Table 1.
Selected demographic, clinical, and biochemical results, clinical course, and outcomes of cases with liver injury from herbal and dietary supplements (HDS) containing Garcinia cambogia (GC), green tea (GT), or Others (non-anabolic steroid HDS).
| Characteristic | GC containing HDS (N=22) |
GT containing HDS (N=57) |
Other HDS (N=103) |
P-values |
|---|---|---|---|---|
| Age, years, median (Min, Max) | 35 (17, 54) | 41 (21, 80) | 53 (21, 81) | <0.001 |
| Female gender | 12/22 (55%) | 38/57 (67%) | 66/103 (64%) | 0.600 |
| Self-reported race | 0.343 | |||
| • White or Caucasian | 14/22 (64%) | 45/56 (80%) | 71/103 (69%) | |
| • Black or African American | 2/22 (9%) | 4/56 (7%) | 10/103 (10%) | |
| • Asian | 1/22 (5%) | 1/56 (2%) | 10/103 (10%) | |
| • Other/Multiracial | 5/22 (23%) | 6/56 (11%) | 12/103 (12%) | |
| Latino/Hispanic | 9/22 (41%) | 19/56 (34%) | 20/103 (19%) | 0.037 |
| Weight (kg) | 82.6 (16.4) | 79.8 (20.2) | 73.1 (18.7) | 0.011 |
| Body mass index (kg/m2) | 28.6 (4.8) | 28.6 (6.8) | 26.4 (5.4) | 0.034 |
| Pre-existing medical conditions | ||||
| • Prior drug allergies | 3/22 (14%) | 14/57 (25%) | 42/103 (41%) | 0.015 |
| • Alcohol use | 12/22 (55%) | 28/52 (54%) | 50/99 (51%) | 0.897 |
| • Chronic hepatitis C | 2/22 (9%) | 1/57 (2%) | 2/103 (2%) | 0.188 |
| Temporal association | ||||
| • Days from primary drug start to earliest sign or symptom | 51.0 (13.0, 223.0) | 65.5 (11.0, 442.0) | 59.5 (0.0, 1885.0) | 0.623 |
| • Days from primary drug start to DILI onset | 71.5 (16.0, 424.0) | 74.5 (15.0, 448.0) | 61.0 (1.0, 1891.0) | 0.153 |
| Signs and symptoms at DILI onset | ||||
| • Jaundice | 19/22 (86%) | 47/57 (83%) | 71/103 (69%) | 0.072 |
| • Nausea | 15/22 (68%) | 41/57 (72%) | 52/103 (51%) | 0.020 |
| • Fever | 3/22 (14%) | 6/57 (11%) | 16/103 (16%) | 0.678 |
| • Abdominal pain | 12/22 (55%) | 24/57 (42%) | 49/103 (48%) | 0.589 |
| • Rash | 2/22 (9%) | 8/57 (14%) | 13/103 (13%) | 0.839 |
| • Itching | 10/22 (46%) | 24/57 (42%) | 39/103 (38%) | 0.751 |
| Liver biopsy performed | 16/22 (73%) | 31/57 (54%) | 61/102 (60%) | 0.329 |
| Treated with Prednisone or Other Corticosteroids | 2/22 (9%) | 7/57 (12%) | 18/101 (18%) | 0.458 |
| At the date of DILI onset | ||||
| • ALT (U/L) | 1975 (1400) | 1650 (1418) | 1091 (1228) | 0.003 |
| • AST (U/L) | 1679 (1958) | 1081 (944) | 900 (1278) | 0.018 |
| • Alkaline phosphatase (U/L) | 170 (66) | 228 (238) | 246 (184) | 0.094 |
| • Total bilirubin (mg/dL) (TB) | 9.3 (5.7) | 9.4 (7.5) | 8.2 (8.0) | 0.244 |
| • INR | 1.4 (0.50) | 1.5 (0.86) | 1.6 (1.12) | 0.907 |
| Pattern of liver injury at DILI onset or earliest after onset (R-value) | 0.160 | |||
| • Hepatocellular (> 5) | 18/22 (82%) | 46/57 (81%) | 69/103 (67%) | |
| • Mixed (2–5) | 3/22 (14%) | 4/57 (7%) | 21/103 (20%) | |
| • Cholestatic (<2) | 1/22 (4.5%) | 7/57 (12%) | 13/103 (13%) | |
| Peak Value from DILI onset to month 6 visit, means (SD) | ||||
| • ALT (U/L) | 2010 (1388) | 1680 (1437) | 1238 (1260) | 0.008 |
| • AST (U/L) | 1767 (1934) | 1335 (1103) | 1065 (1424) | 0.018 |
| • Alkaline phosphatase (U/L) | 215 (80) | 262 (234) | 309 (241) | 0.267 |
| • Total bilirubin (mg/dL) | 18.6 (13.8) | 16.7 (11.44) | 13.6 (11.38) | 0.103 |
| Median Days from onset to peak serum TB (min, max) | 7 (0, 39) | 7 (0, 77) | 7 (0, 178) | 0.834 |
| Median Days from peak to a 50% reduction in serum TB | 10.0 | 17.0 | 13.0 | 0.030 |
| Outcomes | ||||
| Patient was hospitalized or non-DILI hospitalization was prolonged | 20/22 (91%) | 38/57 (67%) | 67/103 (65%) | 0.055 |
| All death | 1/22 (5%) | 1/57 (2%) | 6/103 (6%)* | 0.579 |
| All liver-related death | 0/21 | 0/56 | 0/97 | NC |
| All liver transplant | 1/22 (5%) | 4/57 (7%) | 7/103 (7%) | 0.927 |
| Chronic DILI | 2/19 (11%) | 4/41 (10%) | 12/89 (14%) | 0.933 |
| Severity Score | 0.126 | |||
| • Mild | 0/22 | 8/57 (14%) | 24/103 (23%) | |
| • Moderate | 2/22 (9%) | 12/57 (21%) | 14/103 (14%) | |
| • Moderate-hospitalized | 11/22 (50%) | 21/57 (37%) | 31/103 (30%) | |
| • Severe | 7/22 (32%) | 11/57 (19%) | 22/103 (21%) | |
| • Fatal | 2/22 (9%) | 5/57 (9%) | 12/103 (12%) |
All values are expressed as mean (standard deviation) or number (proportion) with denominator given when there are missing data unless otherwise mentioned.
R = alanine aminotransferase ÷ alkaline phosphatase, both expressed as multiples of the upper limit of the normal range. TB = total bilirubin.
*
One patient died after undergoing liver transplant.