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

Haddad 2004.

Methods Single centre RCT comparing talc slurry and bleomycin pleurodesis (Brazil)
Participants Inclusion: documented recurrent symptomatic MPE (with positive cytology or confirmed metastatic disease elsewhere with no other cause found for the effusion); symptomatic relief by therapeutic aspiration; complete lung re‐expansion after therapeutic aspiration
Exclusion: previous unsuccessful pleurodesis; pleural infection; chronic air leak; karnofsky performance score < 30%
71 participants randomised
Interventions 28 ‐ 36 Fr chest tube inserted under local anaesthetic. Lung re‐expansion confirmed prior to randomisation
Talc group: 4 g talc in 100 ml saline intrapleurally
Bleomycin group: 60 units of bleomycin in 100 ml saline intrapleurally
After instillation, drain clamped for four hours, then put on suction for 24 hours. Drain removed when < 200 ml/24hours drained
Outcomes Pleurodesis success (defined as no recurrence of effusion on clinical and radiologic follow‐up or patient symptom‐free with small residual effusion not requiring thoracentesis) at 1, 3 and 6 months
Length of hospital stay
Cost analysis
Complications
Notes People with trapped lung excluded from trial entry
Included in network meta‐analysis for pleurodesis efficacy and mortality
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation sequence
Allocation concealment (selection bias) Low risk Computer randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk "Study not blinded" (personal communication with authors)
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "study not blinded" (personal communication with authors). Not stated if radiology reported blindly but pleurodesis efficacy also based on symptom recurrence, so could be biased by lack of participant blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All reported
Selective reporting (reporting bias) Low risk All outcomes reported and further clarification received from authors regarding complications and mortality
Other bias High risk High levels of steroid use in participants, which may have effected pleurodesis success rates. Steroid use not well balanced between the treatment arms (4/37 in talc group, 8/34 in beomycin group)