Ruckdeschel 1991.
| Methods | Multicentre RCT of intrapleural bleomycin and tetracycline in MPE (USA) | |
| Participants | Inclusion: exudative MPE (proven on cytology or pleural biopsy); ECOG performance score (PS) 0‐2 Exclusion: previous intrapleural therapy; prior systemic therapy with bleomycin; severe congestive heart failure; radiotherapy to the chest in the previous two weeks 115 participants randomised |
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| Interventions | All participants had a chest tube placed and had evidence of lung re‐expansion on CXR. After the study drug was inserted the tube was clamed and the participant's position rotated. After several hours the chest tube was removed Group 1: tetracycline 1 g intrapleurally in 100 ml saline Group 2: bleomycin 120 units intrapleurally in 100 ml saline (due to slow accrual, this group was dropped after accruing 15 participants) Group 3: bleomycin 60 units intrapleurally in 100 ml saline |
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| Outcomes | Recurrance of effusion at 30 days and 90 days (defined according to CXR) Time to effusion recurrence within 90 days Time to maximum change in ECOG PS Change from initial PS to the best PS (worsened/no change/improved) Adverse events |
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| Notes | People with trapped lung excluded Group 2 dropped due to slow accrual and data on the 15 participants assigned to this group not provided Included in network meta‐analysis for pleurodesis efficacy, mortality, pain and fever |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation, with stratification |
| Allocation concealment (selection bias) | Low risk | Computer randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if anyone was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Lots of patients excluded from analysis (41/115 'non‐evaluable'). Reasons given |
| Selective reporting (reporting bias) | High risk | Data on 15 patients randomised to high dose bleomycin group not reported |
| Other bias | Low risk | No other biases identified |