Han 2002

Methods	Double blind randomised trial.
Participants	N = 131 men with prostate cancer. All patients had scintigraphic and radiologic evidence of at least 4 bone metastases. Patients with bone metastases from malignancies other than prostate cancer were not included in this study. Patients had to present symptomatic bone metastases no longer responding to any medical or surgical endocrine manipulation treatments. (66 on 186Re, 65 on placebo).
Interventions	1. 186Re in doses ranging from 1.295 to 2.960 MBq (35‐80 mCi) administered iv 2. Placebo isotonic sterile saline in 2 ml vials administered iv Follow up: 12 weeks.
Outcomes	Positive response days assessed as a composite endpoint (number of days pain was reduced 25% compared with the median baseline pain index value, while the medication index and daily activity score remained constant or increased, or on which pain was reduced 25% and the medication index or daily activity score improved 25% compared with baseline levels, without worsening of the remaining factor. Pain relief with a 0‐100 VAS assessed by participants twice daily until 12 wk after treatment or until the request for radiotherapy. Analgesic intake assessed by participants daily with a medication index. Daily activities assessed daily by participants through validated questions. Request of palliative radiotherapy. Survival. PSA levels.
Notes	7 patients didn't receive treatment with 186Re, 13 patients didn't receive treatment with placebo. 13 patients were not evaluable on the 186Re group, 16 patients were not evaluable on the placebo group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation was performed by the hospital pharmacist".
Allocation concealment (selection bias)	Low risk	"Predetermined randomization list form the Center for Biostatistics".
Blinding (performance bias and detection bias) Patients	Low risk	"The hospital pharmacist was the only person during the entire study who knew that therapy was prepared and given". "The infusions were identical in appearance after preparation to ensure blinding. Other study personnel, as well as the patients and the investigators, remained unaware of the treatment assigned during the entire study".
Blinding (performance bias and detection bias) Study researchers	Low risk	"The hospital pharmacist was the only person during the entire study who knew that therapy was prepared and given". "The infusions were identical in appearance after preparation to ensure blinding. Other study personnel, as well as the patients and the investigators, remained unaware of the treatment assigned during the entire study".
Blinding (performance bias and detection bias) Outcome assessment	Low risk	"The hospital pharmacist was the only person during the entire study who knew that therapy was prepared and given". "The infusions were identical in appearance after preparation to ensure blinding. Other study personnel, as well as the patients and the investigators, remained unaware of the treatment assigned during the entire study".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Numbers and causes for lost or not evaluated patients are broadly described, but numbers are unequivalent, and the percentage of losses is high".