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

Hamed 1989.

Methods Prospective, single centre RCT of bleomycin and talc in MPE secondary to breast cancer (UK)
Participants Inclusion criteria: breast carcinoma with radiographically confirmed pleural effusion
Exclusion criteria: previous local treatment (apart from simple aspiration); evidence of a non‐malignant cause for the effusion
29 participants randomised
Interventions All participants had effusion drained to dryness under general anaesthetic
Talc group: talc pleurodesis (dose and mode of administration not specified, but assumed to be poudrage from text)
Bleomycin group: chest tube inserted. Bleomycin 1 mg/kg in 50 ml normal saline instilled after a CXR confirming lung re‐expansion
Outcomes Success of pleurodesis (defined as continued absence of re‐accumulation of pleural fluid on all follow‐up radiographs)
Notes Different modes of administration of talc and bleomycin
Contacted study authors for more information, but no reply
People with trapped lung eligible for study entry
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 possible to blind due to the nature of the interventions (talc poudrage vs bleomycin)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated whether radiology reporting was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk A number of participants not included in the primary analysis, but balanced numbers between the two treatment arms (4/13 in talc group, 3/16 in bleomycin group)
Selective reporting (reporting bias) Low risk All reported
Other bias Low risk No other biases identified