A double-blind, randomized, multicenter investigation was conducted to compare the efficacy and safety of
Fioricet,
acetaminophen with
codeine, and placebo for the symptomatic treatment of
tension headache. At the onset of a typical
headache, the patients took two capsules of their assigned study medication and rated responses over the next four hours in three target symptoms areas:
pain, emotional or psychic tension, and muscle contractions or stiffness in the head and neck. Physicians made global assessments of the same symptom responses and of adverse reactions for each patient. One hundred ninety-eight patients were evaluated. Both active
analgesic preparations were more effective than placebo in relieving
pain and muscle stiffness or contractions.
Fioricet, but not
acetaminophen with
codeine, was significantly better than placebo in alleviating emotional or psychic tension;
Fioricet was also significantly better than
acetaminophen with
codeine in relieving this symptom. Certain analyses suggested the possibility that
Fioricet had a faster and more sustained
analgesic effect than
acetaminophen with
codeine. By the end of the four-hour trial, significantly more patients achieved complete
pain relief with
Fioricet than with
acetaminophen with
codeine. The quality and quantity of adverse reactions did not differ significantly among the treatment groups. None was serious, and all abated without medical intervention.