Placebo, usual care and wait-list interventions for all mental health disorders

Cochrane Database of Systematic Reviews

Volumn 2019, Issue 1, 2019, Pages

  Faltinsen, Erlend ^a   Todorovac, Adnan ^a   Hróbjartsson, Asbjørn ^b   Gluud, Christian ^c   Kongerslev, Mickey T ^a   Simonsen, Erik ^a,d   Storebø, Ole Jakob ^a,e  

^a Psychiatric Research Unit   (Denmark)

^b ODENSE UNIVERSITY HOSPITAL   (Denmark)

^c Mental Health Services CPH   (Denmark)

^d UNIVERSITY OF COPENHAGEN   (Denmark)

^e UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

ACUPUNCTURE; ARTICLE; CLINICAL PRACTICE; EXERCISE; HOSPITAL ADMISSION; HUMAN; INTERMETHOD COMPARISON; MENTAL DISEASE; MIGRAINE; OUTCOME ASSESSMENT; PATIENT CARE; PRIORITY JOURNAL; PSYCHOLOGICAL ASPECT; RISK ASSESSMENT; SENSITIVITY ANALYSIS; SEQUENTIAL ANALYSIS; SYSTEMATIC REVIEW;

EID: 85060804236     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.MR000050     Document Type: Article

References (129)

1. Allen EN, Chandler CI, Mandimika N, Leisegang C, Barnes K. Eliciting adverse effects data from participants in clinical trials. Cochrane Database of Systematic Reviews 2018, Issue 1. [DOI: 10.1002/14651858.MR000039.pub2]
2. Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. Journal of Clinical Epidemiology 2013;66(7):719-25.
3. Andrews JC, Schünemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15. Going from evidence to recommendation - determinants of a recommendation's direction and strength. Journal of Clinical Epidemiology 2013;66(7):726-35.
4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 1st Edition. Washington (DC): American Psychiatric Association, 1952.
5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 2st. Washington (DC): American Psychiatric Association, 1968.
6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3rd Edition. Washington (DC): American Psychiatric Association, 1980.
7. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3rd Edition. Washington (DC): American Psychiatric Association, 1987.
8. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th Edition. Washington (DC): American Psychiatric Association, 1994.
9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th Edition. Washington (DC): American Psychiatric Association, 2000.
10. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th Edition. Washington (DC): American Psychiatric Association, 2013.
11. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2018;64(4):401-6.
12. Barth J, Munder T, Gerger H, Nüesch E, Trelle S, Znoj H, et al. Comparative efficacy of seven psychotherapeutic interventions for patients with depression: a network meta-analysis. PLOS Medicine 2013;10(5):e1001454.
13. Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. American Journal of Psychiatry 2009;166(12):1355-64.
14. Bateman A, Campbell C, Luyten P, Fonagy P. A mentalization-based approach to common factors in the treatment of borderline personality disorder. Current Opinion in Psychology 2017;21:44-9.
15. Berkey CS, Mosteller F, Lau J, Antman EM. Uncertainty of the time of first significance in random effects cumulative meta-analysis. Controlled Clinical Trials 1996;17(5):357-71.
16. Blease C, Colloca L, Kaptchuk TJ. Are open-label placebos ethical? Informed consent and ethical equivocations. Bioethics 2016;30(6):407-14.
17. Blease CR, Bishop FL, Kaptchuk TJ. Informed consent and clinical trials: where is the placebo effect?. BMJ 2017;463:j463.
18. Borduin CM, Schaeffer CM, Heiblum N. A randomized clinical trial of multisystemic therapy with juvenile sexual offenders: effects on youth social ecology and criminal activity. Journal of Consulting and Clinical Psychology 2009;77(1):26-37.
19. Borkovec TD, Sibrava NJ. Problems with the use of placebo conditions in psychotherapy research, suggested alternatives, and some strategies for the pursuit of the placebo phenomenon. Journal of Clinical Psychology 2005;61(7):805-18.
20. Bramer WM, Rethlefsen ML, Kleijnen J, Franco OH. Optimal database combinations for literature searches in systematic reviews: a prospective exploratory study. Systematic Reviews 2017;6:245.
21. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. Journal of Clinical Epidemiology 2008;61(8):763-9.
22. Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive-Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. International Journal of Epidemiology 2009;38(1):287-98.
23. Brunetti M, Shemilt I, Pregno S, Vale L, Oxman AD, Lord J, et al. GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence. Journal of Clinical Epidemiology 2013;66(2):140-50.
24. Chanen AM, Jackson HJ, McCutcheon LK, Jovev M, Dudgeon P, Hok PY, et al. Early intervention for adolescents with borderline personality disorder using cognitive analytic therapy: randomised controlled trial. British Journal of Psychiatry 2008;193(6):477-84.
25. Charlesworth JE, Petkovic G, Kelley JM, Hunter M, Onakpoya I, Roberts N, et al. Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis. Journal of Evidence Based Medicine 2017;10(2):97-107.
26. Comer JS, Kendall PC. Methodology, design, and evaluation in psychotherapy research. In: Lambert MJ editor(s). Bergin and Garfields's Handbook of Psychotherapy and Behavior Change. 6th Edition. New York: Wiley, 2013:21-48.
27. TSA - Trial sequential analysis. Copenhagen Trial Unit. [www.ctu.dk/tsa (accessed April 23 2018)]
28. Cristea IA, Gentili C, Cotet CD, Palomba D, Barbui C, Cuijpers P. Efficacy of psychotherapies for borderline personality disorder: A systematic review and meta-analysis. JAMA Psychiatry 2017;74(4):319-28.
29. Cunningham JA, Kypri K, McCambridge J. Exploratory randomized controlled trial evaluating the impact of a waiting list control design. BMC Medical Research Methodology 2013;13(1):150.
30. da Costa BR, Nüesch E, Rutjes AW, Johnston BC, Reichenbach S, Trelle S, et al. Combining follow-up and change data is valid in meta-analyses of continuous outcomes: a meta-epidemiological study. Journal of Clinical Epidemiology 2013;66(8):847-55.
31. Donner A, Klar N. Issues in the meta-analysis of cluster randomized trials. Statistics in Medicine 2002;21(19):2971-80.
32. Double DB, Warren GC, Evans M, Rowlands MP. Efficacy of maintenance use of anticholinergic agents. Acta Psychiatrica Scandinavica 1993;88(5):381-4.
33. Egger M, Smith GD, Phillips AN. Meta-analysis: principles and procedures. BMJ 1997;315(7121):1533-7.
34. Eldrige S, Campbell M, Campbell M, Dahota A, Giraudeau B, Higgins J, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0) Additional considerations for cluster-randomized trials. University of Bristol 2016.
35. Enck P, Bingel U, Schedlowski M, Rief W. The placebo response in medicine: minimize, maximize or personalize?. Nature Reviews Drug Discovery 2013;12(3):191.
36. Erlen JA, Tamres LK, Reynolds N, Golin CE, Rosen MI, Remien RH, et al. Assessing usual care in clinical trials. Western Journal of Nursing Research. Los Angeles, CA: SAGE Publications, 2015; Vol. 37, issue 3:288-98.
37. Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA 2011;306(5):503-12.
38. Freedland KE, Mohr DC, Davidson KW, Schwartz JE. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosomatic Medicine 2011;73(4):323-35.
39. Furukawa TA, Noma H, Caldwell DM, Honyashiki M, Shinohara K, Imai H, et al. Waiting list may be a nocebo condition in psychotherapy trials: a contribution from network meta-analysis. Acta Psychiatrica Scandinavica 2014;130(3):181-92.
40. Fässler M, Meissner K, Schneider A, Linde K. Frequency and circumstances of placebo use in clinical practice-a systematic review of empirical studies. BMC Medicine 2010;8:15.
41. Fässler M, Meissner K, Kleijnen J, Hróbjartsson A, Linde K. A systematic review found no consistent difference in effect between more and less intensive placebo interventions. Journal of Clinical Epidemiology 2015;68(4):442-51.
42. Gold SM, Enck P, Hasselmann H, Friede T, Hegerl, Mohr DC, et al. Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework. Lancet Psychiatry 2018;4(9):725-32.
43. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328(7454):1490.
44. Greville-Harris M, Dieppe P. Bad is more powerful than good: the nocebo response in medical consultations. American Journal of Medicine 2015;128(2):126-9.
45. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction - GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011;64(4):383-94.
46. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. Journal of Clinical Epidemiology 2011;64(4):395-400.
47. Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidence - study limitations (risk of bias). Journal of Clinical Epidemiology 2011;64(4):407-15.
48. Guyatt GH, Oxman AD, Montori V, Vist G, Kunz R, Brozek J, et al. GRADE guidelines: 5. Rating the quality of evidence - publication bias. Journal of Clinical Epidemiology 2011;64(12):1277-82.
49. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence - imprecision. Journal of Clinical Epidemiology 2011;64(12):1283-93.
50. Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand, et al. GRADE guidelines: 7. Rating the quality of evidence - inconsistency. Journal of Clinical Epidemiology 2011;64(12):1294-302.
51. Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 8. Rating the quality of evidence - indirectness. Journal of Clinical Epidemiology 2011;64(12):1303-10.
52. Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, et al. GRADE guidelines: 9. Rating up the quality of evidence. Journal of Clinical Epidemiology 2011;64(12):1311-6.
53. Guyatt G, Oxman AD, Sultan S, Brozek J, Glasziou P, Alonso-Coello P, et al. GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. Journal of Clinical Epidemiology 2013;66(2):151-7.
54. Guyatt GH, Oxman AD, Santesso N, Helfand M, Vist G, Kunz R, et al. GRADE guidelines: 12. Preparing Summary of Findings tables- binary outcomes. Journal of Clinical Epidemiology 2013;66(2):158-72.
55. Haresnape C. An exploration of the relationship between placebo and homeopathy and the implications for clinical trial design. Journal of the Royal Society of Medicine 2013;4(9):2042533313490927.
56. Hesser H, Weise C, Rief W, Andersson G. The effect of waiting: a meta-analysis of wait-list control groups in trials for tinnitus distress. Journal of Psychosomatic Research 2011;70(4):378-84.
57. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
58. Higgin JP, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
59. Higgins JP, Altman DG, Sterne JA. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, Editors. Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0 (updated June 2017). The Cochrane Collaboration, 2017. Available from training.cochrane.org/handbook.
60. Holmes R D, Tiwari A K, Kennedy J L. Mechanisms of the placebo effect in pain and psychiatric disorders. Pharmacogenomics Journal 2016;16(6):491.
61. Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, et al. The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. Lancet Psychiatry 2018;5(3):237-86.
62. Howick J, Bishop FL, Heneghan C, Wolstenholme J, Stevens S, Hobbs FD, et al. Placebo use in the United kingdom: results from a national survey of primary care practitioners. PLOS One 2013;8(3):e58247.
63. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. New England Journal of Medicine 2001;344:1594-602.
64. Hróbjartsson A, Götzsche P C. Placebo treatment versus no treatment. Cochrane Database of Systematic Reviews 2002, Issue 4. [DOI: 10.1002/14651858.CD003974]
65. Hróbjartsson A, Götzsche PC. Placebo interventions for all clinical conditions. Cochrane Database of Systematic Reviews 2004, Issue 2. [DOI: 10.1002/14651858.CD003974.pub2]
66. Hróbjartsson A, Götzsche PC. Placebo interventions for all clinical conditions. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: 10.1002/14651858.CD003974.pub3]
67. Hróbjartsson, Kaptchuk TJ, Miller FG. Placebo effect studies are susceptible to response bias and to other types of biases. Journal of Clinical Epidemiology 2011;64(11):1223-9.
68. Hróbjartsson A, Miller FG. Placebo in nonpharmacological randomized trials. In: Boutron I, Ravaud P, Moher D editor(s). Randomized Clincial Trials of Nonpharmacological Treatments. Taylor & Francis Group, LLC, 2012:11-26.
69. ICH Expert Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice E6(R1). www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (accessed 24 April 2018).
70. Jakobsen JC, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Medical Research Methodology 2014;14(1):120.
71. Jensen KB, Kirsch I, Pontén M, Rosén A, Yang K, Gollub RL, et al. Certainty of genuine treatment increases drug responses among intellectually disabled patients. Neurology 2017;88(20):1912-8.
72. Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, et al. Placebos without deception: A randomized controlled trial in irritable bowel syndrome. PLOS One 2010;5(12):e15591.
73. Kaptchuk TJ, Miller FG. Placebo effects in medicine. New England Journal of Medicine 2015;373(1):8-9.
74. Kazdin AE. Treatment as usual and routine care in research and clinical practice. Clinical Psychology Review 2015;42:168.
75. Kazdin AE. Methodological Issues & Strategies in Clinical Research. 4th Edition. Washington DC: American Psychological Association, 2016.
76. Kienle GS, Kiene H. The powerful placebo effect- fact or fiction?. Journal of Clinical Epidemiology 1997;50(12):1311-8.
77. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Annals of Internal Medicine 2001;135(11):982.
78. Kongerslev MT, Chanen AM, Simonsen E. Personality disorder in childhood and adolescence comes of age: a review of the current evidence and prospects for future research. Scandinavian Journal of Child and Adolescent Psychiatry and Psychology 2015;3(1):31-48.
79. Kube T, Rief W. Are placebo and drug-specific effects additive? Questioning basic assumptions of double- blinded randomized clinical trials and presenting novel study designs. Drug Discovery Today 2017;22:729-35.
80. Levine J, Schooler NR. SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin 1986;22(2):343-81.
81. Lilienfeld SO. Psychological treatments that cause harm. Perspectives on Psychological Science 2007;2(1):53-70.
82. Linden M, Schermuly-Haupt M. Definition, assessment and rate of psychotherapy side effects. World Psychiatry 2014;13(3):306-9.
83. Lund K, Vase L, Petersen GL, Jensen TS, Finnerup NB. Randomised controlled trials may underestimate drug effects: balanced placebo trial design. PLOS One 2014;9(1):1-7.
84. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2017, Issue 2. [DOI: 10.1002/14651858.MR000033.pub3]
85. Löfholm AC, Brännström L, Olsson M, Hansson K. Treatment-as-usual in effectiveness studies: What is it and does it matter?. International Journal of Social Welfare 2013;22(1):25-34.
86. Meissner K, Bingel U, Colloca L, Wager TD, Watson A, Flaten MA. The placebo effect: advances from different methodological approaches. Journal of Neuroscience 2011;31(45):16117-24.
87. Meissner K, Kohls N, Colloca L. Introduction to placebo effects in medicine: mechanisms and clinical implications. Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences 2011;366(1572):1783-9.
88. Meissner K, Fässler M, Rücker G, Kleijnen J, Hróbjartsson A, Schneider A, et al. Differential effectiveness of placebo treatments: A systematic review of migraine prophylaxis. JAMA Internal Medicine 2013;173(21):1941-51.
89. Miranda J, Chung JY, Green BL, Krupnick J, Siddique J, Revicki DA, et al. Treating depression in predominantly low-income young minority women: a randomized controlled trial. JAMA 2003;290(1):57-65.
90. Moher M, Moher D, Pham B, Jones Al, Cook DJ, Jadad AR, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet 1998;352(9128):609-13.
91. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ (Clinical Research Ed.) 2009;339:b2535. [DOI: 10.1136/bmj.b2535]
92. Mohr DC, Spring B, Freedland KE, Beckner V, Arean P, Hollon SD, et al. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychotherapy and Psychosomatics 2009;78(5):275-84.
93. Mohr DC, Ho J, Hart TL, Baron KG, Berendsen M, Beckner V, et al. Control condition design and implementation features in controlled trials: a meta-analysis of trials evaluating psychotherapy for depression. Translational Behavioral Medicine 2014;4(4):407-23.
94. Mustafa RA, Santesso N, Brozek J, Akl EA, Walter SD, Norman G, et al. The GRADE approach is reproducible in assessing the quality of evidence of quantitative evidence syntheses. Journal of Clinical Epidemiology 2013;66(7):736-42.e5.
95. O'Leary KD, Borkovec TD. Conceptual, methodological, and ethical problems of placebo groups in psychotherapy research. American Psychologist 1978;33(9):821-30.
96. Pagsberg AK, Jeppesen P, Klauber DG, Jensen KG, Rudå D, Stentebjerg-Oleson M, et al. Quetiapine extended release versus aripiprazole in children and adolescents with first-episode psychosis: the multicentre, double-blind, randomised tolerability and efficacy of antipsychotics (TEA) trial. Lancet Psychiatry 2017;4(8):605-18.
97. Raicek JE, Stone BH, Kaptchuk TJ. Placebos in 19th century medicine: a quantiative analysis of the BMJ. BMJ 2012;345:e8326.
98. Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan 5). Version 5.3. Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
99. Rosenberg L. Assisted outpatient treatment: we can do better. Journal of Behavioral Health Services and Research 2014;41(3):251-3.
100. Rutherford BR, Pott E, Tandler JM, Wall MM, Roose SP, Lieberman JA. Placebo response in antipsychotic clinical trials: A meta-analysis. JAMA Psychiatry 2014;71(12):1409-21.
101. Savovic J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Annals of Internal Medicine 2012;157(6):429.
102. Scherer RW, Meerpohl JJ, Pfeifer N, Schmucker C, Schwarzer G, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database of Systematic Reviews 2018, Issue 11. [DOI: 10.1002/14651858.MR000005.pub4]
103. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
104. Sibbald B, Roland M. Understanding controlled trials: why are randomised controlled trials important?. BMJ 1998;316(7126):201.
105. Sommer J, Jansen A, Dräger B, Steinsträter O, Breitenstein C, Deppe M, et al. Transcranial magnetic stimulation - a sandwich coil design for a better sham. Clinical Neurophysiology 2006;117(2):440-6.
106. Storebø OJ, Pedersen N, Ramstad E, Kielsholm ML, Nielsen SS, Krogh HB, et al. Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies. Cochrane Database of Systematic Reviews 2018, Issue 5. [DOI: 10.1002/14651858.CD012069.pub2]
107. Swanson JW, Swartz MS. Why the evidence for outpatient commitment is good enough. Psychiatric Services 2014;65(6):808-11.
108. Tan SY, Bruni J. Cognitive-behavior therapy with adult patients with epilepsy: a controlled outcome study. Epilepsia 1986;27(3):303-7.
109. Thomas J, Brunton J, Graziosi S. EPPI-Reviewer 4: software for research synthesis. Version 4.7.1.0. London, UK: EPPI-Centre Software. Social Science Research Unit, UCL Institute of Education, 2010.
110. Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, et al. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses?. International Journal of Epidemiology 2009;38(1):276-86.
111. Thorlund K, Imberger G, Walsh M, Chu R, Gluud C, Wetterslev J, et al. The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysis - a simulation study. PLOS One 2011;6(10):e25491.
112. Tough EA, White AR, Richards SH, Lord B, Campbell JL. Developing and validating a sham acupuncture needle. Acupuncture in Medicine 2009;27(3):118-22.
113. Walach H. Placebo controls: historical, methodological and general aspects. Philosophical Transactions: Biological Sciences 2011;366(1572):1870-8.
114. Wampold BE, Imiel ZE. Great Psychotherapy Debate (Counseling and Psychotherapy) - The Evidence for What Makes Psychotherapy Work. 2. Taylor & Francis Inc, 2010.
115. Wampold BE, Frost ND, Yulish NE. Placebo effects in psychotherapy: a flawed concept and a contorted history. Psychology of Consciousness: Theory, Research, and Practice. Wampold, Bruce E.: Department of Counseling Psychology, University of Wisconsin, 335 Education Building, 1000 Bascom Mall, Madison, WI, US, 53705, bwampold@wisc.edu: Educational Publishing Foundation, 2016; Vol. 3, issue 2:108-20.
116. We SR, Koog YH, Park MS, Min B-Il. Placebo effect was influenced by publication year in three-armed acupuncture trials. Complementary Therapies in Medicine 2012;20(1-2):83-92.
117. Weimer K, Colloca L, Enck P. Placebo effects in psychiatry: mediators and moderators. Lancet Psychiatry 2015;2(3):246-57.
118. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. Journal of Clinical Epidemiology 2008;61(1):64-75.
119. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Medical Research Methodology 2009;9(1):86.
120. Wetterslev J, Jakobsen JC, Gluud C. Trial Sequential Analysis in systematic reviews with meta-analysis. BMC Medical Research Methodology 2017;17(1):39.
121. Manual of the International Classification of Diseases, Sixth Revision (ICD-6). World Health Organization 1949.
122. Manual of the International Classification of Diseases, Seventh Revision (ICD-7). World Health Organization 1955.
123. Manual of the International Classification of Diseases, Eighth Revision (ICD-8). World Health Organization 1967.
124. Manual of the international classification of diseases, Ninth Revision (ICD-9). World Health Organization 1975.
125. Manual of the International Classification of Diseases, Tenth Revision (ICD-10). World Health Organization 1993.
126. Manual of the International Classification of Diseases, Eleventh Revision (ICD-11). World Health Organization 2018.
127. 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 (Clinical Research Ed.) 2008;336(7644):601. [DOI: 10.1136/bmj.39465.451748.AD]
128. Yeung V, Sharpe L, Glozier N, Hackett ML, Colagiuri B. A systematic review and meta-analysis of placebo versus no treatment for insomnia symptoms. Sleep Medicine Reviews 2017;38:17-27.
129. Young T, Hopewell S. Methods for obtaining unpublished data. Cochrane Database of Systematic Reviews 2011, Issue 1110.1002/14651858.MR000027.pub2. [DOI: 10.1002/14651858.MR000027.pub2]