Groth 1991.
| Methods | RCT comparing intrapleural mitoxantrone with normal saline after thoracoscopy in patients with MPE (Germany) | |
| Participants | Inclusion: complete resolution of the effusion after thoracoscopy; malignancy on pleural biopsy Exclusion: No chemotherapy within four weeks of pleurodesis 103 participants randomised |
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| Interventions | All participants underwent thoracoscopy. After 24 hours participants were randomised Mitoxantrone arm: 30 mg mitoxantrone given intrapleurally Control arm: isotonic saline instilled intrapleurally Drain clamped for 48 hours and if > 300 ml effusion after 48 hours, a second dose was given; if not the drain was removed. If a second dose was given, the drain was removed 48 hours later |
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| Outcomes | Pleural fluid re‐accumulation at two months (defined as a complete response (complete disappearance of all pleural effusion), partial response (half of the effusion or doubling of the time for thoracocentesis) no change (the same volume of effusion) or progressive disease (uncontrollable effusion) Toxicity Remission duration Survival |
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| Notes | Treatment response definitions somewhat unclear People with trapped lung eligible for trial involvement Included in network meta‐analysis for pleurodesis efficacy and fever. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not specified |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding or whether drugs were of similar appearances or volumes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated whether CXR interpretation was blinded to treatment allocation. Side effects and performance status reporting could be biased if participants and personnel were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/103 participants excluded from the analysis (7 died within four weeks of randomisation due to tumour progression; 1 was lost to follow up) |
| Selective reporting (reporting bias) | Low risk | All reported |
| Other bias | High risk | Ambiguous definitions of pleurodesis success |