BACKGROUND: Most @entity1 with @entity2701 treat @entity10 episodes with over-the-counter medication. Combination analgesics containing @entity5834 may be more effective and as well tolerated as monotherapy. The aim of this study was to evaluate the efficacy of the combination of @entity117 , @entity1443 ( @entity1443 ) and @entity5834 in @entity2701 using recently recommended endpoints. METHODS: Four randomized, controlled trials of identical design in 1,900 @entity1 with @entity2701 comparing @entity117 , @entity1443 and @entity5834 vs. @entity1443 or placebo were pooled. Analysis populations were 'all @entity10 episodes' and those with 'severe @entity158 at baseline'. Post-hoc defined primary endpoint: @entity10 episodes @entity158 -free at 2  h. Secondary endpoints: @entity10 episodes @entity158 -free at 1  h, @entity10 response at 2  h (mild or no @entity158 ), degree of interference with daily activities. RESULTS: 6,861 @entity10 episodes were treated, including 2,215 severe @entity10 episodes. The proportion of @entity10 episodes @entity158 -free at 2  h was significantly higher with the triple combination (28.5%) vs. @entity1443 (21.0%) and placebo (18.0%) (p   <   0.0001), and similarly for those severe at baseline (20.2% vs. 12.1% and 10.8%; p    <=   0.0003). A similar pattern of superiority was observed for secondary endpoints. The triple combination was generally well tolerated. CONCLUSIONS: The combination of @entity117 , @entity1443 and @entity5834 is effective and well tolerated in @entity2701 , and significantly superior to @entity1443 with regard to being @entity158 -free at 2  h, @entity10 response at 2  h and ability to return to daily activities, even in those with @entity158 rated severe at baseline.

Use of a fixed combination of @entity117 , @entity1443 and XXXX compared with @entity1443 alone in @entity2701 : meta-analysis of four randomized, double-blind, placebo-controlled, crossover studies.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['acetylsalicylic acid'] @entity1443 :: ('MESH:D000082', 'Chemical') :: ['paracetamol', 'acetaminophen'] @entity5834 :: ('MESH:D002110', 'Chemical') :: ['caffeine'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity2701 :: ('MESH:D018781', 'Disease') :: ['episodic tension-type headache'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache']
@entity5834 :: (MESH:D002110,Chemical) :: ['caffeine']
