Mercadante 2007.
Study characteristics | ||
Methods | Prospective, randomised, controlled study of steroids as adjuvant drugs to opioids Study duration: 9 weeks |
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Participants | 76 patients with advanced cancer (31 opioid, 35 dexamethasone) with pain requiring strong opioids Other co‐analgesics allowed |
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Interventions | Group O: conventional opioid treatment Group OS: 8 mg dexamethasone orally along with conventional treatment |
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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) |
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Notes | No difference between groups in OEI Other co‐analgesics allowed, not standardised Difference in OEI between arms at baseline |
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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 |