Parris 1998.
Methods | Design: multicentre, randomised, double‐blind (double dummy), parallel group study Duration: 5 days Setting: Not stated |
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Participants | Cancer‐related pain requiring 6 to 12 tablets or capsules per day of fixed‐combination analgesics for acceptable control. Most common cancer diagnoses were breast, gastrointestinal, lung, and gynaecological N = 103 50% female Mean age 57 years (range 31‐80) |
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Interventions |
Stable doses of non opioid analgesics or analgesic adjuvants allowed after protocol amendment Rescue medication: participants needing titration of analgesic or supplemental medication were required to discontinue from the study |
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Outcomes | PI: 4‐point categorical scale (0 ‐ 3) x 4 daily Acceptability of therapy: 5‐point categorical scale (1 ‐ 5), x 2 daily Adverse events, daily |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized". Method used to generate sequence not clearly stated |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double dummy method |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double dummy method |
Incomplete adverse event outcome data‐ patient level | Low risk | >90% participants included |
Selective reporting bias for adverse events | High risk | Selective reporting of >5% of patients with an AE |
Size | Unclear risk | 50 ‐ 199 participants per treatment arm |