Antioxidants and other supplements can improve the effectiveness of radiotherapy and chemotherapy. (Originally published in icon Issue 4 2006)

The myth of the Clinical Trial

Increasingly, the orthodox medical world is demanding that all cancer treatments must have scientific research evidence to support their use. The ‘gold standard’, often quoted, is largely limited to chemotherapy drugs and is called the ‘Clinical Trial’.

At icon we agree with this need.  Unfortunately, less clear is which types of research are acceptable.  Scientists attempt to produce hard evidence on the successful performance of a drug, citing how many people in a trial group had a positive effect against an identical group taking (unknowingly) a placebo.  Various other controls are incorporated to rule out unwanted outside influences.

accurate measurements of the negative side effects of a drug are every         bit as important as measuring the benefits

However, only about 15 per cent of all drugs on the market have been through a clinical trial, the placebo effect is seeing the sugar pill produce side effects and even cure some patients, and the normal use of combinations or cocktails of drugs have never been near a clinical trial.

Furthermore, the rigour of exactly how many people benefit from the drug often falls woefully short when the issue of side effects is considered. These are most usually ‘touched upon’ rather than provided as accurate percentages in the same way the benefits are measured. We have covered (in a previous issue – Vol 2 ; 2006) the concerns expressed by experts in the Lancet Oncology magazine of the negative effects of, say, monoclonal antibodies. As we have expressed before in icon, accurate measurements over a sensible period of time of the negative side effects of a drug are every bit as important as measuring the benefits.

Finally, in some cases, euphoria on the positive findings is seeing some ´wonder´ drugs pulled out of Clinical Trials before they have even completed their allotted time span. How rigorous is that?

Bashing antioxidants

The other problem with the use of ‘hard scientific evidence’ is that, all too often, papers are presented by ‘interested parties’ with a resultant bias.

In 2004 and 2005 two ‘megastudies’ of anti-oxidants were covered in this magazine. In response to a concern expressed by Professor Tony Howell, one of our charity patrons, we analysed the data to find, for example in one case with vitamin E, that far from being a ‘megastudy’, the scientists had only looked at 14 studies out of over 800 available, (far less than we considered for our own report on vitamin E) and far from looking at the natural vitamin in its 4 tocopherol forms or its 4 tocotrienol forms, the only research taken by the scientists was for the synthetic vitamin E in solely the alpha-tocopherol form. (Which, for example, has virtually no proven benefit with breast cancer, unlike the tocotrienol forms).Worse, recent Japanese research says it can knock out the effects of two of the tocotrienols!

From this megastudy they managed to conclude that ‘vitamin E could actually increase your risks of dying by 10-30%’. Poor research at best (Cancer Research UK agreed with us), but possibly by co-incidence, it was published shortly before the decisions in the EU were to be made on whether vitamins should be treated as drugs and which would be permitted for sale in the shops.

In Cancer Watch we cover research, again from the Lancet, on how ‘vested interest’ research is reducing the credibility of Doctors and Specialists alike amongst the general public.

For the record, our view is that these high street antioxidants are often synthetic copies of the real thing, and with less available variant forms than occur naturally. For example you take antioxidant vitamin E to find it is synthetic and contains only one of the forms nature provides; beta-carotene can be synthetic and contain only one of the two naturally occuring forms. Synthetic vitamin C, contains no co-factors or bioflavenoids. Research on a side by side test against fresh orange juice, should the synthetic vitamin provide no antioxidant power whatso ever during a 24 hour period.

I liken them to Thai copies of Gucci Handbags. Are you surprised when the handle falls off?f

Doctors have no idea

A further problem occursin providing information on research and doctors.  In icon we previously reported on the senior Australian Government Medical Advisor who has set up a website for doctors on pharmaceutical clinical trials, listing all benefits and side effects, because he was so concerned that ‘doctors only get that information from PR releases and media coverage, both of which are provided by the pharmaceutical companies themselves and may be biased’.

Doctors don’t get time to read endless research reports and, anyway, outside the area of drug clinical trials lie a minefield of different types of research and, often subjective, opinion.

Now for the real thing - natural compounds

As an example, one of the most commonly asked questions by people ringing our offices is, ‘Should I be taking my anti-oxidants when I have chemo or radiotherapy?’

Our answer is a categoric, ‘YES’. Hitherto we have read the ‘tome’ by John Boik, one of the senior staff at the prestigious MD Anderson Cancer Centre in Houston, Texas. This book is over an inch thick, published in 2001 and called ‘Natural Compounds in cancer therapy’. It contains over 4000 references to scientific papers and basically concludes that, far from in some way interfering with the biochemical process involved in chemo or radiotherapy, taking anti-oxidants actually improves the success rates of both. Support for this stance came in 2005 – again covered in icon Cancer Watch, when UCLA produced the conclusion that healthy cells are self regulators and will pick up the maximum concentrations of anti-oxidants available in order to maximize their biochemical processes. However cancer cells have lost most of this regulatory ability and will overload on anti-oxidants. Their view is that this will help the chemo or radio ‘kill them off’.

a number of oncologists adamantly tell their patients that they do not want them taking anti-oxidants during their chemo or radiotherapy .......but requests for ‘hard scientific research evidence’ supporting the oncologist’s concern have come to nothing

The problem for us, and especially for the cancer patients who call us, is that a number of oncologists adamantly tell their patients that they do not want them taking anti-oxidants during their chemo or radiotherapy as this will somehow weaken the effect. Patients are thus ‘scared’ into dropping their supplementation programmes. Our problem is compounded because we are very open minded on this issue still, but frequent requests to be sent the ‘hard scientific research evidence’ supporting the oncologist’s concern have come to nothing. We would be happy to print it. But does any actually exist, or is the concern pure subjective opinion and mythology?

In September 2005 a paper was actually published in the USA in ´A Cancer Journal for Clinicians´ (Gabriella D’Andrea MD). More of an article than a genuine scientific paper, it warned against using anti-oxidants with chemo and radiotherapy. However by chance, or oversight, it missed all the papers supporting anti-oxidants, used only clinical laboratory research rather than human or epidemology

specific and synthetic anti-oxidants are approved by the FDA and recommended for use with chemotherapy

studies, and omitted the fact that in certain cases (e.g. the use of amifostine) some specific and synthetic anti-oxidants are approved by the FDA and recommended for use with chemotherapy and are known to have enhancing benefits in, say, oral and lung cancers and child leukemia. icon, for example, carried clinical research in 2004 that vitamin E supplementation could produce the same positive effects from Tamoxifen, at a 25  per cent lowered drug dosage. Great for the patient – but not so great for the profitability of the pharmaceutical company concerned. We doubt any oncologist has even noticed the research. Further research has shown that the use of natural compound indole3carbinol also means you need to use less Tamoxifen. 

The D’Andrea article did, however, re-open the debate about taking anti-oxidants with chemotherapy and radiotherapy.

The whole matter has recently been highlighted by Ralph W. Moss PhD, the famous US cancer researcher. In a paper ‘Should patients undergoing Chemotherapy and Radiotherapy be prescribed antioxidants? (Integrative Cancer Therapies Vol 5, 1; 63-82. http://ict.sagepub.com/cgi/reprint/5/1/63. Also on PubMed) Moss expertly takes the reader through the myriad of research, including clinical trials, stating clearly that the D’Andrea paper was incomplete and that there is far more information available than either she included or is widely acknowledged. His conclusion is that a ‘blanket rejection of the concurrent use of anti-oxidants with chemotherapy is not justified by the preponderance of evidence’. For the more scientifically biased amongst our readers we have listed below some of the main scientific references on this subject.

If taking anti-oxidants is of such a concern, why do many of the same oncologists tell the patient to eat plenty

of fresh fruit and vegetables instead?

Moss raises another important point - one we have repeatedly made. If taking anti-oxidants is of such a concern, why do many of the same oncologists tell the patient to eat plenty of fresh fruit and vegetables instead? Is it because they believe fresh fruit and vegetables are devoid of anti-oxidants these days and thus can’t interfere with their chemotherapy? Or is it because they are fearful of the synthetically produced ones? (Just as we are – you’ll note in icon we continually tell you to take the natural forms). Perhaps it is neither of these. Perhaps they are just not aware of the enormous amount of research in the US alone.  However, the answer may lie in an article from the early days of icon, when Dr. Graham Henderson wrote a piece for us telling our readers just why UK Doctors were so negative towards complementary therapies. To summarise: UK Doctors want to be the fount of all knowledge for their patients, and many have neither studied formally, nor had the time to study since leaving medical school, these complementary therapies and especially nutrition. (Only recently a newly qualified doctor was in our offices openly stating that (apart from a morning on combating heart disease) she had not spent one day formally studying nutrition in her whole seven years training!) As Dr. Henderson concluded, most UK Doctors are outside their both knowledge and comfort zones.

Nothing brings this home more than reading Moss’ conclusions, one of which is that ‘Patients would be well advised to seek the opinion of physicians who are adequately trained and experienced in the intersection of 2 complex fields, that is, chemotherapy and nutritional oncology’.

If all UK NHS oncologists who qualify e-mail us on enquiries@canceractive.com with their name, phone number and qualifications we will happily publish a list in the magazine and on our web site. This debate will not be settled until we have more experts who are fully qualified in both oncology and nutritional therapy.

Meanwhile, a similar view on the benefits and the increasingly vacuous criticism of natural compounds as beneficial adjuncts to chemo and radiotherapy can be found in the article on Herbs by the expert Alan Hopking in icon Issue 3 2006.

For the record, we continue to recommend that all patients having chemo and radiotherapy supplement using natural supplements (like Chlorella, garlic, astragalus, Aloe Vera, medicinal mushrooms, natural vitamin E etc) as we increasingly find positive research-based evidence.  (For example:  Prasad K. N:  Int. Cancer Therapies 2004, 3:3, 310-323.  Multiple dietary antioxidant therapies enhance the efficacy of standard and experimental cancer therapies and decrease their toxicity. But we especially recommend that patients load up on the foods that can provide them with the biggest range of cancer fighting agents possible.

          At last - the definitive, research based book on how to build a diet to help beat cancer. Click here to read about it.

References:

For those of you who want to check the scientific references used, we have selected a mere 75 from those recorded by Ralph Moss

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Some detailed references:

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