Low dose oral curcumin is not effective in induction of remission in mild to moderate ulcerative colitis: Results from a randomized double blind placebo controlled trial

Table 1 Baseline clinical and biochemical parameters of the randomized patients n (%)

	Curcumin group (n = 29)	Placebo group (n = 33)
Age (yr)	36 ± 12	34 ± 7
Sex (females)	13 (44.83)	8 (24.24)
Weight (kg)	55.1 ± 10.0	55.7 ± 11.7
BMI (kg/m2)	20.8 ± 3.1	20.5 ± 3.3
Disease duration (yr)	3.83 ± 4.00	3.64 ± 2.59
Disease extent
E3 (pancolitis)	7 (25.9)	6 (20.7)
E2 (left sided colitis)	17 (58.6)	21 (63.6)
E1 (proctitis)	3 (11.1)	2 (6.90)
Current smoking	5 (17.24)	4 (14.81)
Current alcohol use	3 (10.34)	4 (14.81)
Hemoglobin (g/dL)	12.12 ± 2.76	13.35 ± 1.72
Total leukocyte count (per cubic millimeter)	8586 ± 2306	8221 ± 2104
Platelet count(× 1000/mm3)	256.25 ± 131.98	257.53 ± 113.01
ESR (mm/1st h)	3 ± 2	4 ± 3
Urea (mg/dL)	22.0 ± 5.2	21.5 ± 5.2
Creatinine (mg/dL)	0.84 ± 0.26	1.19 ± 1.69
Potassium (meq/L)	4.41 ± 0.33	4.26 ± 0.78
Bilirubin (mg/dL)	0.7 ± 0.2	0.6 ± 0.1
Aspartate aminotransferase (U/L)	28 ± 6	30 ± 8
Alanine aminotransferase(U/L)	26 ± 9	28 ± 19
Total protein (g/L)	8.0 ± 0.2	7.9 ± 0.8
Albumin (g/L)	4.4 ± 0.5	4.5 ± 0.3
Current treatment
5-ASA	29 (100)	33 (100)
Steroids	0	0
Azathioprine	2 (6.9)	2 (6.2)
Rectal steroids	0	0
Mesalamine enema	0	0

Data are given as mean ± SD. 5-ASA: 5-aminosalicylates; BMI: Body mass index; ESR: Erythrocyte sedimentation rate.

Table 2 Comparison of the Ulcerative Colitis Disease Activity Index between the two randomized groups at baseline, 4, and 8 wk

	Curcumin group		Placebo group		Mean difference (95%CI)	Significance
	n	UCDAI	n	UCDAI
Week 0	29	5.2 ± 2.0	33	5.5 ± 1.9	-0.244 (-1.256 to 0.77)	0.632
Week 4	16	3.6 ± 2.4	23	4.4 ± 3.2	-0.823 (-2.678 to 1.020)	0.37
Week 8	16	3.4 ± 3.1	25	3.8 ± 2.8	-0.362 (-2.343 to 1.168)	0.711

UCDAI is expressed as mean ± SD. UCDAI: Ulcerative Colitis Disease Activity Index.

Table 3 Comparison of clinical remission, improvement in Ulcerative Colitis Disease Activity Index and Baron’s score, and mucosal healing at 8^th week between two randomized groups

	Curcumin group	Placebo group	OR (95%CI)	P value
Clinical remission
PP1	9/16 (56.25%)	9/25 (36%)	2.28 (0.634-8.264)	0.202
ITT2	9/29 (31.03%)	9/33 (27.27%)	1.20 (0.40-3.60)	0.745
UCDAI improvement by ≥ 3
PP	6/16 (37.5%)	12/25 (48%)	0.65 (0.18-2.34)	0.509
ITT	6/29 (20.69%)	12/33 (36.36%)	0.46 (0.14-1.43)	0.175
Mucosal healing1
PP	10/16 (62.5%)	10/25 (40%)	2.50 (0.69-9.09)	0.16
ITT	10/29 (34.5%)	10/33 (30.3%)	1.21 (0.4 – 3.5)	0.72

¹Healing defined by either endoscopically normal mucosa or only mucosal granularity. Any ulceration or friability was taken as non-healed mucosa. PP: Per-protocol; ITT: Intention to treat; UCDAI: Ulcerative Colitis Disease Activity Index.

Table 4 Comparison of the biochemical parameters between the two randomized groups at 4 and 8 wk

	Week 4			Week 8
	Curcumin group	Placebo group	P value	Curcumin group	Placebo group	P value
Hemoglobin (g/dL)	12.0 ± 2.3	13.3 ± 2.2	0.235	12.1 ± 2.7	13.2 ± 2.6	0.404
Total leukocyte count (per cubic millimeter)	7900 ± 2449	8085 ± 2494	0.87	8957 ± 1705	7086 ± 1969	0.082
ESR (mm/1st h)	21.5 ± 13.4	22.2 ± 15.2	0.91	23.0 ± 17.1	25.9 ± 9.4	0.707
Urea (mg/dL)	23.1 ± 8.5	22.8 ± 7.0	0.922	24.7 ± 6.0	24.3 ± 6.7	0.89
Alanine aminotransferase (U/L)	26.5 ± 8.4	35.5 ± 20.6	0.178	29.5 ± 15.4	25.3 ± 5.4	0.516
Total protein (g/L)	7.9 ± 0.4	8.1 ± 0.8	0.666	8.3 ± 0.3	8.3 ± 0.9	0.963
Albumin (g/L)	4.7 ± 0.2	4.6 ± 0.3	0.869	4.8 ± 0.2	4.6 ± 0.2	0.169