Authors: Melissa Rayhill, Brian McGeeney, Peter Goadsby and Elizabeth Loder
Source: Neurology, April 24, 2017
Objective: We evaluated patient perspectives regarding the acceptability of placebo in cluster headache clinical trials in order to help establish ethical guidelines for investigators.
Background: Cluster headache is a disabling form of primary headache, and suicidal tendencies are common. Performing placebo-controlled trials is controversial in this population, given the severity of pain. No one has reported on patient acceptability of placebo use in cluster headache trials.
Design/Methods: This was an observational survey study administered to individuals over age 18 who identify themselves as having cluster headache. Patient perspectives on the use of placebo in cluster headache clinical trials were assessed using a paper-based survey. Participants were recruited during a national conference held for patients with cluster headaches (“Clusterbusters” in Austin, TX, September 2016). Informed consent was obtained and no identifiable data were collected.
Results: We received 37 completed surveys (180 attendees). 22 (59%) were male. All respondents reported a diagnosis of cluster headache by a physician. Most had episodic symptoms for over 10 years. Only 22% (n=36) described headaches as responsive to traditional therapies.
67% (n=27) of respondents correctly chose the World Health Organization definition of placebo; one described placebo as “cruel and unusual punishment”. In preventive drug and non-invasive device trials, most felt placebo was at least somewhat acceptable, with less agreement about comparing experimental treatments to established treatments. Most felt using placebo or established treatment comparisons (67% and 57%, n=33) in surgical device trials was unacceptable. Respondents felt using placebo in abortive drug (43%, n=37) and non-invasive device trails (67%, n=36) was not at all acceptable.
Conclusions: About 2/3 of respondents identified the correct definition of placebo. Placebo-controlled trials of preventive drugs and non-invasive medical devices were more acceptable than placebo-controlled preventive surgical device and abortive trials. There was less agreement about what was acceptable when experimental treatments were compared to established therapies.
Download and read entire article at Neurology.