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. 2015 Apr 24;2015(4):CD010756. doi: 10.1002/14651858.CD010756.pub2

Bruera 2004.

Study characteristics
Methods Double‐blind, parallel‐arm trial
5 international centres
Study duration: 7 days
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)
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)
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
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