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. 2015 Apr 24;2015(4):CD010756. doi: 10.1002/14651858.CD010756.pub2

Graham 2006.

Study characteristics
Methods Pilot randomised controlled trial
8 recruiting centres
Study duration: 14 days
Participants 20 participants with malignant spinal cord compression (MSCC)
Inclusion criteria:
  • malignant disease

  • at least one of: pain, weakness, sensory symptoms, sphincter problems

  • ECOG performance status ≥ 4 before the MSCC event

  • minimum limb power 1/5

  • estimated minimum survival of 2 months

Interventions High‐dose: 96 mg dexamethasone intravenously day 0, continued to day 2 then weaned to 0 by day 15
or
Low‐dose: 16 mg dexamethasone intravenously day 0, continued to day 2 then weaned to 0 by day 15
Radiotherapy in both arms
Outcomes Visual analogue pain score (0 to 10)
Toxicity (method not specified)
Survival
Ambulation and functional outcome (method not specified)
Notes High‐dose versus low‐dose dexamethasone study terminated because of inadequate recruitment
No significant difference in pain in the first week
Analgesic use tended to be lower in high dose arm
Pilot study, not powered for outcome, descriptive analysis
Pain one of several endpoints
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients randomised via the Superdex website
Allocation concealment (selection bias) Low risk Website protected with password unique to each investigator
Blinding of participants and personnel (performance bias)
All outcomes High risk Physicians were provided with patient's assigned treatment
Blinding of outcome assessment (detection bias)
All outcomes High risk Physicians were provided with patient's assigned treatment
Incomplete outcome data (attrition bias)
All outcomes High risk 4 out of 20 patients not evaluable
Selective reporting (reporting bias) Low risk None detected
Other bias High risk Sample size: 20 participants (pilot study); < 50 participants per treatment arm