Kessinger 1987.
| Methods | Single centre RCT comparing intrapleural (IP) bleomycin and tetracycline in MPE (USA) | |
| Participants | Inclusion: histologically proven malignancy; symptomatic pleural effusion with either > 3 g/dl protein or malignant cells on cytology Exclusion: allergy to either study drug 42 procedures randomised in 34 participants |
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| Interventions | All participants underwent chest tube drainage Tetracycline arm: 500 mg tetracycline in 50 ml saline IP. 1 dose Bleomycin arm: 89 units in 50 ml saline IP. 1 dose For both arms, drain clamped for eight hours after instillation and participant moved positions. Thereafter, tube opened and suction applied. Drain removed when < 40 ml/24hours drained (or on day 7 if ongoing high output) |
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| Outcomes | Treatment response at one month ('Complete response' (no re‐accumulation of the effusion); 'Partial response' (asymptomatic re‐accumulation of the effusion developed that was < 50% of its original volume); 'no response') Side effects Length of time chest tube in place following pleurodesis |
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| Notes | Bilateral disease included. Some participants randomised to the trial more than once People with trapped lung eligible for trial entry 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 | "Toss of coin" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding. Both drugs administered in 50 ml saline |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. No mention of whether CXR interpretation was performed by a blinded individual |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 11/34 (32%) participants non‐evaluable for pleurodesis outcome (3 in bleomycin group and 8 in tetracycline group) |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | High risk | Unclear whether participants who were given both agents because the first agent failed were included in the analysis |