Salomaa 1995.
| Methods | Single centre RCT of pleurodesis with doxycycline and C. parvum in MPE (Finland) | |
| Participants | Inclusion: pleural effusion refractory to repeat aspirations; pleural malignancy ‐ all cell types (histocytologically proven or confirmed malignancy elsewhere) Exclusion: none 41 participants randomised |
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| Interventions | 16 Fr Argyll drain inserted under local anaesthetic and drained with suction until output < 100 ml/day. CXR to confirm lung re‐expansion prior to pleurodesis D100 group: doxycycline 100 mg given intrapleurally. 1 dose D600 group: doxycycline 600 mg given intrapleurally. 1 dose C1 group: C. parvum 1 mg intrapleurally. 1 dose C7 group: C. parvum 7 mg intrapleurally. 1 dose All drugs diluted in 20 ml saline and a 50 ml flush was administered after the dose. Chest tube removed immediately after sclerosant given |
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| Outcomes | Pleurodesis success (defined using CXR and need for repeat thoracentesis at 30 days) Mortality Side effects Blood/pleural fluid IL‐6 Daily CRP for seven days |
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| Notes | For the purposes of our analysis, we have decided to combine the two doses of each agent to allow comparison between the agents themselves People with trapped lung excluded from study 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) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if anyone was blinded. Unable to contact study authors |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded. Unable to contact study authors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6/41 (15%) patients LTFU |
| Selective reporting (reporting bias) | High risk | Minimal data provided on survival or biochemical markers. Minimal data on baseline participant characteristics and whether the treatment groups were well matched |
| Other bias | Low risk | Underpowered |