Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
Headache during fasting is a known entity in the scientific literature. The prevalence of
 such a headache is high and in a study conducted in Israel was found in 60% of people with a
 previous predilection for headache. A prior study showed a significant decrease in the
 incidence of fasting headache using rofecoxib, but the drug has been taken off the market.
 The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before
 the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced
 headache. The study will be a prospective double blind placebo controlled trial using adult
 volunteers with a history of a fasting headache who will be abstaining from food and drink on
 Yom Kippur.

 The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease
 the incidence of fasting headache.
Fasting is a known trigger for headache. More specifically, headache associated with ritual
 fasting in compliance with religious edict has been documented and described in the
 literature. These have been described in Jewish and Muslim ritual fasts, and have been dubbed
 'Yom Kippur headache,' and 'First of Ramadan headache' respectively. The incidence of fasting
 associated headache during the 25 hour fast of Yom Kippur (YK) wherein no food or drink is
 ingested, has been documented in approximately 40% of participants, but as high as 66% of
 those prone to headache. (1) A recent study was published in which the authors were able to
 show a marked reduction in YK headache using rofecoxib 50mg, a Cox 2 specific nonsteroidal
 anti-inflammatory medication with a relatively long (17 hour) half life. In a placebo
 controlled double blind randomized trial, in a population with a history of fasting headache,
 the drug was ingested just prior to the start of the fast. The placebo group had an incidence
 of headache 65% of the time whereas the treatment group had an incidence of 19%. Headache in
 the treatment set was also on average milder than in the controls. These results were all
 significant statistically. (3)

 Unfortunately for sufferers of fasting headache, rofecoxib (Vioxx), has been removed from the
 market and is no longer available.

 We therefore propose to conduct a second study using etoricoxib (Arcoxia) - a Cox 2 specific
 antiinflammatory medication with a longer half life than rofecoxib.
Inclusion Criteria:

 -  Age 18 -65.

 -  Patients will be enrolled if they declared that they intended to complete the 25 hour
 YK fast, and had demonstrated their commitment by doing so for the previous three
 years (unless medically prevented.)

 -  We will only enroll patients who stated that they typically suffered from headache
 during the fast.

 Exclusion Criteria:

 -  Patients with chronic medical problems including:

 -  Heart disease,

 -  Kidney disease,

 -  Liver disease,

 -  Peptic ulcer disease,

 -  Hypertension,

 -  Diabetes,

 -  Lung disease including asthma,

 -  History of gastrointestinal bleeding,

 -  Patients with allergies or intolerance in the past to NSAIDs,

 -  Pregnancy or lactation.