Table 1 Comparison of included studies in this meta-analysis.
Hazebroek et al.13 | Wojnicz et al.15 | Frustaci et al.16 | Schultheiss et al.17 | Parrillo et al.18 | Poloczkova et al.14 | Mason et al.19 | |
|---|---|---|---|---|---|---|---|
Design | |||||||
Major inclusion criteria | LVEF < 45%, idiopathic chronic DCM | Chronic HF due to DCM: dyspnea and/or fatigue at rest or exertion, > 6 months, EF ≤ 40% | Dilatation and left ventricular dysfunction (LVEF < 45%), age 18–75, chronic HF (> 6 months) unresponsive to conventional therapy, histologic/immunohistochemical evidence of active lymphocytic MYO, absence of PCR evident cardiotropic viruses, No congenital/valcular/CAD | Chronic viral CMP, Chronic HF symptoms/left ventricular dysfunction > 6 months despite OMT (dyspnea, fatigue, impaired exercise capacity, peripheral edema), age 18–75 | LVEF < 35%, Symptoms of CHF due to DCM with exclusion of coronary, hypertensive, valvular, congenital or toxic causes | LV systolic dysfunction (LVEF ≤ 40%), age 18–65, Duration of symptoms; CZECH-ICIT1; 2 weeks – 6 months, CZECH-ICIT2; more than 6 months, HF Symptoms NYHA II-IV with biopsy confirmed myocardial inflammation | Histologic evidence of Myocardial inflammation, LVEF < 45% |
Disease | Chronic DCM | Chronic MYO, inflammatory dilated CMP | Inflammatory CMP | Chronic CMP | DCM | Inflammatory CMP | MYO |
Presence of inflammation/viral presence | Inflammation + , Virus + | Inflammation + , Virus - | Inflammation + , Virus - | Inflammation + , Virus + | – | Inflammation + , Virus – (low PVB19 load allowed) | Inflammation + , Virus: not evaluated |
Intervention | IVIG | Prednisone + Azathioprine | Prednisone + Azathioprine | Interferon- ß-1b | Prednisone | Prednisone + Azathioprine | Azathioprine or Cyclosporine + Prednisone |
Intervention dosing rules | IVIG 2 g/kg | Prednisone Starting dose: 1 mg/kg/d. Maintenance: 0.2 mg/kg/d for 90 days Azathioprine 1 mg/kg/d for 100 days | Prednisone 1 mg/kg/d for 4 weeks, followed by 0.33mg/kg/d for 5 months Azathioprine 2 mg/kg/d for 6 months | (A): 2 MIU IFN- ß -1b in week 1, 4 MIU IFN- ß -1b week 2 to 24, every other day. (B): 2 MIU IFN- ß -1b in week 1, 4 MIU IFN- ß -1b week 2–3, 8 MIU IFN- ß -1b week 4–24, every other day | Oral Prednisone, 60 mg/d for 3 months | (A) Prednisone (90 d) 1 mg/kg/d for 12 days, every 5 days reduced to 0.2 mg/kg/d, Azathioprine 1 mg/kg/d (100 d) (B) Prednisone 1 mg/kg/d for 4 weeks then 0.33 mg/kg/d for 5 months, Azathioprine 2 mg/kg/d for 6 months | (A) bd 1 mg/kg Azathioprine for 24, Prednisone 1.25 mg/kg/d for 1 week, decreased by 0.08 mg/kg/week until 0.33 mg/kg/d at week 12 to week 20, then tapered off until week 24. (B) bd oral cyclosporine 5 mg/kg to achieve concentration of 200–300 ng/ml at week 1, then tapered off to 100–200 ng/ml at week 2 to 4. 60–150 ng/ml until week 24. Prednisone 1.25 mg/kg/d for 1 week, decreased to 0.15 mg/kg/d at week 23, halved to week 24 |
Centres | Single-centre | Two-centre | Single-centre | – | – | Multi-centre | Multi-centre |
Randomization | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Comparator | Placebo | Placebo | Placebo | Placebo | OMT | OMT | OMT |
Blinding | Double-blind | Open-label | Double-blind | Double-blind | Open-label | Open-label | Open-label |
Treatment time | 4 days | Prednisone 90 days, Azathioprine 100 days | 6 months | 6 months | 3 months | First arm: Prednisone for 90 days, Azathioprine for 100 days. Second arm: Prednisone + Azathioprine for 6 months | 6 months |
Follow-up (assessments) | 2 weeks, 3 months, 6 months | 3 months, 6 months, 12 months, 24 months | 6 months | 6 months | 3 months, 9 months, 15 months | 1 month, 3 months, 6 months, 12 months | 12 weeks, 28 weeks, 52 weeks |
Power analysis | Yes | No | Yes | No | Yes | No | Yes |
Endpoints: parameters | |||||||
LVEF | + | + | + | – | + | + | + |
NYHA | – | + | – | + | + | + | – |
