MD, PhD, FMedSci, FSB, FRCP, FRCPEd

commercial interests

Systematic reviews are widely considered to be the most reliable type of evidence for judging the effectiveness of therapeutic interventions. Such reviews should be focused on a well-defined research question and identify, critically appraise and synthesize the totality of the high quality research evidence relevant to that question. Often it is possible to pool the data from individual studies and thus create a new numerical result of the existing evidence; in this case, we speak of a meta-analysis, a sub-category of systematic reviews.

One strength of systematic review is that they minimise selection and random biases by considering at the totality of the evidence of a pre-defined nature and quality. A crucial precondition, however, is that the quality of the primary studies is critically assessed. If this is done well, the researchers will usually be able to determine how robust any given result is, and whether high quality trials generate similar findings as those of lower quality. If there is a discrepancy between findings from rigorous and flimsy studies, it is obviously advisable to trust the former and discard the latter.

And this is where systematic reviews of alternative treatments can run into difficulties. For any given research question in this area we usually have a paucity of primary studies. Equally important is the fact that many of the available trials tend to be of low quality. Consequently, there often is a lack of high quality studies, and this makes it all the more important to include a robust critical evaluation of the primary data. Not doing so would render the overall result of the review less than reliable – in fact, such a paper would not qualify as a systematic review at all; it would be a pseudo-systematic review, i.e. a review which pretends to be systematic but, in fact, is not. Such papers are a menace in that they can seriously mislead us, particularly if we are not familiar with the essential requirements for a reliable review.

This is precisely where some promoters of bogus treatments seem to see their opportunity of making their unproven therapy look as though it was evidence-based. Pseudo-systematic reviews can be manipulated to yield a desired outcome. In my last post, I have shown that this can be done by including treatments which are effective so that an ineffective therapy appears effective (“chiropractic is so much more than just spinal manipulation”). An even simpler method is to exclude some of the studies that contradict one’s belief from the review. Obviously, the review would then not comprise the totality of the available evidence. But, unless the reader bothers to do a considerable amount of research, he/she would be highly unlikely to notice. All one needs to do is to smuggle the paper past the peer-review process – hardly a difficult task, given the plethora of alternative medicine journals that bend over backwards to publish any rubbish as long as it promotes alternative medicine.

Alternatively (or in addition) one can save oneself a lot of work and omit the process of critically evaluating the primary studies. This method is increasingly popular in alternative medicine. It is a fool-proof method of generating a false-positive overall result. As poor quality trials have a tendency to deliver false-positive results, it is obvious that a predominance of flimsy studies must create a false-positive result.

A particularly notorious example of a pseudo-systematic review that used this as well as most of the other tricks for misleading the reader is the famous ‘systematic’ review by Bronfort et al. It was commissioned by the UK GENERAL CHIROPRACTIC COUNCIL after the chiropractic profession got into trouble and was keen to defend those bogus treatments disclosed by Simon Singh. Bronfort and his colleagues thus swiftly published (of course, in a chiro-journal) an all-encompassing review attempting to show that, at least for some conditions, chiropractic was effective. Its lengthy conclusions seemed encouraging: Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation. Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic. 

Chiropractors across the world cite this paper as evidence that chiropractic has at least some evidence base. What they omit to tell us (perhaps because they do not appreciate it themselves) is the fact that Bronfort et al

  • failed to formulate a focussed research question,
  • invented his own categories of inconclusive findings,
  • included all sorts of studies which had nothing to do with chiropractic,
  • and did not to make an assessment of the quality of the included primary studies they included in their review.

If, for a certain condition, three trials were included, for instance, two of which were positive but of poor quality and one was negative but of good quality, the authors would conclude that, overall, there is sound evidence.

Bronfort himself is, of course, more than likely to know all that (he has learnt his trade with an excellent Dutch research team and published several high quality reviews) – but his readers mostly don’t. And for chiropractors, this ‘systematic’ review is now considered to be the most reliable evidence in their field.

Imagine a type of therapeutic intervention that has been shown to be useless. Let’s take surgery, for instance. Imagine that research had established with a high degree of certainty that surgical operations are ineffective. Imagine further that surgeons, once they can no longer hide this evidence, argue that good surgeons do much more than just operate: surgeons wash their hands which effectively reduces the risk of infections, they prescribe medications, they recommend rehabilitative and preventative treatments, etc. All of these measures are demonstratively effective in their own right, never mind the actual surgery. Therefore, surgeons could argue that the things surgeons do are demonstrably effective and helpful, even though surgery itself would be useless in this imagined scenario.

I am, of course, not for a minute claiming that surgery is rubbish, but I have used this rather extreme example to expose the flawed argument that is often used in alternative medicine for white-washing bogus treatments. The notion is that, because a particular alternative health care profession employs not just one but multiple forms of treatments, it should not be judged by the effectiveness of its signature-therapy, particularly if it happens to be ineffective.

This type of logic seems nowhere more prevalent than in the realm of chiropractic. Its founding father, D.D. Palmer, dreamt up the bizarre notion that all human disease is caused by ‘subluxations’ which require spinal manipulation for returning the ill person to good health. Consequently, most chiropractors see spinal manipulation as a panacea and use this type of treatment for almost 100% of their patients. In other words, spinal manipulation is as much the hallmark-therapy for chiropractic as surgery is for surgeons.

When someone points out that, for this or that condition, spinal manipulation is not of proven effectiveness or even of proven ineffectiveness, chiropractors have in recent years taken to answering as outlined above; they might say: WE DO ALL SORTS OF OTHER THINGS TOO, YOU KNOW. FOR INSTANCE, WE EMPLOY OTHER MANUAL TECHNIQUES, GIVE LIFE-STYLE ADVICE AND USE NO END OF PHYSIOTHERAPEUTIC INTERVENTIONS. YOU CANNOT SAY THAT THESE APPROACHES ARE BOGUS. THEREFORE CHIROPRACTIC IS FAR FROM USELESS.

To increase the chances of convincing us with this notion, they have, in recent months, produced dozens of ‘systematic reviews’ which allegedly prove their point. Here are some of the conclusions from these articles which usually get published in chiro-journals:

The use of manual techniques on children with respiratory diseases seems to be beneficial.

The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant.

A limited amount of research has been published that supports a role for manual therapy in improving postural stability and balance.

…a trial of chiropractic care for sufferers of autism is prudent and warranted.

This study found a level of B or fair evidence for manual manipulative therapy of the shoulder, shoulder girdle, and/or the FKC combined with multimodal or exercise therapy for rotator cuff injuries/disorders, disease, or dysfunction.

Chiropractic care is an alternative approach to the care of the child with colic.

There is a baseline of evidence that suggests chiropractic care improves cervical range of motion (cROM) and pain in the management of whiplash-associated disorders.

Results of the eight retrieved studies indicated that chiropractic care showed improvements [for asthma].

Personally, I find this kind of ‘logic’ irritatingly illogical. If we accept it as valid, the boundaries between sense and nonsense disappear, and our tools of differentiating between quackery and ethical health care become blunt.

The next step could then even be to claim that a homeopathic hospital must be a good thing because some of its clinicians occasionally also prescribe non-homeopathic treatments.

The efficacy or effectiveness of medical interventions is, of course, best tested in clinical trials. The principle of a clinical trial is fairly simple: typically, a group of patients is divided (preferably at random) into two subgroups, one (the ‘verum’ group) is treated with the experimental treatment and the other (the ‘control’ group) with another option (often a placebo), and the eventual outcomes of the two groups is compared. If done well, such studies are able to exclude biases and confounding factors such that their findings allow causal inference. In other words, they can tell us whether an outcome was caused by the intervention per se or by some other factor such as the natural history of the disease, regression towards the mean etc.

A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about NON-CONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo NON-CONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘NON-CONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

It is usually BIG PHARMA who stands accused of being less than honest with the evidence, particularly when it runs against commercial interests; and the allegations prove to be correct with depressing regularity. In alternative medicine, commercial interests exist too, but there is usually much less money at stake. So, a common assumption is that conflicts of interest are less relevant in alternative medicine. Like so many assumptions in this area, this notion is clearly and demonstrably erroneous.

The sums of money are definitely smaller, but non-commercial conflicts of interest are potentially more important than the commercial ones. I am thinking of the quasi-religious beliefs that are so very prevalent in alternative medicine. Belief can move mountains, they say – it can surely delude people and make them do the most extraordinary things. Belief can transform advocates of alternative medicine into ‘ALCHEMISTS OF ALTERNATIVE EVIDENCE’ who turn negative/unfavourable into positive/favourable evidence.

The alchemists’ ‘tricks of the trade’ are often the same as used by BIG PHARMA; they include:

  • drawing conclusions which are not supported by the data
  • designing studies such that they will inevitably generate a favourable result
  • cherry-picking the evidence
  • hiding unfavourable findings
  • publishing favourable results multiple times
  • submitting data-sets to multiple statistical tests until a positive result emerges
  • defaming scientists who publish unfavourable findings
  • bribing experts
  • prettify data
  • falsifying data

As I said, these methods, albeit despicable, are well-known to pseudoscientists in all fields of inquiry. To assume that they are unknown in alternative medicine is naïve and unrealistic, as many of my previous posts confirm.

In addition to these ubiquitous ‘standard’ methods of scientific misconduct and fraud, there are a few techniques which are more or less unique to and typical for the alchemists of alternative medicine. In the following parts of this series of articles, I will try to explain these methods in more detail.

Steve Scrutton is a UK homeopath on a mission; he seems to want to promote homeopathy at all cost – so much so that he recently ran into trouble with the ASA for breaching CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicines, medical devices, health-related products and beauty products). Scrutton happens to be a Director of the ‘ALLIANCE OF REGISTERED HOMEOPATHS’ (ARH) which represents nearly 700 homeopaths in the UK. On one of his websites, he promotes homeopathy as a treatment and prevention for measles:

Many homeopaths feel that it is better for children, who are otherwise healthy, to contract measles naturally. Homeopathy is less concerned with doing this as it has remedies to treat measles, especially if it persists, or become severe.Other homeopaths will use the measles nosode, Morbillinum, for prevention.Homeopaths have been treating measles for over 200 years with success.

The main remedies used for the condition, according to Scrutton, are the following: Aconite, Belladonna, Gelsemium, Euphrasia, Bryonia, Pulsatilla, Kali Bich, Sulphur, Apis Mel or Arsenicum – depending on the exact set of presenting symptoms.

At the very end of this revealing post, Scrutton makes the following statement: To my knowledge, there have been no RCTs conducted on either the prevention or treatment of Measles with Homeopathy. However, homeopaths have been treating Measles safely and effectively since the early 19th Century, and through many serious epidemics throughout the world.

Why would anyone write such dangerous nonsense, particularly in the position of a director of the ARH? There can, in my view be only one answer: he must be seriously deluded and bar any knowledge what sound medical evidence looks like. One of his articles seems to confirm this suspicion; in 2008, Scrutton wrote: What ‘scientific’ medicine does not like about homeopathy is not the lack of an evidence base – it is the ability to help people get well – and perhaps even more important, we can do it safely.

Intriguingly, the ARH has a code of ethics which states that members must not claim or imply, orally or in writing, to be able to cure any named disease and that they should be aware of the extent and limits of their clinical skills.

Could it be that a director of the ARH violates his own code of ethics?

I am sure, we have all heard it hundreds of times: THERE ARE IMPORTANT LINKS BETWEEN OUR DIET AND CERTAIN CANCERS. The evidence for this statement seems fairly compelling. Yet it also is complex and often confusing.

A recent review, for instance, suggested that fruits (particularly citrus) and vegetable consumption may be beneficial in the primary prevention of pancreatic cancer, the consumption of whole grains has been shown to reduce the risk and fortification of whole grains with folate may confer further protection. Red meat, cooked at high temperatures, should be avoided, and replaced with poultry or fish. Total fat should be reduced. The use of curcumin and other flavonoids should be encouraged in the diet. Another equally recent review, however, indicated that there is no conclusive evidence as an independent risk factor for isolated nutrients versus adoption of dietary patterns for cancer risk. Cancer colon risk derived from meat intake is influenced by both total intake and its frequency. The interaction of phenolic compounds on metabolic and signalling pathways seems to exert an inhibitory effect on cell proliferation and tumor metastasis and induces apoptosis in various types of cancer cells, including colon, lung, prostate, hepatocellular or breast cancer. A third recent review concluded that cruciferous vegetable intake protects against cancer of the colon, while a forth review suggested that the Mediterranean dietary pattern and diets composed largely of vegetables, fruit, fish, and soy are associated with a decreased risk of breast cancer. There was no evidence of an association between traditional dietary patterns and risk of breast cancer.

Not least based on these mixed messages from the scientific literature, an entire industry has developed selling uncounted alternative cancer-diets and dietary supplements to desperate patients and consumers. They promise much more than just cancer prevention, in fact, leave little doubt about the notion that cancer might be curable by diet. Here are just a few quotes from the thousands of websites promoting alternative cancer diets:

  • The Ketogenic Diet is believed capable of starving cancer cells to death, and thus capable of restricting tumour development.
  • a more alkaline body makes it difficult for tumors to grow.
  • Budwig diet: This diet was developed by Dr. Johanna Budwig who was nominated for the noble Prize sixth times. The diet is intended as a preventative as well as an alternative cancer treatment.
  • the Gerson Therapy naturally reactivates your body’s magnificent ability to heal itself – with no damaging side effects. This a powerful, natural treatment boosts the body’s own immune system to heal cancer, arthritis, heart disease, allergies, and many other degenerative diseases. Dr. Max Gerson developed the Gerson Therapy in the 1930s, initially as a treatment for his own debilitating migraines, and eventually as a treatment for degenerative diseases such as skin tuberculosis, diabetes and, most famously, cancer.
  • the concept of macrobiotics is much more than an alternative diet for cancer, or any other illness, but rather the ancient Chinese belief that all life, indeed the whole universe, is a balance of two opposing forces Yin and Yang.

Confused? Yes, I do worry how many cancer patients listen to these claims and pin their hopes on one of these diets. But what exactly does the evidence tell us about them?

A German team of researchers evaluated the following alternative cancer-diets: raw vegetables and fruits, alkaline diet, macrobiotics, Gerson’s regime, Budwig’s and low carbohydrate or ketogenic diet. Their extensive searches of the published literature failed to find clinical evidence supporting any of the diets. Furthermore, case reports and pre-clinical data pointed to the potential harm of some of these diets. The authors concluded that considering the lack of evidence of benefits from cancer diets and potential harm by malnutrition, oncologists should engage more in counselling cancer patients on such diets.

In other words, alternative cancer diets – and I mean not just the ones mentioned above, but all of them – are not supported by good evidence for efficacy as a treatment or prevention of any type of cancer. In addition, they might also cause harm.

What follows is obvious: cancer patients should take sound nutritional advice and adopt a healthy general life-style. But they should run a mile as soon as anyone suggests an alternative dietary cure for their disease.

There is not a discussion about homeopathy where an apologist would eventually state: HOMEOPATHY CANNOT BE A PLACEBO, BECAUSE IT WORKS IN ANIMALS!!! Those who are not well-versed in this subject tend to be impressed, and the argument has won many consumers over to the dark side, I am sure. But is it really correct?

The short answer to this question is NO.

Pavlov discovered the phenomenon of ‘conditioning’ in animals, and ‘conditioning’ is considered to be a major part of the placebo-response. So, depending on the circumstances, animals do respond to placebo (my dog, for instance, used to go into a distinct depressive mood when he saw me packing a suitcase).

Then there is the fact that the animal’s response might be less important than the owner’s reaction to homeopathic treatment. This is particularly important with pets, of course. Homeopathy-believing pet owners might over-interpret the pet’s response and report that the homeopathic remedy has worked wonders when, in fact, it has made no difference.

Finally, there may be some situations where neither of the above two phenomena can play a decisive role. Homeopaths like to cite studies where entire herds of cows were treated homeopathically to prevent mastitis, a common problem in milk-cows. It is unlikely that conditioning or wishful thinking of the owner are decisive in such a study. Let’s see whether homeopathy-promoters will also be fond of this new study of exactly this subject.

New Zealand vets compared clinical and bacteriological cure rates of clinical mastitis following treatment with either antimicrobials or homeopathic preparations. They used 7 spring-calving herds from the Waikato region of New Zealand to source cases of clinical mastitis (n=263 glands) during the first 90 days following calving. Duplicate milk samples were collected for bacteriology from each clinically infected gland at diagnosis and 25 (SD 5.3) days after the initial treatment. Affected glands were treated with either an antimicrobial formulation or a homeopathic remedy. Generalised linear models with binomial error distribution and logit link were used to analyse the proportion of cows that presented clinical treatment cures and the proportion of glands that were classified as bacteriological cures, based on initial and post-treatment milk samples.

The results show that the mean cumulative incidence of clinical mastitis was 7% (range 2-13% across herds) of cows. Streptococcus uberis was the most common pathogen isolated from culture-positive samples from affected glands (140/209; 67%). The clinical cure rate was higher for cows treated with antimicrobials (107/113; 95%) than for cows treated with homeopathic remedies (72/114; 63%) (p<0.001) based on the observance of clinical signs following initial treatment. Across all pathogen types bacteriological cure rate at gland level was higher for those cows treated with antimicrobials (75/102; 74%) than for those treated with a homeopathic preparation (39/107; 36%) (p<0.001).

The authors conclude that homeopathic remedies had significantly lower clinical and bacteriological cure rates compared with antimicrobials when used to treat post-calving clinical mastitis where S. uberis was the most common pathogen. The proportion of cows that needed retreatment was significantly higher for the homeopathic treated cows. This, combined with lower bacteriological cure rates, has implications for duration of infection, individual cow somatic cell count, costs associated with treatment and animal welfare.

Yes, I know, this is just one single study, and we need to consider the totality of the reliable evidence. Currently, there are 203 clinical trials of homeopathic treatments of animals; and they are being reviewed at the very moment (unfortunately by a team that is not known for its objective stance on homeopathy). So, we will have to wait and see. When, in 1999, A. Vickers reviewed all per-clinical studies, including those on animals, he concluded that there is a lack of independent replication of any pre-clinical research in homoeopathy. In the few instances where a research team has set out to replicate the work of another, either the results were negative or the methodology was questionable.

All this is to say that, until truly convincing evidence to the contrary is available, the homeopaths’ argument ‘HOMEOPATHY CANNOT BE A PLACEBO, BECAUSE IT WORKS IN ANIMALS!!!’ is, in my view, as weak as the dilution of their remedies.

Visceral Manipulation (VM) was developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, VM is a miracle cure for just about every disease imaginable. On one of his many websites, Barral claims that: Comparative Studies found Visceral Manipulation Beneficial for Various Disorders

Acute Disorders Whiplash Seatbelt Injuries Chest or Abdominal Sports Injuries
Digestive Disorders Bloating and Constipation Nausea and Acid Reflux GERD Swallowing Dysfunctions
Women’s and Men’s Health Issues Chronic Pelvic Pain Endometriosis Fibroids and Cysts Dysmenorrhea Bladder Incontinence Prostate Dysfunction Referred Testicular Pain Effects of Menopause
Emotional Issues Anxiety and Depression Post-Traumatic Stress Disorder
Musculoskeletal Disorders Somatic-Visceral Interactions Chronic Spinal Dysfunction Headaches and Migraines Carpal Tunnel Syndrome Peripheral Joint Pain Sciatica
Pain Related to Post-operative Scar Tissue Post-infection Scar Tissue Autonomic Mechanisms
Pediatric Issues Constipation and Gastritis Persistent Vomiting Vesicoureteral Reflux Infant Colic

This sounds truly wonderful, and we want to learn more. The text goes on to explain that:

VM assists functional and structural imbalances throughout the body including musculoskeletal, vascular, nervous, urogenital, respiratory, digestive and lymphatic dysfunction. It evaluates and treats the dynamics of motion and suspension in relation to organs, membranes, fascia and ligaments. VM increases proprioceptive communication within the body, thereby revitalizing a person and relieving symptoms of pain, dysfunction, and poor posture.

Fascinating! Sceptics might think that such phraseology is a prime example of pseudo-scientific gobbledegook – but wait:

An integrative approach to evaluation and treatment of a patient requires assessment of the structural relationships between the viscera, and their fascial or ligamentous attachments to the musculoskeletal system. Strains in the connective tissue of the viscera can result from surgical scars, adhesions, illness, posture or injury. Tension patterns form through the fascial network deep within the body, creating a cascade of effects far from their sources for which the body will have to compensate. This creates fixed, abnormal points of tension that the body must move around, and this chronic irritation gives way to functional and structural problems.

Imagine an adhesion around the lungs. It would create a modified axis that demands abnormal accommodations from nearby body structures. For example, the adhesion could alter rib motion, which could then create imbalanced forces on the vertebral column and, with time, possibly develop a dysfunctional relationship with other structures. This scenario highlights just one of hundreds of possible ramifications of a small dysfunction – magnified by thousands of repetitions each day….the sinuvertebral nerves innervate the intervertebral disks and have direct connections with the sympathetic nervous system, which innervates the visceral organs. The sinuvertebral nerves and sympathetic nervous system are linked to the spinal cord, which has connections with the brain. In this way someone with chronic pain can have irritations and facilitated areas not only in the musculoskeletal system (including joints, muscles, fascia, and disks) but also the visceral organs and their connective tissues (including the liver, stomach, gallbladder, intestines and adrenal glands), the peripheral nervous system, the sympathetic nervous system and even the spinal cord and brain….

Visceral Manipulation is based on the specific placement of soft manual forces to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations can potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body….Visceral Manipulation works only to assist the forces already at work. Because of that, trained therapists can be sure of benefiting the body rather than adding further injury or disorganization.

By now, we are all wondering how Barral was able to dream up this truly fantastic panacea. Reading on, we learn that it was not ‘dreamt up’ at all – it was developed through painstaking research and rigorous science:

Jean-Pierre Barral first became interested in biomechanics while working as a registered physical therapist of the Lung Disease Hospital in Grenoble, France. That’s where he met Dr. Arnaud, a recognized specialist in lung diseases and a master of cadaver dissection. Working with Dr. Arnaud, Barral followed patterns of stress in the tissues of cadavers and studied biomechanics in living subjects. This introduced him to the visceral system, its potential to promote lines of tension within the body, and the notion that tissues have memory. All this was fundamental to his development of Visceral Manipulation. In 1974, Barral earned his diploma in osteopathic medicine from the European School of Osteopathy in Maidstone, England. Working primarily with articular and structural manipulation, he began forming the basis for Visceral Manipulation during an unusual session with a patient he’d been treating with spinal manipulations.

During the preliminary examination, Barral was surprised to find appreciable movement. The patient confirmed that he felt relief from his back pain after going to an “old man who pushed something in his abdomen.”

This incident piqued Barral’s interest in the relationship between the viscera and the spine. That’s when he began exploring stomach manipulations with several patients, with successful results gradually leading him to develop Visceral Manipulation. Between 1975 and 1982, Barral taught spinal biomechanics at England’s European School of Osteopathy. In collaboration with Dr. Jean-Paul Mathieu and Dr. Pierre Mercier, he published Articular Vertebrae Diagnosis.

With all this serious science, we are, of course, keen to learn about the studies of VM published in peer-reviewed journals. Amazingly, there seems to be an acute shortage of that sort of thing. You can buy many books by Barral, but to the best of my knowledge, there are no studies of VM by Barral or anyone else in medical journals. My own searches resulted in precisely zero papers, and Medline returns not a single article of Barral J-P on VM, osteopathy or manipulation.

This is odd, I must say!

Could all this important-sounding scientific (some might say pseudo-scientific) text be a complete fake? Where are the ‘COMPARATIVE STUDIES’ mentioned above? Could it be that VM is nothing more than a rip-off for gullible half-wits?

I really cannot imagine – after all, VM is even being taught at some universities! And one could never make all this up; that would be dishonest!!!

I hope my readers can point me to the proper science of VM and thus put my suspicions to rest.

Cancer patients are understandably desperate and leave no stone unturned to improve their prognosis. Thus they become easy prey of charlatans who claim that this or that alternative therapy will cure them or improve their outlook. One of the most popular alternative cancer therapies is mistletoe, a treatment dreamt up by Rudolf Steiner on the basis of the ‘like cures like’ principle: the mistletoe plant grows on a host tree like a cancer in the human body. One of many websites on this subject, for instance, states:

Mistletoe therapy

  • integrates with conventional cancer treatments
  • can be used for a wide range of cancers
  • may be started at any stage of the illness….

potential benefits…include:

  • Improved quality of life
  • generally feeling better
  • increased appetite and weight
  • less tired/more energy
  • reduced pain
  • better sleep pattern
  • felling more hopeful and motivated
  • reduced adverse effects from chemo and radiotherapy
  • reduced risk of cancer spread and recurrence
  • increased life expectancy.

Mistletoe extracts have been shown in studies to:

  • stimulate the immune system
  • cause cancer cell death
  • protect healthy cells against harmful effects of radiation and chemotherapy.

In fact, the debate about the efficacy of mistletoe either as a cancer cure, a supportive therapy, or a palliative measure is often less than rational and seems never-ending.

The latest contribution to this saga comes from US oncologists who published a phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC). The trial was aimed at evaluating: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM.

A total of 44 study participants were enrolled; 20 were treated in stage I (mistletoe dose escalation phase) and 24 in stage II (gemcitabine dose escalation phase). All patients had stage IV disease; the majority had received previous chemo-, hormonal, immunological, or radiation therapy, and 23% were chemotherapy-naïve.

Patients were treated with increasing doses of a mistletoe-extract (HELIXOR Apis (A), growing on fir trees) plus a fixed GEM dose in stage I, and with increasing doses of GEM plus a fixed dose of mistletoe in stage II. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery.

The results show that dose-limiting toxicities were neutropenia, thrombocytopenia, acute renal failure, and cellulitis, attributed to mistletoe. GEM 1380 mg/m2 and mistletoe 250 mg combined were the MTD. Of the 44 patients, 24 developed non-neutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation.

6% of patients showed a partial response, and 42% had stable disease. Of the 44 study participants, three died during the study, 10 participants requested to terminate the study, 23 participants progressed while on study, one terminated the study due to a dose limiting toxicity, 6 left due to complicating disease issues which may be tied to progression, and one voluntarily withdrew.

An attempt was made to follow study subjects once they terminated study treatment until death. At the last attempt to contact former participants, three were still alive and five others were lost to follow-up. The median time to death of any cause was approximately 200 days. Compliance with mistletoe injections was high.

The authors explain that a partial response rate of 6% is comparable to what would be expected from single agent gemcitabine in this population of patients with advanced, mostly heavily pretreated carcinomas. The median survival from study enrollment of about 200 days is within the range of what would be expected from single agent gemcitabine.

The authors concluded that GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response  is similar to GEM alone.

These results are hardly encouraging but they originate from just one (not particularly rigorous) study and might thus not be reliable. So, what does the totality of the reliable evidence tell us? Our 2003 systematic review of 10 RCTs found that none of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

Will this stop the highly lucrative trade in mistletoe extracts? will it prevent desperate cancer patients being misled about the value of mistletoe treatment? I fear not.

Continuing on the theme from my previous post, a website of a homeopath (and member of the UK ‘Society of Homeopaths’) caught my attention. In in it, Neil Spence makes a wide range of far-reaching statements. Because they seem rather typical of the claims made by homeopaths, I intent to scrutinize them in this post. For clarity, I put the (unaltered and unabbreviated) text from Neil Spence’s site in italics, while my own comments are in Roman print.

The holistic model of health says all disease comes from a disturbance in the vitality (life force) of the body. The energetic disturbance creates symptoms in the mind, the emotions and the physical body. Each patient has their own store of how this disturbance in vitality came about and each person has individual symptoms.

What is a ‘holistic model of health’, I wonder? Holism in health care means to treat patients as whole individuals which is a hallmark of any good health care; this means that all good medicine is holistic.

Holism and vitalism are two separate things entirely. Vitalism is the obsolete notion of a vital force or energy that determines our health. ‘Disturbances in vitality’ are not the cause of illness.

We will attempt, as far as possible, to treat the whole person and to change the conditions that created your susceptibility to cancer.

Much of the susceptibility to cancer is genetically determined and cannot be altered homeopathically.

Using Homeopathy to treat people with cancer

Homeopathic treatment can help someone with cancer. It can also be helpful for people who have a history of cancer in their family or have cared for a relative or friend with cancer. There are a number of methods of using homeopathic remedies to help people with cancer.

There is no good evidence that homeopathic remedies are effective for cancer patients or their carers.

Constitutional treatment: Treat the person who suffers the illness. A constitutional homeopathic remedy suits your nature as a person and its symptom picture reflects the unique expression of your symptoms. It can arouse the bodyʼs natural ability to heal itself and this can have profound benefits. It is appropriate if your vitality is strong.

There is no evidence that constitutional homeopathic treatments increase the body’s self-healing ability.

Stimulate the immune system to fight cancer: Remedies can be used to help the body fight the cancer, using specific homeopathic remedies called nosodes. A second treatment may be used to support the weakened organ. This method is most useful for people who are not using chemotherapy or radiotherapy.

There is no evidence that nosodes or other homeopathic remedies have any effect on the immune system ( – if they did, they would be contra-indicated for people suffering from auto-immune diseases).

Support the failing organs and the functions of the body that are not working: Remedies can be used to support weakened organs; to help with appetite; to help sleep and to treat sleep disturbances; to reduce the toxic symptoms; to help the body eliminate toxins. These treatments are helpful to people undergoing chemotherapy or radiotherapy.

For none of these claims is there good evidence; they are pure fantasy. The notion that homeopathy can help eliminate toxins is so wide-spread that it merits a further comment. It would be easy to measure such a detoxifying effect, but there is no evidence that it exists. Moreover, I would question whether, in the particular situation of a cancer patient on chemotherapy, a hastened elimination of the toxin (= chemotherapeutic agent) would be desirable; it would merely diminish the efficacy of the chemotherapy and reduce the chances of a cure.

Treat the pain: Homeopathic remedies can be very effective in aiding pain control. Remedies such as calendula can be effective in situations of intractable pain. If the cancer is at the terminal stage, remedies can be used to increase the quality of life. These remedies are palliative and can assist the patient keep mentally and emotionally alert so they can have quality time with loved ones.

Where is the evidence? Pain can obviously be a serious problem for cancer patients, and the notion that calendula in homeopathic dilutions reduces pain such that it significantly improves quality of life is laughable. Conventional medicine has powerful drugs to alleviate cancer pain but even they sometimes do not suffice to make patients pain-free.

Homeopathy in conjunction with other therapies

When a patient chooses to use chemotherapy or radiotherapy to treat their cancer the homeopath will prescribe remedies to support the body and ease the side-effects. Remedies can also be very useful after surgery to encourage the body to heal and allow greater mobility at an early stage.

Again no good evidence exists to support these claims – pure fantasy.

Other therapies can complement homeopathy but the homeopath will advise that you do not use every therapy just because they are available. It may be better to choose two or perhaps three main approaches to improving your health and ensure each one has positive effects that suit you very well.

Is he saying that cancer patients are best advised to listen to a homeopath rather than to their oncology-team? Is he encouraging them to not use all possible mainstream options available? If so, he is most irresponsible.

Each person will have different needs. It is always appropriate to change your diet. Nutritional and dietary advice is of the utmost importance to support the bodyʼs healing process. Cancer has many symptoms of disturbed metabolism and a poor diet has often contributed to the disturbance in the body that allowed the cancer to flourish. It is essential to remedy this situation. Nutritional advice puts you back in charge of your body; with good homeopathic treatments this provides the basis for improving your health.

Dietary advice can be useful and is therefore routinely provided by professionals who understand this subject much better than the average homeopath.

CONCLUSION

The thought that some cancer patients might be following such recommendations is most disturbing. Advice of this nature has doubtlessly the potential to significantly shorten the life and decrease the well-being of cancer patients. People who recommend treatments that clearly harm vulnerable patients are charlatans who should not be allowed to treat patients.

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