Effectiveness of sumatriptan in reducing productivity loss due to migraine: results of a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: To determine the effect of sumatriptan on migraine-related workplace productivity loss. PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, parallel-group trial, adult migraineurs self-injected 6 mg of sumatriptan or matching placebo to treat a moderate or severe migraine within the first 4 hours of a minimum of an 8-hour work shift. Outcome measures included productivity loss and number of patients returning to normal work performance 2 hours after injection and across the work shift, time to return to normal work performance, and time to headache relief. RESULTS: A total of 206 patients underwent screening, 140 (safety population) of whom returned for clinic treatment. Of these 140 patients, 119 received migraine treatment in the workplace (intent-to-treat population), 116 of whom comprised the study population. Of these 116 patients, 76 self-administered sumatriptan, and 40 self-administered placebo. Sumatriptan treatment tended to reduce median productivity loss 2 hours after injection compared with placebo (25.2 vs 29.9 minutes, respectively; P = .14). Significant reductions in productivity loss were obtained across the work shift after sumatriptan treatment compared with placebo (36.8 vs 72.6 minutes, respectively; P = .001). Significantly more sumatriptan-treated patients vs placebo-treated patients experienced shorter return to normal work performance at 2 hours (53/76 [70%] vs 12/40 [30%], respectively) and across the work shift (64/76 [84%] vs 23/40 [58%], respectively; P < .001). Significantly more sumatriptan-treated patients experienced headache relief 1 hour after injection compared with placebo-treated patients (48/76 [63%] vs 13/40 [33%], respectively; P = .004). CONCLUSION: Across an 8-hour work shift, sumatriptan was superior to placebo in reducing productivity loss due to migraine.

Attention deficit disorder with hyperactivity and methylphenidate: the effects of dose and mastery level on children's learning performance.

This investigation examined the relationship between methylphenidate (MPH) and the learning and recall of paired associations by children with attention deficit disorder with hyperactivity (ADDH). Forty-five children with ADDH were randomly assigned to one of three groups (novel, partial mastery, and mastery learning) that varied in the amount of previous learning of paired associations and participated in a double-blind, placebo-control, repeated-measures-across-dose (crossover) design. Each child received four doses of MPH (5 mg, 10 mg, 15 mg, and 20 mg) and a placebo in a random, counterbalanced sequence. The results indicated that both the rate of acquisition and accuracy in learning paired associations were significantly, but differentially, affected by MPH dose and the degree of learning mastery. The implications of these results for psychopharmacological research and the monitoring of psychostimulant effects on children's learning performance in academic settings are discussed.