Table 2.
Select demographic, clinical, and biochemical results, clinical course, and outcomes of cases with liver injury from Garcinia cambogia (GC) alone or in combination with green tea (GT). All values are expressed as mean (standard deviation) unless otherwise mentioned.
| GC Alone (n=5) | GC + GT (n=16) | P-values | |
|---|---|---|---|
| Age, years median (min, max) | 34.9 (33.3, 37.2) | 33.4 (26.6, 43.6) | 0.741 |
| Female gender | 4/5 (80%) | 7/16 (44%) | 0.311 |
| Self-reported race | 0.356 | ||
| • White or Caucasian | 3/5 (60%) | 11/16 (69%) | |
| • Black or African American | 0/5 | 2/16 (13%) | |
| • Asian | 1/5 (20%) | 0/16 | |
| • Other/Multiracial | 1/5 (20%) | 3/16 (19%) | |
| Latino/Hispanic | 1/5 (20%) | 7/16 (44%) | 0.606 |
| Body mass index (kg/m2) | 27.7 (3.5) | 28.6 (5.2) | 0.965 |
| Liver injury | |||
| Days from primary drug start to DILI onset, median (min, max) | 87 (35, 139) | 72 (16, 424) | 0.710 |
| Signs and symptoms at DILI onset | |||
| • Jaundice | 3/5 (60%) | 15/16 (94%) | 0.128 |
| • Nausea | 3/5 (60%) | 11/16 (69%) | >0.999 |
| • Fever | 0/5 | 3/16 (19%) | 0.549 |
| • Abdominal pain | 2/5 (40%) | 10/16 (63%) | 0.611 |
| • Rash | 0/5 | 2/16 (13%) | >0.999 |
| • Itching | 1/5 (20%) | 8/16 (50%) | 0.338 |
| Liver enzymes at the date of DILI onset | |||
| • ALT (U/L) | 2383 (1211) | 1870 (1514) | 0.315 |
| • AST (U/L) | 1489 (754) | 1803 (2286) | 0.458 |
| • Alkaline phosphatase (U/L) | 198 (62) | 160 (69) | 0.127 |
| • Total bilirubin (mg/dL) | 8.3 (5.6) | 9.7 (6.1) | 0.689 |
| • INR | 1.1 (0.0) | 1.5 (0.6) | 0.551 |
| Pattern of liver injury at DILI onset or earliest after onset (R-value) | >0.999 | ||
| • Hepatocellular (>5) | 4/5 (80%) | 13/16 (81%) | |
| • Mixed (2–5) | 1/5 (20%) | 2/16 (13%) | |
| • Cholestatic (<2) | 0/5 | 1/16 (6%) | |
| Peak values from DILI onset to month 6 visit, means (SD) | |||
| • ALT (U/L) | 2493 (1002) | 1890 (1523) | 0.322 |
| • AST (U/L) | 1536 (655) | 1900 (2240) | 0.741 |
| • Alkaline phosphatase (U/L) | 215 (60) | 218 (89) | 0.836 |
| • Total bilirubin (mg/dL) | 21.4 (12.6) | 18.5 (14.6) | 0.457 |
| • INR | 1.7 (1.3) | 1.6 (0.4) | 0.535 |
| Time to peak and recovery (total bilirubin peak must be >=2.5 mg/dL) | |||
| • Days from onset to peak | 18 (1, 39) | 7 (0, 37) | 0.220 |
| • Days from peak to <2.5 mg/dL | 39 | 35 | 0.337 |
| • Days from peak to a 50% reduction from the peak | 10 | 10 | 0.903 |
| Outcomes | |||
| Patient was hospitalized or non-DILI hospitalization was prolonged | 5/5 (100%) | 14/16 (88%) | >0.999 |
| All death | 0/5 | 1/16 (6%) | >0.999 |
| All liver-related death | 0/5 | 0/15 | NC |
| All liver transplant | 1/5 (20%) | 0/16 | 0.238 |
| Chronic DILI | 1/4 (25%) | 1/14 (7%) | 0.405 |
| Severity Score | 0.180 | ||
| • Mild | 0/5 | 0/16 | |
| • Moderate | 0/5 | 2/16 (13%) | |
| • Moderate-hospitalized | 4/5 (80%) | 6/16 (38%) | |
| • Severe | 0/5 | 7/16 (44%) | |
| • Fatal | 1/5 (20%) | 1/16 (6%) |
One case of GC with Ashwagandha was excluded from this analysis.