In this double-blind, randomized, parallel group, multicentre study the efficacy of a fixed combination of
indomethacin,
prochlorperazine, and
caffeine (
IndoProCaf) and
nimesulide were compared over an 8-h period in the treatment of two consecutive episodes of
tension-type headache (TTH). Both drugs were administered orally. Of 54 randomized patients, 40 were compliant to the protocol. More patients on
IndoProCaf than on
nimesulide were
pain-free at 2 h post-dose (45% vs. 10%; P<0.05), reached a
pain reduction of at least 50% at 2 (75% vs. 30%; P<0.05) and 4 h post-dose (90% vs. 58%; P<0.05), and had a statistically significant lower mean time to a 50 and 100%
pain reduction in the second TTH episode. A higher percentage of patients reached a 50 or 100%
pain reduction at 2 h post-dose with
IndoProCaf compared with
nimesulide, in two of two treated TTH episodes. A clinically and statistically significant change within each treatment group over time was found for the severity of
pain, the
headache intensity difference (HID), the sum of
headache intensity difference (SHID), the maximum
headache intensity difference (MAXHID), the
headache relief (HER), the sum of total
headache relief (TOTHER) and the maximum
headache relief (MAXHER). In conclusion,
IndoProCaf showed to be superior, but globally not statistically different from
nimesulide in the treatment of episodic TTH. Both drugs were very effective and well tolerated.