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. 2023 May 4;2023(5):CD013854. doi: 10.1002/14651858.CD013854.pub2

1. Study and participant details.

Study ID Trial registration Disease type (IG/CG) Disease state (relapse/remission) (IG/CG) Disease duration Numbers randomised (IG/CG) Concurrent therapies (number of participants in IG/CG)
Berding 2017 NR IBD (UC and CD) for study completers
 
IG UC/CD (n = 86): 57%/43% = 49/37
 
CG UC/CD (n = 95):
52.6%/47.4% = 50/45
 
 
 		 All in remission Mean (SD) years
 
IG: 10.9 (10.8), CG: 9.6 (8.9)		 IG: 105
CG: 102		 5‐aminosalicylic acid: IG 57.8%; CG 64.9%
Steroids: IG 28.9%; CG 53.2%
Immunosuppressants: IG 45.3%; CG 34.7%
Biologicals: IG 10.5%; CG 12.6%
Borgaonkar 2002 NR IG: CD/UC 18/16
 
CG: CD/UC: 18/7		 IG active/inactive disease: 40% of 34 = 13.6 probably rounded to 14/20
 
CG active/inactive disease: 48% of 25 = 12/13		 Mean (SD) months
 
IG: 96.4 (85.21),
CG: 43 (124.2)		 IG: 34
CG: 25
 		 Steroids IG: 11 (32%); CG: 5 (20%)
 
Immunosuppressives IG: 3 (9%); CG: 5 (20%)
 
5‐aminosalicylates IG: 15 (44%); CG: 15 (60%)
 
None IG: 6 (18%); CG: 4 (16%)
Cross 2019 NR CD participants (n = 236)
IG1 (TELE‐IBD EOW): 79
IG2 (TELE‐IBD W): 78
CG: 79
 
CD participants (n = 112)
IG1 (TELE‐IBD EOW): 36
IG2 (TELE‐IBD W): 38
CG: 38		 Number of participants with active disease:
IG1 (TELE‐IBD EOW): 31 (41%)
IG2 (TELE‐IBD W): 25 (36%)
CG: 40 (54%)
 
Number of participants in remission:
IG1 (TELE‐IBD EOW): 44 (59%)
IG2 (TELE‐IBD W): 45 (64%)
CG: 34 (46%)		 Mean (SD) years
 
IG: 12.4 (9.7), CG: 11.7 (10.0)		 IG1 (TELE‐IBD EOW): 115
 
IG2 (TELE‐IBD W): 116
 
CG: 117		 NR
De Jong 2017 ClinicalTrials.gov (NCT02173002) IG: 282 (61%) CD patients and 183 (39%) UC patients
 
CG: 262 (59%) CD patients and 182 (41%) UC patients		 IG: remission 394 (85%) and active disease 71 (15%)
 
CG: remission 380 (86%) and active disease 64 (14%)		 Mean (SD) years
 
IG: 12.8 (10.4),
CG: 13.1 (10.8)		 IG: 465
CG: 444		 No medication or mesalazine: IG: 173 (37%); CG: 147 (33%)
 
Immunosuppressive drugs: IG: 122 (26%); CG: 131 (30%)
 
Biological therapy: IG: 170 (37%); CG: 166 (37%)
Jaghult 2007 NR CD
IG/CG: 26/16
 
UC
IG/CG: 26/16		 All participants were in remission Mean (range) years
 
IG: 1.60 (1‐2), CG: 1.59 (1‐2)		 IG: 55
CG: 44		 NR
Kennedy 2002 NR IBD (Crohn's or UC) Active disease
CG: 85 (23.3%)
IG: 69 (29.6%)
 
Relapse in past 18 months
CG: 196 (53.7%)
IG: 137 (50.7%)
 
In remission—no flare‐ups in past 18 months
CG: 58 (15.9%)
IG: 47 (17.4%)		 Diagnosed in the past year:
IG: 15/119
CG: 21/121
 
Diagnosed over 20 years ago:
IG: 14/119
CG: 12/121		 IG: 119 (9 clusters)
CG: 121 (10 clusters)		 NR
Moreau 2021 NCT02550158 Number(%)
IG: CD 95 (71.4%); UC 38 (28.6%)
 
CG: CD 97 (75.2%); UC: 32 (24.8%)		 NR
 		 Median (IQR) months
 
IG: 49.5 (6.4‐111.9), CG: 40.6 (7.3‐ 122.8)		 IG: 133
CG: 130		 Steroids: IG: 39 (92.5%); CG: 107 (83.0%)
Thiopurines or methotrexate: IG: 94 (70.7%); CG: 83 (64.3%)
Anti‐TNF‐α (infliximab or adalimumab): IG: 80 (60.2%); CG 77 (59.7%)
Nikolaus 2017 DRKS00008905 All participants had UC. Clinical activity index used to measure disease state (CAI)
CAI 0–4 (remission): IG: 82 (65.1%), CG: 89 (73%)
 
CAI > 4–9 (mild to moderate activity): IG 25 (19.9%), CG 14 (11.5%)
CAI > 9 (severe activity/relapse): IG 3 (2.4%),CG 5 (4%)
 
Missing: IG: 16 (12.7%), CG: 14 (11.5%)		 Median (range) years
 
IG: 5.34 (0.35–40.36), CG: 5.71 (0.27–26.64)		 IG: 126
CG: 122		 Steroids: IG: 84 (67.7%); CG: 93 (76.2%)
Mesalamine: IG: 124 (98.4%); CG: 122 (100%)
Sulphasalazine: IG: 6 (5%); CG: 9 (7.6%)
Azathioprine: IG: 54 (43.6%); CG: 56 (46.3%)
Methotrexate: IG: 9 (7.3%); CG: 7 (5.8%)
Cyclosporine: IG: 2 (1.6%); CG: 3 (2.5%)
Tacrolimus: IG: 2 (1.6%); CG: 2 (1.7%)
Anti‐TNF: IG: 31 (25%); CG: 13 (10.7%)
Oxelmark 2007 NR Both UC and CD.
UC: IG: 11; CG: 6
CD: IG: 13; CG: 14
 
 
 		 All patients were in remission or had low disease activity at inclusion, but numbers were not specified. Mean (range) years
 
IG: 4.6 (1‐11), CG: 5.2 (1‐10)		 IG: 24; CG: 22 Prednisolone (< 10 mg): IG: 10; CG: 3
Budesonide: IG: 1; CG: 0
5‐aminosalicylic acid/sulfasalazine: IG: 8; CG: 5
Immunomodulator: IG: 9; CG: 5
Antibiotics: IG: 4; CG: 4
None: IG: 5; CG: 7
 
Uran 2019 NR IG (web‐based education): 16 UC and 14 CD
CG (standard education): 16 UC and 14 CD		 IG:
Disease activity of UC:

  • Remission: 5

  • Mild disease: 5

  • Severe disease:6


 
Disease activity of CD:

  • Remission: 5

  • Mild disease: 8

  • Severe disease: 1


 
CG:
Disease activity of UC:

  • Remission: 4

  • Mild disease: 8

  • Severe disease: 4


 
Disease activity of CD:

  • Remission: 9

  • Mild disease: 4

  • Severe disease: 1


 		 Mean (SD) months
 
IG: 82.23 (54.52), CG: 81.93 (56.71)		 IG (web‐based education): 30
CG (standard education): 30		 NR
Uran 2019 NR Both UC and CD.
67% of participants had CD and 33% had UC. Numbers not specified for IG and CG
 		 All randomised participants had inactive disease at baseline. NR IG: 7; CG: 6 All participants were prescribed at least 1 daily oral medication for the control of IBD (i.e. steroid, thiopurine, or aminosalicylate) but specific figures not given for IG and CG.
Walkiewicz 2011 NR IBD (UC and CD). Specific numbers for IG and CG NR NR NR Total randomised 36
 
Specific numbers for IG and CG NR		 NR
Waters 2005 NR Both UC and CD
 
UC/CD:
IG: 14/31, CG: 18/26		 Mean (SD)
 
Measured using the Crohn's Disease Activity Index (CDAI) and Activity Index (mean score): IG: 126.8 (93.3); CG: 188.3 (117.1)
Activity index (mean score):
IG: 111.8 (25.8); CG: 114.1 (37.8)		 Mean (SD) years
 
IG: 10.5 (9.0), CG: 13.4 (9.84)		 IG: 45
CG: 44		 Steroids: IG:3 (7); CG: 9 (20)
 
Azathioprine/6‐mercaptopurine: IG: 9 (20);
CG: 9 (20)
Methotrexate: IG: 1 (2); CG: 1 (2)
 
5‐aminosalicylate: IG: 12 (27); CG: 22 (50)
Antibiotics (chronic therapy): IG: 3 (7); CG: 3 (7)
Monoclonal antibody: IG: 4 (9); CG: 3 (7)
Osteoporosis therapy: IG: 9 (20); CG: 13 (29)
Alternative therapy: IG: 3 (7); CG: 6 (14)
Weizman 2021 NCT02569333 91 patients with UC All participants with active disease flare up NR IG: 46; CG: 45 5‐aminosalicylate: IG: 16 (36%); CG:18 (43%)
 
Steroids: IG:18 (40%); CG:21 (50%)
 
Thiopurine: IG:3 (7%); CG:7 (17%)
 
Anti‐TNF: IG:12 (27%); CG:16 (38%)

CAI: Colitis Activity Index; CD: Crohn's disease; CG: control group;HRQoL: health‐related quality of life; IBD: inflammatory bowel disease; IG: Intervention group; IQR: interquartile range; SD: standard deviation; TNF‐α: tumour necrosis factor alpha; UC: ulcerative colitis