For Tension Headache, Combo Rx Tops Acetaminophen


Pain relief is better with a triple combination medication that includes acetaminophen than with acetaminophen by itself, researchers found, suggesting a new therapeutic option.

Combo therapy works better for headache relief.

A triple combination medication for tension headache that includes acetaminophen is more effective for pain relief than acetaminophen by itself, an international group of researchers has found.

The researchers sought to evaluate whether a combination pain-reliever that includes acetylsalicylic acid (aspirin), acetaminophen (often referred to as Paracetamol in Europe and Tylenol in the United States), and caffeine is more effective for treating patients with tension headache than acetaminophen alone.

Led by Hans-Christoph Diener, MD, of Department of Neurology and Headache Center, University Hospital Essen, Germany, in collaboration with Novartis, the investigators conducted 4 identical randomized, controlled trials in 1900 patients who had episodic tension-type headache. Data were pooled from the 4 studies.

The main end point for this study was the percentage of patients who were pain-free at 2 hours after taking the medication. The researchers also measured headaches at 1 hour after medication, whether patients had mild or no pain at 2 hours after medication, and how much headaches interfered with daily activities.

The combination medication indeed seemed to work better than acetaminophen alone-29% of the patients were pain free at 2 hours after taking the combination medication, compared with 21% who took acetaminophen and 18% who received placebo. This was a statistically significant effect.

Differences among the 3 treatments were even greater for patients who had severe pain at baseline. Of those who received the combination, 20% were pain-free at 2 hours post-medication, compared with 12% who were taking acetaminophen and 11% taking placebo. Combination medication also was superior for the other measurements, including pain relief at 1 hour, pain reduction at 2 hours, and reductions in interference with daily living.

“Clearly, the combination offers an important alternative when acetaminophen alone is not effective enough,” the authors noted in this report. “Caffeine, in particular, contributes to the greater efficacy of the combination vs acetaminophen alone; patients with tension-type headache or other pain conditions who take an analgesic without caffeine need about 40% more medication to get the same relief as patients taking the same analgesic with caffeine.”

The combination therapy could offer a welcome additional alternative for patients who have tension headaches.

Tension-type headaches are the most common headaches among adults, it was noted. Unlike migraine headaches, they are characterized by nonspecific aching rather than throbbing. About 3% of the US population experiences chronic daily tension headaches.1 Over-the-counter medication is standard treatment for patients with this type of headache.

The study was published on November 19 in the Journal of Headache and Pain.2

Key points

• Combination medication for tension headache, including acetaminophen, aspirin, and caffeine, is more effective for pain relief than acetaminophen alone.

• Combination medication for tension headache may be more effective in patients with severe pain than acetaminophen alone.

• The triple combination therapy could offer an additional alternative for patients with chronic tension headaches.


1. Cleveland Clinic. Diseases & Conditions: What are "tension-type" headaches?

2. Diener HC, Gold M, Hagen M. Use of a fixed combination of acetylsalicylic acid, acetaminophen and caffeine compared with acetaminophen alone in episodic tension-type headache: meta-analysis of four randomized, double-blind, placebo-controlled, crossover studies. J Headache Pain. 2014;15:76. [Epub ahead of print.]

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