Is Ireland's echinacea ban justified?

In a recent article in the Irish Times, Sylvia Thompson reviewed the Irish Medicines Board’s (IMB) recent decision to ban the sale of echinacea products marketed for children and asks if this decision was really the best course of action.  The ban, instituted earlier this month, was based on a review from the European Medicines Agency (EMA) which found that there was insufficient evidence to support the use of echinacea either in adults or children as the therapeutic benefits did not outweigh the risks of allergic reactions. In the article, Thompson also presents the views of Irish “medical herbalists” who commonly recommend echinacea as a treatment for the common cold. Unsurprisingly, these herbalists disagree with the ban and even more predictably fail to produce any convincing reasons that it was unwarranted.

In the article, Anne Varley, chairwoman of the Irish Medical Herbalists Organisation (IMHO) disputes the results of one of the main studies examined by the EMA as it tested the efficacy of an echinacea preparation made from the flowering plant. This study, published in the Journal of the American Medical Association (JAMA) found that echinacea had no effect on the duration or severity of illness and that around 7% of participants taking the preparation developed skin rashes. Varley argues that this was an unfair test as including the plant’s flower in the preparation used may have produced a product containing large amounts of pollen. She claims that preparations made from other parts of the plant would not produce the same reactions as they would not contain the same quantity of pollen. While she may very well be right that preparations with a high pollen count may lead to more allergic reactions, it does nothing to support her view that the ban is unjustified. The flowering plant is commonly used in the production of a number of echinacea supplements including the popular Echinaforce and the recently banned Echinaforce Junior. This form of echinacea was chosen for examination specifically for this reason so that the results of the trial would be applicable and relevant to the general population. Unfortunately, Varley appears to have misunderstood this and instead just provides additional support to the findings of the study.  

Varley’s contention that the ban is unjustified is further undermined by a review published in the Journal of Pharmacy and Pharmacology (JPP) in 2005. This review examined three of the main varieties of Echinacea commonly used in the production of herbal supplements and found that each of these species contained different chemical compounds. The researchers state that due to the lack of research on the toxicity of these compounds they should be avoided. The review also found that some samples did not contain the echinacea species they claimed and that the pharmaceutical quality and labelling of some products was inadequate. This hardly inspires confidence in the safety of echinacea supplements. Even if an effective and safe form of echinacea could be produced it seems that, due to poor manufacturing standards, there is no guarantee that it is the form of the plant that the consumer will eventually swallow.

The Irish Association of Health Stores are also quoted in Thompson’s article and make the once again predictable claim that echinacea must be safe as children in Ireland have been using it for over twenty years without any evidence of an adverse event. This is a simply indefensible position for a number of reasons. First of all, saying that a drug is safe because no-one has noticed any adverse effects is very different to proving that it is safe. Several forms of cocaine were used for hundreds of years to treat everything from exhaustion to morphine addiction until the early 20^th century before its negative effects were noted. While I’m not suggesting that echinacea could produce the same level of harm as cocaine, the absence of reported adverse events is insufficient evidence to support the safety of its use.  Secondly, the incidence of adverse reactions to echinacea such as allergic rashes may be significantly underreported, especially in children. Rashes are a relatively common problem in children and may be provoked by a viral infection such as the common cold. In an isolated case, it would be almost impossible to determine if a rash in a sick child was provoked by the virus or an allergic reaction to echinacea and would be unlikely to be reported as an adverse effect of the herbal medicine. However, as I mentioned above, the JAMA article criticised by Anne Varley showed that these rashes occurred more often in children taking echinacea than in children taking a placebo. While extremely rare, there is also the potential for a more serious and possibly life-threatening allergic reactions. Until there is conclusive evidence that the risk of serious allergic reactions is minimal, recommending the use of echinacea in children is irresponsible and shows complete ignorance of current research.  

The article also features a contribution from someone who should really know better. Although the professions should really be mutually exclusive, Dr Dilis Clare is both a GP and a medical herbalist. I can only assume that Dr Clare was wearing her herbalist hat when she said that the ban on echinacea products for children is pointless as it will only force use of the supplement underground. Ignoring the principles of evidence-based practice, she states that she would continue to give it to children and that parents will continue giving it to their children despite the warning from the Irish Medicines Board. Only a distorted form of reasoning could produce the conclusion that this “illicit” use of echinacea is a valid reason to revoke the ban. The “illicit” use or sale of any banned substance is almost impossible to completely eradicate but a ban does prevent the overwhelming majority of the population from being exposed to the substance. Reducing the residual “illicit” use of echinacea in children can only be accomplished by informing parents, and worryingly herbalists as well, about the reasons why it should not be used and not by revoking the ban.

On the basis of current evidence the ban on sale of Echinacea products for children is justified. The common cold is generally a mild illness that will resolve itself in a week or two and does not require any specific treatment. It’s really more of an annoyance than a serious threat to the health of a child. The best available evidence shows that echinacea has no effect greater than a placebo in shortening the duration of this illness or decreasing the severity of symptoms. It should not be recommended for the treatment of the common cold for much the same reason as antibiotics. While the risks involved with its use may be minimal, the benefits are either even more minute or completely non-existent. Why take even a small risk of giving your child an itchy and irritating rash when the treatment will have absolutely no benefit? By disagreeing with this ban, so-called “medical herbalists” display a complete ignorance of current evidence and in inexcusably poor understanding of the balance between risk and benefit. As a profession, they also demonstrate disregard for patient safety by failing to even establish a standardised echinacea preparation that is of adequate quality and standardised dosage regimens.

The authors of a NEJM study sum up the problems with echinacea and many herbal medicines by stating that given the variety of preparations available, it is almost impossible to conclusively prove that it has no role in the treatment of the common cold. Every time new evidence is produced showing that echinacea or another herbal medicine has no therapeutic benefits, herbalists like Anne Varley and Dr Clare can poke holes in it by claiming that the type of preparation used, the dosage regimen or some other part of the trial was inappropriate. The burden of proof should lie not with regulatory bodies such as the IMB or EMA but with herbalists themselves. If these treatments work anywhere other than in the minds of the herbalists themselves, surely they should jump at the chance to prove their worth in the prevention and treatment of illness and disease. However, given herbalists obvious aversion to randomised, double-blinded, placebo-controlled trials, I won’t be holding my breath.