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OTC analgesics in headache treatment: Open-label phase vs randomized double-blind phase of a large clinical trial
Headache: The Journal of Head and Face Pain, 03/31/09

Pfaffenrath V et al. – Efficacy results from double-blind, randomized clinical trials with nonprescription analgesics may be generalized for daily conditions based on carefully selected pts and study design.

• Study to compare superior efficacy of fixed combination of acetylsalicylic acid, paracetamol, and caffeine over single substances
• Analysis of results of the randomized, double-blind phase of clinical trial
• Review of efficacy of usual nonprescription drug for pts in open-label pre-phase of the same study
• Prior to randomized treatment phase, recording of headache episode treated with pt’s usual nonprescription drug (open-label pre-phase)
• Pt assessment of pain intensity on 100-mm visual analog scale
• For 1734 pts in efficacy analysis, comparison of time course of pain intensity difference (PID) to baseline after usual drug vs randomized study drug

• Similar time course of PID after intake of pt’s usual drug vs randomized study drug
• For pts who took usual triple combination (acetylsalicylic acid, paracetamol, caffeine), pain reduction on visual analog scale after 2 hrs: average 43.0
• For single agents in open-label phase: acetylsalicylic acid 38.2 mm, paracetamol 38.1 mm, ibuprofen 37.7 mm
• For pts allocated to acetylsalicylic acid/paracetamol/caffeine triple combination, corresponding mean pain reduction for single agents in randomized, double-blind phase: acetylsalicylic acid 44.7 mm, paracetamol 40.7 mm, ibuprofen 39.5 mm

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