Popiela 1989.
Study characteristics | ||
Methods | Randomised, prospective, double‐blind, placebo‐controlled, multi‐site clinical trial Study duration: 8 weeks |
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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 |
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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 |
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Notes | No significant changes with time for pain or sleep No significant changes in opioid use Better overall LASA score for patients on MPSS |
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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 |