Table 2. Worldwide countries with a selection of published HILI cases assessed for causality using RUCAM providing various causality gradings.
| Country | Assessable cases/initial cases/% [n/n/%] | Highly probable [n/%] | Probable [n/%] | Possible [n/%] | Other grades [n/%] | Comments |
|---|---|---|---|---|---|---|
| All countries worldwide | 11,404/12,068 94.5% |
487/4.2% | 1,765/15.5% | 8,016/70.3% | 1,136/10.0% | Out of 12,068 published RUCAM based HILI cases, 11,404 cases (94.5%) were assessable for causality grading |
| Australia | 2/2/100% | - | 2/100% | - | - | Low case numbers but all cases received a high causality grading of probable and benefitted from this classification |
| Austria | 2/2/100% | - | 1/50% | 1/50% | - | One case was provided with a causality grading of probable |
| Brazil | 1/1/100% | – | 1/100% | – | – | In this single case, perfect and appreciated causality grading of probable |
| China | 10,663/10,993/97.0% | 447/4.2% | 1,497/14.0% | 7,611/71.4% | 1,108/10.4% | Valuable are the 1,944 HILI cases with a highly probable or probable causality grading, but associated with 1,108 cases with an unlikely or excluded causality grading |
| Colombia | 1/1/100% | – | 1/100% | – | – | Perfect causality grading in this single case |
| France | 10/10/100% | 2/20% | 8/8% | – | – | Appreciated high causality gradings of highly probable and probable |
| Germany | 111/112/99.1% | 10/9.0% | 35/31.5% | 57/51.4% | 9/8.1% | Virtually all published cases (99.1%) provided causality gradings, but high case numbers with a possible or lower causality gradings |
| India | 50/111/45.0% | – | – | 50/100% | – | All cases reached only a possible causality grading |
| Italy | 75/75/100% | 1/1.3% | 40/53.3% | 29/38.7% | 5/6.7% | Many HILI cases with a probable causality grading as compared with lower cases numbers of causality gradings of possible |
| Japan | 3/3/100% | – | 3/100% | – | – | Small case numbers but with causality gradings of probable |
| Korea | 300/493/60.9% | 14/4.7% | 52/17.3% | 234/78.0% | – | Among the published 439 cases, only 60.9% provided causality gradings including extremely high case numbers (n=234) with an unlikely or excluded causality grading |
| Singapore | 25/25/100% | – | 15/60% | 1/4.0% | 9/36.0% | All 25 cases provided a causality grading including a probable grading in 15 cases |
| South Africa | 47/47/100% | 4/8.5% | 27/57.5% | 15/31.9% | 1/2.1% | All published HILI cases were assessable regarding causality grading with higher case numbers [31] providing a highly probable and probable grading compared with 15 cases presenting a possible one |
| Spain | 33/47/70.2% | 8/24.2% | 20/60.6% | 5/15.2% | – | Out of 47 published HILI case, 33 cases were assessable for causality grading, providing 28 cases with a highly probable and probable grading as opposed to 5 cases with a possible grading |
| Sweden | 5/5/100% | – | 5/100% | – | – | Excellent study, all cases were assessable and provided a probable causality ranking |
| Switzer-Land | 1/1/100% | – | 1/100% | – | – | Perfect single case report with a probable causality grading |
| Turkey | 1/1/100% | – | 1/100% | – | – | Single case report, fulfilling with a causality grading of probable all requirements for a good case evaluation |
| United States | 74/91/81.3% | – | 56/75.7% | 13/17.6% | 4/5.4% | Out of published 91 HILI cases, 74 cases (81.3%) were assessable for causality grading and presented 57 cases with a highly probable and probable grading as opposed to 13 cases with a less desired possible grading |
Listed are for each country the causality gradings with HILI case numbers and in percentages calculated from assessable cases of the respective country. Occasionally, published reports presented scores ≥6 that would include causality gradings of probable and highly probable, for reasons of clarity and homogeneity, all these cases were included in the lower grading category of probable. Similarly, all cases with a score ≥3 or ≥4 were included in the possible causality category, and cases with a score ranging from 3 to 12 were incorporated in the possible causality grading group. Data are derived from Table1 that provides additional details. HILI, herb-induced liver injury; RUCAM, Roussel Uclaf Causality Assessment Method.