Koldsland 1993.
| Methods | Single centre, prospective RCT of mepacrine versus bleomycin as pleurodesis agent in malignant pleural effusion (Norway) | |
| Participants | Inclusion: malignant pleural effusion; previous treatment with a therapeutic tap; life expectancy of > 1 month Exclusion: previous pleurodesis; renal failure; participantrequiring continuous oxygen 40 patients randomised. |
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| Interventions | 28 or 32 Fr chest tube inserted under local anaesthetic. Suction applied until fluid production about 100 ml/day and no effusion on CXR. Tube clamped and sclerosing agent injected. Patient rotation for two hours after instillation. Drain removed when < 100 ml/day output Mepacrine group: 800 mg mepacrine in 20 ml saline Bleomycin group: 60 mg bleomycin in 100 ml saline |
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| Outcomes | Pleurodesis success (classified as (1) no re‐accumulation (2) small amounts of fluid re‐accumulation with no or mild symptoms (3) re‐accumulation of fluid with severe dyspnoea needing thoracocentesis) Median survival Side effects |
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| Notes | People with trapped lung not excluded from trial entry For purposes of this review, participants with no re‐accumulation or small amount of re‐accumulation with no or mild symptoms were counted as pleurodesis successes Included in network meta‐analysis for pleurodesis efficacy, fever and pain |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised using sealed envelopes |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated specifically but drugs reconstituted in different volumes |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participant reporting of symptoms may be effected by lack of blinding. Not stated whether CXR interpretation was blind to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | High mortality in first three months, therefore data only analysed at month 1 |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | No other biases identified |