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KMID : 0911820230240020070
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Korean Journal of Headache
2023 Volume.24 No. 2 p.70 ~ p.76
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Secular Trend of Sex Ratio in Participants under Randomized Controlled Trials for Cluster Headache
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Chun Pil-Wook
Moon Heui-Soo
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Abstract
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Background: Although cluster headache (CH) is well known as a disorder of predominantly young males, the male to female ratio decreased from 5-7:1 before 1980s to -2:1 in the 2000s and afterward in Western observational studies. It is unclear whether this represents a true rise of CH in women or better recognition of CH in women. We sought to assess whether the sex ratio of CH were changing or not in randomized controlled trials (RCTs) over time in accordance with observational studies.
Methods: We included RCTs regarding pharmacologic medication, as well as procedural and surgical treatment, devices. Time trend of sex ratio was compared among 3 different publication era (1985-2000 vs 2001-2010 vs 2011-). Sex ratio between different cluster headache type (Episodic vs Chronic) was also compared.
Results: 22 acute treatment trials and 25 preventive treatment trials were initially selected for inclusion. 5 acute treatment trials and 10 preventive treatment trials were excluded due to small sample size (n<20) and/or no demographic information. All studies were underwent in western countries. Of 32 trials finally included, 10 studies were published between 1985 to 2000 (1st era), 8 studies from 2001 to 2010 (2nd era), 14 studies after 2010 (3rd era). Of the 2,476 patients, 80% were male. Secular tendency of decreasing male predominance was shown over time. 542 of 623 patients (87%) were male in 1st era, while 83% were male in 2nd era, and 75.3% were male in 3rd era (p<0.001). Male to female ratio was 6.7:1 in 1st era, 4.9:1 in 2nd era, and 3:1 in 3rd era. In chronic CH, 28% of subjects were female, while in episodic CH, 14.6% were female (p<0.001).
Conclusions: As suggested by observational and registry data, the population enrolled in the RCT also exhibited a decreasing trend in male predominance over time in CH.
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KEYWORD
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Cluster headache, Randomized controlled trial, Sex ratio, Secular trend
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