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Cover of Evidence review for acupuncture for chronic primary pain

Evidence review for acupuncture for chronic primary pain

Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain

Evidence review G

NICE Guideline, No. 193

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London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4066-0

1. Acupuncture for chronic primary pain

1.1. Review question: What is the clinical and cost effectiveness of acupuncture or dry needling for the management of chronic primary pain?

1.2. Introduction

Acupuncture is one of the treatment modalities many pain sufferers seek or get in contact with whilst living with pain and seeing a variety of healthcare professionals in both publicly funded and private settings. Reasons for getting in contact with an acupuncture therapist may include the quest for alternative formulations and treatment strategies for chronic pain, the desire to have temporary or even persistent relief from pain, being dissatisfied with what has already been tried or the lack of treatments that have not been tried before.

There are wide variations in what people associate with the term “acupuncture”. From a simplistic sense, all acupuncture treatments have in common the placement of needles in various parts of the body. The depth of needle penetration ranges from just touching the skin to penetration of deeper body layers, such as bones and deep muscle tissues. In the majority of cases the needles are placed in muscle tissue close to nerve endplates. The placement of needles depends on the theoretical framework therapists apply. Therapists trained in traditional Chinese medicine operate under the assumption of optimising the flow of the vital energy “Qi” in the body. Western approaches in contrast locate their strategy in a neurobiological paradigm and have somatosensory stimulation as the concept underpinning their therapeutic strategies.

Dry needling is a concept aimed at the treatment of painful areas in striated muscle, myofascial trigger points. In this concept therapists aim to needle “as close to where it hurts without making it worse”. In contrast protagonists of traditional Chinese medicine (TCM) choose distant points in their attempts to harmonise the perceived misbalance of body functions and emotions.

Recent research demonstrated that contextual factors, such as therapeutic setting, interpersonal skills of the therapist or even the therapist themselves (“practitioner-effect”) have a significant influence on the outcome of the intervention. In the context of chronic pain, acupuncture treatments are often delivered in sequences of several sittings over time, which can facilitate building a therapeutic relationship. Acupuncture treatments offer the opportunity to treat several painful places and affected body functions at one time, which makes it an attractive option for people with many ailments and emotional components to their predicament. Acupuncture is often delivered in individually tailored one-to-one-settings, but some service providers have moved to deliver acupuncture therapy in group settings.

This review intends to determine the effectiveness of acupuncture and electroacupuncture in people with chronic pain.

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

32 studies were included in the review5, 7, 10, 16, 28, 32, 33, 42, 49, 55, 82, 85, 86, 93, 101, 111, 126, 131, 136, 139, 143, 150, 152, 168, 175, 176, 183, 201, 208, 211, 216, 220, 232 and these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary tables below (Table 3, Table 4 and Table 5).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.4.2. Excluded studies

One Cochrane review was identified but did not match the PICO characteristics of this review (Deare 201347), due to differences in the population, outcomes and comparisons. All included studies were cross-checked for inclusion in this review as relevant.

See the excluded studies list in appendix I.

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See appendix D for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Table 3. Acupuncture compared to sham acupuncture.

Table 3

Acupuncture compared to sham acupuncture.

Table 4. Acupuncture compared to usual care.

Table 4

Acupuncture compared to usual care.

Table 5. Electro-acupuncture compared to sham electro-acupuncture.

Table 5

Electro-acupuncture compared to sham electro-acupuncture.

See appendix F for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

Two health economic studies were identified with the relevant comparison and have been included in this review.218 These are summarised in the health economic evidence profiles below (Table 6 and Table 7) and the health economic evidence table in appendix H.

1.5.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.5.3. Summary of studies included in the economic evidence review

Table 6. Health economic evidence profile: Acupuncture in addition to usual care vs. waiting list control.

Table 6

Health economic evidence profile: Acupuncture in addition to usual care vs. waiting list control.

Table 7. Health economic evidence profile: Acupuncture in addition to usual care vs. usual care.

Table 7

Health economic evidence profile: Acupuncture in addition to usual care vs. usual care.

1.5.4. Health economic modelling

This area was prioritised for new economic modelling. The rationale, methods and results are summarised below. Full details are available in the ‘Acupuncture modelling report’.

The clinical evidence showed a benefit of acupuncture compared to both sham acupuncture and usual care, in reducing pain and improving quality of life.

Two economic evaluations were identified for this review comparing acupuncture to treatment as usual. One UK-based within-trial economic analysis compared acupuncture in addition to usual care with usual care. This was in people with chronic neck pain, and had a 1 year follow up, although the intervention itself was around 5 months long. Resource use included all appointments and prescriptions. The study found that acupuncture was cost effective (using complete case analysis). The 95% confidence interval was very wide (95% CI: £,4,426 to £74,562). However, a sensitivity analysis where missing data was imputed (40% of data was missing in the acupuncture arm) showed an ICER of £43,838, again with a very large confidence interval (−£216,427 to £395,047). The committee opinion was that the confidence interval led to uncertainty around cost effectiveness, although this would be the more relevant study as it is from a UK perspective. The costs of providing acupuncture (£35 per session) are likely to be lower than current staff costs that might provide acupuncture in the NHS. This might be because of the date of the costs (2012/13) or also because the costs of the sessions were based on the level of practitioner delivering the intervention in the trial, which was unclear. The second study was a German within-trial analysis, comparing acupuncture to a waiting list control in people with chronic neck pain, with a three month follow-up. People in the acupuncture group received between 10 to 15 sessions of acupuncture over the three months. The study considered costs of acupuncture as well as physician visits, medication and hospital stays in both groups. This paper suggested that acupuncture is cost effective compared to waiting list control (ICER: £11,430 per QALY gained). Although acupuncture costs per session used in the analysis (€35/£28) seem lower than current UK costs. Both studies had limitations regarding intervention costs potentially being underestimated, and uncertainty remained around cost effectiveness.

Uncertainty remained about the cost effectiveness of acupuncture from the included studies. Also, acupuncture for chronic primary pain is not currently used in the NHS, therefore, a recommendation could have a resource impact to the NHS in England given the large size of the population living with chronic primary pain. For the above reasons, a probabilistic lifetime cost-utility analysis was undertaken, from the NHS perspective, that compared acupuncture with no acupuncture (both groups had usual care therefore this was not included in the model).

The analysis was based on studies from the clinical review that were compared to usual care (not sham), as the committee agreed usual care was the most appropriate comparator for the economic analysis as would give the full benefit likely to be achieved in a real world scenario and sham would not be used in the NHS except in research (for a more detailed rationale for this decision see the full technical report). Studies were included in the analysis if they reported utilities (EQ-5D), or measures that could be mapped to utilities like QoL measures (the SF-36), and pain scales (this was 7 out of 9 usual care comparison studies). All acupuncture types were pooled. For each study, the difference between EQ-5D outcomes (whether this was during treatment, at the end of treatment or later) and the baseline EQ-5D was taken for the intervention and usual care group, to take account of any baseline differences between the two groups. The difference in EQ-5D was then taken between the intervention and usual care group for each study. Therefore, the treatment benefit is the EQ-5D gain from acupuncture compared to usual care, taking into account baseline differences.

In the economic analysis, the EQ-5D data from different time points (meta-analysed if there was more than one study with a measurement at a particular time point) were used to estimate QALY gain with acupuncture. Looking at the pattern of the QoL improvement from acupuncture over time plotted graphically showed that there was an increasing QoL trend up to 12 weeks in the data. It was also noted that in studies that measured QoL at the end of the intervention and then again at a later follow-up point, the QoL gain at the follow point was lower, but a difference remained. It was agreed that the analysis should be split into two parts for the economic analysis: the first analysing the data up to 12 weeks and a second looking at how treatment effect changed over time after the end of the intervention. A trend line was estimated using all observed data points up to and including 12 weeks. The linear trend line was generated using weighted least squares regression to apply a higher weight to the treatment effect from timepoints that had smaller variance. In addition, the average change per week was estimated after the end of the intervention using studies that reported at least 2 time points after the end of the intervention (for example one post intervention and a follow-up a number of weeks later). In the economic analysis QOL gain over time was initially modelled using the ≤12 weeks trend line. A linear increase in EQ-5D from zero difference at time zero to the point estimated by the trend line at the first trial observation was also assumed. After 12 weeks the change per week from the follow-up analysis was applied up to 18 weeks (6 weeks follow-up data from studies included) in the base case. Analyses were included with and without further extrapolation of treatment effect beyond this point. . Extrapolation assumptions were based on committee opinion, and different assumptions were needed for different scenarios that occurred in probabilistic analyses. Note the treatment effect was extrapolated only until there was no additional quality of life benefit from acupuncture. QALY gain with acupuncture was estimated by calculating the area under the curve.

The key difference in costs was agreed to be those related to delivering acupuncture. No other costs were incorporated in the analysis. The average resource use from the interventions in each study were identified and costed, and a weighted average cost calculated, weighting by the number of participants in the studies. The committee agreed that in the base case a band 6 staff member should be used for costing purposes. Use of other staff bands and other cost assumptions were tested in sensitivity analyses.

Results

The probabilistic and deterministic base case results can be seen in the table below. Results are presented for both base cases. Both analyses show the ICER is below the NICE threshold of £20,000, and therefore acupuncture would be considered cost effective. The probability of acupuncture being cost effective is also high.

Table 8. Base case results (discounted).

Table 8

Base case results (discounted).

The deterministic results are somewhat different to the probabilistic in the lifetime analysis as there is a larger incremental QALY gain in the probabilistic analysis because the QALY gains have a skewed distribution. This occurs because there are some simulations in the probabilistic model where the post intervention QOL is a shallow downward slope which leads to a large QALY gain in the lifetime analysis because the point at which there is no longer a difference in treatment effect from acupuncture are far into the future. This was visualised by reviewing the patterns of the regression lines graphically and summarising the distribution of QALY gains. In the first base case, where no extrapolation of the data is modelled, then the probabilistic and deterministic results are very close, proving that the extrapolation assumptions and the nature of the data in the probabilistic analysis created the discord between the probabilistic and deterministic models using a lifetime horizon. However, both models and both base cases are still well below the NICE cost effectiveness threshold.

Various sensitivity analyses were undertaken for both base cases. Alternative data about post-treatment effects was incorporated that was not included in the base cases. Sensitivity analysis also tested various resource use assumptions about bands of staff, treatment overlap (i.e. people being simultaneously treated), and resource use considered more typical in England. All sensitivity analyses did not change the conclusions.

Limitations of the analysis include that data was pooled across clinical studies that had different intensities (in terms of frequency of sessions and overall number of sessions) of acupuncture, differences in the type of acupuncture and differences in the number of acupuncture points. This is likely to affect costs and treatment effects. However, there is uncertainty around whether the pooled costs correspond with the pooled treatment effect. This is because it is unclear what it is about acupuncture that causes a benefit i.e. the frequency, or the number of sessions, type of acupuncture, number of acupuncture points or the training and experience of the individual and therefore the extent of the contextual effect. Another limitation of the model is that the linear trend lines representing treatment effect over time is a simplification of how people’s quality of life would fluctuate in reality. The quality of life gain taken from the studies could also be an overestimate because it is likely that people who respond to follow up questionnaires or that have not dropped out of a trial are more engaged with the intervention. Additionally uncertainty not captured by the model included what outcomes and resource use occurred after the intervention or, for instance, whether some people received further courses of acupuncture. Some assumptions were made regarding patterns of extrapolation of the regression trend lines following discussion with the committee. No other costs have been accounted for in the analysis except for intervention costs.

Overall, this analysis has pooled data from the clinical review that reported utilities or measures that could be mapped to utilities, to estimate the potential cost effectiveness of acupuncture in general. The heterogeneity of the studies, and the number of studies used, should be taken into account when interpreting this analysis.

1.5.5. Unit costs

The unit cost of acupuncture is presented below for illustration. Acupuncture for pain management is most commonly performed as an outpatient procedure.

Table 9. Unit costs of acupuncture for pain management.

Table 9

Unit costs of acupuncture for pain management.

Alternatively, acupuncture can be provided in a community setting. The unit cost for the bands of staff that might deliver acupuncture are provided below for consideration of cost effectiveness. The cost of acupuncture equipment has also been included for consideration.

Table 10. UK costs of healthcare professionals.

Table 10

UK costs of healthcare professionals.

Table 11. UK costs of acupuncture equipment.

Table 11

UK costs of acupuncture equipment.

1.5.6. Threshold calculations

As the economic evaluations that have been identified for inclusion in this review have limitations, such as the costs of delivering acupuncture appearing low compared to UK costs, some threshold calculations have been undertaken to crudely identify what level of acupuncture might be afforded based on UK staff costs, that would make acupuncture cost effective at the £20,000 per QALY gained threshold.

Note that for Essex 2017, this had two analyses that could be treated as base cases, and the QALYs from both have been reported here.

Table 12. Summary of QALYs from the included economic evaluations.

Table 12

Summary of QALYs from the included economic evaluations.

Assuming no difference in resource use other than acupuncture treatment between usual care and acupuncture groups, the table below illustrates some threshold calculations on the maximum cost of acupuncture that would make it cost effective, and what this cost could fund. The number of sessions afforded have been calculated based on a band 6 staff member (used as the base case cost in the original model on acupuncture undertaken for this guideline), and band 7. The threshold calculations have been undertaken for each QALY from Table 12 individually.

Table 13. Incremental cost needed to make acupuncture cost effective.

Table 13

Incremental cost needed to make acupuncture cost effective.

The results of the threshold calculations in Table 13 show the range of hours of staff time that could be afforded, depending on the magnitude of the QALY, and based on UK staff costs. The committee discussed that each session of acupuncture is not usually an hour. Sometimes it can be as little as 10 minutes, although if traditional Chinese medicine is undertaken this can take an hour. Typically, the committee opinion was that although there might be variation in how acupuncture is delivered, there was some agreement that around 6 sessions of about 30 minutes might be considered a typical course that would be offered to patients. Using the lowest QALY estimate from Table 13, shows that this could afford around 5 hours of staff time, which would mean roughly 10 sessions of 30 minutes. Therefore 6 sessions of 30 minutes could be cost effective based on the above calculations.

1.6. Evidence statements

1.6.1. Clinical evidence statements

1.6.1.1. Acupuncture versus sham acupuncture
Pain reduction

Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.

Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months

Quality of life

Low to moderate quality evidence from 2 studies with 210 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Moderate quality evidence from 1 study with 158 participants showed sham acupuncture to have a clinically important improvement compared to acupuncture at ≤3 months. Very low quality evidence from 3 studies with 244 participants showed no clinically important difference between acupuncture and sham acupuncture at ≤3 months. Very low quality evidence from 2 studies with 168 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Very low to low quality evidence from 1 study with 178 participants showed a clinically important benefit, clinically important harm and no clinically important difference of acupuncture compared to sham acupuncture at ≤3 months (various quality of life subscales). Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 1 study with 72 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.

Very low quality evidence from 1 study with 76 participants showed a clinically important benefit of sham acupuncture compared to verum acupuncture at >3 months. Low quality evidence from 1 study with 96 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Low quality evidence from 1 study with 153 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Moderate quality evidence from 1 study with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months.

Physical function

Very low quality evidence from 1 study with 118 participants showed no clinically important difference between acupuncture and sham acupuncture at ≤3 months. Very low quality evidence from 1 study with 106 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months.

Psychological distress

Low quality evidence from 1 study with 50 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 206 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 1 study with 155 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months.

Pain interference

No evidence identified

Pain self-efficacy

No evidence identified

Sleep

Low quality evidence from 1 study with 52 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Moderate quality evidence from 1 study with 72 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Moderate quality evidence from 1 study with 96 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months.

Discontinuation

Very low quality evidence from 17 studies with 1477 participants showed no clinically important difference between acupuncture and sham acupuncture at ≤3 months. Low quality evidence from 3 studies with 360 participants demonstrated that more people discontinued from acupuncture compared to sham acupuncture at >3 months.

1.6.1.2. Acupuncture versus usual care
Pain reduction

Low quality evidence from 5 studies with 234 participants showed a clinically important benefit of acupuncture compared to usual care at ≤3 months. Low quality evidence from 2 studies with 384 participants showed no clinically important difference between acupuncture and usual care at ≤3 months. Moderate quality evidence from 1 study with 3162 participants showed a clinically important benefit of acupuncture compared to usual care at ≤3 months.

Moderate quality evidence from 1 study with 344 participants showed no clinically important difference between acupuncture and usual care at >3 months.

Quality of life

Moderate quality evidence from 1 study with 3213 participants showed a clinically important benefit of acupuncture compared to usual care at ≤3 months. Very low quality evidence from 1 study with 100 participants showed both a clinically important benefit and no clinically important difference between acupuncture and usual care at ≤3 months (various quality of life subscales).

Low quality evidence from 1 study with 204 participants showed a clinically important benefit of acupuncture compared to usual care at >3 months.

Physical function

Very low quality evidence from 1 study with 45 participants showed no clinically important difference between acupuncture and usual care at ≤3 months. Very low quality evidence from 1 study with 100 participants showed a clinically important benefit of acupuncture compared to usual care at ≤3 months.

Psychological distress

Low quality evidence from 2 studies with 145 participants showed no clinically important difference between acupuncture and usual care at ≤3 months. Very low quality evidence from 1 study with 100 participants showed no clinically important difference between acupuncture and usual care at ≤3 months.

Pain self-efficacy

Very low quality evidence from 1 study with 294 participants showed a clinically important benefit of acupuncture compared to usual care at ≤3 months.

Pain interference

Very low quality evidence from 1 study with 100 participants showed a clinically important benefit of acupuncture compared to usual care at >3 months.

Sleep

Very low quality evidence from 1 study with 100 participants showed no clinically important difference between acupuncture and usual care at ≤3 months.

Discontinuation

Low quality evidence from 1 study with 66 participants showed no clinically important difference between acupuncture and usual care at ≤3 months.

1.6.1.3. Electro-acupuncture versus sham electro-acupuncture
1.6.1.4. Pain reduction

Very low quality evidence from 1 study with 61 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at ≤3 months. Very low quality evidence from 1 study with 61 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at >3 months.

Quality of life

Moderate quality evidence from 1 study with 163 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at ≤3 months. Low quality evidence from 1 study with 49 participants showed a clinically important benefit of electro-acupuncture compared to sham electro-acupuncture at ≤3 months. Moderate to low quality evidence from 1 study with 160 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at >3 months. Low quality evidence from 1 study with 49 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at >3 months.

Physical function

No evidence identified.

Psychological distress

No evidence identified.

Pain interference

Low quality evidence from 1 study with 49 participants showed a clinically important benefit of electro-acupuncture compared to sham electro-acupuncture at ≤3 months and >3 months.

Pain self-efficacy

No evidence identified.

Sleep

Very low quality evidence from 1 study with 55 participants showed no clinically important difference between electro-acupuncture and sham electro-acupuncture at ≤3 months.

Discontinuation

Low quality evidence from 6 studies with 444 participants showed a clinically important benefit of electro-acupuncture compared to sham electro-acupuncture at ≤3 months.

1.6.2. Health economic evidence statements

  • One cost-utility analysis found that acupuncture is cost effective compared to waiting list control for the management of chronic neck pain (ICER: £11,430 per QALY gained). This analysis was assessed as partially applicable with potentially serious limitations.
  • One cost-utility analysis found that acupuncture for the management of chronic neck pain:
    • is cost effective compared to usual care in the complete case analysis (ICER: £18,767 per QALY gained).
    • is not cost effective compared to usual care in the imputed data analysis (ICER: £43,838 per QALY gained).
    This analysis was assessed as directly applicable with potentially serious limitations.
  • One original cost-utility analysis found that acupuncture was cost effective compared to no acupuncture for treating chronic primary pain (probabilistic ICERs: £5,710 per QALY gained (lifetime analysis), £14,552 per QALY gained (no extrapolation analysis), deterministic ICERS: £9,113 per QALY gained (lifetime analysis), £14,310 per QALY gained (no extrapolation analysis). This analysis was assessed as directly applicable with minor limitations.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The committee considered pain reduction, health-related quality of life, physical function and psychological distress, pain interference and pain self-efficacy to be critical outcomes for decision-making. Use of healthcare services, sleep and discontinuation were also considered to be important outcomes. The critical and important outcomes agreed by the committee were adapted by consensus from relevant core outcome sets registered under the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. This included the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations.

Evidence was identified for all critical and important outcomes.

1.7.1.2. The quality of the evidence

Evidence from 32 randomised controlled trials was identified for 3 different comparisons in this review. Comparisons with the most evidence were acupuncture versus sham acupuncture and acupuncture versus usual care, with a smaller amount of evidence available for electro-acupuncture versus sham electro-acupuncture. No evidence was identified comparing electro-acupuncture to usual care.

The majority of the evidence identified was of low to very low quality, with only a small amount of moderate quality evidence. The evidence was mainly downgraded due to risk of bias and imprecision. Risk of bias was often high due to attrition and selection bias. In the usual care comparisons there was a lack of blinding in the studies due to the nature of the intervention; this combined with the mostly subjective outcomes resulted in a high risk of performance bias. The committee took into account the low quality in their interpretation of the evidence, particularly when considering the small amount of evidence for comparisons of different types of acupuncture.

There was wide variation in the types of and intensity of interventions being applied within the evidence, which the committee noted to be a limitation of the evidence as a whole. There were also limitations related to sham procedures within the review, due mainly to the difficulty of blinding participants to acupuncture or sham acupuncture due to the nature of the intervention. A large range of sham procedures were included within this review, which were pooled in the analysis. These included procedures such as not fully inserting needles, needles contacting the skin only or needles inserted in the wrong acupoints.

1.7.1.3. Benefits and harms
Acupuncture versus sham acupuncture

Evidence of acupuncture versus sham acupuncture was based on 19 studies and showed a benefit of treatment in terms of pain and quality of life. There was evidence for all critical and important outcomes other than pain interference and pain self-efficacy. At less than 3 months, evidence showed a benefit of acupuncture for pain, quality of life, psychological distress and sleep. Although the evidence was generally positive, the committee noted that evidence for quality of life was more uncertain, with some outcomes crossing the line of no effect or the MID threshold. The main outcome for pain showed a clinically important benefit of acupuncture, based on 13 studies and over 1000 participants. Some uncertainty again existed within this outcome, with confidence intervals crossing the MID. However, the committee agreed that this uncertainty was marginal (crossing the MID by a difference of 0.3), and agreed this outcome was therefore demonstrating a benefit of acupuncture. There was no benefit of treatment seen for physical function at less than 3 months, although this evidence was very low quality and based on one small study. The longer-term evidence (over 3 months) showed some benefit of acupuncture, although there was less evidence from which to draw a conclusion. Evidence showed a benefit for pain, quality of life and psychological distress. However, results were mixed with some evidence contrastingly showing no benefit for similar outcomes. The committee agreed that the short-term evidence for acupuncture showed a benefit for pain and was based on large sample sizes. They agreed that there was not enough evidence to determine the long-term benefits of acupuncture compared to sham acupuncture.

The committee noted that, in their experience, non-verbal communication and the belief system of the practitioner giving the acupuncture is an important aspect of the intervention, and therefore something that could have impacted the validity of the sham. The committee discussed the implications of poor blinding and noted that these could lead to overestimation of the treatment effect for acupuncture, because sham could be less effective if blinding is broken, due to loss of the placebo effect. Conversely, the committee agreed that some of the sham procedures could have a therapeutic effect, such as traditional acupuncture sham methods that involve inserting the needle a few centimetres away from the actual acupoint or meridian. In theory, these points could be deemed as an appropriate needle insertion under the definitions of western acupuncture or dry needling, and therefore underestimate the effect estimates for acupuncture treatment. Sham acupuncture could also be therapeutic by involving both validation of the person’s pain and by an empathic approach from the clinician. For these reasons, the committee agreed that the benefit of acupuncture compared to sham procedures was a promising finding.

Acupuncture versus usual care

Evidence of acupuncture versus usual care was based on 9 studies and showed a benefit of acupuncture (mainly for pain and quality of life), which was consistent to the sham comparison. There was evidence for all critical and important outcomes and the evidence quality was downgraded mainly due to risk of bias and imprecision, ranging from very low to moderate.

At less than 3 months, evidence showed a benefit of acupuncture for improving outcomes of pain with only a small amount of uncertainty around the effect size (with 95% CIs marginally crossing the MID threshold in one outcome). There was also evidence of benefit for quality of life, which was mainly based on one study with over 3000 participants. Evidence for the physical component of the SF-36 scale had minimal uncertainty (confidence intervals did not cross the MID threshold). For the mental component of the SF-36, there was some uncertainty although the confidence intervals crossed the MID by only 0.5. Other quality of life outcomes were based on much smaller sample sizes and so the committee placed less weight on these in decision-making (with some outcomes showing a benefit for some quality of life, and others showing no difference). In addition, a small amount of evidence suggested a benefit of acupuncture for pain interference and pain self-efficacy. Evidence for physical function was mixed and based on small sample sizes, with some evidence indicating a benefit of acupuncture and other evidence indicating no benefit. There was no benefit of treatment seen for psychological distress or sleep, however this evidence was low to very low quality and based on smaller sample sizes. The evidence at over 3 months was limited, with a benefit of acupuncture for quality of life and pain self-efficacy but no difference seen for pain. The committee again agreed that the short-term evidence was promising, showing a benefit for quality of life and based on large sample sizes. They agreed that there was not enough evidence to determine the long-term benefits of acupuncture compared to sham acupuncture

Electro-acupuncture versus sham electro-acupuncture

There was less evidence for electro-acupuncture within the review. The evidence quality was downgraded mainly due to risk of bias and imprecision, and ranged from very low to low quality. For outcomes under 3 months, there was no clinically important difference seen for pain, quality of life and sleep. A clinically important benefit was seen for one quality of life outcome and discontinuation. At over 3 months follow up, there was no clinically important difference for pain or quality of life. No evidence was available for physical function, psychological distress, pain interference or pain self-efficacy.

Overall

The committee discussed the applicability of the evidence to clinical practice, and noted that there was variation among the interventions included within the review. They agreed that this was reflected in current practice, which showed a similarly wide variation in terms of type of acupuncture, length of sessions and duration of treatment programme. The committee noted that the evidence review did not demonstrate evidence of harm. They considered the potential harms related to the use of acupuncture. One of the most serious possible harms of acupuncture is organ puncture, although there were no reports of this within the evidence. The committee noted that guidance on acupuncture techniques should establish a depth of needle injection based on the target body area and other factors such as the physique or build of individuals with chronic pain. The committee also noted the importance of demonstrated competence of the person delivering acupuncture, and that single use sterile needles should be used to prevent infection.

The committee considered the overall benefit of acupuncture, particularly for reducing pain and improving quality of life, in combination with the lack of harm, other than discontinuation from the therapy. The committee agreed that although there was some uncertainty within some of the outcomes (with a small proportion of outcomes crossing the line of no effect), there was generally a benefit of acupuncture seen within the evidence when compared to both usual care and sham. The committee considered that the evidence base was large enough to justify a recommendation, and therefore agreed to recommend the use of acupuncture in clinical practice for people with chronic primary pain.

The committee noted that the majority of evidence was based on women with chronic neck pain or fibromyalgia, but that studies were also included in people with myofascial pain, vulvodynia, chronic pelvic pain and shoulder pain. The populations were pooled in the clinical review. Where there was heterogeneity in the pooled analysis, subgroup analysis was undertaken by type of chronic primary pain, but this did not explain the heterogeneity. The committee therefore agreed that there wasn’t evidence that effect differed according to type of chronic primary pain and there was no reason recommendations made based on this evidence should not apply for all types of chronic primary pain. They also noted that the specific type of acupuncture may differ according to type of pain, which would be informed by expertise of the practitioner delivering acupuncture.

The evidence review did not compare the effectiveness of different types of acupuncture and included a wide range of acupuncture methods. There was no heterogeneity seen in the evidence that could be explained by the different types of acupuncture, and this was considered when wording the recommendation.

1.7.2. Cost effectiveness and resource use

The economic evidence review identified two relevant published economic evaluations. Original economic modelling was also undertaken.

One study was a UK-based within-trial analysis, comparing acupuncture in addition to usual care with usual care. This was in people with chronic neck pain, and had a 1 year follow up, although the intervention itself was around 5 months long (up to 12 × 50-minute treatments delivered once per week and then once every 2 weeks). Resource use included all appointments and prescriptions. Quality of life was measured using the EQ-5D. The study found that acupuncture had an ICER of £18,767 per QALY gained, suggesting acupuncture is cost effective. The 95% confidence interval was very wide (95% CI: £4,426 to £74,562). However a sensitivity analysis where missing data was imputed (and 40% of data was missing in the acupuncture arm) showed an ICER of £43,838, again with a very large confidence interval (−£216,427 to £395,047). The committee opinion was that the confidence interval led to uncertainty around cost effectiveness, although this would be the more relevant study as it is from a UK perspective. The study was directly applicable because it is a UK study and uses the EQ-5D measure of quality of life, but had potentially serious limitations because of a large amount of missing data (although it is not clear what was missing), and resource use was self-reported. Furthermore, people were asked to report resource use for both neck pain and overall resource use, and people may have been confused between the two. This could have increased the missing data or led to double counting, so pre-specified assumptions were made by the authors depending on what patients filled in. The costs of providing acupuncture (£35 per session) are likely to be lower than current staff costs that might provide acupuncture in the NHS. This might be because of the date of the costs (2012/13) or also because the costs of the sessions were based on the level of practitioner delivering the intervention in the trial, which was unclear. The study is a within trial analysis of a single study rather than incorporating clinical studies from a wider evidence-base, which may limit the generalisability of the conclusions.

The second study was a within-trial analysis conducted in Germany, comparing acupuncture to a waiting list control in people with chronic neck pain, with a three month follow-up. People in the acupuncture group received between 10 to 15 sessions of acupuncture over the three months. The study considered costs of acupuncture as well as physician visits, medication and hospital stays in both groups. This paper suggests that acupuncture is cost effective compared to waiting list control (ICER: £11,430 per QALY gained). This was assessed as partially applicable with potentially serious limitations. Limitations include: non-UK study and therefore not UK NHS setting, it used the SF-6D (mapped from the SF-36) to derive utilities as opposed to the EQ-5D, acupuncture costs were arbitrarily derived because acupuncture was not reimbursed by health insurance companies in Germany at the time and so there was no national tariff cost. Costs were also thought to be low in this study (€32/£28 per session) compared to current UK costs. The analysis was also a within-trial analysis of a single study with a short follow-up period. Sensitivity analysis conducted in this study found that results were highly sensitive to the cost of the acupuncture sessions, and hence this may be an important factor in determining whether the intervention is cost effective in the current UK NHS setting.

Overall, although both studies had outcomes favouring acupuncture, the committee noted that there still remained uncertainties about the cost effectiveness of acupuncture, as it is a limited evidence base and there are uncertainties around the cost of the intervention.

To address the uncertainty in the costs of the interventions, threshold analyses were undertaken whereby the QALYs from the published economic evaluations were used to calculate the cost of acupuncture and amount of staff time that could be afforded based on the £20,000 per QALY threshold. This showed that for acupuncture to be cost effective, the maximum incremental cost for acupuncture ranged from £380 to £640. Taking the most conservative estimate, this could fund a total of around 5 hours of sessions with a band 7 community staff member, using current NHS staffing costs (PSSRU 2018). Although this illustrates the maximum cost that would make acupuncture cost effective at the £20,000 threshold, there still remain uncertainties as to whether the same treatment effect can be gained from fewer of sessions. More specifically, the study reporting the QALY gain feeding into this calculation, provided up to 12 sessions of 50 minutes. But 5 hours of staff time would only provide five 50 minute sessions. Additionally, if sessions in UK practice are not as long, then more sessions might be afforded, however again whether more shorter sessions would provide the same QALY gain as fewer longer sessions is also uncertain. The relationship between treatment intensity and effectiveness has not been investigated in this review.

To help further explore the cost effectiveness of acupuncture, an original economic analysis was undertaken. This was a cost-utility analysis using a lifetime horizon comparing acupuncture with no acupuncture. Treatment effects were based on trials in the clinical review that reported utilities, or measures that could be mapped to utilities (SF-36, pain scales), with the model meta-analysing all available data that reported outcomes at the same time points, to derive an average treatment effect over time. Note that only studies with a usual care comparison were included in the model, as the committee view was that this is the most appropriate comparator for the economic analysis as these would give the full benefit likely to be achieved in a real world scenario. 7 out of 9 studies with a usual care comparison had outcomes that could be used in the model. Differences in quality of life between the acupuncture and no acupuncture group in each study were calculated, taking into account the change from baseline in each arm, to derive the quality of life gain from acupuncture compared to no acupuncture for each study. Note the intervention being modelled is based on a single course of acupuncture, and there was no information on repeat courses. The model estimated QALYs based on the available data by using a linear trend line fitted to the pooled quality of life gain at each time point up to 12 weeks and then applying the average change in treatment effect over time after the end of the intervention up to 18 weeks. The average treatment effect was also extrapolated beyond the available trial data, based on committee assumptions in the lifetime analysis. Costs included only the costs of the staff time involved in providing acupuncture. The total resource use from each study being used for treatment effect was identified and costed up, and a weighted average was taken based on the number of participants analysed in the intervention arm of each trial.

Two base cases were modelled, one using a lifetime horizon where treatment effects were extrapolated beyond the trial data and the other assuming no extrapolation beyond the trial data. Both base cases showed that acupuncture was cost effective compared with no acupuncture, with probabilistic ICERs of £5,710 (90% probability of acupuncture being cost effective at a threshold of £20,000 per QALY gained), and £14,552 (88% probability) respectively, and deterministic ICERs of £9,113 and £14,310 respectively. Various sensitivity analyses were undertaken, including varying resource use such as band of staff, assuming overlap of treatment, and including data omitted from the base case. The overall conclusion was robust to all sensitivity analyses tested.

The committee discussed the limitations of the analysis. These included how data was pooled across clinical studies that had different intensities of acupuncture (in terms of frequency of sessions and overall number of sessions), differences in the type of acupuncture and differences in the number of acupuncture points. They also discussed the limitations of mapping pain scores and SF36 quality of life scores to EQ-5D quality of life scores. However, they agreed that the studies used in the economic analysis were generally representative of the populations in the review as a whole and that the mapping was appropriate as the same methodology had also been used in other cost-effectiveness studies (notably a large acupuncture meta-analysis). The committee noted the uncertainty around the relationship between resource use and treatment benefit, which needs to be taken account when interpreting the results. It was not considered appropriate to explore this relationship more formally in the model (such as by modelling each study separately), as the clinical review did not establish which characteristics of acupuncture improve outcomes.

Overall, although the committee had reservations about the two published studies, the original economic analysis used a wider pool of data, and the committee considered this to be more robust than the published evidence. Various sensitivity analyses were undertaken showing that if a higher band of staff was used for example, this would still lead to acupuncture being cost effective. Pooling the resource use from the studies using a weighted average method, led to an average of 10 sessions of around 30 minutes. A threshold analysis in the model showed that up to 15 sessions of 30 minutes could be afforded at the £20,000 per QALY threshold (based on the non-extrapolated base case). The threshold analysis on the published studies was also useful because this showed that using the most conservative published QALY, a maximum of 5 hours of band 6 staff time could be afforded, which is similar to the average resource use in the model. The model resulted in higher QALYs than some of the published estimates because it pooled many studies together and led to an overall larger treatment effect.

Based on the above, the committee were confident in the evidence to support a ‘consider’ recommendation. This was supported by clinical and cost effectiveness evidence but was not thought appropriate to have an ‘offer’ recommendation due to the uncertainty of the effects being sustained long term as well as there being some uncertainty in the cost-effectiveness and there being a high resource impact of implementing this in current practice. The recommendation was caveated with information on the number of hours of staff time, and banding of staff that would make the delivery of acupuncture cost effective. 5 hours of acupuncture was recommended as the maximum that should be considered, as this was the average resource use used in the model based on the trials included. Around 5 hours was also the most conservative estimate from the threshold calculations using the published QALYs, which increases certainty that this level of acupuncture is likely to be cost effective, as the model in fact showed that QALYs are likely to be higher than the most conservative published QALY, as it pooled many more studies. The band of staff caveated in the recommendation was a band 7. There was some debate with the committee in terms of bands of staff that would generally deliver acupuncture and so this was tested in the model. In the model a band 6 was used as the base case, however band 7 was also tested in a sensitivity analysis and the ICER remained below £20,000, and therefore a caveat of band 7 or below was felt appropriate in order to capture the variation in staff that might deliver the intervention. Stakeholder feedback highlighted that that there may be other service configurations that would allow delivery of acupuncture for a similar cost and this was also incorporated into the recommendation.

The committee noted that acupuncture used to be widely available in clinical settings but many services have been decommissioned over recent years. It was acknowledged that there is likely to be a significant resource impact even with limited uptake, given the size of the population.

1.7.3. Other factors the committee took into account

The evidence reviewed was only able to inform a recommendation for a single course of acupuncture. The committee noted that they could not assume repeated courses would have the same effectiveness, and this would have implications for cost effectiveness if repeat courses were provided within the NHS. They therefore agreed that a research recommendation should be drafted to determine the clinical and cost-effectiveness of repeat courses of acupuncture.

The committee were aware of self-acupuncture techniques whereby a person delivers acupuncture to themselves, but no evidence was identified within this area and thus no recommendations related to this were made.

The NICE low back pain guideline (NG59) did not recommend the routine use of acupuncture. The committee discussed and compared the evidence within this guideline to the low back pain guideline and agreed there was a difference in the available evidence base between the two guidelines, with less consistent results demonstrated in NG59, and the current review demonstrating more favourable results when compared to sham acupuncture. Of most importance, they noted that the low back pain guideline included acute pain, which is not covered in this guideline; this difference in the population covered could have resulted in differences in outcomes seen across the evidence. The committee also noted that acupuncture is recommended in the NICE guideline for headaches (CG150) for prophylactic treatment of chronic tension type headache, where there was also evidence of benefit of acupuncture compared to sham.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.158

For more information, please see the Methods Report published as part of the accompanying documents for this guideline.

Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 15. Database date parameters and filters used

Medline search terms

Embase search terms

Cochrane search terms

Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to a Chronic Pain population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics and economic modelling.

Table 16. Database date parameters and filters used

Medline search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

Download PDF (1024K)

Appendix E. Forest plots

E.1. Acupuncture versus sham acupuncture

Figure 2. Pain (VAS/NRS; 0–10; final & change scores; high is poor outcome) at ≤3 months

Figure 3. Pain (NIH-CPSI; 0–21, high is poor outcome, final values) at ≤3 months

Figure 4. Pain (VAS; 0–10; final & change scores; high is poor outcome) at >3 months

Figure 5. Pain (NIH-CPSI; 0–20; high is poor outcome, final values) at >3 months

Figure 6. Pain (least square mean difference; VAS; 0–10, final values, high is poor outcome) at >3 months

Figure 7. Health related quality of life (SF12 physical composite; 0–100, final values; high is good outcome) at ≤3 months

Figure 8. Health related quality of life (SF12 mental composite; 0–100, final values; high is good outcome) at ≤3 months

Figure 9. Health related quality of life (SF36 physical component summary; 0–100, high is good outcome, final values) at ≤3 months

Figure 10. Health related quality of life (SF36 mental component summary; 0–100, high is good outcome, final values) at ≤3 months

Figure 11. Health related quality of life (SF36 physical functioning subscale; final values, 0–100, high is good outcome, final values) at ≤3 months

Figure 12. Health related quality of life (SF36 physical role subscale, final values and change scores; 0–100, high is good outcome, final values) at ≤3 months

Figure 13. Health related quality of life (SF36 bodily pain subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 14. Health related quality of life (SF36 general health subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 15. Health related quality of life (SF36 emotional role subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 16. Health related quality of life (SF36 vitality subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 17. Health related quality of life (SF36 social functioning subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 18. Health related quality of life (SF36 mental health subscale, final values; 0–100, high is good outcome, final values) at ≤3 months

Figure 19. Health related quality of life (NIH-CPSI; 0–12; high is poor outcome, final values) at ≤3 months

Figure 20. Health related quality of life (FIQ; 0–100; high is poor outcome final values) at ≤3 months

Figure 21. Health related quality of life (SF36 physical component summary; 0–100, high is good outcome, change scores) at >3 months

Figure 22. Health related quality of life (SF36 physical component summary; change scores; 0–100, high is good outcome) at >3 months

Figure 23. Health related quality of life (SF36 mental component summary; change scores; 0–100, high is good outcome) at >3 months

Figure 24. Health related quality of life (SF12 physical component summary; change scores; 0–100, high is good outcome) at >3 months

Figure 25. Health related quality of life (SF12 mental component summary; change scores; 0–100, high is good outcome) at >3 months

Figure 26. Health related quality of life (NIH-CPSI; 0–12; final values, high is poor outcome) at >3 months

Figure 27. Physical function (Neck Pain Questionnaire/Neck Disability Index; 0–100; high is poor outcome, final values) at ≤3 months

Figure 28. Physical function (Neck Disability Index; 0–100;high is poor outcome, final values) at >3 months

Figure 29. Psychological distress (BDI; 0–63) high is poor outcome final values) at ≤3 months

Figure 30. Psychological distress HDRS; 0–52; high is poor outcome; change scores and final values at ≤3 months

Figure 31. Psychological distress (HDRS; change score; 0–52; high is poor outcome) at >3 months

Figure 32. Sleep (Visual analogue sleep quality scale; 0–10, final values, high is good outcome) at ≤3 months

Figure 33. Sleep (Nottingham Health Profile sleep subscale; 0–100; final values, high is poor outcome) at ≤3 months

Figure 34. Sleep (VAS; 0–10, change scores, high is poor outcome) at >3 months

Figure 35. Discontinuation at ≤3 months

Figure 36. Discontinuation at >3 months

E.2. Acupuncture versus usual care

Figure 37. Pain (VAS; 0–10; final & change scores; high is poor outcome) at ≤3 months

Figure 38. Pain (SF McGill Pain Questionnaire and Northwick pain questionnaire; final values, high is poor outcome) at ≤3 months

Figure 39. Pain (Neck pain and disability scale; 0–100, change scores, high is poor outcome) at ≤3 months

Figure 40. Pain (Northwick park questionnaire; 0–100, final values, high is poor outcome) at >3 months

Figure 41. Quality of life (SF36 physical component; 0–100; change scores; high is good outcome) at ≤3 months

Figure 42. Quality of life (SF36 mental component; 0–100; change scores; high is good outcome) at ≤3 months

Figure 43. Quality of life (SF36 physical functioning subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 44. Quality of life (SF36 role limitation subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 45. Quality of life (SF36 pain subscale; 0–100; change scores; high is good outcome at ≤3 months

Figure 46. Quality of life (SF36 general health subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 47. Quality of life (SF36 vitality subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 48. Quality of life (SF36 social functioning subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 49. Quality of life (SF36 role limitation subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 50. Quality of life (SF36 mental health subscale; 0–100; change scores; high is good outcome) at ≤3 months

Figure 51. Quality of life (EQ-5D, high is good outcome, −0.594–1, final values) at >3 months

Figure 52. Physical function (Neck Disability Index; 0–100; final scores; high is poor outcome) at ≤3 months

Figure 53. Physical function (6 minute walk test; metres, change scores) at ≤3 months

Figure 54. Psychological distress (BDI depression subscale; 0–62, high is poor outcome, final values) at ≤3 months

Figure 55. Psychological distress (BDI anxiety subscale;0–62, high is poor outcome, final values) at ≤3 months

Figure 56. Pain self-efficacy (Chronic pain self-efficacy scale, 0–8, high is good outcome) at >3 months

Figure 57. Pain interference (BPI pain interference subscale; 0–10; final scores; high is poor outcome) at ≤3 months

Figure 58. Sleep (Pittsbugh Sleep Quality Index; 0–21; final values, high is poor outcome) at ≤3 months

Figure 59. Discontinuation at ≤3 months

Appendix H. Health economic evidence tables

Download PDF (292K)

Appendix I. Excluded studies

I.2. Excluded health economic studies

None.

Appendix J. Research recommendations

Research question:

What is the clinical and cost-effectiveness of repeat courses of acupuncture or dry needling for the management of chronic primary pain in adults?

Why this is important:

Evidence from this guideline has demonstrated that acupuncture is a clinically and cost effective treatment option for the management of chronic primary pain. This has therefore been recommended as an intervention that should be considered for this population. The recommendation for acupuncture is restricted to a course of acupuncture that lasts no more than 5 hours in total. As a chronic condition, treatments with sustained benefits or those that remain effective when reintroduced are of utmost relevance to people with chronic primary pain. However, there was no evidence included in the review to inform whether or not the benefits of acupuncture would be sustained once treatment finished, or what the effectiveness would be if repeat courses were offered should the benefits wear off. Repeat courses would have cost implications for the NHS, therefore without evidence of effectiveness they cannot be recommended. This research would seek to answer that question in order to inform future updates of this guideline.

PICO question

Population: People with Primary Chronic Pain aged 16 years or over who have received one course of acupuncture according to the guideline recommendations.

Intervention(s):

  • Chinese or Western Acupuncture, maximum 5 hours of healthcare professional’s time. Delivered by a band 7 or lower healthcare professional in a community setting.
Comparison:
  • Usual care
  • Sham or placebo.
Outcome(s):
  • Pain reduction
  • Health related quality of life (measured by the EQ5D)
  • Physical function (e.g. Oswestry disability inventory, Roland Morris disability questionnaire)
  • Psychological distress (depression/anxiety) (preferably Hospital Anxiety and Depression Scale)
  • Pain interference (brief pain inventory interference subscale)
  • Pain self-efficacy (pain self-efficacy questionnaire)
Secondary outcomes: healthcare utilisation, sleep, discontinuation.

Importance to patients or the populationIf there is additional benefit from repeat courses of interventions which have already proven to be effective, patients could be offered further treatment if their symptoms worsened, following initial good response to intervention. Conversely, if repeat courses are demonstrated not to be effective, it would enable treatment to be targeted to alternative options that would be more likely to be of benefit to the patient.
Relevance to NICE guidanceThe evidence reviewed within the current guideline only enabled recommendations to be made for one course of treatment. High quality research in this area would generate new evidence and may enable future updates of this guidance to make recommendations for ongoing treatment.
Relevance to the NHSEvidence informing whether repeat courses of the intervention are effective for those who have benefitted previously would help make best use of NHS resources. Although an intervention should not be offered without evidence of effectiveness, if evidence does support its use it can help reduce unnecessary resource use and better target the treatment for this population, potentially reducing downstream resource use.
National prioritiesNone
Current evidence baseThe evidence included in chapter G all relates to single courses of treatment. It cannot be assumed that repeat courses in people who have already received this intervention will have equal effectiveness, and the number of repeat courses offered would also impact on the cost-effectiveness. Without the clinical evidence to inform this, recommendations cannot be made on repeat courses.
EqualityNo specific equality issues
Study designRandomised controlled trial with a long-term follow up, minimum 12 months, in people with chronic primary pain who have previously had a course of acupuncture that was deemed to be beneficial.
FeasibilityThere are no feasibility issues with this proposed research. There are a large number of people with chronic primary pain, and if some of these people acupuncture as part of their care as this guideline recommends, there will be people suitable to be recruited into such a trial.
Other commentsNone.
ImportanceHigh: the research is essential to inform future updates of key recommendations in the guideline.

Intervention evidence review underpinning recommendation 1.2.5 and the research recommendation in the NICE guideline

This evidence review was developed by the National Guideline Centre based at the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK569984PMID: 33939355

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