Rafiei 2014.
Methods | Single centre RCT comparing the pleurodesis success of doxycycline and bleomycin in MPE (Iran) | |
Participants | Inclusion: symptomatic, cytologically proven MPE Exclusion: allergy to doxycycline or bleomycin; past history of sclerotherapy; systemic chemotherapy immediately prior to or in the next two months after sclerotherapy 42 participants randomised |
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Interventions | All participants underwent 'fluid evacuation'. Agent then instilled through the tube, which was clamped for one hour. Then suction applied and drain removed when < 100 ml/24 hr drainage Bleomycin group: 45 mg bleomycin intrapleurally Doxycyclline group: 600 mg doxycycline in 50 ml saline and 10 ml 1% lignocaine intrapleurally |
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Outcomes | CXR appearances of the effusion size at two months (mild, moderate or severe) Need for repeat pleural fluid drainage Dyspnoea (mild, moderate or severe) Complications |
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Notes | People with trapped lung not excluded Pleurodesis success primarily defined radiologically, but data presented at three months for need for repeat pleural intervention For this review, need for repeat pleural drainage was used as measure of pleurodesis success 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 and no response from study authors to clarify |
Allocation concealment (selection bias) | Unclear risk | Not stated and no response from study authors to clarify |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if anyone was blinded. No response from study authors |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded. No response from study authors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow up |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |