Double-blind randomized cross-over trial comparing methylprednisolone with placebo in chemotherapy-induced nausea and vomiting: a study with special reference to efficacy parameters.
Sixty-one patients with breast cancer who received chemotherapy participated in a double-blind randomized cross-over study with methylprednisolone (MP) 250 mg as a single i.v. injection before chemotherapy and placebo as antiemetic treatment. The determining efficacy parameter was preference. Other parameters used were a visual analogue scale for nausea, a categorical four-point nausea intensity scale recorded by a nurse observer, emetic amounts, emetic episodes, acceptance of nausea and vomiting, and global assessments for nausea and vomiting. MP showed a significant antiemetic effect compared with placebo which was most pronounced for moderately emetogenic chemotherapy. The visual analogue scale, emetic amounts, acceptance and global assessments were easy to handle and showed coherence with preference, whereas nausea intensity and emetic episodes were resource demanding to record and showed no coherence with preference. It is concluded that for a precise evaluation of nausea and vomiting the visual analogue scale and emetic amounts are most reliable; for ambulatory patients global assessments seem to be sufficient.
Havsteen
H
H
Department of Oncology ONA, Finsen Institute, Rigshospitalet, Copenhagen, Denmark.
Kjaer
M
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control*; D010919:Placebos; D014839:Vomiting / Q000517:prevention & control*
D010919:Placebos; D002945:Cisplatin; D005472:Fluorouracil; D008775:Methylprednisolone; D008727:Methotrexate