McNamara 2001.
| Study characteristics | ||
| Methods | Randomised, placebo‐controlled, double‐blind trial; block randomisation was stratified by clinical centre; intention‐to‐treat analysis was not performed | |
| Participants | 62 adults (mean age 43.0, SD 12.3 years; 37 men; 4 participants met the Dallas criteria for acute myocarditis); participants had recent onset (≤ 6 months of symptoms) of dilated cardiomyopathy and LVEF ≤ 0.40. Exclusion criteria: coronary artery disease, significant valvular disease, significant diabetes mellitus, significant hypertension, uncorrected thyroid disease, giant cell myocarditis, sarcoid, haemochromatosis | |
| Interventions | Treatment: 2 g/kg IVIG (Gamimune N, 10%, Bayer Corporation); administered at 1 g/kg IV each day on 2 consecutive days Control: 0.1% albumin in 10% maltose solution given in equivalent volume (10 mL/kg IV) each day on 2 consecutive days | |
| Outcomes | Primary endpoint: change in LVEF from baseline to 6 months and 12 months; secondary endpoints: event‐free survival (events defined as death, cardiac transplantation, or placement of an LVAD) and functional capacity as assessed by metabolic stress testing at 12 months | |
| Notes | Funding: educational grant from the Bayer Corporation Language of publication: English | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Blocked randomisation was stratified by clinical centre, but no further details were provided on how the randomisation schedule was created. |
| Allocation concealment (selection bias) | Unclear risk | "Double‐blinding" is mentioned but not explained. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | It is not clear how those who assessed outcomes were blinded. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Double‐blinding" is mentioned but is not explained. It is not clear if the placebo appeared identical to IVIG. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcome data are complete for the primary outcome but incomplete for measurements of functional capacity, with no explanation provided for missing data. |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
IV: intravenous
IVIG: intravenous immunoglobulin
LVAD: left ventricular assist device
LVEF: left ventricular ejection fraction
LVEDD: left ventricular end‐diastolic diameter
LVSF: left ventricular shortening fraction
SD: standard deviation