Gaafar 2014.
| Methods | Single centre, prospective RCT comparing intrapleural administration of mistletoe preparation (viscum fraxini‐2) with bleomycin in patients with MPE (Egypt) | |
| Participants | Inclusion: histologically confirmed, recurrent, symptomatic MPE (all cell types); > 18 years old; ECOG performance score ≤ 2; adequate bone marrow, liver and kidney function; written consent; ability to comply with the follow up Exclusion: chronic air leak; known hypersensitivity to mistletoe; uncorrectable bleeding tendency; encysted pleural effusion; pregnancy/breastfeeding; currently active second malignancy; co‐enrolment in another clinical trial; previous unsuccessful pleurodesis; pleural infection 23 participants randomised |
|
| Interventions | Participants underwent effusion drainage using a chest tube or needle drainage (depending on effusion size). Agent injected through the needle or chest tube viscum group: 5 ampoules in 10 ml 5% glucose instilled intrapleurally Bleomycin group: 60 units delivered intrapleurally |
|
| Outcomes | Pleurodesis efficacy (assessed at six weeks) Toxicity (measured using NCI common terminology for adverse events) |
|
| Notes | People with trapped lung not excluded from participation Pleurodesis defined using radiology and symptomatic effusion recurrence Included in network meta‐analysis for pleurodesis efficacy. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised". No other details given and no response from study authors |
| Allocation concealment (selection bias) | Unclear risk | "randomised". No other details given and no response from study authors |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated explicitly but drugs were of different formulations |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if outcome assessment was blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Two patients in viscum arm excluded from analysis as treatment was discontinued due to an allergic reaction |
| Selective reporting (reporting bias) | Low risk | Data available although minimal data on side effects |
| Other bias | Low risk | No other risks of bias identified |