Comparison of a fixed combination of domperidone and paracetamol (Domperamol) with sumatriptan 50 mg in moderate to severe migraine: a randomised UK primary care study. Double-blind controlled study of paramax in the acute treatment of common and classical migraine. A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. [Tolfenamic acid versus paracetamol in migraine attacks. A double-blind study in general practice]. Efficacy and tolerability of coadministration of rizatriptan and acetaminophen vs rizatriptan or acetaminophen alone for acute migraine treatment. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Domperidone plus paracetamol in the treatment of migraine. [Treatment of migraine attacks: combination of dihydroergotamine tartrate and paracetamol in comparison with individual drugs and placebo].
Migraine is a common and debilitating condition routinely managed in primary care. A number of treatment options--both acute and prophylactic--are currently available but may differ in terms of efficacy, tolerability and cost. The aim of this study was to compare the effectiveness and tolerability of a fixed combination of domperidone and paracetamol (Domperamol; Servier), which has anti-nauseant and anti-emetic activity, with sumatriptan 50 mg in moderate to severe migraine. To do this, 120 patients were recruited from 23 primary care practices throughout the UK and were enrolled into the six-month trial. Patients were randomised at entry to one of the comparator regimens (used to treat their first migraine attack) and then crossed over to the alternative treatment for their second attack. Detailed diary cards were completed for each attack using a scale of pain severity. At two hours and four hours post-dose, the two treatments showed comparable efficacy (< or = 15% difference) in relieving headache and reducing nausea and vomiting. Both were well tolerated and there were no serious adverse effects. In the management of migraine patients typically seen in routine general practice, this trial showed that the effects of Domperamol and sumatriptan 50 mg were broadly comparable. Since Domperamol is considerably less expensive than sumatriptan (and other triptans), a first-line role for this agent appears appropriate. nan To evaluate the efficacy and safety of acetaminophen 1000 mg for the treatment of episodic migraine headache.
                While acetaminophen is commonly used to treat migraine, there have been limited published clinical trial efficacy results.
                Ten investigators at 13 private, ambulatory, primary care sites in the United States enrolled and treated 346 outpatient adults 18-72 years of age with migraine headache of moderate to severe intensity into a randomized, placebo-controlled, double-blind clinical trial of 6 hours duration. Each patient was randomly assigned to a single dose of study medication of acetaminophen 1000 mg (n = 177) or placebo (n = 169). The percentage of patients with a reduction in baseline headache pain intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none were also assessed.
                Significantly (P = .001) more patients treated with acetaminophen 1000 mg reported mild to no pain after 2 hours (52.0%) compared with those treated with placebo (32.0%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < .001) greater for patients treated with acetaminophen 1000 mg (0.82) compared with those treated with placebo (0.46). A significant difference in favor of acetaminophen 1000 mg over placebo was also observed at 1 hour after treatment for the percentage of patients with mild to no pain and for mean pain intensity difference from baseline. Acetaminophen 1000 mg was significantly more effective than placebo for all but 1 (pain reduced to none at 2 hours) clinically important secondary pain relief outcomes. Mean severity changes from baseline in migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < .001) in favor of acetaminophen over placebo; the percentage of patients with no symptoms at 2 and 6 hours statistically significantly favored acetaminophen in 6 of 8 comparisons. Adverse events, overall, and specifically for nausea, were reported more frequently in the placebo group.
                Acetaminophen 1000 mg, a nonprescription drug, is an effective and well-tolerated treatment for episodic and moderate migraine headache. In addition, acetaminophen generally provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability. To compare the effect of tolfenamic acid and paracetamol in acute migraine, 149 patients participated in a double-blind controlled, multipractice study. 116 patients completed both treatments. The patients were asked to evaluate the two drugs in terms of the following parametres: 1) intensity of headache after three hours: as usual or less, 2) necessity of further medicine after three hours, 3) assessment of test medicine regarding the effect on strength, duration, and other inconveniences connected with the headache, 4) possible side effect connected with test medicine, and how these were experienced. After both forms of treatment, the patients were asked to give an overall judgement of the medicine, which had the best effect. No statistically significant difference was observed between the effect of 400 mg tolfenamic acid and 1 g paracetamol as to the five test parametres when using parametric or non-parametric statistics with a significance level of 5%. However, tolfenamic acid was numerically better than paracetamol with regard to headache after three hours, necessity of further medicine, judgement of attacks, and preference. To evaluate the efficacy and tolerability of coadministration of rizatriptan and acetaminophen in the acute treatment of migraine.
                Rizatriptan is a selective 5-HT1B/1D agonist approved for the acute treatment of migraine. Acetaminophen has been studied for acute migraine treatment. In consideration of the prominent central and peripheral mechanisms in migraine, the use of "multi-mechanism therapy" is gaining momentum in the treatment of acute migraine attacks.
                This was a randomized, double-blind, placebo-controlled trial conducted at 10 centers. Eligible patients with migraine according to International Headache Society criteria treated a single migraine attack of moderate or severe intensity within 4 h from pain onset. Patients were randomized into 1 of 4 groups (rizatriptan 10 mg + acetaminophen 1000 mg [RA], rizatriptan alone [R], acetaminophen alone [A], and placebo [P]). There were 3 co-primary hypotheses tested sequentially for 2-h pain relief: (1) RA would be superior to P; (2) if the first was fulfilled, RA would be superior to A; and (3) if the first 2 were fulfilled, RA would be superior to R.
                Of 173 patients who treated a migraine, 123 patients (71.5%) achieved pain relief within 2 h. RA (90%) was significantly better than P (46%) and A (70%), but only numerically better than R (77%) for 2-h pain relief. No significant differences were seen between the active treatment groups in adverse events.
                Rizatriptan coadministered with acetaminophen achieved 2 of the 3 primary hypotheses, proving superior to both acetaminophen and placebo for 2-h pain relief, but failing to achieve superiority to rizatriptan alone. RA was as well tolerated as each of the individual agents. Although most persons with migraine treat their headaches with over-the-counter medication, systematic data on the safety and efficacy of widely used treatment, including acetaminophen, are sparse.
                This is a randomized, double-blind, placebo-controlled study comparing oral acetaminophen, 1000 mg (two 500-mg Extra Strength Tylenol tablets), with identical placebo in the treatment of a single acute migraine attack. Eligible subjects met International Headache Society diagnostic criteria for migraine with or without aura. Patients who usually required bed rest with their headaches or who vomited more than 20% of the time were excluded.
                The percentage of subjects who, at 2 hours after dosing, experienced a change in baseline pain intensity from severe or moderate pain to mild or no pain (headache response); and pain intensity difference from baseline at the 2-hour postmedication assessment.
                The headache response rate 2 hours after dosing was 57.8% in the acetaminophen group and 38.7% in the placebo group (P =.002). Pain-free rates at 2 hours were 22.4% in the acetaminophen group and 11.3% in the placebo group (P =.01). The mean pain intensity difference from baseline 2 hours after dosing was 1.08 in the acetaminophen group and 0.73 in the placebo group (P<.001). At 2 hours, other migraine headache characteristics, such as functional disability (P =.002), photophobia (P =.02), and phonophobia (P =.08), were significantly improved after treatment with acetaminophen vs placebo.
                Acetaminophen was highly effective for treating pain, functional disability, photophobia, and phonophobia in a population-based sample of persons with migraine, excluding the most disabled persons with migraine. The drug also had an excellent safety profile and was well tolerated. Arch Intern Med. 2000;160:3486-3492. This study was designed to evaluate the safety and efficacy of domperidone in combination with paracetamol in the treatment of migraine. Severity of headache, duration of migraine attack and overall efficacy of treatment were amongst the variables assessed in a randomized, double-blind, three-way cross-over comparison of 1 g paracetamol plus either domperidone 30 mg, domperidone 20 mg or placebo, taken at onset of headache. Forty-six patients attending the City of London Migraine Clinic completed the study. A significant difference was observed in the duration of the migraine attack: a median of 17.5 h with paracetamol alone was reduced to 12.0 h with the addition of domperidone 20 mg, and to 12.0 h with domperidone 30 mg. No significant adverse events were reported. A reduction in pain intensity and nausea was noted but this was not statistically significant. It was concluded that domperidone shortens the duration of a migraine attack and may help reduce headache and associated symptoms. In a multi-center, double-blind, placebo-controlled crossover study safety and efficacy of oral dihydroergotamine tartrate (DHE) 2 mg, paracetamol 1000 mg, and a fixed combination of these two agents was compared for the relief of migraine attacks. The effect of the four different treatments on severity and duration of migraine headache was assessed pretreatment and at one and two hours post-treatment in the patient diary (10 point numerical rating scale 0 = no pain, 9 = unbearable pain). Nausea, vomiting, photophobia, phonophobia, and adverse events were also recorded in the patient diary.
                For 288 patients (81% female, 19% male) of 474 enrolled the results of four consecutive migraine attacks could be evaluated; 186 patients were excluded from the analyses because of missing data or protocol violations. Compared with placebo, headache severity was significantly reduced after all three treatments at one and two hours and all three treatments resulted in statistically significant rapid relief of pain, proving a superior effect of the combination over the mono agents. Duration of headache was significantly shorter when the combination was taken and the number of patients having either no headache or a reduction of pain of more than 50% after one and two hours was bigger in the combination group. Eight adverse events were experienced in patients during placebo treatment, seven in patients during treatment with the fixed combination, five in patients during DHE treatment and two in patients during paracetamol treatment. All adverse events were transitory and none was serious.
                The oral combination of 2 mg DHE and 1000 mg paracetamol is safe and effective in the treatment of acute migraine attacks and should be first choice of therapy in patients who do not respond to mild analgesics like paracetamol alone.
Paracetamol 1000 mg alone is statistically superior to placebo in the treatment of acute migraine, but the NNT of 12 for pain-free response at two hours is inferior to at of other commonly used analgesics. Given the low cost and wide availability of paracetamol, it may be a useful first choice drug for acute migraine in those with contraindications to, or who cannot tolerate, non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin. The addition of 10 mg metoclopramide gives short-term efficacy equivalent to oral sumatriptan 100 mg. Adverse events with paracetamol did not differ from placebo; serious and/or severe adverse events were slightly more common with sumatriptan than with paracetamol plus metoclopramide.