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

Mercadante 2007.

Study characteristics
Methods Prospective, randomised, controlled study of steroids as adjuvant drugs to opioids
Study duration: 9 weeks
Participants 76 patients with advanced cancer (31 opioid, 35 dexamethasone) with pain requiring strong opioids
Other co‐analgesics allowed
Interventions Group O: conventional opioid treatment
Group OS: 8 mg dexamethasone orally along with conventional treatment
Outcomes Average daily pain intensity measured using the patient's self report on NRS from 0 (absent) to 10 (maximum)
Well‐being sensation, rated by means of a NRS from 0 to 10
Symptoms associated with opioid therapy or commonly present in advanced cancer patients (nausea and vomiting, weakness, drowsiness, constipation, confusion), scale from 0 to 3 (not at all, slight, a lot, awful)
Opioid escalation index percentage (OEI%) and absolute dose (OEI mg)
Notes No difference between groups in OEI
Other co‐analgesics allowed, not standardised
Difference in OEI between arms at baseline
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients randomly divided into 2 groups
Method not described
Allocation concealment (selection bias) High risk Method not stated
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding
Blinding of outcome assessment (detection bias)
All outcomes High risk Not stated
Incomplete outcome data (attrition bias)
All outcomes High risk Half of the patients died before the third week making the interpretation of any long‐term corticosteroid benefit difficult
Selective reporting (reporting bias) Unclear risk Authors did not specify the adverse drug reactions where they claimed symptomatic improvement except for nausea, vomiting and constipation
Other bias High risk Sample size: 76 participants; < 50 participants per treatment arm