Extract

Background and study aims A migraine is a severe headache felt as a throbbing pain at the front or side of the head. The cause of migraine is still not completely understood and treatment is complicated by the differing symptoms experienced. The most common treatments are drugs, either over the counter or those prescribed by a GP or specialist. Some people find that avoiding certain foods and drinks can reduce the number and/or severity of their migraines. The aim of this study is to find out whether a simple blood test is able to identify foods to which people with migraine may be sensitive, and to test whether eliminating these foods from the diet reduces their migraine symptoms. Who can participate? Patients aged 18 to 65 who have migraines What does the study involve? Participants undergo a pin prick blood test to detect food intolerances. Participants with a positive test result (that is, they are found to have at least one food intolerance) are randomly allocated to one of two groups, either the True Diet (treatment) or Sham Diet (control) group. Both groups are given a diet sheet and are asked to eliminate all foods on their diet sheet for a period of 12 weeks. The True Diet group are sent a diet sheet with the results of their food intolerance test, while the Sham Diet group are sent a diet sheet of equal difficulty but the foods listed are not the true results of their test. Both groups are asked to follow the diet for 12 weeks, completing a daily diary and questionnaires at various time points. At the end of 12 weeks they are asked to reintroduce in a stepwise fashion the foods which they have been asked to eliminate. They are asked to reintroduce one food at a time on a weekly basis and continue with the food if no migraine occurs. This occurs over a 4-week period with all eliminated foods (if no migraine has occurred) being introduced in the final week. At the end of the study all participants are told which diet group they were allocated to and those in the Sham Diet group are provided with their true diet sheet. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? York Trials Unit, Department of Health Sciences, University of York (UK) When is the study starting and how long is it expected to run for? March 2008 to February 2009 Who is funding the study? University of York (UK) Who is the main contact? Prof David Torgerson

Inclusion criteria

• Migraine

Links

• ictrp
• isrctn