Long-Acting Propranolol in Migraine Prophylaxis: Results of a Double-Blind, Placebo-Controlled Study

Pradalier, A; Serratrice, G; Collard, M; Hirsch, Édouard; Feve, J. R.; Masson, M; Masson, Catherine; Dry, J.; Koulikovsky, G; Nguyen, Giang-Truong; Schbath, J; Carpentier, M Duym-de

doi:10.1046/j.1468-2982.1989.0904247.x

Cited by 32 publications

(12 citation statements)

References 5 publications

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“…Fifty‐seven studies were analysed with a total of 5906 patients in the placebo groups (11–67): triptans (3618 placebo/12496 active drug); NSAIDs (1656 placebo/3966 active drug); ergot alkaloids (258 placebo/677 active drug) and preventive agents (374 placebo/790 active drug). The triptan group had 31 studies: sumatriptan ( n = 10), rizatriptan ( n = 9), naratriptan ( n = 4), zolmitriptan ( n = 4), almotriptan ( n = 2), eletriptan ( n = 2).…”

Section: Resultsmentioning

confidence: 99%

Placebo Adverse Events in Headache Trials: Headache as an Adverse Event of Placebo

Reuter

Río

Carpay³

et al. 2003

Cephalalgia

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We analysed the adverse events of placebo in acute and preventive randomized, double-blind, placebo-controlled studies for migraine treatment. Fifty-seven trials (oral triptans, non-steroidal anti-inflammatory drugs, nasal ergot alkaloids and preventive agents) were included. From 10 to 30% of subjects reported adverse events after placebo. Most common were features associated with a migraine attack, such as nausea, phono- and photophobia. Other frequent complaints resembled those of the active drug (e.g. chest pressure in triptan trials). A third group of adverse events appeared to be coincidental (e.g. sleep disturbance). Adverse events following placebo are probably related to the drug under study and the symptomatology of migraine; some have no obvious explanation.

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Section: Resultsmentioning

confidence: 99%

Placebo Adverse Events in Headache Trials: Headache as an Adverse Event of Placebo

Reuter

Río

Carpay³

et al. 2003

Cephalalgia

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“…The dose of propranolol used in the present study is effective in migraine prophylaxis (7, 23). However, in the present study we could not show a prophylactic effect on GTN‐induced migraine.…”

Section: Discussionmentioning

confidence: 99%

The Effect of Propranolol on Glyceryltrinitrate-Induced Headache and Arterial Response

et al. 2004

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Prophylactic drug trials in migraine are long-lasting and expensive and require long-term toxicology information. A human migraine model would therefore be helpful in testing new drugs. Immediate headache and delayed migraine after glyceryltrinitrate (GTN) has been well characterized. We have recently shown that sodium valproate has prophylactic effect in the GTN model. Here we report our experience with propranolol in this model. Nineteen subjects with migraine without aura and 16 sex- and aged-matched healthy subjects were included in a two-centre randomized double-blind cross-over study. Fourteen migraine subjects and 14 healthy subjects completed the study and results from comparison of the 28 subjects are reported. Randomly propranolol 160 mg or placebo were each given daily for 14 days to both migraine and healthy subjects. A 20-min intravenous infusion of GTN 0.25 microg/kg per min was administered on a study day at the end of both pretreatment periods. Headache was registered for 12 h after GTN infusions. Its intensity was scored on a numerical verbal rating scale from 0 to 10. Fulfilment of International Headache Society (HIS) criteria was recorded for 24 h. Radial and superficial temporal artery diameters and blood velocity of both middle cerebral arteries were measured. All migraine subjects developed headache after GTN. No reduction of overall peak headache was found after propranolol (median 5, range 0-7) compared with placebo (median 5, range 0-10) (P = 0.441). Eight of the 14 completing migraine subject developed IHS 1.1 migraine after GTN, two subjects on both days, three subjects only after placebo, and three subjects only after propranolol. No reduction of GTN-induced migraine was found after propranolol compared with placebo (5 vs. 5, P = 1.000). All healthy subjects developed headache after GTN. No reduction of overall peak headache was found after propranolol (median 2, range 1-5) compared with placebo (median 1, range 1-7) (P = 0.315). Two subjects fulfilled IHS criteria 1.1 for migraine without aura after propranolol but not after placebo. The fulfilment was short lasting and did not require rescue medication. Headache after GTN was more pronounced in migraine subjects than in healthy subjects both with (P = 0.003) and without pretreatment with propranolol (P = 0.017). We found that 2 weeks of propranolol constricted the radial artery in healthy subjects but not in migraine subjects. GTN-induced vasodilatation abolished this difference. Mean maximum blood flow velocity in the middle cerebral artery was higher in healthy subjects than in migraine patients (P = 0.003-0.033) and unaffected by propranolol. We observed no effect of propranolol on GTN-induced headache and migraine. This could indicate that GTN induces migraine at a deeper level of the pathophysiological cascade of migraine than the prophylactic effect of propranolol. Propranolol does not constrict cerebral arteries, which therefore cannot be part of its mechanism of action in migraine.

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“…atenolol, metoprolol and timolol (2)(3)(4). Propranolol, however, remains the most commonly used beta blocker (5,6). The lack of efficacy of propranolol in our study was surprising, and the reasons for this are not clear.…”

Section: Resultsmentioning

confidence: 62%

Comparison of Propranolol LA 80 mg and Propranolol LA 160 mg in Migraine Prophylaxis: A Placebo Controlled Study

Al-Qassab

Findley

1993

Cephalalgia

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Thirty patients with severe classical and common migraine participated in a double-blind placebo-controlled cross-over study of migraine prophylaxis with propranolol LA (long-acting) 80 mg once daily, or propranolol LA 160 mg once daily or placebo. Each treatment was given for two months. There were no significant differences between the three treatment periods in headache frequency, headache severity, nausea frequency or severity. There was a non-significant trend for reduced duration of headache with the two doses of propranolol. The possible reasons for this negative effect are discussed. The safety of propranolol and its lack of serious side effects were demonstrated.

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Long-Acting Propranolol in Migraine Prophylaxis: Results of a Double-Blind, Placebo-Controlled Study

Cited by 32 publications

References 5 publications

Placebo Adverse Events in Headache Trials: Headache as an Adverse Event of Placebo

Placebo Adverse Events in Headache Trials: Headache as an Adverse Event of Placebo

The Effect of Propranolol on Glyceryltrinitrate-Induced Headache and Arterial Response

Comparison of Propranolol LA 80 mg and Propranolol LA 160 mg in Migraine Prophylaxis: A Placebo Controlled Study

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