Table 1

Patients description (Denmark)

Patients at randomisationWeb N=117Control N=116p Value
Gender
 Male, N (%)57 (48.7)35 (30.2)0.005*
 Female, N (%)60 (51.3)81 (69.8)
 Total117116
Age at diagnosis, median (range)33 (3–66)35 (14–65)ns
Age at inclusion, median (range)41 (21–69)48 (21–69)0.01
Disease duration (years), median (range)4 (0–45)6 (0–37)ns
Disease extension at diagnosis, N, (%)
 Proctitis31 (26.5)29 (25)
 Left sided60 (51.3)70 (60.3)ns
 Pancolitis26 (22.2)17 (14.7)
Patients at baselineWeb N=105Control N=106P-ValueHistorical control N=106
Gender
 Male, N (%)52 (49.5)33 (31.1)40 (37.7)
 Female, N (%)53 (50.5)73 (68.9)0.00866 (62.3)
 Total105106106
Age at diagnosis, median (range)33 (3–66)35 (14–65)ns32 (15–68)
Age at inclusion, Median (range)40 (21-69)44 (21–69)0.0340 (18–69)
Disease duration (years) median (range)4 (0–45)6 (0–37)ns3 (0–42)
Disease extension, N (%)
 Proctitis24 (22.9)25 (23.6)44 (41.5)
 Left sided57 (54.3)67 (63.2)ns40 (37.7)
 Pancolitis24 (22.9)14 (13.2)22 (20.8)
SCCAI, median (range)1 (0–10)1 (0–11)nsNot recorded
5-ASA treatment systemic, N (%)
 Asacol78 (74.3)68 (64.2)56 (52.8)
 Pentasa8 (7.6)7 (6.6)14 (13.2)
 Dipentum2 (1.9)4 (3.8)ns0 (0)
 Premid2 (1.9)2 (1.9)0 (0)
 Salazopyrin3 (2.9)6 (5.7)8 (7.5)
 Mezavant0 (0)0 (0)0 (0)
 None12 (11.4)19 (17.9)28 (26.4)
Suppositories, N (%)
 Asacol3 (2.9)2 (1.9)1 (0.9)
 Pentasa12 (11.4)9 (8.5)ns5 (4.7)
 Mesasal3 (2.9)1 (0.9)1 (0.9)
 Prednisolon1 (1.0)0 (0)4 (3.8)
 None86 (81.9)94 (88.7)95 (89.6)
Enema/Foam, N (%)
 Asacol4 (3.8)4 (3.8)1 (0.9)
 Pentasa7 (6.7)6 (5.7)ns0 (0)
 Colifoam4 (3.8)4 (3.8)0 (0)
 Pred-Clysma0 (0)0 (0)2 (1.9)
 None90 (85.7)92 (86.8)103 (97.2)
 BMI, Median (range)24 (18–42)24 (18–46)nsNot recorded
Smoking (%)
 Non-smoker39 (37.1)46 (43.4)
 Active smoker19 (18.1)18 (17)nsNot recorded
 Ex-smoker47 (44.8)42 (39.6)
Marital status (%)
 Married69 (65.7)82 (77.4)
 Single36 (34.3)24 (22.6)nsNot recorded
Education (%)
 Academic33 (31.4)29 (27.4)
 Other education55 (52.4)64 (60.4)
 During education16 (15.2)5 (4.7)nsNot recorded
 No education1 (1.0)8 (7.5)
Occupation (%)
 Paid82 (77.1)86 (81.1)
 Unpaid1 (1.0)4 (3.7)nsNot recorded
 Support15 (14.3)6 (5.7)
 Pensioner7 (6.7)10 (9.4)
  • * p=0.005 (Fisher's exact test).

  • p=0.011 (Wilcoxon test).