Methods | Randomised double blind trial. | |
Participants | N = 49 men with prostate cancer. Metastatic bone lesions confirmed by 99mTcEHDP bone scan and radiographs. (25 on 89Sr, 24 on placebo). |
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Interventions | 1. 75 MBq/mo for 3 months 89Sr administered iv 2. Placebo. Follow up: 36 months. |
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Outcomes | Patient reported subjective pain palliation. Survival up to 2 years. Toxicity assessed at 3, 6 and 12 months. |
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Notes | 8 patients had no pain at start of treatment, 10 patients died whilst on treatment, 0 patients withdrawn, 0 patients lost to follow up. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Patients | Low risk | "Patients were selected randomly, and the group they were in was not uncovered earlier than one year after the start of treatment". |
Blinding (performance bias and detection bias) Study researchers | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Outcome assessment | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers described but no causes. High attrition rate. |