Sykes 1991a.
Methods | RCT, single‐centre, cross‐over group design | |
Participants | 51 people with cancer in UK hospice who had not under gone bowel diversion, were not clinically obstructed and who required a laxative. Participants were receiving either > 80 or < 80 mg of strong opioid a day | |
Interventions | Drug 1: senna plus lactulose (in equal quantities) liquid Drug 2: equivalent volume of co‐danthramer plus poloxamer Starting doses of laxatives were set by the protocol in relation to opioid dosage and subsequently modulated according to clinical response. No further details on doses Duration of treatment: 1 week twice daily Cross‐over: switched to the alternative for 1 further week |
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Outcomes | Stool form and frequency, failure (absence of a single stool passed spontaneously during 1 treatment week), use of rescue laxatives, participant's assessment of bowel function, participant preference and adverse events | |
Notes | No details provided | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding (performance bias and detection bias) All outcomes | High risk | "Not possible because of physical characteristics of drugs" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 58/117 participants completed the cross‐over (of the 58, 6 participants were excluded from analysis because of breaches in the protocol and 1 as "data unclear") 0 dropped out because of inefficacy Not reported if intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No details provided |