Ong 2000.
Methods | Single centre RCT of talc vs bleomycin in MPE (Singapore) | |
Participants | Inclusion: symptomatic, unilateral MPE confirmed by cytology or pleural biopsy (all cell types) Exclusion: trapped lung or loculated effusion; incomplete drainage (e.g. > 100 ml/day for 10 days); previously treated effusions; life expectancy < 1month 50 participants randomised |
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Interventions | 20 ‐ 24 Fr tube thoracostomy until complete lung re‐expansion on CXR and < 100 ml/day for two days. Both drugs diluted in 50 ml saline and 10 ml 1% lignocaine. After study drug inserted, drain clamped for six hours with patient rotation. Then suction applied. Drain removed when < 200 ml/day drainage Talc group: 1 dose. 5 g talc intrapleurally Bleomycin group: 1 dose. 1 unit/kg bleomycin intrapleurally |
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Outcomes | Treatment response at one month (according to recurrence of effusion on CXR. Scoring system 0‐3 used for size of effusion) Hospital stay (days) Side effects within 48 hours of pleurodesis |
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Notes | People with trapped lung excluded from trial entry Pleurodesis success based only on radiology Included in network meta‐analysis for pluerodesis efficacy, pain, fever and mortality |
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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 stated explicitly, however drugs have differing appearances |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "A single investigator who was blinded to treatment allocation scored all the follow up chest x rays" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12/50 patients excluded due to death or LTFU in first month, but balanced between treatment arms |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |