Review Article

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 eventsRisk*
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 pain1.80.68.34.41.80.6
 Abdominal fullness4.21.412.96.91.70.6
 Dizziness1.80.6
 Chest pain0.60.23.11.70.30.1
 Fever0.60.21.00.20.20.1
 Somnolence11.96.3
 Musculoskeletal system
 Muscle cramps10.35.50.10.1
 Headache1.80.64.62.5
Respiratory system
 Cough3.01.012.46.62.60.9
 Rhinitis1.80.68.34.41.90.7
 Pharyngitis1.80.68.34.42.50.9
Digestive system
 Diarrhea3.61.210.35.51.60.6
 Nausea1.20.43.11.70.80.3
 Vomit0.60.20.50.30.30.1
 Oral ulcer1.50.80.20.1
 Stomachache0.60.20.50.2
Skin and appendages
 Urticaria0.50.30.10.0
 Pruritus0.60.21.60.6
 Skin discolor0.50.30.30.1
 Rash 0.60.214.57.70.80.3

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.