MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.

Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.

This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.

The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.

The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.

Why do I call this ‘wishful thinking’?

I have several reasons:

  1. A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
  2. Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
  3. To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
  4. The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.

I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.

14 Responses to Integrative oncology is based on wishful thinking and lies

  • This makes me depressed with regard to the planned new chair at the medical faculty in Tübingen, Germany, which will “research” “integrative methods” at an oncological hospital… (but not homeopathy, as the dean – so far – emphasises).

    • I am puzzled by the dean’s assertion: academic freedom means the chair can do what he/she feels is right. in my view, the future of the chair depends solely on the person who is appointed.

  • The authors of this article on the integrative oncology clinic report on the benefits that their patients received. The entire package of care was assumed to be “the treatment,” and if YOU had cancer, the only thing you’d care about would be the RESULTS, not any theories.

    And boy, this clinic provided RESULTS! “Comparison of clinical conditions before and after treatment showed a significant amelioration of nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy, and all symptoms. Moreover, in a subgroup of 17 patients in radiotherapy undergoing integrative treatment, the level of toxicities and the severity of radiodermatitis were much lower than in the 13 patients without integrative treatment.”

    In comparison, you seem to only care about “theories” about causation, not association or correlation.

    And it is remarkable how often people who use CAM and homeopathy just happen to get better…what a coincidence…and “only” a coincidence!?

    • no, I too care about the results! so much so that I want to find out what causes good results. the point of my post was to explain that they could be due to several factors unrelated to the CMs given.
      don’t you find that important?
      are you not interested in cause and effect?
      don’t you want as many other patients to benefit as well?
      how would you do that without knowing more about cause and effect?

      • Edzard is great in express false outrage. He has support “evidence based oncology” for many decades, even though the efficacy of conventional oncology throughout the 20th century was piss-poor, except in a small number of cancers…and yet, the vast majority of cancer treatment was NOT effective and clearly caused more harm than benefit…AND it cost a shit-load of money.

        At that time, conventional medicine provide “rationale” for its treatment and assumed that their cause-effect explanation was part of their “evidence based” medicine…and yet, we all know that their understanding of cause-effect was WRONG.

        Ernst seems to want to know cause-effect on his own term and in his own paradigm…and as long as it provide a certain rationale to HIS liking, he deems it “evidence based.”

        I’m interested in RESULTS. Explanations are secondary. And yes, explanations are helpful, but they are not primary.

    • @Dana

      Thanks for your contribution. There are many more oncologists than anti homeopathy activists behind the push for more research on the effects of homeopathy to lessen the adverse side effects of conventional cancer treatment.

      • Sandra said:

        There are many more oncologists than anti homeopathy activists behind the push for more research on the effects of homeopathy to lessen the adverse side effects of conventional cancer treatment.

        Please do tell us about these oncologists…

      • I doubt it. Oncologists have a sound scientific training and are well aware of the implausibility of homeopathy given that its foundations contradict all that we know of chemistry and physics. Though I suppose an anti-homeopathy activist (whatever that is) might not be in favour of research at all, whereas oncologists like doing clinical trials at every opportunity.

      • In your dreams, Sandra. In your dreams. Oncologists are scientists who recognise homeopathy for the nonsense it is and would not waste their time with such hapless nostrums.

    • It can be very hard, but you have to understand at some point in your deluded life that some things are simply coincidences, regardless of observed frequency.

      Every day, (probably a lot) more than a million people on this planet wake up within 5-10 minutes from each other. You think they plan this in advance…?

  • “Complementary” has morphed into “Integrative” in the USA and UK. Changing the name doesn’t change the product. “Integrative” before “medicine” still gives the game away. Not yet has CAM been accepted simply as medicine. The reason is simple. No solid evidence to support it. Why do clinics like this one offer it? Again that’s simple too – patients want it. Acupuncture has become the paradigm case. Integrated despite the voluminous and constantly accumulating mountain of research repeating ad nauseam the mantra: “more research needed”. On and on.

    Research going nowhere, forever.

  • I have just read this paper. It is utter nonsense.

    I am rather worried about certain aspects of the dietary advice given, in that substances which can potentially reduce the effect of chemotherapy (such as grapefruit) are banned, but substances that can potentiate the effects (such as cucurmin) are encouraged. I have no idea whether cucurmin really does potentiate the effects of gemcitabine and oxaliplatin as claimed, but if so this should be banned, too. These drugs have a very narrow therapeutic index, and a slight potentiation in effect can lead to a great increase in toxicity.

    I am curious that, with the emphasis on antioxidants, there should be a preference for wines that do not contain sulphates (do they mean sulphites?). Sulphites are added to grape juice prior to fermentation in order to prevent oxidation which otherwise ruins the taste of the wine (I had this demonstrated to me once by a winemaker – first I tasted the juice immediately off the press, which was very fresh, then the same juice about 15 minutes later, which had gone brown and tasted quite different, then again after the addition of a tiny quantity of sulphite to the tank, which cleared the brown colour and restored the fresh flavour. I have tasted wines made without antioxidants by the same winemaker, in comparison to his regular wines (and by other winemakers), and there is an unpleasant taint to the flavour reminiscent of scrumpy cider.

    The rest of the dietary advice seems eminently sensible, as is the advice to take regular exercise, which is known to improve the outcome in cancer patients.

    The discussion of radiation toxicity does not seem to be informed by any knowledge of radiobiology. The only immediate effects of radiotherapy (i.e. within hours of exposure) are nausea and vomiting, and then only if the abdomen (particularly the liver) is irradiated; it is not very common as the radiotherapy is usually planned so as to avoid it. Indeed, vomiting after whole-body exposure in a nuclear accident predicts that the exposure will be fatal. Fatigue can also occur within 24 hours.

    Radiotherapy side-effects are classified as early or late. Early effects (such as radiodermatitis) take several weeks to appear and generally resolve within a few months. Late effects appear after more than a year and do not resolve, often getting worse with time.

    The authors compared the severity of radiodermatitis in 30 consecutive patients, 17 of which had followed the integrative protocol. These were a self-selected group, and there is no information as to whether the radiotherapy techniques and doses used were comparable between them and the controls. They found that 3 of 13 patients in the “control” group suffered Grade 4 dermatitis according to the RTOG scale. Grade 4 dermatitis means full-thickness necrosis of the skin. I don’t know what sort of radiotherapy they were receiving that would give this, but it isn’t something that you would normally expect to see at all (except in one of those rare patients with a genetic defect of DNA repair, or in the case of a massive overdose). I should add that in their explanation of RTOG toxicity, they use the word “sweating” instead of “exudation”; possibly this is a misunderstanding by Italian speakers of the English term, but sweating and exudation are not the same thing.

    Leaving radiodermatitis aside, all of the other toxicities were only evaluated with regard to how they changed over time, with no comparison with any control group. Although in the Methods section the authors imply that most patients had multiple follow-up visits, in the Results section they only compare toxicities between the initial visit and follow-up at some undefined time, which could therefore be weeks, months or years. It is not surprising that most of these improved, and indeed you expect the toxicity of any treatment to resolve with time (with the exception of late radiation effects, which don’t seem to have been evaluated at all).

    Some of the patients were assessed several times during a course of chemotherapy, though these do not seem to have been analysed separately from those who had completed their treatment. Assuming that they, too, improved with time, I am not sure that the integrative protocol can take credit as it is normal practice in an oncology clinic to assess toxicity after each cycle of treatment before giving the next, and modifying the treatment accordingly (for instance by changing antiemetics, or quite commonly by reducing the chemotherapy dose).

    I am quite surprised at some of the findings. For instance, there were 5 patients with grade 3 neuropathy at the initial visit, which at follow-up had resolved completely in two, and to grades 1 – 2 in the rest. Neuropathy is quite a common side-effect of certain cytotoxic drugs, but it generally resolves very slowly indeed, over many months or even years. They also found depression to resolve over the study period, though generally oncology patients are too busy with their treatment and too shocked by the changes in their life to be depressed, and depression comes many months later when they no longer have the support of frequent hospital visits and the full implications of their illness eventually sink in.

    I suspect that the assessments were not made to the same standards that you would expect from a conventional clinical trial, and indeed since this was a retrospective study I wonder in practice how they were made at all, as it is not routine practice to quiz patients on their symptoms in the rigorous detail required by a research protocol (usually by a dedicated research nurse).

    You have already discussed the statistical shortcomings making it impossible to draw any kind of sensible conclusion from such a study, other than to confirm what we already know, which is that most things get better given enough time.

    I don’t think I need to comment on Dana Ullman’s post. Res ipsa loquitur.

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