Table 4. RUCAM based HILI reports with negative or rare causality.
| Country | Author | Year | Initially suspected HILI [n] | Products | Comments |
|---|---|---|---|---|---|
| Germany | Teschke (108) | 2008 | HILI [26] | Piper methysticum, syn. Kava | RUCAM was used providing for most cases negative causality gradings: in 18/26 cases, causality for kava was unassessable or excluded; among the remaining 8 cases, a probable causality grading for kava was attributed to 1 patient who adhered on the regulatory daily dose and maximum duration of the therapy, with another patient who received a highly probable causality grading for kava because of a positive result due to an unintentional reexposure, whereas for the remaining 6 cases variable causality gradings for kava ± comedicated drugs were found |
| Teschke (109) | 2010 | HILI [69] | Actacea racemosa, formerly Cimicifuga racemosa, syn. Black cohosh | Using RUCAM in all 69 cases, in none of the cases a probable or highly probable causality grading was evident; causality for Actacea recemosa was excluded in 27 cases, unlikely in 21, unrelated in 8, and unassessable in 12 cases; only 1/69 cases received a possible causality grading | |
| Teschke (110) | 2012 | HILI [15] | Pelargonium sidoides | With RUCAM, scores ranged from +5 to −1 points, signifying neither a highly probable nor a probable causality grading for PS in any of the 15 patients: causality for PS was found possible in 3 cases, unlikely in 8, and excluded in 4 cases |
|
| Teschke (111) | 2016 | HILI [10] | Petasides hybridus | Using the updated RUCAM, 9/10 cases received scores from 0 to 2, equivalent to an excluded or unlikely causality grading, whereas for 1/10 cases a score of 3 was attributed, signifying a low graded possible causality grading | |
| United Kingdom | EMA (112) | 2007 | HILI [47] | Actacea racemoae, syn. Cimicifuga racemose, syn. Black cohosh | RUCAM used in 31 cases: cases qualified for unassessable, excluded or unrelated causality. RUCAM in additional 16 cases provided causality gradings: excluded in 5 cases (scores between 0 and −2), unlikely (scores between 1 and 2) in 8 cases, possible (scores 3, 4, and 5) in 3 cases, and probable (scores 7 and 6) in 2 cases |
EMA, European Medicines Agency; HILI, herb-induced liver injury; RUCAM, Roussel Uclaf Causality Assessment Method.