Serafini 1998

Methods	Randomised double blind trial.
Participants	N = 118 patients with any primary tumour histology (80 with prostate cancer, 21 with breast cancer, 6 with lung cancer and 13 with other cancers). Patients had to have painful metastes to bone overlying enhanced uptake on a diagnostic bone scan. (39 1.0 dose of 153Sm, 40 on 0.5 dose of 153Sm, 39 on placebo).
Interventions	1. 153Sm 0.5 mCi/Kg iv monodose. 2. 153Sm 1.0 mCi/Kg iv monodose. 3. Placebo iv monodose. Follow up: 16 weeks.
Outcomes	Pain relief assessed daily by patients on a 0‐10 VAS. Opioid analgesic intake (type and dose) assessed daily by patients. Physician Global Assessment assessed weekly/monthly. Toxicity assessed weekly/monthly according to National Cancer Institut Common Toxicity Criteria.
Notes	2 patients unassessable at 4 weeks, 0 patients withdrawn, 0 patients lost to follow up.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	"Placebo was prepared identically to the active drug, except that it contained nonradioactive 152Sm. The study agents were shipped frozen to each site and stored frozen until dose preparation by an unblinded third party." "Radiation exposure was measured by a radiation safety officer with a silent meter to maintain blinding."
Blinding (performance bias and detection bias) Study researchers	Low risk	"Placebo was prepared identically to the active drug, except that it contained nonradioactive 152Sm. The study agents were shipped frozen to each site and stored frozen until dose preparation by an unblinded third party." "Radiation exposure was measured by a radiation safety officer with a silent meter to maintain blinding."
Blinding (performance bias and detection bias) Outcome assessment	Unclear risk	Not described.
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 patients in the placebo group were excluded from efficacy analyses (but not from safety analyses) due to being considered outliers. Apparently, no other pt was lost on week 4. Number and causes of losses at 16 weeks are described.