Edzard Ernst

MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Cancer patients are bombarded with information about supplements which allegedly are effective for their condition. I estimate that 99.99% of this information is unreliable and much of it is outright dangerous. So, there is an urgent need for trustworthy, objective information. But which source can we trust?

The authors of a recent article in ‘INTEGRATIVE CANCER THARAPIES’ (the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments) review the issue of dietary supplements in the treatment of cancer patients. They claim that the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. This sounds promising, and we might thus trust them to deliver something reliable.

In order to enable doctors and other health care professionals to have such discussion, the authors then report on the work of the ‘Clinical Practice Committee’ of ‘The Society of Integrative Oncology’. This panel undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of supplements that have the best suggestions of benefit was constructed by leading researchers and clinicians who have experience in using these supplements:

  1. curcumin,
  2. glutamine,
  3. vitamin D,
  4. maitake mushrooms,
  5. fish oil,
  6. green tea,
  7. milk thistle,
  8. astragalus,
  9. melatonin,
  10. probiotics.

The authors claim that their review includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would be aware of the supplements and be able to discuss realistic expectations and potential benefits and risks (my emphasis).

At first glance, this task looks ambitious but laudable; however, after studying the paper in some detail, I must admit that I have considerable problems taking it seriously – and here is why.

The first question I ask myself when reading the abstract is: Who are these “leading researchers and clinicians”? Surely such a consensus exercise crucially depends on who is being consulted. The article itself does not reveal who these experts are, merely that they are all members of the ‘Society of Integrative Oncology’. A little research reveals this organisation to be devoted to integrating all sorts of alternative therapies into cancer care. If we assume that the experts are identical with the authors of the review; one should point out that most of them are proponents of alternative medicine. This lack of critical input seems more than a little disconcerting.

My next questions are: How did they identify the 10 supplements and how did they evaluate the evidence for or against them? The article informs us that a 5-step procedure was employed:

1. Each clinician in this project was requested to construct a list of supplements that they tend to use frequently in their practice.

2. An initial list of close to 25 supplements was constructed. This list included supplements that have suggestions of some possible benefit and likely to carry minimal risk in cancer care.

3. From that long list, the group agreed on the 10 leading supplements that have the best suggestions of benefit.

4. Each participant selected 1 to 2 supplements that they have interest and experience in their use and wrote a manuscript related to the selected supplement in a uniformed and agreed format. The agreed format was constructed to provide a base of knowledge, so physicians and other health care providers would be able to discuss realistic expectations and potential benefits and risks with patients and families that seek that kind of information.

5. The revised document was circulated among participants for revisions and comments.

This method might look fine to proponents of alternative medicine, but from a scientific point of view, it is seriously wanting. Essentially, they asked those experts who are in favour of a given supplement to write a report to justify his/her preference. This method is not just open bias, it formally invites bias.

Predictably then, the reviews of the 10 chosen supplements are woefully inadequate. These is no evidence of a systematic approach; the cited evidence is demonstrably cherry-picked; there is a complete lack of critical analysis; for several supplements, clinical data are virtually absent without the authors finding this embarrassing void a reason for concern; dosage recommendations are often vague and naïve, to say the least (for instance, for milk thistle: 200 to 400 mg per day – without indication of what the named weight range refers to, the fresh plant, dried powder, extract…?); safety data are incomplete and nobody seems to mind that supplements are not subject to systematic post-marketing surveillance; the text is full of naïve thinking and contradictions (e.g.”There are no reported side effects of the mushroom extracts or the Maitake D-fraction. As Maitake may lower blood sugar, it should be used with caution in patients with diabetes“); evidence suggesting that a given supplement might reduce the risk of cancer is presented as though this means it is an effective treatment for an existing cancer; cancer is usually treated as though it is one disease entity without any differentiation of different cancer types.

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. But I do wonder, isn’t being in favour of integrating half-baked nonsense into cancer care and being selected for one’s favourable attitude towards certain supplements already a conflict of interest?

In any case, the review is in my view not of sufficient rigor to form the basis for well-informed discussions with patients. The authors of the review cite a guideline by the ‘Society of Integrative Oncology’ for the use of supplements in cancer care which states: For cancer patients who wish to use nutritional supplements, including botanicals for purported antitumor effects, it is recommended that they consult a trained professional. During the consultation, the professional should provide support, discuss realistic expectations, and explore potential benefits and risks. It is recommended that use of those agents occur only in the context of clinical trials, recognized nutritional guidelines, clinical evaluation of the risk/benefit ratio based on available evidence, and close monitoring of adverse effects. It seems to me that, with this review, the authors have not adhered to their own guideline.

Criticising the work of others is perhaps not very difficult, however, doing a better job usually is. So, can I offer anything that is better than the above criticised review? The answer is YES. Our initiative ‘CAM cancer’ provides up-to-date, concise and evidence-based systematic reviews of many supplements and other alternative treatments that cancer patients are likely to hear about. Their conclusions are not nearly as uncritically positive as those of the article in ‘INTEGRATIVE CANCER THERAPIES’.

I happen to believe that it is important for cancer patients to have access to reliable information and that it is unethical to mislead them with biased accounts about the value of any treatment.

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.

Chiropractors are notorious for their overuse and misuse of x-rays for non-specific back and neck pain as well as other conditions. A recent study from the US has shown that the rate of spine radiographs within 5 days of an initial patient visit to a chiropractor is 204 per 1000 new patient examinations. Considering that X-rays are not usually necessary for patients with non-specific back pain, such rates are far too high. Therefore, a team of US/Canadian researchers conducted a study to evaluate the impact of web-based dissemination of a diagnostic imaging guideline discouraging the use of spine x-rays among chiropractors.

They disseminated an imaging guideline online in April 2008. Administrative claims data were extracted between January 2006 and December 2010. Segmented regression analysis with autoregressive error was used to estimate the impact of guideline recommendations on the rate of spine x-rays. Sensitivity analysis considered the effect of two additional quality improvement strategies, a policy change and an education intervention.

The results show a significant change in the level of spine x-ray ordering weeks after introduction of the guidelines (-0.01; 95% confidence interval=-0.01, -0.002; p=.01), but no change in trend of the regression lines. The monthly mean rate of spine x-rays within 5 days of initial visit per new patient exams decreased by 10 per 1000, a 5.26% relative decrease after guideline dissemination.

The authors concluded that Web-based guideline dissemination was associated with an immediate reduction in spine x-ray claims. Sensitivity analysis suggests our results are robust. This passive strategy is likely cost-effective in a chiropractic network setting.

These findings are encouraging because they suggest that at least some chiropractors are capable of learning, even if this means altering their practice against their financial interests – after all, there is money to be earned with x-ray investigations! At the same time, the results indicate that, despite sound evidence, chiropractors still order far too many x-rays for non-specific back pain. I am not aware of any recent UK data on chiropractic x-ray usage, but judging from old evidence, it might be very high.

It would be interesting to know why chiropractors order spinal x-rays for patients with non-specific back pain or other conditions. A likely answer is that they need them for the diagnosis of spinal ‘subluxations’. To cite just one of thousands of chiropractors with the same opinion: spinography is a necessary part of the chiropractic examination. Detailed analysis of spinographic film and motion x-ray studies helps facilitate a specific and timely correction of vertebral subluxation by the Doctor of Chiropractic. The correction of a vertebral subluxation is called: Adjustment.

This, of course, merely highlights the futility of this practice: despite the fact that the concept is still deeply engrained in the teaching of chiropractic, ‘subluxation’ is a mystical entity or dogma which “is similar to the Santa Claus construct”, characterised by a “significant lack of evidence to fulfil the basic criteria of causation”. But even if chiropractic ‘subluxation’ were real, it would not be diagnosable with spinal x-ray investigations.

The inescapable conclusion from all this, I believe, is that the sooner chiropractors abandon their over-use of x-ray studies, the better for us all.

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.

I have written about this subject before, and I probably will do so again. The reason for my insistence is simple: some homeopathy-fans’ attitude towards and advice about immunizations is, in my view, nothing short of a scandal. Here are excerpts from two articles published in the current issue of ‘HOMEOPATHY 4 EVERYONE’ which amply explain what I mean.

The first paper is by Alan Phillips, a leading U.S. vaccine rights attorney and self-declared fan of homeopathy. It goes through the usual arguments suggesting that immunizations are not effective, outright harmful and a vicious ploy to enrich the pharmaceutical industry at the cost of public health. Subsequently, the author gives advice as to how US citizens can avoid mandatory immunizations: 

God bless homeopathy! A particularly wonderful example was in Cuba in the fall of 2008, when homeoprophylaxis was used in place of allopathic immunizations to respond to a leptospirosis outbreak. Two and a half million people were each given 2 doses of a remedy, and the results not only substantially exceeded prior experience with vaccines, it was about 1/15 the cost! And to the best of my knowledge, there are no serious adverse events with homeopathy as there are with virtually any widespread use of vaccines. The failure of our government health agencies to seize upon the Cuban and other homeoprophylaxis successes by aggressively pursuing further research in this area, and the incorporation of homeoprophylaxis into standard infectious disease control strategies, reveals a public health policy driven by something other than the best health interests of the members of our society.

With all of the problems in the allopathic world, and obvious safe and effective alternatives to immunizations that are being systematically ignored, it’s no wonder that a growing number of people are looking for ways to legally avoid immunization mandates. Ironically, vaccines are being required in greater and greater numbers for more and more people. The reason is simple: The federal government subsidizes vaccine research and development; state and federal governments mandate vaccines; state and federal governments purchase vaccines; and state and federal governments compensate those injured or killed by vaccines. So, for those who are able to throw ethics and morality out the window without a second thought, there’s a racket here offering profound profits, and a convenient vehicle for injecting who knows what into literally billions of people worldwide. The multi-billion dollar international vaccine industry is projected to grow at some 10-12% annually for the next several years…

So you’ve done your research, and you’ve decided that you’d like to postpone, or even forego some or all vaccines altogether. Can you do that? How do you do that? Well, it depends on your specific situation… 

Fortunately, everywhere vaccines are mandated in the U.S., one or more exemptions are available…

Medical exemptions can be hard to get. They usually require the support of a medical doctor, and there are usually specific, narrow criteria that must be met to qualify… So, if you’re considering a medical exemption, make sure you find out first what qualifies for the exemption in your specific situation; and if you can get a doctor to support you for a qualifying reason, then pursuing a medical exemption may be an appropriate route to take.

Religious exemptions are probably the most commonly used exemption. What qualifies is a topic too lengthy for an article, but in brief, it doesn’t require membership in an organized religion, and it doesn’t matter what religion you belong to, if you do belong to one…

Philosophical exemptions, when available, are great in that they don’t require you to justify your beliefs or to state reasons. But states have been changing laws to make them harder to get… The long-held notion of a presumed net benefit from vaccines has been slowly undermined by medical science, though the medical authorities, increasingly controlled by the pharmaceutical industry, continue to actively suppress this reality to the best of their ability… However, in those religious exemption situations where you are required to state your beliefs, and where the authorities involved have authority to scrutinize your beliefs, it is highly advisable to seek out professional help from an experienced attorney…

The second article is by Fran Sheffield, a homeopath from NSW, who began her homeopathic studies after “seeing the benefits homeopathy brought to her vaccine-injured child”, and a founding member of ‘The Do No Harm Initiative Inc.’, a lobby group misinforming communities and governments about ‘homeopathic immunisation’:

Homeoprophylaxis has a remarkable record of safety – vaccines less so. From the homeopath’s point of view they are still associated with risks: the dose is too strong, they have toxic additives, and they’re given by inappropriate pathways.

Homeoprophylaxis has avoided these problems. It’s also versatile, inexpensive, quick to produce and easy to distribute.

Keeping these points in mind, I’ll return to Von Behring who went on to say:

“I am touching here upon a subject anathematized till very recently by medical penalty: but if I am to present these problems in historical illumination, dogmatic imprecations must not deter me”…

The same sentiments are true today – dogma and penalty must not be allowed to restrict information on homeoprophylaxis or deprive others of this safe, simple option. The time has come for all of us – governments and individuals – to take a closer look at homeoprophylaxis and how it relieves the burden of disease…

Future posts show what I did with the prophylactic information, why some were offended or upset, the inevitable backlash that followed, attempts at intimidation and suppression, what happens when a matter like this goes to court, what is lost when we don’t speak out about the truth, and what we should do for the future.

I think I will abstain from any comment; if I did, I would be in danger of being libellous. However, I do hope that my readers will post their opinions freely.

 

One of the questions I hear regularly is ‘HOW DO THE EFFECTS OF THIS ALTERNATIVE TREATMENT COMPARE TO THOSE OF CONVENTIONAL OPTIONS’? Take acupuncture in the management of osteoarthritis, for instance. There is some encouraging evidence suggesting it might help. The most recent systematic review that I know of concluded that “acupuncture provided significantly better relief from knee osteoarthritis pain and a larger improvement in function than sham acupuncture, standard care treatment, or waiting for further treatment.” However, in order to estimate its value in practice, we ought to know whether it is as good as or perhaps even better than standard treatments. In other words, what we really want to know is its relative effectiveness.

Data to evaluate the relative effectiveness of acupuncture or other alternative therapies are hard to come by. Ideally, one would require clinical trials which provide direct comparisons between the alternative and the conventional therapy. Sadly, such studies are scarce or even non-existent. Therefore we might have to rely on more indirect evidence. A new paper could be a step in the right direction.

The aim of this systematic review was to critically evaluate existing osteoarthritis (OA) management guidelines to better understand potential issues and barriers.

A systematic review of the literature in MEDLINE published from January 1, 2000 to April 1, 2013 was performed and supplemented by bibliographic reviews, following PRISMA guidelines and a written protocol. Following initial title and abstract screening, two authors independently reviewed full-text articles; a third settled disagreements. Two independent reviewers extracted data into a standardized form. Two authors independently assessed guideline quality; three generated summary recommendations based on the extracted guideline data.

Overall, 16 articles were included in the final review. There was broad agreement on recommendations by the various organizations. For non-pharmacologic modalities, education/self-management, exercise, weight loss if overweight, walking aids as indicated, and thermal modalities were widely recommended. For appropriate patients, joint replacement was recommended; arthroscopy with debridement was not recommended for symptomatic knee OA. Pharmacologic modalities most recommended included acetaminophen/paracetamol for first line treatment and oral or topical NSAIDs for second line therapy. Intra-articular corticosteroids were generally recommended for hip and knee OA. Controversy remains about the use of acupuncture, knee braces, heel wedges, intra-articular hyaluronans, and glucosamine/chondroitin.

I think that this tells us fairly clearly that, compared to other options, acupuncture is not considered to be an overwhelmingly effective treatment for osteoarthritis by those who understand that condition best. Several other therapies seem to be preferable because the evidence is clearer and stronger and their effect sizes is larger. This, I think begs the question whether it is in the best interest of patients or indeed ethical to ignore this knowledge and recommend acupuncture as a treatment of osteoarthritis.

More generally speaking, we should always bear in mind that it is not enough proving a therapy to be effective; we usually also need to consider what else is on offer. And if you think that this is rather complex, you are, of course, correct – but wait until someone mentions issues such as safety and cost of all the relevant therapeutic options.

I am constantly on the look-out for good studies of alternative medicine, particularly those that yield positive findings. The trouble is that there aren’t many of those; studies tend to be either good or positive. Could this one be an exception?

The aim of this brand-new trial was to determine, if  dietary supplements of glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain in patients with knee osteoarthritis. It was designed as a  double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45–75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both of these dietary  supplements (n=151) or placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0–10) was self-reported in a participant diary for 7 days every 2 months over 1 year.

The results indicate that, after adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden’s nodes), allocation to the dietary supplement combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm 0.20 mm); no significant structural effect for the single treatment allocations was detected. All 4 groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period.

The authors drew the following conclusions: allocation to the glucosamine–chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo.

This study has many strengths: it addresses a relevant research question, has a sufficiently large sample size, includes a long follow-up, and is well reported. So, it is a good study of an alternative therapy that is used by many patients. But did it really produce a positive result, i.e. findings which suggest that the tested treatments are effective? The answer seems ‘yes and no’. The combined, regular intake of both supplements caused less joint space narrowing which is a good objective sign of reduced disease activity. However, this was not paralleled by a reduction in pain that was better than that on placebo.

So, if you are a fan of glucosamine/chondroitin supplements, you will be pleased with this study, but if you are not in favour of such medications or do not have the spare cash to afford the considerable costs, you might say: I told you, they are pretty useless!

A recent survey included a random sample of 1179 Brits who were asked about their attitude towards and usage of homeopathy as well as other forms of alternative medicine (AM). The results indicate that a slim majority had never used AM at all. The most popular treatments within the group of AM-users were herbal medicines, homeopathy and acupuncture.

Perhaps because they are more up-to-date, these findings are considerably different from our own results obtained from the Health Survey for England 2005. We used data of all 7630 respondents and showed that lifetime and 12-month prevalence of AM-use were 44.0% and 26.3% respectively; 12.1% had consulted a practitioner in the preceding 12 months. Massage, aromatherapy and acupuncture were the most commonly used therapies. Twenty-nine percent of respondents taking prescription drugs had used AM in the last 12 months. Women, university educated respondents, those suffering from anxiety or depression, people with poorer mental health and lower levels of perceived social support, people consuming ≥ 5 portions of fruit and vegetables a day were significantly more likely to use AM.

In the new survey, a quarter of those not using homeopathy said this was because they had never heard of it; a third because they had never been advised to use it and/or that they’d never had an illness that required it; and 3% said it was because homeopathic remedies were too expensive. About a quarter of non-users said that they avoided homeopathy because they didn’t believe that it worked, or that conventional medicine worked better.

Of the homeopathy-users, 49% said they were “willing to try anything and didn’t think it could do any harm”. Only 16% claimed to use it because they believed it worked better than conventional medicine. This means that only around 3% of the population have used homeopathy because of a belief that it works where conventional medicine doesn’t. The rest either have not used it, or used it for other reasons.

The researchers arrived at the following conclusions and predictions: Our research suggests that nearly half of the public don’t believe and act as if AM and conventional medicine are at odds. Coupled with the significant global industry that has grown up around AM, it is easy to see why politicians have been unwilling to respond to the clear evidence that homeopathy and AM are ineffective. In the US, it’s a $34bn industry where half of people report using them.

The competition between proponents and opponents of AM in all likelihood is set to continue. But there’s some evidence that better science education can help people to distinguish between scientific and pseudo-scientific claims, and it appears that at least some of the openness to AM might stem from concerns about how medical research is regulated. And it is these that might hold the key to who ultimately comes out of the ring in better shape.

There are dozens of observational studies of homeopathy which seem to suggest – at least to homeopaths – that homeopathic treatments generate health benefits. As these investigations lack a control group, their results can be all to easily invalidated by pointing out that factors like ‘regression towards the mean‘ (RTM, a statistical artefact caused by the phenomenon that a variable that is extreme on its first measurement tends to be closer to the average on its second measurement) might be the cause of the observed change. Thus the debate whether such observational data are reliable or not has been raging for decades. Now, German (pro-homeopathy) investigators have published a paper which potentially could resolve this dispute.

With this re-analysis of an observational study, the investigators wanted to evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects. SF-36 quality-of-life (QoL) data from a cohort of 2827 chronically diseased adults treated with homeopathy were reanalysed using a method described in 1991 by Mee and Chua’s. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06-0.19, P < 0.001) in the mental and 0.25 (0.22-0.28, P < 0.001) in the physical summary score of the SF-36. Small-to-moderate effects were confirmed for most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses.

The authors reached the following conclusion: “In our paper we showed that the effects on quality of life observed in patients receiving homeopathic care in a usual care setting are small or moderate at maximum, but cannot be explained by RTM alone. Due to the uncontrolled study design they may, however, completely be due to nonspecific effects. All our analyses made a restrictive and conservative assumption, so the true treatment effects might be larger than shown.” 

Of course, the analysis heavily relies on the validity of Mee and Chua’s modified t-test. It requires the true mean in the target population to be known, a requirement that seldom can be fulfilled. The authors therefore took the SF-36 mean summary scores from the 1998 German health survey as proxies. I am not a statistician and therefore unable to tell how reliable this method might be (- if there is someone out there who can give us some guidance here, please post your comment).

In order to make sense of these data, we need to consider that, during the study period, about half of the patients admitted to have had additional visits to non-homeopathic doctors, and 27% also received conventional drugs. In addition, they would have benefitted from:

  • the benign history of the conditions they were suffering from,
  • a placebo-effect,
  • the care and attention they received
  • and all sorts of other non-specific effects.

So, considering these factors, what does this interesting re-analysis really tell us? My interpretation is as follows: the type of observational study that homeopaths are so fond of yields false-positive results. If we correct them – as the authors have done here for just one single factor, the RTM – the effect size gets significantly smaller. If we were able to correct them for some of the other factors mentioned above, the effect size would shrink more and more. And if we were able to correct them for all confounders, their results would almost certainly concur with those of rigorously controlled trials which demonstrate that homeopathic remedies are pure placebos.

I am quite sure that this interpretation is unpopular with homeopaths, but I am equally certain that it is correct.

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