Open-label placebo Improves Quality of Life but Not Headache Frequency in Migraine: JAMA
A new study published in the Journal of the American Medical Association revealed that open-label placebo (OLPs) treatment did not reduce migraine frequency but enhanced quality of life and reduced pain-related disability, warranting further investigation. The trial explored whether taking placebos knowingly could offer benefits to migraine sufferers without the ethical dilemma of deception. Placebo effects have long been known to play a major role in the success of various treatments, particularly those targeting pain.
From November 2020 to November 2022, this research enrolled 120 adult patients diagnosed with episodic or chronic migraine. The median age was just over 34 years, and the vast majority (86%) were women, who were consistent with known migraine demographics. The participants were randomly assigned to receive either open-label placebo pills in addition to their usual treatment (OLP + TAU) or their usual treatment alone (TAU).
The OLP group was instructed to take the pills twice daily for 3 months, fully informed that the capsules contained no active medication but had been shown in prior research to trigger beneficial mind–body responses.
This research compared changes in headache frequency and found no statistically significant difference between those taking OLPs and those relying solely on standard care. Both groups experienced roughly similar numbers of headache and migraine days by the end of the 3-month period.
However, secondary outcomes revealed a more encouraging picture. The participants who took OLPs reported marked improvements in daily functioning and overall well-being. Scores on the 12-Item Short-Form Health Survey showed a meaningful rise in the physical quality-of-life index (average increase of 4.25 points, P = .01).
Measures of pain-related disability also improved, where the Pain Disability Index dropped by nearly 6 points on average, and the Headache Impact Test showed a modest but statistically significant improvement. Moreover, patients in the OLP group rated their overall condition as “globally improved” far more often than those receiving usual care.
Although the placebo pills did not reduce headache frequency or intensity, these findings suggest that their positive influence on patients’ perceived well-being and functional ability warrants further study. Future studies are expected to investigate how open-label placebos activate brain mechanisms related to pain perception and self-healing.
Source:
Kleine-Borgmann, J., Schmidt, K., Ludwig, L., Schulz, M., Holle-Lee, D., Gaul, C., & Bingel, U. (2025). Open-label placebos as adjunct for the preventive treatment of migraine: A randomized clinical trial: A randomized clinical trial. JAMA Network Open, 8(10), e2535739. https://doi.org/10.1001/jamanetworkopen.2025.35739
