Guo‐Zhu 1997.
Methods | Design: randomised, open label, parallel group study comparing 2 doses of Mm/r capsules with 2 doses of Mm/r tablets (4 groups in total). No dose titration; lower dose given to those who had not used, or rarely used, opiates previously Duration of treatment: 7 days Setting: hospital |
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Participants | Terminal cancer and moderate to severe pain
N = 120 M 72, F 48 Mean age approximately 55 years |
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Interventions |
Rescue medication not mentioned Use of antidepressants, non opioid drugs, acupuncture and TCM prohibited |
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Outcomes | PI: 10‐point NRS PR: 5‐point categorical scale Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 0, W = 0. Total = 1/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly divided". 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 | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | Low risk | All AEs appear to be included |
Size | High risk | < 50 participants per treatment arm |