E13013 2000

Methods	Published data for the Chinese patients of a multinational International Atomic Energy Agency trial (E13013) that's never been published in full.
Participants	N = 160 cancer patients were enlisted in the Chinese portion of the trial. Total number of randomised patients unclear. 105 patients analysed in the Chinese paper. Patients with any primary tumour histology had to present histologically confirmed bone metastases with pain.
Interventions	1. 153Sm EDTMP 37 mBq/Kg (1.0 mCi) administered iv 2. 153Sm EDTMP 18.5 mBq/Kg (0.5 mCi) administered iv Follow up: 16 weeks.
Outcomes	Pain relief with a 5 categories nominal scale. Response to the therapy based on the patient's pain score and the corresponding time after treatment. Analgesia consumption. Karnofsky Performance Score assessed weekly/2 weekly/monthly. Adverse effects assessed weekly/2 weekly/monthly. Analgesic consumption, symptoms and sleeping and eating patterns were recorded by patients and/or family members.
Notes	This trial is included in the review, but it's not analysed due to insufficient information. Information about full trial accessed from http://www‐crp.iaea.org/html/rifa‐show‐detail.asp?ProgCode=E13013 on 3/12/2008. The original trial compared 3 different doses of 153SM EDTMP, although the Chinese publication states they only tested two doses. Full trial is described summarily in an abstract (Olea 2000).
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	"At the beginning, the dose was kept blind from the patient but not from his/her family and the referring doctor".
Blinding (performance bias and detection bias) Study researchers	High risk	"During the later part of the project, no one except the working team was informed of the dose used".
Blinding (performance bias and detection bias) Outcome assessment	High risk	"Analgesic consumption, symptoms and sleeping and eating patterns were recorded by patients and/or family members".
Incomplete outcome data (attrition bias) All outcomes	High risk	It's not clear the total and arm‐wise number of randomised patients, because they only analyse those who have a follow up of 16 weeks in October 1997 from 160 enlisted patients. "During the initial phase of the study, the lower dose was more frequently refused by the referring doctor and/or the patient's family resulting in withdrawal of the patient from the follow‐up". Thus, the patients described in the trial are biased towards the higher dose.