• Cephalalgia · Jun 2001

    Randomized Controlled Trial Multicenter Study Clinical Trial

    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.

    • P Martínez-Martín, E Raffaelli, 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, and Co-operative Study Group.
    • Department of Neurology, Hospital General Universitario de Getafe, Madrid, Spain.
    • Cephalalgia. 2001 Jun 1;21(5):604-10.

    AbstractWe 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.

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