Table 4.
Trials for immunosuppressive treatment in myocarditis [modified from Maisch and Pankuweit (9) with permission from Springer-Nature].
| References | Treatment | No pts/Controls | Treated pts improved | Treated pts Unch/deter. | Controls improved | Controls unch/deter. | Endpoint/Comments | ||
|---|---|---|---|---|---|---|---|---|---|
| A. OBSERVATIONAL STUDIES AND SMALL TRIALS WITH IMMUNOSUPPRESSION | |||||||||
| Fenoglio et al. (75) | P, A & P | 18/4 | 7 (39%) | 11 (61%) | 2 (50%) | 2 (50%) | EF/observational, no PCR | ||
| Hosenpud et al. (76) | A & P | 6/0 | 0 (0%) | 6 (100%) | EF/No co, no PCR, no co biopsy | ||||
| Anderson et al. (77) | A & P | 10/7 | 3 (30%) | 7 (70%) | 2 (28,5%) | 5 (71,5%) | Prospective, open label, randomized | ||
| Marboe and Fenoglio (78) | P, A & P | 16/18 | 9 (56%) | 7 (44%) | 7 (39%) | 11 (61%) | P, A & P mixed | ||
| Latham et al., (79) | P | 26/26 | Majority | Minority | nd | nd | EF/No viral PCR, no biopsy | ||
| Maisch et al. (80) | A & P | 21/21 all virus negative | 10 (47%) | 11 (53%) | 3 (14%) | 18 (86%) | EF (6 mo)/RCT pilot | ||
| Kühl et al. (81) | P | 31/0 | 20 (54%) | 11 (46%) | nd | nd | EF; observational/ No co EMB | ||
| Camargo et al. (82) | P | 68/0 | Majority | Minority | nd | nd | EF/observational, No viral PCR | ||
| Liu Dezue et al. (83) | D | 128/0 | Favorable, but no data | nd | nd | nd | Observational/No EMB, CM | ||
| Sun (84) | D | 32/0 | Majority | Minority | nd | nd | EF/observational, EKG only, no PCR, CM | ||
| Wu and Chen (85) | D & P | 31/0 | Majority | Minority | nd | nd | Observational/ No EMB, CM | ||
| Frustaci et al. (86) | A & P | 41/0 | 21 (51%) | 20 (49%) | nd | nd | EF/RCT, virus negative pts improved | ||
| Escher et al. (87) | A & P | 114 | Majority | Minority | nd | nd | EF 6 mo/observational, no co biopsy | ||
| References | No pts/Co | Treatment | Endpoints | Treated pts improved | Treated pts Unch/deter. | Controls improved | Controls unch/deter. | Comments | |
| B. DOUBLE BLIND, RANDOMIZED, AND CONTROLLED TREATMENT TRIALS (RCT) WITH IMMUNOSUPPRESSIVE DRUGS IN MYOCARDITIS | |||||||||
| Parillo et al. (88) | 51 /51 | P vs. Pl | EF after 3 mo, mortality | 53% No difference |
47% No difference | 27% No difference |
73% No difference |
RCT, no PCR |
|
| Mason et al. (89) MTT | 64/47 | A/C & P vs. Pl |
EF/function +Mortality |
No difference No difference |
No difference No difference | No difference No difference |
No difference No difference |
RCT, no PCR (90) | |
| Wojnicz et al. (91) | 41/43 | A & P vs. Pl |
EF/function | In majority | In minority | Minority with spontaneous improvement | Majority | No PCR, HLA as criterium of inflammation | |
| Cooper et al. (74), Maisch et al. (69, 70) | 11/? | Cyclo+P vs. Pl |
Mortality 12 mo | Improved | nd | nd | nd | RCT, stopped for lack of pts | |
| Frustaci et al. (92) TIMIC |
43/42 | A & P vs. Pl |
EF (6 mo) Mortality |
88,3 nd |
11,7 nd |
0 nd |
100 nd |
WHF, RCT, virus negative pts only | |
| Maisch et al. (93) ESETCID | 54/47 | Tx arms with A& P vs. Pl |
EF/function MACE |
EF+MACE improved after 6 month |
Some spontaneous improvement | WHF, RCT, intermediate results | |||
A, Azathioprin; co, controls; CM, Chinese medicine; Cyclo, Cyclosporine; D, Dexamethason; DC, dilated cardiomyopathy; deter, deteriorated; EF, Ejection fraction; EMB, endomyocardial biopsy; mo, months; nd, no data; P, prednisone; Pl, placebo; PCR, polymerase chain reaction for viral RNA and DNA in EMB; pts, patients; RCT, randomized controlled trial; unch, unchanged; WHF, quantitative World Heart Federation biopsy criteria.