Open-label placebo for chronic low back pain: a 5-year follow-up.


Journal

Pain
ISSN: 1872-6623
Titre abrégé: Pain
Pays: United States
ID NLM: 7508686

Informations de publication

Date de publication:
01 05 2021
Historique:
received: 05 02 2020
accepted: 18 11 2020
pubmed: 2 12 2020
medline: 20 5 2021
entrez: 1 12 2020
Statut: ppublish

Résumé

Long-term follow-up of patients treated with open-label placebo (OLP) are nonexistent. In this article, we report a 5-year follow-up of a 3-week OLP randomized controlled trial (RCT) in patients with chronic low back pain. We recontacted the participants of original RCT and reassessed their pain, disability, and use of pain medication. We obtained follow-up data from 55 participants (82% of those who took OLP during the parent RCT), with a mean elapsed time between the end of the 3 weeks placebo trial and the follow-up interview of 55 months (SD = 7.85). We found significant reductions in both pain and disability between the baseline assessment immediately before the 3 weeks trial with placebo pills and the original trial endpoint (P < 0.00001 for the 2 primary outcomes of pain and disability). At the 5-year follow-up, we found no significant differences in either outcome between original trial endpoint and follow-up. Improvements persisted after 5 years and were accompanied by substantial reductions compared with baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%), antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%). By contrast, the use of alternative approaches to pain management increased (from 18% to 29%). Although the reduction in pain and medication is comparable with the improvements that occurred in the original study, a major limitation of this long-term follow-up is the absence of controls for spontaneous improvement and new cointerventions. Nonetheless, our data suggest that reductions in pain and disability after OLP may be long lasting.

Identifiants

pubmed: 33259459
pii: 00006396-202105000-00023
doi: 10.1097/j.pain.0000000000002162
doi:

Substances chimiques

Analgesics 0

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1521-1527

Informations de copyright

Copyright © 2020 International Association for the Study of Pain.

Références

Ashar J, Knight K, Gordon A, Lumley M, Geuter S, Flood T, Clark J, Anderson Z, Polisky L, Carlisle J, Dimidjan S, Wager T. Open-label placebo injection for chronic low back pain: a randomized controlled trial. Abstract #P3.51. 2nd Official SIPS Conference, Society for Interdisciplinary Placebo Studies (SIPS), Leiden (NL), 2019.
Bendix AE, Bendix T, Haestrup C, Busch E. A prospective, randomized 5-year follow-up study of functional restoration in chronic low back pain patients. Eur Spine J 1998;7:111–9.
Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. PAIN 2016;157:2766–72.
Carvalho C, Kirsch I, Kaptchuk TJ. Comment. PAIN 2017;158:535–7.
Charlesworth JEG, Petkovic G, Kelley JM, Hunter M, Onakpoya I, Roberts N, Miller FG. Howick J Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis. J Evid Based Med 2017;10:97–107.
Duthey B. Background paper 6.24: low back pain. In: World Health Organisation (WHO) (ed.) Priority medicines for Europe and the world “A public health approach to innovation”. Geneva: WHO, 2013. Available at: https://www.who.int/medicines/areas/priority_medicines/BP6_24LBP.pdf .
Endler P, Ekman P, Berglund I, Möller H, Gerdhem P. Long-term outcome of fusion for degenerative disc disease in the lumbar spine. Bone Joint J 2019;101-B:1526–33.
Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J 2020;29:1925–34.
Friedrich M, Gittler G, Arendasy M, Friedrich KM. Long-term effect of a combined exercise and motivational program on the level of disability of patients with chronic low back pain. Spine 2005;1:995–1000.
Groot D, van Hooff ML, Kroeze RJ, Monshouwer M, O'Dowd J, Horsting P, Spruit M. Long-term results of an intensive cognitive behavioral pain management program for patients with chronic low back pain: a concise report of an extended cohort with a minimum of 5-year follow-up. Eur Spine J 2019;28:1579–85.
Hoenemeyer TW, Kaptchuk TJ, Mehta TS, Fontaine KR. Open-label placebo treatment for cancer-related fatigue: a randomized-controlled clinical trial. Scientific Rep 2018;8:2784.
Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Translational Med 2014;6:218ra5–218.
Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 2010;5:e15591.
Kaptchuk TJ, Miller FG. Placebo effects in medicine. New Engl J Med 2015;373:8–9.
Kaptchuk TJ. Placebo studies and ritual theory: a comparative analysis of Navajo, acupuncture and biomedical healing. Philos Trans R Soc Lond B Biol Sci 2011;366:1849–58.
Kareem H, Ulbricht C. A prospective long-term follow-up study of the posterior dynamic stabilizing system to treat back pain associated with degenerative disc disease. Glob Spine J 2020;10:30–8.
Kirmayer LJ. Mind and body as metaphors: hidden values in biomedicine. In: Lock M, Gordon D, editors. Biomedicine examined. Dordrecht, The Netherlands: Kluwer Academic, 1988.
Kislaya I, Neto M. Sociodemographic characterization of self-reported chronic low back pain prevalence in Portugal: results from the National Health Survey 2014. Boletim Epidemiológico Observações 2017;6(suppl 9):39–42.
Kleine-Borgmann J, Schmidt K, Hellmann A, Bingel U. Effects of open-label placebo on pain, functional disability, and spine mobility in patients with chronic back pain: a randomized controlled trial. PAIN 2019;160:2891–7.
Machado GC, Maher CG, Ferreira PH, Pinheiro MB, Lin C-WC, Day RO, McLachlan AJ, Ferreira ML. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. Br Med J 2015;350:h1225.
McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. PAIN 2004;107:159–66.
Monteiro J, Faísca L, Nunes O, Hipólito J. Roland Morris disability questionnaire-adaptation and validation for the Portuguese speaking patients with back pain. Acta Médica Portuguesa 2010;23:761–6.
Murray CJ, Abraham J, Ali MK, Alvarado M, Atkinson C, Baddour LM, Bartels DH, Benjamin EJ, Bhalla K, Birbeck G. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA 2013;310:591–606.
Nicholas MK. The pain self-efficacy questionnaire: taking pain into account. Eur J Pain 2007;11:153–63.
Nitzan U, Kaptchuk T, Kirsch I, Schefet D, Krieger I, Braw Y, Bloch Y, Lichtenberg P. Open-label placebo for the treatment of depression – a randomized controlled trial. Abstract #P2.20. 2nd Official SIPS Conference, Society for Interdisciplinary Placebo Studies (SIPS), Leiden (NL), July7-9, 2019.
Olliges E, Stroppe S, Haile A, Malhis M, Funke SA, Meissner K. Open-label placebo for elderly patients with chronic knee pain: effects of pain, functionality and quality of life. Abstract #P2.01 2nd Official SIPS Conference, Society for Interdisciplinary Placebo Studies (SIPS), Leiden (NL), July7-9, 2019.
Park LC, Covi L. Nonblind placebo trial: an exploration of neurotic patients' responses to placebo when its inert content is disclosed. Arch Gen Psychiatry 1965;12:336–45.
Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child 2008;34:104–10.
Sandler AD1, Glesne CE, Bodfish JW. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder. J Dev Behav Pediatr JDBP 2010;31:369–75.
Schaefer M, Harke R, Denke C. Open-label placebos improve symptoms in allergic rhinitis: a randomized controlled trial. Psychother Psychosom 2016;85:373–4.
Schaefer M, Sahin T, Berstecher B. Why do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis. PLoS One 2018;13:e0192758.
Sköld C, Tropp H, Berg S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J 2013;22:2288–95.
Sturgeon JA, Zautra AJ. Resilience: a new paradigm for adaptation to chronic pain. Curr Pain Headache Rep 2010;14:105–12.
Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA, Miller FG. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ 2008;337:a1938.
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavandʼhomme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JW, Wang SJ. A classification of chronic pain for ICD-11. PAIN 2015; 156:1003–7.
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA III, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2163–96.
Williams CM, Maher CG, Latimer J, McLachlan AJ, Hancock MJ, Day RO, Lin C-WC. Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet 2014;384:1586–96.
Zhou ES, Hall KT, Michaud AL, Blackmon JE, Partridge AH, Recklitis CJ. Open-label placebo reduces fatigue in cancer survivors: a randomized trial. Support Care Cancer 2019;27:1–9.

Auteurs

Claudia Carvalho (C)

ISPA-Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Rua Jardim do Tabaco, Lisbon, Portugal.

Maria Pais (M)

Santa Casa da Misericórdia de Lisboa, Largo Trindade Coelho, Lisbon, Portugal.

Lidia Cunha (L)

Unidade de Terapia de Dor do Hospital de Egas Moniz/Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.

Paula Rebouta (P)

Unidade de Terapia de Dor do Hospital de Egas Moniz/Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.

Ted J Kaptchuk (TJ)

Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.

Irving Kirsch (I)

Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH