MD, PhD, FMedSci, FSB, FRCP, FRCPEd

scientific misconduct

My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:

Claudia Witt

George Lewith

John Licciardone

But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.

For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:

SYSTEMATIC REVIEW COMPARING DIFFERENT YOGA STYLES (2016)

RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.

SYSTEMATIC REVIEW OF YOGA FOR WEIGHT LOSS (2016)

Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)

…there is published, positive level I evidence for a number of CAM treatment forms.

SYSTEMATIC REVIEW OF MINDFULNESS FOR PSYCHOSES (2016)

Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.

RCT OF CABBAGE LEAF WRAPS FOR OSTEOARTHOSIS (2016)

Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.

SYSTEMATIC REVIEW OF HERBAL MEDICINES FOR COUGH (2015)

This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.

SYSTEMATIC REVIEW OF DIETARY APPROACHES FOR METABOLIC SYNDROME (2016)

Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.

SYSTEMATIC REVIEW OF MIND BODY MEDICINE FOR CORONARY HEART DISEASE (2015)

In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.

CRANIOSACRAL THERAPY (CST) FOR BACK PAIN (2016)

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

REVIEW OF INTEGRATED MEDICINE FOR BREAST CANCER (2015)

Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.

Amazed?

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”

The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.

The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”

Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.

In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.

I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.

 

Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”

The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”

This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”

How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.

On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.

Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”

RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.

Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.

I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.

After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.

WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.

What a question, you might say. And you would be right, it’s a most awkward one, so much so that I cannot answer it for myself.

I NEED YOUR HELP.

Here is the story:

Ten years ago, with the help of S Lejeune and an EU grant, my team conducted a Cochrane review of Laertrile. To do the ‘ground work’, we hired an Italian research assistant, S Milazzo, who was supervised mainly by my research fellow Katja Schmidt. Consequently, the review was published under the names of all main contributors: Milazzo, Ernst, Lejeune, Schmidt.

In 2011, an update was due for which the help of Dr Markus Horneber, the head of a German research team investigating alt med in relation to cancer, was recruited. By then, Milazzo and Schmidt had left my unit and, with my consent, Horneber, Milazzo and Schmidt took charge of the review. I was then sent a draft of their update and did a revision of it which consisted mostly in checking the facts and making linguistic changes. The article was then published under the following authorship: Milazzo S, Ernst E, Lejeune S, Boehm K, Horneber M (Katja had married meanwhile, so Boehm and Schmidt are the same person).

A few days ago, I noticed that a further update had been published in 2015. Amazingly, I had not been told, asked to contribute, or informed that my name as co-author had been scrapped. The authors of the new update are simply Milazzo and Horneber (the latter being the senior author). Katja Boehm had apparently indicated that she did no longer want to be involved; I am not sure what happened to Lejeune.

I know Markus Horneber since donkey’s years and had co-authored several other papers with him in the past, so I (admittedly miffed about my discovery) sent him an email and asked him whether he did not consider this behaviour to amount to plagiarism. His reply was, in my view, unhelpful in explaining why I had not been asked to get involved and Horneber asked me to withdraw the allegation of plagiarism (which I had not even made) – or else he would take legal action (this was the moment when I got truly suspicious).

Next, I contacted the responsible editor at the Cochrane Collaboration, not least because Horneber had claimed that she had condoned the disputed change of authorship. Her reply confirmed that “excluding previous authors without giving them a chance to comment is not normal Cochrane policy” and that she did, in fact, not condone the omission of my name from the list of co-authors.

The question that I am asking myself (not for the first time, I am afraid – a similar, arguably worse case has been described in the comments section of this post) is the following: IS THIS A CASE OF PLAGIARISM OR NOT? In the name of honesty, transparency and science, it requires an answer, I think.

Even after contemplating it for several days, I seem to be unable to find a conclusive response. On the one hand, I did clearly not contribute to the latest (2015) update and should therefore not be a co-author. On the other hand, I feel that I should have been asked to contribute, in which case I would certainly have done so and remained a co-author.

For a fuller understanding of this case, I here copy the various sections of the abstracts of the 2011 update (marked OLD) and the 2015 update without my co-authorship (marked NEW):

 

OLD

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

NEW

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

OBJECTIVES:

OLD

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

NEW

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

SEARCH METHODS:

OLD

We searched the following databases: CENTRAL (2011, Issue 1); MEDLINE (1951-2011); EMBASE (1980-2011); AMED; Scirus; CancerLit; CINAHL (all from 1982-2011); CAMbase (from 1998-2011); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

NEW

We searched the following databases: CENTRAL (2014, Issue 9); MEDLINE (1951-2014); EMBASE (1980-2014); AMED; Scirus; CINAHL (all from 1982-2015); CAMbase (from 1998-2015); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

SELECTION CRITERIA:

OLD

Randomized controlled trials (RCTs) and quasi-RCTs.

NEW

Randomized controlled trials (RCTs) and quasi-RCTs.

DATA COLLECTION AND ANALYSIS:

OLD

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

NEW

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

MAIN RESULTS:

OLD

We located over 200 references, 63 were evaluated in the original review and an additional 6 in this update. However, we did not identify any studies that met our inclusion criteria.

NEW

We located over 200 references, 63 were evaluated in the original review, 6 in the 2011 and none in this update. However, we did not identify any studies that met our inclusion criteria.

AUTHORS’ CONCLUSIONS:

OLD

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

NEW

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

END OF ABSTRACT

I HOPE THAT YOU, THE READER OF THIS POST, ARE NOW ABLE TO TELL ME:

HAVE I BEEN PLAGIARISED?

P S

After the response from the Cochrane editor, I asked Horneber whether he wanted to make a further comment because I was thinking to blog about this. So far, I have not received a reply.

Researching and reporting shocking stories like this one can only make me more enemies, I know. Yet I do think they need to be told; if we cannot learn from history, what hope is there?

I first became aware of Sigmund Rascher‘s work when I was studying the effects of temperature on blood rheology at the University of Munich. I then leant of Rascher’s unspeakably cruel experiments on exposing humans to extreme hypothermia in the Dachau concentration camp. Many of his ‘volunteers’ had lost their lives, and the SS-doctor Rascher later became the symbol of a ‘Nazi doctor from hell’. In 1990, R L Berger aptly described Rascher and his sadistic pseudo-science in his NEJM article:

“Sigmund Rascher was born in 1909. He started his medical studies in 1930 and joined both the Nazi party and the storm troopers (the SA) three years later. After a volunteer internship, Rascher served for three years as an unpaid surgical assistant. He was barred temporarily from the University of Munich for suspected Communist sympathies. In 1939, the young doctor denounced his physician father, joined the SS, and was inducted into the Luftwaffe. A liaison with and eventual marriage to Nini Diehl, a widow 15 years his senior who was a one-time cabaret singer but also the former secretary and possibly mistress of the Reichsführer, gained Rascher direct access to Himmler. A strange partnership evolved between the junior medical officer and one of the highest officials of the Third Reich. One week after their first meeting, Rascher presented a “Report on the Development and Solution to Some of the Reichsführer’s Assigned Tasks During a Discussion Held on April 24, 1939.” The title of this paper foretold the character of the ensuing relationship between the two men. Because of Rascher’s servile and ingratiating approach to Himmler, his “connections were so strong that practically every superior trembled in fear of the intriguing Rascher who consequently held a position of enormous power.

Rascher’s short investigative career included a leading role in the infamous high-altitude experiments on humans at Dachau, which resulted in 70 to 80 deaths. He was also involved in testing a plant extract as a cure for cancer. The genesis of this project illustrates Rascher’s style and influence. Professor Blome, the deputy health minister and plenipotentiary for cancer research, favored testing the extract in mice. Rascher insisted on experiments in humans. Himmler sided with Rascher. A Human Cancer Testing Station was set up at Dachau. The deputy health minister collaborated on the project, held approximately 20 meetings with Rascher, and visited the junior officer at Dachau several times.

Another of Rascher’s major research efforts focused on the introduction of a pectin-based preparation, Polygal, to promote blood clotting. He predicted that the prophylactic use of Polygal tablets would reduce bleeding from wounds sustained in combat or during surgical procedures. The agent was also recommended for the control of spontaneous gastrointestinal and pulmonary hemorrhages. Combat wounds were simulated by the amputation of the viable extremities of camp prisoners without anesthesia or by shooting the prisoners through the neck and chest.

Rascher also claimed that oral premedication with Polygal minimized bleeding during major surgical procedures, rendering hemostatic clips or ligatures unnecessary and shortening operating times. He published an enthusiastic article about his clinical experience with Polygal, without specifying the nature of some of the trials in humans. The paper concluded, “The tests of this medicine ‘Polygal 10’ showed no failures under the most varied circumstances.” Rascher also formed a company to manufacture Polygal and used prisoners to work in the factory. A prisoner who was later liberated testified that Rascher’s enthusiasm for Polygal’s antiinfectious properties was probably sparked by news of the introduction of penicillin by the Allies and by his eagerness to reap fame and receive the award established for inventing a German equivalent. He initiated experiments in humans apparently without any preliminary laboratory testing. In one experiment, pus was injected into the legs of prisoners. The experimental group was given Polygal. The controls received no treatment. Information filtered to Dr. Kurt Plotner, Rascher’s physician rival, that the controls were given large, deep subcutaneous inoculations, whereas the victims in the experiments received smaller volumes of pus injected intracutaneously. Plotner reportedly investigated the matter and discovered that the Polygal used was saline colored with a fluorescent dye.

The frequent references to Rascher in top-level documents indicate that this junior medical officer attracted extraordinary attention from Germany’s highest officials. His work was reported even to Hitler, who was pleased with the accounts. Rascher was not well regarded in professional circles, however, and his superiors repeatedly expressed reservations about his performance. In one encounter, Professor Karl Gebhardt, a general in the SS and Himmler’s personal physician, told Rascher in connection with his experiments on hypothermia through exposure to cold air that “the report was unscientific; if a student of the second term dared submit a treatise of the kind [Gebhardt] would throw him out.” Despite Himmler’s strong support, Rascher was rejected for faculty positions at several universities. A book by German scientists on the accomplishments of German aviation medicine during the war devoted an entire chapter to hypothermia but failed to mention Rascher’s name or his work.”

For those who can stomach the sickening tale, a very detailed biography of Rascher is available here.

I had hoped to never hear of this monster of a man again – yet, more recently, I came across Rascher in the context of alternative medicine. Rascher had been brought up in Rudolf Steiner’s anthroposophical tradition, and his very first ‘research’ project was on a alternantive blood test developed in anthroposophy.

A close friend of Rascher, the anthroposoph and chemist Ehrenfried Pfeiffer had developed a bizarre diagnostic method using copper chloride crystallization of blood and other materials. This copper chloride biocrystallization (CCBC) became the subject of Rascher’s dissertation in Munich. Rascher first tried the CCBC for diagnosing pregnancies and later for detecting early cancer (incidentally, he conducted this work in the very same building where I worked for many years, about half a century later). The CCBC involves a visual evaluation of copper crystals which form with blood or other fluids; the method is, of course, wide open to interpretation. Bizarrely, the CCBC is still used by some anthroposophical or homeopathic doctors today – see, for instance, this recent article or this website, this website or this website which explains:

“Hierbei werden einige Tropfen Blut mit Kupferchlorid in einer Klimakammer zur Kristallisation gebracht.
Jahrzehntelange Erfahrung ermöglicht eine ganz frühe Hinweisdiagnostik sowohl für alle Funktionsschwächen der Organe, auch z.B. der Drüsen, als auch für eine Krebserkrankung. Diese kann oft so früh erkannt werden, daß sie sich mit keiner anderen Methode sichern läßt.” My translation: “A few drops of blood are brought to crystallisation with copper chloride in a climate chamber. Decades of experience allow a very early diagnosis of all functional weaknesses of the organs and glands as well as of cancer. Cancer can often be detected earlier than with any other method.”

The reference to ‘decades of experience’ is more than ironic because the evidence suggesting that the CCBC might be valid originates from Rascher’s work in the 1930s; to the best of my knowledge no other ‘validation’ of the CCBC has ever become available. With his initial thesis, Rascher had produced amazingly positive results and subsequently lobbied to get an official research grant for testing the CCBC’s usefulness in cancer diagnosis. Intriguingly, he had to disguise the CCBC’s connection to anthroposophy; even though taken by most other alternative medicines, the Nazis had banned the Steiner cult.

Most but not all of Rascher’s research was conducted in the Dachau concentration camp where in 1941 a research unit was established in ‘block 5’ which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.

Today, all experts believe Rascher’s results, even those on CCBC, to be fraudulent. Rascher seems to have been not merely an over-ambitious yet mediocre physician turned sadistic slaughterer of innocent prisoners, he also was a serial falsifier of research data. It is likely that his fraudulent thesis on the anthroposophic blood test set him off on a life-long career of consummate research misconduct.

Before the end of the Third Reich, Rascher lost the support of Himmler and was imprisoned for a string of offences which were largely unrelated to his ‘research’. He was eventually brought back to the place of his worst atrocities, the concentration camp in Dachau. Days before the liberation of the camp by the US forces, Rascher was executed under somewhat mysterious circumstances. In my view, the CCBC should have vanished with him.

If the Flat Earth Society (FES) really exists at all, I must confess I know nothing about it. Here I use the term ‘FES’ merely as an analogy; you might replace FES with SoH or BHA or BAA or BCA or with most of the other acronyms used in my field of inquiry.

What I do know about is alternative medicine, particularly publications in this area, and the authors of such papers. As it happens, the members of my imaginary FES have a lot in common with the authors of articles on alternative medicine. Their publication policy, for instance, is remarkably simple yet astonishingly effective. Its aim is straight forward: mislead the public. As far as I can see, it is being pursued by just two main strategies.

1 SWAMP THE MARKET WITH TRASH

This is a simple and most successful strategy. It consists of publishing an ever-growing mountain of utter nonsense. Anyone who is  interested in alternative medicine and conducts a search would thus find tons of articles listed in Medline or other databases. This will instantly generate the impression that Flat Earth research is highly active. Those who can bear the pain might even try to read a few of these papers; they will soon give up in despair. Too many are hardly understandable; they are often badly written, lack essential methodological detail, and invariably arrive at positive conclusions.

The strategy can only work, if there are journals who publish such rubbish. I am glad to say, there is no shortage of them! To attain a veneer of credibility, the journals need to be peer-reviewed, of course. This is no real problem, as long as the peer-reviewers are carefully chosen to be ‘cooperative’. The trick is to make sure to ask the authors submitting articles to name two or three uncritical friends who might, one day, be happy to act as peer-reviewers for their own papers. This works very smoothly indeed: one pseudo-scientist is sure to help another in their desire to publish some pseudo-science in a ‘peer-reviewed’ journal.

To oil the system well, we need money, of course. Again, no problem: most of these journals ask for a hefty publication fee.

The result is as obvious as it is satisfying. The journal earns well, the pseudo-researchers can publish their pseudo-research at will, and the peer-reviewers know precisely where to go for a favour when they need one. Crucially, the first hurdle to misleading the public is taken with bravura.

2. REFUTE ANY EVIDENCE THAT IS UNFAVOURABLE

There are, of course, journals which refuse to play along. Annoyingly, they adhere to such old-fashioned things like standards and ethics; they have a peer-review system that is critical and independent; and they don’t rely on pseudo-scientists for their income. Every now and then, such a journal publishes an article on alternative medicine. It goes without saying that, in all likelihood, such an article is of high quality and therefore would not be in favour of Flat Earth assumptions.

This is a serious threat to the aim of the FES. What can be done?

No panic, the solution is simple!

An article is urgently needed to criticise the paper with the unfavourable evidence – never mind that it is of much better quality than the average paper in the Flat Earth-journals. If one looks hard enough, one can find a flaw in almost every article. And if there is none, the FES can always invent one. And if the proper science journal refuses to publish the pseudo-criticism as a comment, there are always enough pseudo-journals that are only too keen to oblige.

The important thing is to get something that vaguely looks like a rebuttal in print (the public will not realise that it is phony!).

Once this aim is achieved, the world is back in order again. As soon as someone dares to cite the high quality, negative evidence, the FES members can all shout with one voice: BUT THIS PAPER HAS BEEN HEAVILY CRITICISED; IT IS NOT RELIABLE! WHOEVER CITED THE PAPER IS ILL-INFORMED AND THEREFORE NOT CREDIBLE.

3. MISSION ACCOMPLISHED

The overall effect is clear. The public, journalists, politicians etc. get the impression that the earth is indeed flat – or, at the very minimum, they are convinced that there is a real scientific debate about the question.

Anyone who has looked into the discussions around homeopathy for more than 10 minutes will have come across Dana Ullman (DU). Some 15 years ago, I had the pleasure to meet him in person during a conference in Boston. After the brief chat, I asked a UK homeopath who this bizarre person was. “Oh Dana!” he replied “Dana is alright.”

But is he? Let’s have a look at the evidence.

There are very few papers by DU listed in Medline, and most of these articles are simply opinion pieces. The opinions DU expresses there (or anywhere else) are usually not supported by good evidence; some of them are even outright dangerous. Here are a few quotes:

“…homeopathic care is cost effective…”

“…homeopathic medicines are effective…”

“…homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy [for HIV infections]”

“[There are]…significant effects of homeopathic treatment in allergic patients.”

Occasionally, DU writes little essays full of utter nonsense, logical fallacies and falsehoods for HUFFPOST where he is nevertheless characterised in glowing terms: Dana Ullman, M.P.H. (Masters in Public Health, U.C. Berkeley), CCH (Certification in Classical Homeopathy) is “homeopathic.com” and is widely recognized as the foremost spokesperson for homeopathic medicine in the U.S.

Wikipedia, however, is more critical and cites the opinion of a judge who was presiding over a class action against a US homeopathic producer in which DU had been called as an expert witness: The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted…Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.

The Encyclopedia of Americam Loons is even more poignant and describes DU as: A master of cognitive dissonance and memory bias, Ullman seems clinically unable to grasp the possibility that he may be wrong. Combined with a lack of understanding of science or medicine – and the possession of certain marketing skills – what we end up with is rather insidious.

Anyone who has debated with DU will have to concur with the claim that he fails to understand science or medicine. If you don’t believe me, please read his recent comments on the post about Prof Frass on this blog where he excels in producing one fallacy after the next (if he were on a mission to give homeopathy a bad name, he would be doing a sterling job!).

Despite all this abysmal ignorance, DU has one undisputed and outstanding talent: the knack of getting on people’s nerves and thus driving rational thinkers to distraction. In this way he even managed to be headlined as an ‘idiot‘!

I find it tempting to agree with the many experts who have called him an idiot, a moron or a laughing stock but, for now, I will resist that temptation. On the contrary, I want point out that he is much more cunning and clever than we give him credit for: after all, he runs a thriving business and lives off the nonsense he produces. To my mind, this is not idiotic; devious and unethical surely, but not idiotic nor laughable!

Homeopathy seems to attract some kind of miracle worker. Elsewhere I have, for instance, reported the curious case of Prof Claudia Witt who published more than anyone on homeopathy in recent years without hardly ever arriving at a negative conclusion. Recently, I came across a researcher with an even better track record: Prof Michael Frass.

Wikipedia describes his achievements as follows: “Michael Frass studied medicine from 1972 to 1978 at the Medical University of Vienna followed by visits abroad at the Pasteur Institute, Paris and at the Porter Memorial Hospital (USA). Since March 2004 he directs the Outpatients Unit of Homeopathy for Malign Diseases at the Department Clinic for Internal of Medicine I at the Medical University of Vienna. Since 2005 Frass also works as a coordinator of the lecture series Homeopathy at the Medical University of Vienna. Beginning with the winter semester 2001/02 he is the coordinator of a lecture series Basics and practise of complementary medical methods at the Medical University of Vienna. From 2002 to 2005 he led the Ludwig Boltzmanm Institute of Homeopathy. Since 2005 Frass is president of the Institute for Homeopathic Research. Actually he works at the Division of Oncology at the Department of Medicine I in Vienna. He is First Chairman of the Scientific Society for Homeopathy (WissHom), founded in 2010, president of the Umbrella organization of Austrian Doctors for Holistic Medicine.”

He directs the WHAT? The Outpatients Unit of Homeopathy for Malign Diseases at the Department Clinic for Internal of Medicine I at the Medical University of Vienna? This is my former medical school, and I had no idea that such a unit even existed – but, of course, I left in 1993 for Exeter (a few months ago, I followed an invitation to give a lecture on homeopathy at the Medical University of Vienna ; sadly neither Prof Frass nor anyone of his team attended).

And what about the Scientific Society for Homeopathy? I am sure that the name of this organisation will make some people wonder. From the society’s website, we learn that “the intention of WissHom is to contribute to the progress of medicine and to the collective good. To this end, WissHom intents to further develop homeopathy both practically and theoretically. It will be WissHom’s task to breathe life into this committed objective.”

Breathing life into homeopathy seems exactly what Prof Frass does. He seems to have found his way to homeopathy relatively late in his career (the 1st Medline-listed article was published only in 2003) but he has nevertheless published many studies on this subject (I use the term ‘study’ here to describe both clinical, pre-clinical and basic research papers); in total, I found 12 such articles on Medline. They cover extremely diverse areas and a wide range of methodologies. Yet they all have one remarkable feature in common: they arrive at positive conclusions.

You find this hard to believe? Join the club!

But it is undeniably true, here are the conclusions (or the bit that comes close to a conclusion) from the Medline-listed abstracts (only the headings in capital letters are mine, and they simply depict the nature of the paper)

AN RCT WITH CANCER PATIENTS (2015)

Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.

TWO CASE REPORTS OF HOMEOPATHICALLY TREATED INTOXICATIONS (2014)

Based on the 2 cases, including 1 extreme situation, we suggest that adjunctive homeopathic treatment has a role in the treatment of acute Amanita phalloides-induced toxicity following mushroom poisoning. Additional studies may clarify a more precise dosing regimen, standardization, and better acceptance of homeopathic medicine in the intensive care setting.

RETORSPECTIVE ANALYSIS OF CANER SURVIVAL UNDER HOMEOPATHIC TREATMENT (2014)

Extended survival time in this sample of cancer patients with fatal prognosis but additive homeopathic treatment is interesting. However, findings are based on a small sample, and with only limited data available about patient and treatment characteristics. The relationship between homeopathic treatment and survival time requires prospective investigation in larger samples possibly using matched-pair control analysis or randomized trials.

OBSERVATIONAL STUDY OF HOMEOPATHIC TREATMENT FOR ALLERGIES (2012)

The symptoms of patients undergoing homeopathic treatment were shown to improve substantially and conventional medication dosage could be substantially reduced. While the real-life effect assessed indicates that there is a potential for enhancing therapeutic measures and reducing healthcare cost, it does not allow to draw conclusions as to the efficacy of homeopathic treatment per se.

IN-VITRO STUDY OF THE EFFECTS OF HOMEOPATHICS ON HELIOBACTER PYLORI (2010)

The data suggest that both drugs prepared in ethanolic solution are potent inhibitors of H. pylori induced gene expression.

SYSTEMATIC REVIEW OF HOMEOPATHY FOR RESPIRATORY ALLERGIES (2010)

Most of these clinical studies have been deemed to be high quality trials, according to the three most commonly referenced meta-analyses of homeopathic research. Basic in vitro experimental studies also provide evidence that the effects of homeopathy differ from placebo.

CASE SERIES OF PATIENTS TREATED WITH HOMEOPATHIC PETROLEUM (2008)

This study is based on 25 well documented reports of cases which responded well to treatment with Petroleum.

ANIMAL EXPERIMENT WITH HOMEOPATHY ( 2008)

Animals treated with the standard test solution thyroxine 10(-30) metamorphosed more slowly than the control animals, ie the effect of the homeopathically prepared thyroxine was opposed to the usual physiological effect of molecular thyroxine.

OVERVIEW OF HOMEOPATHIC TREATMENT IN INTENSIVE CARE (2005)

Our report suggests that homeopathy may be applicable even for critically ill patients.

RCT OF HOMEOPATHY FOR SEVERE SEPSIS (2005)

Our data suggest that homeopathic treatment may be a useful additional therapeutic measure with a long-term benefit for severely septic patients admitted to the intensive care unit. A constraint to wider application of this method is the limited number of trained homeopaths.

RCT OF HOMEOPATHY FOR COPD (2005)

These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.

ANIMAL STUDY OF A HOMEOPATHIC REMEDY (2003)

These animals reacted to the homeopathically prepared thyroxine with a slowing down of metamorphosis, even when they had not been prestimulated with a molecular dose of the hormone. This effect was observed in all 3 laboratories and is consistent with the results of previous studies.

Surprised?

So am I!

How can homeopathy produce nothing but positive results in the hands of this researcher? How can it work in so many entirely different conditions? How is it possible that homeopathic remedies are better than placebo regardless of the methodology used? Why does homeopathy, in the hands of Prof Frass, not even once produce a result that disappoints the aspirations of homeopaths and its advocates? Why are these sensational results almost invariably published in very minor journals? Crucially, why has not one of the findings (as far as I can see) ever been independently reproduced?

I do not know the answers to these questions.

If anyone does, I would like to hear them.

Bach flower remedies (BFR) are amazingly popular. They have been the subject of posts on this blog before (see here and here, for instance). They are as dilute as most homeopathic remedies and just as implausible. All the rigorous trials that have tested BFR have so far been squarely negative. Here is a truly surprising new study where BFR was administered externally which would seem to make an effect not more but less likely.

A randomized, placebo-controlled clinical trial was conducted with the aim of evaluating the effectiveness of a cream based on BFR for symptoms of carpal tunnel syndrome. Forty-three patients with mild to moderate carpal tunnel syndrome during their “waiting” time for surgical option were randomized into 3 parallel groups: Placebo (n = 14), blinded BFR (n = 16), and non-blinded BFR (n = 13). These groups were treated during 21 days with topical placebo or a cream based on BFR.

Significant improvements were observed on self-reported symptom severity and pain intensity favorable to BFR groups with large effect sizes. In addition, all signs observed during the clinical exam showed significant improvements among the groups as well as symptoms of pain, night pain, and tingling, also with large effect sizes (φ > 0.5). Finally, there were significant differences between the blinded and non-blinded BFR groups for signs and pain registered in clinical exam but not in self-reports.

The Cuban authors of this study concluded that the proposed BFR cream could be an effective intervention in the management of mild and moderate carpal tunnel syndrome, reducing the severity symptoms and providing pain relief.

This is truly amazing, not least because there is not much that we can offer such patients except for surgery which usually is very successful. The current Cochrane review of non-surgical interventions for carpal tunnel syndrome shows significant short-term benefit from oral steroids, splinting, ultrasound, yoga and carpal bone mobilisation. Other non-surgical treatments do not produce significant benefit. More trials are needed to compare treatments and ascertain the duration of benefit.

What then should we make of the new study?

I have to admit, I am not sure. It was published in one of the worst journals I know which has attracted our attention on this blog before. It was published by authors from Cuba who I know nothing about. More importantly, its findings sound far too good to be true.

If I had been the editor in charge, I would have asked for the original data and had them re-analysed by an independent statistician. As we cannot do that, our only option is to apply common sense and wait for an independent replication before conceding that BFR are effective.

Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.

The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.

The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.

At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.

The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.

Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.

Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).

To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.

But why was there no improvement in the control group?

I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.

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