Low-dose diclofenac potassium in the treatment of episodic tension-type headache.

The aims of this placebo-controlled study were to determine whether single doses of diclofenac-K 12.5 and 25 mg effectively relieve episodic tension headache (ETH) in adults and to compare it to ibuprofen 400 mg. A single-dose, multicentre, randomized, double-blind, double-dummy, clinical trial was conducted at 22 primary care centres in Germany. All subjects had a history of ETH according to the classification of the International Headache Society. Of 684 subjects, 620 used the study drugs for an episode of tension headache occurring within one month after enrollment: diclofenac-K 12.5mg (160), diclofenac-K 25mg (156), ibuprofen 400mg (151) and placebo (153). The primary efficacy variable was total pain relief, calculated as the time-weighted sum of the pain relief assessments from baseline to the 3 hr evaluation time. Results of the study show that all active treatments were superior to placebo; no statistically significant difference between the three active treatments could be detected. The final conclusion drawn is that diclofenac-K, administered as single doses of 12.5 and 25 mg effectively relieves ETH and is comparable to ibuprofen 400 mg. (PsycInfo Database Record (c) 2021 APA, all rights reserved)