CLINICAL PAPER - AACP...The aim of the present paper is to put forward and discuss the evidence for the integration of acupuncture into the National Health Service (NHS). In this review,

JOBNAME: jaacp PAGE: 1 SESS: 7 OUTPUT: Thu Jun 28 16:27:25 2012/hling/journals/jaacp/183/00260

Journal of the Acupuncture Association of Chartered Physiotherapists, Autumn 2012, 00–00

CLINICAL PAPER

Reviewing the current evidence base: does it support ouracupuncture service?

A. WhitePeninsula Medical School, Plymouth University, Plymouth, UK

AbstractAcupuncturists know from their clinical experience that acupuncture helps many patients whomight otherwise experience little relief from their symptoms. However, the provision ofacupuncture within physiotherapy services in the UK National Health Service (NHS) variesbetween trusts. Since NHS decisions are made on the basis of evidence, the facts that supportacupuncture need to be presented well and defended effectively in order to overcome anynatural resistance to this form of treatment from those who are insufficiently well informedabout it. First, the evidence shows that acupuncture is safe in the hands of trained professionals.The evidence for the efficacy and cost-effectiveness of acupuncture is now sufficiently welldeveloped for physiotherapists to be able to argue strongly for its integration in treatment forthree conditions: knee pain, back pain and tension-type headache. The evidence is alsopromising for shoulder conditions, neck pain and post-operative pain. More proof is requiredin order to support acupuncture treatment for other musculoskeletal conditions, such as lateralepicondylitis and plantar fasciitis, and neurological or respiratory conditions before recommen-dations can be made to integrate it in routine healthcare.

Keywords: acupuncture, evidence-based medicine, headache, low back pain, osteoarthritis.

IntroductionAcupuncture has been adopted with enthusiasmby practitioners in many different fields and isbecoming established as a valuable therapy, bothin its own right and in conjunction with othertreatments, for many conditions that are other-wise difficult to treat. The reasons why manypractitioners are individually so enthusiasticabout acupuncture and are convinced that it isnot ‘‘just a placebo’’ have not been studiedclosely, but their interest is more likely to bebased on clinical observations than evidencefrom clinical trials. The pattern of the responsein different conditions is convincingly differentfrom a placebo effect: expectation seems to beruled out when the response is delayed until the

following day, even when not suggested, oroccurs only after the treatment has beenchanged; and a conditioned response seems to beexcluded if there is no reaction to the firsttreatment, but response accumulates over severalsessions. Further evidence that acupuncture nee-dles stimulate biological mechanisms is the con-sistency of adverse systemic events such asnausea, headache or lethargy. Additionally, lab-oratory evidence from animal studies, or objec-tive measures in human subjects, supportsacupuncture’s potential to have effects beyondplacebo.

Acupuncture seems to be increasingly adoptedin healthcare, but common experience suggests itis far from completely integrated for all patientswho could benefit. Despite many positive expe-riences from patients and acupuncturists, otherclinicians are still cautious and are concerned thatacupuncture is implausible, or ‘‘not quite respect-able’’, because they think it is not based on

Correspondence: Dr Adrian White, Clinical Research

Fellow, Peninsula Medical School, Plymouth University,

N21 ITTC Building, Tamar Science Park, Plymouth

PL6 8BX, UK (e-mail: [email protected]).

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scientific principles (McLachlan 2010). Manyacupuncturists continue to practise using tradi-tional concepts, such as that diseases involvedisturbance of Qi, which can be diagnosed fromthe history and corrected by needling specificpoints. The fact is that the traditional Chineseapproach to acupuncture has been battered byclinical trial evidence, particularly the results ofthe large German ‘‘Modellvorhaben’’ series ofstudies (Cummings 2009), which showed thatacupuncture is greatly superior to usual care, butthe precise location of needling makes littledifference.

NeuromodulationThe current evidence from clinical trials givesmore support to the concept that acupunctureneedles operate by ‘‘neuromodulation’’, i.e. influ-encing the function of the nervous system bystimulating peripheral nerves (Zhao 2008). Thesite of the stimulation will be more important forsome conditions than for others; for example,myofascial trigger points are best needled quiteprecisely, but generalized effects (e.g. onmigraine or hot flushes) can be obtained bystimulating nerves in many places, although theeffect is probably stronger at specific sites, asdiscovered by the Chinese. This is the funda-mental approach that has variously been called‘‘Western medical’’ or ‘‘scientific’’ acupuncture,and that seems best for promoting the integra-tion of acupuncture in a modern health service.Many non-acupuncturists are still not aware ofthe neurological explanation, and until they are, itseems that acupuncture will continue to have anuphill struggle for adoption. This should not beunderstood as a total rejection of the Chineseconcepts, but a comment that the idea of neuro-modulation is easier for a conventional healthservice to understand than Qi, meridians,Stomach points in the leg and the body’s rep-resentation in the ear.

Integration of acupuncture should depend onthe evidence – first, evidence of safety, and thenof effectiveness and cost-effectiveness.

There is little doubt about the safety of acu-puncture when used by trained professionals.Members of the Acupuncture Association ofChartered Physiotherapists collaborated with theSurvey of Adverse Events Following Acupunc-ture (SAFA) study in which 23 physiotherapists

and 36 doctors kept accurate records of alladverse events over 21 months in 32 000 consul-tations. There were no serious adverse eventsand minor events occurred in approximately 7%of consultations (White et al. 2001a, b). The datafrom the German studies also demonstrate acu-puncture’s safety in routine care (Witt et al.2009). Acupuncture in the hands of profession-als is safe and often much less dangerous thanother treatment options such as non-steroidalanti-inflammatory drugs.

Towards an understanding of theevidenceTherefore, integration depends on evidence ofeffectiveness and cost-effectiveness. Presentingsuch evidence clearly and convincingly, anddefending it against criticism, is not always easy.While anyone preparing themselves for this taskdoes not need advanced research skills, he or shedoes need to study the evidence carefully, par-ticularly with regard to the following threeaspects:

(1) Study design. What is the study designed toshow? Those that simply describe theimprovement in a group of patients treatedwith acupuncture show very little since theimprovement could be a result of time (i.e.the natural history of the condition) or ofother treatments. Therefore, the essentialpurpose of clinical research is to comparetwo groups of patients – an acupuncturegroup and a control group. Different con-trol groups address different questionsand have different degrees of relevance(Table 1).

(2) Critical appraisal. A study might show a par-ticular effect (or perhaps no effect), but thatresult might not be accurate. There are threegeneral reasons for this inaccuracy. Theresult it could be influenced by bias (e.g.patients or acupuncturists wanting to reportgood effects, which would not happen ifthey were blinded), confounding (e.g.patients in the control arm using moremedication) or error (there could be many,including mistakes in the design). Assessingthese inaccuracies is the basis of criticalappraisal. It is recommended that youshould be aware of a study’s weaknesses

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before using it to push for the integration ofacupuncture.

(3) Effect size. The main result of a trial that weare interested in is the difference in theeffects of the treatment and the control onthe outcome score; for example, pain orfunction. However, studies often use differ-ent scales, so these cannot be easily com-pared when combined in a review. Thestandard way of combining informationfrom different scales is called the effect size,which also happens to give good infor-mation for the purpose of assessing whetherresearch is worth using. For example, withregard to pain, the effect size clearly has tobe based on the difference between groupsin the average, or ‘‘mean’’, pain score, but itallows for the idea that the pain scores ofindividual patients are spread around thatmean – some scores will be quite somedistance from the mean, while others will becloser. That spread of scores can be calcu-lated and is called the standard deviation.The effect size is simply the number ofstandard deviations of difference betweenthe groups. In reality, it is unusual to see adifference that is as large as one standarddeviation (although it is possible for anti-biotics, for example), and it is usually lessthan this. By agreement, effect sizes of lessthan 0.3 are ‘‘small’’, those of approximately0.5 are ‘‘moderate’’, and 0.8 or more are‘‘large’’.

Fortunately, effect size is exactly the same asthe figure often used in systematic reviews,although this is called the standardized mean

difference (SMD). The actual amount of theSMD may be negative or positive depending onhow the data have been entered, so a little care isneeded to check that the difference is in thedirection you want. Care is also needed todistinguish SMD from the weighted mean differ-ence, which is simply the difference in scores(e.g. pain scores).

Sham rather than ‘‘placebo’’ acupunctureThe subject of ‘‘placebo’’ acupuncture has beendebated in many papers. The current prevailingview is that, because all the various forms of‘‘pretend’’ acupuncture stimulate the skin to acertain extent (Lundeberg et al. 2008), these arenot inert and should not be called ‘‘placebo’’.Here we use the term ‘‘sham’’ to preserve theidea that it is ‘‘pretend’’ acupuncture, but allowthat it could be an active treatment. A largenumber of patients are needed to show a differ-ence because the effects of real and sham acu-puncture are so similar. One calculation (Linde et

al. 2010) makes that sample size of 800! There-fore, there are no trials that are individually largeenough to be reliable.

AimsThe aim of the present paper is to put forwardand discuss the evidence for the integration ofacupuncture into the National Health Service(NHS).

In this review, the conditions are groupedaccording to the strength of the evidence in theirsupport. The sources for this paper are generallythe latest systematic reviews, particularly

Table 1. Different comparison (control) groups commonly used in acupuncture studies and the relevance of the information that theseprovide

Comparison group Question Greatest relevance

Sham acupuncture (non-penetration, or‘‘incorrect’’ point and/or superficialinsertion)

Does the acupuncture needle have‘‘specific’’ or biological effects in addition to‘‘placebo’’ effects? (Known as ‘‘efficacy’’)

Theoretical, to establish mechanisms; someregard this as testing the validity ofacupuncture

Usual care Is acupuncture effective and cost-effective? Decisions on introducing acupuncture; forchronic conditions when no other treatmentis available

Other interventions Is acupuncture effective and cost-effective? Decisions on refining treatments alreadyoffered

Acupuncture as adjunct to therapy versustherapy alone

Does acupuncture add to the effect of othertreatments?

Decisions on addition of acupuncture (e.g.to physiotherapy departments)

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Cochrane Reviews, updated with subsequenttrials, if necessary, and published guidelines suchas those of the National Institute for Health andClinical Excellence (NICE). Another usefulresource is the BMJ Group’s Clinical Evidencedatabase (http://clinicalevidence.bmj.com/).

In addition, information is emerging from theAcupuncture Trialists’ Collaboration, a partner-ship between the principal investigators of 29trials of spinal pain, osteoarthritis (OA) andheadache that meet certain quality criteria. Theanalysis combines the data from 17 892 individ-ual patients. Publication of the full results is stillawaited, but the headline figures reported atmeetings show that acupuncture has significanteffects compared with sham as well as with noacupuncture (including all kinds of control inter-ventions). The data will clearly be of high qualityand reliable, and will be particularly useful forexamining factors that predict which type ofpatient responds best.

Section 1: Acupunctureeffectiveness clearly based onevidenceThe evidence for the following is mainly basedon Cochrane Reviews, recent randomized con-trolled trials (RCTs) not included in the latestreview and NICE guidelines, where applicable.

Knee osteoarthritisThe evidence for the effectiveness of acupunc-ture for the symptoms of knee OA is clear,probably the clearest for any condition. The

balance of studies show that acupuncture issuperior to sham acupuncture for pain andfunction, and very much superior to waiting listcontrol. One study alone is out of line with thisevidence and merits closer scrutiny. Acupunctureis also demonstrably safe and cost-effective fortreating knee pain.

The current Cochrane Review of acupunctureincludes OA of all peripheral joints (Manheimeret al. 2010), and appraises a total of 16 trials and3498 participants. Twelve of the RCTs examinedincluded only people with OA of the knee, threeonly OA of the hip and one of either. Onepositive RCT (Weiner et al. 2007), which usedperiosteal pecking, was excluded because thiswas not traditional Chinese acupuncture. Sixother RCTs were excluded because they hadobservation periods of less than 6 weeks. This isa long, scrupulously argued review, and it istempting to use the ‘‘Plain language summary’’ asa short-cut. Unfortunately, that summary onlydescribes the comparison between acupunctureand sham.

The meta-analysis of acupuncture againstsham acupuncture, which is what the authorswere most interested in, is shown in Fig. 1, andthe main results of all the analyses are listed inTable 2. For short-term pain, the effect sizeagainst sham is small (–0.28), whereas the effectsize against no acupuncture is large (–0.96).

The (‘‘small’’) matter of clinical relevance. The mainconclusion of Manheimer et al.’s (2010) report

Heterogeneity:

Figure 1. Meta-analysis of acupuncture versus sham acupuncture for osteoarthritis: (SMD) standardized mean difference;and (CI) confidence interval.

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could be seen as a ‘‘killer blow’’ against acupunc-ture – that the effects are small and not clinically

relevant. They defined ‘‘clinically relevant’’ on thebasis of a study in which patients with knee OAscored the change in the Western Ontario andMcMaster Universities Arthritis Index(WOMAC) with a course of rehabilitation, andat the same time, judged whether they regardedthemselves as improved or not. The minimumclinical difference was an approximately 20%reduction in the starting symptom, which con-verts to effect sizes of 0.39 for WOMAC painand 0.37 for WOMAC function (Angst et al.2002). Acupuncture’s difference from sham wassmaller than this.

Nevertheless, the present author believes thatthis argument is misguided: the purpose ofcomparing acupuncture with sham is to settle anacademic question: Does acupuncture operateentirely by placebo or do the needles have some‘‘biological’’ effect? Any treatment that is to bepurchased by health services using publicresources needs to demonstrate first that it is notentirely placebo. Then it needs to demonstratethat it is clinically valuable, which is the conceptof ‘‘clinical relevance’’. This involves comparingthe treatment with other existing choices. Butsham acupuncture is designed to be inactive or atleast less active than the real thing: so shamacupuncture is not a treatment choice, and infact, it would be unethical to offer sham acu-puncture to patients without informing them.Therefore, comparison with sham acupuncturecannot be used for establishing clinical relevance!

For ‘‘clinical relevance’’, acupuncture has to becompared with other clinical options. In mostcases, this will be usual care (overall effectsize=0.97, a large effect). Even compared withguideline-based treatment, medication, infor-

mation and physical therapy, acupunctureshowed an effect size of 0.67 (Scharf et al. 2006).These effect sizes are much larger than the effectof needles alone, and of course, they includeexpectation, the practitioner effect, the ritual ofacupuncture and so on – but both of these areintegral to the acupuncture experience. Theseare the figures to use when assessing clinicalrelevance.

Adequacy of acupuncture: more than six sessions and

electroacupuncture (EA). Unfortunately, there islittle definite knowledge on the best form ofacupuncture to produce the greatest effect, andthe small amount of objective clinical researchthat does exist is not particularly helpful (Whiteet al. 2008). Reviewers have shown that morethan six sessions produce greater effects (Ezzo et

al. 2000), and both Manheimer et al. (2010) andothers found that EA is independently associatedwith the greater effect than manual acupuncture.

Systematic reviews could be including RCTsthat used inadequate acupuncture. Manheimer et

al. (2010) dealt with this by asking experts toassess the studies for: the choice of acupuncturepoints; the number of sessions; the needlingtechnique; and the acupuncturist’s experience.Five studies (Christensen et al. 1992; Takeda &Wessel 1994; Haslam 2001; Foster et al. 2007;Williamson et al. 2007) were declared inadequatebecause of too few acupuncture treatments. Insubgroup analysis, the trials that used a ‘‘suf-ficient’’ number of sessions and those that usedEA showed larger effects. However, the ‘‘head-line’’ results used in the summary included evi-dence from studies with inadequate acupuncture.

Another approach is to set objective criteria.In the paper by White et al. (2007), the authorsonly included studies that fulfilled the followingcriteria: those involving at least six treatments ata minimum of weekly intervals; those using atleast four needles for a minimum of 20 min; andthose in which De Qi was elicited or electricalstimulation was used.

A closer look at the trials. One of these sham-controlled trials is particularly relevant to thepresent paper because it found no additionalbenefit from adding a 6-week course of manualacupuncture to a 6-week course of physio-therapy-led exercise (Foster et al. 2007). Patients

Table 2. Effect sizes of acupuncture for peripheral joint osteo-arthritis (from Manheimer et al. 2010): (SMD) standardized meandifference

Outcome Effect size (SMD) Confidence interval

Sham acupuncture

Pain, short-term –0.28 –0.45 to –0.11Function, short-term –0.28 –0.46 to –0.09Pain, 6 months –0.10 –0.21 to –0.01

Waiting list

Pain, short-term –0.96 –1.19 to –0.72Function –0.89 –1.18 to –0.60



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referred for NHS physiotherapy were random-ized to three groups, all receiving six sessions oflower-limb-focused exercise. One group receivedno additional treatment, another underwentadjunctive treatment with real acupuncture andthe third were given sham acupuncture withnon-penetrating needles. Neither real nor shamacupuncture added significant improvements forpain during activities or physical function overthe exercise-only group over the following12 months – nor was there any differencebetween the acupuncture and sham acupuncturetreatment groups.

The study was designed and conducted tohigh standards and published in an eminentjournal. Therefore, its results are highly relevantto decisions about providing acupuncture intypical NHS physiotherapy environments. Thesefindings warrant close attention and carefulinterpretation. Foster et al.’s (2007) principalconclusion was that acupuncture (as providedin the trial) brings no benefit in addition to agood exercise intervention (as delivered in thetrial) when provided to the typical patientreferred for NHS physiotherapy from primarycare. A simultaneous commentary (Herbert &Fransen 2007) stated: ‘‘There is little point inrecommending acupuncture to people withchronic knee pain who are already undertaking acourse of exercise.’’ This sweeping interpretationis likely to lead to a disservice to our patients.It is important to recognize that the Fosteret al.’s (2007) conclusions apply only to thecircumstances of the study and not to allcircumstances.

For example, the study is not relevant whenphysiotherapists offer acupuncture to selectedpatients who will not, or cannot, undertakeexercise (e.g. because of pain) or who have hadno response to exercise. In this trial, the partici-pants did not have very severe knee pain atbaseline and might not have been selected foracupuncture by other physiotherapists. Thestudy is also not relevant when physiotherapistsoffer patients EA or more than six sessions.

The negative conclusion of Foster et al.’s(2007) paper only applies to the arrangements inthat study, i.e. six sessions of manual acupunc-ture in unselected patients. In clinical practice, itis perfectly reasonable to provide 10 sessions ofEA to selected patients; for example, those who

are not benefitting from exercise alone. Indeed,this latter option gains some support fromanother RCT in which physiotherapy (six physi-cal therapy sessions including isometric trainingof muscles, walking school and exercises withmedical equipment) and medication were offeredto all (Scharf et al. 2006). The RCTs are notentirely comparable because the acupuncturistsinvolved in this latter study did not give thephysical therapy, and only around one-third ofparticipants in the acupuncture group took upthe offer of physical therapy compared toapproximately two-thirds of those in the conven-tional medical care group. Nevertheless, therewas a large effect in this German study: successrates were significantly greater for acupuncture(53%) and sham acupuncture (51%) than forconservative therapy alone (29%).

To continue exploring the possible reasons forthe lack of any additional effect of acupuncturein Foster et al.’s (2007) trial, the combination ofexercise and acupuncture as co-interventions isproblematic since these may both produce aneffect via muscles (Andersson & Lundeberg1995). In these moderately affected patients, theregime of exercise alone might have achieved allor nearly all the benefit that was possible, whichis called a ‘‘ceiling’’ effect, leaving no room foracupuncture to add any more benefit.

This lack of effect of acupuncture is a problemwhen we consider the second major finding –that acupuncture was not superior to shamacupuncture. One could argue that this analysiswas not justified: since neither real nor shamacupuncture showed an effect, then it is super-fluous to compare them. Equally, the compari-son of acupuncture and sham acupuncture byFoster et al. (2007) should not be included insystematic reviews of acupuncture against shamacupuncture.

Other analyses of acupuncture for osteoarthritis. So far,the discussion has centred on sham-controlledstudies (Table 1, comparison 1), which are noteven relevant to patients! Compared with waitinglist group, acupuncture showed statistically sig-nificant, clinically relevant short-term improve-ments in OA pain and function, as shown inTable 2. These changes represent about a 30%improvement in patients’ symptoms – worth-while, though not dramatic.

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In the head-on comparisons of acupuncturewith the ‘‘supervised osteoarthritis education’’and the ‘‘physician consultation’’ control groups,acupuncture was associated with clinically rel-evant short- and long-term improvements inpain and function. In the head-on comparisonsof acupuncture with ‘‘home exercises/adviceleaflet’’ and ‘‘supervised exercise’’, acupuncturewas associated with similar treatment effects tothe controls.

The role of placebo effects in practice. In concluding,Manheimer et al. (2010, p. 000) seem to dismissacupuncture on the grounds that it ‘‘may be due to

expectation or placebo effects’’ [present author’s ital-ics]. Commissioners also might produce thisargument and one must be prepared for it.Acupuncture produces a strong placeboresponse, one which is stronger than that ofdrugs, but acupuncture is acceptable because italso has a true ‘‘specific’’ effect. In any case,non-specific effects are just as ‘‘biological’’ or‘‘specific’’ as the so-called specific effects causedby changes in the brain function. AnthonyCampbell (2009) argued that this distinctionbetween ‘‘specific’’ and ‘‘placebo’’ effects islargely a function of language, which in turnlimits the way we understand all this.

Cost-effectiveness and the impact of group acupuncture.

Three economic analyses of acupuncture forknee pain have been published. First, Reinhold et

al. (2008) found that acupuncture cost V22 314per quality-adjusted life year (QALY) from asocietal perspective – which means taking allcosts and savings into account such as loss ofwork, not just health costs. Secondly, interest-ingly, Foster et al.’s (2007) study, which foundthat acupuncture was not more effective whenadded to physiotherapy, nevertheless reportedthat it improved cost-effectiveness. Althoughacupuncture raised the cost of treatment slightly(from £209 to £314), it also improved quality oflife (QoL), which made the small extra costworthwhile at £3889 per QALY (Whitehurst et

al. 2011). Thirdly, a conference abstract from theUSA reported the mean cost-effectiveness ofacupuncture as $32 000 per QALY gained(Whitehurst et al. 2011).

The main cost of acupuncture is the acupunc-turist’s time. To increase the efficiency of the

clinic, there are several projects in which acu-puncture is given to patients in a group by asuitably trained nurse. Patients may even takepart in their own treatment by manipulatingneedles or adjusting the EA apparatus. Oneproject operates in primary care in St Albans,UK, and a qualitative analysis suggests that thegroup itself brings several added benefits to thepatients – such as support while waiting for theacupuncture effect to start, information aboutresources for people with disabilities and thevalue of meeting other people with similar prob-lems (Asprey et al. 2012). Group acupuncturealso brings benefits to the commissioning groupin savings estimated to be approximately £100000 per annum (White et al. 2012). It could be anappropriate approach for some physiotherapydepartments.

Recommendations for acupuncture in guidelines. Acu-puncture is recommend by five out of eightguidelines on treatment for OA (Zhang et al.2007). The current American College of Rheu-matology guidelines recommend acupuncture forpatients with severe pain who do not want or areunsuitable for knee replacement surgery (Hoch-berg et al. 2012). On the basis of the Modell-vorhaben studies, the German insurancecompanies agreed that acupuncture should beincluded in health provision for knee pain (aswell as back pain) under certain terms andconditions. The Drug and Therapeutics Bulletin con-cluded: ‘‘Acupuncture seems a reasonable optionfor knee OA when lifestyle measures (e.g. edu-cation, weight loss and exercise) and paracetamolare insufficient or contraindicated.’’

However, in the UK, the NICE (2008) guide-line on OA did not recommend acupuncture.This decision was largely based on economicmodelling in the absence of appropriate trial dataon cost-effectiveness. Economic modellingmakes a large number of assumptions and tendsto be inaccurate. ‘‘Clinical relevance’’ is a particu-lar problem again: the modelling was done onstudies of acupuncture compared with shamacupuncture, not with the nearest treatmentalternative. The NICE guidelines were underrevision at the time of writing.

Osteoarthritis of other joints. The individual evi-dence for treating the other common forms of



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OA, i.e. in wrist and hip, is much less, and muchless clear, than for the knee. It is a clinicalimpression amongst some that acupunctureseems less effective for OA in joints other thanthe knee.

Low back painThe NICE (2009) report on non-specificchronic low back pain (LBP) (of 6–52 weeks induration) was a landmark for acupuncture – thefirst recommendation by NICE (Savigny et al.2009). Physical exercise and manual therapy werealso recommended. Unfortunately, variousaspects of the NICE recommendations metopposition, including the recommendation foracupuncture because these were announced atthe same time as a new, high-quality RCT thatshowed no difference between acupuncture andsham (Cherkin et al. 2009). Therefore, our mainaim must be to provide information to defendthe NICE recommendation against criticism.

The guidelines for chronic LBP were based onthe Cochrane Review by Furlan (Furlan et al.2005b), which was updated with informationfrom four subsequent RCTs (Brinkhaus et al.2006; Thomas et al. 2006; Witt et al. 2006b; Haakeet al. 2007) and the economic analysis of Thomaset al.’s (2006) study (Ratcliffe et al. 2006). Sincethe NICE report, there has been one furtherlarge, well-performed study. A summary of thedata available at the time of writing was providedby Furlan et al. (2012). For LBP, there were 33

studies in total, including one in Chinese andfour in Japanese.

Acupuncture versus sham acupuncture. The CochraneReview showed that acupuncture had a signifi-cant superiority over sham for pain, but not forfunction (Furlan et al. 2005b). The NICE (2009)guideline included two new studies from thehigh-quality German series (Brinkhaus et al.2006; Haake et al. 2007). Both showed strongtrends towards acupuncture being superior tosham acupuncture (off-point needling). With theaddition of the study by Cherkin et al. (2009), theevidence is still positive overall: acupuncture hasa statistically significant effect over sham acu-puncture in the treatment of chronic LBP (Fur-lan et al. 2012). These results are reproduced inFig. 2. There were 10 trials with 1727 participantsand the effect size was –0.28 [confidence interval(CI)=–0.45 to 0.11].

This small difference is equivalent to about 0.6of a point on a 10-point visual analogue scale(VAS) score, which is not clinically relevant, but ispolitically relevant in demonstrating a specific or‘‘biological’’ effect on chronic LBP. Therefore,the use of public funds is justified in principle:the decision on whether to use it or not dependson the size of its effect and cost compared withother treatments.

Acupuncture compared with usual care and other treat-

ments. The evidence for these comparisons(Table 1, comparisons 2 and 3) is sparse. In

Heterogeneity:

Figure 2. Meta-analysis of sham-controlled randomized controlled trials of acupuncture for low back pain (data derivedfrom Furlan et al. 2012): (SMD) standardized mean difference; and (CI) confidence interval.

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contrast to usual care, acupuncture was superiorfor pain at the end of treatment in three studies(VAS=1.19, 95% CI= �2.17 to�0.21) (Furlanet al. 2012). One of these studies was large,pragmatic and well conducted: patients whoreceived acupuncture had a 37% reduction inpain scores at 3 months compared with a 10%reduction in those on the waiting list (Witt et al.2006b). This is clearly a useful benefit.

Four trials found acupuncture to be no differ-ent from medication and two studies found thatmanipulation was superior to acupuncture.

Acupuncture as an adjunct. In the Cochrane Review(Furlan et al. 2005a), four studies (289 partici-pants) used acupuncture as an adjunct to variousforms of exercise, and compared it to the othertherapy alone. The combined results werestrongly positive for pain and function up to12 months. The effect sizes at 12 months were apain SMD of –0.76 (95% CI=–1.02 to –0.5) anda function SMD of –0.55 (95% CI=–0.92 to–0.18).

Economic evaluation. An economic evaluation wasmade of Thomas et al.’s (2006) study, in which241 patients with LBP recruited by their generalpractitioner (GP) were allocated to acupunctureor usual GP care in a ratio of 2:1 (Ratcliffe et al.2006). The acupuncture treatment increasedcosts by £115 per patient, but improved the QoLso that its cost-effectiveness was £4241 perQALY. This study fits the second comparison inTable 1.

Summary of the evidence and the basis of the NICE

recommendation. The current evidence on chronicLBP demonstrates that acupuncture is signifi-cantly superior to sham acupuncture and so has abiological effect. Acupuncture is superior tousual care, and although there are inconsistenciesin the size of the effect, the one large, well-performed study shows a clinically useful effect(37% compared with 10%) (Witt et al. 2006b).Acupuncture clearly has a clinically useful effectwhen given as an adjunct to other therapies(SMD=0.76).

The overwhelming impression made by theNICE (2009) review is that its authors took acommon-sense approach to the evidence. Theyrecognized the major personal and economic

impact of chronic LBP, and found no evidencethat any particular form of conservative treat-ment was much superior to any other – notsurprisingly. They decided not to put excessiveweight on comparisons with placebo, but weremore impressed by evidence of cost-effectiveness in everyday practice. And, impor-tantly, they recognized that the patient’sexpectations contribute to the effect of anytherapy, specifically recommending that patientpreference should be an important factor indeciding treatment. In these ways, it was alandmark in being guided by the practicalities ofhealth care rather than by the theoretical consid-erations of statisticians. It is worth noting thatthe guideline development group was basedfirmly in primary care, not secondary care likemany other groups.

The NICE (2009) report on LBP did notrecommend electrotherapy treatments such aslaser and interferential current modalities, ultra-sound, or transcutaneous electrical nerve stimu-lation (TENS). Most of the controversy aboutthe NICE report arose from its rejection ofinjection therapy: facet joint injection with eithermethylprednisolone, prolotherapy (sclerosingagents) and intradiscal corticosteroid injectionswere not recommended because of a lack ofevidence for their effectiveness.

HeadacheThe discussion here is based on the evidencepublished in a pair of Cochrane Reviews (Lindeet al. 2009a, b) that used the number of headachedays as the main outcome measure. Patients withchronic headaches would rather spend an extraday without a headache rather than still have aheadache, even if it was milder or shorter. Inlooking at the meta-analyses, headache days inthe two groups can be compared directly or beexpressed as a ‘‘response rate’’, i.e. the numbersof participants who reported a 50% reduction.The response rates of two groups are comparedby a ‘‘risk ratio’’ of responder rates, so that aresult of ratio of 1.0 means no difference. Notethat ‘‘risk’’ can refer to something good, not justsomething bad. Thus, patients are compared fortheir ‘‘risk of having days free of headache’’.

The reviews’ conclusions were based onrisk ratio, but the number of headache days iseasier to apply clinically and so is used here,



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even though the data are sometimes not quiteconsistent.

Tension-type headache. The evidence compiled fortension-type headache is in favour of acupunc-ture, which is both superior to sham and at leastas good as, or superior to, other treatment. Theonly weakness is the small number of studies.

For acupuncture compared with sham acu-puncture, five trials provided data for the meta-analysis and the results were significant. Forexample, in the time window of 3–4 monthsafter randomization, the mean difference inheadache days per 4 weeks was 1.9 days(CI=0.72 to 3.15). This difference was small butsignificant in favour of acupuncture. The effect isalmost entirely a result of one large (n=409)study in the German Modellvorhaben series(Endres et al. 2007), but this work was of verygood quality. Figure 3 shows the reduction inheadache days per month with acupuncture ver-sus sham.

Comparing acupuncture with just using drugsto treat acute headaches, two RCTs with a totalof 1065 patients showed a significant benefitfrom acupuncture. The differences between acu-puncture and waiting list groups for the numberof headache days per month after 3 months were6.4 days (CI=4.0 to 8.8) (Melchart et al. 2005)and 3.4 days (CI=2.6 to 4.2) (Jena et al. 2008),respectively. For technical reasons, these studiescannot be combined.

Comparing acupuncture with physiotherapy,massage or relaxation, the majority of studies hadimportant methodological or reporting short-comings, but generally, these did not find acu-puncture superior.

It is interesting to note a significant shift inthis Cochrane Review’s conclusion from theprevious one (Melchart et al. 2001). The con-clusion changed from ‘‘insufficient evidence’’ to‘‘acupuncture could be a valuable non-pharmacological tool in patients with frequentepisodic or chronic tension-type headaches’’(Linde et al. 2009b, p. 1).

Migraine. Although there is some evidence tosupport using acupuncture to treat acute attacksof migraine, for which, the main concern ofpatients with this condition is the prevention ofsuch attacks. In contrast to tension-type head-ache, acupuncture was not shown to be superiorto sham acupuncture for migraine. Fourteentrials found no significant difference in the effectcompared to sham acupuncture at the end oftreatment (–0.47 days, CI=–2.31 to 1.36).

However, four studies found acupuncture tobe more effective than prophylactic drug thera-pies, mostly metoprolol (–0.58 days, CI=–1.09to –0.07). In addition, in three trials and 2064patients, acupuncture was superior to no acu-puncture by –2.09 days (CI=–2.60 to –1.58).

The Cochrane reviewers concluded that acu-puncture was likely to reduce the frequency ofmigraine headaches, both in combination with orindependent of medication, and that these ben-efits were associated with minimal unwantedeffects. However, the selection of specific pointsis not as important as had been previouslythought. Acupuncture ‘‘should be considered asa treatment option’’ (Linde et al. 2009a, p. 2) forpatients with migraine who need prophylactictreatment because of frequent or insufficientlycontrolled attacks, particularly those who refuse

Heterogeneity:

Figure 3. Meta-analysis of the reduction in headache days per month with acupuncture versus sham: (SMD) standardizedmean difference; and (CI) confidence interval.

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prophylactic drug treatment or experienceadverse effects from such treatment.

According to current evidence, acupuncture issuperior to sham for tension-type headache, butnot for migraine. One reason for this differenceis the possibility of different mechanisms.Migraine is generated centrally within the centralnervous system and so responds in a general wayto needling, and is not very dependent on thelocation or type of needling. Tension-type head-ache will include at least some cases that origi-nate in trigger points around the neck, whichare likely to respond better to local needling ator near the point than to general needlingelsewhere.

Cost-effectiveness. One RCT (Vickers et al. 2004)involved physiotherapists administering up to 12sessions of acupuncture compared with usualcare in 401 participants with chronic headache(predominately migraine) recruited from GPdatabases. The benefits of acupuncture were stillmeasurable at 12 months and patients whoreceived acupuncture experienced 22 fewer head-ache days per year than the control group. Theauthors concluded that the ‘‘[e]xpansion of NHSservices should be considered’’ (Vickers et al.2004, p. 744).

An economic analysis of the above study(Wonderling et al. 2004) found that acupunctureincreased the average cost of health care from£217 to £403, but increased the QoL by a factorof 0.021 QALYs: the cost-effectiveness was£9180 per QALY.

Recommendations for acupuncture in guidelines. Arti-cles reviewing the treatment of tension-typeheadache have been positive for acupuncture; forexample, Nicholson et al. (2011) called it a‘‘first-line treatment’’ for migraine and tension-type headache. The Drug and Therapeutics Bulletin

for tension-type headache and migraine con-cluded: ‘‘Acupuncture seems a reasonableadjunctive treatment for migraine or tension-typeheadaches, particularly in patients not managedby medication or those wishing to pursue non-drug options.’’ Treatments for headache arecurrently being reviewed by NICE is: its draftreport includes acupuncture as an option forboth migraine and tension-type headache.

Section 2: Promising evidenceThis section covers three conditions in which theevidence shows positive trends but is not con-clusive: in an open-minded environment wherepatient preference is taken into account, a casecan certainly be made for treatment with acu-puncture within the NHS.

One major problem with the evidence here isstudy heterogeneity: these are all different fromeach other in their designs – in the diagnosis ofpatients included; in the acupuncture treatment,such as single-point acupuncture, or standardacupuncture with or without EA; in the way thatthe outcome is assessed; and in the time points atwhich this is done. As a result, the trials aredifficult to combine into a meaningful analysis.

Shoulder painThe current Cochrane Review dates from 2005,when the nine available trials provided inad-equate evidence to draw any conclusions (Greenet al. 2005). Several new RCTs have been pub-lished since then and, in particular, the hugeGerman Randomized Acupuncture Trial forchronic shoulder pain (GRASP) study is highlyinfluential (Molsberger et al. 2010). Meta-analyseswere performed for the GRASP paper, but theseshould be regarded with caution because thestudies are heterogeneous and limited to Englishpublications. In addition, it was not possible hereto take formal account of bias and this evidencehas not been peer-reviewed, so it should beregarded as a guide and not definitive.

Acupuncture versus sham treatment. The studiesusing standard acupuncture are summarized inTable 3, and the fresh meta-analysis includingthree new studies shows consistent positiveresults for acupuncture compared with sham(Fig. 4).

Single-point acupuncture. Two studies of this tech-nique used acupuncture as an adjunct to physio-therapy. The first RCT included 35 patients with‘‘frozen shoulder’’, who were given deep acu-puncture 12 times to the Zhongping point on theleg [between Stomach (ST) 36 and ST37, deepneedle 2.5’’ insertion] while exercising the arm, aswell as exercises (Sun et al. 2001). The controlgroup had exercises alone. The second RCT



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included 425 patients with chronic symptoms ofunilateral subacromial syndrome (i.e. rotator cufftendinitis or subacromial bursitis, in some casesassociated with capsulitis) (Vas et al. 2008). Theparticipants had 15 sessions of physiotherapyover 3 weeks, and also received acupuncture ormock TENS once a week. Acupuncture wasgiven deeply to ST38 (5-cm deep) with fourstimulations in a period of 20 min. The resultsare combined in a meta-analysis shown in Fig. 5.The results are consistently in favour of single-point acupuncture, which is a quick and efficienttechnique.

Acupuncture versus other treatments. Four studiespublished in English that involved standard acu-puncture are summarized in Table 4. Reportswere not available for two other studies (Ma et al.2006, Romoli et al. 2000). The positive study bySun et al. (2001) of single-point acupuncture ismentioned above. The overall finding is thatacupuncture is equivalent or superior to anyother treatment for shoulder pain it has beentested against. One study that is particularlyrelevant to physiotherapists found no significantdifference between acupuncture and cortico-steroid injection for subacromial impingement

Table 3. Data for randomized controlled trials of acupuncture versus sham control for shoulder pain: (MA) manual acupuncture; (NSAIDs)non-steroidal anti-inflammatory drugs; and (EA) electroacupuncture

Reference Diagnosis Interventions

Moore & Berk (1976) Peri-articular disease (n=42) MA versus sham (blunt): data not available

Berry et al. (1980) Rotator cuff (n=60) NSAIDs and injection injection versus acupuncture versus placeboNSAIDs versus ultrasound

Kleinhenz et al. (1999) Athletes, rotator cuff (n=52) MA versus sham (blunt)

Ceccherelli et al. (2001) No particular diagnosis (n=44) MA deep versus superficial

Guerra de Hoyos et al. (2004) Any soft tissue diagnosis (n=130) EA versus sham (blunt)

Molsberger et al. (2010) No particular diagnosis (n=424) MA or sham or just exercise

Heterogeneity:

Figure 4. Meta-analysis of acupuncture versus sham for shoulder pain: (SMD) standardized mean difference; and (CI)confidence interval.

Heterogeneity:

Figure 5. Meta-analysis of single-point acupuncture for shoulder pain: (SMD) standardized mean difference; and (CI)confidence interval.

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syndrome (Johansson et al. 2011). Table 4 sum-marizes studies of standard acupuncture versusother treatments for shoulder pain.

Neck painThe Cochrane Review by Green et al. (2005)reached the cautiously positive conclusion thatacupuncture ‘‘may be’’ at least as good as othertreatments for chronic neck pain and possiblybetter than sham (Trinh et al. 2007). The datawere updated this year by Furlan et al. (2012).Not only are the studies for neck pain againheterogeneous, but here the results of individualstudies are inconsistent and so do not provide aconvincing overall picture.

Against sham, there were separate meta-analyses for chronic specific (two trials) orchronic non-specific pain (three trials) (Furlan et

al. 2012). Here, the data are combined into asingle analysis, and added together with twofurther studies comparing acupuncture withsham TENS (White et al. 2004; Vas et al. 2006).Despite the strongly positive result of the studyby Vas et al. (2006), the overall evidence that

acupuncture is superior to sham for treatment ofneck pain is not convincing. Figure 6 shows ameta-analysis of acupuncture compared withsham interventions for short-term neck pain.

In a pragmatic study reflecting routine prac-tice, however, acupuncture proved convincinglymore effective for pain and function: painimproved by 30% in 1880 patients who receivedacupuncture, compared with only 7% of thoseon the waiting list (Witt et al. 2006a).

The evidence on acupuncture is summarizedby the Clinical Evidence database as ‘‘likely to bebeneficial’’.

Post-operative painFor post-operative pain, a review of 15 RCTs ofacupuncture found significant effects of acu-puncture for pain and reduced opioid require-ment up to 72 h after surgery (Sun et al. 2008).This was true for sham-controlled studies foropioid requirement. A review of auricular acu-puncture found eight out of 23 trials positiveand overall ‘‘promising though not compelling’’(Usichenko et al. 2008, p. 000). Since that time, a

Table 4. Summary of studies of standard acupuncture versus other treatments for shoulder pain: (MA) manual acupuncture; (EA)electroacupuncture; and (IFE) interferential electrotherapy

Reference Diagnosis Interventions Result

Dyson-Hudson et al. (2001) Wheelchair users (n=18) MA versus exercise plus bodyworkre-education (Trager)

No difference

Johansson et al. (2005) Impingement (n=85) MA versus ultrasound Acupuncture superior

Cheing et al. (2008) Frozen shoulder (n=70) EA plus exercise versus interferentialplus exercise versus untreated control

No difference

Johansson et al. (2011) Impingement Syndrome (n=91) MA versus corticosteroid injections No difference

Heterogeneity:

Figure 6. Meta-analysis of acupuncture compared with sham interventions for short-term pain: (SMD) standardized meandifference; and (CI) confidence interval.



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survey of the literature has presented moremixed results (Table 5), with one study showinganalgesic effects no different from morphineand others showing effects against shamacupuncture.

An adequate dose of acupuncture seemsessential. Kindberg et al. (2009) found manualauricular needling ineffective for perineal repaircompared with local anaesthetic, which couldhave been anticipated. Table 5 shows a summaryof recent RCTs of acupuncture for postoperativepain.

Section 3: Neutral, inadequate orunsupportive evidenceFor other conditions that a physiotherapist islikely to treat, the balance of evidence cannot beconvincingly stated to be in favour of acupunc-ture. Readers should note that this is certainlynot the same as saying that acupuncture does notwork for these conditions, but simply that the

evidence so far is inadequate to reach anyconclusion.

The evidence on acupuncture for lateral epi-condylitis is provided by small studies withheterogeneous designs, so cannot be regarded asconclusive although it shows interesting trends(see Table 6).

The other conditions for which the evidenceof acupuncture’s effectiveness is generally posi-tive, but less convincingly so, include: othermusculoskeletal conditions such as plantar fascii-tis; gynaecological conditions such as dysmenor-rhoea; neurological conditions including strokeand neuropathy; respiratory conditions includingchronic bronchitis and asthma; and insomnia.

ConclusionThe conditions that physiotherapists commonlytreat that would be better served, at least inselected patients, with additional acupuncturecertainly include OA of the knee, LBP and

Table 5. Summary of recent randomized controlled trials of acupuncture for post-operative pain: (EA) electroacupuncture; and (TENS)transcutaneous electrical nerve stimulation

Reference Surgery Design Result (treatment versus control)

Holzer et al. (2011) Laparoscopy (n=40) Auricular EA versus sham Piritramide dose: 2.3 mg versus 2.6 mg(no significant difference)

Colak et al. (2010) Sternotomy (n=30) Daily EA versus no EA Pethidine dose: 87 mg versus 223 mg

Coura et al. (2011) Cardiac (n=22) EA versus sham TENS, bothpre-operative

Patient-controlled dose: 4.1 mg versus 6.9 mg

Yeh et al. (2010) Spinal (n=99) EA versus sham versus noacupuncture

Significant differences, but not forpatient-controlled analgesic dose

Sahmeddini et al. (2010) Nasal septal (n=90) EA versus sham plus morphine Pain: no significant difference

El-Rakshy et al. (2009) Abdominal (n=107) EA or no EA No significant difference

Kindberg et al. (2009) Post-partum repair (n=207) Auricular acupuncture or localanaesthetic

Pain reports: 89% versus 54%

Usichenko et al. (2007) Arthroscopy (n=120) Indwelling auricular needles in truepoints versus control helix

Ibuprofen dose: 200 mg versus 600 mg

Table 6. Summary of randomized controlled trials of acupuncture for lateral epicondylitis: (EA) electroacupuncture; (MA) manualacupuncture; and (VAS) visual analogue scale

Reference Number of subjects Control group Result (treatment and control)

Fink et al. (2002) 45 Sham Pain VAS=–8.4 versus –4.9

Molsberger & Hille (1994) 48 Sham Response rate=79% versus 25%

Haker & Lundeberg (1990) 82 Sham Response rate=50% versus 21%

Tsui & Leung (2002) 20 EA versus MA Response rate=50% versus 32%

Huang et al. (1998) 93 ‘‘Floating’’ Acupuncture versus EA ‘‘Floating’’ acupuncture was better

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headache, and possibly include shoulder pain,neck conditions and post-operative pain. Cur-rently, the evidence from clinical trials is notconclusively in support of acupuncture for otherconditions. For many other musculoskeletal con-ditions, observational studies suggest that acu-puncture has useful effects, even if the evidenceis not yet convincing. However, other findingsshow that acupuncture is safe and several studieshave demonstrated its cost-effectiveness. Therewill be increasing opportunities to discuss theprovision of acupuncture with GP commission-ers, who may be receptive to acupuncturebecause of its safety and acceptability to patients.Proof of effectiveness will be required to supportthe discussion, and anyone preparing evidenceshould be clear what a trial was designed toshow, whether it counts as high quality and whatthe size of the effect is. Clinically relevant effectsshould be judged in comparison with otheravailable treatments, not sham. Proponentsshould also prepare to argue that the evidence isalready good that acupuncture is superior tosham acupuncture in some conditions and sodoes have a biological effect. It may not benecessary to test acupuncture against shamrepeatedly for every individual condition.

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of Chinese Medicine 30 (1), 13–28.

Adrian White is Clinical Research Fellow at the

Peninsula Medical School, Plymouth University. A

former general practitioner, he has practised acupuncture

since 1979 and has been researching it since 1999.

Adrian has published a number of systematic reviews,

including Cochrane Reviews of acupuncture for smoking

cessation (as first author), tension-type headache and

migraine (both as co-author), and has completed a

number of clinical trials of acupuncture. He is currently

exploring the use of group acupuncture as a cost-saving

initiative in the NHS. Adrian is Editor-in-Chief of

Acupuncture in Medicine.

A. White


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Documents

CLINICAL PAPER - AACP...The aim of the present paper is to put forward and discuss the evidence for the integration of acupuncture into the National Health Service (NHS). In this review,