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

Realgar, α-As4S4, is an arsenic sulfide mineral, also known as “ruby sulphur” or “ruby of arsenic”. It is a soft, sectile mineral occurring in monoclinic crystals, or in granular, compact, or powdery form, often in association with the related mineral, orpiment (As2S3).

In Traditional Chinese Medicine (TCM), realgar is often used in combination with herbs. An investigation found a total of 191 different, realgar-containing traditional Chinese patent medicines, and about 87% of them were for oral application. Realgar is said to: 

counteract toxic pathogen both externally and internally. For abscess swelling and sores, it can be used singly or in compound prescription for external application mostly. When taken internally, it is combined with blood-activating and abscess-curing herbs to obtain the action of activating blood to relieve swelling, removing toxicity to cure sores. For example, it is combined with Ru Xiang, Mo Yao and She Xiang in Xing Xiao Wan from Wai Ke Quan Sheng Ji. For itching of skin due to scabies and ringworm, it is often combined with dampness-astringing and itching-relieving herbs to obtain actions of killing parasites and curing ringworm, astringing dampness and relieving itching. For instance, it is combined with the same dose of Bai Fan in powder mixed with clear tea for external application in Er Wei Ba Du San from Yi Zong Jin Jian. For poisonous insect bite, it is mixed with sesame oil and then applied on the afflicted sites.

This herb can kill parasites so it is indicated for intestine track parasites. For roundworm induced abdominal pain, it is often combined with other roundworm-killing herbs to reinforce action. For instance, it is combined with Qian Niu Zi and Bing Lang, etc. in Qian Niu Wan from Shen Shi Zun Sheng Shu. For anus pruritus caused by pinworm, it can be made into gauze strip by mixing with vaseline, and then inserted into the anus.

In addition, according to some ancient formulas, this herb can dispel phlegm and check malaria for internal application, so it can also be indicated for epilepsy, asthma and malaria.

Longtime topical over-dose or oral intake of realgar can cause chronic arsenic poisoning and even death. Chinese authors recently published the case of a 35-year-old Chinese man, who was diagnosed with severe psoriasis and died of fatal acute arsenic poisoning after he applied a local folk prescription ointment containing mainly realgar to the affected skin for about 4 days. The autopsy showed multiple punctate haemorrhages over the limbs, pleural effusion, oedematous lungs with consolidation, mild myocardial hypertrophy and normal-looking kidneys. The histopathological examination of renal tissue showed severe degeneration, necrosis and desquamation of renal tubular epithelial cells, presence of protein cast and a widened oedematous interstitium with interstitial fibrosis. The presence of arsenic in large amount in the ointment (about 6%), in blood (1.76 μg/mL), and in skin (4.71 μg/g), were confirmed analytically. The authors also review 7 similar cases in literature.

My advice is that, when you see recommendations by TCM practitioners like this one

the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically

you think again and consider that TCM really is not a form of healthcare that can be trusted to be safe.

8 Responses to Death by Traditional Chinese medicine (TCM)

  • Astonishing. With the dynamics of the Eastern World being the dominant force in the next 150 years. I expect to see a lot more of this unless the West collectively tackles it now. Is there any EU initiative on this? Does anyone know

    • not to my knowledge

    • Well – there is the directive on human medicinal products which enforces all drugs, including traditional ones, to be registered or approved accordingly before they are legally sold. So unless this process has been done things like TCM drugs are illegal drugs. However, there are som EU (or soon to be former EU) countries with special exemptions for certain kinds of herbalism…

      • I smell a rat here, I see that there is a “tradition” of mixing active materials with inert “herbs” do you think perhaps the regulations are being circumvented like this

        • I am not sure what you are getting at – regardless of any exemptions mixing undeclared ingredients into products brakes all kinds of laws. Mixing conventional drug substances into herbal preparations makes the preparation a conventional drug and needs to fullfil those legal requirements. However, there is (as frequently pointed out by E.Ernst) a common disregard for constituents in traditional preparations/medications/drugs and in several countries all these are treated as “herbals” even if they contain minerals or animals (TCM, antroposophics, ayurveda, unani etc) or even nothing at all (homeopathics). Within the EU, as well as in USA and Australia, a bigger issue is the blurring line between drugs and dietary supplements due to political acceptance of “health claims” for the latter. A drug needs prior approval or at least registration (including production-quality control) before being sold to the public, but a supplement is usually considered as food stuff and can be sold without any quality control up until the market either looses interest or adverse effects proves them dangerous. Inspections of the supplement industry is also usually less regulated than corresponding rules for the pharmaceutical industry.

          • The EMA has a reduced system for herbal medicine approval compared to conventional medicine. It is this branch of “traditional” medicine into which many of the compounds of TCM fall. However, the criteria for admission to the groups is that they are medicines which are “theoretically capable” of providing a benefit and have been in circulation for 30 years 15 of which must be within an EU country – ie they are EU traditional herbal remedies –

            however as you point out, the disregard for herbal medicines is clear, they short circuit the system. Therefore you can boast of EU licensed authority very easily and by the time the truth is out you have already seen widespread sales.

            Look at new psychoactive substances, endless variations of compounds designed only to flaut the archaic banned substance laws in the UK. I suspect the exemption for herbal remedies is likely to mean that its just a matter of time before Chinese sub authorities realize the potential for “herbal opoid” hybrids is very high if marketed as remedies for pain / inflammation etc instead of legal highs.

            I take your point on additives but not that it is “bigger issue” having been the advocate in inquests for the family of recently deceased users of new psychoactive drugs.

  • oh dear, a bit of internetting reveals this

    http://www.sigesbeckia.com/mhra-licences-chinese-medicine/

    it would seem the world of TCM is about to become mainstream.

  • The EMA do have a procedure for herbal medicines regulation and its baisis can be found here https://www.ema.europa.eu/en/committees/committee-herbal-medicinal-products-hmpc

    at present it would seem that there are no UK procedures for transition post brexit (surprise surprise). The fast track system in the EU currently has a threshold test in that there has to be a plausibility that the outcomes from the medicine are capable of being determined by the chemical make up of the product.

    The EU are quick to point out that TCM is not targeted by this regulation, it is matter for individual states to assess and impose an objective test if they consider that the medicine is not effective. The EU is merely interested in ensuring that only verified and approved medicines are available for sale in the EU – they do not tackle cross border smuggling or illegally obtained medicines.

    post brexit if there are no rules in place, we should be wary of outlets distributing these items.

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