Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients

Table 1 Demographic and parameters of two groups, mean ± SD/n (%)

	Modulen group	Budesonide group	P value
Number of patients	21	9
Gender			0.22
Female	15 (71)	4 (44)
Male	6 (29)	5 (56)
Age, years	34.7 ± 12.9	39.9 ± 15.8	0.35
BMI	25.0 ± 4.8	27.5 ± 5.6	0.22
Non-smokers	14/19 (73.7)	7/8 (87.5)	0.63
Time from diagnosis, months	2.28 ± 1.23	2.33 ± 1.66	0.93
SB/colon involvement			NA
SB only (L1)	17 (81)	8 (88.9)
SB + colon (L3)	4 (19)	1 (11.1)
Previous surgery	1	1	NA
No previous treatment	21 (100)	9 (100)	NA
Baseline CDAI (range)	216.8 ± 78.2 (40-387)	191.4 ± 60.6 (88-279)	0.39
Baseline IBDQ (range)	129.9 ± 31.6 (86-201)	149.3 ± 35.8 (98-218)	0.15
Baseline Lewis score (median with IQR)	477.5 (337-951)	412 (337-1379)	0.91
Baseline total inflammatory score (median with IQR range)	745 (365-1229)	637 (476-1264)	0.91
Baseline stenosis score	1 patient-2352	1 patient-2352	NA
Baseline SES-CD	1 patient-6	4 patients with average 75	NA
Baseline total symptoms score	4.61 ± 1.99	3.72 ± 1.83	0.26
Baseline calprotectin score, μg/mg (median with IQR range)	59 (25-121.5)	336 (84-697)	0.055
Baseline hemoglobin, g/dL	13.9 ± 1.6	13.4 ± 1.3	0.39
Baseline CRP level (median with IQR range)	1.65 (0.5-4.40)	3.6 (1.15-15.6)	0.14

Median with interquartile range was evaluated if the distribution of values was asymmetric. IQR: Interquartile range; NA: Not applicable; BMI: Body mass index; SB: Small bowel; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; SES-CD: Simple endoscopic score for Crohn’s disease; CRP: C-reactive protein.