Patz 1998.
| Methods | Prospective RCT of bleomycin vs doxycycline in MPE (USA) | |
| Participants | Inclusion: symptomatic effusion; proven or strongly suspected that malignancy is the cause for the effusion Exclusion: previous pleurodesis; allergy to bleomycin or doxycycline; chemotherapy in the previous 30 days 106 participants randomised |
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| Interventions | All participants underwent a 14 Fr chest drain insertion. When drainage < 200 ml/day and lung fully re‐expanded on CXR, participant randomised Bleomycin group: 60 units bleomycin in 50 ml saline intrapleurally Doxycycline group: 500 mg doxycycline in 50 ml saline + 10 ml lignocaine After 18 ‐ 24 hours, if drainage < 200 ml, drain removed. If > 200 ml, second dose of the same agent given and drain then removed |
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| Outcomes | Radiographic response at 30 days (classified as: complete response, partial response, progressive disease, expired with no re‐accumulation, expired with re‐accumulation, lost to follow up) Mortality Side effects |
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| Notes | Trapped lung not accounted for If participants died prior to day 30, included in analysis according to their outcome at the time of their death For this review, complete response, partial response and expired with no re‐accumulation counted as pleurodesis success Included in network meta‐analysis for pleurodesis efficacy, mortality, fever and pain |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Computer‐generated randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Study investigators and participants not blinded to treatment allocation" (personal communication with study authors) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "Study investigators and participants not blinded to treatment allocation" (personal communication with authors) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Significant LTFU rate (26/106 (ie 25%)) |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | Radiological outcome on CXR used to define pleurodesis success |