Original Article
Copyright ©2013 Baishideng Publishing Group Co.
World J Hepatol. Jul 27, 2013; 5(7): 353-363
Published online Jul 27, 2013. doi: 10.4254/wjh.v5.i7.353
Table 5 Causality assessment of all eight patients with primarily suspected Herbalife hepatotoxicity and an initially assumed positive reexposure test
Items for hepatocellular type of injuryScore12345678
1 Time to onset from the beginning of Herbalife
5-90 d (rechallenge: 1-15 d)+2+2
< 5 or > 90 d (rechallenge: > 15 d)+1+1+1+1+1+1+1+1
Alternative: Time to onset from cessation of Herbalife
≤ 15 d (except for slowly metabolized chemicals: > 15 d)+1
2 Course of ALT after cessation of Herbalife
Percentage difference between ALT peak and N
Decrease ≥ 50% within 8 d+3
Decrease ≥ 50% within 30 d+2+2
No information00000000
Decrease ≥ 50% after the 30th d0
Decrease < 50% after the 30th d or recurrent increase-2
3 Risk factors
Alcohol use (drinks/d: > 2 for woman, > 3 for men)+1
Alcohol use (drinks/d: ≤ 2 for woman, ≤ 3 for men)000000000
Age ≥ 55 yr+1+1+1+1
Age < 55 yr000000
4 Concomitant drug(s)
None or no information000
Concomitant drug with incompatible time to onset00
Concomitant drug with compatible or suggestive time to onset-1
Concomitant drug known as hepatotoxin and with compatible or suggestive time to onset-2-2-2-2-2-2
Concomitant drug with evidence for is role in this case (positive rechallenge or validated test)-3
5 Search for non Herbalife causes
Group I (6 causes)
Hepato-biliary sonography/colour Doppler sonography of liver vessels/endosonography/CT/MRC+----
Alcoholism (AST/ALT ≥ 2)-------
Acute recent hypotension history (particularly if underlying heart disease)------
Group II (6 causes)
Complications of underlying disease(s), such as sepsis, autoimmune hepatitis, chronic hepatitis B or C, primary biliary cirrhosis or sclerosing cholangitis, genetic liver diseases-----
Infection suggested by PCR and titer change for
CMV (Anti-CMV-IgM/IgG)----
EBV (Anti-EBV-IgM/IgG)----
HEV (Anti-HEV-IgM/IgG)+
HSV (Anti-HSV-IgM/IgG)
VZV (Anti-VZV-IgM/IgG)
Evaluation of group I and II
All causes - group I and II - reasonably ruled out+2
The 6 causes of group I ruled out+1+1+1+1+1
5 or 4 causes of group I ruled out0
Less than 4 causes of group I ruled out-2-2-2-2
Non Herbalife cause highly probable-3-3
6 Previous information on hepatotoxicity of Herbalife
Reaction labelled in the product characteristics+2
Reaction published but unlabelled+1+1+1+1+1+1+1+1+1
Reaction unknown0
7 Response to readministration
Doubling of ALT with Herbalife alone, provided ALT below 5 N before reexposure+3+3
Doubling of ALT with Herbalife and herb(s) or drug(s) already given at the time of first reaction+1
Increase of ALT but less than N in the same conditions as for the first administration
Other situations00000000
Total points for patients+07+02+01+02-01-02+010