An End to the Yom Kippur (and Ramadan) Headache
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|ClinicalTrials.gov Identifier: NCT00263094|
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : January 27, 2006
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Rofecoxib||Not Applicable|
Introduction: Religious fasting is associated with headache. This has been documented as ‘Yom Kippur Headache’ and ‘ First- of - Ramadan Headache.’ The Cox2 inhibitor, rofecoxib, has been reported effective in preventing perimenstrual migraine and in preventing recurrence of migraine. Given its 17 hour half-life, we undertook this study to see whether 50mg rofecoxib taken just prior to the 25 hour Yom Kippur fast would be effective in preventing headache.
Methods: We performed a double blind randomized prospective trial of rofecoxib 50mg vs placebo, taken just prior to the onset of fasting, Yom Kippur 2004. Healthy adults aged 18 – 65 were enrolled from the community and from hospital staff. Subjects completed a demographic data form and questions regarding headache history and a post-fast survey on headache during the fast, headache intensity, general ease of fasting and side effects.
Results: We sent out 170 forms of which 105 were completed and returned. Of those subjects receiving rofecoxib (n=53), ten or 18.9% vs 34 or 65.4 % of the placebo group (n=52) had headache at some point during the fast (p<.0001). Severity of headache in the treatment group was significantly less for the treatment group (3.45 vs 6.29 on a visual analog scale of 10 (p = .009)). None of those receiving rofecoxib reported a ‘more difficult than usual fast’ whereas the distribution of difficult to easy fast among the placebo group was more even.
Conclusion: Rofecoxib 50mg taken prior to a twenty five hour ritual fast prevents and attenuates fasting headache.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||: An End to the Yom Kippur (and Ramadan) Headache: A Double Blind Placebo Controlled Trial of Prophylactic Rofecoxib in Preventing Ritual Fasting Headache.|
|Study Start Date :||September 2004|
|Study Completion Date :||November 2004|
- Reduction in incidence of headache during fast in treatment group versus control group
- Reduction in severity of headache in treatment versus control groups.
- General ease of fast in treatment vs control groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263094
|Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Michael J Drescher, MD||Hartford Hospital|