A multicenter, randomized, double-blind trial was conducted to compare the efficacy of
Cafergot P-B with that of its components,
Cafergot,
pentobarbital, and Bellafoline, and with placebo for the treatment of
migraine. Patients with
vascular headaches of the
migraine type who regularly experienced nervous tension and some form of gastrointestinal distress with their
headaches were randomized to one of five treatment groups. They were given treatment packets containing their assigned
drug for use during two separate
migraine attacks. Patients made pretreatment evaluations of the following symptoms:
head pain, nervous tension,
nausea,
vomiting,
anorexia,
abdominal cramps, and
photophobia. They made posttreatment evaluations of these symptoms 0.5, 1.0, 1.5, 2.0, and 3.0 hours after ingesting their assigned
drug. Improvement scores were calculated from the differences between the pretreatment and the posttreatment ratings. Patients also made a final global assessment of their
drug's efficacy. All patients who took at least one dose of the study medication and completed a baseline evaluation and at least one postdose evaluation of severity of
pain were included in the analysis (n = 254). The comparisons of particular interest were those between
Cafergot P-B and
Cafergot and between
Cafergot P-B and placebo.
Cafergot P-B was significantly more effective than
Cafergot in relieving
head pain at hours 2 and 3, nervous tension,
nausea,
vomiting,
anorexia, and
photophobia.
Cafergot P-B was significantly more effective than placebo in relieving
head pain, nervous tension,
nausea (second
headache only),
vomiting, and photphobia. The incidence of reported adverse effects was no greater with
Cafergot P-B than with
Cafergot; however, patients given
Cafergot P-B reported less
vomiting than did patients given
Cafergot. The results of this study show that addition of
pentobarbital and Bellafoline to
Cafergot provides greater relief of
pain,
vomiting, nervous tension,
photophobia, and other symptoms associated with
migraine, while reducing the severity of the
nausea that may accompany a
migraine headache or
Cafergot therapy.