Agarwal 2011.
Methods | Single centre RCT comparing the efficacy of cosmetic talc with iodopovidone for pleurodesis (India) | |
Participants | Inclusion: recurrent symptomatic pleural effusion with improvement of breathlessness with thoracentesis; or primary or secondary pneumothorax Exclusion: allergy to iodine; thyroid disorder; trapped lung; air leak; advanced malignancy with expected survival < 30 days 36 participants randomised |
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Interventions | 28 Fr intercostal drain to completely drain effusion or treat pneumothorax. Pleurodesis agent given when < 150ml/day drainage and complete lung re‐expansion on chest x‐ray. All participants received intrapleural lignocaine (2 mg/kg) and IV tramadol prior to pleurodesis. Iodopovidone: 20 ml 10% iodopovidone in 80 ml saline Cosmetic talc: 5 g sterilised 'baby powder' After agent administered, chest tube clamped for four hours. Repeat administration of agent if > 250 ml/day drainage. Drain removed when < 100 ml/day output Followed up at 1 week, 1 month, 3 months and 6 months and then every 3 months thereafter |
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Outcomes | Pleurodesis success according to need for thoracentesis (complete success = relief of symptoms related to the effusion and no re‐accumulation on CXR at 30 days; partial success = reduced dyspnoea related to the effusion with only partial re‐accumulation of fluid on chest x‐ray and no requirement for therapeutic thoracentesis; failure = lack of success as defined above) Chest pain (measured by visual analogue scale score) Complications Time to pleurodesis |
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Notes | People with trapped lung excluded. Unpublished data obtained from authors relating to subgroup of participants in the study with malignant pleural effusion‐ only this data was included for the purposes of this review Included in network meta‐analysis for pleurodesis efficacy and fever. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "Blinding of the allocation to treatments was not possible". Agents have different appearances |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom recurrence, visucal analogue scale scores and complications would all be biased by lack of patient blinding. Mortality would not be effected by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow up. Intention‐to‐treat analysis performed |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | Low risk | Cosmetic talc used rather than medicinal talc, but sterilised and comparable particle size by electron microscopy. No external funding for the study |