Lynch 1996.
Methods | RCT of bleomycin, tetracycline and talc for pleurodesis of malignant pleural effusion | |
Participants | Inclusion: MPE (either cytology positive or an exudative effusion attributed to a histologically confirmed malignancy elsewhere) (all cell types); life expectancy > 2 months Exclusion: contraindication to placement of a chest tube; allergy to bleomycin, talc or tetracycline 50 participants randomised |
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Interventions | Chest tube placed using blunt dissection and allowed to drain for at least 24 hours until < 150 ml/day output. Sclerosing agent instilled intrapleurally. Participants repositioned every seven minutes after agent instilled. Then, tube unclamped and suction applied, until < 150 ml/24hours drainage when the drain was removed. If the drainage remained high, a second instillation was attempted Bleomycin group: 60 units bleomycin in 50 ml 5% dextrose Tetracycline group: 750 mg tetracycline in 100 ml saline, with 100 mg lidocaine Talc group: 5 g talc in 250 ml saline, with 100 mg lidocaine |
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Outcomes | Successs of sclerosis at 30 days (defined as a lack of significant re‐accumulation on CXR with control of symptoms due to the effusion) Survival Median length of hospitalisation from date of sclerosis to discharge Side effects |
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Notes | Participantswho died within 30 days of the sclerosis were included as treatment failures in the study Small difference in median age and cell types between the treatment arms Trapped lung not accounted for Included in network meta‐analysis for pleurodesis efficacy, fever and pain |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator |
Allocation concealment (selection bias) | Low risk | Random number generator |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated explicitly if the study was blinded, but the different drugs were given as different volumes |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom and side effect reporting would be affected by lack of blinding. Not stated if CXR interpretation was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4/50 (8%) loss to follow up for primary outcome but balanced between the treatment arms |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | Low risk | No other biases identified |