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.

Cefaléia relacionada à hemodiálise: análise dos possíveis fatores desencadeantes e do tratamento empregado

“…Isso pode simplesmente refletir que essa droga é o medicamento parenteral mais frequentemente prescrito para o tratamento da cefaléia no Brasil 16,17 . É bastante interessante observar que a frequência relativa dos medicamentos prescritos para esse grupo especial de pacientes com cefaléias é praticamente especular à observada em pacientes com migrânea em nosso país, demonstrando o arraigado conceito, embasado por evidên-cias 18,19 , que os médicos reputam a esses medicamentos. Por outro lado, é certo que o tratamento medicamentoso em pacientes com IRC, seja profilático ou de uso agudo, torna-se um dilema para o médico, não somente pelas alterações metabólicas e excretórias desses pacientes, mas também pela ausência de estudos controlados sobre a eficácia das drogas utilizadas em pacientes com ambas as patologias.…”

Intravenous dipyrone for the acute treatment of episodic tension-type headache: A randomized, placebo-controlled, double-blind study

“…Oral dipyrone is effective in the treatment of episodic tension-type headache (12). The present study is the first in which intravenous dipyrone was assessed in the acute treatment of episodic tension-type headache.…”

Metamizole: A Review Profile of a Well-Known “Forgotten” Drug. Part II: Clinical Profile

“…in 417 patients with moderate episodic tension-type headache the efficacy and safety of oral single doses of 0.5 g and 1 g metamizole versus 1 g acetylsalicylic acid (ASA) was assessed in a randomized, double-blind, placebo-and active-controlled, parallel, multicentre trial (62). treatment arms were metamizole 0.5 g (n = 102), metamizole 1 g (n = 108), ASA 1 g (n = 102), and placebo (n = 105).…”