Table 6

Trials of 5-ASA preparations where data presented separately for isolated colonic CD

Author/refN (isolated colonic CD)5-ASAPlacebop ValueConclusions
Singleton et al13864CDAI 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/refN (isolated colonic CD)5-ASA relapse rate 12 monthsPlacebo relapse rate 12 months p Value Conclusions
International Mesalazine Study Group1395632.1%
(9/28)
38.9%
(11/28)
0.495-ASA only showed benefit in ileal disease
Prantera et al1401840%
(2/5)
55%
(6/11) extrapolated from table
NS5-ASA only showed benefit in ileal disease
Gendre et al141485-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 al1423645%
(8/17) (extrapolated from figure)
45%
(9/19)
1.05-ASA ineffective in ileal, colonic or ileocolonic
(a) Placebo-controlled trials of oral 5-ASA in isolated colonic CD (ii) maintenance
Author/refN (isolated colonic CD) Sulfasalazine remissionPlacebo
remission
p Value Conclusions
Singleton et al14320NSBoth groups also received tapering prednisolone.
Placebo better than sulfasalazine in patients with ileal disease
Summers et al144170.006
(comparison of outcome ranks)
Sulfasalazine better than placebo in colonic CD (also effective in ileocolonic but not ileal only)
Malchow et al1452731%
(4/13)
14%
(2/14)
0.4NS 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/refN (isolated colonic CD)Sulfasalazine relapse rate 12 monthsPlacebo relapse rate 12 months p Value Conclusions
Singleton et al14320NSSulfasalazine not significantly different from placebo in CD overall and no relation to disease location
Summers et al14419NSNo significant effect (judged by outcome rank based on CDAI)
(b) Placebo-controlled trials of oral sulfasalazine in isolated colonic CD (ii) maintenance
Author/refN (isolated colonic CD)Olsalazine relapse /failure rate 12 monthsPlacebo relapse /failure rate 12 monthsp Value Comments
Mahmud et al14614565.4%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.