Diclofenac-K (50 and 100 mg) and Placebo in the Acute Treatment of Migraine

Abstract

The aim of the present study was to assess the efficacy and tolerability of single oral doses of 50 mg and 100 mg of diclofenac-K compared to placebo in migraine sufferers during three attacks. The study was conducted in a double-blind, randomized, placebo-controlled, three-period, within-patient comparative trial; 72 migraine patients were treated with diclofenac-K (50 mg or 100 mg) or placebo at six centres (1 in Sweden and 5 in Finland). The primary efficacy end-point was the change in pain intensity assessed on a 100 mm Visual Analogue Scale (VAS) at 120 min after taking the study medication. We found that 50 mg and 100 mg of diclofenac-K reduced the pain intensity significantly better than placebo (p = 0.003 and p = 0.001, respectively), without difference between the doses; 100 mg diclofenac-K was significantly better than placebo in improving phonophobia, photophobia, working ability and need for rescue medication. Diclofenac-K 50 mg or 100 mg is an effective and well-tolerated acute treatment for migraine headache and its associated symptoms. The higher dose of diclofenac-K was only marginally more effective than the lower dose.

Assessment of Health-Related Quality of Life in Migraine

“…Nevertheless, we have carried out investigations to evaluate how different drugs which relieve the attacks influence patient's quality of life in comparison with placebo. In one such study, 50 mg and 100 mg of the NSAID diclofenac-K were compared with placebo in acute treatment of migraine (22). Both doses of diclofenac-K gave significantly better relief of pain than placebo 2 and 3 h after intake of the dose.…”

“…Diclofenac-K was also significantly better than placebo with respect to working capacity, sensitivity to sound and light and need of additional analgesics. The improvement of these traditional efficacy variables was also reflected in an intermediate improvement of the patient's general well-being according to the Minor Symptoms Evaluation Profile-acute questionnaire (MSEP-acute) 3 h after administration (17,18,22). As the therapeutic efficacy of the higher dose of diclofenac-K differed only marginally from that of the lower dose, 50 mg diclofenac-K was recommended as the initial dose (22).…”

Современные Подходы К Фармакотерапии Мигрени

“…Свидетельством эффективного лечения мигрени яв-ляется по крайней мере одно плацебо-контролируемое исследование, в котором изучались ацетилсалициловая кислота (АСК) до 1000 мг [11], ибупрофен 200-800 мг [11], диклофенак 50-100 мг [12], феназон 1000 мг [13], метамизол 1000 мг [14], толфенаминовая кислота 200 мг [15] и парацетамол 1000 мг [16]. Кроме того, фиксиро-ванные комбинации АСК, парацетамола и кофеина являются эффективными при лечении острой мигрени, а также более эффективны, чем отдельные вещества или их сочетания без кофеина [17].…”

Diclofenaco intramuscular no tratamento agudo da migrânea: um estudo duplo cego placebo controlado

“…A eficácia da administração, em dose única, de 50 e 100 mg de diclofenaco, por via oral, foi investigada em um estudo duplo cego, randomizado, placebo controlado, multicêntrico. Ambas as doses reduziram a dor, em pacientes com migrânea com e sem aura, sem diferença entre as doses 19 . Alguns autores, revendo a literatura, concluem que o diclofenaco é semelhante ao sumatriptano e tão ou mais efetivo que os derivados ergotamínicos no alívio das crises de migrânea 20 .…”