Galetta 2005.
Study characteristics | ||
Methods | Method of randomisation not clear. | |
Participants | 20 participants (median age 54 years (all < 60 years); 11 males and 9 females) with non‐Hodgkin lymphoma (stage 2, 3 or 4) treated with epirubicin (cumulative dose nm; peak dose (i.e. maximal dose received in 1 week) 40 mg/m2; bolus infusion), cyclophosphamide, etoposide, prednisolone, vincristine, methotrexate, aracytin and bleomycin. No prior anthracyclines. No prior cardiac radiotherapy. No prior cardiac dysfunction (defined as uncontrolled congestive heart failure; baseline resting LVEF < 50%). | |
Interventions | Dexrazoxane (10:1 ratio of dexrazoxane to epirubicin; IV infusion over 15 minutes immediately after epirubicin) (n = 10) versus no cardioprotective intervention (n = 10) | |
Outcomes | The primary objective of this study was to assess QT‐dispersion on ECG, not to assess heart failure. Data on subclinical myocardial dysfunction were available, but not on clinical heart failure; results were thus not eligible for the review. | |
Notes | Length of follow‐up nm. Age in intervention and control group nm. Cumulative anthracycline dose per treatment group nm. Gender in intervention and control group nm. Stage of disease per treatment group nm. Funding sources nm. Declaration of interests nm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was stated that this was a randomised study, but no further information on the method of randomisation was provided. |
Allocation concealment (selection bias) | Unclear risk | It was stated that this was a randomised study, but no further information on the method of randomisation was provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to the received intervention (either dexrazoxane or no cardioprotective intervention). |
Selective reporting (reporting bias) | High risk | Not all expected outcomes were reported (e.g. overall survival was missing; subclinical myocardial dysfunction was reported but was not eligible for inclusion in the review) |
Other bias | Unclear risk |
Block randomisation in unblinded trials: unclear (information on both method of randomisation and blinding of outcome assessors not provided). Baseline imbalance between treatment groups related to outcome (prior cardiotoxic treatment (anthracyclines and cardiac irradiation), age, gender, stage of disease and prior cardiac dysfunction): unclear (no prior cardiotoxic treatment and no prior cardiac dysfunction, but age, gender, stage of disease not reported) Difference in length of follow‐up between treatment groups: unclear (length of follow‐up nm) |