Can acupuncture treatment be double-blinded? An evaluation of double-blind acupuncture treatment of postoperative pain

PLoS ONE

Volumn 10, Issue 3, 2015, Pages

  Vase, Lene ^a,b   Baram, Sara ^a   Takakura, Nobuari ^c   Takayama, Miho ^c   Yajima, Hiroyoshi ^c   Kawase, Akiko ^c   Schuster, Lars ^d   Kaptchuk, Ted J ^e   Schou, Søren ^a   Jensen, Troels Staehelin ^b   Zachariae, Robert ^a,b   Svensson, Peter ^a  

^a AARHUS UNIVERSITY   (Denmark)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c TOKYO ARIAKE UNIVERSITY OF MEDICAL AND HEALTH SCIENCES   (Japan)

^d Acupuncture Academy   (Denmark)

^e HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACUPUNCTURE; ACUPUNCTURE NEEDLE; ADULT; ANALGESIA; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; METHODOLOGY; MOLAR TOOTH; PAIN ASSESSMENT; PATIENT ATTITUDE; PATIENT SELECTION; PLACEBO EFFECT; POSTOPERATIVE PAIN; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; TOOTH EXTRACTION; ACUPUNCTURE ANALGESIA; ADVERSE EFFECTS; DEVICES; PAIN, POSTOPERATIVE; PROCEDURES;

ACUPUNCTURE ANALGESIA; ADULT; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PAIN MANAGEMENT; PAIN, POSTOPERATIVE; TOOTH EXTRACTION;

EID: 84924095403     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0119612     Document Type: Article

References (39)

1. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011; 9: 672-677. doi: 10.1016/j.ijsu.2011.09.004 PMID: 22019563
2. Fergusson D, Glass KC, Waring D, Shapiro S. Turning a blind eye: the success of blinding reported in a random sample of randomized, placebo controlled trials. BMJ. 2004; 328: 432. PMID: 14761905
3. Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004; 57: 543-550. PMID: 15246122
4. Hróbjartsson A, Forfang E, Haahr MT, Als-Nielsen B, Brorson S. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol. 2007; 36: 654-663. PMID: 17440024
5. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004; 141: 901-910. PMID: 15611487
6. Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A et al.; GERAC Migraine Study Group. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol. 2006; 5: 310-316. PMID: 16545747
7. Lewith GT, Jonas WB, Walach HH, editors. Clinical Research in Complementary Therapies. Principles, Problems and Solutions. 2nd ed. Elsevier Health Sciences; 2010.
8. 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: 168-174. PMID: 12512790
9. Kaptchuk TJ. Acupuncture: theory, efficacy, and practice. Ann Intern Med. 2002; 136: 374-383. PMID: 11874310
10. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998; 352: 364-365. PMID: 9717924
11. Takakura N, Takayama M, Kawase A, Yajima H. Double blinding with a new placebo needle: a validation study on participant blinding. Acupunct Med. 2011; 29: 203-207. doi: 10.1136/aim.2010.002857 PMID: 21402558
12. Takakura N, Yajima H. A placebo acupuncture needle with potential for double blinding - a validation study. Acupunct Med. 2008; 26: 224-230. PMID: 19098693
13. Takakura N, Yajima H. A double-blind placebo needle for acupuncture research. BMC Complement Altern Med. 2007; 7: 31. PMID: 17925042
14. Takakura N, Takayama M, Kawase A, Kaptchuk TJ, Yajima H. Double blinding with a new placebo needle: a further validation study. Acupunct Med. 2010; 28: 144-148. doi: 10.1136/aim.2009.001230 PMID: 20530096
15. Takakura N, Yajima H. Analgesic effect of acupuncture needle penetration: a double-blind crossover study. Open Med. 2009; 3: e54-61. PMID: 19946394
16. Turner JA, Jensen MP, Warms CA, Cardenas DD. Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial. Pain. 2002; 99: 91-99. PMID: 12237187
17. nd ed. Massachusetts: Paradigm publications; 1998.
18. Kong J, Gollub R, Huang T, Polich G, Napadow V, Hui K et al. Acupuncture de qi, from qualitative history to quantitative measurement. J Altern Complement Med. 2007; 13: 1059-1070. doi: 10.1089/acm.2007.0524 PMID: 18166116
19. Vase L, Baram S, Takakura N, Takayama M, Yajima H, Kaptchuk TJ, et al. Specifying the non-specific components of acupuncture analgesia. Pain. 2013; 154: 1659-1667. doi: 10.1016/j.pain.2013.05.008 PMID: 23707680
20. Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997; 72: 95-97. PMID: 9272792
21. Owens WD, Felts JA, Spitznagel EL. ASA Physical Status Classification. Anesthesiology 1978; 49:239-243. PMID: 697077
22. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008; 336: 999-1003. doi: 10.1136/bmj.39524.439618.25 PMID: 18390493
23. Kelley JM, Lembo AJ, Ablon JS, Villanueva JJ, Conboy LA, Levy R, et al. Patient and practitioner influences on the placebo effect in irritable bowel syndrome. Psychosom Med. 2009; 71: 789-797. doi: 10.1097/PSY.0b013e3181acee12 PMID: 19661195
24. Bausell RB, Lao L, Bergman S, Lee WL, Berman BM. Is acupuncture analgesia an expectancy effect?Preliminary evidence based on participants' perceived assignments in two placebo-controlled trials. Eval Health Prof. 2005; 28: 9-26. PMID: 15677384
25. World Health Organization. Regional Office for the Western Pacific. WHO standard acupuncture point locations in the Western Pacific Region. Manila: World Health Organization, Western Pacific Region; 2008.
26. Pomeranz B, Berman B. Scientific basics of acupuncture. In: Strux G, German B, Pomeranz B, editors. Basics of Acupuncture. 5th ed. New York: Springer-Verlag; 2003. pp. 7-86.
27. Teig S, Peacock S, Stevens L, Tordoff K, Maguire E, Watson P. An audit of self acupuncture for chronic musculoskeletal pain. Acupunct Med. 2006; 24: 80-86. PMID: 16783283
28. Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994; 56: 217-226. PMID: 8008411
29. Good P. Permutations Test. A practical guide to resampling methods for testing hypotheses. New York: Springer-Verlag; 1994.
30. Rabkin JG, Markowitz JS, Stewart J, McGrath P, Harrison W, Quitkin FM, et al. How blind is blind? Assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine. Psychiatry Res. 1986; 19: 75-86. PMID: 3538107
31. Byington RP, Curb JD, Mattson ME. Assessment of Double-blindness at the Conclusion of the β-Blocker Heart Attack Trial. JAMA. 1985; 253: 1733-1736. PMID: 3974051
32. Margraf J, Ehlers A, Roth WT, Clark DB, Sheikh J, Agras WS, et al. How "blind" are double-blind studies?J Consult Clin Psychol. 1991; 59: 184-187. PMID: 2002136
33. Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser D. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain. 2002; 96; 365-373. PMID: 11973011
34. Gracely RH, Dubner R, Deeter WR, Woolskee PJ. Clinicians' expectations influence placebo analgesia. Lancet. 1985; 5(1): 43.
35. Kobayashi A, Uefuji M, Yasumo W. History and progress of Japanese Acupuncture. Evid Based Complement Alternat Med. 2010; 7: 359-365. doi: 10.1093/ecam/nem155 PMID: 18955321
36. 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: 1892-1898. PMID: 17893311
37. Vase L, Robinson ME, Verne GN, Price DD. The contribution of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients. An empirical investigation. Pain. 2003; 105: 17-25. PMID: 14499416
38. Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: Recent advances and current thought. Annu Rev Psychol. 2008; 59: 565-590. PMID: 17550344
39. Price DD, Vase L. The contributions of Desire, Expectation and Reduced Negative Emotions to Placebo Anti-hyperalgesia in Irritable Bowel Syndrome. In: Colloca L, Flaten M, and Meissner K, editors. Placebo and Pain. From Bench to Bedside. Amsterdam: Elsevier; 2013. pp. 215-226.