Ahmedzai 2012.
Methods | Design: randomised double blind, active controlled, double dummy, parallel group study. Pre‐study opioid and laxative stopped prior to randomisation Duration: 4 weeks Setting: Probably community‐ not clearly stated |
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Participants | Cancer pain‐ moderate or severe requiring round the clock opioid therapy equivalent to Oxycodone 20‐80mg/day. Participants who had chemotherapy in previous 2 weeks excluded or radiotherapy that could influence bowel function or pain N = 184 M 94, F 90 Mean age 63 years (range 36 ‐ 84) |
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Interventions | 1. Oxycodone prolonged release 2. Oxycodone prolonged release with naloxone |
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Outcomes | Pain control using BPI‐SF Bowel function Use of rescue medication Use of laxatives QoL Adverse events |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 'pseudo random number generator in a computer programme' |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'treatments were masked in a double dummy fashion' |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 'treatments were masked in a double dummy fashion' |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | High risk | Incomplete breakdown of AEs |
Size | Unclear risk | 185 participants |