Traditional Chinese herbal medicine in the UK: safety and regulation

Traditional Chinese medicine (TCM) is a whole system that includes acupuncture, tai chi and herbal products. NIH reports that acupuncture and tai chi may help some pain conditions and balance, while studies of Chinese herbal products across many conditions have had mixed results and many were of poor quality, so no firm conclusions can be made about effectiveness. The safety issues concentrate on herbal products specifically.

The MHRA commissioned research in 2008 which found that 5% of adults had used TCM from a practitioner, clinic or shop. TCM users were the group most likely to believe that natural means safe (76%) and a higher share than other groups believed such products were regulated (44%). Those beliefs make unlicensed products with hidden ingredients especially hazardous.

In 2007 the MHRA warned that it continued to identify herbal medicines, particularly traditional Chinese medicines, containing Aristolochia or aristolochic acids, often with no mention on the ingredient list. Aristolochia use in UK herbal medicines was prohibited in 1999. The toxin is associated with a distinctive kidney scarring syndrome sometimes called Chinese herb nephropathy, which can lead to end-stage kidney failure within months to a couple of years, and some patients developed urinary tract cancers.

In 2011 the MHRA advised consumers not to use unlicensed products containing lei gong teng, promoted for rheumatoid arthritis, other autoimmune diseases and psoriasis, because of concerns about serious effects on fertility, liver, kidneys, immune system, blood and heart. A later MHRA warning concerned a cream sold as a natural Chinese remedy for eczema, psoriasis and rosacea that contained the steroid clobetasol propionate, a prescription-only ingredient, which was not declared on the label.

• Undeclared prescription drugs, including steroids, have been found in products marketed as natural.

• NIH lists contamination with undeclared plant or animal material, heavy metals such as arsenic, lead and cadmium, pesticides, sulfites, and substitution with incorrect herbs that have caused organ damage.

• NIH also reports warfarin and diclofenac among drugs found in some Chinese herbal products.

The MHRA says a traditional herbal registration must be obtained before a traditional herbal medicinal product can be marketed in the UK, and that it is granted only for minor health conditions where medical supervision is not required. A product that claims to treat a major condition needs a full marketing authorisation. The MHRA also publishes a list of banned or restricted herbal ingredients drawn from the Human Medicines Regulations 2012, which sellers must check.

Herbal practitioners do not need to be registered by law, as the NHS notes, so a practitioner's title is not itself a safety guarantee. The MHRA's own advice to patients is to look for a THR number and certification mark or a product licence number on the label, which shows the product has been assessed for quality, safety and patient information.

Ask what is in it: a genuine product has a full ingredient list in English, a manufacturer and a batch number. Be wary of products promising to cure serious conditions, products sold for skin disease, slimming, joint disease or erectile dysfunction with no ingredient detail, and anything bought from a market stall or website that offers no way to contact a UK business. The MHRA says illegal ingredients are commonly found in slimming and erectile dysfunction products.

The NHS advises people not to buy unlicensed herbal medicines online, to check with a pharmacist before taking a herbal medicine with prescribed drugs such as statins, antidepressants, diabetes medicines, blood pressure tablets, blood thinners or hormonal contraception, and to tell every clinician treating them about any herbal product used.

Seek advice from a GP or NHS 111 for new tiredness, swelling, reduced urine, blood in urine or a rise in blood pressure after starting a herbal remedy, since kidney damage may be silent early on. Yellow skin or eyes, dark urine, pale stools or abdominal pain suggest the liver. Thin skin, easy bruising or a rebound flare after stopping a "herbal" skin cream suggest hidden steroid exposure. Call 999 for breathing difficulty, collapse, fits or severe allergic reactions.

Keep the product, packaging and any leaflet, because the MHRA may test suspect products for banned or prescription-only ingredients. Report the reaction through the Yellow Card scheme with the brand, ingredient list, manufacturer, supplier and any other medicines taken in the previous three months.

NIH advises people with a health condition to talk to their conventional provider before using TCM herbal products, not to use TCM to replace or delay conventional care, and to take particular care in pregnancy, while breastfeeding and when treating a child. Tell the practitioner what prescription medicines you take, and tell your GP or specialist what the practitioner has supplied. Cancer treatment, anticoagulation, transplant medicines and epilepsy treatment are examples where an unexpected herbal interaction can be dangerous.