An End to the Yom Kippur (and Ramadan) Headache

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00263094
First received: December 6, 2005
Last updated: January 25, 2006
Last verified: January 2006
  Purpose

Fasting is a known trigger for headache. People who fast to comply with religious edict have been shown to be prone to headache which becomes more likely to occur with increasing length of fasting, and in people prone to headache. This has been documented as 'Yom Kippur Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would prevent or attenuate headache when taken just prior to the complete (no food or drink) 25 hour fast of Yom Kippur.


Condition Intervention
Headache
Drug: Rofecoxib

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Reduction in incidence of headache during fast in treatment group versus control group

Secondary Outcome Measures:
  • Reduction in severity of headache in treatment versus control groups.
  • General ease of fast in treatment vs control groups

Estimated Enrollment: 220
Study Start Date: September 2004
Estimated Study Completion Date: November 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of fasting headache
  • Age 18-65
  • Intention to fast on Yom Kippur
  • History of Fasting on Yom Kippur

Exclusion Criteria:

  • Pregnant or Nursing Women
  • Known allergy to NSAID type medication
  • History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263094

Locations
Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michael J Drescher, MD Hartford Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00263094     History of Changes
Other Study ID Numbers: SHEBA-04-3395-MD-CTIL
Study First Received: December 6, 2005
Last Updated: January 25, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Fasting
Headache
Cox 2 Inhibitors
Pain
Prophylaxis

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 23, 2014