Universidade Federal do Ceará
Grupo de Atenção Integral e Pesquisa em Acupuntura e Medicina Tradicional Chinesa – GAIPA UFC

Acupuntura Sham e Placebo

A literatura mostra que o tamanho de efeito da Acupuntura varia de acordo com o tipo de controle estudado, sendo maior quando comparada ao grupo sem intervenção ou tratamento convencional, e reduzindo quando comparada a Acupuntura Placebo (fisiologicamente inerte) ou Acupuntura Sham (simulada) penetrando o tecido (VICKERS ET AL., 2018; MACPHERSON ET AL., 2014). Este efeito também é observado nos outros tratamentos não-farmacológicos, como o exercício (MILLER ET AL., 2021).

É importante entender que é inadequado considerar Acupuntura Sham como sinônimo de Acupuntura Placebo, uma vez que a Acupuntura Sham não é fisiologicamente inerte pois há a estimulação do tecido e do sistema nervoso periférico e central, mesmo que em doses mínimas como o agulhamento inespecífico ou superficial (BIRCH ET AL., 2022). Segundo Appleyard et al. (2014) os tipos de controle mais utilizados em acupuntura são: Non-penetrating needle, Superficial insertion of needle, Non-specific acupuncture points, Non-acupuncture points. A seleção do tipo de controle mais adequado para o estudo vai depender da pergunta de pesquisa.

Para mais informações sobre desenhos de pesquisa em Acupuntura acesse o CONSORT/STRICTA “Clicando aqui“.

Acupuntura Sham e Placebo:

• Yu C et al. Effects of sham acupuncture for chronic musculoskeletal pain syndrome: A systematic review and network meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Nov 17;102(46):e35275. <https://pubmed.ncbi.nlm.nih.gov/37986368/>.
• 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 Sep 5;6(9):e2332452. <https://pubmed.ncbi.nlm.nih.gov/37672270/>.
• Zhou R et al. Retracted: Effect of Sham Acupuncture on Chronic Pain: A Bayesian Network Meta-Analysis. Pain Med. 2023 Apr 3;24(4):382-396. <https://pubmed.ncbi.nlm.nih.gov/35993612/>.
• Kim TH et al. Sham Acupuncture Is Not Just a Placebo. J Acupunct Meridian Stud. 2022 Dec 31;15(6):333-335. <https://pubmed.ncbi.nlm.nih.gov/36537115/>.
• Kim TH et al. Plausible Mechanism of Sham Acupuncture Based on Biomarkers: A Systematic Review of Randomized Controlled Trials. Front Neurosci. 2022 Feb 3;16:834112. <https://pubmed.ncbi.nlm.nih.gov/35185461/>.
• Zhou R et al. Effect of Sham Acupuncture on Chronic Pain: A Bayesian Network Meta-analysis. Pain Med. 2022 Aug 22;pnac126. <https://pubmed.ncbi.nlm.nih.gov/35993612/>.
• Birch S et al. On defining acupuncture and its techniques: A commentary on the problem of sham. Integr Med Res. 2022 Jun;11(2):100834. <https://pubmed.ncbi.nlm.nih.gov/35111572/>.
• Kim TH et al. Plausible Mechanism of Sham Acupuncture Based on Biomarkers: A Systematic Review of Randomized Controlled Trials. Front Neurosci. 2022 Feb 3;16:834112. <https://pubmed.ncbi.nlm.nih.gov/35185461/>.
• Zeng D et al. Placebo response varies between different types of sham acupuncture: A randomized double-blind trial in neck pain patients. Eur J Pain. 2022 Feb 7. <https://pubmed.ncbi.nlm.nih.gov/35129852/>.
• Miller CT et al. Attempting to Separate Placebo Effects from Exercise in Chronic Pain: A Systematic Review and Meta-analysis. Sports Med. 2021 Aug 27. <https://pubmed.ncbi.nlm.nih.gov/34453277/>.
• Cushman DM et al. Validity of a Sham Dry Needling Technique on a Healthy Population. Int J Sports Phys Ther. 2021 Feb 1;16(1):49-56. <https://pubmed.ncbi.nlm.nih.gov/33604134/>.
• MacPherson H, Charlesworth K. The Challenges of Evaluating Specific and Nonspecific Effects in Clinical Trials of Acupuncture for Chronic Pain. Med Acupunct. 2020 Dec 1;32(6):385-387. <https://pubmed.ncbi.nlm.nih.gov/33362893/>.
• Kaptchuk TJ. Placebo Effects in Acupuncture. Med Acupunct. 2020 Dec 1;32(6):352-356. <https://pubmed.ncbi.nlm.nih.gov/33362886/>.
• Kaptchuk TJ, Hemond CC, Miller FG. Placebos in chronic pain: evidence, theory, ethics, and use in clinical practice. BMJ. 2020 Jul 20;370:m1668. <https://pubmed.ncbi.nlm.nih.gov/32690477/>.
• Ots T et al. The selection of dermatomes for sham (placebo) acupuncture points is relevant for the outcome of acupuncture studies: a systematic review of sham (placebo)-controlled randomized acupuncture trials. Acupunct Med. 2020 Aug;38(4):211-226. <https://pubmed.ncbi.nlm.nih.gov/32026725/>.
• Musial F. Acupuncture for the Treatment of Pain – A Mega-Placebo? Front Neurosci. 2019 Oct 17;13:1110. <https://pubmed.ncbi.nlm.nih.gov/31680841/>.
• Chae Y et al. How Placebo Needles Differ From Placebo Pills? Front Psychiatry. 2018 Jun 5;9:243. <https://pubmed.ncbi.nlm.nih.gov/29930521/>.
• Lee YS, Chae Y. Powerful effects of placebo needles. Acupunct Med. 2018 Jun;36(3):197-198. doi: 10.1136/acupmed-2017-011516.  <https://pubmed.ncbi.nlm.nih.gov/29567666/>.
• Chae Y, Olausson H. The role of touch in acupuncture treatment. Acupunct Med. 2017 Apr;35(2):148-152. <https://pubmed.ncbi.nlm.nih.gov/28151404/>.
• Chen H et al. Types of Control in Acupuncture Clinical Trials Might Affect the Conclusion of the Trials: A Review of Acupuncture on Pain Management. J Acupunct Meridian Stud. 2016 Oct;9(5):227-233. <https://pubmed.ncbi.nlm.nih.gov/27776760/>.
• Tan JY et al. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique. PLoS One. 2015 Jul 15;10(7):e0132989. <https://pubmed.ncbi.nlm.nih.gov/26177378/>.
• Appleyard I et al. Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures? Eur J Integr Med. 2014;6:234–243. <https://www.sciencedirect.com/science/article/pii/S1876382014000365>.
• Zhang CS et al. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. <https://pubmed.ncbi.nlm.nih.gov/24138333/>.
• MacPherson H et al. 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 Apr 4;94):e93739. <https://pubmed.ncbi.nlm.nih.gov/24705624/>.
• Xing JJ et al. Acupuncture point specificity. Int Rev Neurobiol. 2013;111:49-65. <https://pubmed.ncbi.nlm.nih.gov/24215917/>.
• Williams CM, Kamper SJ. Non-specific effects of acupuncture – does the ‘placebo’ effect play an important role? Br J Sports Med. 2012 Jun;46(8):578-9. <https://pubmed.ncbi.nlm.nih.gov/22554843/>.
• Linde K, Niemann K, Schneider A, Meissner K. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials. BMC Med. 2010 Nov 23;8:75. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001416/>.
• Enck P et al. Acupuncture, psyche and the placebo response. Auton Neurosci. 2010 Oct 28;157(1-2):68-73. <https://pubmed.ncbi.nlm.nih.gov/20359961/>.
• Madsen MV et al. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009 Jan 27;338:a3115. <https://pubmed.ncbi.nlm.nih.gov/19174438/>.
• Harris RE et al. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. <https://pubmed.ncbi.nlm.nih.gov/19501658/>.
• Moffet H. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009 Mar;15(3):213-6. <https://pubmed.ncbi.nlm.nih.gov/19250001/>.
• Lundeberg T et al. The Emperors sham – wrong assumption that sham needling is sham. Acupunct Med. 2008 Dec;26(4):239-42. <https://pubmed.ncbi.nlm.nih.gov/19098696/>.
• Lundeberg T, Lund JNI. Acupuncture–self-appraisal and the reward system. Acupunct Med. 2007 Sep;25(3):87-99. <https://pubmed.ncbi.nlm.nih.gov/17906602/>.
• Lund I, Lundeberg T. Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Acupunct Med. 2006 Mar;24(1):13-5. <https://pubmed.ncbi.nlm.nih.gov/16618044/>.
• Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. <https://pubmed.ncbi.nlm.nih.gov/16646730/>.
• Kaptchuk TJ et al. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 Feb 18;332(7538):391-7. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1370970/>.
• Vickers AJ. Placebo controls in randomized trials of acupuncture. Eval Health Prof. 2002 Dec;25(4):421-35. <https://pubmed.ncbi.nlm.nih.gov/12449085/>.
• White AR et al. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001 Dec;9(4):237-45. <https://pubmed.ncbi.nlm.nih.gov/12184353/>.

Dispositivos de Acupuntura Placebo

• Maciel LYS et al. Comparison of the placebo effect between different non-penetrating acupuncture devices and real acupuncture in healthy subjects: a randomized clinical trial. BMC Complement Altern Med. 2016 Dec 15;16(1):518. <https://pubmed.ncbi.nlm.nih.gov/27978834/>.

Paradoxo da Eficácia

• Walach H. The efficacy paradox in randomized controlled trials of CAM and elsewhere: beware of the placebo trap. J Altern Complement Med. 2001 Jun;7(3):213-8. <https://pubmed.ncbi.nlm.nih.gov/11439833/>.
• Meissner K et al. Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxis. JAMA Intern Med. 2013 Nov 25;173(21):1941-51. <https://pubmed.ncbi.nlm.nih.gov/24126676/>.
• Zhang W, Doherty M. Efficacy paradox and proportional contextual effect (PCE). Clin Immunol. 2018 Jan;186:82-86. <https://pubmed.ncbi.nlm.nih.gov/28736278/>.

Abordagens de Pesquisa

• Fønnebø V et al. Researching complementary and alternative treatments-the gatekeepers are not at home. BMC Med Res Methodol. 2007 Feb 11;7:7. <https://pubmed.ncbi.nlm.nih.gov/17291355/>.
• Witt CM et al. Which research is needed to support clinical decision-making on integrative medicine?- Can comparative effectiveness research close the gap? Chin J Integr Med. 2012 Oct;18(10):723-9. <https://pubmed.ncbi.nlm.nih.gov/22965697/>.
• Witt CM. Clinical research on acupuncture – Concepts and guidance on efficacy and effectiveness research. Chin J Integr Med. 2011 Mar;17(3):166-72. <https://pubmed.ncbi.nlm.nih.gov/21359916/>.
• Langevin HM et al. Paradoxes in acupuncture research: strategies for moving forward. Evid Based Complement Alternat Med. 2011;2011:180805. <https://pubmed.ncbi.nlm.nih.gov/20976074/>.
• White A et al. Defining an adequate dose of acupuncture using a neurophysiological approach–a narrative review of the literature. Acupunct Med. 2008 Jun;26(2):111-20. <https://pubmed.ncbi.nlm.nih.gov/18591910/>.
• MacPherson H et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010 Jun 8;7(6):e1000261. <https://pubmed.ncbi.nlm.nih.gov/20543992/>.
• NIH consensus development panel on acupuncture. Acupuncture. JAMA. 1998 Nov 4;280(17):1518-24. <https://pubmed.ncbi.nlm.nih.gov/9809733/>
• Vincent CA, Richardson PH. The evaluation of therapeutic acupuncture: concepts and methods. Pain. 1986 Jan;24(1):1-13. <https://pubmed.ncbi.nlm.nih.gov/3513094/>.
• Acupuncture: How to improve the evidence base <https://www.bmj.com/acupuncture>.
• Bewley S, Ernst E. Positive spin in acupuncture systematic review requires correction. BJOG. 2022 Jun;129(7):1168-1169. <https://pubmed.ncbi.nlm.nih.gov/34964240/>.

CONFUNDIDORES

Expectativa 

• Zieger A et al. Do patients’ pre-treatment expectations about acupuncture effectiveness predict treatment outcome in patients with chronic low back pain? A secondary analysis of data from a randomised controlled clinical trial. PLoS One. 2022 May 20;17(5):e0268646. <https://pubmed.ncbi.nlm.nih.gov/35594274/>.
• Foster NE et al. The relationship between patient and practitioner expectations and preferences and clinical outcomes in a trial of exercise and acupuncture for knee osteoarthritis. Eur J Pain. 2010 Apr;14(4):402-9. <https://pubmed.ncbi.nlm.nih.gov/19665403/>.
• Kong J et al. An fMRI study on the interaction and dissociation between expectation of pain relief and acupuncture treatment. Neuroimage. 2009 Sep;47(3):1066-76. <https://pubmed.ncbi.nlm.nih.gov/19501656/>.

Contextual effect

• Zou K, Wong J, Abdullah N, Chen X, Smith T, Doherty M, Zhang W. Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2016 Nov;75(11):1964-1970. <https://pubmed.ncbi.nlm.nih.gov/26882927/>.

Patient-provider communication

• Suarez-Almazor ME et al. A randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of patient-provider communication. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1229-36. <https://pubmed.ncbi.nlm.nih.gov/20506122/>.

MARCADORES BIOLÓGICOS E PLACEBO

• Meissner K et al. Evidence for placebo effects on physical but not on biochemical outcome parameters: a review of clinical trials. BMC Med. 2007 Mar 19;5:3. <https://pubmed.ncbi.nlm.nih.gov/17371590/>.

CRÍTICAS

• Ernst E et al. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011 Apr;152(4):755-764. <https://pubmed.ncbi.nlm.nih.gov/21440191/>.
• Vickers A et al. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998 Apr;19(2):159-66. <https://pubmed.ncbi.nlm.nih.gov/9551280/>.
• Su CX et al. Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: comparison of registered records and subsequent publications. Trials. 2015 Jan 27;16:28. <https://pubmed.ncbi.nlm.nih.gov/25626862/>.
• Ernst E. Integrative medicine: more than the promotion of unproven treatments? Med J Aust. 2016 Mar 21;204(5):174-174e1. <https://pubmed.ncbi.nlm.nih.gov/26985838/>.
• Cummings M, Hróbjartsson A, Ernst E. Should doctors recommend acupuncture for pain? BMJ. 2018 Mar 7;360:k970. <https://pubmed.ncbi.nlm.nih.gov/29514785/>.
• Ernst E. Alternative Practitioners Amuse the Patient, While Medics Cure the Disease. J Clin Med. 2018 Jun 5;7(6):137. <https://pubmed.ncbi.nlm.nih.gov/29874872/>.
• Ernst E. Fallacies of esoteric medicine. Wien Klin Wochenschr. 2020 May;132(9-10):224-227.  <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253392/>.
• Matsuura Y, Takazawa Wlch N, Sakai T, Tsutani K. Clinical trial registration, and publication in acupuncture studies: A systematic review. Integr Med Res. 2020 Mar;9(1):56-61. <https://pubmed.ncbi.nlm.nih.gov/32082988/>.

Carta ao editor

• Won J et al. Trial registration as a safeguard against outcome reporting bias and spin? A case study of randomized controlled trials of acupuncture. PLoS One. 2019 Oct 3;14(10):e0223305. <https://pubmed.ncbi.nlm.nih.gov/31581278/>.
• Braillon A, Ernst E. Acupuncture and Smoking Cessation? One Swallow Doesn’t Make a Summer! Chest. 2018 Jun;153(6):1516. <https://pubmed.ncbi.nlm.nih.gov/29884271/>.
• Ernst E, Lee MS. Do randomised studies of traditional Asian therapies generate different results than non-randomised trials? Int J Clin Pract. 2014 May;68(5):655-7. <https://pubmed.ncbi.nlm.nih.gov/24750528/>.

Critica a Ernest

• Doney IE. Edzard Ernst and complementary medicine. Br J Gen Pract. 2007 Jun;57(539):500; author reply 500. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2078193/>.
• Wider B, Pittler MH, Thompson-Coon J, Ernst E. WITHDRAWN: Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database Syst Rev. 2016 May 19;(5):CD003335. <https://pubmed.ncbi.nlm.nih.gov/27195440/>.