Table 1. Characteristics of the included studies.
| Author (year) | Country | No. of patients | Mean age | Patients | Interventions | Concomitant therapy |
|---|---|---|---|---|---|---|
| Sandborn (2015) | USA | 134/147 | 44.3/41.9 | mild to severe UP or UPS | budesonide foam 4 mg/day for 2 weeks, then 2 mg/day for 4 weeks vs placebo | 5-ASA |
| Sandborn (2015*) | USA | 133/132 | 43.2/41.4 | mild to moderate UP or UPS | budesonide foam 4 mg/day for 2 weeks, then 2 mg/day for 4 weeks vs placebo | 5-ASA |
| Crispino (2015) | Italy | 40/40/40 | 52/54/53 | mild to moderately active distal UC | 5-ASA 4 g/day vs BDP 3 mg/day vs 5-ASA 1.5 g + BDP 3 mg/day enema | 5-ASA |
| Kobayashi (2014) | Japan | 64/61 | — | mild to moderately active distal UC | 5-ASA suppository 1 g vs placebo | 5-ASA |
| Watanabe (2013) | Japan | 65/64 | 41.9/41.3 | mild to moderate UP | 5-ASA suppository 1 g vs placebo | 5-ASA or sulfasalazine |
| Hartmann (2010) | Germany | 118/119 | 41.8/43.6 | mild to moderate left-sided UC | budesonide enema 2 mg/day vs 5-ASA enema 4 g/day | 5-ASA |
| Andus (2010) | Multicenter | 200/203 | 41.4/42.7 | mild to moderately active UP | 5-ASA suppository 1 g/day vs 5-ASA suppository 1.5 g/day | No |
| Biancone (2007) | Italy | 50/42 | — | mild to moderate distal UC | BDP enema 3 mg/day vs 5-ASA enema 2 g/day | 5-ASA or sulfasalazine |
| Gionchetti (2005) | Italy | 111/106 | 42/41 | mild to moderate active left-sided UC UP, and UPS | BDP enema 3 mg/day vs 5-ASA enema 1 g/day | 5-ASA or sulfasalazine |
| Hammond (2004) | Germany | 22/16 | 43.1/42.4 | active distal UC | budesonide foam 2 mg/day vs betamethasone(BMT) enema 5 mg bid for the first 2 weeks and OD for the next fortnight | 5-ASA or sulfasalazine |
| Bar-Meir (2003) | Multicenter | 120/128 | 42/42 | active UP or UPS | budesonide foam 2 mg/day vs hydrocortisone acetate foam100 mg/day | 5-ASA |
| Malchow (2002) | Multicenter | 111/118 | — | active distal UC | 5-ASA foam 2 g/day vs 5-ASA enema 4 g/day | 5-ASA or sulfasalazine |
| Lindgren (2002) | Sweden | 73/76 | — | active distal UC or UP | budesonide enema 2 mg/day vs budesonide enema 4 mg/day | No |
| Pokrotnieks(2000) | Multicenter | 54/57 | 44.1/45.4 | mildly to moderately active UP, UPS, or left-sided UC | 5-ASA foam 2 g/day vs placebo | 5-ASA, olsalazine, or sulfasalazine |
| Franzè (1999) | Italy | 30/29 | — | active distal UC | BDP enema 3 mg/day vs 5-ASA enema 4 g/day | — |
| Hanauer (1998) | USA | 60/57/56/60 | 43/39/42/40 | active distal UC | placebo enema vs budesonide 0.5, 2, or 8 mg enema | 5-ASA |
| Hanauer (1998*) | USA | 73/71/73/70 | 40.7/42.4/37.7/39.5 | active distal UC | 5-ASA enema 1, 2, or 4 g/day vs placebo | 5-ASA |
| Campieri (1998) | Italy | 80/77 | 41.2/42.2 | active distal UC | BDP enema 3 mg/day vs prednisolone enema 30 mg/day | 5-ASA or sulfasalazine |
| Mulder (1996) | Netherlands | 19/20/21 | 36.3/39.8/42.95 | active UP or UPS | BDP 3 mg + 5-ASA 2 g enema vs BDP 3 mg enema vs 5-ASA 2 g enema | 5-ASA or sulfasalazine |
| Lee (1996) | UK | 149/146 | 44/45 | active distal UC | 5-ASA foam 2 g/day vs prednisolone foam 20 mg/day | 5-ASA or sulfasalazine |
| Lemann (1995) | Multicenter | 48/49 | 39/38 | active distal UC or UP | budesonide enema 2 mg/day vs 5-ASA enema 1 g/day | 5-ASA |
| Lofberg (1994) | Multicenter | 45/55 | 41/38 | active distal UC | budesonide enema 2 mg/day vs prednisolone enema 25 mg/day | 5-ASA, olsalazine, or sulfasalazine |
| Porro (1994) | Italy | 44/44 | 42.6/43.3 | active distal UC or UPS | budesonide enema 2.0 mg/day vs prednisolone enema 20 mg/day | 5-ASA or sulfasalazine |
| Farup (1994) | Norwegian | 41/38 | 40/39 | active UP and UPS | 5-ASA suppositories 1 g/day vs hydrocortisone foam 356 mg/day | 5-ASA or sulfasalazine |
| Campieri (1991) | Italy | 27/30/29/27 | 36/42/37/40 | mild to moderate distal UC | 5-ASA enema 1, 2, or 4 g/day vs placebo | sulphasalazine |
| Campieri (1990) | Italy | 32/30 | 37/34 | mild to moderate distal UC | 5-ASA suppositories 1.5 g/day vs placebo | sulphasalazine |
| Campieri (1990*) | Italy | 32/31/31 | 42.1/37.1/41.2 | mild to moderate UP or UPS | 5-ASA suppositories 1 g/day vs 5-ASA suppositories 1.5 g/day vs placebo | 5-ASA or sulfasalazine |
| Danielsson (1987) | Sweden | 31/33 | — | active distal UC | budesonide 2 mg enema vs prednisolone 25 mg enema | 5-ASA or sulfasalazine |
| Williams (1987) | Canada | 13/11 | 37.3/42.7 | active UP | 5-ASA suppositories 1.5 g/day vs placebo | sulfasalazine or prednisone |
| Sutherland (1987) | Canada | 29/30 | 40/36 | active distal UC | 5-ASA enema 4 g/day vs placebo | sulfasalazine or prednisone |
| Sutherland(1987*) | Multicenter | 76/77 | 40/38 | active distal UC | 5-ASA enema 4 g/day vs placebo | sulfasalazine or prednisone |
| Binder (1987) | Denmark | 53/61 | 36/40.1 | mild to moderate UP or UPS | 5-ASA enema 1 g/day vs prednisolone enema 25 mg/day | sulphasalazine |
| Campieri (1981) | Italy | 44/42 | 40/37 | mild to moderate distal UC | 5-ASA enema 4 g/day vs hydrocortisone enema 100 mg/day | sulphasalazine |
| Jones (1971) | UK | 51/54 | 41.5/41 | active UP or left-sided UC | betamethasone enema 5 mg/day vs prednisolone enema 20 mg/day | sulphasalazine |
| Author (year) | Primary end points | Secondary end points | Evaluated method for clinical remission | Evaluated method for endoscopic remission | Evaluated method for histological remission | Duration (weeks) |
| Sandborn (2015) | clinical remission; endoscopic remission | AEs | Modified Mayo Disease | Mayo endoscopic subscore | — | 6 |
| Sandborn (2015*) | clinical remission; endoscopic remission | AEs | Modified Mayo Disease Activity Index score | Mayo endoscopic subscore | — | 6 |
| Crispino (2015) | clinical remission; endoscopic remission | AEs | Rachmilewitz Index | Baron et al. criteria | Truelove and Richards criteria | 8 |
| Kobayashi (2014) | endoscopic remission | AEs | — | Mayo endoscopic subscore | — | 4 |
| Watanabe (2013) | clinical remission; endoscopic remission | AEs | Sutherland Index | — | — | 4 |
| Hartmann (2010) | clinical remission; endoscopic remission | histopathological remission; AEs | Rachmilewitz Index | Löfberg Score | Floren | 4 |
| Andus (2010) | clinical remission; endoscopic remission | histopathological remission; AEs | Sutherland Index | Rachmilewitz Endoscopic Index | Riley et al. | 6 |
| Biancone (2007) | clinical remission | AEs | Rachmilewitz Index | — | — | 8 |
| Gionchetti (2005) | clinical remission | — | Schroeder Score or Mayo Score | Baron’s criteria | — | 6 |
| Hammond (2004) | clinical remission | AEs | Rachmilewitz Index | Rachmilewitz Endoscopic Index | Floren | 4 |
| Bar-Meir (2003) | clinical remission | AEs | Sutherland Index | Baron’s criteria | Floren | 8 |
| Malchow (2002) | clinical remission; endoscopic remission | AEs | Rachmilewitz Index | Rachmilewitz Endoscopic Index | — | 4 |
| Lindgren (2002) | clinical remission | AEs | — | Floren | 8 | |
| Pokrotnieks(2000) | clinical remission; endoscopic remission | AEs | Rachmilewitz Index | Rachmilewitz Endoscopic Index | Floren | 6 |
| Franzè (1999) | clinical remission | — | — | — | — | 4 |
| Hanauer (1998) | clinical remission; endoscopic remission | AEs | Sutherland Index | Löfberg Score | Truelove and Richards criteria | 6 |
| Hanauer (1998*) | clinical remission; endoscopic remission | histopathological remission; AEs | PGA scores | The Siginoidoscopic Index | Truelove and Richards criteria | 8 |
| Campieri (1998) | clinical remission; endoscopic remission | AEs | — | Baron’s criteria | Truelove and Richards criteria | 4 |
| Mulder (1996) | endoscopical remission | AEs | Rachmilewitz Index | Löfberg Score | Truelove and Richards criteria | 4 |
| Lee (1996) | clinical remission; endoscopic remission | histopathological remission; AEs | Sutherland Index | Sutherland Index subscore | Riley et al. | 4 |
| Lemann (1995) | clinical remission; endoscopic remission | histopathological remission; AEs | Sutherland Index | Lémann Endoscopic Index | Floren | 4 |
| Lofberg (1994) | clinical remission; endoscopic remission | histopathological remission; AEs | — | Löfberg Score | Floren | 8 |
| Porro (1994) | clinical remission; endoscopic remission | histopathological remission; AEs | Truelove and Witts Severity Index | — | Floren | 4 |
| Farup (1994) | clinical remission | AEs | Rachmilewitz Index | — | Friedman et al. | 4 |
| Campieri (1991) | clinical remission; endoscopic remission | histopathological remission; AEs | Truelove & Richard | Truelove & Richard | Truelove & Richard | 4 |
| Campieri (1990) | clinical remission; endoscopic remission | histopathological remission; AEs | Truelove & Richard | Truelove & Richard | Truelove & Richard | 4 |
| Campieri (1990*) | clinical remission; endoscopic remission | histopathological remission; AEs | Truelove & Richard | Baron’s criteria | Truelove & Richard | 4 |
| Danielsson (1987) | endoscopical remission | AEs | — | Truelove & Richard | Floren | 4 |
| Williams (1987) | clinical remission | AEs | Sutherland Index | — | — | 6 |
| Sutherland (1987) | clinical remission | AEs | Sutherland Index | — | — | 6 |
| Sutherland(1987*) | clinical remission | AEs | Sutherland Index | — | — | 6 |
| Binder (1987) | clinical remission; endoscopic remission | AEs | Binder | Binder | — | 4 |
| Campieri (1981) | clinical remission; endoscopic remission | AEs | Truelove & Richard | Truelove & Richard | — | 2 |
| Jones (1971) | clinical remission | AEs | — | Baron’s criteria | — | 4 |
5-ASA, 5-aminosalicylic acid; BDP, beclomethasone dipropionate; UC, Ulcerative colitis; UP, Ulcerative proctitis; UPS, Ulcerative proctosigmoiditis.