Solubilized Ibuprofen: Evaluation of Onset, Relief, and Safety of a Novel Formulation in the Treatment of Episodic Tension-type Headache
Article first published online: 25 DEC 2001
Headache: The Journal of Head and Face Pain
Volume 40, Issue 7, pages 561–567, July 2000
How to Cite
Packman, B., Packman, E., Doyle, G., Cooper, S., Ashraf, E., Koronkiewicz, K. and Jayawardena, S. (2000), Solubilized Ibuprofen: Evaluation of Onset, Relief, and Safety of a Novel Formulation in the Treatment of Episodic Tension-type Headache. Headache: The Journal of Head and Face Pain, 40: 561–567. doi: 10.1046/j.1526-4610.2000.00087.x
- Issue published online: 25 DEC 2001
- Article first published online: 25 DEC 2001
- Accepted for publication January 14, 2000.
- tension-type headache;
- headache relief;
- time to headache relief
Objective.—To evaluate the relative efficacy of a new solubilized formulation of ibuprofen compared with acetaminophen caplets.
Methods.—This double-blind, randomized, parallel group study evaluated 154 subjects taking a single dose of solubilized ibuprofen, 400 mg; acetaminophen, 1000 mg; or placebo for the relief of episodic tension-type headache. Time to relief was measured using a stopwatch, and overall efficacy was measured using traditional categorical pain and relief scales.
Results.—Ibuprofen capsules (liquigel), 400 mg, were significantly faster than both acetaminophen, 1000 mg, and placebo for all time-to-relief measures. Ibuprofen liquigel had a median time to first perceptible pain relief of 39 minutes compared with 47 minutes for acetaminophen and 113 minutes for placebo. For median time to meaningful relief, ibuprofen liquigel had a time of 39 minutes compared with 53 minutes for acetaminophen and more than 180 minutes for placebo (P.02 for both measures). In addition, ibuprofen liquigels demonstrated significantly superior overall analgesic efficacy compared with acetaminophen, 1000 mg, for the relief of episodic tension-type headache. Both active treatments had a side effect profile similar to placebo.
Conclusions.—Although several other studies have demonstrated the overall analgesic superiority of ibuprofen to acetaminophen, this study demonstrated that the liquigel formulation also provides a clinically relevant advantage for time to analgesic effects.