Mejer 1977.
| Methods | Single centre RCT of mepacrine hydrochloride, triethylenethiophosphoramide and pleurocentesis alone in the treatment of MPE (Denmark) | |
| Participants | Inclusion: unilateral MPE (positive cytology, > 200 IU/L LDH and > 30 g/L protein) (all cell types); one previous pleurocentesis of > 500 ml Exclusion: participant receiving chemotherapy or radiotherapy 41 participants randomised |
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| Interventions | Pleurocenteis with intrapleural instillation of the study agent, three times a week for one week Mepacrine group: 100 mg for first dose, 200 mg for second dose, 200 mg for third dose (ie 500 mg in total) Triethylenethiophosphoromide group: 20 mg at each instillation (ie 60 mg total) Pleurocentesis group: 10 ml saline at each instillation All participants were followed up at 3 weeks, 6 weeks, 2 months and 3 months, when a pleurocentesis was performed |
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| Outcomes | Treatment effect (a beneficial effect was defined as < 500 ml fluid aspirated at each pleurocentesis performed up to three months) Side effects |
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| Notes | People with trapped lung not excluded from trial entry Minimal data presented on whether the treatment groups were well balanced at baseline Included in network meta‐analysis for pleurodesis efficacy, pain and fever |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given |
| Allocation concealment (selection bias) | Unclear risk | No details given |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding in the paper |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding in the paper |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Minimal early deaths (3/25) and numbers well matched between the groups |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | High risk | Unsure if groups well balanced at baseline. Pleurodesis success defined by aspirating fluid on all participants and not by clinical need for pleural intervention |