Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial
Table 5
Adverse events in patients reported in the two groups during treatment.
Variable
Treatment group Number of patients (%) ()
Control group Number of patients (%) ()
χ
2 (Chi-square test)
values
Abdominal pain
9 (4.5)
3 (3)
0.3906
0.5320
Abdominal distension
15 (7.5)
2 (2)
3.7726
0.0521
Diarrhea
14 (7)
3 (3)
1.9954
0.1578
Nausea
5 (2.5)
2 (2)
0.0000△
1.0000
Increased appetite
34 (17)
1 (1)
16.5606
0.0000
Appetite decreases
5 (2.5)
4 (4)
0.1289△
0.7196
Feel thirsty
4 (2)
3 (3)
0.0183△
0.8924
Stomach disturbances
19 (9.5)
5 (5)
1.8342
0.1756
Constipation
4 (2)
3 (3)
0.0183△
0.8924
Malaise
5 (2.5)
2 (2)
0.0000△
1.0000
Insomnia
3 (1.5)
1 (1)
0.0000△
1.0000
Headache
3 (1.5)
2 (2)
0.0000△
1.0000
Dizziness
5 (2.5)
1 (1)
0.1913△
0.6618
Fatigue
3 (1.5)
2 (2)
0.0000△
1.0000
Chest tightness
4 (2)
3 (3)
0.0183△
0.8924
URTI syndromes※
3 (1.5)
3 (3)
0.1913△
0.6618
Mouth ulceration
3 (1.5)
2 (2)
0.0000△
1.0000
Rash
5 (2.5)
0 (0)
1.2458△
0.2644
Dysuria
2 (1)
0 (0)
0.0629△
0.8019
Urethral burning pain
2 (1)
0 (0)
0.0629△
0.8019
Increased serum ALT※
3 (1.5)
0 (0)
0.3788△
0.5383
※URTI: upper respiratory tract infection; increased serum ALT defined as >40 U/L. △Correction.
