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. 2017 Mar 23;2017(3):CD003347. doi: 10.1002/14651858.CD003347.pub3
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).
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.
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.
Notes 0 patients were lost or withdrawn.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.