Prophylactic etoricoxib is effective in preventing "first of Ramadan" headache: a placebo-controlled double-blind and randomized trial of prophylactic etoricoxib for ritual fasting headache.

BACKGROUND

Religious fasting is associated with headache. This has been documented as "Yom Kippur headache" and "first of Ramadan headache." Etoricoxib, a Cox-2 inhibitor with a 22-hour half-life, has been shown effective in preventing fasting headache when taken just prior to the 25-hour Yom Kippur fast. We hypothesized that etoricoxib would also be effective in preventing headache during Ramadan, despite the different characteristics of the fast.

METHODS

We performed a double-blind randomized prospective crossover trial of etoricoxib 90mg vs placebo, taken just prior to the onset of fasting, during the first 2 weeks of Ramadan 2010. Healthy adults aged 18-65 years were enrolled. Demographics, headache history and a daily post-fast survey were collected. We compared incidence, time of onset, and intensity of headache on each day and side effects in control and treatment groups.

RESULTS

We enrolled 222 patients and 189 completed the post-fast questionnaire (87%). Etoricoxib reduced the incidence of "first of Ramadan" headache by 54% (46% in placebo group [n=92] vs 21% [n=96] in etoricoxib group) (P<.0001, OR 3.19 [95% CI 1.68-6.06]). For days 1-6, the mean number of headache days for the placebo group was 1.60 (n=92) and for the treatment group the mean was 0.86 (n=99) headache days (P=.003). Median severity of headache in the treatment group was significantly lower. In the second week, there was no significant difference in incidence of headache between groups, and the incidence of headache in the placebo group dropped markedly over time.

CONCLUSION

Etoricoxib 90mg taken prior to a 15-hour ritual fast decreases incidence of and attenuates headache during the first 5 days of the month of Ramadan.