Bruera 2004.
Study characteristics | ||
Methods | Double‐blind, parallel‐arm trial 5 international centres Study duration: 7 days |
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Participants | 51 participants (25 intervention, 26 control) with advanced cancer and chronic nausea (> 2 weeks) resulting from advanced cancer despite treatment with metoclopramide at a minimal daily dose of 40 to 60 mg for 2 days | |
Interventions | Intervention: 20 mg/day dexamethasone orally in addition to metoclopramide (60 mg/day orally) Control: placebo in addition to metoclopramide (60 mg/day) |
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Outcomes | Pain, appetite, fatigue and nausea, measured on a 0 to 10 numerical rating scale (NRS) (0 = symptom absent, 10 = worst possible symptom) Quality of life: physical well‐being, social well‐being, functional well‐being, emotional well‐being Toxicity assessment: presence or absence of ankle oedema, insomnia, restlessness or other symptoms (patient‐rated) |
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Notes | Pain secondary outcome measure. Nausea as primary endpoint Pain intensity at baseline low in both arms. Authors therefore query meaningfulness of pain as outcome measure |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, method not specified |
Allocation concealment (selection bias) | Low risk | Capsules containing both drugs identical in appearance, randomisation in pharmacy |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 of 25 patients receiving dexamethasone dropped out 5 of 26 patients receiving placebo dropped out |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | High risk | Sample size: 51 participants; < 50 participants per treatment arm |