title: Efficacy and safety of metamizol vs. acetylsalicylic acid in patients with moderate episodic tension-type headache: a randomized, double-blind, placebo- and active-controlled, multicentre study.
abstract: We assessed the efficacy and safety of oral single doses of 0.5 and 1 g metamizol vs. 1 g acetylsalicylic acid (ASA) in 417 patients with moderate episodic tension-type headache included in a randomized, double-blind, placebo- and active-controlled, parallel, multicentre trial. Eligibility criteria included 18-65 years of age, history of at least two episodes of tension-type headache per month in the 3 months prior to enrollment, and successful previous pain relief with a non-opioid analgesic. Treatment arms were metamizol 0.5 g (n = 102), metamizol 1 g (n = 108), ASA 1 g (n = 102) and placebo (n = 105). The analgesic efficacy of 0.5 and 1 g metamizol vs. placebo was highly statistically significant (alpha: 0.025; one-sided) for sum of pain intensity differences, maximum pain intensity difference, number of patients with at least 50% pain reduction, time to 50% pain reduction, maximum pain relief and total pain relief. A trend towards an earlier onset of a more profound pain relief of 0.5 and 1 g metamizol over 1 g ASA was noticed. All medications including placebo were almost equally safe and well tolerated.
authors.affiliation: Department of Neurology, Hospital General Universitario de Getafe, Madrid, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Martínez-Martín
authors.forename: E
authors.initials: E
authors.lastname: Raffaelli
authors.forename: F
authors.initials: F
authors.lastname: Titus
authors.forename: J
authors.initials: J
authors.lastname: Despuig
authors.forename: Y D
authors.initials: YD
authors.lastname: Fragoso
authors.forename: E
authors.initials: E
authors.lastname: Díez-Tejedor
authors.forename: H
authors.initials: H
authors.lastname: Liaño
authors.forename: R
authors.initials: R
authors.lastname: Leira
authors.forename: M E
authors.initials: ME
authors.lastname: Cornet
authors.forename: B S
authors.initials: BS
authors.lastname: van Toor
authors.forename: J
authors.initials: J
authors.lastname: Cámara
authors.forename: H
authors.initials: H
authors.lastname: Peil
authors.forename: J M
authors.initials: JM
authors.lastname: Vix
authors.forename: P
authors.initials: P
authors.lastname: Ortiz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D004177:Dipyrone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D012449:Safety; D013651:Taste Disorders / Q000209:etiology; D018781:Tension-Type Headache / Q000188:drug therapy*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004177:Dipyrone; D001241:Aspirin