Bjermer 1995.
| Methods | RCT of mitoxantrone versus mepacrine via an intercostal drain (Sweden ‐ number of centres not specified) | |
| Participants | Cytologically proven, symptomatic MPE with an expected survival of greater than three months (Karnofsky Performance Score > 60). Excluded if cytotoxic chemotherapy in the preceding month All cell types included 30 participants randomised |
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| Interventions | Both groups had a 12‐14 Fr chest tube inserted and effusion drained. Pleurodesis agent was given through the chest tube and patient's position changed for two hours after administration Group 1: 1 dose of intrapleural mitoxantrone 30 mg in 50 ml N saline was given; the drain was closed for 48 hours and removed after the 'pleural cavity was emptied' Group 2: 2 doses of intrapleural mepacrine chloride 200 mg in 20 ml N saline were given on consecutive days and the drain removed when < 150 ml fluid production/day |
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| Outcomes | Pleural fluid re‐accumulation at 4 and 12 weeks (defined as 'Complete response' (CR), 'Partial response' (PR) (if recurrence of pleural fluid but thoracocentesis not considered to be indicated) or 'Progressive disease'. Side effects/toxicity (visual analogue scale pain and fever scores) Symptom questionnaires (participant grades symptom on a numeric scale for four key symptoms‐ pain, shortness of breath, nausea and tiredness) Pharmacokinetics of mitoxantrone |
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| Notes | People with trapped lung not excluded from the study CR and PR counted as pleurodesis success for analysis 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) | Unclear risk | Not specified and unable to find contact details for study authors |
| Allocation concealment (selection bias) | Unclear risk | Not specified and unable to find contact details for study authors |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study personnel not blinded as drugs are of different colours. However, participants were blinded to treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants blind to treatment allocation, therefore fever, pain and symptom scores unbiased. "Radiological evaluation was made by an independent radiologist' |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant in each study arm did not receive treatment due to "unexpected medical emergencies", therefore deemed non‐evaluable. Follow‐up data clearly documented for the remaining patients |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
| Other bias | Low risk | Drain suction use was imbalanced between the treatment arms (10/14 received suction in mepacrine group vs 1/14 in mitoxantrone group) |