Open-Label Placebos as Adjunct for the Preventive Treatment of Migraine: A Randomized Clinical Trial
Abstract
IMPORTANCE: Placebo effects contribute substantially to the therapeutic success of many treatments, particularly in pain-related conditions. Open-label placebos (OLPs) offer an ethically acceptable approach to harness this potential without deception.
OBJECTIVE: To evaluate the efficacy of a 3-month OLP regimen in reducing headache and migraine days and improving migraine-related outcomes, including medication use, disability, and quality of life, in patients with migraine.
DESIGN, SETTING, AND PATIENTS: This controlled, bicenter, parallel-group randomized clinical trial, with a 3-month treatment phase, enrolled adults with episodic or chronic migraine between November 9, 2020, and November 1, 2022. The trial was conducted at 2 tertiary headache centers in Germany (University Medicine Essen and Headache Center Frankfurt).
INTERVENTIONS: Participants received OLPs plus treatment as usual (TAU) or TAU alone. OLPs were administered twice daily for 3 months.
MAIN OUTCOMES AND MEASURES: The preregistered primary outcome was the change in monthly headache days from a baseline to a test period after 3 months. Secondary outcomes included patient-reported quality of life assessed using the 12-Item Short-Form Health Survey physical component summary, pain-related disability assessed using the Pain Disability Index and Headache Impact Test, and global improvement.
RESULTS: Of the 120 patients (median age, 34.2 years; 95% CI, 29.8-39.3 years; 103 [86%] female), 102 (85%) had episodic…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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