Prophylactic Etoricoxib Is Effective in Preventing Yom Kippur Headache: A Placebo-Controlled Double-Blind and Randomized Trial of Prophylaxis for Ritual Fasting Headache

Background.-Religious fasting is associated with headache. This has been documented as "Yom Kippur Headache" and "First-of-Ramadan Headache." Rofecoxib (Vioxx (R)), a cyclooxygenase-2 (Cox-2) inhibitor with a 17-hour half-life, has been shown to be effective in preventing fasting headache when taken just prior to the 25-hour Yom Kippur fast. Unfortunately for fasters rofecoxib is no longer available. We hypothesized that etoricoxib, another Cox-2 inhibitor with a longer half-life, would also be effective in preventing fasting headache. Methods.-We performed a double-blind randomized prospective trial of etoricoxib 120 mg vs placebo, taken just prior to the onset of fasting, Yom Kippur 2008. Healthy adults aged 18-65 years were enrolled from the community. Subjects completed a demographic data form and questions regarding headache history and a post-fast survey on headache during the fast. We compared incidence, time of onset and intensity of headache, general ease of fasting, and side effects in control and treatment groups. Results.-We enrolled 211 patients and 195 completed the post-fast questionnaire (92%). Of those subjects receiving etoricoxib (n = 99), 36 or 36.4% vs 65 or 67.7% of the placebo group (n = 96) developed any headache during the fast (P<.0001). Median severity of headache in the treatment group was significantly lower for the treatment group (3.0 vs 5.0 on a visual analog scale of 10; P =.024). Also, participants in the treatment group reported an easier fast than the placebo group, as compared with previous fasting experience (4.0 vs 3.5 on a scale of 1-5; P<.0001). Conclusion.-Etoricoxib 120 mg taken prior to a 25-hour ritual fast decreases incidence of and attenuates fasting headache. NCT number is NCTT00752921.