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 |
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| 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 |
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| 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 |
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| Notes | People with trapped lung excluded from trial entry Included in network meta‐analysis for pleurodesis efficacy and mortality |
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| 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) |