The efficacy and safety of dipyrone (Novalgin) tablets in the treatment of acute migraine attacks: a double-blind, cross-over, randomized, placebo-controlled, multi-center study.
Dipyrone, an effective analgesic drug, is widely used in the management of headache. However, few studies have evaluated its efficacy and safety in migraine. We aimed to assess the efficacy and safety of 1 g dipyrone (Novalgin, two 500 mg tablets) on pain and related symptoms in acute migraine attacks with or without aura in a double-blind, cross-over, randomized, placebo-controlled, multi-center study design. Seventy-three migraine with or without aura patients, diagnosed according to the IHS criteria, were randomized to receive dipyrone (for 2 attacks) and placebo (for 1 attack). Pain intensity was measured on a four-point verbal pain scale before and 1, 2, 4 and 24 hours after drug intake. Significant improvement of pain was achieved with dipyrone compared to placebo at all time points measured. Both patient and physician evaluations were significantly in favor of dipyrone. Side effects were few and trivial in both groups. We conclude that dipyrone is an effective, safe and cost-effective option in acute migraine management.
Tulunay
F Cankat
FC
Department of Pharmacology and Clinical Pharmacology, Ankara University School of Medicine, Ankara, Turkey. tulunay@dialup.ankara.edu.tr
Ergün
Hakan
H
Gülmez
Sinem Ezgi
SE
Ozbenli
Taner
T
Ozmenoğlu
Mehmet
M
Boz
Cavit
C
Erdemoglu
Ali Kemal
AK
Varlikbas
Adnan
A
Göksan
Baki
B
Inan
Levent
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D018592:Cross-Over Studies; D004177:Dipyrone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020325:Migraine with Aura / Q000150:complications / Q000188:drug therapy*; D020326:Migraine without Aura / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D012720:Severity of Illness Index
D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004177:Dipyrone