Headache pain model for assessing and comparing the efficacy of over-the-counter analgesic agents.
To refine the assessment of over-the-counter analgesic agents in the treatment of muscle-contraction headache, we designed a single-dose model with attention to specific methodologic features and two relevant assessments--the percentage of subjects who achieve complete relief and the time until pain is no longer experienced. Subjects were randomly assigned to receive a single dose of 1000 mg acetaminophen, 1000 mg aspirin with 64 mg caffeine, or placebo. Under double-blind conditions, subjects rated headache pain intensity and relief over 4 hours and provided a Comparative Evaluation at the end of the trial. Both active agents were significantly distinguished from placebo on the time-point analyses (p less than 0.05) and summary end point measurements (sum of pain intensity difference [SPID], total of pain relief, percentage of patients with complete relief, percentage of treatment failures, and the Comparative Evaluation), as well as causing a faster elimination of headache (p less than 0.05). The aspirin-caffeine combination was rated higher than acetaminophen on all summary measurements, particularly SPID (p less than 0.05), with significantly more patients obtaining complete relief with aspirin-caffeine (p less than 0.01) than with acetaminophen. We conclude that this headache pain model can be used to demonstrate the efficacy of over-the-counter analgesic agents and to assess their relative efficacy.
Medical Department, Whitehall Laboratories, Inc., New York 10017.
B P
BP
Schachtel
W R
WR
Thoden
J P
JP
Konerman
A
A
Brown
D S
DS
Chaing
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D002110:Caffeine / Q000008:administration & dosage; D004311:Double-Blind Method; D004338:Drug Combinations; D004341:Drug Evaluation; D005260:Female; D006261:Headache / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008487:Medical History Taking; D008875:Middle Aged; D008954:Models, Biological; D004366:Nonprescription Drugs / Q000627:therapeutic use*
D000700:Analgesics; D004338:Drug Combinations; D004366:Nonprescription Drugs; D000082:Acetaminophen; D002110:Caffeine; D001241:Aspirin