Two hundred and nineteen children (boys: 56%, girls: 44%) were included in a randomized, double-blind, multicentre (4 centres) controlled trial designed to assess the efficacy and safety of ibuprofen (IBU) in the treatment of 1 to 6 year-old children with otoscopically proven acute otitis media (AOM), either unilateral or bilateral. They randomly received 10 mg/kg IBU (n = 71), or acetaminophen (PARA) (n = 73) or placebo (PLA) (n = 75), orally, tid, for 48 hours. All received oral cefaclor (Alfatil, Lilly, France) for seven days. They were evaluated before (D0) and at the end of treatment (D2). The main criterion of response was the aspect (landmarks and color) of the tympanic membrane assessed on a semi-quantitative scale from 0 to 6. Other criteria, assessed on semi-quantitative scales, included relief of pain (0 or 1), rectal temperature (0 to 2), and overall evaluation by parents of the improvement of quality of life on three items: appetite (0 to 2), sleep (0 to 2), and playing activity (0 to 2). The results at D2 were as follows: there was no significant difference between treatment groups as to the main criterion, but only a trend for IBU and PARA to do better than PLA but not for IBU to do better than PARA. From these data there is no argument to emphasize the utility of non-steroidal anti-inflammatory drugs (NSAIDs) in treating the inflammatory signs of the tympanic membrane in otitis. There was a statistically significant difference between treatment groups at D2 for pain, IBU being superior to PLA (P < 0.01): 7%, 10% and 25% of the children were still suffering at D2 in the IBU, PARA and PLA treatment groups, respectively. The difference between PARA and PLA for pain was not statistically significant. There was no significant difference between treatment groups for the other criteria. All treatments were well and equally tolerated. Although no significant difference was found between the treatment groups on the aspect of the tympanic membrane, the efficacy of IBU was evidenced on the relief of pain, the symptom that most disturbs the child.

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We compared the efficacy and safety of subcutaneous (SC) sumatriptan (6 mg) with that of dihydroergotamine (DHE) nasal spray (1 mg plus optional 1 mg) in the acute treatment of migraine. Two hundred sixty-six adult migraineurs (International Headache Society criteria) completed a multicenter, double-blind, double-dummy, cross-over study. Patients took SC sumatriptan for one attack and DHE nasal spray for the other in random order. Data from both treatment periods show that at all time points from 15 minutes, SC sumatriptan was significantly better than DHE nasal spray at providing both headache relief (moderate/severe headache improving to mild/none) and resolution of headache. Similarly, SC sumatriptan was superior to DHE nasal spray for the other efficacy end points assessed in the study. Patients reported that both treatments were well tolerated. Adverse events were reported by 43% of patients taking SC sumatriptan and 22% of patients taking DHE nasal spray. These were usually mild and transient. We conclude that subcutaneous sumatriptan has a faster onset of action than DHE nasal spray and provides greater relief of acute migraine symptoms.

The efficacy of sumatriptan, a 5-HT1 receptor agonist, in patients with migraine attacks occurring despite prophylactic treatment with oral dihydroergotamine, was assessed in a double-blind placebo-controlled study involving 76 patients. Thirty-seven patients were treated with a subcutaneous injection of 6 mg sumatriptan self-administered with an auto-injector and 39 with placebo given by the same route. Patients having inadequate relief were allowed to use a second injection of test medication 1 hour later and rescue treatment between 2 hours and 24 hours after the first dose. Headache relief was achieved within 2 hours after sumatriptan in 26 patients (70%) compared to 8 patients (21%) in the placebo group (P < 0.0001). Of these patients, 19 (51%) and 3 (8%) were, respectively, pain free at this time. A second injection of sumatriptan was used by 8 (22%) patients compared to 30 (77%) patients in the placebo group (P < 0.0001), whereas rescue medication was used respectively by 13 (35%) and 22 (58%) patients (P < 0.024). The adverse event profile of sumatriptan was not affected by the concomitant use of dihydroergotamine and side-effects were all minor and transient. Patient satisfaction was significantly higher in the sumatriptan group (75%) compared to patient satisfaction with placebo (16%). These results show that the high efficacy rate of subcutaneous sumatriptan and its safety profile remain unchanged in migraine patients receiving oral dihydroergotamine as prophylaxis.

246 migraine patients (International Headache Society definition, 1-6 severe attacks per month) were randomised into a multicentre, cross-over study comparing subcutaneous (s.c.) sumatriptan 6 mg administered by an auto-injector (Glaxo device) with usual acute migraine treatments. Patients were treated for 2 months or up to 12 attacks, and then crossed over to the alternative treatment for the same duration. Usual treatments were: analgesics (including combinations), 49%; ergotamine, 24%; NSAIDs 19%; DHE, 7%. Rescue medication was allowed 2 h after the first dose. Headache was assessed on a 4-point self-rating scale (0: none, 1: mild, 2: moderate, 3: severe). Other migraine symptoms were assessed as present or absent. Quality of life was assessed before the study and at the end of each treatment period. Two hundred and seventeen patients were eligible for the cross-over analysis. At 2 h post-dosing, an average of 78% of attacks per patient were successfully relieved (grade 3 or 2 to 1 or 0) by s.c. sumatriptan, compared with 34% for the usual treatments (p < 0.001) and 63% of attacks per patient were completely relieved (grade 0) by s.c. sumatriptan compared with 15% for the usual treatments (p < 0.001). Sumatriptan-treated patients used rescue medication for 19% of their attacks, compared to 59% for comparator drugs (p = 0.001). Results for patient preference were: s.c. sumatriptan, 85%; usual treatments, 10%; no preference, 5% (p < 0.001). Sumatriptan was significantly superior to comparator drugs for all other efficacy end-points (p < 0.001). Improvements in quality of life scores were 3 times higher in sumatriptan-treated patients than in those taking usual treatments (p < 0.0001); the tolerability of both treatments was good. In conclusion, s.c. sumatriptan was superior to the usual acute treatments for both the relief of all migraine symptoms and the improvement in quality of life.