Long-term follow-up of patients treated with open-label placebo (OLP) are non-existent. Herein, we report a 5-year follow-up of a three-weeks OLP randomized controlled trial (RCT) in chronic low back pain patients. We re-contacted the original 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 three-weeks trial with placebo pills and the original trial endpoint (p < .00001 for the two 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 to 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%). In contrast, the use of alternative approaches to pain management increased (from 18% to 29%). Although the reduction in pain and medication is comparable to 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 co-interventions. Nonetheless, our data suggest that reductions in pain and disability following OLP may be long lasting.
About The Expert
Claudia Carvalho
Maria Pais
Lidia Cunha
Paula Rebouta
Ted J Kaptchuk
Irving Kirsch
References
PubMed