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Placebo response in cluster headache trials: a review
A I M Nilsson Remahl1, E Laudon Meyer, C Cordonnier
1Department of Neurology at Karolinska Institutet, Huddinge University Hospital, Sweden.
Cephalalgia : an International Journal of Headache
|September 3, 2003
Summary
Cluster headache (CH) trials show a significant placebo response, similar to migraine studies. Future research should optimize trial design using established guidelines to better understand CH treatment efficacy.
Area of Science:
- Neurology
- Clinical Trials
- Headache Medicine
Background:
- Cluster headache (CH) is a rare primary headache disorder with limited well-controlled clinical trials.
- The placebo response in CH trials has been historically considered small due to pain severity.
- Early double-blind, placebo-controlled trials in the 1980s demonstrated placebo responses in CH.
Purpose of the Study:
- To review and assess the magnitude of placebo response in cluster headache clinical trials.
- To provide recommendations for optimizing future cluster headache study designs.
Main Methods:
- Systematic review of six double-blind, placebo-controlled, cross-over trials for acute CH treatments.
- Analysis of five double-blind, placebo-controlled, parallel-group trials for prophylactic CH treatments.
- Evaluation of placebo response rates based on primary endpoints, including headache cessation.
Main Results:
- Placebo responses in acute CH trials ranged from 7% to 42% for endpoints of no or mild headache.
- Placebo responses in prophylactic CH trials varied from 14% to 43%, with the lowest reported for headache cessation.
- The magnitude of placebo response in CH trials is comparable to that observed in migraine studies.
Conclusions:
- A notable placebo response exists in clinical trials involving cluster headache patients.
- The placebo response in CH trials is similar in magnitude to that seen in migraine trials.
- Adherence to International Headache Society (IHS) guidelines is recommended for future CH trial design.