ECCH Statement

EASAC heeft geen opdracht gekregen van het Europees Parlement of DGSante, de Europese
Gezondheidscommissie om dit rapport (1) te schrijven en opereert onafhankelijk van de
Europese Unie.

Europeanen hebben keuzevrijheid in de gezondheidszorg.

In februari 2017 zijn de rechten voor toegang tot complementaire en alternatieve medi-
cijnen, waaronder homeopathie, door het Europees Parlement vastgelegd.(2)

Er is aantoonbaar bewijs dat het werkmechanisme van homeopathie door EASAC (3,4)
bewust is genegeerd en/of onheus is belicht.

Homeopathische geneesmiddelen zijn in de EU gereguleerd. (5)

Homeopathie is veilig; Er zijn weinig bijwerkingen gemeld. (6)

Patiënten worden niet goed geïnformeerd door het vooringenomen EASAC rapport.

ECCH kijkt daarom uit naar een samenwerking met andere Europese organisaties om gezamenlijk
een positief dialoog op EU- en nationaal niveau met EASAC te voeren. Om daarmee tot een
meer constructieve en realistische evaluatie van de wetenschappelijke research van de
homeopathie te komen.

Link: http://www.homeopathy-ecch.org/2017/10/the-european-academies-science-advisory-council-easac-statement-homeopathic-products-and-practices/

Referenties statement.

1. European Academies’ Science Advisory Council. Homeopathic products and practices:
   assessing the evidence and ensuring consistency in regulating medical claims in the EU.
   http://www.easac.eu/home/reports-and-statements/detail- view/article/homeopathic.html
2. http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A8- 2017-0040&format=XML&language=EN

3. Ed Chaplin C. Special issue: The Memory of Water. Homeopathy (2007):96;141-230 

4. Mathie RT. Controlled clinical studies of homeopathy. Homeopathy 2015;104:328- 
332 

5. www.echamp.eu/echamp-resources/echamp-positions/2017-09-22-easac-echamp-response.pdf
   
6. http://www.echamp.eu/our-sector/practice-and-evidence/clinical-data-and-research/fewer-side-effects

Homeopathie werkt bewezen beter dan placebo
Homeopathische geneesmiddelen werken. Dat is in 1997 al bewezen. De European Academies Science Advisory Council (EASAC) beweert echter in een recent advies dat er geen bewijs zou zijn, maar baseert dit op onbetrouwbare, deels frauduleuze rapporten. De Artsen Vereniging Integrale Geneeskunde (AVIG) roept de EASAC op tot een wetenschappelijke dialoog over homeopathische geneeskunde samen met homeopathische onderzoekers.
Het bewijs voor homeopathie doet niet onder voor dat van regulier.
De conclusie van de eerste vier meta-analyses die er gedaan zijn naar alle dubbelblinde, gerandomiseerde onderzoeken (RCT’s) waren positief. De conclusie van de vierde meta-analyse (Klaus Linde, Lancet, 1997) was dat homeopathie significant beter werkt dan placebo. Met andere woorden: homeopathie werkt. De alom gerespecteerde epidemioloog Vandenbroucke noemde zelfs de hoge kwaliteit van dit onderzoek tijdens zijn jubileumlezing van The Lancet in 1998.
De EASAC baseert haar conclusie echter op een vijfde meta-analyse, namelijk die van Shang en Egger. Deze meta-analyse is gebaseerd op voornamelijk dezelfde RCT’s als de vierde meta-analyse en werd in 2005 gepubliceerd. Hun conclusie, ‘zwak bewijs voor homeopathie en sterk bewijs voor reguliere middelen’, bleek later bij een analyse door de onderzoekers Lüdtke en Rutten te berusten op een niet openbaar gemaakte selectie van 8 van de 110 homeopathische onderzoeken en 6 van de 110 reguliere onderzoeken. Zo’n geheime selectie is verdacht en ongeoorloofd. Uiteindelijk ging het om onvergelijkbare onderzoeken.
Het effect van alle 110 homeopathische onderzoeken bleken bij deze analyse van dezelfde sterkte te zijn als de reguliere onderzoeken en de kwaliteit van de homeopathische onderzoeken was beter.
Ook een Australisch rapport met een negatieve conclusie over het bewijs van homeopathie wordt aangehaald. Deze conclusie kon onder andere worden bereikt door alle studies met minder dan honderdvijftig proefpersonen uit te sluiten – een maatregel die elke wetenschappelijke grond mist en die ingaat tegen de richtlijnen van het onderzoeksinstituut dat het rapport uitbracht.
Een onafhankelijk onderzoeker als de Zweedse professor Hahn stelde recent zelfs vast dat het bewijs voor homeopathie alleen onderuit gehaald kan worden door meer dan 90% van de onderzoeken te schrappen of door dubieuze statistiek.

 
Bijwerkingen
Ook stelt de EASAC, zonder onderbouwing, dat homeopathie schadelijk kan zijn. Alle onderzoeken wijzen echter uit dat homeopathie – bij oordeelkundig gebruik – veilig is en in principe – door de wijze van bereiden waarbij het middel verdund en geschud wordt – geen bijwerkingen heeft. Een bekende tegenstander van homeopathie, Edzard Ernst, vond in de wereldliteratuur over 34 jaar slechts vier overlijdens die mogelijk met homeopathie te maken konden hebben. Volgens de EMA overlijden in de EU jaarlijks ongeveer 200.000 mensen aan bijwerkingen van reguliere middelen…
De EASAC noemt het onthouden van een reguliere behandeling als een gevaar van een homeopathische behandeling. Het onthouden van een noodzakelijke behandeling is volgens ons gewoon slechte geneeskunde en heeft niets te maken met homeopathie. Leden van de Artsen Vereniging Integrale Geneeskunde (AVIG) hebben als artsen de opleiding en nascholing genoten om goed te kunnen beoordelen welke methode een patiënt nodig heeft. Binnen de visie van de integrale geneeskunde staat juist het kiezen van het beste uit beide werelden voorop.
Zelfde soort bewijs voor homeopathische als voor reguliere geneesmiddelen?
Dat adviseert de EASAC. Blijkbaar hebben zij zich niet verdiept in de homeopathische methode. Geneesmiddelen worden in de homeopathische geneeskunde namelijk niet alleen uitgezocht op de ziekte of klacht maar ook op het totaalbeeld van de mens. Het is een individuele vorm van geneeskunde. Ook in de reguliere geneeskunde is gebleken dat niet iedereen op hetzelfde middel hetzelfde reageert en wordt er gestreefd naar een individueel voorschrift.
Homeopathie in veel landen geaccepteerd
In een aantal landen is homeopathie een geaccepteerde en geïmplementeerde vorm van geneeskunde. In India, Brazilië en in verschillende staten van de VS zelfs als medisch specialisme. In de ons omringende landen is homeopathie een officieel erkende behandelmethode die vaak aan de universiteit wordt onderwezen. In Zwitserland wordt homeopathie, naast natuurgeneeskunde, acupunctuur en antroposofie volledig vergoed vanuit de basisverzekering, onder meer op basis van wetenschappelijk onderzoek. Recente Zwitserse evaluaties tonen in alle opzichten positieve resultaten, ook financieel. In Nederland maken veel mensen naar tevredenheid gebruik van homeopathie, vooral mensen met een chronische aandoening. Een Nederlandse studie toonde enkele jaren geleden aan dat huisartsen die naast reguliere ook homeopathische geneeskunde toepassen ruim 12% goedkoper werken dan gemiddeld. 
Samenwerken als wetenschappers in plaats van elkaar bestrijden
Ten slotte doet de AVIG samen met internationale belangenverenigingen en onderzoekers een oproep aan de EASAC om samen te werken. In een gezamenlijke conferentie kan de stand van zaken van het wetenschappelijk homeopathisch onderzoek worden vastgesteld.
Referenties kunt u vinden op www.homeopathie.nl

The Lancet paper by Shang et al.
In August 2005, the Lancet published a study1 which was reported as having compared 110 similar trials on homeopathy and conventional medicine, and reached the conclusion that homeopathy is no better than placebo.
An accompanying editorial by The Lancet editor entitled ‘The end of homoeopathy’2 lead to widespread media attention.
However, the conclusions of this study were in fact based on only 8 of the 110 trials, none of which involved usual homeopathic care. Furthermore, if you switch just one of the 8 trials they picked from the 110 for a different one, the results are reversed, showing that homeopathy works beyond placebo.3
This demonstrates that the findings of this paper are completely unreliable.
The sequence of events surrounding this issue of The Lancet, the political controversy which followed and key flaws of the study itself, are summarised in ‘Homeopathy and the Lancet‘.3
A paper with continued global impact
The Shang et al. paper has become notorious because, despite such fundamental flaws, it continues to be mis-quoted to this day as definitive ‘proof’ that homeopathy doesn’t work e.g.:
“Over 150 trials have failed to show it works”
Dr Ellie Cannon – resident GP for the Mail on Sunday. ‘Health Comment’, Mail on Sunday, 14 September 2014

“We’ve had over 100 trials of homeopathy now. For any medical treatment, after 100 trials have failed to give good overall evidence of benefit, this is the point at which a sensible person, with no vested interests in that one particular treatment, would loudly and clearly state: “No more money should be spent researching this blind alley”.
Ben Goldacre – British physician, academic and science writer.‘Pharma Chameleon’, New Europe, 17 April 2011 – Issue 93.
Results of the Shang paper
Shang et al.’s findings as reported in the abstract of the paper are:
110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0·88 (95% CI 0·65–1·19) for homoeopathy (eight trials) and 0·58 (0·39–0·85) for conventional medicine (six trials).
Note: These ‘odds ratios’ mean that, for these particular 8 trials of homeopathy, if you analyse them together, the results suggest that the effects seen are due to placebo rather than a real clinical effect.
How reliable are these results?
The role of the Shang paper in the homeopathy debate cannot be overstated, so the issue of quality and reliability of the paper is paramount.
Unfortunately, the poor scientific quality of the paper is obvious, having been described by experts in the field of homeopathy research3,4,5,6,7 as well as independent researcher Prof Hahn, who highlights the main problem:
To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded.8
 
More
Relevance of Shang’s 2005 paper in 2015
Reliability of the analysis is not the only problem with the Shang paper. As we take a fresh look at the evidence in 2015, we also need to consider how well this study reflects the entirety of today’s evidence base.
A rigorous study by Mathie et al. published in 2014, found that homeopathic medicines, when prescribed during individualised treatment, are 1.5- to 2.0-times more likely to have a beneficial effect than placebo.13
This study includes 151 placebo-controlled randomised trials – 41 more than Shang’s team identified in 2005, but which would have met their inclusion criteria if they had been available at the time.
This demonstrates the extent to which the 10 year-old Shang et al. paper, which now covers only 73% of the eligible trials, has been superseded.
Read HRI’s brief summary of Mathie et al.’s study or listen to Robert Mathie presenting his findings at the HRI Rome 2015 conference.
Shang et al. key facts

• Although 110 homoeopathy trials and 110 matched conventional medicine trials were included in the study, the results were based on only 8 homeopathy trials and 6 conventional medicine trials described as ‘larger higher quality trials’.
• If all 21 homeopathy trials they identified as higher quality had been analysed, they would have got the opposite result – that homeopathy has an effect beyond placebo.10 No justification has been given for discounting the other 13 high quality trials just because they were smaller.
• The study fails a ‘sensitivity analysis’ i.e. if you switch just one of the 8 homeopathy trials they chose from the 110, you get the opposite result i.e. that homeopathy works better than placebo.4
• None of the 8 homeopathy trials they used involved individualised homeopathic treatment – the form of homeopathy considered to be ‘usual care’ – instead they were testing non-individualised homeopathic medicines given without a consultation. The conclusions of this study therefore have no relevance to the evidence base ‘for or against’ usual homeopathic treatment.
• The 8 trials used were testing a range of different homeopathic medicines being used for different conditions. One would assume that, as with conventional medicine, some homeopathic treatments work and others don’t, so it is no surprise that some of these studies were negative whilst others were positive. Mixing the results together to decide whether they show ‘homeopathy’ works makes no scientific sense.
• In the original paper Shang et al. do not state which 8 homeopathy trials and which 6 conventional trials they used. Such lack of reporting transparency and precision is typically not tolerated in studies of conventional medicine.6 Following an outcry, the authors eventually provided this information.
• The decade-old Shang paper is out of date and has been superseded. Since 2005, 41 more placebo-controlled randomised trials have been published which would have been suitable for inclusion in Shang’s review. These have been included in the most recent meta-analysis by Mathie et al. published in 2014 which reached a positive conclusion.13

https://www.hri-research.org/resources/homeopathy-the-debate/the-lancet-paper-by-shang-et-al/
 

The Australian report
In March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy, commonly referred to as ‘The Australian Report’.1
This document concludes that “…there are no health conditions for which there is reliable evidence that homeopathy is effective”.
This report triggered headlines around the world suggesting NHMRC had found that homeopathy doesn’t work for any condition.3
Australian Report key facts
An extensive detailed investigation by Gerry Dendrinos of the Australian Homeopathic Association (AHA) into NHMRC’s conduct, combined with an in-depth scientific analysis of the report by HRI, revealed evidence of serious procedural and scientific misconduct in producing this report:

• NHMRC did the homeopathy review twice, producing two reports, one in July 2012 and the one released to the public in March 2015.
• The existence of the first report has never been disclosed to the public – it was only discovered by AHA through Freedom of Information (FOI) requests.
• NHMRC say they rejected the first report because it was poor quality despite it being undertaken by a reputable scientist and author of NHMRC’s own guidelines on how to conduct evidence reviews.
• FOI requests have revealed that a member of NHMRC’s expert committee overseeing the review process – Professor Fred Mendelsohn – confirmed the first review to be high quality saying,  “I am impressed by the rigor, thoroughness and systematic approach given to this evaluation of the published reviews of efficacy and side effects of homeopathy [….] Overall, a lot of excellent work has gone into this review and the results are presented in a systematic, unbiased and convincing manner.” 
• NHMRC said the results of the report published in 2015 were based on a “rigorous assessment of over 1800 studies”. In fact results were based on only 176 studies.
• NHMRC used a method that has never been used in any other review, before or since. NHMRC decided that for trials to be ‘reliable’ they had to have at least 150 participants and reach an unusually high threshold for quality. This is despite the fact that NHMRC itself routinely conducts studies with less than 150 participants.
• These unprecedented and arbitrary rules meant the results of 171 of the trials were completely disregarded as being ‘unreliable’ leaving only 5 trials NHMRC considered to be ‘reliable’. As they assessed all 5 of these trials as negative, this explains how NHMRC could conclude that there was no ‘reliable’ evidence.
• Professor Peter Brooks, Chair of the NHMRC committee that conducted the 2015 review, initially failed to declare that he was a member of the anti-homeopathy lobby group ‘Friends of Science in Medicine’.
• In violation of NHMRC’s own guidelines there was not one homeopathy expert on the committee.

 
Complaint submitted to Commonwealth Ombudsman
In August 2016 HRI’s in-depth scientific analysis was used as part of a submission of complaint to the Commonwealth Ombudsman brought by Complementary Medicines Australia, Australian Homoeopathic Association and Australian Traditional Medicine Society.
Download the Executive Summary of the Ombudsman submission here.
 
Rachel Roberts, Chief Executive of HRI says “NHMRC’s review is just bad science. Decision-makers and the scientific community rely on these kinds of reports and need to trust their accuracy. This is not about anyone’s personal opinion as to whether homeopathy works or not. It is about the importance of evidence being reported objectively, whatever it says, and the NHMRC did not do that.”
As the complaint is ongoing, our full analysis – some 60 pages – cannot be shared as yet, but HRI’s data provided details demonstrating the following scientific failures by NHMRC which necessitate retraction of the Australian Report:

• Use of an inappropriate scientific method
• Failure to use standardised, accepted methods
• Failure to obtain sufficiently accurate data to perform a meaningful review
• Failure to conduct an effective preliminary and public consultation
• Significant post-hoc changes to the research protocol
• Impact of NHMRC’s unusual method on the review results
• Further evidence of bias and misreporting
• Poor reporting – lack of clarity, inconsistencies and errors
• Evidence that this was a case of deliberate bias, not scientific error.

Dr Alex Tournier, Executive Director of HRI, explains: “The inaccuracies in NHMRC’s report are so extreme that we decided to work with the AHA to conduct a thorough investigation to fully uncover exactly what went on.”
The complainants are now waiting to hear back from the Ombudsman regarding their submission. As NHMRC’s inaccurate Homeopathy Review has had a significant impact on the field of homeopathy research worldwide, HRI will share any news regarding the complaint as the case progresses.
Roberts says: “The public has a right to know that there are high quality studies showing homeopathy works for some medical conditions, such as hay fever, sinusitis and diarrhoea in children – information that was lost only due to NHMRC’s mishandling of the evidence. If the evidence on conventional medicine was treated this way there would be an outcry – and rightly so. NHMRC’s job was to accurately summarise the body of evidence for homeopathy for the public, a task in which they categorically failed.”
The missing first report
NHMRC’s investigation into Homeopathy ran from 2010 to 2015. NHMRC initially worked with an external contractor – from April 2012-August 2012 – to produce a review of the evidence on Homeopathy to inform the Australian public.
The report produced was called ‘A Systematic Review of the Evidence on the Effectiveness of Homeopathy’.
This review, paid for by Australian tax payers, was never made public and NHMRC continue to refuse to release it, despite repeated Freedom of Information requests.
After terminating the contract with the first review team, a second external contractor – OptumInsight – was hired to do the Homeopathy review again from December 2012-March 2015.
HRI is not alone in criticising the accuracy of NHMRC’s findings
FOI requests have brought to light that two independent experts also raised concerns over the conclusions of the 2015 report during peer review, prior to final publication. The Australasian Cochrane Centre commented that for some conditions, “…. ‘no reliable evidence’ does not seem an accurate reflection of the body of evidence”; a second expert felt “uncertain of the definitive nature of the Report’s conclusions”. NHMRC chose not to act on this feedback and did not amend their conclusions.
The real story behind the headlines
The Information Paper is designed for the general public and aims to provide a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans.2
Confusing ‘lack of evidence of effect’ with ‘evidence of a lack of effect’
The Report’s conclusion that there is ‘no reliable evidence’ that homeopathy works, has been widely misunderstood, with people believing it meant that the NHMRC found that homeopathy does not work for the conditions tested, which would be a completely different result.
This misunderstanding triggered widespread media coverage, propagating the inaccurate story that the NHMRC found homeopathy to be no better than placebo for all the conditions.
In fact, NHMRC concluded that homeopathy worked no better than placebo for only 13 of the 61 health conditions they investigated.
HRI’s in-depth scientific analysis of the Australian Report revealed multiple examples of bias and misreporting which explain how NHMRC arrived at such a definitive and negative position, at odds with the conclusions of the majority of other more academically rigorous systematic reviews and meta-analyses on homeopathy.
Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence: for a trial to be deemed ‘reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ‘insufficient quality and/or size to warrant further consideration of their findings’.
Setting such a high quality threshold is very unusual, but the N=150 minimum sample size criterion is arbitrary, without scientific justification, and unprecedented in evidence reviews.
Out of 176 individual studies the NHMRC included in the homeopathy review, only 5 trials met their definition of ‘reliable‘, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ‘no reliable evidence’ that homeopathy is effective.
For context it is worth remembering that if it was indeed the case that ‘no reliable evidence’ existed for homeopathy, it would put homeopathy in the same evidence category (“unknown effectiveness”) as 46% of conventional treatments used in the NHS, but in fact this conclusion is inaccurate.
Contrary to NHMRC’s findings, there are ‘good quality, well-designed studies with enough participants for a meaningful result‘ (to use NHMRC’s description of a reliable study) which show that certain homeopathic treatments are effective for certain conditions such as hay fever, sinusitis, upper respiratory tract infections, diarrhoea in children and lower back pain. The fact that the results of such studies were unjustifiably dismissed means that NHMRC have misled the public by misreporting the evidence for effectiveness of homeopathy.
Find out more on our Australian Report FAQs page
https://www.hri-research.org/resources/homeopathy-the-debate/the-australian-report-on-homeopathy/

Liesbeth Ellinger schreef 02 oktober in de NRC:
 
Lees dit artikel uit NRC.next Homeopathie werkt wel


Homeopathie werkt wel
Wetenschap
Homeopathie werkt wel
Nu zeggen onderzoekers van EASAC, een raad van nationale wetenschappelijke kennisinstituten, weer dat homeopathische medicijnen niet langer als medisch product zouden mogen worden aangemerkt, omdat onvoldoende vaststaat dat ze echt werken. (Homeopathie-middelen niet langer vergoeden, 21/9).
Als er gezegd wordt „er is geen enkel wetenschappelijk bewijs dat homeopathie werkt”, weet dan dat dit een leugen is. Homeopathie werkt wel degelijk, en dat is zelfs wetenschappelijk bewezen. Zelf hebben we een overtuigend dubbelblind onderzoek gedaan naar het voorkómen van diarree bij biggen.
Het idee dat homeopathie alleen werkt als je erin gelooft, is onzin. Als dierenarts, gespecialiseerd in homeopathie, behandel ik dagelijks honden, katten en paarden, vaak met al jarenlange, zogenaamd ongeneeslijke klachten. Als die binnen een week gaan opknappen, is dat dan geloof van het paard in homeopathie? Of geloof van de eigenaar, die ziet dat zijn kreupele paard plots weer goed loopt? Geloof van de dierenarts, die op de röntgenfoto ziet dat de artrose verdwijnt?
Met veehouders werken we hard om het gebruik van antibiotica terug te dringen. Door homeopathische middelen te gebruiken, lukt het een aantal veehouders om antibioticumvrij te werken. Dat is enorm belangrijk, omdat we steeds meer problemen krijgen met antibioticumresistentie.
Liesbeth Ellinger
dierenarts en onderzoeker, gespecialiseerd in homeopathie