Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine.

OBJECTIVES: To study the efficacy and tolerability of prochlorperazine (PCZ) management of acute migraine. DESIGN AND METHODS: A double blind comparative study was conducted to assess the efficacy of buccal PCZ 3 mg compared with oral ergotamine tartarate 1 mg plus caffeine 100 mg (ERG) or placebo (buccal or oral) for treatment of acute migraine. In all, 114 episodes of acute migraine were evaluated. Patients graded symptoms on a four-point scale before and up to 4 hours after treatment. The primary efficacy parameters included headache resolution within 2 hours (grade 3 or 2 to grade 0) and alleviation of other accompanying symptoms of migraine. The supplementary endpoints included improvement in quality of life (QOL). RESULTS: The percentage of patients reporting resolution of headache (to grade 0) was 51.4% for buccal PCZ and 21.7% for buccal placebo, 23.1% for oral ERG and 28.6% for oral placebo, headache tended to recur in both the placebo and ERG groups after initial improvement. Buccal PCZ was well tolerated; no signs of local irritation were evident, and patients found the formulation easy to use. Mild but transient sedation and drowsiness were observed in 41%. CONCLUSIONS: In the present study, PCZ 3 mg via the buccal route produced faster improvement and greater efficacy than placebo (oral as well as buccal) or oral ERG. The global QOL score 2 hours after treatment scores was higher in the PCZ group. Buccal PCZ may represent a particularly effective alternative for acute migraine treatment.

Evaluation of prochlorperazine buccal tablets (Bukatel) and metoclopramide oral tablets in the treatment of acute emesis.

The dizziness associated with vertiginous disorders is often accompanied with nausea and/or vomiting. Antiemetic effect of prochlorperazine (PCZ) is diminished by its low bioavailability owing to a significant gastric and hepatic first pass effect. This effect could be further diminished by likelihood of regurgitation of nauseating patients further limiting the therapeutic effect of oral PCZ. A buccal preparation achieves higher plasma concentrations through direct systemic absorption. In this study buccal prochlorperazine (Bukatel) was compared for its efficacy and tolerability with commonly used metoclopramide. Bukatel was well tolerated and well rated by both patients and investigators with no adverse effects on buccal mucosa and causing less drowsiness and sedation. Results indicate that Bukatel is safe and effective for the treatment of nausea and/or vomiting in patients suffering from vertiginous disorders and could be safely and strongly recommended as an alternative to less bioavailable and indiscriminately used oral metoclopramide tablets.

P6 acupressure and nausea and vomiting after gynaecological surgery.

We studied the effect of P6 acupressure on 46 women undergoing laparotomy for major gynaecological surgery who received patient-controlled analgesia. Half the patients received acupressure at the P6 site, the remainder received acupressure at a "sham" site. There was a reduction in the requests for anti-emetic therapy in the group receiving P6 acupressure but there was no difference in the incidence of nausea and vomiting. There was no difference in total morphine consumption between the two groups.

Cannabis and cancer chemotherapy: a comparison of oral delta-9-THC and prochlorperazine.

Delta-9-tetrahydrocannabinol (THC) and prochlorperazine (Compazine) were found to be equally efficacious in reducing nausea and vomiting associated with cancer chemotherapy across a wide range of chemotherapeutic regimens and tumor types. Both drugs were administered orally one hour before chemotherapy, then every four hours for a total of four doses. Compazine was administered in a fixed dose of 10 mg; THC was administered by body surface area (BSA): BSA less than 1.4 m2 = 7.5 mg; BSA 1.4-1.8 m2 = 10- mg; and BSA greater than 1.8 m2 = 12.5 mg. Two hundred and fourteen subjects (75% of whom had previously received Compazine with varying results) were evaluated employing a double-blind, crossover design. Additional parameters evaluated were study drug effects on appetite, food intake, mood, activity, relaxation, interaction, and concentration. There were significant drug effects with THC: less ability to concentrate (P less than 0.01), less social interaction (P less than 0.05), and less activity (P less than 0.05). There were no significant differences between the two drugs in the level of food intake or appetite. Patients of all ages did equally well on both drugs. Neither past marijuana use nor past Compazine use were related to study the drug efficacy. Those patients who correctly identified their THC cycle did better on THC versus those who could not correctly identify which antiemetic they had received (P less than 0.05). There were more drug-related effects associated with THC, but these did not reduce the patients' preference for the drug, and were associated with nausea reduction (P less than 0.05).