title: Efficacy, end points and eventualities: sumatriptan/naproxen versus butalbital/paracetamol/caffeine in the treatment of migraine.
abstract: Migraine is a widespread, relapsing, remittent syndrome. No animal model predicts whether test medications will be clinically useful. Using a modern, well-controlled, sophisticated study design, Derosier et al. demonstrates not only that a butalbital formulation has modest efficacy as an acute treatment for migraine but also that a sumatriptan-naproxen combination is superior. These conclusions are reached using a variety of internally consistent secondary efficacy end points. The primary end point chosen (highly conservative and fashionable in some academic circles) was a technical failure (and not a negative experimental finding). Migraine is intrinsically pleiomorphic: diverse treatment options help match patient with therapy. This study does not justify blanket bans on (admittedly hazardous) barbiturate therapies, and regulators should not impose end point conservatism to an extent that will stifle further progress.
authors.affiliation: Department of Pharmaceutical Medicine, King's College London, London, UK. tony.fox@kcl.ac.uk
authors.forename: Anthony W
authors.initials: AW
authors.lastname: Fox
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D001463:Barbiturates / Q000627:therapeutic use*; D002110:Caffeine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D023381:Endpoint Determination / Q000379:methods / Q000592:standards; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000627:therapeutic use*; D012720:Severity of Illness Index; D018170:Sumatriptan / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001463:Barbiturates; D004338:Drug Combinations; C056076:acetaminophen, butalbital, caffeine drug combination; D000082:Acetaminophen; D002110:Caffeine; D009288:Naproxen; D018170:Sumatriptan