Loutsidis 1994.
Methods | Single centre RCT of tetracycline and mechlorethamine (mustine) for pleurodesis of malignant pleural effusions (Greece) | |
Participants | Inclusion: documented MPE (all tumour types); respiratory distress was the main problem of the participants Exclusion: other therapy given simultaneously (chemotherapy or radiation therapy) 40 participants randomised |
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Interventions | All participants had a 32 Fr intercostal drain inserted with local anaesthetic and effusion drained overnight. Complete drainage confirmed on CXR After pleurodesis, drain flushed with 20 ml saline. Participants rotated and drain unclamped after two hours and put onto ‐20 cm H2O suction. Drain removed when < 50 ml/day drainage Tetracycline group: 500 mg tetracycline in 20 ml 2% lignocaine intrapleurally. 1 dose Mechlorethamine group: 0.2 mg/kg of mechlorethamine in 20 ml saline intrapleurally. 1 dose |
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Outcomes | Response to therapy at 60 days ('complete response' (CR) (complete lack of re‐accumulation of pleural fluid for at least 60 days), 'partial response' (PR) (small pleural effusion, asymptomatic, not requiring further treatment), 'failure' (all other cases)) Side effects |
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Notes | Minimal data provided on baseline participantcharacteristics of the two groups Pleurodesis defined according to symptomatic effusion recurrence For the purposes of this review, CR and PR included as a successful pleurodesis People with trapped lung included in the study Included in network meta‐analysis for pleurodesis efficacy |
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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 | Unclear risk | No mention of blinding in the paper. Drugs given in the same volume but not stated whether their appearances were similar |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if CXR interpretation was blinded for assessment of pleurodesis efficacy |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants followed up until the primary endpoint at 60 days |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |