Acetylsalicylic acid (ASA) in combination with
metoclopramide has been frequently used in clinical trials in the acute treatment of
migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without
metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a
triptan and a nonsteroidal anti-inflammatory drug (
ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated
sumatriptan (50 mg),
ibuprofen (400 mg) and placebo. The percentage of patients with reduction in
headache severity from moderate or severe to mild or no
pain (primary endpoint) was 52.5% for ASA, 60.2% for
ibuprofen, 55.8% for
sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were
pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA,
ibuprofen,
sumatriptan or placebo, respectively. The difference between ASA and
sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and
ibuprofen or
sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA,
ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg
sumatriptan and 400 mg
ibuprofen in the treatment of
migraine attacks regarding
headache relief from moderate/severe to mild/no
pain at 2 h. Regarding
pain-free at 2 h
sumatriptan was most effective.