The efficacy and safety of dipyrone (NOVALGIN) tablets in the treatment of acute migraine attacks: a double-blind, cross-over, randomized, placebo-controlled, multicenter pilot study

11th Congress of the International-Headache-Society -- SEP 12-16, 2003 -- ROME, ITALYGulmez, Sinem Ezgi/0000-0001-8815-9128;WOS: 000185115000057…Int Headache So

The efficacy and safety of dipyrone (Novalgin (R)) tablets in the treatment of acute migraine attacks: a double-blind, cross-over, randomized, placebo-controlled, multi-center study

Gulmez, Sinem Ezgi/0000-0001-8815-9128; ERGUN, HAKAN/0000-0002-7839-966XWOS: 000226353400008PubMed: 15595715Dipyrone, 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(R), 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

The efficacy and safety of dipyrone (Novalgin (R)) 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(R), 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

Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire

Objectives.-The aim of this study is to assess the comprehensibility, internal consistency, patient-physician reliability, test-retest reliability, and validity of Turkish version of Migraine Disability Assessment (MIDAS) questionnaire in patients with headache

Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire

Objectives.-The aim of this study is to assess the comprehensibility, internal consistency, patient-physician reliability, test-retest reliability, and validity of Turkish version of Migraine Disability Assessment (MIDAS) questionnaire in patients with headache.Background.-MIDAS questionnaire has been developed by Stewart et al and shown to be reliable and valid to determine the degree of disability caused by migraine.Design and Methods.-This study was designed as a national multicenter study to demonstrate the reliability and validity of Turkish version of MIDAS questionnaire. Patients applying to 17 Neurology Clinics in Turkey were evaluated at the baseline (visit 1), week 4 (visit 2), and week 12 (visit 3) visits in terms of disease severity and comprehensibility, internal consistency, test-retest reliability, and validity of MIDAS. Since the severity of the disease has been found to change significantly at visit 2 compared to visit 1, test-retest reliability was assessed using the MIDAS scores of a subgroup of patients whose disease severity remained unchanged (up to +/- 3 days difference in the number of days with headache between visits 1 and 2).Results.-A total of 306 patients (86.2% female, mean age: 35.0 +/- 9.8 years) were enrolled into the study. A total of 65.7%, 77.5%, 82.0% of patients reported that "they had fully understood the MIDAS questionnaire" in visits 1, 2, and 3, respectively. A highly positive correlation was found between physician and patient and the applied total MIDAS scores in all three visits (Spearman correlation coefficients were R = 0.87, 0.83, and 0.90, respectively, P 0.7) or excellent (>0.8) levels in both patient and physician applied MIDAS scores, respectively. Total MIDAS score showed good test-retest reliability (R = 0.68). Both the number of days with headache and the total MIDAS scores were positively correlated at all visits with correlation coefficients between 0.47 and 0.63. There was also a moderate degree of correlation (R = 0.54) between the total MIDAS score at week 12 and the number of days with headache at visit 2 + visit 3, which quantify headache-related disability over a 3-month period similar to MIDAS questionnaire.Conclusion.-These findings demonstrated that the Turkish translation is equivalent to the English version of MIDAS in terms of internal consistency, test-retest reliability, and validity. Physicians can reliably use the Turkish translation of the MIDAS questionnaire in defining the severity of illness and its treatment strategy when applied as a self-administered report by migraine patients themselves