Subcutaneous Sumatriptan in the Acute Treatment of Migraine in Patients Using Dihydroergotamine as Prophylaxis

Henry, Patrick; D'allens, H.; Abadie, Pascale; Aliotti, C.; Archirnbaud, A.; Aurouze, J; Boibelet, J.‐P.; Bouchet, J; Brejoux, G.; Cazal, Y.; Deleuze, Jean-Paul; Ducarré, M.; Dufour, Jean‐François; Foissac, R.; Giner, M.T.; Guillemet, S.; Jozereau, P.; Lafuma, G; Laugier, J; Longobardi, B.; Manhas, Atisha; Marteau, Émilie; Mathas, B.; Mauret, D.; Maurin, J P; Mongin, Gérald; Paulet, C.; Robert, Chang; Rousch, D.; Sachetat, P.; Salvi, Mario; Sdrigotti, D.; Toores, J.; Wien, E.; Bertin, L.

doi:10.1111/j.1526-4610.1993.hed3308432.x

Cited by 24 publications

(20 citation statements)

References 3 publications

(3 reference statements)

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“…Adverse events were more frequent in the sumatriptan group than in the other two groups. In the literature, rates of adverse events after treatment with sumatriptan s.c. vary from 27%[20] to 85% of patients [21]. In our trial, elevated blood pressure was the most commonly reported adverse event in all three groups, but it occurred most frequently in the sumatriptan group.…”

Section: Discussionmentioning

confidence: 68%

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial

Melchart

Thormaehlen²,

Häger³

et al. 2003

Journal of Internal Medicine

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Objectives. To investigate whether acupuncture is superior to placebo and equivalent to sumatriptan for the early treatment of an acute migraine attack. Design. Randomized, partly double-blind (sumatriptan versus placebo) trial. Setting. Two hospitals in Germany (one specialized in traditional Chinese medicine and one in the treatment of headache). Subjects. A total of 179 migraineurs experiencing the first symptoms of a developing migraine attack. Interventions. Traditional Chinese acupuncture, sumatriptan (6 mg subcutaneously) or placebo injection. Main outcome measure. Number of patients in whom a full migraine attack (defined as severe migraine headache) within 48 h was prevented. In patients who developed a migraine attack in spite of early treatment, acupuncture and sumatriptan were applied a second time, whilst patients initially randomized to placebo received sumatriptan. Results. A full migraine attack was prevented in 21 of 60 (35%) patients receiving acupuncture, 21 of 58 (36%) patients receiving sumatriptan and 11 of 61 (18%) patients receiving placebo (relative risk of having a full attack 0.79 (95% CI, 0.64-0.99) for acupuncture versus placebo, and 0.78 (95% CI, 0.62-0.98) for sumatriptan versus placebo). Response to the second intervention in patients who developed a full attack was better with sumatriptan (17/31 patients who received sumatriptan twice and 37/46 patients who had had placebo first) than with acupuncture (4/31). The number of patients reporting side-effects was 14 in the acupuncture group, 23 in the sumatriptan group and 10 in the placebo group. Conclusions. In this trial acupuncture and sumatriptan were more effective than a placebo injection in the early treatment of an acute migraine attack. When an attack could not be prevented, sumatriptan was more effective than acupuncture at relieving headache.

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Section: Discussionmentioning

confidence: 68%

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial

Melchart

Thormaehlen²,

Häger³

et al. 2003

Journal of Internal Medicine

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“…Sumatriptan.-We identified 23 randomized trials of subcutaneous sumatriptan. 10,26,45,46,51,[53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70] Fifteen placebo controlled studies revealed large and consistent statistically significant differences between sumatriptan and placebo in four class 1 studies, 64,66,68,70 seven class 2 studies, 54,56,58,60,61,63,67 and four class 3 studies. 55,57,62,65 In a class 1 study, 66 patients were randomized to sumatriptan 6 mg SC or prochlorperazine 10 mg 1 diphenhydramine 12.5 mg IV.…”

Section: Resultsmentioning

confidence: 99%

Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies

et al. 2016

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Objective.-To provide evidence-based treatment recommendations for adults with acute migraine who require treatment with injectable medication in an emergency department (ED). We addressed two clinically relevant questions: (1) Which injectable medications should be considered first-line treatment for adults who present to an ED with acute migraine? (2) Do parenteral corticosteroids prevent recurrence of migraine in adults discharged from an ED?Methods.-The American Headache Society convened an expert panel of authors who defined a search strategy and then performed a search of Medline, Embase, the Cochrane database and clinical trial registries from inception through 2015. Identified articles were rated using the American Academy of Neurology's risk of bias tool. For each medication, the expert panel determined likelihood of efficacy. Recommendations were created accounting for efficacy, adverse events, availability of alternate therapies, and principles of medication action.Results/Conclusions.-The search identified 68 unique randomized controlled trials utilizing 28 injectable medications. Of these, 19 were rated class 1 (low risk of bias), 21 were rated class 2 (higher risk of bias), and 28 were rated class 3 (highest risk of bias). Metoclopramide, prochlorperazine, and sumatriptan each had multiple class 1 studies supporting acute efficacy, as did dexamethasone for prevention of headache recurrence. All other medications had lower levels of evidence.Recommendations.-Intravenous metoclopramide and prochlorperazine, and subcutaneous sumatriptan should be offered to eligible adults who present to an ED with acute migraine (Should offer-Level B). Dexamethasone should be offered to these patients to prevent recurrence of headache (Should offer-Level B). Because of lack of evidence demonstrating efficacy and concern about sub-acute or long-term sequelae, injectable morphine and hydromorphone are best avoided as first-line therapy (May avoid-Level C).

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“…one was published twice [18], one was an interim analysis of a trial that was later published in full [19], one was a subgroup analysis of patients in two trials which had been published previously [20], one contained inconsistencies about the number of patients with adequate pain relief [21], one assessed pain relief but not at 2 h [22], and two did not provide data on the first administration in a cross-over design [23,24]. Thus a total of 22 trials, reported in 20 publications, were included in the analysis [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44], including three trials in which the 2-h relief rates were obtained from the authors [30,34,39].…”

Section: Search For Studies and Inclusion Criteriamentioning

confidence: 99%

Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos

Craen¹,

Tijssen²,

Gans

et al. 2000

Journal of Neurology

241

157

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We carried out a meta-analysis of 22 trials to determine the comparative placebo effect of (a) subcutaneous vs. oral and (b) in-hospital vs. at-home administration in the treatment of migraine. The headache relief rates were combined from the placebo arms of these randomised clinical trials assessing the value of sumatriptan in acute treatment of migraine. The main outcome measure was the proportion of patients reclassified from severe or moderate headache severity to no or mild headache severity 2 h after the beginning of treatment. In the oral regimen 222 of 865 patients (25.7%) reported no or mild headache severity after 2 h, compared to 279 of 862 patients (32.4%) of those receiving subcutaneous placebo (6.7% difference; 95% CI 2.4-11.0%). Adjusting for treatment setting and severity of headache at baseline did not change the observed difference. After placebo treatment at home 285 of 1,054 patients (27.0%) reported no or mild headache severity after 2 h, compared to 216 of 673 patients (32.1%) among those receiving placebo in hospital (5.1 % difference; 95% CI 0.6-9.5%). When adjusted for route of administration and severity of headache at baseline, the difference in relief rates between home and hospital setting disappeared. These findings indicate that subcutaneous administration enhances the placebo effect of acute treatment of migraine. Future trials of antimigraine drugs assessing the relative efficacy of various routes of administration should use a double-dummy technique. The interpreting of placebo-controlled trial results must therefore consider that the effect in the drug arm of the trial depends in part on the route of administration.

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Subcutaneous Sumatriptan in the Acute Treatment of Migraine in Patients Using Dihydroergotamine as Prophylaxis

Cited by 24 publications

References 3 publications

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial

Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies

Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos

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