An End to the Yom Kippur (and Ramadan) Headache
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|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.|
- 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
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||November 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263094
|Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Michael J Drescher, MD||Hartford Hospital|