Methods | Open label randomised trial. | |
Participants | N = 50 patients with breast cancer (48 women, 2 men). Multiple metastatic bone lesions confirmed by 99mTcMDP bone scan. Patients had to have pain resistant to chronic analgesic intake (both opiate and NSAIDs). (25 to 89Sr, 25 to 186ReHEDP). |
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Interventions | 1. 89Sr 148 MBq administered as bolus through iv saline drip. 2. 186Re HEDP 1406 MBq administered as bolus through iv saline drip. Follow up: 6 months. |
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Outcomes | Pain relief assessed daily by patients. Pain score assessed through a modified Wisconsin test consisting of a five‐point pain‐rating scale (from 0 to 4) recording pain severity, pain frequency, analgesic intake and change in sleep patterns. Analgesic intake. Karnofsky Performance Score assessed monthly. Hematologic toxicity and adverse effects reported monthly according to WHO guidelines. |
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Notes | 0 patients were lost or withdrawn. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Patients | High risk | Open label study. |
Blinding (performance bias and detection bias) Study researchers | High risk | Open label study. |
Blinding (performance bias and detection bias) Outcome assessment | High risk | Open label study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Apparently, all randomised patients were evaluated. |