Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine
Table 1
Active surveillance system for herbs safety: top 20 adverse events detected by the panel of investigators and study nurses during the study period.
Adverse events
Risk*
Suan Zao Ren Tang
Duhuo Jisheng Tang
TMN-1
/103 person-daysa
/103 person-sachetsa
/103 person-daysb
/103
person-sachetsb
/103 person-daysc
/103
person-sachetsc
Body as a whole
Abdominal pain
1.8
0.6
8.3
4.4
1.8
0.6
Abdominal fullness
4.2
1.4
12.9
6.9
1.7
0.6
Dizziness
1.8
0.6
Chest pain
0.6
0.2
3.1
1.7
0.3
0.1
Fever
0.6
0.2
1.0
0.2
0.2
0.1
Somnolence
—
—
11.9
6.3
—
—
Musculoskeletal system
Muscle cramps
—
—
10.3
5.5
0.1
0.1
Headache
1.8
0.6
4.6
2.5
—
—
Respiratory system
Cough
3.0
1.0
12.4
6.6
2.6
0.9
Rhinitis
1.8
0.6
8.3
4.4
1.9
0.7
Pharyngitis
1.8
0.6
8.3
4.4
2.5
0.9
Digestive system
Diarrhea
3.6
1.2
10.3
5.5
1.6
0.6
Nausea
1.2
0.4
3.1
1.7
0.8
0.3
Vomit
0.6
0.2
0.5
0.3
0.3
0.1
Oral ulcer
—
—
1.5
0.8
0.2
0.1
Stomachache
0.6
0.2
—
—
0.5
0.2
Skin and appendages
Urticaria
—
—
0.5
0.3
0.1
0.0
Pruritus
0.6
0.2
—
—
1.6
0.6
Skin discolor
—
—
0.5
0.3
0.3
0.1
Rash
0.6
0.2
14.5
7.7
0.8
0.3
Number of cases was used as the numerator for calculation of risk.
aThe denominators for the calculation of the risks were 1,691 person-days and 5,122 person-sachets.
bThe denominators for the calculation of the risks were 1,936 person-days and 3,633 person-sachets.
cThe denominators for calculation of risks were 10,133 person-days and 28,744 person-sachets.