Paulsen 2014.

Study characteristics
Methods	Randomised, placebo‐controlled, double‐blind, parallel‐group, multi‐centre, phase III trial
Participants	Patients with cancer experiencing pain > 4/10 receiving opioids
Interventions	Methylprednisolone 16 mg or placebo 16 mg twice daily for 7 days
Outcomes	Primary outcome: average pain intensity measured by BPI (0 to 10) Secondary outcome: daily pain intensity at rest (ESAS 0 to 10) change in fatigue and appetite baseline to day 7 (EORTC–C30) adverse events
Notes	592 patients screened, 50 recruited over 3 to 4‐year time period
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised randomisation conducted independently
Allocation concealment (selection bias)	Low risk	Methylprednisolone and placebo capsules were identical in appearance
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All parties blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Randomisation was blinded for all parties until the completion of data collection
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 patient died in the placebo group and 1 patient withdrew from the intervention group as a result of malignant bowel obstruction; none lost to follow‐up ITT analysis
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	High risk	Sample size: 50 participants; < 50 participants per treatment arm