Zaloznik 1983.
| Methods | RCT of tetracycline pleurodesis versus placebo of the same pH as tetracycline (USA) | |
| Participants | Inclusion: biopsy proven malignancy; recurrent pleural effusion; expected survival > 1 month; Karnofsky performance score ≥ 40% 30 participants randomised |
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| Interventions | Chest tube inserted and in place for at least 24 hours. After pleurodesis agent instilled, tube clamped for two hours and participant's position changed. Then left in place for 12 ‐ 24 hours until minimal drainage Tetracycline group: 500 mg tetracycline in 50 ml saline intrapleurally. 1 dose Control group: 0.6 ml multivitamins, 5 ml of 0.1 N HCl and 50 ml saline intrapleurally. 1 dose |
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| Outcomes | Reaccumulation of effusion on CXR at 1 month and 3 months (CR/PR/Stabilisation/progression) Side effects |
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| Notes | CR, PR & stable disease counted as pleurodesis success for purposes of analysis Some participants with bilateral effusions entered into the study, but not clear whether both sides were randomised. Therefore for purposes of analysis, only the first side has been included Included in network meta‐analysis for pleurodesis efficacy |
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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 | Low risk | "Double‐Blind" (no further details given) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Double‐Blind" (no further details given) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Time point at which primary outcome measured not clear. Minimal data on baseline participant characteristics. Participants who died within one month excluded from analysis (11/30 not evaluable) |
| Selective reporting (reporting bias) | Low risk | All outcomes reported on |
| Other bias | Low risk | No other biases identified |