BuRO: ‘Black cohosh supplement use risky for select groups’
In a statement, the independent advisory body advises pregnant, breastfeeding women and children to avoid the supplement, warning of a link to chest or abdominal pain, diarrhoea, nausea, or even bleeding and liver disease.
Along with the number of liver toxicity cases recorded, the list also extends to patients with a history of liver disease or have had treatment for breast cancer or other hormone-dependent tumours and people who are hypersensitive to black cohosh active ingredients.
“These risk groups should be warned about the risks that can be associated with black cohosh,” states BuRO, which advises this course of action to the Dutch Minister for Medical Care and Sport.
BuRo cites human and animal studies in which doses of black cohosh extracts up to 40 milligrams per day (mg/day) can generally be considered safe.
“However, in the absence of information on the safe use of black cohosh during pregnancy, lactation or children, the safe dose of 40 mg/day does not apply to these risk groups,” BuRo adds.
What is black cohosh?
Black cohosh supplements contain extracts of the root and rhizome of Cimicifuga racemosa (L) Nutt. also known as Actaea racemosa L., (spray) black cohosh or woman's root.
The extract is used for the treatment of menopausal symptoms such as hot flashes and heavy sweating, for menstrual complaints and to induce contractions.
While the supplement does not appear to be widely available, retailers such as Holland & Barrett and Amazon still make the product available online.
Regulation-wise, the European Food and Safety Authority (EFSA) have placed ‘on-hold’ the claim that black cohosh can, “help maintain a calm and comfortable menopause,” and “help women coping with the tell-tale signs associated with menopause, such as hot flushes, sweating, restlessness and irritability.”
A study back in March 2018 revealed that postmenopausal women consuming black cohosh daily for eight weeks noted a decrease in the number and severity of their hot flashes.
The North American Menopause society said of black cohosh supplements that “black cohosh does not act like oestrogen, reducing concerns about its effect on hormone-sensitive tissue (eg, uterus, breast).
“Black cohosh has had a good safety record over a number of years,” the society said acknowledging the reports linking black cohosh to liver problems. This connection, they said continues to be studied.
BuRO adds that the safety and efficacy of non-standardised black cohosh extracts is difficult to assess because the composition is not (fully) known.
“This leads to an unknown composition of the extract and possibly to an exposure higher than 40 mg/day. Such an extract can also contain other toxic substances that can cause adverse health effects.”