Oral @entity8894 prophylaxis of frequent XXXX in @entity1 : a randomized, double-blind, placebo-controlled trial.

@entity1 @entity8894 @entity390 @entity391 @entity448 @entity2704 @entity281 @entity10 @entity3917
OBJECTIVE: To assess whether, in @entity1 , oral @entity8894 reduces @entity2704 frequency, severity, and associated features compared to placebo. BACKGROUND: There is no single, safe, widely well-tolerated, and effective prophylactic treatment for all @entity1 and adolescents with frequent @entity2704 . DESIGN: Randomized, double-blind, placebo-controlled, parallel-group trial. METHODS: This study was conducted between June 1997 and January 2000 using 7 selected Northern California Kaiser Permanente sites. We recruited @entity1 of ages 3 to 17 years who reported a 4-week history of at least weekly, moderate-to-severe @entity10 with a throbbing or pulsatile quality, associated @entity448 / @entity390 , @entity391 , @entity3917 , sonophobia, or relief with sleep, but no fever or evidence of @entity281 . Subjects were randomly assigned to receive either @entity8894 (9 mg/kg per day by mouth divided 3 times a day with food) (n = 58) or matching placebo (n = 60) for 16 weeks. The number of @entity10 days (days with at least one @entity10 ) during each of eight 2-week intervals was chosen to be the primary outcome variable. RESULTS: Of those enrolled, 86 (73%) completed the study (42 received @entity8894 and 44 placebo); 74 of 192 eligible subjects declined to participate. Baseline information on demographic factors, health status, and @entity10 history was similar comparing the 2 groups. By intention-to-treat analysis, we found a statistically significant decrease over time in @entity10 frequency in the @entity8894 group (P =.0037) but not in the placebo group (P =.086), although the slopes of these 2 lines were not statistically significantly different from each other (P =.88). The group treated with @entity8894 had significantly lower @entity10 severity (P =.0029) relative to the placebo group. CONCLUSIONS: This study does not unequivocally determine whether oral @entity8894 is or is not superior to placebo in preventing frequent @entity2704 in @entity1 , but treatment with the active agent did lead to a significant reduction in @entity10 days. Larger trials involving this safe, appealing complementary therapy are needed.
