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Randomized controlled trial · 2016

Open-label placebo treatment in chronic low back pain: a randomized controlled trial

Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I

Pain, 2016 · PMID 27755279

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In short

An open-label placebo added on top of patients' existing treatment as usual for chronic low back pain, tested over three weeks in Portugal.

Study type
Randomized controlled trial
Published
Pain, 2016
Topics
Open-label placebo, Chronic pain, Add-on treatment

open-label placebo chronic low back pain trial?

Yes — adding an openly labelled placebo to existing treatment reduced reported pain and disability more than treatment as usual alone in this 2016 trial. It was among the first replications of open-label placebo outside the original research group and condition.

This trial moved open-label placebo out of a single condition and a single research group, and tested it as an addition to care patients were already receiving rather than as a replacement for it.

The question

Does adding an openly labelled placebo to treatment as usual change reported pain and disability in chronic low back pain?

How it was done

  • 83 adults with chronic low back pain, randomized to treatment as usual, or treatment as usual plus open-label placebo.
  • Three-week duration; participants in the placebo arm took capsules clearly identified as placebo.
  • Outcomes were composite pain scores and the Roland–Morris Disability Questionnaire.
  • Control participants were offered the placebo regimen after the trial ended.

What was reported

  • The open-label placebo arm reported larger reductions in pain scores and in disability than treatment as usual alone.
  • Control participants who took placebo after the trial period reported reductions as well.

Limitations

  • Short duration and self-reported outcomes.
  • No blinded placebo comparison arm, so the specific contribution of open labelling is not isolated.
  • Participants knew which group they were in, which can itself influence reporting.

Why it matters

It was among the first replications outside the original research group and in a different condition, which is what moved open-label placebo from a curiosity to a research programme.

Citation

Carvalho C, et al. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016;157(12):2766–2772.

PMID 27755279

This summary is written by Efficacy Labs and is not a substitute for the original publication. The research described here is independent work by third parties and was not conducted using Efficacy Labs products. Efficacy Labs products contain no active therapeutic ingredient and are not intended as substitutes for prescribed medication or professional medical care. Information on this website is provided for general educational and research purposes and is not medical advice. References to published research describe independent scientific literature and do not imply that the research was conducted using Efficacy Labs products unless explicitly stated.

Background

What the placebo effect is, explained simply

How the effect is defined, what researchers think drives it, and how it is measured in trials like this one.

Products

Placebo pills for research and education

Inert capsules from Efficacy Labs, what they contain, and how to order them for a study or a classroom.

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