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

Popiela 1989.

Study characteristics
Methods Randomised, prospective, double‐blind, placebo‐controlled, multi‐site clinical trial
Study duration: 8 weeks
Participants 173 female participants (85 intervention, 88 control) with advanced, terminal cancer and symptoms (pain, debility, nausea, cachexia etc)
Interventions Intervention: 125 mg infusion of methylprednisolone sodium succinate (MPSS) IV
Control: matching placebo (P)
Both for 56 consecutive days
Outcomes Linear Analogue Self‐Assessment scale (LASA), patient ratings for pain, appetite, sense of well‐being completed weekly x 8 weeks
Mortality
Concomitant medications
Adverse events
Notes No significant changes with time for pain or sleep
No significant changes in opioid use
Better overall LASA score for patients on MPSS
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation specified by a computer‐generated randomisation scheme
Allocation concealment (selection bias) Low risk Double‐blind
Study medication was provided in blinded packages containing vials of either placebo or MPSS
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, data from 2 sites removed ("significant investigator interaction")
Incomplete outcome data (attrition bias)
All outcomes Low risk 38% MPSS and 30% P died before study completion
ITT analysis
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Unclear risk Sample size: 173 participants; 50 to 199 participants per treatment arm