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Susan Mayor
Review shows no evidence that individualised herbal treatments are effective
BMJ 2007; 335: 743 [Full text]
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[Read Rapid Response] A startling inadequacy in the links between the review evidence and the authors’ conclusions.
Ally Broughton MNIMH   (14 October 2007)
[Read Rapid Response] CAM is tested unfairly against placebo – CAM is offering highly efficient placebo cures that should be tested with respect for its nature
Søren Ventegodt, Isack Kandel, and Joav Merrick   (14 October 2007)

A startling inadequacy in the links between the review evidence and the authors’ conclusions. 14 October 2007
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Ally Broughton MNIMH,
Herbal practitioner and researcher
Edinburgh EH1 1EZ

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Re: A startling inadequacy in the links between the review evidence and the authors’ conclusions.

A startling inadequacy in the links between the review evidence and the authors’ conclusions.

Response to: R Guo, PH Canter, E Ernst. A systematic review of randomised clinical trials of individualised herbal medicine in any indication. Postgrad Med J 2007;83:633-637

From: Ally Broughton Bsc (Hons) MNIMH Director of Research for, and Member of, the National Institute of Medical Herbalists (NIMH) Contact: ally.broughton@blueyonder.co.uk

I am a trained herbal practitioner of 12 years and teach research methodology on BSc and MSc courses in herbal medicine.

A herbal practitioner undergoes a 3-4 year degree level accredited training course which includes clinical skills and differential diagnosis, materia medica (plant medicine), and clinical experience in accredited training clinics. Professional bodies are currently self regulating and exist to ensure professional and best clinical practice.

In teaching, I use critical appraisal tools developed by the Critical Appraisal Skills Programme (CASP)(i) , I used a tool to evaluate this review to minimise bias.

Study validity Only 3 small scale clinical studies are included for review, one of which is a pilot study. The review can have no statistical significance.

The studies have very different outcome measures and investigate entirely different conditions, making comparison difficult.

Selection criteria From the 1345 references identified, 3 studies were selected. There was no clear pre-determined strategy used to determine which studies were included.

The reviewers recognise this limitation saying they had ‘difficulties designing a search strategy to locate RCTs of individualised herbal medicine because of the large number of potential descriptors for such studies’. This is a strong limitation in the review methodology.

Statistical Analysis The results for each of the studies are assessed by statistical significance, however there is no clear indication given of p values or confidence intervals used by any of the studies.

Critical Analysis The analysis focus is on statistical data. Some potentially valid points are not reviewed. For example in the Bensoussan trial(ii) there was no significant difference between the individualised and standard treatments at 16 weeks were reported, however, on follow-up 14 weeks after treatment, only the individualised treatment group maintained improvement. The reviewers entirely dismissed this as statistically non significant. It is an important point considering that individualised, holistic treatment addresses underlying causes of illness which takes longer to resolve but often with longer lasting benefit compared to symptomatic treatments.

Discussion Analysis In the discussion analysis there is consistently inadequate links made between the review evidence and the conclusions made by the authors. Discussion on herbal practice and safety issues are not substantiated or referenced, in fact there are only 7 references for the entire review.

Conclusions There is a lack of scientific rigour in the review methodology. Based on the evidence presented in the review the conclusions made by the authors appear arbitrary and insufficiently based on the evidence presented.

Designing a randomised controlled trial to investigate individual treatment is highly complex and not without limitations. Within the field of complementary medicine current research is looking for new or adapted research paradigms appropriate to holistic medicine(iii, iv) .

(i)Oxman AD, Cook DJ, Guyatt GH, Users’ guides to medical literature. VI. How to use an overview. JAMA 1994; 272(17): 1367-1371 (ii) Bensoussan A et al. Treatment of irritable bowel syndrome with Chinese herbal medicine. JAMA 1998;280:1585-9

(iii) Boon H et al. Evaluating complex healthcare systems: A critique of four approaches. eCAM Advance Access 2006; doi:10.1093/ecam/nel079

(iv) Fonnebo V et al. Researching complementary and alternative treatments – the gatekeepers are not at home. BMC Medical Research Methodology 2007;7:7

Competing interests: Member of the National Institute of Medical Herbalists
CAM is tested unfairly against placebo – CAM is offering highly efficient placebo cures that should be tested with respect for its nature 14 October 2007
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Søren Ventegodt,
Director
1Quality of Life Research Center, Classensgade 11C, 1 sal, DK-2100 Copenhagen O,, Denmark,
Isack Kandel, and Joav Merrick

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Re: CAM is tested unfairly against placebo – CAM is offering highly efficient placebo cures that should be tested with respect for its nature

EDITOR---CAM (complementary and alternative medicine) is being tested scientifically and it seems that CAM is not passing the test (1). Funds are being withdrawn and homeopathic hospitals closed down. Science is doing its job: Discriminating between good and bad, between efficient and inefficient. And this is exactly why we are so fond of science.

But there are problems. Imagine for a moment that it primarily is our consciousness that is responsible for our quality of life, health and general ability of functioning. Consciousness meaning our beliefs, our self-esteem, our attitude to life, self, other people, love, sex etc. This idea, how farfetched and un-materialistic as it might seem, is actually in accordance with new science (2), as well as in accordance with the whole tradition of psychoanalysis (2,3) and psychodynamic psychotherapy (4-6). Leichsenring and Leibing has very recently in a metanalysis done after Cochrane protocol documented that psychodynamic therapy is more efficient than treatment as usual for most of the psychiatric diseases (6). It thus seems that placebo treatment is the optimal treatment even for the most difficult and chronic of illnesses.

PLACEBO

If that is the case, most of what works in medicine is the placebo effect in some way or another, placebo meaning an “induced change in consciousness that influence the patient’s health positively”. We have tested this hypothesis with five groups of patients with chronic mental, physical, sexual, existential (low self-esteem, poor quality of life) health problems, that could not be alleviated with pharmaca, and quite surprisingly found that just by intervening directly on consciousness every second patient’s experience of being ill changed into being not-ill, in only 20 hours of therapy and only one year (7-12). So it might be that it actually works, at least with some patients.

If it is the case that placebo is the real factor making the difference for the patients, homeopathy and herbal treatments should most definitely NOT be tested against placebo, because this will artificially annulate the positive effect of the treatment. One should use chronic patients for the test, and the patient should be his or her own control. Testing the patient before and after intervention and then long after seems to be an extremely efficient and scientific way to document the effect of a placebo-based cure (13).

Gentlemen, please be fair. Science is not fair in itself. It must be used fairly. To shut CAM down, because it is no better than placebo is killing the only medicine that might be working in the end, as we know by know that most chronic health problems cannot be solved with drugs. That is exactly why they are chronic, right?!? We do not say that all drugs are inefficient, but we need to remember that about 40% of our population is chronically ill in spite of taking the pharmaca constantly and for years.

Our international team has designed placebo cures – using what we found was most efficient and called the “cocktail of scientific holistic medicine” for “Clinical holistic medicine” for the 40 most common health problems (14-47) and it seems from our testing of them that these cures in most cases work wonders for the patients that believes in them (8-12).

By repeating again and again that the CAM-cures are not working, when compared to placebo – which we believe is absolutely correct - we are weakening their real and large effect day by day, until we one day pretty soon might be left only with the drugs that we already know do not work either.

STRONG FORCES WORKING

Please understand that there are strong financial and political forces working against CAM. The problem with CAM is definitely not that it does not work, according to our research. The problem is that money not only rules the world, but also the way we make science and even the way we think science. It is time to sober up and test CAM on its own conditions, not on the conditions of the pharmaceutical industry. That is were we are going to find the medicine of the future. We will have CAM under all circumstances. But only by funding the CAM-research can we be sure that the scientific and efficient methods is what will be used in the future.

SUPPORT CAM RESEARCH INSTEAD

Do not defund CAM research; do not defund the National Center for Complementary and Alternative Medicine (NCCAM). Please start casting real money after scientific CAM, and lets develop the efficient, affordable, “adverse-effect-less”, “green” and sustainable medicine that the world so desperately needs.

AFFILIATIONS

Søren Ventegodt, MD, MMedSci, MSc, Director, Quality of Life Research Center, Classensgade 11C, 1 sal, DK-2100 Copenhagen O, Denmark. Tel: +45- 33-141113; Fax: +45-33-141123; E-mail: ventegodt@livskvalitet.org Website: http://www.livskvalitet.org

Isack Kandel, MA, PhD Faculty of Social Sciences, Department of Behavioral Sciences, Ariel University Center of Samaria, Ariel, Israel E-mail: kandelii@zahav.net.il

Joav Merrick, MD, MMedSci, DMSc National Institute of Child Health and Human Development, Office of the Medical Director, Division for Mental Retardation, Ministry of Social Affairs, Jerusalem and Kentucky Children’s Hospital, University of Kentucky, Lexington, United States. E-Mail: jmerrick@internet-zahav.net. Website: www.nichd-israel.com

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Competing interests: None declared