OBJECTIVE: To compare the efficacy of mouth-dispersible aspirin 900 mg and placebo in the treatment of migraine. BACKGROUND:Aspirin is widely accepted as an effective therapy for migraine. Previous studies have indicated that gastric stasis and delayed gastric emptying, which occur during migraine attacks, delay aspirin absorption. Mouth-dispersible formulations are considered to be more quickly absorbed than solid formulations and, therefore, may be more effective in treating migraine. DESIGN: Randomized, double-blind, placebo-controlled, crossover study in four specialized migraine clinics in the United Kingdom. METHODS:One hundred one patients diagnosed with migraine (according to the International Headache Society diagnostic criteria) participated in the study. Patients received either single doses of mouth-dispersible aspirin (3 x 300 mg) or placebo for moderate pain in the treatment of two migraine attacks. Rescue medication could be taken after 2 hours, if required. The primary efficacy parameter was response to therapy at 2 hours posttreatment. Other efficacy parameters were response to treatment, pain-free, and pain intensity at all other time points. Functional disability, nausea, vomiting, photophobia, phonophobia, symptom relief, patient and investigator global evaluation, use of rescue medication, headache recurrence, and palatability and convenience were also recorded. RESULTS:Of 101 patients, 73 took both treatments. At 2 hours, 48% of patients taking mouth-dispersible aspirin responded, compared to only 19% taking placebo (P =.0005). Mouth-dispersible aspirin was significantly better than placebo for response to treatment (P<.05) and pain intensity difference (P<.01) at all time points from 30 minutes posttreatment; for pain-free (P<.05) and use of rescue medication (P<.01) from 3 hours posttreatment; for headache recurrence (P<.05); and for patients' and investigators' global evaluations of efficacy (P =.0001 in both cases). CONCLUSIONS:Mouth-dispersible aspirin 900 mg is effective compared with placebo for the treatment of moderate migraine head pain, with relief seen from as early as 30 minutes after taking medication.
RCT Entities:
OBJECTIVE: To compare the efficacy of mouth-dispersible aspirin 900 mg and placebo in the treatment of migraine. BACKGROUND:Aspirin is widely accepted as an effective therapy for migraine. Previous studies have indicated that gastric stasis and delayed gastric emptying, which occur during migraine attacks, delay aspirin absorption. Mouth-dispersible formulations are considered to be more quickly absorbed than solid formulations and, therefore, may be more effective in treating migraine. DESIGN: Randomized, double-blind, placebo-controlled, crossover study in four specialized migraine clinics in the United Kingdom. METHODS: One hundred one patients diagnosed with migraine (according to the International Headache Society diagnostic criteria) participated in the study. Patients received either single doses of mouth-dispersible aspirin (3 x 300 mg) or placebo for moderate pain in the treatment of two migraine attacks. Rescue medication could be taken after 2 hours, if required. The primary efficacy parameter was response to therapy at 2 hours posttreatment. Other efficacy parameters were response to treatment, pain-free, and pain intensity at all other time points. Functional disability, nausea, vomiting, photophobia, phonophobia, symptom relief, patient and investigator global evaluation, use of rescue medication, headache recurrence, and palatability and convenience were also recorded. RESULTS: Of 101 patients, 73 took both treatments. At 2 hours, 48% of patients taking mouth-dispersible aspirin responded, compared to only 19% taking placebo (P =.0005). Mouth-dispersible aspirin was significantly better than placebo for response to treatment (P<.05) and pain intensity difference (P<.01) at all time points from 30 minutes posttreatment; for pain-free (P<.05) and use of rescue medication (P<.01) from 3 hours posttreatment; for headache recurrence (P<.05); and for patients' and investigators' global evaluations of efficacy (P =.0001 in both cases). CONCLUSIONS: Mouth-dispersible aspirin 900 mg is effective compared with placebo for the treatment of moderate migrainehead pain, with relief seen from as early as 30 minutes after taking medication.