Open Access Open Access  Restricted Access Subscription Access

BBC Horizon placebo back pain study: a public trial of the effectiveness of placebos

Jeremy Howick, Sarah J Kennedy, Joe Myerscough, Michael Mosley, Claire Madigan

Abstract


Background: Systematic reviews of randomized trials show that empathic care (a core component of person-centered care) and placebos can reduce chronic back pain. However, this evidence has rarely been implemented and public knowledge of empathy and placebos is limited.
Objectives: We conducted a trial (‘OPTICARE’) in a real-life setting. The trial and its aftermath were filmed for a British Broadcasting Corporation (BBC) Horizon documentary.
Methods: Eligible participants aged 18-75 years with self-reported persistent back pain (>3 months) were randomised to: (1) Control group (SC): had a standard consultation and a leaflet describing NHS recommendations for back pain. (2) Standard placebo group (SP): received a three-week course of placebo pills (2 capsules, twice a day) and a standard (5-10 minute) general practice (GP) consultation. (3) Empathy and placebo group (EP): received the same as SP treatment as the standard placebo group and a longer (15-30 minute) consultation with a doctor prompted to be highly empathetic. Self-reported changes in pain after 3 weeks were measured using the Visual Analogue Scale and the Roland Morris Disability Questionnaire. The process was filmed by Windfall Films.
Results: The documentary, entitled ‘The Placebo Experiment: Can My Brain Cure My Body?’ was first broadcast on BBC Two in the UK on 4 October 2018. It was watched by 1.9 million people. Almost all of the 117 participants in the trial reported a reduction in pain and magnitude of placebo effects is similar in real world settings as it is in clinical trials.
Conclusions: This was the largest placebo study we are aware of that was conducted with a main purpose of educating the public about placebo effects and the first known published report of a study designed for a documentary. Although the trial suffered from a number of limitations, including contamination and lack of power, it is contended that randomised trials of placebo treatments can be conducted so that they benefit and educate the public.


Keywords


Back pain, empathy, general practice, NHS recommendations, person-centered healthcare, placebo, randomised controlled trial, systematic reviews

Full Text:

PDF

References


Hoy, D., Bain, C., Williams, G., March, L., Brooks, P., Blyth, F., Woolf, A., Vos, T. & Buchbinder, R. (2012). A systematic review of the global prevalence of low back pain. Arthritis and Rheumatism 64 (6) 2028-2037.

Enthoven, W.T., Roelofs, P.D., Deyo, R.A., van Tulder, M.W. & Koes, B.W. (2016). Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database of Systematic Reviews 2:CD012087.

Saragiotto, B.T., Machado, G.C., Ferreira, M.L., Pinheiro, M.B., Abdel Shaheed, C. & Maher, C.G. (2016). Paracetamol for low back pain. Cochrane Database of Systematic Reviews 6:CD012230.

Derry, S., Wiffen, P.J., Moore, R.A., McNicol, E.D., Bell, R.F., Carr, D.B., McIntyre, M. & Wee, B. (2017). Oral nonsteroidal anti-inflammatory drugs (NSAIDs) for cancer pain in adults. Cochrane Database of Systematic Reviews 7:CD012638.

Derry, S., Moore, R.A., Gaskell, H., McIntyre, M. & Wiffen, P.J. (2015). Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database of Systematic Reviews 6:CD007402.

Chaparro, L.E., Furlan, A.D., Deshpande, A., Mailis-Gagnon, A., Atlas, S. & Turk, D.C. (2014). Opioids compared with placebo or other treatments for chronic low back pain: an update of the Cochrane Review. Spine 39 (7) 556-563.

The Lancet Gastroenterology & Hepatology. (2017). The opioid crisis: the needle and the damage done. The Lancet Gastroenterology & Hepatology 2 (6) 385.

Benedetti, F., Carlino, E. & Pollo, A. (2011). How placebos change the patient's brain. Neuropsychopharmacology 36 (1) 339-354.

Chen, P.A., Cheong, J.H., Jolly, E., Elhence, H., Wager, T.D. & Chang, L.J. (2019). Socially transmitted placebo effects. Nature Human Behaviour 3 (12) 1295-1305.

Charlesworth, J.E.G., Petkovic, G., Kelley, J.M., Hunter, M., Onakpoya, I., Roberts, N., Miller, F.G. & Howick, J. (2017). Effects of placebos without deception compared with no treatment: A systematic review and meta-analysis. Journal of Evidence-Based Medicine 10 (2) 97-107.

Howick, J., Friedemann, C., Tsakok, M., Watson, R., Tsakok, T., Thomas, J., Perera, R., Fleming, S. & Heneghan, C. (2013). Are treatments more effective than placebos? A systematic review and meta-analysis. PLoS One 8 (5) e62599.

Carvalho, C., Caetano, J.M., Cunha, L., Rebouta, P., Kaptchuk, T.J. & Kirsch, I. (2016). Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain 157 (12) 2766-2772.

Hardman, D.I., Geraghty, A.W., Howick, J., Roberts, N. & Bishop, F.L. (2019). A discursive exploration of public perspectives on placebos and their effects. Health Psychology Open 6 (1) 2055102919832313.

Howick, J., Bishop, F.L., Heneghan, C., Wolstenholme, J., Stevens, S., Hobbs, F.D.R. & Lewith, G. (2013). Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners. Plos One 8 (3) e58247.

Bishop, F.L., Aizlewood, L. & Adams, A.E. (2014). When and Why Placebo-Prescribing Is Acceptable and Unacceptable: A Focus Group Study of Patients' Views. PLoS One 9 (7) e101822.

Hardman, D. & Howick, J. (2019). The friendly relationship between therapeutic empathy and person-centered care. European Journal for Person Centered Healthcare 7 (2) 351-357.

sealedenvelope.com: Clerkenwell Workshops. (2001). Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists.

Roland, M. & Morris, R. (1983). A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine 8 (2) 145-150.

Maier, W., Buller, R., Philipp, M. & Heuser, I. (1988). The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. Journal of Affective Disorders 14 (1) 61-68.

Olsen, M.F., Bjerre, E., Hansen, M.D., Hilden, J., Landler, N.E., Tendal, B. & Hróbjartsson A. (2017). Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. BMC Medicine 15 (1) 35.

Briel, M., Olu, K.K., von Elm, E., Kasenda, B., Alturki, R., Agarwal, A., Bhatnagar, N. & Schandelmaier, S. (2016). A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable. Journal of Clinical Epidemiology 80, 8-15.

Hayden, J.A., Wilson, M.N., Riley, R.D., Iles, R., Pincus, T. & Ogilvie, R. (2019). Individual recovery expectations and prognosis of outcomes in non-specific low back pain: prognostic factor review. Cochrane Database of Systematic Reviews 2019 (11).

Ikeda, T., Sugiyama, K., Aida, J., Tsuboya, T., Watabiki, N., Kondo, K. & Osaka, K. (2019). Socioeconomic inequalities in low back pain among older people: the JAGES cross-sectional study. International Journal for Equity in Health 18 (1) 15.




DOI: http://dx.doi.org/10.5750/ejpch.v7i4.1787

Refbacks

  • There are currently no refbacks.