|
Parameter (Units)
| |
Baseline
|
Day 180
|
|---|
|
Normal range
|
Placebo (n = 58)
|
GC (n = 65)
|
UC-II (n = 63)
|
p value GC vs PBO
|
p value UC-II vs PBO
|
p value UC-II vs GC
|
Placebo (n = 53)
|
GC (n = 56)
|
UC-II (n = 53)
|
p value GC vs PBO
|
p value UC-II vs PBO
|
p value UC-II vs GC
|
|---|
|
Hematology
| |
|
Hemoglobin (gm/dL)
|
12.1–17.2
|
12.1 ± 0.22
|
11.9 ± 0.21
|
12.1 ± 0.20
|
0.7613
|
0.9948
|
0.8095
|
12.7 ± 0.24
|
12.4 ± 0.20
|
12.7 ± 0.18
|
0.4454
|
0.9727
|
0.5851
|
|
ESR (mm/h)
|
0–29
|
21.1 ± 1.77
|
23.9 ± 2.18
|
17.5 ± 1.56
|
0.7629
|
0.1034
|
0.0144
|
15.1 ± 1.24
|
17.0 ± 1.91
|
13.6 ± 1.28
|
0.9424
|
0.5364
|
0.3387
|
|
RBC (million/mm3)
|
4.7–6.1
|
4.29 ± 0.08
|
4.21 ± 0.08
|
4.33 ± 0.09
|
0.7747
|
0.9388
|
0.5498
|
4.32 ± 0.08
|
4.25 ± 0.08
|
4.37 ± 0.08
|
0.7935
|
0.8946
|
0.5129
|
|
WBC (/mm3)
|
4500-10,000
|
7979 ± 234
|
8248 ± 222
|
7795 ± 249
|
0.7020
|
0.8483
|
0.3523
|
7984 ± 204
|
7981 ± 209
|
7769 ± 204
|
1.0000
|
0.7706
|
0.7639
|
|
Platelet count (x100000/mm3)
|
1.5-4.5
|
2.77 ± 0.08
|
2.84 ± 0.08
|
2.78 ± 0.08
|
0.7837
|
0.9946
|
0.8319
|
2.77 ± 0.07
|
2.84 ± 0.07
|
2.77 ± 0.09
|
0.8304
|
0.9993
|
0.8113
|
|
Liver Function
| |
|
Albumin (gm/dL)
|
3.5–5.5
|
3.98 ± 0.06
|
4.02 ± 0.06
|
3.94 ± 0.06
|
0.8957
|
0.9089
|
0.6503
|
4.00 ± 0.05
|
4.03 ± 0.05
|
3.96 ± 0.04
|
0.8931
|
0.8902
|
0.6292
|
|
ALP (IU/L)
|
44–147
|
117 ± 5.74
|
118 ± 5.84
|
115 ± 5.57
|
0.9871
|
0.9838
|
0.9404
|
123 ± 5.72
|
116 ± 5.49
|
115 ± 5.59
|
0.5622
|
0.4847
|
0.9890
|
|
SGOT (U/L)
|
10–34
|
25.2 ± 0.93
|
24.0 ± 0.97
|
24.4 ± 0.60
|
0.5778
|
0.7796
|
0.9421
|
24.6 ± 0.73
|
23.9 ± 0.81
|
23.9 ± 0.65
|
0.7711
|
0.7930
|
0.9995
|
|
SGPT (U/L)
|
5–35
|
25.9 ± 1.23
|
25.0 ± 1.40
|
24.1 ± 0.95
|
0.5977
|
0.6004
|
1.0000
|
24.5 ± 0.94
|
24.3 ± 1.00
|
23.3 ± 0.99
|
0.9688
|
0.7119
|
0.8427
|
|
Total bilirubin (mg/dL)
|
0.3–1.9
|
0.78 ± 0.08
|
0.69 ± 0.03
|
0.72 ± 0.03
|
0.5376
|
0.9424
|
0.7343
|
0.72 ± 0.03
|
0.67 ± 0.03
|
0.78 ± 0.04
|
0.4243
|
0.6098
|
0.0718
|
|
Cardiac Function
| |
|
Systolic BP (mm Hg)
|
<120
|
125 ± 1.28
|
127 ± 1.35
|
127 ± 1.21
|
0.5980
|
0.7320
|
0.9752
|
127 ± 1.18
|
125 ± 1.33
|
128 ± 1.22
|
0.7263
|
0.8949
|
0.4409
|
|
Diastolic BP (mm Hg)
|
< 80
|
81.2 ± 1.19
|
80.2 ± 0.83
|
81.7 ± 1.02
|
0.7544
|
0.9283
|
0.5094
|
80.2 ± 1.03
|
80.5 ± 1.07
|
78.9 ± 0.96
|
0.9877
|
0.6233
|
0.5180
|
|
Pulse rate (beats/min)
|
60–100
|
80.0 ± 0.92
|
79.6 ± 0.98
|
80.3 ± 0.99
|
0.9149
|
0.9719
|
0.7956
|
80.0 ± 0.89
|
78.2 ± 0.82
|
79.2 ± 1.03
|
0.3201
|
0.8018
|
0.6989
|
|
Renal Function
| |
|
Creatinine (mg/dL)
|
0.6–1.3
|
1.00 ± 0.03
|
1.01 ± 0.04
|
0.96 ± 0.03
|
0.9995
|
0.5767
|
0.5778
|
0.96 ± 0.03
|
0.95 ± 0.02
|
0.96 ± 0.02
|
0.9904
|
0.9846
|
0.9508
|
|
BUN (mg/dL)
|
6–24
|
18.1 ± 1.08
|
18.0 ± 1.11
|
18.0 ± 1.15
|
0.9929
|
0.9878
|
0.9992
|
18.6 ± 1.11
|
17.8 ± 1.09
|
17.9 ± 1.02
|
0.7602
|
0.7953
|
0.9985
|
- Results are presented as Mean ± SE. Normal ranges were obtained from Medlinea and the Mayo Clinicb. Data was analyzed using ANCOVA followed by Tukey’s multiple comparisons test (p > 0.05)
-
Abbreviations:
-
ESR erythrocyte sedimentation rate; RBC red blood cell; WBC white blood cell; ALP alkaline phosphatase; SGOT serum glutamic oxaloacetic transaminase; SGPT serum glutamic pyruvic transaminase; BP blood pressure; BUN blood urea nitrogen
-
aADAM, Inc.: http://www.nlm.nih.gov/medlineplus/encyclopedia.html (accessed October 2015)
-
bMayo Foundation for Medical Education and Research: Mayo Clinic. www.mayoclinic.org (accessed October 2015)
