained under the care of their general practitioner and patients in both groups received NHS treatment according to their general practitioner’s assessment of need. During the trial we asked acupuncturists to record on standardised reporting forms the diagnosis and treatment, including any auxiliary therapy. This data is discussed more fully below.
What we found Overall, we recruited 241 patients to the trial between August 1999 and January 200l. After randomisation, there were 160 in the acupuncture group and 81 in the group receiving usual GP care alone. The patients’ mean age was 42 (range 20 to 64) and 38% were male and 62% female. As one would expect, both groups started out the trial with similar levels of severity and duration of pain. For example, both groups had, on average, their most recent episode of back pain lasting for four months, and about half the patients reported more than five previous episodes of back pain.
About the acupuncturists in the trial All patients randomised to acupuncture accepted the referral, and apart from a few for whom their condition had already resolved quickly, patients received treatment from one of the six acupuncturists whose details are provided in Table 1. The protocol allowed for up to 10 treatments per patient, the precise number being agreed between patient and practitioner. A total of 1,269 treatments were provided, averaging eight treatments per patient (range 1-10) and 9.6 needles per treatment (range 6-12). The needles used were usually 25mm or 40mm long and between 0.20mm to 0.30mm in diameter. Practitioners customised the treatment time for individual patients, usually within a range of 10 to 30 minutes, and exceptionally as low as five minutes and as high as 40 minutes. We also know that all practitioners attempted to attain de qi most of the time. However de qi was not always sought, and not always attained. In sensitive patients, needles were sometimes inserted without obtaining qi.
Diagnostic data Prior to commencement of the trial, we also drew on a previous literature review and, through discussion, agreed on a short-list of what we have called ‘key’ syndromes: qi and blood stagnation, bi syndrome and kidney deficiency, with the added option of an ‘Other’. For bi syndrome, we included sub-categories of cold bi and damp bi. For kidney deficiency, we listed the sub-categories of kidney yang deficiency and kidney yin deficiency. Practitioners agreed to complete this diagnostic process at the first consultation of each patient, see Table 2.
We also checked the levels of agreement on syndromes between acupuncturists, and found agreement (beyond chance) for 59% comparisons that were made for the primary syndrome, with full details for this sub-study published elsewhere.
Treatment data A total of 177 different acupuncture points were used throughout the trial. The most commonly used channels were bladder channel (38% of points used), especially Bl 26, Bl 32, Bl 40, Bl 53 and Bl 54, followed by GB channel points (15%), especially GB 30 and GB 34. Kidney points were used specifically for kidney deficiency and accounted for 3% of all points used, primarily Ki 3. Other much used points were the Huatuojiaji points (23%), as well as, to lesser extent, Ahshi points (3%) and the extra point Shiqizhuxia (3%), while all other points accounted for 15% of all points used.
Auxiliary treatments were used by all practitioners, but to varying degrees. Moxa was used in 18% of treatments, mostly in the form of a ‘moxa box’ (11%), but also ‘moxa on the needle’ (5%) and ‘sparrow-pecking’ with a moxa stick (2%). Moxa was used by all practitioners, who reported using it to target cold bi or kidney yang deficiency. Massage (42%), acupressure (13%), cupping (5%) and Chinese herbs (3%) were also used. Practitioners reported using massage and acupressure often briefly and early on in the treatment session, to enable accurate localisation of the back pain, to refine point selection and to build a stronger therapeutic relationship with the patient. Self-help was also prescribed adjunctively by all practitioners, commonly diet (11%), yoga exercises (3%), other specific exercises (3%), and relaxation exercises (3%). Practitioners reported prescribing yoga or stretching exercises to move a patient’s low back qi, relaxation exercises to calm the shen, and dietary change to strengthen the spleen, tonify the qi and help clear damp bi.
At the end of the trial, we interviewed the acupuncturists about their involvement in the trial, and found that the goals of treatment went beyond the alleviation of immediate pain-related symptoms. Acupuncturists in this study all described an approach to patient-centred care based on a therapeutic partnership. Study participants confirmed the importance of three processes that characterised acupuncture care in this trial, each contributing to the goal of a positive long-term outcome: building a therapeutic relationship; individualising care; and facilitating the active engagement of patients in their own recovery. Acupuncturists described elements of care that characterised these processes, including establishing rapport, facilitating communication throughout the period of care, using an interactive diagnostic process, and matching treatment to the individual patient. Practitioners also provided patients with explanations of their condition based on the theory of Chinese medicine. This led to discussions that helped develop a shared understanding of the patient’s condition and to motivate lifestyle changes that reinforced the potential for the recovery of health. For more details of this qualitative study, see MacPherson et al 2006.
Usual GP care comprised a mix of interventions. Half the patients randomised to usual care received physiotherapy or manipulation during the first three months. Other interventions included drugs and recommended back exercises.
Clinical outcomes Differences in pain scores between groups over time are shown in Figure 1. Acupuncture patients on average, on the SF-36 Pain scale of 0 to 100, had 5.6 points less pain at 12 months. By 24 months a statistically significant difference was found between the groups, with an estimated difference of 8.0 points. We found no statistical difference in the pain outcomes when comparing the patients of different acupuncturists. No significant changes were found on functional ability, nor were any serious or life threatening events reported. At three months, patients in the acupuncture group were significantly more likely to be ‘very satisfied’ with their treatment and with their overall care compared with patients receiving usual care. At 24 months the acupuncture group were more likely to report fewer concerns about their back pain, less likely to report current use of analgesics for their pain, and more likely to report no pain for the past 12 months. Patients who believed acupuncture would help their backs, prior to being randomised, did not show quite such improvement compared to those who were sceptical of its benefit (i.e. either did not know, or did not think, acupuncture would help them.) This is a counter-intuitive finding, as the conventional wisdom is that belief is associated with a placebo effect. Details of all the clinical outcomes have been reported more fully elsewhere.
Economic outcomes We measured the costs of the total NHS resource use (including GP visits and referrals) in both arms of the trial over the 24 month period and found that the costs were higher on average for the acupuncture group (£460) than for the usual care group (£345). The difference was primarily associated with receiving the course of acupuncture treatment. Cost-effectiveness is currently evaluated by determining the ‘incremental cost per QALY gained’, where the QALY is a single quality adjusted life year – meaning one year of good quality life. The cost per QALY gained then becomes a means of comparing the benefits not only of different treatments for the same condition but also for different conditions, with a single benchmark (like a currency). We found acupuncture to be highly cost-effective, with the incremental cost per QALY gained being £4,241. This is considerably less that the current threshold at the National Institute for Health and Clinical Excellence (NICE), who have set a £20,000 cost per QALY threshold for a treatment to be considered acceptable by the NHS. The conclusion is that, ‘A short course of traditional acupuncture for the treatment of lower back pain in primary care confers a modest health benefit measured in QALYS for a relatively minor extra NHS cost relative to usual care. The use of acupuncture care for the treatment of lower back pain therefore appears highly cost-effective.’
What this study adds to the evidence base Our formal conclusions from this trial were that, ‘weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months.’ This is a remarkable finding, in that normally treatment effects fall off over time after the end of a course of treatment. We are unsure whether our results are typical of what one should expect from acupuncture when it is delivered according to traditional principles, or indeed whether this effect is associated with other conditions when treated with acupuncture in the same sort of way. We know from the practitioner interviews that the acupuncturists on the trial made considerable efforts to elicit longer term changes. That these inputs may have had a learning component might in part explain the growing gap between groups between 12 and 24 months. However, for a fuller exploration of the differences between groups, we are conducting a very long term follow-up which will be at least six years after randomisation. As part of this study, we are interviewing patients to explore differences in coping strategies, which we hope will throw light on this unexpected finding.
It should be noted that a difference of at least five points in the mean score of the SF-36 bodily pain dimension is considered to represent a clinically worthwhile benefit. Other patient-relevant outcomes included patient satisfaction with acupuncture care, and reduced use of analgesics. Patients in the acupuncture group also reported a substantial reduction in worry about their back pain that was not observed in the usual care group. We also concluded that ‘referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.’
A limitation of our study was that we were unable to isolate the individual components of treatment, as we focused on evaluating the overall package of care. To measure components, however, would require placebo controlled trials, and the task of isolating and measuring the effects of the whole range of needling processes, as well as those processes that are acupuncture specific beyond needling (as discussed above), is a challenge beyond the scope of our investigations. At this point we leave this task to others, with the concern that over-simplifying acupuncture to better be able to ascribe effects to components of treatment may result in sub-optimal acupuncture being evaluated.
It is sometimes claimed that people who do well with acupuncture do so because they expect that acupuncture will help them. One of the most unexpected findings from this study was that patients in the acupuncture group with a prior positive belief in the effectiveness of acupuncture seemed to fare less well than those randomised to usual care, although this trend was not quite statistically significant. Counter-intuitively, we observed that sceptical patients with either neutral or negative prior expectations gained more benefit from acupuncture than those with prior positive belief.
One of the challenges in conducting a randomised controlled trial is to be able to generalise the results to other patient and practitioner populations. Our patients were drawn from primary care, and as we had broad entry criteria for the trial, they seemed to be fairly representative of normal primary care patients with low back pain. There are likely however to be some differences between NHS patients and those who would normally consult acupuncturists privately, but the results of our study should be generalisable to other NHS patient populations. One of the strengths of our study was the pragmatic randomised design that allowed acupuncturists to treat patients as they would do in every day practise. The study acupuncturists were selected via reproducible criteria (members of the British Acupuncture Council with at least three years experience) and the ratio of six practitioners to 16 GP practices is similar to the national ratio of BAcC acupuncturists to GP practices. Low back pain is the most commonly treated condition by BAcC acupuncturists. All these factors enhance the relevance of the results by replicating conditions under which GP in primary care might offer a patient the option of a referral to a BAcC acupuncturist for treatment for their low back pain.
One of the more interesting findings from the study was that all patients in both groups improved dramatically, even in the case of the control group of whom many received no treatment (see Figure 1). This finding of a rebound in both groups may reflect the fact that patients with low back pain will tend to seek help at a time when their back pain is most severe (known as the natural history of the condition), as well as the statistical artefact known as ‘regression to the mean’. This phenomenon has led commentators to argue for more longer term studies, and especially studies focusing on interventions that reduce recurrence, given that once someone has had back pain, they are more likely to experience recurrence. It is possible that repeated short courses of acupuncture may be more beneficial than a single course of treatment. Other questions that remain include: how early in the duration of the back pain condition is the ideal time to consult an acupuncturist? and how does acupuncture compare with other treatment modalities, such as physiotherapy or chiropractic?
Conclusion We have found that when patients in primary care with low back pain are referred to a BAcC acupuncturist for a short course of treatment, they will, on average, improve over time and show greater improvement than if they had received GP usual care alone. While the course of acupuncture only lasted around three months, their situation improved over time, and continued to improve between 12 and 24 months. Our recommendation from this study is that GPs should consider referring patients with low back pain to a qualified acupuncturist.
Acknowledgements We would like to thank all those who helped in the conduct of this trial, including the patients, the GPs and the practitioners. Lucy Thorpe was the trial coordinator. Many other staff at the University of Sheffield and University of York helped bring this trial to fruition. Anne Burton at the University of York helped with preparation of this manuscript. This study was funded by the UK NHS Executive Health Technology Assessment programme. York Health Authority funded the treatment costs of the acupuncture.
(Tables, Figures and References for this article are printed in the hard copy of The European Journal of Oriental Medicine Vol. 5 No. 4; 2007.)
Hugh MacPherson Hugh MacPherson trained in acupuncture and Chinese herbal medicine in the 1980s and currently practises in York. He founded the Northern College of Acupuncture and in 1995 steered the College towards the first acupuncture degree course in the UK, validated bu the University of Wales. With Ted Kaptchuk, he co-edited the book Acupuncture in Practice: Case History Insights from the West. Since 1997 as Research Director of the Foundation for Traditional Chinese Medicine, he has undertaken a series of research projects evaluating acupuncture's effectiveness and safety. more recently he has joined the Department of Health Sciences, University of York, as a Senior Research Fellow funded by the Department of Health.
Kate Thomas Kate Thomas is Professor of Complementary and Alternative Medicine Research at the School of Healthcare, University of Leeds. She has undertaken research into complementary and alternative therapies, including acupuncture, for a number of years. She has completed a large pragmatic trial of acupuncture for patients with low back pain being treated in primary care, which found acupuncture to be cost effective treatment for this group of patients and recommended its consideration for inclusion in National Health Service (state-funded) provision. Her current research interests are in the clinical and economic evaluation of complementary therapies for use in the UK National Health Service, the evaluation of different models of service delivery, and population/patient group patterns of use and access to complementary therapies.
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