Author/ref | N (isolated colonic CD) | 5-ASA | Placebo | p Value | Conclusions |
---|---|---|---|---|---|
Singleton et al138 | 64 | CDAI mean change: −77 (±27) at 2 g/day −81 (±31) at 4 g/day | CDAI mean change −52 (±31) | Overall <0.01 for mesalazine vs placebo in all CD, p=0.42 for difference in ileal vs ileocolonic vs colonic | High placebo response rate in isolated colonic CD so NS if this group taken alone; better response in ileal only disease |
(a) Placebo-controlled trials of oral 5-ASA in isolated colonic CD (i) induction | |||||
Author/ref | N (isolated colonic CD) | 5-ASA relapse rate 12 months | Placebo relapse rate 12 months | p Value | Conclusions |
International Mesalazine Study Group139 | 56 | 32.1% (9/28) | 38.9% (11/28) | 0.49 | 5-ASA only showed benefit in ileal disease |
Prantera et al140 | 18 | 40% (2/5) | 55% (6/11) extrapolated from table | NS | 5-ASA only showed benefit in ileal disease |
Gendre et al141 | 48 | – | – | – | 5-ASA better (p<0.003) than placebo in all patients with CD in remission <3 months at onset, no significant difference according to disease location |
de Franchis et al142 | 36 | 45% (8/17) (extrapolated from figure) | 45% (9/19) | 1.0 | 5-ASA ineffective in ileal, colonic or ileocolonic |
(a) Placebo-controlled trials of oral 5-ASA in isolated colonic CD (ii) maintenance | |||||
Author/ref | N (isolated colonic CD) | Sulfasalazine remission | Placebo remission | p Value | Conclusions |
Singleton et al143 | 20 | – | – | NS | Both groups also received tapering prednisolone. Placebo better than sulfasalazine in patients with ileal disease |
Summers et al144 | 17 | – | – | 0.006 (comparison of outcome ranks) | Sulfasalazine better than placebo in colonic CD (also effective in ileocolonic but not ileal only) |
Malchow et al145 | 27 | 31% (4/13) | 14% (2/14) | 0.4 | NS for remission but p<0.01 for effect when judged by ‘failure and relapse’ |
(b) Placebo-controlled trials of oral sulfasalazine in isolated colonic CD (i) induction | |||||
Author/ref | N (isolated colonic CD) | Sulfasalazine relapse rate 12 months | Placebo relapse rate 12 months | p Value | Conclusions |
Singleton et al143 | 20 | – | – | NS | Sulfasalazine not significantly different from placebo in CD overall and no relation to disease location |
Summers et al144 | 19 | – | – | NS | No significant effect (judged by outcome rank based on CDAI) |
(b) Placebo-controlled trials of oral sulfasalazine in isolated colonic CD (ii) maintenance | |||||
Author/ref | N (isolated colonic CD) | Olsalazine relapse /failure rate 12 months | Placebo relapse /failure rate 12 months | p Value | Comments |
Mahmud et al146 | 145 | 65.4% | 53.6% | 0.035 (olsalazine worse) | Olsalazine induces diarrhoea, no evidence of efficacy |
(c) Placebo-controlled trial of olsalazine in isolated colonic Crohn's maintenance |
5-ASA, 5-aminosalicylic acid; CD, Crohn's disease; NS, not significant.