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Open-label placebos do not reduce cardiac anxiety, improve sleep quality, or enhance well-being in inpatients with cardiovascular disease undergoing cardiac rehabilitation.

In a randomized controlled trial of 122 inpatients with cardiovascular disease, open-label placebos (OLPs) added to treatment as usual and self-monitoring did not significantly improve cardiac anxiety, sleep quality, or well-being compared to control groups. All groups showed significant improvements over time, but no between-group differences were found for any primary outcome.

Last updated: Jul 28, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score48/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Efficacy of open-label placebos for cardiac anxiety in inpatients with cardiovascular disease: A randomized controlled trial.

rct

Tanzmeister S, Harringer L, Vogel LL, Schienle A · Journal of psychosomatic research (2026)

Participants: 122
Duration: 2 weeks
Intervention: Open-label placebo (water-based pump spray) administered twice daily for two weeks, plus treatment as usual and self-monitoring
Outcome: Cardiac anxiety, sleep quality, and well-being (questionnaire-based assessments)
Effect Size: N/A (no significant between-group differences)
Population: Inpatients with cardiovascular disease undergoing cardiac rehabilitation (38% female; aged 40-83 years)

Result: In a randomized controlled trial of 122 inpatients with cardiovascular disease, open-label placebos (OLPs) added to treatment as usual and self-monitoring did not significantly improve cardiac anxiety, sleep quality, or well-being compared to control groups. All groups showed significant improvements over time, but no between-group differences were found for any primary outcome.

PubMed: 42492114DOI: 10.1016/j.jpsychores.2026.112929

Mechanism Graph

Patients received open-label placebo with transparent explanation of its nature
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Patients self-monitored symptoms daily
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All groups received standard cardiac rehabilitation treatment
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No additional benefit from OLP beyond standard care and self-monitoring

Limitations

  • ⚠Study conducted in a structured inpatient setting with effective standard treatment, limiting generalizability to outpatient or less controlled environments
  • ⚠Short two-week intervention period may not capture long-term OLP effects

Frequently Asked Questions

What is an open-label placebo?▼

An open-label placebo is a placebo treatment given transparently to patients, without deception, meaning patients know they are receiving an inactive substance.

Did the open-label placebo improve sleep quality in this study?▼

No, the open-label placebo did not significantly improve sleep quality compared to treatment as usual or self-monitoring alone.

Who were the participants in this trial?▼

The trial included 122 inpatients with cardiovascular disease, aged 40 to 83 years, undergoing cardiac rehabilitation.

Why might open-label placebos not work in this setting?▼

The structured and effective standard treatment in an inpatient cardiac rehabilitation setting may have limited the potential for additional placebo effects.

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References

  1. 1.Tanzmeister S, Harringer L, Vogel LL, Schienle A. "Efficacy of open-label placebos for cardiac anxiety in inpatients with cardiovascular disease: A randomized controlled trial.." Journal of psychosomatic research, 2026. PMID: 42492114 DOI: 10.1016/j.jpsychores.2026.112929
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.