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. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

Zimmer 1997.

Methods Prospective RCT of talc vs bleomycin pleurodesis for symptomatic MPE (USA)
Participants Inclusion: MPE (all cell types); life expectancy > 1 month
Exclusions: significant loculated effusions; trapped lung
40 procedures randomised in 35 participants
Interventions All participants underwent tube thoracostomy (either at the end of a limited thoracotomy (two participants) or inserted at bedside (33 participants)). Tube remained on suction. After sclerosant injected intrapleurally, tube clamped for two hours and participant rotated
Talc group: 5 g talc in 50 ml saline, with 20 ml 1% lignocaine. 1 dose
Bleomycin group: 60 U bleomycin in 50 ml saline, with 20 ml 1% lignocaine. 1 dose
Outcomes Effusion control on CXR (at a minimum of two weeks)
Dyspnoea (according to functional class 1 ‐ 4)
Pain (according to scale 0 ‐ 10)
Cost
Length of hospital stay
Notes People with trapped lung excluded
Participants only included in primary analysis if out of hospital and able to attend follow up at two weeks
Study authors emailed for more information, but no response
Included in network meta‐analysis for pleurodesis efficacy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not explicitly stated but drugs had different appearances
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Symptom recurrence, pain, breathlessness, duration of stay and adverse events could all be biased by lack of blinding. Not stated radiology reported blindly
Incomplete outcome data (attrition bias) 
 All outcomes High risk No clear time point when follow up performed. Only those available for follow up included in the analysis. Unclear how many randomised to each arm (only data on numbers analysed by treatment arm)
Selective reporting (reporting bias) Low risk All outcomes reported on
Other bias Low risk No other biases identified

ECOG: electrocochleography

IV: intravenous

LTFU: loss to follow up

QOL: quality of life

RCT: randomised controlled trial