Fentiman 1986.
| Methods | Single centre RCT of intrapleural talc and tetracycline in MPE secondary to breast cancer (UK) | |
| Participants | Inclusion criteria: histologically confirmed breast cancer and a symptomatic pleural effusion on radiology Exclusion criteria: previous treatment for effusion, other than simple needle aspiration; non‐malignant cause for effusion; unsuitable for general anaesthetic; history of sensitivity to tetracycline 41 participants randomised |
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| Interventions | Talc group: thoracoscopy, talc insufflated (dose not stated). Intercostal drain remained in situ for five days Tetracycline group: thoracoscopy. Tetracycline 500 mg in 40 ml N saline inserted 16 ‐ 24 hours later via chest tube. Intercostal drain left in place for 3 ‐ 5 days |
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| Outcomes | Pleurodesis success (defined by lack of re‐accumulation on CXR); complications; mortality | |
| Notes | Pleurodesis success defined according to CXR only Participants with trapped lung eligible for trial entry Included in network meta‐analysis of pleurodesis efficacy and mortality. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised with stratification for metastatic disease" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind patients or personnel due to the nature of the procedures |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated whether radiographic interpretation of CXRs were performed by a blinded person. Reporting of complications could be biased by lack of participant and personnel blinding |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Participants were excluded from the primary analysis if they died within the first month. Higher proportion of deaths in the talc group (6/18 = 33%) compared to the tetracycline group (2/23 = 9%) |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | No other biases identified |