MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.

A recent case-report  suggests that it might not be as safe as often assumed.

A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.

After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.

The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.

Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).

Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.

Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.

The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.

29 Responses to Fatal liver failure after long-term intake of a popular and ‘time-tested’ herbal remedy

  • “Natural” is plants evolving toxins to sicken and kill the animals that would otherwise eat them.

    Why is it that “healthy-living” alties are so keen to fill their bodies with plant-manufactured poisons?

  • Is there an alternative hypothesis to this conclusion, which appears to be derived from marginal anecdote?

    In comparison, I wonder if there are any established, trusted “Western medicine” substances (necessarily with less history) which may also cause liver damage in the West.

    • @Will
      Is there different liver damage in the west than the east? Or north, or south?

    • There are lots of drugs which can cause liver damage. We monitor them with regular blood tests to pick up the early signs of toxicity so that they can be discontinued.

      As far as I can see, the main difference between herbal medicines and pharmaceuticals is that the latter are strictly quality-controlled, particularly with regard to dose, and the effects, including toxicities, are well-characterised. This includes the pharrmacokinetics (how the drugs is absorbed and distributed through the various tissues of the body, how the levels vary following dosing, how it is metabolised and eliminated).

      There are also idiosyncratic reactions, which are rare, but information about them is still usually available in the data sheet. These might be when an individual is missing an enzyme involved in the usual metabolic pathway of the drug, for instance. An example from oncology is 5-fluorouracil and diphyridamole dehydrogenase deficiency leading to catastrophic toxicity from a commonly-prescribed chemotherapy drug.

      “necessarily with less history”
      However interesting it may be to medical historians, as a prescriber, I would much rather know what a drug does in the body, its mechanism of action, pharmakokinetics, toxicity, interactions, what effect reduced liver or kidney function has on it, what monitoring is required in order to use it safely etc. than its history of use by practitioners with little knowledge of physiology, pathology or pharmacology.

      Just because something has been used as a treatment for a long time doesn’t mean that anybody knows very much about it.

      As has has pointed out, plants (and poisonous animals) have evolved to produce pharmacologically active substances in order to defend themselves and also to attract other species. Anything which has enough of an effect on the body to be useful as a medicine also has the potential to be toxic.

      The point is that when a doctor prescribes a drug, he has a lot of information available including exactly what is in it and what it does. The same can’t be said for those prescribing herbal medicines.

      • Julian,

        “The point is that when a doctor prescribes a drug, he has a lot of information available including exactly what is in it and what it does. The same can’t be said for those prescribing herbal medicines.”

        This (https://www.washingtonpost.com/news/wonk/wp/2015/07/23/one-big-myth-about-medicine-we-know-how-drugs-work/?noredirect=on&utm_term=.6a4ca0f060be) is from a Washington Post article is from 2015, so maybe things are different now. But at the time, they wrote:

        “Knowing why a drug works has historically trailed the treatment, sometimes by decades. Some of the most recognizable drugs — acetaminophen for pain relief, penicillin for infections, and lithium for bipolar disorder, continue to be scientific mysteries today.”

        I always assumed that the main danger with herbal prescriptions was that in a lot of places, anyone can hang out a shingle and call themselves an herbalist – with minimal or no training. Or google your symptoms, and buy herbal medicines on Amazon.

        A prescription from a Doctor of Traditional Medicine really isn’t all that different than a prescription from a modern MD of allopathic medicine, if the Post article is accurate:

        “Here’s how we actually develop a surprising number of treatments: good old-fashioned observation, trial and error, and luck. Detailed scientific understanding of how a drug works often comes, ironically enough, near the end of the process.”

        The process is the same in traditional systems. Traditional Medicine doctors use different models for anatomy, physiology, and pathology – and if someone doesn’t understand the models, they might argue the “detailed scientific understanding” part. But I have yet to meet anyone that has taken the time to (even superficially) understand a traditional model and come to the conclusion that the model is “unscientific”.

        Whatever system you prefer, medicine has inherent risks. So it goes.

  • Oh what a pointless ‘exposure’ again. Far more people die or suffer damage to their health from statins, alcohol, over the counter medicines, chemo therapy et al. Move on, nothing to see here.

    • thank you for posting another idiotic comment.

    • jm,

      I don’t think you have read my post very carefully. I did not say that we knew the exact mechanism of action of pharmaceuticals, because very often we don’t. But a prescribing doctor does have a lot of detailed information about the drug which I won’t go to the trouble of explaining a second time.

      I do not regard the Washington Post or any other newspaper as a substitute for a university course in pharmacology, or a reliable source of information about anything.

      • Julian,

        If you think my comment was suggesting that a Washington Post article was a substitute for a university course in pharmacology…I don’t think you read my post very carefully.

        Your “The same can’t be said for those prescribing herbal medicines.” is technically true, if you include all the random folk out there with minimal (if any) training. And/or the google/amazon system of medicine. But prescribing doctor of traditional medicine does have a lot of detailed information about the drug.

    • Well of course they are if you add all these together, but that wasn’t really what the post was about.

  • I agree with Helen Murray. Also, the person who died could have had previous undetected liver issues. One swallow does not make a summer. There are far more deaths caused by modern medicine than by herbal medicine.

    Now that doesn’t mean it’s information that should be ignored, but investigated and put in perspective.

    Herbal medicine has a really great long term safety record, it is true that certain herbs should be prescribed only by qualified herbalists with robust training.

    Attacking herbal medicine over an isolated case seems like using any means to justify a position. I don’t mind a logical, well supported view, but unfortunately ( at least in this article) I haven’t found any evidence of such reasoning.

    • “There are far more deaths caused by modern medicine than by herbal medicine.”

      As indicated above, please remember: if you make a claim in a comment, support it with evidence. Is it even possible to measure that? Please pass along the evidence.

    • Herbal medicine has a really great long term safety record

      Sure. So does not intervening at all.

    • “There are far more deaths caused by modern medicine than by herbal medicine”
      Do you have any evidence to back up that claim? We already know that the claims about the number of deaths in the USA due to medical errors are impossible if you actually look at the numbers and were arrived at using unsound methods of analysis from data which had been collected for a completely different purpose by people who had no training in statistics or epidemiology and extrapolated to a different population altogether.

      I don’t know of any data that has been collected about herbal medicine so as far as I no there is no safety record at all, good or bad. This is one of the reasons why it is so important to highlight this sort of adverse reaction.

      “Also, the person who died could have had previous undetected liver issues.”
      Yes, they could. However, if an apparantly healthy person develops acute fulminant hepatitis usually it turns out that their liver was fine to beging with and the problem is toxicity from something that they have been exposed to.

      If this happened unexpectedly following ingestion of a prescription medicine it would be thoroughly investigated and alerts would be sent out to all doctors, even if causation hadn’t been established.

      “One swallow does not make a summer.”
      That is a reckless position to take if you are treating patients.

  • Just look at the dose… Every medicine is toxic if not taken in appropriate doses. The biggest problem is self medication is so prevalent in using herbal medicine thinking that it ‘it is natural/herbal so it would have no harm’. A qualified physician in traditional medicinal systems would know that the dosage is extremely important.

    And this is only a case report and should be validated by detailed clinical studies.
    These types of publication is only guiding the public to revere these herbal medicines.

    • “a case report … should be validated by detailed clinical studies”
      YOU SEEM TO HAVE AN EXCELLENT UNDERSTANDING OF BOTH THESE METHODOLOGIES!

  • One ladies negative reaction. The amount she was taking blew my mind. I have been on these herbal medicine my therapist told me one to take for one month and I had to return for check up. Upon returning I was told to cease taking and my body would now take over. So it comes down to people thing more is better. Dosage is so important to follow instruction and A qualified therapist

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