Efficacy and Safety of Acetaminophen and Naproxen in the Treatment of Tension-Type Headache. A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

The objective of this study was to evaluate and compare the efficacy and safety of single doses of acetaminophen (paracetamol) 1000 mg and naproxen 375 mg vs. placebo over a six-hour period in the treatment of tension-type headache. The treatments were compared in a randomized, double-blind, multicentre, placebo-controlled study. Efficacy was evaluated using four standard analgesic summary endpoints (the sum of pain intensity differences from baseline, the maximum pain intensity from baseline, the sum of the pain relief scores, and the maximum pain relief score). Both acetaminophen 1000 mg and naproxen 375 mg were significantly superior to placebo (P<or=0.009 and P<or=0.021, respectively) but not significantly different from each other (P>or=0.498) for these four endpoints. For example, the mean sum of pain intensity differences from baseline was 9.14+/-0.34 for acetaminophen 1000 mg and 8.81+/-0.35 for naproxen 375 mg compared with 7.42+/-0.34 for placebo. Other efficacy endpoints (percentage of responders (pain reduced to none) at two hours, onset of meaningful relief, time to use of rescue medication and subject's overall impression of study medication) showed similar trends. A significantly larger mean pain intensity difference from baseline was observed for acetaminophen 1000 mg (1.13) than for naproxen 375 mg (0.95) (P=0.036) at one hour after treatment. There was no significant difference among the treatment groups in the incidence of adverse events (P=0.730). In summary, the results of this well-controlled, double-blind study demonstrate that over-the-counter acetaminophen 1000 mg and prescription naproxen 375 mg are effective and well tolerated in the treatment of tough (moderate-to-severe) tension-type headache.

Drug therapy in headache

“…[9][10][11][12] Paracetamol has not been shown to be effective at doses below 1,000 mg and some studies have shown it to be less effective than NSAIDs. Combination analgesics containing caffeine may be more effective still, 13 but are likely to carry a greater propensity to induce medication overuse headache -though it is unlikely that patients with TTH alone, without a personal or family history of migraine, are susceptible to this condition.…”

Taking Care of the Challenging Tension Headache Patient

“…In treatment trials, aspirin doses of 500 to 1,000 mg and acetaminophen doses of 1,000 mg were utilized. In terms of NSAIDs, ibuprofen doses of 200 to 400 mg, naproxen sodium doses of 375 to 550 mg, ketoprofen doses of 25 to 50 mg, and diclofenac potassium doses of 50 to 100 mg all have demonstrated efficacy [8][9][10][11].…”

Review: Drug and nondrug treatment in tension-type headache

“…Simple analgesics Most randomized placebocontrolled trials have demonstrated that aspirin in doses of 500 mg and 1000 mg [Steiner et al 2003] and acetaminophen (paracetamol) 1000 mg [Steiner et al 2003;Prior et al 2002] are effective in the acute therapy of TTH. One study found no difference in efficacy between solid and effervescent aspirin [Langemark and Olesen 1987].…”