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. 2017 Mar 23;2017(3):CD003347. doi: 10.1002/14651858.CD003347.pub3
Methods Published data for the Indian subset of patients of a multinational International Atomic Energy Agency randomised trial (E13010), that's never been published in full.
Participants N = 31 cancer patients with any primary tumour histology (13 with prostate cancer, 12 with breast cancer, 3 with lung cancer, 3 with other cancers). Metastatic bone lesions confirmed by radionuclide bone scan. Patients had to present a minimum level of pain from the scan‐positive sites (score of 5 to 10 on a 0‐10 VAS ) not relieved by therapy with non‐narcotic analgesia or with narcotic medication.
(15 on 89Sr, 16 on 32P).
Interventions 1. 89Sr 4 mCi (148 MBq).
2. 32P 12 mCi.
Follow up: 4 months.
Outcomes Pain relief assessed daily by patients through a 0‐10 VAS.
Analgesic score based on daily assessed analgesic type and administration frequency (0‐20 range).
Mobility score assessed every two weeks by a 4‐points score.
Pain flares.
Toxicity graded as recommended by the IAEA (White blood cell X 109/L:grade 0> = 4.0; grade 1 = 3.0‐3.9; grade 2 2.0‐2.9; grade 3 = 1.0‐1.9; grade 4 < 1.0. Platelets X 109/L:grade 0 = 150‐400; grade 1 = 75‐149.9; grade 2 = 50.0‐74.9; grade 3 = 25.0‐49.9; grade 4 < 25.0. Absolute granulocyte counts of less than 1000 were considered as significant toxicity).
Death.
Notes Summary description of full trial in http://www‐crp.iaea.org/html/rifa‐show‐detail.asp?ProgCode=E13010.
It's not clear whether the outcomes were assessed by the patient or their relatives. "A set of data sheets was given to the patient's relatives to fill out and return every 2 weeks".
0 patients lost to follow up or withdrawn.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Low risk "Randomization of patients to the radionuclide was done at the IAEA, which then informed the center of the radionuclide to be used in a given patient".
Blinding (performance bias and detection bias) Patients Unclear risk "Two responsible relatives of the patient were taken into confidence and the details of treatment, the stage of the disease and the expected outcome were explained".
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 Low risk Apparently, all randomised patients were assessed.