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: P Martínez-Martín, E Raffaelli Jr, F Titus, J Despuig, Y D Fragoso, E Díez-Tejedor, H Liaño, R Leira, M E Cornet, B S van Toor, J Cámara, H Peil, J M Vix, P Ortiz, Co-operative Study Group
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 21 Issue 5 Pg. 604-10 (Jun 2001) ISSN: 0333-1024 [Print] England
• PMID: 11472387 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Non-Narcotic
• Anti-Inflammatory Agents, Non-Steroidal
• Dipyrone
• Aspirin

Topics

• Adolescent
• Adult
• Aged
• Analgesics, Non-Narcotic (adverse effects, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
• Aspirin (adverse effects, therapeutic use)
• Dipyrone (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Hypersensitivity (etiology)
• Female
• Germany
• Humans
• Male
• Middle Aged
• Nausea (chemically induced)
• Pain Measurement
• Safety
• Taste Disorders (etiology)
• Tension-Type Headache (drug therapy)
• Treatment Outcome
• Vomiting (chemically induced)