Dismantling open-label placebos and their rationales: A remote 4-arm randomized controlled trial protocol

Area of Science:

• Pain Management
• Clinical Psychology
• Medical Ethics

Background:

• Open-label placebos (OLPs), honestly described as inactive pills, are increasingly studied for therapeutic effects.
• Prior research on OLPs for chronic pain has limitations, including inadequate controls and lack of blinding.
• The specific impact of different rationales provided to patients about OLPs remains underexplored.

Purpose of the Study:

• To explore the effect of rationales on open-label placebos (OLPs) in managing chronic pain.
• To compare the efficacy of different OLP rationales (standard vs. mindfulness-based) against a control group.
• To investigate the placebo effect, rationale effect, and pill effect in the context of OLPs for chronic pain.

Main Methods:

• A 4-arm randomized controlled trial with 340 US-based chronic pain patients (aged 18-89).
• Participants were randomized before consent using the Zelen procedure into four groups: no-treatment, standard OLP, mindfulness OLP, or control OLP.
• The study involved remote participation over 42 days, with pain intensity as the primary outcome measure.

Main Results:

• The study is designed to compare the effects of different rationales on OLP efficacy.
• It will allow for the examination of the placebo effect, rationale effect, and pill effect.
• Primary outcome is pain intensity measured over 42 days.

Conclusions:

• This trial will elucidate how various components of OLPs influence pain in chronic pain patients.
• It addresses limitations of previous OLP studies, such as inadequate blinding and control groups.
• Findings may inform the development of more effective OLP-based pain management strategies.