Ukale 2004.
| Methods | Single centre RCT comparing intrapleural talc and mepacrine given via a chest tube after thoracoscopy (Sweden) | |
| Participants | Inclusion criteria: recurrant, symptomatic pleural effusions, known or suspected to be due to malignancy; eligible for thoracoscopy and pleurodesis Exclusion criteria: incomplete lung re‐expansion after thoracoscopy 89 participants with confirmed malignant pleural effusions were randomised (110 participants randomised in total, but some had benign causes) |
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| Interventions | All participants underwent a local anaesthetic thoracoscopy, with biopsies and a 20 Fr drain was inserted at the end of the procedure. A chest X‐ray was performed to ensure lung re‐expansion before randomisation Mepacrine group: 500 mg mepacrine in 200 ml saline intrapleurally Talc group: 5 g talc in 200 ml saline intrapleurally In both groups, a second dose was given if > 50 ml/day drainage on day 3. Drains removed when < 50 ml/24hour drainage |
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| Outcomes | Primary: pleurodesis success (using clinical and radiological definition). Reported at day 6, 2 weeks, 2 months, 4 months and 6 months Secondary: analgesia use; side effects; mortality |
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| Notes | People with trapped lung excluded. Note that two doses may have been given Included in network meta‐analysis for pleurodesis efficacy and mortality |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind as drugs different appearances |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Radiologists reporting CXRs were blind to treatment allocation. Symptom recurrence and adverse event reporting may be biased by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for loss to follow up and exclusions reported and well matched between the groups |
| Selective reporting (reporting bias) | Low risk | Data for those with proven MPE obtained from authors |
| Other bias | Low risk | No other biases identified |