Does the outcome of acupuncture differ according to the location of sham needling points in acupuncture trials for migraine? A systematic review and network meta-analysis

Abstract

Various acupuncture clinical trials have been conducted on migraine; however, the conclusions remain controversial especially when acupuncture was compared with sham acupuncture. Sham acupuncture is sometimes performed at the same acupuncture points used for verum acupuncture despite the evidence on acupuncture point specificity. Four databases were searched for sham acupuncture or waiting list-controlled acupuncture trials for migraine on December 25, 2023. Sham acupuncture was classified according to the needling points: sham acupuncture therapy at verum points (SATV) or at sham points (SATS). Network meta-analysis was performed based on the frequentist framework for headache pain intensity and response rate. A total of 18 studies involving 1936 participants were analyzed. Headache pain intensity and response rate were significantly improved in verum acupuncture compared with SATS. However, there was no significant difference between SATV and verum acupuncture. When comparing SATS and SATV, there was no significant difference in headache pain intensity and response rate; however, the results were in favor of SATV. The effect of the risk of bias on the certainty of evidence between verum and sham acupunctures was judged to be generally low. SATV should not be misused as a placebo control to evaluate the efficacy of acupuncture.

Keywords

acupuncture therapy / migraine / migraine disorders / sham acupuncture / placebo

References

[1] Shi GX, Yang XM, Liu CZ, Wang LP. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials. Trials 2012; 13(1): 42

[2] Lund I, Näslund J, Lundeberg T. Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist’s perspective. Chin Med 2009; 4(1): 1

[3] Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998; 352(9125): 364–365

[4] Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med 2002; 20(4): 168–174

[5] Birch S, Lee MS, Kim TH, Alraek T. Historical perspectives on using sham acupuncture in acupuncture clinical trials. Integr Med Res 2022; 11(1): 100725

[6] BirchSAlraek TKimKHLeeMS. Placebo-controlled trials in acupuncture: problems and solutions. In: Leung SW, Hu H. Evidence-based Research Methods for Chinese Medicine. Singapore: Springer, 2016: 55–64

[7] Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: a systematic review and network meta-analysis. Heliyon 2024; 10(4): e25650

[8] Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. Needling point location used in sham acupuncture for chronic nonspecific low back pain: a systematic review and network meta-analysis. JAMA Netw Open 2023; 6(9): e2332452

[9] Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. Different outcomes according to needling point location used in sham acupuncture for cancer-related pain: a systematic review and network meta-analysis. Cancers (Basel) 2023; 15(24): 5875

[10] Xing JJ, Zeng BY, Li J, Zhuang Y, Liang FR. Acupuncture point specificity. Int Rev Neurobiol 2013; 111: 49–65

[11] Hsueh KC, Wang JH, Chen CY, Chen JH, Hsiao G, Kuo YC. Harmonic effects of sham acupuncture at Tsu San Li (St-36) in the radial pulse wave. J Tradit Complement Med 2023; 13(6): 568–574

[12] Qiu K, Yin T, Hong X, Sun R, He Z, Liu X, Ma P, Yang J, Lan L, Li Z, Tang C, Cheng S, Liang F, Zeng F. Does the acupoint specificity exist? evidence from functional neuroimaging studies. Curr Med Imaging 2020; 16(6): 629–638

[13] Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ 2013; 185(6): 473–479

[14] MacPherson H, Vertosick E, Lewith G, Linde K, Sherman KJ, Witt CM, Vickers AJ. Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis. PLoS One 2014; 9(4): e93739

[15] Appleyard I, Lundeberg T, Robinson N. Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures. Eur J Integr Med 2014; 6(2): 234–243

[16] Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J 2018; 27(11): 2791–2803

[17] Ng JY, Hanna C. Headache and migraine clinical practice guidelines: a systematic review and assessment of complementary and alternative medicine recommendations. BMC Complement Med Ther 2021; 21(1): 236

[18] National Institute for Health and Care Excellence. Guidelines. Headaches in over 12s: diagnosis and management. London: National Institute for Health and Care Excellence (NICE). 2021

[19] Steiner TJ, Stovner LJ. Global epidemiology of migraine and its implications for public health and health policy. Nat Rev Neurol 2023; 19(2): 109–117

[20] Eltrafi A, Shrestha S, Ahmed A, Mistry H, Paudyal V, Khanal S. Economic burden of chronic migraine in OECD countries: a systematic review. Health Econ Rev 2023; 13(1): 43

[21] Haghdoost F, Togha M. Migraine management: non-pharmacological points for patients and health care professionals. Open Med (Wars) 2022; 17(1): 1869–1882

[22] LewCPunnapuzha S. Migraine Medications. StatPearls. Treasure Island (FL): StatPearls Publishing LLC. 2023

[23] Naguit N, Laeeq S, Jakkoju R, Reghefaoui T, Zahoor H, Yook JH, Rizwan M, Shahid NUA, Mohammed L. Is acupuncture safe and effective treatment for migraine? a systematic review of randomized controlled trials. Cureus 2022; 14(1): e20888

[24] Linde K, Allais G, Brinkhaus B, Fei Y, Mehring M, Vertosick EA, Vickers A, White AR. Acupuncture for the prevention of episodic migraine. Cochrane Libr 2016; 2016(6): Cd001218

[25] Li M, Wang W, Gao W, Yang D. Comparison of acupuncture and sham acupuncture in migraine treatment: an overview of systematic reviews. Neurologist 2022; 27(3): 111–118

[26] Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011; 343(oct18 2): d5928

[27] Brignardello-Petersen R, Bonner A, Alexander PE, Siemieniuk RA, Furukawa TA, Rochwerg B, Hazlewood GS, Alhazzani W, Mustafa RA, Murad MH, Puhan MA, Schünemann HJ, Guyatt GH. Advances in the GRADE approach to rate the certainty in estimates from a network meta-analysis. J Clin Epidemiol 2018; 93: 36–44

[28] Alecrim-Andrade J, Maciel-Junior JA, Carne X, Severino Vasconcelos GM, Correa HR. Acupuncture in migraine prevention — a randomized sham controlled study with 6-months posttreatment follow-up. Clin J Pain 2008; 24(2): 98–105

[29] Allais G, Romoli M, Rolando S, Airola G, Castagnoli Gabellari I, Allais R, Benedetto C. Ear acupuncture in the treatment of migraine attacks: a randomized trial on the efficacy of appropriate versus inappropriate acupoints. Neurol Sci 2011; 32(S1 Suppl 1): S173–S175

[30] Bäcker M, Grossman P, Schneider J, Michalsen A, Knoblauch N, Tan L, Niggemeyer C, Linde K, Melchart D, Dobos GJ. Acupuncture in migraine: investigation of autonomic effects. Clin J Pain 2008; 24(2): 106–115

[31] Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, Tegenthoff M, Trampisch HJ, Zenz M, Meinert R. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 2006; 5(4): 310–316

[32] Farahmand S, Shafazand S, Alinia E, Bagheri-Hariri S, Baratloo A. Pain management using acupuncture method in migraine headache patients; a single blinded randomized clinical trial. Anesth Pain Med 2018; 8(6): e81688

[33] Foroughipour M, Golchian AR, Kalhor M, Akhlaghi S, Farzadfard MT, Azizi H. A sham-controlled trial of acupuncture as an adjunct in migraine prophylaxis. Acupunct Med 2014; 32(1): 12–16

[34] Habibabadi MR, Ashtari F, Raeisi I. Effect of auricular acupuncture with semi-permanent ear needles on controlling migraine symptoms: a single-blind randomized clinical trial. J Acupunct Meridian Stud 2021; 14(2): 58–66

[35] Li C, Li X, He K, Wu Y, Xie X, Yang J, Zhang F, Yue Y, Hao H, Zhao S, Li X, Tian G. Discovery of the mechanisms of acupuncture in the treatment of migraine based on functional magnetic resonance imaging and omics. Front Med 2023; 17(5): 993–1005

[36] Li Z, Zeng F, Yin T, Lan L, Makris N, Jorgenson K, Guo T, Wu F, Gao Y, Dong M, Liu M, Yang J, Li Y, Gong Q, Liang F, Kong J. Acupuncture modulates the abnormal brainstem activity in migraine without aura patients. Neuroimage Clin 2017; 15: 367–375

[37] Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA 2005; 293(17): 2118–2125

[38] Linde M, Fjell A, Carlsson J, Dahlöf C. Role of the needling per se in acupuncture as prophylaxis for menstrually related migraine: a randomized placebo-controlled study. Cephalalgia 2005; 25(1): 41–47

[39] Wallasch TM, Weinschuetz T, Mueller B, Kropp P. Cerebrovascular response in migraineurs during prophylactic treatment with acupuncture: a randomized controlled trial. J Altern Complement Med 2012; 18(8): 777–783

[40] Wang J, Qin X, Xie W, Wang W. Migraine without aura treated with balance acupuncture therapy: a randomized controlled trial. Chinese Acupuncture & Moxibustion (Zhongguo Zhenjiu) 2017; 37(8): 805–809

[41] Wang LP, Zhang XZ, Guo J, Liu HL, Zhang Y, Liu CZ, Yi JH, Wang LP, Zhao JP, Li SS. Efficacy of acupuncture for acute migraine attack: a multicenter single blinded, randomized controlled trial. Pain Med 2012; 13(5): 623–630

[42] Wang Y, Xue CC, Helme R, Da Costa C, Zheng Z. Acupuncture for frequent migraine: a randomized, patient/assessor blinded, controlled trial with one-year follow-up. Evid Based Complement Alternat Med 2015; 2015: 920353

[43] Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ 2020; 368: m697

[44] Yu X, Salmoni A. Comparison of the prophylactic effect between acupuncture and acupressure on menstrual migraine: results of a pilot study. J Acupunct Meridian Stud 2018; 11(5): 303–314

[45] Zhao L, Liu J, Zhang F, Dong X, Peng Y, Qin W, Wu F, Li Y, Yuan K, von Deneen KM, Gong Q, Tang Z, Liang F. Effects of long-term acupuncture treatment on resting-state brain activity in migraine patients: a randomized controlled trial on active acupoints and inactive acupoints. PLoS One 2014; 9(6): e99538

[46] Lee YS, Kim SY, Kim M, Kim M, Won J, Lee H, Lee MS, Chae Y. Reporting quality of sham needles used as controls in acupuncture trials: a methodological evaluation. Chin Med 2022; 17(1): 64

[47] MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med 2010; 28(2): 83–93

[48] Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340(mar23 1): c869

[49] Lee YS, Kim SY, Lee H, Chae Y, Lee MS. ACURATE: a guide for reporting sham controls in trials using acupuncture. J Evid Based Med 2023; 16(1): 82–90

[50] Lee B, Kwon CY, Lee YS, Alraek T, Birch S, Lee HW, Ang L, Lee MS. Global research trends of sham acupuncture: a bibliometric analysis. Complement Ther Med 2023; 79: 103001

[51] Zhang ZJ, Wang XM, McAlonan GM. Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. Evid Based Complement Alternat Med 2012; 2012: 429412

[52] Birch S, Lee MS, Kim TH, Alraek T. On defining acupuncture and its techniques: a commentary on the problem of sham. Integr Med Res 2022; 11(2): 100834

[53] Kim TH, Lee MS, Birch S, Alraek T. Plausible mechanism of sham acupuncture based on biomarkers: a systematic review of randomized controlled trials. Front Neurosci 2022; 16: 834112

[54] So EW, Ng EH, Wong YY, Lau EY, Yeung WS, Ho PC. A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Hum Reprod 2009; 24(2): 341–348

[55] Zhang CS, Tan HY, Zhang GS, Zhang AL, Xue CC, Xie YM. Placebo devices as effective control methods in acupuncture clinical trials: a systematic review. PLoS One 2015; 10(11): e0140825

[56] Kim TH, Kang JW, Lee MS. What is lost in the acupuncture trial when using a sham intervention. Acupunct Med 2017; 35(5): 384–386

[57] Kim TH, Lee MS, Alraek T, Birch S. Acupuncture in sham device controlled trials may not be as effective as acupuncture in the real world: a preliminary network meta-analysis of studies of acupuncture for hot flashes in menopausal women. Acupunct Med 2020; 38(1): 37–44

[58] Lee B, Kim TH, Birch S, Alraek T, Lee HW, Nielsen A, Wieland LS, Lee MS. Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: a systematic review and network meta-analysis. Front Med (Lausanne) 2022; 9: 1061878

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