MD, PhD, FMedSci, FSB, FRCP, FRCPEd

fraud

Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.

This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!

The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.

The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.

Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”

I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.

Homeopathic products are safe!

At least this is what the homeopathy-lobby tries to make us believe. On this blog, we have repeatedly questioned this notion, and recently it was reported by several sources, for instance this website, that the FDA has taken action against one specific homeopathic remedy over safety concerns:

Some homeopathic tablets and gels aimed at helping to soothe babies’ teething pains may be dangerous for infants and toddlers, the FDA announced and stated they are now investigating reports of seizures in infants and children who were given homeopathic teething products: “consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation” after using homeopathic teething tablets and gels. The FDA also said it is not aware of any proven health benefit of using homeopathic teething tablets and gels.

Already in 2010, the FDA had issued a safety alert about a homeopathic teething tablet that contained belladonna. Belladonna, a poisonous plant that contains atropine. At high levels, atropine can be deadly. In homeopathy, it is used to treat redness and inflammation. At the time, the FDA found that the teething tablets contained inconsistent amounts of belladonna. The company that made the tablets, Hyland, subsequently recalled the product.

The full FDA statement is here:

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

END OF QUOTE

What follows is, I think, simple: homeopathic products are not necessarily safe, and there can be several reasons for that:

  • they can be contaminated,
  • they can be adulterated,
  • some can contain high concentrations  of toxic ingredients,
  • most contain nothing active at all and are dangerous when mistaken for an effective therapy.

 

I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:

Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.

Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.

In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.

The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

END OF QUOTE

Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:

A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.

And what should we conclude from all this?

I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.

A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:

1. Addiction recovery

Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.

2. Helps the body heal itself

The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.

3. Builds a stronger immune system

The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.

4. Eliminate that killer hangover

While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.

5. Mood stabilizer

If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.

6. Chronic stomach problems

Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.

7. Coping with death

Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.

END OF QUOTE

The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:

  1. There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation.  There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
  2. Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
  3. Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
  4. Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
  5. The same applies to acupuncture to ‘stabilize’ your mood.
  6. Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
  7. I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.

So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!

Why?

Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!

IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE

  1. Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
  2. ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
  3. Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
  4. Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
  5. For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
  6. The claim of acupuncturists that acupuncture is entirely safe is false.
  7. Acupuncture studies from China cannot be trusted.

Bogus claims of alternative therapists are legion, particularly in homeopathy. But bogus claims are neither ethical nor legal. Homeopathy works for no human condition, and therefore any medical claim made for homeopathy is unethical, false, misleading and illegal.

This is not just my view (after studying the subject for more than two decades) but also that of the UK regulators. In case you doubt it, please read the full notice which the UK ‘Advertising Standards Authority’ has just published (dated 29/9/2016):

This week, our sister organisation, the Committee of Advertising Practice (CAP) Compliance team has written to homeopaths across the UK to remind them of the rules that govern what they can and can’t say in their marketing materials, including on their websites.

Homeopathy is based on the principle of treating like with like; in other words a substance which causes certain symptoms can also help remove those symptoms when it is diluted heavily in water before being consumed. Practitioners believe that this stimulates the body to heal itself. However, to date, despite having considered a body of evidence, neither us nor CAP has seen robust evidence that homeopathy works. Practitioners should therefore avoid making direct or implied claims that homeopathy can treat medical conditions.  

We have no intention of restricting the ability of practitioners to advertise legitimate and legal services, nor do we seek to restrict the right of individuals to choose treatment. However, when advertisers make claims about these products or services, in all sectors, they must hold appropriate evidence to back up those claims. If they do not, then we have a responsibility to intervene to protect consumers by ensuring that those ads are amended or withdrawn.

If you are a practicing homeopath, please ensure that you carefully read CAP’s advice and guidance. It includes a non-exhaustive list of the types of claims you can and can’t make. You will then need to make changes, as necessary, to your marketing materials, including on your website, if you have one. 

Further guidance can be found on the Society of Homeopaths’ website. We have worked closely with the Society over the course of the last year, to help them produce detailed guidance to support their members.

If you are a homeopath but have not received a letter from us, please download a copy here, together with supporting FAQs about Advertising Regulation.

I think this notice speaks for itself. All I want to add at this stage is my hope that UK homeopaths comply asap to avoid getting penalised and – much more importantly – to avoid continuing to mislead consumers.

Chiropractic for animals?

Can’t be!

Yes, it can!!!

Animal Chiropractic “is a field of animal health care that focuses on the preservation and health of the neuro-musculo-skeletal system. Why? Nerves control everything that happens in your animals. Anything adversely affecting the nervous system will have detrimental effects that will resonate throughout the entire body. The command centers of the nervous system are the brain and spinal cord which are protected by the spine. The spine is a complex framework of bones (vertebra), ligaments, muscles and nerves. If the movement and biomechanics of the vertebra become dysfunctional, they can interfere with the performance of the nerves that are branching off of the spinal cord and going to the all of the muscles and organs. As this occurs, your animal can lose normal mobility; resulting in stiffness, tension, pain and even organ dysfunction. Additionally, when normal movement is affected, and left unattended, it will ultimately impact your animal’s entire wellbeing and quality of life…”

As you see, much the same nonsense as for human chiropractic is now also advertised for animals, particularly horses. Chiropractic for horses and other animals has become a thriving business; today there are even colleges that specialise in ‘educating’ animal chiropractors, and the ‘AMERICAN VETERINARY CHIROPRACTIC ASSOCIATION promotes “animal chiropractic to professionals and the public, and [acts] as the certifying agency for doctors who have undergone post-graduate animal chiropractic training. Members working together within their disciplines to expand and promote the knowledge and acceptance of animal chiropractic to their professions, the public and governments; locally, nationally and internationally.”

Recently I came across a remarkable website which promoted chiropractic specifically for horses. Here are a few paragraphs from the promotional text:

In recent years, the demand among horse owners for alternative equine therapies has spurred many veterinarians to explore therapies like acupuncture and chiropractic. Equine chiropractic techniques provide relief by restoring movement to the spinal column and promoting healthy neurologic functioning. In turn, the entire musculoskeletal system benefits, and the overall health of the animal increases.

Perhaps the greatest clinical application of chiropractic techniques is for animals with a vague sort of lameness that is not localized to any specific area, and for horses that experience a sudden decline in performance for seemingly no reason. These issues often relate back to musculoskeletal disorders that can be diagnosed through chiropractic techniques.

Some horse owners use chiropractic as a preventative measure. Subclinical conditions, meaning those that do not yet show symptoms, can often be detected by an equine chiropractor, as can abnormal biomechanics that could cause lameness down the road. Conditions that originate in the spine often result in a changed gait that can affect how force is applied to joints in the lower limbs. Over time, this shifted force can cause lameness, but chiropractic attention may help identify and deal with problems before they become a real issue…

Several situations can benefit from meeting with an equine chiropractor. The most significant sign that a horse could benefit from chiropractic treatment is pain. If the animal’s behavior suddenly changes or its posture seems abnormal, the horse may be experiencing pain. Similarly, reduced performance, refusing to jump, and tossing the head under saddle can indicate pain.

Owners should familiarize themselves with the many signs that a horse is experiencing pain. Some other indicators include chronic weight loss, sensitivity when being groomed, and difficulty turning. A chiropractor is a great option for identifying the issues leading to these behaviors and correcting them as quickly as possible — before the problems compound.

While pain is a great reason to seek equine chiropractic therapy, individuals may also want to consider the option if the horse is not responding to more conventional therapies. Chiropractors can also aid in recovery after significant trauma or lameness. However, horse owners should recognize that chiropractic therapy does not reverse degenerative changes already present, so working with a practitioner early in a disease’s progression can slow its advancement. Chiropractic may also help manage chronic conditions and prevent them from worsening…

END OF QUOTE

And where is the evidence for all this? I did a quick search and found virtually nothing to write home about. A review which I did locate made it clear why: “…only anecdotal evidence exists in horses…”

And that statement does, of course, prompt me to quickly remind everyone: THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!

 

What? Holistic dentistry? Dentists drilling holes in our teeth?

No, it is something quite different; this article tries to explain it in some detail:

… holistic dentistry involves an awareness of dental care as it relates to the entire person, with the belief that patients should be provided with information to make choices to enhance their personal health and wellness…

Some of the philosophies include:

— Alternatives to amalgam/mercury fillings

— Knowing and following proper mercury removal

— Multi-disciplinary, or integrated, health care

— Nutritional and preventive therapies and temporomandibular joint disorder therapy.

Personally, I find this sounds a bit like a string of platitudes designed to lure in new customers and boost the dental business. An awareness that the mouth and its content is part of the whole body is not a philosophy; alternatives to amalgam have existed since decades and are used by ‘normal’ dentists, integrated health care is a con, nutrition is part of conventional healthcare and temporomandibular joint disorders are most certainly an issue for conventional dentistry. Perhaps another article might do a better job at explaining what ‘holistic dentistry’ is all about:

…Holistic dentistry is not considered a specialty of the dental profession, but a philosophy of practice. For those dentists who take the concept to its core, holistic dentistry includes an understanding of each patient’s total well-being, from their specific cosmetic, structural, functional, and health-related dental needs to the concerns of their total body and its wellness. Holistic dentists tend to attract very health-conscious individuals.

Some of the things holistic dentists are especially concerned about are the mercury found in traditional amalgam dental fillings, fluoride in drinking water, and the potential relationship of root canal therapy to disease in other parts of the body. Holistic dentists’ primary focus is on the underlying reasons why a person has dental concerns, and then help correct those issues by strategic changes in diet, hygiene and lifestyle habits.

Natural remedies to prevent and arrest decay and periodontal (gum) disease can also be utilized. Many holistic dentists are skilled in advanced levels of nutritional physiology and use natural means of healing patients, often avoiding the more standard use of systemic antibiotics, pain control management and surgical procedures.

This partly describes what good dentists have always done and partly it seems to be nonsense. For instance, natural remedies for tooth decay and gum disease? Really? Which remedies precisely? I know of no such treatments that are backed by sound evidence. Let me try a third quote; this one is directly from the horse’s mouth (pun intended), i. e. from a holistic dentist:

Holistic Dentistry, many times referred to today as “Biological” or “Biocompatible” Dentistry, is based on the concept that the mouth and oral structures are an integrated part of the body. It is a paradigm or a philosophy within dentistry and not a specialty.

Holistic dentistry supports your choice to live a healthier, more natural and less toxic life. We bridge the gap between conventional clinical dentistry and natural healing modalities. All holistic health care models share basic philosophical foundations. They all promote health and well being through healthful nourishment, elimination of toxins, and the promotion of physical, mental and energetic balance.

As holistic dentists we recognize that the mouth is connected to the body and that it cannot be viewed as an independent system. It is a reflection of the overall health of the body and much can be done to impact it both positively and negatively. Like many conventional dentists we first look to see if the foundation is solid. Are your gums bleeding and swollen? Is this a reflection of poor nutritional habits? Or are there signs of infection and disease? Are the teeth moving? Is there a stable bite? Can you chew comfortably on both sides of your mouth? Do you get frequent headaches? Are your teeth in harmony with your jaw joint? Are there signs of oral cancer?
The Basic Principles of Holistic Dentistry
Proper nutrition for the prevention and reversal of degenerative dental disease.
Avoidance and elimination of toxins from dental materials.
Prevention and treatment of dental malocclusion (bite problems = physical imbalance)
Prevention and treatment of gum disease at its biological basis
We check the condition of the teeth themselves. Is there more filling than tooth structure? Are the fillings made from the most non-toxic materials available? Are they supporting the bite correctly? Will they be there in five years? Is there decay? Does your diet support your oral health? Then together with our patients we formulate a plan to determine what we can do to help you achieve a stable and healthy mouth. This examination can be a first visit scenario in many dental offices.
Holistic dentists also make fillings, take x-rays and use anesthesia to numb your mouth. However we only use mercury-free white fillings. More importantly, we take extra precautions when removing your old silver fillings to minimize your exposure to mercury vapor. Why don’t we use Mercury? Mercury is one of the heavy metal toxins implicated in Alzheimer’s Disease and autism. However according to the American Dental Association, it is a safe filling material and, as recently as two years ago, the Florida board of dentistry attempted to pass legislation to prevent doctors from advertising as mercury-free dentists.

In holistic dentistry we minimize your exposure to toxic substances in every area of our work. Therefore we use a digital computer generated x-ray unit to take your x-rays which reduces your exposure to radiation by as much as 90%. We don’t advocate the indiscriminant use of fluoride in adults or children, for it is a known poison (check the label on your toothpaste tube) and a commonly used pesticide. We have installed distilled water sources in our office to minimize bacterial contamination. We research and attend courses to find the safest and most biocompatible materials available for dental work. Further, because we recognize that each individual has a different threshold of tolerance for dental materials, we sometimes suggest further testing to determine an individual’s ability to tolerate particular restorative material over long periods of time.

Ultimately you are responsible for your own health. You can choose your health care partners consciously. You can reunite with a part of your body that has been disenfranchised and polluted with toxins. You can reclaim your own unity and wholeness by taking the time to notice what goes into your mouth and how it comes out of it. Your mouth is a sacred portal through which breath, mantra and food travel in and out of your body.

See what I mean?

This is more of the same again. PHILOSOPHY? PARADIGM? REUNITE WITH DISENFRANCHISED PARTS OF THE BODY? The more I read about holistic dentistry, the more I suspect that it is the equivalent of integrative/integrated medicine: a smoke-screen for smuggling bogus treatments into conventional care, a bonanza of BS to attract gullible customers, a distraction for highjacking a few core principles from real medicine/dentistry without getting noticed, and a dubious con for maximizing income.

‘Holistic dentistry’ makes not much more sense than holistic banking, holistic hairdressing, holistic pedicure, holistic car-repair, etc., etc. Dentistry, medicine, hairdressing, etc. are either good, not so good, or bad. The term holistic as it is currently used in dentistry is just a gimmick, I am afraid.

If I am wrong, please tell me so, and explain what, in your view, ‘holistic dentistry’ means.

WARNING: THIS MIGHT MAKE YOU LAUGH OUT LOUDLY AND UNCONTROLLABLY.

Deepak Chopra rarely publishes in medical journals (I suppose, he has better things to do). I was therefore intrigued when I saw a recent article of which he is a co-author.

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation. Deepak Chopra is the co-founder of The Chopra Center for Wellbeing.

Did I promise too much?

Isn’t this paper hilarious?

Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better.

This is hardly something one needs to write home about; and certainly nothing to do a study on!

But which journal would publish such unadulterated advertising?

On this blog, I have mentioned the JACM several times before. Recently, I wrote about the new man in charge of it. I concluded stating WATCH THIS SPACE.

I think the wait is now over – this paper is from the latest issue of the JACM, and I am sure we all agree that the new editor has just shown us of what he is made and where he wants to take his journal.

Just as I thought that this cannot get any better, it did! It did so in the form of a second paper which is evidently reporting from the same ‘study’. Here is its abstract unaltered in its full beauty:

The effects of integrative medicine practices such as meditation and Ayurveda on human physiology are not fully understood. The aim of this study was to identify altered metabolomic profiles following an Ayurveda-based intervention. In the experimental group, 65 healthy male and female subjects participated in a 6-day Panchakarma-based Ayurvedic intervention which included herbs, vegetarian diet, meditation, yoga, and massage. A set of 12 plasma phosphatidylcholines decreased (adjusted p < 0.01) post-intervention in the experimental (n = 65) compared to control group (n = 54) after Bonferroni correction for multiple testing; within these compounds, the phosphatidylcholine with the greatest decrease in abundance was PC ae C36:4 (delta = -0.34). Application of a 10% FDR revealed an additional 57 metabolites that were differentially abundant between groups. Pathway analysis suggests that the intervention results in changes in metabolites across many pathways such as phospholipid biosynthesis, choline metabolism, and lipoprotein metabolism. The observed plasma metabolomic alterations may reflect a Panchakarma-induced modulation of metabotypes. Panchakarma promoted statistically significant changes in plasma levels of phosphatidylcholines, sphingomyelins and others in just 6 days. Forthcoming studies that integrate metabolomics with genomic, microbiome and physiological parameters may facilitate a broader systems-level understanding and mechanistic insights into these integrative practices that are employed to promote health and well-being.

Now that I managed to stop laughing about the first paper, I am not just amused but also puzzled by the amount of contradictions the second article seems to cause. Were there 65 or 69 individuals in the experimental group? Was the study randomised, quasi-randomised or not randomised? All of these versions are implied at different parts of the articles. It turns out that they randomised some patients, while allocating others without randomisation – and this clearly means the study was NOT randomised. Was the aim of the study ‘to identify altered metabolomic profiles following an Ayurveda-based intervention’ or ‘to examine the effects of a comprehensive residential mind–body program on well-being’?

I am sure that others will find further contradictions and implausibilites, if they look hard enough.

The funniest inconsistency, in my opinion, is that Deepak Chopra does not even seem to be sure to which university department he belongs. Is it the ‘Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.’ as indicated in the 1st paper or is it the ‘Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California, USA’ as listed in the 2nd article?

Does he know from which planet he is?

 

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

Did you know that:

  • All diseases are really just psychological conflicts.
  • Conventional medicine is a conspiracy of Jews to decimate the non-Jewish population.
  • Microbes do not cause diseases.
  • AIDS is just a normal allergy.
  • Cancer is the result of a mental shock.

These are just some of the theories of RG Hamer realized in his Germanic (or German) New Medicine.

Hamer once had a medical licence; it was revoked after he was found guilty of malpractice. Subsequently, he continued treating patients as a ‘Heilpraktiker‘. He has been in court many times, sentenced repeatedly and imprisoned at least twice. There is an abundance of information about Hamer available on the Internet (for instance here), and I am therefore not attempting to repeat it here. Yet to give a quick impression of Hamer’s mind-set, I translate what he is quoted stating: ” … I do not even believe in the holocaust…I also do not believe that man was on the moon and, much worse, that the Twin Towers were brought down by Arabs, but hardly anybody believes that today…”

Hamer’s treatments have been associated with several deaths. The most recent case has only just been reported in this article from the Austrian newspaper ‘Der Standard’. As it is in German, I will summarize the essence here:

An Italian couple apparently had refused to let her daughter’s leukaemia be treated with conventional medicine (which usually is life-saving in this condition) but insisted that she receives Hamer’s methods of cancer therapy (which are not evidence-based). They therefore took her to a Swiss clinic where she apparently received cortisol and vitamins. After the interventions of Italian doctors, the parents were forbidden to take charge of their daughter’s care. Meanwhile, however, the daughter, Eleonora Bottaro from Padova, had reached the age of 18 and was therefore legally allowed to decide about her treatments. She opted to continue the treatment in the Swiss clinic and died of her leukaemia in mid August.

Some aspects of this new case are reminiscent of the one of the Austrian, Olivia Pilhar. In 1995, this girl, then aged 6, was diagnosed with a Wilms’ tumour. The parents withheld conventional treatments from her and opted for Hamer’s methods as an alternative. When the authorities intervened, the parents took their child to Malaga where she was treated according to Hamer’s weird ideas. Following a court order, the child eventually did receive proper medical treatment and survived her disease. Her parents received a suspended prison sentence of 8 months in Austria.

Sadly, alternative medicine hosts many miracle healers like Hamer. They have in common that

  • they create their own bizarre ideas about healthcare which are neither plausible nor evidence-based;
  • they mix them with a rich dose of conspiracy theory;
  • they tend to sue those who expose them for what they are;
  • they manage to amass a sizeable following of often quite fanatical believers;
  • they exploit them by selling false hope;
  • they manage to create some sort of cult;
  • they do financially very well with their quackery;
  • they endanger the health of consumers and patients who have the misfortune to come into contact with them;
  • they are undeterred by medical ethics, the law or the authorities.

These people disgust me beyond words. Yet, even in this company of rogues, Hamer is special  – not least because of his rampant racism. He claims, for instance, that conventional medicine is guilty of the “most hideous crime in the whole history of mankind” and alleges that Jews have killed around two billion people with morphine, chemotherapy and radiation.

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