Einzeldosen mit Kortison verringern Wiederkehrkopfschmerzen nicht [Pharma]
01 Mai 06
Speziell in Notaufnahmen wird bei schweren Migräneattacken häufig Kortison verabreicht. In den folgenden Studien wurde untersucht, ob die Gabe von Kortison Wiederkehrkopfschmerzen verhindern kann. Dies wurde negativ beantwortet.
Intravenous Dexamethasone vs. Placebo as Adjunctive Therapy to Reduce the Recurrence Rate of Acute Migraine Headaches: A Multicenter Double-blind Placebo-controlled Randomized Clinical Trial.
Objectives: Corticosteroids are often prescribed as adjunctive therapy for patients with migraine headaches to decrease the rate of rebound headache. The efficacy of this practice has not been tested in the emergency department (ED). Our objective is to determine the efficacy of single-dose dexamethasone as adjunctive therapy for emergency medicine patients with migraine headache in preventing headache recurrence at 3 and 30 days posttreatment.
Methods: From November 2004 to November 2005, we conducted a multicenter double-blind placebo-controlled randomized clinical trial of adult patients who met the International Headache Society (IHS) definition of migraine headache. After informed consent, patients were randomly assigned to one of two groups: receiving either placebo or 24 mg of dexamethasone intravenously. To ensure generalizability, all other aspects of patient care were left to the discretion of the emergency physician. Clinical and demographic information was obtained and patients were subsequently contacted at both three and 30 days to determine headache recurrence, current functional disability, and need for return to the ED. Our primary outcome measures were the recurrence of migraine headache at three and 30 days. We used Fisher's exact test to determine statistical significance.
Results: A total of 115 patients were enrolled with 16 patients lost to follow-up at three days, and 3 additional patients lost at 30 days. Baseline characteristics as well as adverse event profiles were equivalent in both study groups. At 3-day follow-up, 45% (95% confidence interval [95% CI] = 31%-60%) of the placebo group had recurrence of their migraine compared with 35% (95% CI = 24%-48%) in the dexamethasone group (p = 0.68). At 30-day follow-up, this relative reduction in migraine recurrence decreased to a 4% difference between the two groups (p = 0.68).
Conclusions: A single dose of dexamethasone as adjunctive therapy for migraine headache does not significantly decrease the recurrence of migraines at 3 or 30 days.
David Donaldson, Ryan Sundermann, Ray Jackson and Aveh Bastani. Intravenous Dexamethasone vs. Placebo as Adjunctive Therapy to Reduce the Recurrence Rate of Acute Migraine Headaches: A Multicenter Double-blind Placebo-controlled Randomized Clinical Trial. Acad Emerg Med Volume 13, Number 5_suppl_1 16, 2006.
Dexamethasone in Migraine Relapses: A Randomized, Placebo-Controlled Clinical Trial.
Objectives: Migraine is a common presentation in the emergency department (ED). Inflammation is thought to play a role in migraines and there is conflicting evidence regarding the effect of corticosteroids on reducing early recurrences. We designed a randomized clinical trial to test this hypothesis.
Methods: Consenting adults (older than 17 years) presenting with acute migraine at 4 Alberta EDs were enrolled. In addition to standard intravenous (IV) abortive therapy, patients were randomized to receive similar-appearing IV dexamethasone (DEX; 15 mg) or placebo (PLA) using concealed allocation and in a double-blind fashion. Follow-up telephone interviews were conducted 48-72 hours and 7 days after ED discharge. Relapse was defined as a return to the ED, an urgent clinic visit, or a headache that precluded normal activity at the 48-72-hour follow-up. An interim analysis was conducted after 60 patients had completed follow-up. Intention to treat was used for this final analysis.
Results: 130 patients were randomized; 126 patients are included in the analysis (1 patient left prior to treatment and 3 enrolled twice). Mean age was 35 ± 10.5 years, 81% were female; most (77%) suffered from headaches at least monthly. Overall, 64 received DEX and 62 received PLA. On a scale of 0 (no pain) to 10 (worst pain), median pain score was 8 at presentation and 2 at discharge. At 48-72 hours, relapses occurred in 14/64 (22%) and 20/62 (32%) in the DEX and PLA groups, respectively (p = 0.19; odds ratio [OR] = 0.6; 95% confidence interval [95% CI]: 0.3-1.3). By day 7, 18/64 (28%) in the DEX group had relapsed, compared with 25/62 (40%) in the PLA group (p = 0.15). Controlling for treatment assignment, relapse was more common when headache pain was >2 at discharge (OR: 2.24; 95% CI: 1.1, 5.4).
Conclusions: The overall relapse rate differed from those previously reported; however, DEX failed to reduce headache relapses after ED discharge. Further research is needed to determine the factors associated with migraine relapse.
Brian H. Rowe, Sandra Blitz, Ian Coleman and Marcia Edmonds. Dexamethasone in Migraine Relapses: A Randomized, Placebo-Controlled Clinical Trial. Acad Emerg Med Volume 13, Number 5_suppl_1 16-17, 2006.
Dexamethasone for Migraine Headaches: An Emergency Department Randomized Double-blind Placebo-controlled Trial.
Background: Recurrence of headache after treatment for migraines in the emergency department (ED) is common. Conflicting evidence exists regarding the utility of dexamethasone to prevent headache recurrence at 24-48 hours.
Objective: To determine if dexamethasone added to standard treatment decreases the recurrence of headaches in patients treated for migraine headache in the ED.
Methods: Design: Double-blind placebo-controlled randomized trial. Participants: Patients >17 years of age with an initial pain score >5 (10-point visual analog scale [VAS]), ED clinical diagnosis of migraine headache, and presentation requiring intravenous (IV) therapy. The study was performed at a suburban community hospital with an annual volume of 70,000 visits from May 2003 to November 2005. Protocol: Patients received standard medical treatment for their headaches. Informed consent was then obtained. Enrolled patients received either dexamethasone (10 mg IV) or a placebo (similar-appearing saline infusion). Demographic and historical information was collected utilizing a standardized closed-question form. Patients were contacted 24-48 hours after the ED visit by study authors. The primary study end point was the recurrence of headache at follow-up. Chi-square was used for the main study outcome with a preset alpha of 0.05. A pre-enrollment power calculation determined that 44 patients were needed in each group (alpha 0.05, and power of 80%).
Results: A total of 91 patients were enrolled. Six were lost to follow-up: 2 in the dexamethasone group and 4 in the placebo group. Participants had a mean age of 38 ± 10 years, with 90% females. 92% met the International Headache Society criteria for migraine headache. Of the 85 patients with complete data, 19/44 (43%) in the dexamethasone arm and 20/41 (49%) in the placebo arm had recurrent headache upon follow-up (p = 0.60).
Conclusions: Dexamethasone (10 mg IV) does not appear to decrease headache recurrence in patients treated for migraine headache in the ED.
Frederick W. Fiesseler, Richard Shih, Michael E. Silverman, Barnet Eskin, Martin Clement, Paul Szucs and John Allegra. Dexamethasone for Migraine Headaches: An Emergency Department Randomized Double-blind Placebo-controlled Trial. Acad Emerg Med Volume 13, Number 5_suppl_1 137, 2006.