N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: Randomized, placebo-controlled pilot study

Table 1 Basal and demographic data

Data	Group A Mesalamine + NAC (n = 19)	Group B Mesalamine + placebo (n = 18)	Total (n = 37)
Age (mean ± SD)	51.4 ± 14	42.2 ± 13	46.9 ± 14
White race, n (%)	11 (57.8)	13 (72.2)	24 (64.8)
Smoker, n (%)	2 (10.5)	3 (16.7)	5 (13.5)
Male, n (%)	8 (42.1)	5 (27.8)	13 (35.1)
Basal modified Truelove-Witts severity index (mean ± SD)	5.95 ± 2.22	4.61 ± 2.09	5.30 ± 2.20

NAC: N-acetyl-L-cysteine.

Table 2 Changes in disease activity assessed using modified Truelove-Witts Severity Index (mean ± SD) in subjects who received the drugs for 2 wk and 4 wk

Week of treatment	0	2	4	ANOVA statistical test (number of patients)
Group A mesalamine plus NAC	5.95 ± 2.22	4.68 ± 3.40	3.32 ± 3.71a	P = 0.046 (n = 19)
Group B mesalamine plus placebo	4.61 ± 2.09	4.17 ± 3.85	3.72 ± 3.91	P = 0.735 (n = 18)

^aP < 0.05 represents the significance levels compared with the corresponding basal values using the ANOVA statistical test.

Table 3 Hematological parameters

	Group A		Group B
	Basal	4 wk	Basal	4 wk
Haemoglobin (g/100 mL)	14.28	13.98	13.81	13.79
Haematocrit (g/100 mL)	42.55	42.01	40.50	40.61
Erythrocytes (× 106/mm3)	4.81	4.69	4.60	4.58
Platelet count (× 103/mm3)	232.95	249.84	263.22	260.50
VSG (mm/h)	17.13	15.00	19.60	17.38
Leukocytes (× 103/mm3)	7.14	7.06	7.86	7.90
Neutrophils (%)	62.63	61.45	63.75	58.61
Eosinophils (%)	2.56	3.34	3.81	3.22
Basophils (%)	0.32	0.55	0.44	0.22
Lymphocytes (%)	25.89	28.03	27.82	27.74
Monocytes (%)	6.97	7.20	7.14	7.88

Group A: Mesalamine + NAC; Group B: Mesalamine + placebo.

Table 4 Biochemical parameters

	Group A		Group B
	Basal	4 wk	Basal	4 wk
SGOT (units/L)	16.89	16.47	20.47	25.06
SGPT (units/L)	15.58	17.53	36.94	43.59
Phosphatase alkaline (units/L)	93.56	86.61	93.59	86.71
Bilirubin (mg/100 mL)	0.68	0.67	0.50	0.51
LDH (units/L)	258.22	265.45	307.63	299.30
Serum creatinine (mg/100 mL)	0.95	0.95	0.90	0.93
Urea/BUN (mg/100 mL)	35.23	34.64	35.90	33.75
Total Proteins (g/100 mL)	7.17	7.06	7.18	7.08
Albumin (g/100 mL)	4.16	4.11	4.13	4.12
Na+ (mmol/L	138.10	139.20	138.11	139.10
K+ (mmol/L)	4.17	4.24	4.34	4.28
Glucose (mg/100 mL)	91.53	89.54	83.53	85.88
Iron (&mgr;g/dL)	70.27	69.00	78.56	84.82
Orosomucoid (mg/100 mL)	85.19	90.98	98.06	89.98
CRP (mg/L)	5.37	4.27	5.20	4.85

Group A: Mesalamine + NAC; Group B: Mesalamine + placebo.