Clinical trial of subcutaneous steroid injection in patients with migraine disorder

Background: Neurologic literature on therapeutic effect of subcutaneous corticosteroids in patients with migrainous chronic daily headache is scarce. The aim of this research is to assess the therapeutic effects of this management in such patients

Methods: Consecutive patients with migrainous chronic daily headache enrolled a prospective before-after therapeutic study during 2010-2013. Methylprednisolone 40 mg was divided into four subcutaneous injection doses. Two injections were administered in the right and left suboccipital area [exactly at retromastoid cervicocranial junction] and the other two injections in the lower medial frontal area [exactly at medial right and left eyebrows]. A daily headache diary was filled out by the patients before and one month after the intervention. The severity of pain was classified based on a pain intensity instrument using numeric rating scale from 0-10 point scale. Paired t-test and Chi-square test were used for statistical analysis

Results: 504 patients [378 females, 126 males] with migrainous chronic daily headache were enrolled in the study. Dramatic, significant, moderate, mild, or no improvements respectively constituted 28.6%, 33.3%, 23.8%, and 14.3% of the post treatment courses. Therapeutic effect of intervention on mean pain scores was significant; t=7.38, df=20, P=0.000. Two cases developed subcutaneous fat atrophy in frontal injection site and three cases experienced syncope during injection

Conclusion: Subcutaneous corticosteroids could be used as an adjunct therapy in patients with migrainous chronic daily headache

Randomized clinical trial of intravenous valproate [orifil] and dexamethasone in patients with migraine disorder

Background: Intravenous Valproate [IVVP] has been used in the treatment of migraine in some studies; however, it is far better known in the management of status epilepticus

Methods: Consecutive patients with migraine in our Headache Clinic were enrolled in this prospective, randomized clinical trial in 2011. The patients were randomized into two therapeutic groups, one receiving 900 mg IVVP [Orifil] and the other 16 mg IV Dexamethasone [IVDEX] diluted in 150 CC normal saline and infused for 10 minutes. Worst severity of pain before treatment and least severity at 3 hours after the infusion using a 0-10 point numeric rating scale were recorded. An interview with the patient was performed 72 hours after treatment to detect a possible relapse of headache

Results: Thirty-one migraine status patients, comprising 28 women and 3 men at a mean +/- SD age of 33.355 +/- 12.373 SD, were investigated. Differences in the therapeutic effects of IVVP [Orifil] and IVDEX on pain score were not significant between the two groups [t=0.933, df=29; P=0.358]. Relapse of headache occurred in 68.42% of the IVVP [Orifil] group and 66.67% of the IVDEX group. Distribution of relapse was not significantly different between the two therapeutic groups of patients [P=0.870]

Conclusion: IVVP [Orifil] was similar in efficacy to IVDEX as abortive therapy in patients with migraine status. IVVP [Orifil] appears to offer a safe and well-tolerated abortive treatment. Trial Registration Number: IRCT13891146234N2