Microsoft word - evidence for acupuncture relevant to primary care.doc
The latest evidence for acupuncture – updated 28/02/11 Compiled by Mike Cummings, Medical Director of the British Medical Acupuncture Society Contact: Allyson Brown, Support Manager to MD BMAS, 02077139437, [email protected]
o Bowsher D. Mechanisms of acupuncture. In: Filshie J, White A, editors. Medical Acupuncture - A Western Scientific Approach. 1st ed. Edinburgh: Churchill Livingstone; 1998. p. 69-82.
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Oxford Textbook of Palliative Medicine. Oxford: Oxford University Press; 2004. p. 410-24.
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editors. Soft Tissue Rheumatology. Cambridge: Oxford University Press; 2004. p. 275-82.
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McMahon S, Koltzenburg M editors. Wall and Melzack's Textbook of Pain. 5th ed. Philadelphia: Churchill Livingstone; 2005. p. 583-90.
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systems. In: Ernst E, White A, editors. Acupuncture - A Scientific Appraisal. 1 ed. Oxford: Butterworth Heinemann; 1999. p. 93-106.
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Acupuncture in experimental pain
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Medical Acupuncture - A Western Scientific Approach. Edinburgh: Churchill Livingstone; 1998. p. 153-76.
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Acupuncture - A Scientific Appraisal. Oxford: Butterworth Heinemann; 1999. p. 60-92.
o Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol Evidence for acupuncture relevant to primary care Chronic low back pain A Cochrane review by Furlan et al of acupuncture and dry needling for low back pain, which included 35 RCTs, concluded that ‘for chronic low back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short term only’.1 A systematic review published in the same year by Manheimer et al also found acupuncture to be significantly more effective than sham acupuncture in chronic low back pain.2 More recent systematic reviews have not included meta-analysis. The Cochrane review (including meta-analysis) is being updated and will be published soon.
Since these reviews there have been several relevant studies published. The ART (Acupuncture Randomised Trial) study (n=298) from the Charite University Medical Center in Berlin of acupuncture for chronic low back pain shows a trend in favour of verum over minimal (superficial non-point) acupuncture, but a significant difference between verum and the no (additional) treatment control group.3 The standard deviation in the primary outcome measure in this trial exceeded the estimate in the sample size calculation by 50%, which reduced the intended statistical power of the trial considerably.
Thomas et al reported positive results in their pragmatic trial of acupuncture in chronic low back
pain in primary care (n=241). They demonstrated effectiveness and cost-utility at 24 months – the cost per additional QALY was £4241.4 5 The primary outcome for additional acupuncture over
routine GP care was significant at 24 months but not at 12 months. This is a surprising result following a short course of acupuncture, since the systematic reviews demonstrate a short term effect only.1 2
The results of the very large pragmatic ARC (Acupuncture in Routine Care) study on chronic
low back pain (n=3093 randomised; 11 630 total cohort) confirm effectiveness and cost effectiveness of acupuncture, with the cost per additional QALY of €10 526.6
The GERAC (German Acupuncture trial) trial on low back pain (n=1162)7 found acupuncture
and minimal (sham) acupuncture to be superior to guideline-based standard treatment, however, acupuncture was not statistically superior to minimal (superficial non-point) acupuncture. On the basis of this, the German health authorities have decided that acupuncture will be included in routine reimbursement by social health insurance funds for the treatment of low back pain. One of the key findings in this trial was that the minimal (sham) acupuncture (often viewed as a ‘placebo’ control) was superior to guideline-based standard care (twice as good in the primary outcome measure). This calls into question the validity of making judgements about the clinical relevance of the difference between acupuncture and minimal (sham or ‘placebo’ control) acupuncture.
A large (n=638), four-arm sham controlled and comparative trial performed in the US
demonstrated no difference between individualised acupuncture, standardised acupuncture or simulated acupuncture (using blunted cocktail sticks) on mechanical low back pain, but all three groups were more than twice as effective as usual care alone.8
The NICE guidelines for the early management of persistent non-specific low back pain
(between 6 months and 1 year) include consideration of 12 sessions of acupuncture over 3 months.9 Chronic headache The first Cochrane review on acupuncture for idiopathic headache was tentatively positive.10
Vickers and Wonderling show definitive effectiveness (not efficacy) and cost effectiveness – the
cost per additional QALY was £9180.11 12
Efficacy is still in some doubt following the results of the German ART studies in migraine and
TTH.13 14 Responder rates were good for needling but the rates in the minimal (sham) needling groups were also high. Responder rates were confirmed in a large epidemiological study (n=2022).15 The ARC study on headache confirmed effectiveness compared with usual care alone (n=3182 randomised; 15 056 total cohort),16 and confirmed cost effectiveness (n=2682), with the cost per additional QALY of €11 590.17
The GERAC trial on migraine (n=960) showed that outcomes do not differ between acupuncture,
minimal (sham) needling, and standard therapy (1st beta-blocker; 2nd flunarizine; 3rd valproic acid).18 The responder rates at 26 weeks after randomisation were 47%, 39% and 40% respectively.
Recently the Cochrane review has been updated and split into acupuncture for migraine
prophylaxis,19 and acupuncture for tension-type headache.20 The authors’ conclusions are as follows:
Acupuncture for migraine prophylaxis19 In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.
Acupuncture for tension-type headache20 In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches. Knee osteoarthritis (OA knee) The largest sham controlled trial to date is the GERAC OA knee trial (n=1007).21 This trial used off-point superficial acupuncture in the sham, and a third arm of conservative treatment only (physiotherapy and NSAIDs). Both acupuncture groups (traditional Chinese acupuncture and sham acupuncture) were significantly better than conservative treatment alone. The improvement in WOMAC index in the real acupuncture group was very similar to that in the ART OA knee trial (around 20% reduction at 26 weeks).22 The key difference between ART and GERAC appears to be the effect size in the minimal acupuncture group (it was markedly higher in the GERAC trial than in the ART trial).
An SR by White et al included 13 RCTs.23 The results from the five high quality trials (n=1334)
were pooled in meta-analysis for the primary outcome, and demonstrated a significant effect of acupuncture versus sham in short term pain. A subsequent SR by Manheimer et al found very similar results in their meta-analysis,24 although their interpretation differed in terms of clinical relevance.
The pragmatic ARC study on acupuncture for OA in the hip and knee (n=712 randomised; 3633
total cohort) has demonstrated marked clinical improvement, which is maintained at six months, from a 15 session course of treatment.25 The economic analysis performed alongside the ARC study (n=421) demonstrated cost effectiveness of €17 845 per additional QALY.26
The most recent Cochrane review of acupuncture for peripheral joint OA (lead by Manheimer)27
included 16 trials and 3498 participants. Twelve trials were on OA knee, three on OA hip and one included both. The authors concluded:
Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.
We (White & Cummings)28 argue that you can only test the biological plausibility of
acupuncture against sham acupuncture, not its clinical relevance. Neck pain The first SR of acupuncture for neck pain was neutral,29 but this was based on relatively small trials with methodological drawbacks. The ARC study on neck pain (n=3766 randomised; 14 161 total cohort) clearly demonstrates effectiveness,30 and combined with confirmed efficacy over sham for acupuncture in chronic low back pain [see above], it seems reasonable to postulate that there is also specific efficacy for acupuncture in neck pain. The economic analysis that formed part of the ARC study found the cost per additional QALY of acupuncture in chronic neck pain was €12 469.31
A Cochrane review has been published recently,32 although this does not include the ARC study
above. It found moderate evidence that acupuncture relieves pain in chronic mechanical neck disorders. Interestingly the 10 trials included had a total of only 661 subjects.
Shoulder pain The Cochrane review on acupuncture for shoulder pain in 2005 was inconclusive but suggested that there may be a short term benefit on pain and function.33 Since then there have been two interesting trials. Vas et al demonstrated the advantage of manual acupuncture to a single point (ST38) versus sham (mock TENS) along with physical therapy rehabilitation for shoulder pain in 425 subjects.34 More recently the GRASP trial (German Randomized Acupuncture trial for chronic Shoulder Pain) tested acupuncture against a distant superficial off-point sham and conventional orthopaedic care in 424 subjects with chronic shoulder pain.35 Acupuncture proved to be superior to sham and conventional orthopaedic care, although the dropout rate in the sham group was rather high at 45%. Fibromyalgia An SR in 1999 suggested some effect,36 but was based on one high quality trial.37 There have been three trials of acupuncture in fibromyalgia since.37-40 Two high quality trials using EA have been positive.37 41 Another study indicated a dose effect in terms of treatment frequency, but the same study failed to show any effect of correct stimulation or location (in TCM terms).39 One RCT showed no effect of acupuncture over pooled results in three control groups; two of the three control groups used needling, and the study was under powered.38 Nausea & vomiting This was the first area with a positive SR.42 The best evidence is for PONV, in which the NNT is 4 to 5 for early PONV.43 Not so relevant for primary care, but even Bandolier said it was probably worth using! http://www.jr2.ox.ac.uk/bandolier/band71/b71-9.html
The latest Cochrane review on the subject concludes:44 P6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.
Overactive bladder A trial of electroacupuncture to SP6, referred to by urologists as PTNS (percutaneous tibial nerve stimulation), has demonstrated efficacy of this intervention compared with sham (including the Streitberger needle) in 220 subjects with overactive bladder symptoms.45 Other studies suggest that the technique compares favourably to tolterodine,46 and that it is a viable long term therapy.47 Audits in primary care These are small print, but Juliette Ross’s audit shows dramatic reductions in referral rates.48-50 Key to abbreviations ARC – acupuncture in routine care (large cohort studies, some with randomised elements; also part of the German Health Insurance Modellvorhaben; Berlin group) ART – acupuncture randomised trial (part of the German Health Insurance Modellvorhaben – trial phases; Berlin group) GERAC – German acupuncture trial (part of the German Health Insurance Modellvorhaben; Bochum group) GRASP – German randomized acupuncture trial for chronic shoulder pain NNT – number needed to treat OA – osteoarthritis PONV – postoperative nausea and vomiting QALY – quality adjusted life year (parameter used in economic analysis of healthcare interventions) SR – systematic review TENS – transcutaneous electrical nerve stimulation
1. Furlan AD, van Tulder MW, Cherkin DC, Tsukayama H, Lao L, Koes BW et al. Acupuncture and dry-needling for
low back pain. Cochrane Database Syst Rev 2005;(1):CD001351. PM:15674876
2. Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med 2005;142(8):651-63. PM:15838072
3. Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S et al. Acupuncture in patients with chronic low
back pain: a randomized controlled trial. Arch Intern Med 2006;166(4):450-7. PM:16505266
4. Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell MJ et al. Randomised controlled trial of a
short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ 2006;333(7569):623. PM:16980316
5. Ratcliffe J, Thomas KJ, MacPherson H, Brazier J. A randomised controlled trial of acupuncture care for persistent
low back pain: cost effectiveness analysis. BMJ 2006;333(7569):626. PM:16980315
6. Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K et al. Pragmatic randomized trial evaluating the
clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol 2006;164(5):487-96. PM:16798792
7. Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C et al. German Acupuncture Trials
(GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med 2007;167(17):1892-8. PM:17893311
8. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE et al. A randomized trial comparing
acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med 2009;169(9):858-66. PM:19433697
9. NICE guideline on low back pain: early management of persistent non-specific low back pain. 13 May 2009.
Available from http://guidance.nice.org.uk/CG88 (accessed on 13 May 2009).
10. Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A et al. Acupuncture for idiopathic headache.
Cochrane Database Syst Rev 2001;(1):CD001218. PM:11279710
11. Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith CM, Ellis N et al. Acupuncture for chronic headache in
primary care: large, pragmatic, randomised trial. BMJ 2004;328(7442):744. PM:15023828
12. Wonderling D, Vickers AJ, Grieve R, McCarney R. Cost effectiveness analysis of a randomised trial of
acupuncture for chronic headache in primary care. BMJ 2004;328(7442):747. PM:15023830
13. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C et al. Acupuncture for patients with migraine: a
randomized controlled trial. JAMA 2005;293(17):2118-25. PM:15870415
14. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S et al. Acupuncture in patients with tension-
type headache: randomised controlled trial. BMJ 2005;331(7513):376-82. PM:16055451
15. Melchart D, Weidenhammer W, Streng A, Hoppe A, Pfaffenrath V, Linde K. Acupuncture for chronic headaches--
an epidemiological study. Headache 2006;46(4):632-41. PM:16643558
16. Jena S, Witt CM, Brinkhaus B, Wegscheider K, Willich SN. Acupuncture in patients with headache. Cephalalgia
17. Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN. Cost-effectiveness of acupuncture treatment in patients
with headache. Cephalalgia 2008;28(4):334-45. PM:18315686
18. Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A et al. Efficacy of acupuncture for
the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 2006;5(4):310-6. PM:16545747
19. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for migraine prophylaxis.
Cochrane Database Syst Rev 2009;(1):CD001218. PM:19160193
20. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for tension-type headache.
Cochrane Database Syst Rev 2009;(1):CD007587. PM:19160338
21. Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C et al. Acupuncture and knee osteoarthritis: a
three-armed randomized trial. Ann Intern Med 2006;145(1):12-20. PM:16818924
22. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S et al. Acupuncture in patients with osteoarthritis of
the knee: a randomised trial. Lancet 2005;366(9480):136-43. PM:16005336
23. White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review.
Rheumatology (Oxford) 2007. PM:17215263
24. Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Meta-analysis: acupuncture for osteoarthritis of the knee.
Ann Intern Med 2007;146(12):868-77. PM:17577006
25. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with osteoarthritis
of the knee or hip: A randomized, controlled trial with an additional nonrandomized arm. Arthritis Rheum 2006;54(11):3485-93. PM:17075849
26. Reinhold T, Witt CM, Jena S, Brinkhaus B, Willich SN. Quality of life and cost-effectiveness of acupuncture
treatment in patients with osteoarthritis pain. Eur J Health Econ 2007. PM:17638034
27. Manheimer E, Cheng K, Linde K, Lao L, Yoo J, Wieland S et al. Acupuncture for peripheral joint osteoarthritis.
Cochrane Database Syst Rev 2010;(1):CD001977. PM:20091527
28. White A, Cummings M. Does acupuncture relieve pain? BMJ 2009;338:a2760. PM:19174437 29. White AR, Ernst E. A systematic review of randomized controlled trials of acupuncture for neck pain.
Rheumatology 1999;38(2):143-7. PM:0010342627
30. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture for patients with chronic neck
31. Willich SN, Reinhold T, Selim D, Jena S, Brinkhaus B, Witt CM. Cost-effectiveness of acupuncture treatment in
patients with chronic neck pain. Pain 2006. PM:16842918
32. Trinh KV, Graham N, Gross AR, Goldsmith CH, Wang E, Cameron ID et al. Acupuncture for neck disorders.
Cochrane Database Syst Rev 2006;3:CD004870. PM:16856065
33. Green S, Buchbinder R, Hetrick S. Acupuncture for shoulder pain. Cochrane Database Syst Rev
34. Vas J, Ortega C, Olmo V, Perez-Fernandez F, Hernandez L, Medina I et al. Single-point acupuncture and
physiotherapy for the treatment of painful shoulder: a multicentre randomized controlled trial. Rheumatology (Oxford) 2008;47(6):887-93. PM:18403402
35. Molsberger AF, Schneider T, Gotthardt H, Drabik A. German Randomized Acupuncture Trial for chronic shoulder
pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment. Pain 2010;151(1):146-54. PM:20655660
36. Berman BM, Ezzo J, Hadhazy V, Swyers JP. Is acupuncture effective in the treatment of fibromyalgia? J Fam Pract 1999;48(3):213-8. PM:0010086765
37. Deluze C, Bosia L, Zirbs A, Chantraine A, Vischer TL. Electroacupuncture in fibromyalgia: Results of a controlled
trial. BMJ 1992;305(6864):1249-52
38. Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D. A randomized clinical trial of
acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med 2005;143(1):10-9. PM:15998750
39. Harris RE, Tian X, Williams DA, Tian TX, Cupps TR, Petzke F et al. Treatment of fibromyalgia with formula
acupuncture: investigation of needle placement, needle stimulation, and treatment frequency. J Altern Complement Med 2005;11(4):663-71. PM:16131290
40. Martin DP, Sletten CD, Williams BA, Berger IH. Improvement in fibromyalgia symptoms with acupuncture:
results of a randomized controlled trial. Mayo Clin Proc 2006;81(6):749-57. PM:16770975
41. Martin DP, Sletten CD, Williams BA, Berger IH. Improvement in fibromyalgia symptoms with acupuncture:
results of a randomized controlled trial. Mayo Clin Proc 2006;81(6):749-57. PM:16770975
42. Vickers AJ. Can acupuncture have specific effects on health? A systematic review of acupuncture antiemesis trials.
J R Soc Med 1996;89(6):303-11. PM:0008758186
43. Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-
analysis. Anesth Analg 1999;88(6):1362-9. PM:0010357346
44. Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting.
Cochrane Database Syst Rev 2009;(2):CD003281. PM:19370583
45. Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL et al. Randomized trial of
percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol 2010;183(4):1438-43. PM:20171677
46. Peters KM, Macdiarmid SA, Wooldridge LS, Leong FC, Shobeiri SA, Rovner ES et al. Randomized trial of
percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol 2009;182(3):1055-61. PM:19616802
47. Macdiarmid SA, Peters KM, Shobeiri SA, Wooldridge LS, Rovner ES, Leong FC et al. Long-term durability of
percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol 2010;183(1):234-40. PM:19913821
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50. Myers CP. Acupuncture in General Practice: Effect on Drug Expenditure. Acupunct Med 1991;9(2):71-2