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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Jin Bu Huan

Last Update: April 26, 2018.

OVERVIEW

Introduction

Jin Bu Huan is a Chinese herb used for centuries as a mild sedative and analgesic, recently marketed for insomnia, arthritic and orthopedic pain and gastrointestinal complaints. Jin Bu Huan products have been implicated in more than a dozen cases of idiosyncratic, clinically apparent, acute liver injury but the hepatotoxicity was likely due to a contaminant rather than Jin Bu Huan itself.

Background

Jin Bu Huan is a popular and widely used Chinese herbal medication which can contain several unrelated herbal species including Lycopodium serratum, Panax, Pseudo ginseng, Polygala chinensis and two species of Stephania. Jin Bu Huan has been used for centuries in China for multiple purposes including as a sedative, analgesic and decongestant for conditions ranging from asthma and bronchitis to night blindness, delirium, epilepsy, vertigo, fever and inflammation. The bases for the sedative, analgesic and antiinflammatory effects of Jin Bu Huan are not clear. Tetrahydropalmatine has been identified as a major constituent in some preparations of Jin Bu Huan. This compound has sedating effects possibly due to dopamine receptor or calcium channel antagonism.

Hepatotoxicity

More than a dozen cases of hepatotoxicity attributable to products sold as Jin Bu Huan have been reported, with onset of liver test abnormalities or jaundice within 2 to 24 weeks of starting the herbal supplement. The enzyme pattern was typically hepatocellular, and the clinical syndrome resembled acute viral hepatitis with marked serum aminotransferase abnormalities and minimal increases in alkaline phosphatase levels. Fever, headache and dizziness were also common. Eosinophilia and rash have been reported but were not prominent, nor were autoantibodies frequent. In several instances, continuation of Jin Bu Huan led to chronic aminotransferase elevations and a syndrome that resembles chronic hepatitis. Recovery was usually within 1 to 2 months of stopping. Recurrence of hepatic injury with restarting Jin Bu Huan occurred and resulted in more severe injury. The reported cases were associated with a specific commercial preparation of Jin Bu Huan (Anodyne) and it is unclear whether the injury was due to the traditional herbal combination or to a contamination or mislabeling of the subsequently withdrawn commercial product. After withdrawal of the implicated product, there have been no further reports of liver injury related to Jin Bu Huan, which remains a popular and widely available Chinese herbal remedy.

Likelihood score: cannot be assessed.

Mechanism of Injury

The mechanism of hepatotoxicity of Jin Bu Huan is not known, but some extracts are usually rich in levo-tetrahydropalmatine, which may have hepatotoxic potential. On the other hand, the majority of cases of hepatotoxicity from Jin Bu Huan have had features of an idiosyncratic reaction and may have been due to an adulterant or contaminant.

Outcome and Management

The severity of hepatotoxicity from Jin Bu Huan ranges from serum enzyme elevations without symptoms to acute hepatitis with marked jaundice. The injury is usually self-limited and rapidly reversible with stopping the herbal. Rechallenge leads to recurrence of injury and should be avoided. There is no evidence that there is cross sensitivity to hepatic injury between Jin Bu Huan and other Traditional Chinese medicines.

Drug Class: Herbal and Dietary Supplements, Chinese and Other Asian Herbal Medicines

CASE REPORT

Case 1. Chronic hepatitis due to Jin Bu Huan.

[Modified from: Picciotto A, Campo N, Brizzolara R, Giusto R, Guido G, Sinelli N, Lapertosa G, Celle G. Chronic hepatitis induced by jin bu huan. J Hepatol 1998; 28: 165-7. PubMed Citation]

A 49 year old man was found to have elevations in serum aminotransferase levels two months after starting Jin Bu Huan Anodyne tablets. He did not inform his physicians he was taking this “natural” sedative and analgesic and continued it despite the liver test abnormalities. He was asymptomatic of liver disease and had no other major illnesses. His medical history included inguinal hernia repair, appendectomy and kidney stones. He was not taking any conventional medications, denied alcohol abuse and had no previous history of liver disease or risk factors for viral hepatitis. His serum aminotransferase levels were known to have been normal in the past (Table). Physical examination was unrevealing. Laboratory tests showed serum ALT 274 U/L, AST 154 U/L, alkaline phosphatase 249 U/L (normal 96-279 U/L), GGT 110 U/L, and bilirubin 0.8 mg/dL. Tests for hepatitis A, B and C were negative as were autoantibodies, ceruloplasmin and alpha-1-antitrypsin levels, ferritin and iron saturation. His serum ALT and AST remained elevated, and 10 months after initial presentation he underwent liver biopsy which showed chronic hepatitis with moderate inflammation and early bridging fibrosis. At this point, he admitted to use of Jin Bu Huan which he had started approximately two months before his liver tests were found to be abnormal. Within 1 month of stopping the herbal, his serum ALT and AST fell into the normal range and remained normal in follow up.

Key Points

Medication:Jin Bu Huan Anodyne tablets
Pattern:Hepatocellular (R=6.8)
Severity:1+ (serum enzyme elevations without symptoms or jaundice)
Latency:8 weeks
Recovery:4 weeks
Other medications:None

Laboratory Values

Months After StartingMonths After StoppingALT
(U/L)*		AST
(U/L)*		Bilirubin (mg/dL)Other
0Pre2520Jin Bu Huan started
211560
313070
418590
5274154.0.8
6260145
7160100
8280210
10160200Liver biopsy
110100100NormalJin Bu Huan stopped
1213836
1432525
1853022
Normal Values <40 <40 <1.2

* Values estimated from Figure 3.

Comment

The case history is somewhat typical of herbal induced liver injury, in that the patient did not inform his physicians that he was taking a Chinese herb when he first presented, believing that it was a natural product and unlikely to be harmful or medically important. Even when asked directly, patients may deny taking herbal medications, often because of the perception that Western physicians are hostile to the use of “natural” supplements and would be critical of their use. The clinical presentation resembled chronic hepatitis, being marked by serum aminotransferase elevations without jaundice or alkaline phosphatase abnormalities and a paucity of symptoms. The chronic hepatitis phenotype was confirmed by liver biopsy which showed changes that resembled chronic viral hepatitis including fibrosis. Importantly, the chronic elevations occurred during long term continuing therapy and resolved rapidly once the herbal was stopped. Many medications that cause an acute hepatitis-like syndrome can also cause a chronic hepatitis if the injury is less acute and severe and the medication is continued long term (minocycline, nitrofurantoin, isoniazid). While the clinical pattern may resemble chronic hepatitis, it is usually not self-sustaining, and resolves when the medication is stopped (although the resolution may be slow or delayed).

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Jin Bu Huan – Generic

DRUG CLASS

Herbal and Dietary Supplements

CHEMICAL FORMULA AND STRUCTURE

DRUGCAS REGISTRY NUMBERMOLECULAR FORMULASTRUCTURE
Jin Bu HuanNo InformationHerbal mixtureNot applicable

ANNOTATED BIBLIOGRAPHY

References updated: 26 April 2018

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    (49 year old man found to have raised serum enzymes while taking Jin Bu Huan unbeknownst to his physicians [bilirubin 0.8 mg/dL, ALT 274 U/L, Alk P normal], which persisted for 10 months, biopsy showing chronic hepatitis and bridging fibrosis, liver tests falling to normal upon stopping herbal: Case 1).
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    (42 year old woman took 3 herbals including Jin Bu Huan for insomnia and developed jaundice 10 weeks later [bilirubin 1.2 mg/dL, ALT 3386 U/L, Alk P 100 U/L], resolving in 6 weeks; 39 year old woman took several herbs including chaparral and developed jaundice and confusion [bilirubin 42.7 mg/dL, ALT 349 U/L], followed by liver failure and emergency liver transplantation).
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    (30 patients with drug induced liver disease seen at a single medical university in Shanghai between 2000-2008, of which 12 were attributed to Chinese herbs, but specific agents not discussed, 9 were jaundiced, 6 hepatocellular, 3 cholestatic and 2 mixed).
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    (A systematic compilation of all publications on the hepatotoxicity of specific herbals identified 185 publications on 60 different herbs, herbal drugs and supplements including 3 publications on Jin Bu Huan [Woolf 1994, Horowitz 1996, Picciotti 1998]).
  • Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, et al. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 2014; 60:1399-408. [PMC free article: PMC4293199] [PubMed: 25043597]
    (Among 85 cases of HDS associated liver injury [not due to anabolic steroids] enrolled in a US prospective study between 2004 and 2013, none were attributed to a known Jin Bu Huan).
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    (Listing of names of Traditional Chinese Medicines that have been implicated in causing liver injury mentions that Jin Bu Huan hepatotoxicity has been reported from Hong Kong [1 case], the US [11 cases], Canada [1 case] and Italy [1 case], but none since 2002).
  • Teschke R, Zhang L, Long H, Schwarzenboeck A, Schmidt-Taenzer W, Genthner A, Wolff A, et al. Traditional Chinese Medicine and herbal hepatotoxicity: a tabular compilation of reported cases. Ann Hepatol 2015; 14: 7-19. [PubMed: 25536637]
    (Listing of published cases of hepatoxicity from Traditional Chinese Medicines and analysis of causality using RUCAM identified 4 cases attributed to Jin Bu Huan, 3 scored as probable and 1 possible, and rechallenge results being positive for two cases and negative for two).
  • Brown AC. Liver toxicity related to herbs and dietary supplements: Online table of case reports. Part 2 of 5 series. Food Chem Toxicol 2017; 107 (Pt A): 472-501. [PubMed: 27402097]
    (Description of an online compendium of cases of liver toxicity attributed to HDS products, lists 4 publications on Jin Bu Huan describing an acute hepatitis possibly due to levo-tetrahydropalmatine or pyrrolizidine alkaloids).

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