Breakspear Medical Group Ltd (Breakspear) said that chelation therapy was the preferred medical treatment for reducing the toxic effects of metals on the human body. They said that most metals were capable of forming bonds with carbon, resulting in metal-organic compounds which could interfere with functions of various organ systems like the central nervous system, the haematopoietic system, liver, kidneys, etc. Breakspear said that the central nervous system was a particular target of the damaging effects of both aluminium and lead. They said that though not fully proven, aluminium accumulation in the brain was proposed to be associated with neurodegenerative diseases including Alzheimer's, dementia, Parkinson's disease, amyotrophic lateral sclerosis (Motor Neurone disease) and dialysis encephalopathy (dialysis dementia).
With regards to the specific conditions outlined on their website which were claimed to be treatable with chelation therapy, Breakspear provided us with a range of studies.
With regard to the claim to treat cerebrovascular disease, the ASA noted that Breakspear had sent us an extract of a study, which demonstrated a correlation between chelation therapy and an improvement in cardiovascular function. However, it was only an extract and only referred to cardiovascular function, with no reference to coronary or cerebrovascular disease. We noted Breakspear's argument that because chelation therapy had been seen to have an effect on cardiovascular function, it followed that the therapy would also have an impact on cerebrovascular disease. However, because Breakspear did not provide us with the full study, nor did they highlight any area of the extract which indicated a direct link between chelation therapy and the treatment of cerebrovascular disease and nor could we identify a link, we considered this part of the claim to treat the condition was not substantiated.
With regard to the claim to treat chronic fatigue syndrome, Breakspear provided us with a paper on a chelating treatment called D-Penicillamine. We also noted Breakspear's argument that there had been some research which had indicated that there was an association between heavy metal exposure and chronic fatigue syndrome. However, we did not see in the paper a direct link between chelation therapy and the effective treatment of chronic fatigue syndrome. Breakspear also provided us with a paper on the link between mercury toxicity and a range of conditions, including chronic fatigue syndrome. We noted however that where DMSA chelation therapy had been used exclusively to treat chronic fatigue syndrome by removing mercury from the body, no effect was demonstrated and we therefore did not consider that this part of the claim was substantiated.
With regard to the claim to treat autistic spectrum disorders, Breakspear provided us with a study which looked at the efficacy of chelation therapy for children with autistic spectrum disorders. This study was double blinded with an initial base of 65 children. However, we noted that at the conclusion of the study, text stated "this data suggests that the DMSA may have had a beneficial effect on the symptoms of autism. A future randomized, double-blind, placebo-controlled study without an initial screening round of DMSA would help confirm this ... the initial severity of autism significantly correlated with the body burden of toxic metals ... a reduction in exposure to toxic metals might be helpful in partially reducing the incidence of autism. More research is needed to investigate this possibility".
Breakspear also provided us with a study which demonstrated a link between combined anti-androgen therapy and chelation therapy which showed improvement in 11 children with autistic disorders in terms of sociability, cognitive awareness and behaviour. We noted however that the study was not blinded or randomised, the number of subjects was low and the study subjects were specifically selected on the basis that they already had exposure to mercury in their body. We noted the study observed that some of the children showed improvements after the anti-androgen therapy prior to the administration of chelation therapy and concluded that additional studies should be conducted to evaluate the impact of both therapies.
A further review paper provided by Breakspear referred to a study on the effects of chelation therapy demonstrated that the treatment had shown an improvement in 83% of 152 children who suffered from austistic spectrum disorders, but also acknowledged that nobody treated had experienced a marked improvement in their condition. We noted we had not seen the full study.
Because none of the studies provided to us by Breakspear indicated that the correlation between chelation therapy and the effective treatment of autism had been conclusively proven, we did not consider that the claim to treat this condition was substantiated.
With regard to preventative medicine and anti-ageing, Breakspear provided us with a paper which discussed the use of chelation therapy in the treatment of Alzheimer disease. The paper stated "Our findings are promising and we are optimistic that this novel method of chelation will prove useful in the treatment of AD (Alzheimer Disease). More studies are warranted to demonstrate the protective efficacy of the chelator". We therefore considered that the effects of chelation therapy on the treatment of Alzheimer disease had not been substantiated with this study. Breakspear also provided us with a range of extracts from other studies which discussed possible links between excess metals in the body and a range of conditions associated with ageing, including cataracts, osteoporosis, cardiovascular disease and cell necrosis. However, we did not consider that any of these extracts demonstrated a direct link between the treatment of those conditions with chelation therapy.
We noted Breakspear referred to preventative medicine as part of the claim and understood that they had provided the paper on Alzheimer disease to demonstrate that chelation therapy could be used as a preventative treatment for an illness or disorder where excess metal needed to be removed. However, as the paper did not give conclusive results on the effect of metal on Alzheimer disease, we did not consider that the claim that chelation therapy could be considered a form of preventative medicine was substantiated.
We also noted a study which demonstrated a link between chelaton therapy and an improvement in a specific heart condition: Left Ventricular Hypertrophy (LVH). However, we did not consider that this study alone supported the claim that chelation therapy was a preventative medicine or treatment for conditions linked to anti-ageing.
We noted a number of studies provided to us by Breakspear which demonstrated that chelation therapy was effective in removing metals from the body. However, we also noted that none of these studies demonstrated a further effect on the body in relation to the health conditions listed after those metals had been removed.
Taking all of the above into account, we concluded that chelation therapy had not been proven to be an effective treatment for the health conditions listed and the claim that chelation therapy could help with those listed conditions was not substantiated and therefore misleading.
The claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).