Is acupuncture no more than a placebo? Extensive discussion required about possible bias (Review)

Deng,Shizhe; Zhao,Xiaofeng; Du,Rong; He,Si; Wen,Yan; Huang,Linghui; Tian,Guang; Zhang,Chao; Meng,Zhihong; Shi,Xuemin

doi:10.3892/etm.2015.2653

Is acupuncture no more than a placebo? Extensive discussion required about possible bias (Review)

Authors:
- Shizhe Deng
- Xiaofeng Zhao
- Rong Du
- Si He
- Yan Wen
- Linghui Huang
- Guang Tian
- Chao Zhang
- Zhihong Meng
- Xuemin Shi
View Affiliations

Affiliations: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, P.R. China, Institute of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, P.R. China
Published online on: July 23, 2015 https://doi.org/10.3892/etm.2015.2653
Pages: 1247-1252

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

Numerous randomized controlled trials (RCTs) of acupuncture have been conducted in recent years. The results of several studies implied that acupuncture was only a powerful placebo; however, certain studies demonstrated that verum acupuncture had a greater effect than placebo and the mechanisms between a verum acupuncture group and a placebo/sham group were different. Researchers attempted to investigate the inherent factors that may potentially influence the results of trials. Certain problems observed in acupuncture RCTs also occurred in RCTs in other fields, including insufficient sample size, high dropout rates, inadequate follow‑up and randomization. The study of acupuncture is so complex that specific methodological challenges are raised, which are frequently overlooked, including sham interventions, blinding, powerful placebo effects (even stronger than an inert pill) and variations in acupuncture administration. The aforementioned problems may contribute to bias, and researchers systematically attempt to solve these problems. The present review aimed to suggest techniques to design high‑quality studies, minimize the placebo effect and optimize acupuncture administration in acupuncture studies. If these problems are addressed, then the results of acupuncture studies may be different.

View Figures

View References

1	Marwick C: Acceptance of some acupuncture applications. JAMA. 278:1725–1727. 1997. View Article : Google Scholar : PubMed/NCBI
2	Rose DE: Evaluating acupuncture. Science. 186:1961974. View Article : Google Scholar : PubMed/NCBI
3	Cheung F: Modern TCM: Enter the clinic. Nature. 480 (Suppl):94–95. 2011. View Article : Google Scholar : PubMed/NCBI
4	Watts J: Feature: Olympian pins and needles. Lancet. 366 (Suppl 1):62–63. 2005. View Article : Google Scholar
5	Taub A: Thumbs down on acupuncture. Science. 279:1591998. View Article : Google Scholar : PubMed/NCBI
6	Kaptchuk TJ: Acupuncture: Theory, efficacy and practice. Ann Intern Med. 136:374–383. 2002. View Article : Google Scholar : PubMed/NCBI
7	Ernst E: Complementary and alternative medicine: Between evidence and absurdity. Perspect Biol Med. 52:289–303. 2009. View Article : Google Scholar : PubMed/NCBI
8	Haake M, Müller HH, SchadeBrittinger C, et al: German acupuncture trials (GERAC) for chronic low back pain: Randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 167:1892–1898. 2007. View Article : Google Scholar : PubMed/NCBI
9	Ernst E: Acupuncture-a critical analysis. J Intern Med. 259:125–137. 2006. View Article : Google Scholar : PubMed/NCBI
10	Macklin EA, Wayne PM, Kalish LA, et al: Stop hypertension with the acupuncture research program (SHARP): Results of a randomized, controlled clinical trial. Hypertension. 48:838–845. 2006. View Article : Google Scholar : PubMed/NCBI
11	Kong J, Kaptchuk TJ, Polich G, et al: Expectancy and treatment interactions: A dissociation between acupuncture analgesia and expectancy evoked placebo analgesia. Neuroimage. 45:940–949. 2009. View Article : Google Scholar : PubMed/NCBI
12	Kong J, Kaptchuk TJ, Polich G, et al: An fMRI study on the interaction and dissociation between expectation of pain relief and acupuncture treatment. Neuroimage. 47:1066–1076. 2009. View Article : Google Scholar : PubMed/NCBI
13	Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH and Clauw DJ: Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 47:1077–1085. 2009. View Article : Google Scholar : PubMed/NCBI
14	Langevin HM, Hammerschlag R, Lao L, Napadow V, Schnyer RN and Sherman KJ: Controversies in acupuncture research: Selection of controls and outcome measures in acupuncture clinical trials. J Altern Complement Med. 12:943–953. 2006. View Article : Google Scholar : PubMed/NCBI
15	Schulz KF and Grimes DA: Generation of allocation sequences in randomised trials: Chance, not choice. Lancet. 359:515–519. 2002. View Article : Google Scholar : PubMed/NCBI
16	Carroll D, Tramèr M, McQuay H, Nye B and Moore A: Randomization is important in studies with pain outcomes: Systematic review of transcutaneous electrical nerve stimulation in acute postoperative pain. Br J Anaesth. 77:798–803. 1996. View Article : Google Scholar : PubMed/NCBI
17	Schulz KF, Chalmers I, Hayes RJ and Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 273:408–412. 1995. View Article : Google Scholar : PubMed/NCBI
18	Zheng H, Li Y and Chen M: Evidence based acupuncture practice recommendations for peripheral facial paralysis. Am J Chin Med. 37:35–43. 2009. View Article : Google Scholar : PubMed/NCBI
19	Savović J, Jones HE, Altman DG, et al: Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 157:429–438. 2012. View Article : Google Scholar : PubMed/NCBI
20	Wood L, Egger M, Gluud LL, et al: Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta-epidemiological study. BMJ. 336:601–605. 2008. View Article : Google Scholar : PubMed/NCBI
21	Schulz KF and Grimes DA: Blinding in randomised trials: Hiding who got what. Lancet. 359:696–700. 2002. View Article : Google Scholar : PubMed/NCBI
22	Witt CM, Aickin M, Baca T, et al: Effectiveness Guidance Document (EGD) for acupuncture research-a consensus document for conducting trials. BMC Complement Altern Med. 12:1482012. View Article : Google Scholar : PubMed/NCBI
23	Birch S: Clinical research on acupuncture. Part 2. Controlled clinical trials, an overview of their methods. J Altern Complement Med. 10:481–498. 2004. View Article : Google Scholar : PubMed/NCBI
24	Tsukayama H, Yamashita H, Kimura T and Otsuki K: Factors that influence the applicability of sham needle in acupuncture trials: Two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 22:346–349. 2006. View Article : Google Scholar : PubMed/NCBI
25	Enblom A, Hammar M, Steineck G and Börjeson S: Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle? Complement Ther Med. 16:288–294. 2008. View Article : Google Scholar : PubMed/NCBI
26	Hróbjartsson A and Gøtzsche PC: Placebo interventions for all clinical conditions. Cochrane Database Syst Rev CD003974. 2010. View Article : Google Scholar
27	White P, Lewith G, Hopwood V and Prescott P: The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain. 106:401–409. 2003. View Article : Google Scholar : PubMed/NCBI
28	Moffet HH: Sham acupuncture may be as efficacious as true acupuncture: A systematic review of clinical trials. J Altern Complement Med. 15:213–216. 2009. View Article : Google Scholar : PubMed/NCBI
29	Streitberger K and Kleinhenz J: Introducing a placebo needle into acupuncture research. Lancet. 352:364–365. 1998. View Article : Google Scholar : PubMed/NCBI
30	Chae Y, Um SI, Yi SH, et al: Comparison of biomechanical properties between acupuncture and non-penetrating sham needle. Complement Ther Med. 19 (Suppl 1):8–12. 2011. View Article : Google Scholar
31	Berman BM: Seminal studies in acupuncture research. J Altern Complement Med. 7 (Suppl 1):129–137. 2001. View Article : Google Scholar : PubMed/NCBI
32	McManus CA, Schnyer RN, Kong J, et al: Sham acupuncture devices-practical advice for researchers. Acupunct Med. 25:36–40. 2007. View Article : Google Scholar : PubMed/NCBI
33	Langevin HM, Konofagou EE, Badger GJ, et al: Tissue displacements during acupuncture using ultrasound elastography techniques. Ultrasound Med Biol. 30:1173–1183. 2004. View Article : Google Scholar : PubMed/NCBI
34	Linde K, Streng A, Jürgens S, et al: Acupuncture for patients with migraine: A randomized controlled trial. JAMA. 293:2118–2125. 2005. View Article : Google Scholar : PubMed/NCBI
35	Diener HC, Kronfeld K, Boewing G, et al: Efficacy of acupuncture for the prophylaxis of migraine: A multicentre randomised controlled clinical trial. Lancet Neurol. 5:310–316. 2006. View Article : Google Scholar : PubMed/NCBI
36	Manheimer E: Selecting a control for in vitro fertilization and acupuncture randomized controlled trials (RCTs): How sham controls may unnecessarily complicate the RCT evidence base. Fertil Steril. 95:2456–2461. 2011. View Article : Google Scholar : PubMed/NCBI
37	Kaptchuk TJ: Placebo needle for acupuncture. Lancet. 352:9921998. View Article : Google Scholar : PubMed/NCBI
38	Lundeberg T, Lund I, Näslund J and Thomas M: The Emperors sham-wrong assumption that sham needling is sham. Acupunct Med. 26:239–242. 2008. View Article : Google Scholar : PubMed/NCBI
39	Goddard G, Shen Y, Steele B and Springer N: A controlled trial of placebo versus real acupuncture. J Pain. 6:237–242. 2005. View Article : Google Scholar : PubMed/NCBI
40	Itoh K, Hirota S, Katsumi Y, Ochi H and Kitakoji H: Trigger point acupuncture for treatment of knee osteoarthritis - a preliminary RCT for a pragmatic trial. Acupunct Med. 26:17–26. 2008. View Article : Google Scholar : PubMed/NCBI
41	Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM and Linde K: Acupuncture Trialists Collaboration: Acupuncture for chronic pain: Individual patient data meta-analysis. Arch Intern Med. 172:1444–1453. 2012. View Article : Google Scholar : PubMed/NCBI
42	Finniss DG, Kaptchuk TJ, Miller F and Benedetti F: Biological, clinical and ethical advances of placebo effects. Lancet. 375:686–695. 2010. View Article : Google Scholar : PubMed/NCBI
43	Paterson C and Dieppe P: Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ. 330:1202–1205. 2005. View Article : Google Scholar : PubMed/NCBI
44	Barrett B, Brown R, Rakel D, et al: Placebo effects and the common cold: A randomized controlled trial. Ann Fam Med. 9:312–322. 2011. View Article : Google Scholar : PubMed/NCBI
45	Bertisch SM, Legedza AR, Phillips RS, et al: The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill. J Eval Clin Pract. 15:14–19. 2009. View Article : Google Scholar : PubMed/NCBI
46	Wager TD, Rilling JK, Smith EE, et al: Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 303:1162–1167. 2004. View Article : Google Scholar : PubMed/NCBI
47	Kaptchuk TJ, Kelley JM, Conboy LA, et al: Components of placebo effect: Randomised controlled trial in patients with irritable bowel syndrome. BMJ. 336:999–1003. 2008. View Article : Google Scholar : PubMed/NCBI
48	Enck P, Benedetti F and Schedlowski M: New insights into the placebo and nocebo responses. Neuron. 59:195–206. 2008. View Article : Google Scholar : PubMed/NCBI
49	Kaptchuk TJ: The placebo effect in alternative medicine: Can the performance of a healing ritual have clinical significance? Ann Intern Med. 136:817–825. 2002. View Article : Google Scholar : PubMed/NCBI
50	Kaptchuk TJ, Stason WB, Davis RB, et al: Sham device v inert pill: Randomised controlled trial of two placebo treatments. BMJ. 332:391–397. 2006. View Article : Google Scholar : PubMed/NCBI
51	Kaptchuk TJ, Goldman P, Stone DA and Stason WB: Do medical devices have enhanced placebo effects? J Clin Epidemiol. 53:786–792. 2000. View Article : Google Scholar : PubMed/NCBI
52	Kaptchuk TJ, Chen KJ and Song J: Recent clinical trials of acupuncture in the West: Responses from the practitioners. Chin J Integr Med. 16:197–203. 2010. View Article : Google Scholar : PubMed/NCBI
53	Hopton A and MacPherson H: Acupuncture for chronic pain: Is acupuncture more than an effective placebo? A systematic review of pooled data from meta-analyses. Pain Pract. 10:94–102. 2010. View Article : Google Scholar : PubMed/NCBI
54	Berman BM: Clinical applications of acupuncture: An overview of the evidence. J Altern Complement Med. 7 (Suppl 1):111–118. 2001. View Article : Google Scholar
55	Flachskampf FA, Gallasch J, Gefeller O, et al: Randomized trial of acupuncture to lower blood pressure. Circulation. 115:3121–3129. 2007. View Article : Google Scholar : PubMed/NCBI
56	Cheng X: Chinese Acupuncture and Moxibustion. Revised edition. Foreign Language Press; Beijing: 1999
57	Rong PJ, Zhao JJ, Gao JH, et al: Progress of research on specificity of meridian acupoint efficacy. Chin J Integr Med. 19:889–893. 2013. View Article : Google Scholar : PubMed/NCBI
58	Xing JJ, Zeng BY, Li J, Zhuang Y and Liang FR: Acupuncture point specificity. Int Rev Neurobiol. 111:49–65. 2013. View Article : Google Scholar : PubMed/NCBI
59	Na BJ, Jahng GH, Park SU, et al: An fMRI study of neuronal specificity of an acupoint: Electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neurosci Lett. 464:1–5. 2009. View Article : Google Scholar : PubMed/NCBI
60	Bai L, Yan H, Li L, et al: Neural specificity of acupuncture stimulation at pericardium 6: Evidence from an FMRI study. J Magn Reson Imaging. 31:71–77. 2010. View Article : Google Scholar : PubMed/NCBI
61	Ren Y, Bai L, Feng Y, Tian J and Li K: Investigation of acupoint specificity by functional connectivity analysis based on graph theory. Neurosci Lett. 482:95–100. 2010. View Article : Google Scholar : PubMed/NCBI
62	Yang J, Zeng F, Feng Y, et al: A PET-CT study on the specificity of acupoints through acupuncture treatment in migraine patients. BMC Complement Altern Med. 12:1232012. View Article : Google Scholar : PubMed/NCBI
63	Huang T, Zhang W, Jia S, et al: A transcontinental pilot study for acupuncture lifting-thrusting and twisting-rotating manipulations. Evid Based Complement Alternat Med. 2012:1579892012. View Article : Google Scholar : PubMed/NCBI
64	Choi YJ, Lee JE, Moon WK and Cho SH: Does the effect of acupuncture depend on needling sensation and manipulation? Complement Ther Med. 21:207–214. 2013. View Article : Google Scholar : PubMed/NCBI
65	Langevin HM, Bouffard NA, Churchill DL and Badger GJ: Connective tissue fibroblast response to acupuncture: Dose-dependent effect of bidirectional needle rotation. J Altern Complement Med. 13:355–360. 2007. View Article : Google Scholar : PubMed/NCBI
66	Han JS, Chen XH, Sun SL, et al: Effect of low- and high-frequency TENS on Met-enkephalin-Arg-Phe and dynorphin A immunoreactivity in human lumbar CSF. Pain. 47:295–298. 1991. View Article : Google Scholar : PubMed/NCBI
67	Li K, Shan B, Xu J, et al: Changes in FMRI in the human brain related to different durations of manual acupuncture needling. J Altern Complement Med. 12:615–623. 2006. View Article : Google Scholar : PubMed/NCBI
68	Lewith GT, White PJ and Kaptchuk TJ: Developing a research strategy for acupuncture. Clin J Pain. 22:632–638. 2006. View Article : Google Scholar : PubMed/NCBI