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. 2014 May 29;2014(5):CD011056. doi: 10.1002/14651858.CD011056.pub2

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
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)
Interventions 1. Oxycodone prolonged release
2. Oxycodone prolonged release with naloxone
Outcomes Pain control using BPI‐SF
Bowel function
Use of rescue medication
Use of laxatives
QoL
Adverse events
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