Comparison of a Chinese Herbal Medicine (CCH1) and Lactulose as First-Line Treatment of Constipation in Long-Term Care: A Randomized, Double-Blind, Double-Dummy, and Placebo-Controlled Trial
Table 9
Comparison of common adverse events (cumulative incidence >5%).
Variables
Group, number (%)
Value*
CCH1
Lactulose
Flatulence
16 (36.4)
17 (34.7)
0.867
Albumin ↓
15 (34.1)
10 (20.4)
0.137
Diarrhea
15 (34.1)
17 (34.7)
0.951
Hiccup
13 (29.5)
12 (24.5)
0.583
Hemoglobin ↓
12 (27.3)
6 (12.2)
0.067
Abdominal pain
10 (22.7)
8 (16.3)
0.435
Bloating
9 (20.5)
11 (22.4)
0.815
Magnesium ↑
8 (18.2)
12 (24.5)
0.614
Acid regurgitation
8 (18.2)
8 (16.3)
0.813
URI
8 (18.2)
6 (12.2)
0.424
Red blood cell ↓
7 (15.9)
4 (8.2)
0.248
Sugar ↑
6 (13.6)
9 (18.4)
0.536
Calcium ↓
6 (13.6)
2 (4.1)
0.143
Sodium ↓
5 (11.4)
2 (4.1)
0.249
Alkaline phosphatase ↑
4 (9.1)
1 (2.0)
0.186
Albumin ↑
4 (9.1)
1 (2.0)
0.186
Potassium ↑
4 (9.1)
4 (8.2)
1.000
Phosphate ↑
4 (9.1)
1 (2.0)
0.186
Nausea
4 (9.1)
7 (14.3)
0.439
White blood cell ↓
3 (6.8)
2 (4.1)
0.665
Sugar ↓
3 (6.8)
2 (4.1)
0.665
Blood urea nitrogen ↑
3 (6.8)
5 (10.2)
0.718
Dizziness
3 (6.8)
1 (2.0)
0.341
Cough
3 (6.8)
4 (8.2)
0.561
Skin rash
2 (4.5)
3 (6.1)
1.000
Platelet ↑
2 (4.5)
3 (6.1)
1.000
Aspartate aminotransferase ↑
2 (4.5)
4 (8.2)
0.680
Alanine aminotransferase ↑
2 (4.5)
3 (6.1)
1.000
Creatinine ↑
2 (4.5)
3 (6.1)
1.000
Triglyceride ↑
2 (4.5)
5 (10.2)
0.440
Vomiting
2 (4.5)
3 (6.1)
1.000
Diaper rash
1 (2.3)
5 (10.2)
0.207
Cholesterol ↑
1 (2.3)
4 (8.2)
0.365
Cholesterol ↓
1 (2.3)
3 (6.1)
0.619
Creatine phosphokinase ↑
0 (0)
3 (6.1)
0.244
Uric acid ↑
0 (0)
3 (6.1)
0.244
Pruritus
0 (0)
3 (6.1)
0.244
Chest tightness
0 (0)
3 (6.1)
0.244
*A test or Fisher exact test where appropriate was used to compare the number of patients with adverse events between two groups.
