Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

BMC Medical Research Methodology

Volumn 18, Issue 1, 2018, Pages

  Cheon, Soyeon ^a,b   Park, Hi Joon ^a   Chae, Younbyoung ^a   Lee, Hyangsook ^a,c  

^a Kyung Hee University   (South Korea)

^b NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^c UNIVERSITY OF TECHNOLOGY SYDNEY   (Australia)

Author keywords

Blinding; Information disclosure; Informed consent; Outcome; Participant information leaflet; Placebo; Randomized controlled trial

Indexed keywords

ACUPUNCTURE; DOUBLE BLIND PROCEDURE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; OUTCOME ASSESSMENT; PATIENT EDUCATION; PLACEBO EFFECT; PROCEDURES; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ACUPUNCTURE THERAPY; DISCLOSURE; DOUBLE-BLIND METHOD; HUMANS; INFORMED CONSENT; OUTCOME ASSESSMENT (HEALTH CARE); PAMPHLETS; PATIENT EDUCATION AS TOPIC; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85040806763     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/s12874-018-0474-1     Document Type: Article

References (49)

1. World Medical Association. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-4.
2. Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007;4(2):e61.
3. Linde K, Dincer F. How informed is consent in sham-controlled trials of acupuncture? J Altern Complement Med. 2004;10(2):379-85.
4. Miller FG, Kaptchuk TJ. Acupuncture trials and informed consent. J Med Ethics. 2007;33(1):43-4.
5. Miller FG, Colloca L. The placebo phenomenon and medical ethics: rethinking the relationship between informed consent and risk-benefit assessment. Theor Med Bioeth. 2011;32(4):229-43.
6. Tracey I. Getting the pain you expect: mechanisms of placebo, nocebo and reappraisal effects in humans. Nat Med. 2010;16(11):1277-83.
7. Carlino E, Torta DM, Piedimonte A, Frisaldi E, Vighetti S, Benedetti F. Role of explicit verbal information in conditioned analgesia. Eur J Pain. 2015;19(4):546-53.
8. Mitsikostas DD. Nocebo in headache. Curr Opin Neurol. 2016;29(3):331-6.
9. Bishop FL, Adams AE, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One. 2012;7(6):e39661.
10. Moroz A, Freed B, Tiedemann L, Bang H, Howell M, Park JJ. Blinding measured: a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Altern Med. 2013;2013:708251.
11. Finfgeld-Connett D. Use of content analysis to conduct knowledge-building and theory-generating qualitative systematic reviews. Qual Res. 2014;14(3):341-52.
12. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277-88.
13. Mayring P. Qualitative content analysis. Forum Qual Soc Res. 2000;1(2) https://doi.org/10.17169/fqs-1.2.1089.
14. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25(2):143-56.
15. Park J, Bang H, Cañette I. Blinding in clinical trials, time to do it better. Complement Ther Med. 2008;16(3):121-3.
16. Higgins JPT, Deeks JJ, Altman DG. Chapter 16: special topics in statistics. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Oxford: The Cochrane Collaboration; 2011. https://doi.org/10.1002/9780470712184.ch16.
17. Chinn S. A simple method for converting an odds ratio to effect size for use in meta-analysis. Stat Med. 2000;19(22):3127-31.
18. Wang LP, Zhang XZ, Guo J, Liu HL, Zhang Y, Liu CZ, et al. Efficacy of acupuncture for acute migraine attack: a multicenter single blinded, randomized controlled trial. Pain Med. 2012;13(5):623-30.
19. Wang LP, Zhang XZ, Guo J, Liu HL, Zhang Y, Liu CZ, et al. Efficacy of acupuncture for migraine prophylaxis: a single-blinded, double-dummy, randomized controlled trial. Pain. 2011;152(8):1864-71.
20. 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(7651):999-1003.
21. Lembo AJ, Conboy L, Kelley JM, Schnyer RS, McManus CA, Quilty MT, et al. A treatment trial of acupuncture in IBS patients. Am J Gastroenterol. 2009;104(6):1489-97.
22. Lee H, Bang H, Kim Y, Park J, Lee S, Lee H, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011;19(Suppl 1):S41-8.
23. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998;19(2):159-66.
24. American Medical Association. Code of medical ethics, 2014-2015: of the American Medical Association. Annotated ed. United States: American Medical Association Press; 2014.
25. Emanuel EJ, Miller FG. The ethics of placebo-controlled trials - a middle ground. New Engl J Med. 2001;345(12):915-9.
26. Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth. 2012;12(3):22-9.
27. Tan K, Petrie KJ, Faasse K, Bolland MJ, Grey A. Unhelpful information about adverse drug reactions. BMJ. 2014;349:g5019.
28. Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise patient understanding: so why are they lengthening? J Clin Oncol. 2007;25(9):e13-4.
29. Garner M, Ning Z, Francis J. A framework for the evaluation of patient information leaflets. Health Expect. 2012;15(3):283-94.
30. Gillies K, Huang W, Skea Z, Brehaut J, Cotton S. Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials. 2014;15:62.
31. Wilson CB. An updated declaration of Helsinki will provide more protection. Nat Med. 2013;19(6):664.
32. Dhai A. The research ethics evolution: from Nuremberg to Helsinki. S Afr Med J. 2014;104(3):178-80.
33. Djavadkhani Y, Marshall NS, D'Rozario AL, Crawford MR, Yee BJ, Grunstein RR, et al. Ethics, consent and blinding: lessons from a placebo/sham controlled CPAP crossover trial. Thorax. 2015;70(3):265-9.
34. Cheung F. TCM: made in China. Nature. 2011;480(7378):S82-3.
35. Park HL, Lee HS, Shin BC, Liu JP, Shang Q, Yamashita H, et al. Traditional medicine in China, Korea, and Japan: a brief introduction and comparison. Evid Based Complement Altern Med. 2012;2012:429103.
36. Volinn E, Yang B, He J, Sheng X, Ying J, Zuo Y. Do outcomes of acupuncture for back pain differ according to varying sociocultural contexts? The view from China. J Altern Complement Med. 2013;19(5):435-44.
37. Dilli CR, Childs R, Berk J, Christian MK, Nguyen N, Brown RP, et al. Does prior acupuncture exposure affect perception of blinded real or sham acupuncture. Acupunct Med. 2014;32(2):155-9.
38. White P, Lewith G, Hopwood V, 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. 2003;106(3):401-9.
39. Hróbjartsson A, Gøtzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev. 2010;1:CD003974.
40. Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, et al. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014;6(218):218ra5.
41. Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336(7644):601-5.
42. Linde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, Brinkhaus B, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain. 2007;128(3):264-71.
43. Witt CM, Martins F, Willich SN, Schützler L. Can I help you? Physicians' expectations as predictor for treatment outcome. Eur J Pain. 2012;16(10):1455-66.
44. Miller FG, Emanuel EJ, Rosenstein DL, Straus SE. Ethical issues concerning research in complementary and alternative medicine. JAMA. 2004;291(5):599-604.
45. Menoni V, Lucas N, Leforestier JF, Dimet J, Doz F, Chatellier G, et al. The readability of information and consent forms in clinical research in France. PLoS One. 2010;5(5):e10576.
46. Reinert C, Kremmler L, Burock S, Bogdahn U, Wick W, Gleiter CH, et al. Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials. Eur J Cancer. 2014;50(1):150-8.
47. Srnka KJ, Koeszegi ST. From words to numbers: how to transform qualitative data into meaningful quantitative results. Schmalenbach Business Rev. 2007;59(1):29-57.
48. Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther. 1987;42(3):250-3.
49. Pildal J, Hróbjartsson A, Jørgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36(4):847-57.