ANTIEMETIC ACTIVITY OF ORAL LORAZEPAM IN ADDITION TO METHYLPREDNISOLONE AND METOCLOPRAMIDE IN THE PROPHYLACTIC TREATMENT OF VOMITING INDUCED BY CISPLATIN - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH CROSSOVER DESIGN

Aims and Backgorund: It has been suggested that lorazePam has a definite role as an antiemetic drug in antiemetic cocktails. In this study we examined the antiemetic efficacy of metoclopramide (200 mg) and methylprednisolone (1000 mg) with or without lorazepam. Methods: Sixty patients treated with cisplatin-containing regimens were entered into a randomized, double-blind study with cross-over. Lorazepam 2.5 mg or placebo were administered orally the evening before therapy and just after the beginning of fluid infusion for chemotherapy. Degree of nausea and number of vomiting episodes, together with somnolence, were recorded on a data flow sheet and visual-analogue scales. Results: 100 cycles (50 patients) are evaluable. In 39 cycles there was no nausea and vomiting, in 74 cycles acceptable control of emesis was reached (0-2 episodes of vomiting), without significant differences among the two arms. However, nausea was shorter In lorazepam arm (p < 0.01), and 80 % of the patients preferred treatment with lorazepam (p < 0.003). Anxiety was reduced in the patients treated with lorazepam (p < 0.4). Conclusions: Lorazepam improves tolerability to cisplatin-containing chemotherapy, mainly by influencing the psychological status of the patient and favoring the amnestic process.