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Ibuprofen plus caffeine in the treatment of tension-type headache. Clin Pharmacol Ther 2000 Sep;68(3):312-9 PMID: 11014413

Pubmed ID

11014413

Abstract

BACKGROUND: The effectiveness of caffeine as an adjuvant to ibuprofen has been documented in investigations of acute pain. Our objectives were to assess this agent in the treatment of tension-type headache and to establish clinical trial methods capable of assessing this agent in comparison with various tension headache treatments. Stopwatch technology was used for measurement techniques.

METHODS: A randomized, double-blind, parallel, multicenter, single-dose, placebo- and active-controlled study included 301 subjects diagnosed with tension-type headache. Treatment groups included ibuprofen and caffeine, ibuprofen alone, caffeine alone, or placebo. Subjects measured onset of relief (both time to first perceptible relief and time to meaningful relief) after taking a single oral dose of their assigned medication. Pain intensity and pain relief were rated over a 6-hour study period. Overall evaluation was made on completion of all other ratings.

RESULTS: Ibuprofen and caffeine administered together provided significantly greater analgesic activity than ibuprofen alone, caffeine alone, and placebo. Ibuprofen and caffeine administered together demonstrated significantly shorter times to meaningful improvement in headache relief than ibuprofen or placebo; significantly greater total analgesia than ibuprofen alone, caffeine alone, or placebo; and significantly greater peak relief than ibuprofen alone, caffeine alone, or placebo. Significantly more subjects obtained meaningful headache relief with ibuprofen and caffeine administered together than with ibuprofen alone or placebo. More patients reported complete headache relief with ibuprofen and caffeine administered together than with ibuprofen alone, caffeine alone, or placebo. Ibuprofen and caffeine administered together was rated significantly better by patients than either ibuprofen alone, caffeine alone, or placebo. No subjects ended participation in the study early because of adverse events.

CONCLUSIONS: Sensitive methods have been introduced to assess differences in analgesia among over-the-counter analgesic agents in relieving tension-type headache pain. A double-blind study with this method suggests that ibuprofen and caffeine administered together provides greater analgesic effectiveness than either component alone.

Author List

Diamond S, Balm TK, Freitag FG

Author

Frederick G. Freitag DO Associate Professor in the Neurology department at Medical College of Wisconsin




Scopus

2-s2.0-0033834590   75 Citations

MESH terms used to index this publication - Major topics in bold

Administration, Oral
Adult
Aged
Analgesics, Non-Narcotic
Caffeine
Central Nervous System Stimulants
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Ibuprofen
Male
Middle Aged
Pain Measurement
Tension-Type Headache
jenkins-FCD Prod-299 9ef562391eceb2b8f95265c767fbba1ce5a52fd6