Ketoprofen, Acetaminophen, and Placebo in the Treatment of Tension Headache

Seven hundred three subjects completed a randomized, double‐blind, parallel‐group, single‐center study comparing the single‐dose efficacy of ketoprofen 12.5 mg, ketoprofen 25 mg, acetaminophen 1000 mg, and placebo in the treatment of tension headache. For the primary efficacy variable, 4‐hour sum of...

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Bibliographic Details
Published in:Headache 1998-09, Vol.38 (8), p.579-589
Main Authors: Mehlisch, Donald R., Weaver, Melanie, Fladung, Bernward
Format: Article
Language:English
Subjects:
acetaminophen
Acetaminophen - therapeutic use
Adult
Analgesics
Analgesics, Non-Narcotic - therapeutic use
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Biological and medical sciences
Double-Blind Method
Female
Humans
ketoprofen
Ketoprofen - therapeutic use
Male
Medical sciences
Neuropharmacology
NSAIDs
Pain Measurement
pain relief
Pharmacology. Drug treatments
tension headache
Tension-Type Headache - classification
Tension-Type Headache - drug therapy
Time Factors
Treatment Outcome
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Summary:Seven hundred three subjects completed a randomized, double‐blind, parallel‐group, single‐center study comparing the single‐dose efficacy of ketoprofen 12.5 mg, ketoprofen 25 mg, acetaminophen 1000 mg, and placebo in the treatment of tension headache. For the primary efficacy variable, 4‐hour sum of pain relief intensity differences, ketoprofen 25 mg was significantly superior to placebo. Ketoprofen 25 mg also demonstrated superior pain relief in the first hour after dosing, and the time to meaningful pain relief was significantly shorter for the ketoprofen 25‐mg group. Ketoprofen 12.5 mg proved to be significantly superior to placebo for pain relief intensity difference and pain relief at 3 hours, global assessment of medication at 4 hours, and for time to onset of meaningful pain relief. The data suggest a dose response for ketoprofen 12.5 mg and 25 mg.Acetaminophen 1000 mg proved to be numerically more favorable than placebo in most variables, but could not be separated from placebo with statistical significance. In spite of possible inflation of the placebo response due to sensitivity limits of the study, ketoprofen 25 mg demonstrated a more rapid onset of analgesia compared to acetaminophen 1000 mg, and patients' global assessment rated ketoprofen 25 mg higher than acetaminophen 1000 mg.
ISSN:0017-8748
1526-4610
DOI:10.1046/j.1526-4610.1998.3808579.x