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 |