Axelsson 2003.
Methods | Randomised, double‐blind, placebo‐controlled, cross‐over study Treatment for 7 days with each intervention, no washout |
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Participants | Advanced cancer (mainly prostate, pancreas, breast, colorectal), well‐controlled pain (< 4/10), stable opioid doses) receiving oral modified‐release morphine with concurrent paracetamol Excluded: chemotherapy, radiotherapy, strontium therapy within 2 months, started amitriptyline within 1 month, started corticosteroids or NSAIDs within 2 weeks N = 42 (30 completed) Completers: M 19, F 11 Median age 72 years (range 38 to 86) Median PI 2 (range 0 to 3) Median 24‐hour dose morphine 70 mg (range 20 mg to 440 mg) |
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Interventions | In addition to stable dose of oral modified‐release morphine: Paracetamol 4 x 1000 mg daily Placebo |
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Outcomes | Average daily PI: NRS (0 to 10) Additional morphine consumed Quality of life at baseline and end of each treatment period At end of study, judgement about in which period pain and QoL was better |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method used to blind participants and personnel not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method used to blind outcome assessment not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis; 12/42 (29%) did not complete |
Selective reporting (reporting bias) | Unclear risk | Protocol not available, report as letter only. All relevant specified outcomes reported |
Size | High risk | < 50 participants per treatment arm |