A Comparison of Naproxen Sodium, Acetaminophen and Placebo in the Treatment of Muscle Contraction Headache

ABSTRACT

SYNOPSIS

The purpose of the present study was to compare the efficacy and safety of naproxen sodium (550 mg), acetaminophen (650 mg) and placebo in the treatment of muscle-contraction, or tension headache.

Six investigators participated in this randomized, double-blind, 3-way parallel study, in which 149 patients were entered. Each patient treated one episode of moderate-to-severe headache with the test medication. The intensity of the headache pain was recorded on 10 cm visual analogue scales (VASs) by patients for up to 12 hours after treatment with the study medication. In addition, the degree of pain relief (PR) was recorded in a similar manner. Mean pain intensities (Pls), percentage changes in mean pain intensities, pain intensity differences (PIDs) and the sum of these differences (SPIDs) were calculated.

From the data collected in 124 patients eligible for efficacy analysis, naproxen sodium was shown to provide a significantly greater percentage change in mean PI compared to acetaminophen (p<0.01) or placebo (p<0.001). Mean PID and SPID scores also showed naproxen sodium to be significantly more effective in relieving pain compared to acetaminophen (p<0.02) or placebo (p<0.001). Mean pain relief scores and calculated total pain relief (TOTPAR) scores correlated well with the reduction in pain intensity. During the trial 13 patients reported side effects including nausea, dizziness and drowsiness. None of the side effects were considered clinically significant.

The results from this study demonstrated naproxen sodium to be a well tolerated analgesic, which provided statistically significantly superior analgesia compared to acetaminophen or placebo in the treatment of muscle-contraction or tension headaches.