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

Table 2 Intention for treat analysis in the Modulen group (21 patients), mean ± SD

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg)	70.8 ± 13.9	72.4 ± 14.05	69.4 ± 12.4	74.3 ± 12.6	0.761; 0.802; 0.523
CDAI	216.8 ± 78.2	117.6 ± 98.8	126.5 ± 93.5	141.0 ± 106.72	0.0041; 0.0072; 0.0353
IBDQ	129.9 ± 31.6	165.2 ± 33.7	161.9 ± 35.9	158.8 ± 31.3	0.0081; 0.0142; 0.0233
Lewis score (median with IQR)	477.5 (337-951)	NA	322.5 (0-505.75)	NA	0.56
Total inflammatory score (median with IQR)	745 (365-1229)	NA	322.5 (0-865.8)	NA	0.035
I tertile (median with IQR)	0 (0-337)	NA	0 (0-168.3)	NA	0.63
II tertile (median with IQR)	67.5 (0-519)	NA	0 (0-35.8)	NA	0.17
III tertile (median with IQR)	337 (315-730)	NA	322.5 (0-505.8)	NA	0.26
Total symptom score (range)	4.61 ± 1.99	2.46 ± 2.00	2.30 ± 2.04	2.50 ± 1.95	0.0081; 0.0042; 0.013
Calprotectin (μg/mg) (median with IQR)	59 (25-121.5)	34 (14-70)	39.4 (29.5-91.0)	34 (14.3-110)	0.131; 0.502; 0.443
Hemoglobin (d/dL)	13.9 ± 1.6	14.51 ± 1.50	14.59 ± 1.32	14.53 ± 1.31	0.311; 0.272; 0.313
CRP (median with IQR)	1.65 (0.5-4.4)	1.0 (0.5-4.3)	3.8 (0.5-8.2)	1.4 (0.7-13.0)	0.511; 0.932; 0.883
Compliance for Modulen (portions)	NA	2.9 ± 0.91	2.60 ± 1.14	NA	NA

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.