Skip to main content
. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

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
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
Outcomes Response to therapy (defined by re‐accumulation on CXR and need for repeat procedure). Time point unclear
Side effects
Survival
Notes People with trapped lung were included in the study
Included in network meta‐analysis for pleurodesis efficacy and fever
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