Table 1.
Summary of observational studies included
| Description | Levy et al., 2017 | Jeong et al., 2012 |
|---|---|---|
| Study design, population and duration | Cross‐sectional study of 947 patients hospitalized in 12 departments of a tertiary academic medical Centre in Haifa, Israel from 2009 to 2014. | A prospective study of 313 inpatients (87 male and 226 female) hospitalized in two Oriental Hospitals of Daejeon University, Daejeon, Korea from August 2008 to October 2010 |
| Inclusion criteria |
Intake of herbal medicine at least 1 week prior to hospitalization. Patients at 18 years and above who were able to communicate and provide verbal informed consent. |
Intake of herbal medicine at least 10 days during hospitalization. |
| Exclusion criteria | Not mentioned | A life expectancy of <12 months (by judgment of the patient's doctor); current or previous liver diseases including carrier status of hepatitis virus, renal disease, or autoimmune disease; and abnormal baseline results on liver or renal function tests on hospitalization. |
| Sex |
Male: 152 (33%) Female: 306 (67%) |
Male 87 (27.8%) Female 226 (72.2%) |
| Mean age | 61.3 years | 51 years |
| Herb users with different comorbidities | 458 (100%) | 313 (100%) |
| Metabolic | 243 (53%) | |
| Circulatory system | 237 (52%) | 87 (27.8%) |
| Haemato‐oncological | 95 (21%) | 77 (24.6%) |
| Musculoskeletal system | 66 (21.1%) | |
| Neurologic | 38 (8%) | 40 (12.8%) |
| Digestive system | 39 (8.5%) | 17 (5.4%) |
| Endocrine | 132 (29%) | |
| Respiratory | 39 (8.5%) | |
| Renal | 37 (8%) | |
| Rheumatological | 37 (8%) | |
| Pregnancy | 30 (7%) | |
| Psychiatric | 29 (6%) | |
| Ophthalmological | 21 (5%) | |
| Urological | 17 (4%) | |
| Hepatobiliary | 10 (2%) | |
| HIV | 23 (7.3) | |
| Others | 3 (1.0) | |
| Mode of causality assessment | DIPS | RUCAM score |
| Cases of ADR |
Total = 17 Herbs/pure compounds = 7 Other supplements = 10 |
Total = 6 Herb/pure compounds = 6 Other supplements = 0 |
ADRs classified by RUCAM score for liver injury; no provision of patient history and ADRs classified by Horn's DIPS score for other injuries. ADR = adverse drug reaction; HIV = human immunodeficiency virus; DIPS = drug interaction probability scale; RUCAM = Roussel Uclaf Causality Assessment Method