Table 1.
Characteristics of the randomized controlled trials included in the network
| Study [reference] | Condition | Study groups, intervention parameters, patients randomized |
Duration
(weeks) |
Mean age
(years) |
Women
(%) |
|---|---|---|---|---|---|
| Bar‐Meir et al., 1998 34 | CD | Budesonide 9 mg day–1 (n = 100) | 8 | 32.8 | 48.3 |
| Prednisone 40 mg day–1 tapered gradually to 5 mg day–1 (n = 101) | |||||
| Campieri et al., 1997 35 | CD |
Budesonide 9 mg day–1 tapered to 6 mg day–1 after 8 weeks, and to 3 mg day–1 after a further 2 weeks (n = 119) |
12 | 36.7 | 59.3 |
|
Prednisolone 40 mg day–1 tapered to 30 mg day–1 after 2 weeks, and then continuously throughout the study, reaching 5 mg day–1 after 9 weeks (n = 58) | |||||
| Cortot et al., 2001 36 | CD | Budesonide 6 mg day–1 (n = 60) | 13 | 33.5 | 59.0 |
| Placebo (n = 60) | |||||
| Ewe et al., 1999 37 | CD | Budesonide 3 mg day–1 (n = 43) | 52 | 34.0 | 55.4 |
| Placebo (n = 40) | |||||
| Ferguson et al., 1998 38 | CD | Budesonide 6 mg day–1, or 3 mg day–1 (n = 48) | 52 | 35.9 | 54.7 |
| Placebo (n = 27) | |||||
| Greenberg et al., 1996 39 | CD | Budesonide 6 mg day–1, or 3 mg day–1 (n = 69) | 52 | 35.6 | 60.0 |
| Placebo (n = 36) | |||||
| Greenberg et al., 1994 40 | CD | Budesonide 15 mg day–1, 9 mg day–1, or 3 mg day–1 (n = 192) | 8 | NR | 62.4 |
| Placebo (n = 66) | |||||
| Gross et al., 1998 41 | CD | Budesonide 3 mg day–1 (n = 84) | 52 | 32.0 | 59.2 |
| Placebo (n = 95) | |||||
| Gross et al., 1996 42 | CD | Budesonide 9 mg day–1 (n = 34) | 8 | 31.0 | 58.2 |
| M‐Prednisolone 48 mg day–1 tapered gradually to 8 mg day–1 (n = 33) | |||||
| Hanauer et al., 2005 43 | CD | Budesonide 6 mg day–1 (n = 55) | 52 | 40.4 | 62.7 |
| Placebo (n = 55) | |||||
| Hellers et al., 1999 44 | CD | Budesonide 6 mg day–1 (n = 63) | 52 | 35.0 | 51.9 |
| Placebo (n = 67) | |||||
| Löfberg, Danielsson et al., 1996 45 | UC | Budesonide 10 mg day–1 tapered gradually to 4 mg day–1 (n = 34) | 9 | 33.5 | 41.7 |
| Prednisolone 40 mg day–1 tapered gradually to 5 mg day–1 (n = 38) | |||||
| Löfberg, Rutgeerts et al., 1996 46 | CD | Budesonide 6 mg day–1, or 3 mg day–1 (n = 63) | 52 | 35.0 | 60.0 |
| Placebo (n = 27) | |||||
| Malchow et al., 1984 (ECCDS) 47 | CD |
M‐Prednisolone 48 mg day–1 tapered gradually to 12 mg day–1 (active disease), or 8 mg day–1 (quiescent disease) (n = 113) |
104 | 29.9 | 54.7 |
| Placebo (n = 110) | |||||
| Malchow et al., 1984 (ECCDS) 47 | CD |
M‐Prednisolone 48 mg day–1 tapered gradually to 12 mg day–1 (active disease), or 8 mg day–1 (quiescent disease) + sulfasalazine 3 g day–1 (n = 112) |
104 | 30.9 | 54.6 |
| Placebo + sulfasalazine 3 g day–1 (n = 117) | |||||
| Prantera et al., 2011 48 | CD |
Beclomethasone dipropionate 15 mg day–1 for 2 weeks, and then 10 mg day–1 for 22 weeks (n = 37) |
24 | 42.4 | 53.4 |
| Placebo (n = 36) | |||||
| Rizzello et al., 2002 49 | UC | Beclomethasone dipropionate 5 mg day–1 +5‐ASA 3.2 g day–1 (n = 58) | 4 | 43.9 | 29.4 |
| Placebo +5‐ASA 3.2 g day–1 (n = 61) | |||||
| Rutgeerts et al., 1994 50 | CD | Budesonide 9 mg day–1 for 8 weeks, and then 6 mg day–1 for 2 weeks (n = 88) | 10 | 35.5 | 61.9 |
|
Prednisolone 40 mg day–1 for 2 weeks, then gradually reduced to 5 mg day–1 (n = 88) | |||||
| Sandborn et al., 2012 (CORE I) 51 | UC | Budesonide MMX 9 mg day–1, or 6 mg day–1 (n = 255) | 8 | 42.2 | 44.1 |
| Placebo (n = 128) | |||||
| Schoon et al., 2005 52 | CD | Budesonide 9 mg day–1; dose could be adjusted by clinicians (n = 138) | 104 | 36.9 | 51.3 |
| Prednisolone 40 mg day–1; dose could be adjusted by clinicians (n = 134) | |||||
|
Singleton et al., 1979
(NCCDS: part I, phase 1) 53 |
CD |
Prednisone 0.25–0.75 mg kg–1 daily; maximum daily dose was 60 mg (n = 85) |
17 | 32.7 | 50.6 |
| Placebo (n = 77) | |||||
|
Singleton et al., 1979
(NCCDS: part II) 53 |
CD |
Prednisone 0.25 mg kg–1 daily; maximum daily dose was 20 mg (n = 61) |
104 | 32.0 | 47.5 |
| Placebo (n = 101) | |||||
| Suzuki et al., 2013 54 | CD | Budesonide 15 mg day–1, or 9 mg day–1 (n = 51) | 8 | 36.5 | 28.6 |
| Placebo (n = 26) | |||||
| Travis et al., 2014 (CORE II) 55 | UC | Budesonide MMX 9 mg day–1, or 6 mg day–1 (n = 254) | 8 | 38.0 | 45.2 |
| Budesonide 9 mg day–1 (n = 126) | |||||
| Placebo (n = 128) | |||||
| Tremaine et al., 2002 56 | CD | Budesonide 9 mg day–1 (n = 159) | 8 | 39.4 | 64.0 |
| Placebo (n = 41) | |||||
| Tursi et al., 2006 57 | CD | Budesonide 9 mg day–1 (n = 15) | 8 | 33.4 | 56.7 |
| Beclomethasone dipropionate 10 mg day–1 (n = 15) | |||||
| Van Assche et al., 2015 58 | UC |
Beclomethasone dipropionate 5 mg day–1 for 4 weeks, followed by 5 mg every other day for the further 4 weeks (n = 137) |
8 | NR | 40.4 |
|
Prednisone 40 mg day–1 for 2 weeks, tapered of 10 mg every 2 weeks during the 8‐week study period (n = 145) | |||||
| Rubin et al., 2017 59 | UC | Budesonide MMX 9 mg day–1 as add‐on to existing 5‐ASA therapy (n = 255) | 8 | 44.5 | 46.0 |
| Placebo as add‐on to existing 5‐ASA therapy (n = 255) | |||||
| BUC‐16/CDA 60 | CD | Budesonide 18 mg day–1, 9 mg day–1, or 3 mg day–1, followed by a dose reduction period of 2 weeks (n = 307) | 10 | NR | NR |
| Placebo (n = 102) | |||||
| CB‐01‐02/05 & CRO‐03‐53‐period 1 61 | UC | Budesonide MMX 9 mg day–1, or 3 mg day–1 (n = 50) | 4–8 | NR | NR |
| Placebo (n = 35) | |||||
| CB‐01‐02/04 61 | UC | Budesonide MMX 6 mg day–1 (n = 62) | 52 | NR | NR |
| Placebo (n = 60) |
CD, Crohn's disease; UC, ulcerative colitis