Investigating the effect of evening primrose oil on reducing the severity of headache and disability due to menstrual migraine

Investigating the effect of evening primrose oil on reducing the intensity of headache and disability in patients with menstrual migraine referred to the Neurology Clinic of Arak University of Medical Sciences.

This study is a before and after clinical trial with parallel groups. It is three-blind. The sample size is 40 people. They are randomly divided into two control and intervention groups (block randomization method with the size of 4 blocks and the number of 6 blocks).

People referring to the neurology clinics of Arak city (Valiasr Clinic-Imam Reza Clinic) suffering from menstrual migraine are randomly divided into two groups of 20 people, control and intervention by the intern. The control group receives common treatments along with placebo, the intervention group in addition Common treatments receives 2 pearls of 1000 mg evening primrose oil daily from 5 days before to 5 days after menstruation for 3 months.

Criteria for entering the study: Age 18 to 55 years Not taking drugs other than prescribed drugs Obtaining informed consent from the patient Exclusion criteria: Menopause The occurrence of allergic reactions or drug side effects Hospitalization due to illness

People who have the conditions to enter the study will be randomly divided into 2 groups of 20 people (control and intervention) by the project manager. The control group received common treatments (including sodium valproate 200 mg twice a day and nortriptyline 25 mg daily) along with placebo, the intervention group, in addition to the common treatments, received 2 Pearls 1000 mg evening primrose oil daily from 5 days before They receive it 5 days after menstruation for 3 months.

Severity of headache and disability caused by menstrual migraine

In this study, randomization will be done using the block randomization method. A block size of 4 is considered. Therefore, we will have 6 blocks in the following order: AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6), each of which is numbered and addresses 4 patients. will be used; That is, if block number 2 is selected in the lottery, the first patient will receive treatment A (morangiola), the second patient will receive treatment B (placebo), the third patient will receive treatment A (morangiola) and the fourth patient will receive treatment B (placebo). The fifth patient will be randomly selected from one of the blocks and the type of treatment will be allocated to the fifth to eighth patients according to the block, and this process will be repeated until the end of sampling. The lottery is also done in such a way that the numbers of the blocks are written in folded papers and then another person (other than the researcher) takes one of the papers each time to determine the block number.

In this study, the doctor, the patient, and the statistical analyst are not aware of the allocation of patients in the intervention and control groups. In this way, the specialist doctor only examines the patients according to the criteria of the International Headache Society (IHS) to meet the conditions for entering the study, but is not involved in the randomization of their allocation; This is done by an intern colleague. In order to avoid the knowledge of the patients, the drug and placebo (which look the same) are removed from their original packaging and placed in paper packages of the same shape so that they cannot be distinguished. Also, in order to avoid the knowledge of the statistical analyst, the control and intervention groups are marked with code one and two, so that only the intern (researcher) is aware of the control and intervention groups.