Methods | Crossover randomised double blind trial. | |
Participants | N = 20 patients with any primary tumour histology (9 with prostate cancer, 2 with lung cancer, 1 with breast cancer, 1 with thyroid cancer, 7 patients not described). Metastatic bone lesions confirmed by 99mTc bone scan and radiographs. (10 on 186Re, 10 on placebo). |
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Interventions | 1. 186Re (sn)HEDP with mean activity 34.0 +‐ 0.8 mCi (1258+‐ 29.6 MBq) administered iv 2. Placebo 99Tc MDP methylene diphosphonate with mean activity 17.7 +‐ 1.5 mCi (654.9 +‐ 55.5 MBq) administered iv Follow up: 12 weeks after initial treatment. |
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Outcomes | Pain index based on the patient's daily assessment of the severity of their pain at rest and during activity. Patient's and physicians' subjective impression of pain improvement. Analgesia index based on the number of doses and type of medication used for pain relief assessed daily by the patients. Toxicity. |
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Notes | 4 patients were not evaluable on the 186Re group, 3 patients were not evaluable on the placebo group. Outcomes assessed at 3 weeks. |
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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 | Low risk | "All physicians, nurses and patients were kept blinded regarding which compound was administered at any time." |
Blinding (performance bias and detection bias) Study researchers | Low risk | "All physicians, nurses and patients were kept blinded regarding which compound was administered at any time." |
Blinding (performance bias and detection bias) Outcome assessment | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The number and reasons of unevaluable patients are described, but due to the small sample size, the losses represent a high percentage. All but one of the losses could be analysed in a first‐period analysis. |