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

risk

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Some chiropractors seem too uninformed, stupid or greedy to stop claiming that spinal manipulation boosts the immune system. In the current situation, this is not just annoying, it is positively dangerous.

Here is a fine example of such a person; he is even so convinced of his views that he felt like giving an interview:

How can/does chiropractic care improve your immune system? What happens to our bodies physiologically when we get chiropractic adjustments?

Chiropractic care addresses the vertebral subluxation. This occurs when a vertebra becomes misaligned. This misalignment can result in irritation to the spinal nerve roots, which exit the spinal cord.

When a spinal nerve root is irritated, it stresses the nervous system — thus the potential to weaken the immune system. When we evaluate the spine for these subluxations and identify a misalignment, chiropractors can adjust the spine to alleviate the irritation to the spinal nerve root. This in turn helps to remove the stress from the nervous system.

If people have problems with their immune systems, can chiropractic care help make them better?

Chiropractic care is not a panacea for disease. Its main role is to remove the interference on the nervous system. The three main stresses on the nervous system are thoughts, traumas, and toxins. These are mainly caused by poor lifestyle choices.

Negative thoughts and self-doubt, physical trauma, and environmental toxins all affect the body in ways that stress the nervous system, thus weakening the immune response. Chiropractic care can address the entire nervous system by not only creating a physiological change, but also inducing a reduction of stress, which results in emotional regulation.

Is there any particular research that gives evidence on how chiropractic care can improve your immune system?  

Three past studies suggest that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures. Two studies provide evidence that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures.

Two studies provide evidence that manipulation may induce and enhance production of the immunoregulatory cytokine IL-2 and the production of immunoglobulins as well.

There are a multitude of clinical studies demonstrating the effects of stress on the body and the correlation between stress and immune function. More double blind, randomized clinical trials need to be conducted on the direct relationship between spinal subluxation and the effect on the immune system. In private practice, we observe the impact that adjusting the spine has on overall wellness and its undeniable effect on boosting the body’s ability to adapt to stress and improve your immune system.

Is there anything else about the physiology of how chiropractic care impacts the immune system that you think is important for readers to know?

Our health is our wealth. Taking responsibility for our wellbeing and being preventative affords the body the best possible chance of protecting itself from illness and disease.

Chiropractic care is rooted in the fundamentals that our negative thoughts, traumas, and toxins can lead to disease. By properly evaluating every patient and addressing their physical and emotional challenges, we as a profession can be the leaders of preventative care and restore health naturally and effectively.

On the one hand this is embarrassing, as it exposes almost everything that is wrong with chiropractic. On the other hand, it is informative, as it demonstrates how deeply some chiropractors are entrenched in platitudes, half-truths and blatant lies. The inevitable question is: do these chiropractors really believe this nonsense, or do they merely promote it because it is good for business?

Whatever the answer may be, one thing is fairly obvious: the ones who are being harmed by such drivel are the patients who lack sufficient critical thinking abilities to look through it. They pay not just with their money, but also with their health.

SO, PLEASE LEARN TO THINK CRITICALLY, FOLKS!

The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.

The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”

No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.

The FDA issued the warning letters to Hevert Pharmaceuticals, LLCMediNatura, Inc.8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.

Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.

Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.

The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.

The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems

_____________________________________

 

Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:

  • “Arnica,”
  • “Calmvalera comp.,”
  • “Gelsemium comp.,”
  • “Hepar comp.,”
  • “Lymphaden comp.”

The FDA referred to the following injectable homeopathic products from 8046255 Canada:

  • “Articula,”
  • “Mesenchyme,”
  • “Connectissue,”
  • “MuSkel-Neural,”
  • “Ouch,”
  • “Ithurts,”
  • “Adipose,”
  • “Systemic Detox,”
  • “Hair,”
  • “Neuro 3,”
  • “Infla,”
  • “Collagen,”
  • “Prolo,”
  • “Lymph 1,”
  • “GI,”
  • “Neuro,”
  • “Arthros,”
  • “Male+,”
  • “Immunexx,”
  • “Relief+,”
  • “Intra-Cell,”
  • “Facial,”
  • “ANS/CNS”.

The FDA warning to World Health Advanced Technologies, Ltd referred to:

  • “Enercel AM,”
  • “Enercel Forte,”
  • “Enercel Max,”
  • “Enercel Mist-Nasal,”
  • “Enercel Mist Nebulizer,”
  • “Enercel PM,”
  • “Vanicel,”
  • “Enercel Plus,”
  • “Enercel Plus IM.”

The FDA warning referred to the following products by MediNatura, and the claims made for them include:

  • Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
  • Traumeel Injection Solution: … treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
  • Engystol Injection Solution:  support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
  • Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
  • Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
  • Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”

The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.

Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”

Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”

As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.

By guest blogger Loretta Marron

If scientists were fearful of a clinical trial’s producing negative results, would they even pursue it? A draft Chinese regulation issued in late May aims to criminalise individual scientists and organisations whom China claims damage the reputation of Traditional Chinese Medicine (TCM).

Beijing has a reputation for reprimanding those who decry TCM. Such criticism is blocked on Chinese Internet. Silencing doctors is becoming the norm.

In January 2018, former anaesthetist, Tan Qindong, was arrested and spent more than three months in detention after criticising a widely advertised, best-selling ‘medicinal’ TCM liquor. Claiming that it was a ‘poison’, he believed that he was protecting the elderly and vulnerable patients with high blood pressure. Police claimed that a post on social media damaged the reputation of the TCM ‘liquor’ and of the company making it. Shortly after release, he suffered post-traumatic stress and was hospitalised.

On 30 December 2019, Chinese ophthalmologist, the late Dr Li Wenliang, was one of the first to recognise the outbreak of COVD-19. He posted a private warning to a group of fellow doctors about a possible outbreak of an illness resembling severe acute respiratory syndrome (SARS). He encouraged them to protect themselves from infection. Days later, after his post when viral, he was summoned to the Public Security Bureau in Wuhan and forced to “admit to lying about the existence of a worrying new virus”. Li was accused of violating the provisions of the “People’s Republic of China Public Order Management and Punishment Law” for spreading “unlawful spreading of untruthful topics on the internet” and of disturbing the social order. He was made to sign a statement that he would “halt this unlawful behaviour”.

In April 2020, Chinese physician Yu Xiangdong, a senior medico who worked on the front line battling COVID-19, posted on Weibo, a Twitter-like site, a criticism of the use of antibiotics and TCM to treat COVID-19. He was demoted from his positions as assistant dean at the Central Hospital in the central city of Huangshi and director of quality management for the city’s Edong Healthcare Group. Well known for promoting modern medicine amongst the Chinese, Yu had almost a million followers on social media. All his postings vanished.

Beijing insists that TCM has been playing a crucial role in COVID-19 prevention, treatment and rehabilitation. Claims continue to be made for “effective TCM recipes”. However, no randomised clinical trial has been published in any reputable journal.

TCM needs proper scrutiny, but criticising it could land you years in prison. If the benefits of suggested herbal remedies are to be realised, good clinical studies must be encouraged. For TCM, this might never be permitted.

Don’t think for a moment that you are safe in Australia.

Article 8.25 of the Free Trade Agreement Between the Government of Australia and the Government of the People’s Republic of China reads:

Traditional Chinese Medicine Services (“TCM”)

  1. Within the relevant committees to be established in accordance with this Agreement, and subject to available resources, Australia and China shall cooperate on matters relating to trade in TCM services.
  2. Cooperation identified in paragraph 2 shall:

(a)    include exchanging information, where appropriate, and discussing policies, regulations and actions related to TCM services; and

(b)   encourage future collaboration between regulators, registration authorities and relevant professional bodies of the Parties to facilitate trade in TCM and complementary medicines, in a manner consistent with all relevant regulatory frameworks. Such collaboration, involving the competent authorities of both Parties – for Australia, notably the Department of Health, and for China the State Administration of Traditional Chinese Medicine – will foster concrete cooperation and exchanges relating to TCM.

I recently came across a short article from 2009 in the BMJ reporting that: “The World Health Organization has said that homoeopathy should not be used to treat several serious diseases such as HIV, tuberculosis, and malaria...”

At the time most people (including myself) were rather pleased that the WHO took what was considered a clear stance, I remember. Reading the short paragraph again today, I must say I am underwhelmed. In fact, if I analyse it carefully, I have to admit that the statement is nonsense.

This would be inconsequential or trivial, were it not for the hundreds of similar statements warning people that HOMEOPATHY SHOULD NOT BE USED FOR SERIOUS CONDITIONS.

Have I confused you?

No, I am not claiming the homeopathy SHOULD be used for serious conditions! I am saying that the statement is misleading and can easily be misunderstood. Some people might interpret it as meaning that, alright homeopathy must not be used for serious diseases, but can be used for all other conditions. Come to think of it, the WHO has often been seen promoting so-called alternative medicine (SCAM), and therefore I cannot be sure that this is not the message they wanted to send out.

Highly diluted homeopathic remedies contain nothing; they are therefore biologically implausible. Crucially, the best evidence fails to show that they work beyond a placebo effect. Therefore, employing it for a serious condition might hasten the patient’s death. But using it for a less serious condition is surely not much better.

Imagine someone takes it for asthma, or psoriasis, or coronary heart disease, or rheumatoid arthritis, or flu, or food poisoning, or the common cold, etc, etc. If he uses it as a sole treatment, he will suffer needlessly. If he uses it as a complementary treatment (Hahnemann did expressly forbid such combinations), he might not be affected negatively except for the time and money invested. But his health would not benefit, and therefore the WHO (or anyone else for that matter) should not imply that this is fine.

It follows that the warning HOMEOPATHY SHOULD NOT BE USED FOR SERIOUS CONDITIONS is nonsense. The only sound advice is this:

HOMEOPATHY SHOULD NOT BE USED FOR ANY CONDITIONS.

 

Sorry, but (exceptionally) this post is not about so-called alternative medicine (SCAM).

During the last weekend, I had the displeasure watching video clips of Donald Trump being unable to lift a glass of water one-handedly and being unable to walk normally down a ramp. Many observers agree that his health has been in steady decline ever since he was taken to the hospital late last year. Now Trump seems to have deteriorated to the point where he sounds and acts like a zombie, loses his temper, acts irrationally, etc. To me, there is no question: this man is seriously ill, physically and mentally.

Why is that any of my business?

The answer is simple: because he is rapidly destroying not just the US but, with it, much of the world as I know it. Therefore, I feel that Trump’s health should be all our business.

So, what disease might he be suffering from?

There is very little to go by for answering this question. His medical check-ups have apparently attested him perfect health, but they seem as trustworthy as a 4 £ note. Even when he was rushed to hospital, we learnt nothing about his condition. This means, we merely have little more than what we see of his behaviour to suggest a diagnosis which inevitably must remain guesswork.

Watching Trump, I often asked myself: could he be suffering from neurosyphilis? It would certainly fit in with his past life-style.

Neurosyphilis is a syphilis infection of the spinal cord or brain of people who had syphilis that has not been adequately treated. It can occur many years after they had their first infection. The physical symptoms are highly variable and can include:

  • Having abnormal gait
  • Loss of balance
  • Not being able to walk normally
  • Visual disturbances
  • Headaches
  • Incontinence
  • Numbness in legs, toes, or feet
  • Seizures
  • Tremors
  • Stiff neck
  • Muscular weakness
  • Abdominal pain

Most of these have been displayed by Trump. In addition, there are mental symptoms that are also highly variable and can include:

  • Irritability
  • Loss of ability to concentrate
  • Delusional thinking
  • Grandiosity
  • Problems with memory
  • Lack of insight
  • Impaired judgment
  • Emotional instability

Patchy hair loss can also be a sign of the later stages of syphilis, and is something that I find hard to miss when observing Trump.

I know that neurosyphilis is highly speculative as a diagnosis of Trump’s condition. What is not speculative, however, is that he is gravely ill. As such, he should not be in the Oval Office making decisions that affect us all.

Whatever disease Trump has, he is a serious danger to mankind.

This was essentially the question raised in a correspondence with a sceptic friend. His suspicion was that statistical methods might produce false-positive overall findings, if the research is done by enthusiasts of the so-called alternative medicine (SCAM) in question (or other areas of inquiry which I will omit because they are outside my area of expertise). Consciously or inadvertently, such researchers might introduce a pro-SCAM bias into their work. As the research is done mostly by such enthusiasts; the totality of the evidence would turn out to be heavily skewed in favour of the SCAM under investigation. The end-result would then be a false-positive overall impression about the SCAM which is less based on reality than on the wishful thinking of the investigators.

How can one deal with this problem?

How to minimise the risk of being overwhelmed by false-positive research?

Today, we have several mechanisms and initiatives that are at least partly aimed at achieving just this. For instance, there are guidelines on how to conduct the primary research so that bias is minimised. The CONSORT statements are an example. As many studies pre-date CONSORT, we need a different approach for reviews of clinical trials. The PRISMA guideline or the COCHRANE handbook are attempts to make sure systematic reviews are transparent and rigorous. These methods can work quite well in finding the truth, but one needs to be aware, of course, that some researchers do their very best to obscure it. I have also tried to go one step further and shown that the direction of the conclusion correlates with the rigour of the study (btw: this was the paper that prompted Prof Hahn’s criticism and slander of my work and person).

So, problem sorted?

Not quite!

The trouble is that over-enthusiastic researchers may not always adhere to these guidelines, they may pretend to adhere but cut corners, or they may be dishonest and cheat. And what makes this even more tricky is the possibility that they do all this inadvertently; their enthusiasm could get the better of them, and they are doing research not to TEST WHETHER a treatment works but to PROVE THAT it works.

In the realm of SCAM we have a lot of this – trust me, I have seen it often with my own eyes, regrettably sometimes even within my own team of co-workers. The reason for this is that SCAM is loaded with emotion and quasi-religious beliefs; and these provide a much stronger conflict of interest than money could ever do, in my experience.

And how might we tackle this thorny issue?

After thinking long and hard about it, I came up in 2012 with my TRUSTWORTHYNESS INDEX:

If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his TI would be 1.

Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.

An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.

Of course, this is all a bit simplistic, and, like all other citation metrics, my TI provides us not with any level of proof; it merely is a vague indicator that something might be amiss. And, as stressed already, the cut-off point for any scientist’s TI very much depends on the area of clinical research we are dealing with. The lower the plausibility and the higher the uncertainty associated with the efficacy of the experimental treatments, the lower the point where the TI might suggest  something  to be fishy.

Based on this concept, I later created the ALTERNATIVE MEDICINE HALL OF FAME. This is a list of researchers who manage to go through life researching their particular SCAM without ever publishing a negative conclusion about it. In terms of TI, these people have astronomically high values. The current list is not yet long, but it is growing:

John Weeks (editor of JCAM)

Deepak Chopra (US entrepreneur)

Cheryl Hawk (US chiropractor)

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

The logical consequence of a high TI would be that researchers of that nature are banned from obtaining research funds and publishing papers, because their contribution is merely to confuse us and make science less reliable.

I am sure there are other ways of addressing the problem of being mislead by false-positive research. If you can think of one, I’d be pleased to hear about it.

 

The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.

From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine

About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).

The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.

The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.

To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.

I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.

So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.

 

Well, they did not directly admit that homeopathic remedies have no effects, of course. But, on 5/6/2020, they tweeted this :

DHU Arzneimittel
@dhu_de Jun 5
#Homöopathie Wissen
‘Pille’ und #Globuli – geht das? Ja, das geht, #Schwangerschaftsverhütung mit der #Pille und homöopathische Arzneimittel beeinflussen sich nicht gegenseitig.

Let me translate the text of this tweet for you:

The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.

Let me translate the text of this tweet for you:

The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.

And in what way is this an admission that homeopathic remedies have no effect?

Let me explain:

To issue such a categorical assurance, any responsible pharmaceutical company must have sound evidence. If not they would be open to expensive legal action, compensation, etc., in case a woman believed them and did get pregnant while taking both the contraceptive pill and a homeopathic remedy. Claiming that no interactions exist without evidence would be unwise, illegal and unethical. That means, there must be a published trial plus several independent replications demonstrating the absence of interactions between the contraceptive pill and homeopathic remedies.

German homeopathic manufacturers are, of course, responsible; I would never dare to doubt it! Ergo, such trials must be available, I thought. Therefore, I quickly conducted a few literature searches in an attempt to locate them.

Here are my findings:

No study on interactions of homeopathics with contraceptives.

No study on interactions of homeopathics with any drug.

(Should anyone have different information, please contact me without delay)

As I said, I do not doubt for a second that the largest German manufacturer, the ‘Deutsche Homöopathische Union’ (DHU), is a highly responsible company. So, how can they responsibly assure the public that there are no contraceptive/homeopathy interactions? How can they be so sure? Why are they not afraid of legal consequences?

There is really only one plausible explanation: they know very well that homeopathic remedies have no actions, and what has no actions cannot possibly cause any interactions!

Am I right, my dear friends at the DHU?

Please do respond if you have a minute!

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

People who use so-called alternative medicines (SCAM) tend to be more vaccine hesitant. One possible conclusion that can be drawn from this is that trusting SCAM results in people becoming more vaccine hesitant. An alternative possibility is that vaccine hesitancy and use of SCAM are both consequences of a distrust in conventional treatments. an International team of researchers conducted analyses designed to disentangle these two possibilities.

They measured vaccine hesitancy and SCAM use in a representative sample of Spanish residents (N = 5200). They also quantified their trust in three CCAM interventions;     

  1. acupuncture,
  2. reiki,
  3. homeopathy                                                                  

and in two conventional medical interventions:

  1. chemotherapy,
  2. antidepressants.

Vaccine hesitancy turned out to be strongly associated with (dis)trust in conventional medicine, and this relationship was particularly strong among SCAM users. In contrast, trust in SCAM was a relatively weak predictor of vaccine hesitancy, and the relationship was equally weak regardless of whether or not participants themselves had a history of using SCAM.

According to the authors of this paper, the implication for practitioners and policy makers is that SCAM is not necessarily a major obstacle to people’s willingness to vaccinate, and that the more proximal obstacle is people’s mistrust of conventional treatments.

This is an interesting study. Yet, it begs a few questions:

  1.  Is it possible to reliably establish trust in SCAM by asking about just 3 specific therapies?
  2. Is it possible to reliably establish trust in conventional medicine by asking about just 2 treatments?
  3. Why those therapies out of hundreds of options?
  4. Could it be that here are national differences (in other countries distrust in conventional medicine is not a strong determinant of SCAM use)?
  5. Is trust in SCAM and distrust in conventional medicine perhaps the common expression of an anti-science attitude or cultist tendencies?
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