Noppen 1997.
Methods | Single centre RCT of talc vs bleomycin in MPE (Belgium) | |
Participants | Inclusion criteria: hist/cytologically proven, symptomatic MPE; karnofsky performance score ≥ 50; expected survival of one year or less. Exclusion criteria: previous pleurodesis attempt 26 participants randomised |
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Interventions | 14 Fr chest drain with suction drainage until completely drained. Intrapleural lignocaine and subcutaneous morphine given prior to instillation of study drug. After instillation of drug, drain clamped for 30 mins and then left on suction drainage until output < 150 ml/24hours Bleomycin group: 1 mg/kg bleomycin in 50 ml saline intrapleurally. 1 dose Talc group: 5 g in 50 ml saline intrapleurally. 1 dose |
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Outcomes | Response to therapy (defined by re‐accumulation on CXR and need for repeat procedure). Time point unclear Side effects Survival |
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Notes | People with trapped lung were included in the study Included in network meta‐analysis for pleurodesis efficacy and fever |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated numerical table |
Allocation concealment (selection bias) | Low risk | Computer‐generated numerical table |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated explicitly but drugs have different appearances |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom recurrence and side effects could be biased by lack of blinding. Not stated if CXR interpretation was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No LTFU. Outcome data provided on all participants |
Selective reporting (reporting bias) | Low risk | Time point used to define pleurodesis not specified |
Other bias | Unclear risk | No fixed endpoint for follow up |