Integrative Care
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Popular Provocations at CAM Research Meeting

18 June, 2013 by David Finer

Failure to integrate conventional and complementary medicine will soon be viewed as unethical. The “magical” effects of homeopathy are attributable solely to the patient-provider relationship. All raw CAM research data should be made publically available. These were three provocative statements formulated during a popular “soapbox” session at the ICCMR 2013 research meeting in London recently.

There was standing room only at the workshop “soapbox controversies” headed by Torkel Falkenberg, head of I C, The Integrative Care Science Center, Järna and the Unit for Studies of Integrative Health Care, Karolinska Institutet, Stockholm, Sweden.

The name soapbox heralds from the historic speaker tribunes such as Speakers´ Corner in Hyde Park in London, where self-selected orators with an axe to grind have exercised their freedom of speech since 1872.

Three statements
Now the discussion was to be about complementary and alternative medicine. Before and after the speakers stated their case, the audience was asked to vote on the issues. The organizers had filtered out three controversial statements for presentation and discussion.

1. Helmut Roniger, physician and homeopathy practitioner, working in the UK, argued that practicing medicine without integrative medicine would soon be regarded as unethical.

2. Michael Hilands defended the position: “The magic of homeopathy lies not in the subance itself but in the patient-provider relationship”.

3. Klaus Linde represented the statement: “CAM researchers should make their raw data openly available”.

Lower demands on evidence
Helmut Roniger cited the well-known American integrative medicine pioneer Andrew Weil, founder of the Arizona Center for Integrative Medicine, Arizona University stating that the level of evidence required to substantiate a method should be commensurate with the potential risks it entails. One extension of the argument might be that since homeopathy is rather innocuous (by virtue of it being ineffectual, as many would have it), the evidence to support its use need not be as strong as for (more) potent therapies. This, by the way, was the position taken by a Swedish court in 2012, following the acquittal of a homeopathy practitioner facing sanctions.

Furthermore, Rongier argued that all medical treatments are a mixture of two approaches, one viewing the body as a “broken machine”, which leads to passivity, and one seeing the patient as rich in inner resources, which is empowering. Conventional medicine has been very successful in treating acute life-threatening conditions but is inadequate in terms of chronic diseases, Roniger asserted. That is where integrative medicine comes in.

How to shift power?
Integrative medicine combines the best of all traditions with a reasonable evidence base and releases intrinsic healing capacities, which ought to be more cost-effective and hence, more ethical. More evidence is needed, but the good news is that the Chinese sign for crisis means both danger and opportunity, so let us step up to the challenge, Roniger campaigned.

It will however take a substantial shift in power to induce the British Medical Association to agree with your statement, that it should be considered unethical not to practice integrated medicine. How do you intend to shake that power base, Professor George Lewith, Unit of Complementary and Integrated Medical Research, Southampton University, inquired.

The speaker agreed that his statement had perhaps been overly optimistic given the resistence in society. On the other hand, we are being faced with a real health care crisis with runaway health care costs and faulty research priorities, which are moving us farther away from the common good, Roniger emphasized.

Another person in the audience said it was naïve not to take on board the fact of how much evidence is still needed on CAM and integrative care, before it can be taken seriously.

– We need much more robust data to show our medical colleagues. They are not a priori negative, but we need to demonstrate cost-effectiveness, the speaker said.

“Homeopathy a tragedy”
The next argument was put forth by Michael Hilands, who said: ”The magic power of homeopathy lies not in the substance itself but in what happens between patient and practitioner.” Hilands offered the conclusion that while many of the existing clinical trials, meta-analyses and research overviews on homeopathy may well have come to different conclusions, nevertheless any demonstrated positive differences in favor of homeopathy were at best very small.

He interpreted that as meaning that it could not be the homeopathic preparations themselves that achieved the effects. This is certainly not unusual in medicine. At least 80 percent of the effects of antidepressants are placebo effects, he said.

– Homeopathy is a tragedy, which fails to convince. When we are faced with something we do not understand, we tend to call it magical. But we are dealing with a complex interaction between practitioner and patient. I do not want to call it a placebo effect but rather a psychologically mediated mechanism.

Do small effects matter?
But why then do homeopathic preparations work on my children and on my cat, a voice from the audience objected. They work when my children have temper tantrums. That is remarkable, surely!? It could signify a specific effect. On the other hand, I know we are dealing with a powerful form of collaboration between adults and children.

Other people also felt that the clinical trials done on homeopathy were too tiny to reveal small clinical effects. And if the effects are that small, then do they matter? Hilands interjected. Another public testimonial was expressed to the effect that tests using homeopathic preparations on cell lines had shown effects, something we cannot explain.

Also, some people in the audience stressed the importance of differentiating between short- and long-term placebo effects, that we have to be more candid in admitting that we do not understand how homeopathy works, and that lack of evidence of an effect is not the same thing as evidence of a lack of effect.

Only rigorous research justified
The third and last controversy was presented by Klaus Linde, Münchener Modell, Center of Complementary Medicine Research, Technical University/Ludwig-Maximilians-Universität, Munich, Germany. Linde is principal author behind a meta-analysis of homeopathy published in the Lancet.

His conclusions were that the results of the meta-analysis were not congruent with the hypothesis that the clinical effects of homeopathy could be completely attributed to placebo. Researchers however did not find evidence for homeopathy being beneficial in any particular disease state. Continued homeopathy research is only justified if it is rigorous and systematic, the researchers concluded.

Revealing raw data or not
The thesis which Linde had chosen to defend at the workshop was: “Investigators in complementary and alternative medicine should make their raw data freely accessible”

– Following scientific publication of results, raw data are usually not available to anyone else. This is not acceptable, since the patient never signs an exclusive permit for you as an individual researcher to use his or her data. We do not have the right to keep data as private property. If data were accessible to everybody, this openness might of course be abused. On the other hand, it would be possible for other researchers to reanalyse the data and reveal any mistakes made. Other researchers might also want to investigate new issues or hypotheses, which were not thought of, when the primary study was designed. Furthermore, data may be used in training, in planning future research, and so on. So there would be many advantages. So, is everyone in this room prepared to put your raw data out on the web tomorrow? The answer was: not likely.

Enormous hurdles
Someone spoke of enormous political and ethical hurdles. Commercial rivals or adversaries might abuse the freedom and damage us as researchers, someone said. An Australian researcher said her university would never let her publish raw data. They even strongly question the use of secondary analyses based on existing data, today, she said. A second scientist agreed, explaining that in her view, patients who have given their informed consent have done so to a certain researcher for a certain purpose, and that this is no carte blanche for all uses by anyone. Yet, if it were possible to guarantee anonymity, I do not think that patients would mind, Linde rebutted.

One homeopathy researcher also felt that the openness might be counterproductive.

– I want to share my data with other researchers, not with people who might damage us, she said. Yet another researcher said statistics can be abused. She was keen to maintain control of her data. A British researcher added that if another scientist were to publish something based on your data, you would be “toast”. In the end, even Linde himself admitted that he was not prepared to completely release his data. If he were to do so, they would have to be thoroughly reviewed and made more presentable, which might involve lots of extra work for the researchers involved.

The controversial soapbox workshop format seemed to be a huge success and might well be tried again at some future conference.

David Finer

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