Bayly 1978.
| Methods | Two‐centre RCT of intrapleural quinacrine (mepacrine) vs tetracycline via tube thoracostomy for malignant pleural effusion (USA) | |
| Participants | Inclusion: (1) documented cancer with pleural effusion (2) pleural fluid cytology or pleural biopsy confirming malignancy or exudate effusion presumed to be malignant (3) symptomatic from the effusion or rapidly re‐accumulating effusion > 500 ml All cell types. No exclusion criteria 20 participants randomised. |
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| Interventions | Both groups had a closed tube thoracostomy, drained overnight prior to the installation Quinacrine group: intrapleural quinacrine (100 mg in 30 ml normal saline) once daily for four days Tetracycline group: one dose of intrapleural tetracycline (500 mg in 30 ml N saline) The drains were clamped for six hours post installation with patient rotation. Drain removed when < 60 ml/24 hour drainage |
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| Outcomes | Pleurodesis success (defined on chest x‐ray criteria only at 30 days as 'Complete response' (complete lack of re‐accumulation of pleural fluid); 'Partial response' (re‐accumulation of pleural fluid < 50% of the volume present before the sclerosis); 'Failure' (re‐accumulation of fluid to > 50% of the volume present before the attempted sclerosis)) Side effects of treatment (pain, fever) |
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| Notes | People with trapped lung not excluded. CR and PR counted as a pleurodesis success for purposes of analysis One participant allocated to quinacrine arm having had treatment failure with tetracycline not included in the analysis Included in network meta‐analysis for pleurodesis efficacy and pain. |
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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 contact study authors |
| Allocation concealment (selection bias) | Unclear risk | Not specified and unable to contact study authors |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No comment on whether study was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated whether CXR evaluation was blinded. Pain and fever outcomes may have been affected if patients were unblinded to treatment allocation, however not stated in the paper whether this was the case |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Two of 14 randomised to tetracycline excluded from analysis (one died and one LTFU). No LTFU in mepacrine arm (overall LTFU 13%) |
| Selective reporting (reporting bias) | Low risk | All specified endpoints reported |
| Other bias | High risk | Eight of 22 participants included in the study did not have proven pleural malignancy |