MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk

Guest post by Richard Rawlins MB BS MBA FRCS

Doctors who are registered medical practitioners (RMPs) must comply with the standards of practice set down by the General Medical Council. ‘Homeopathy’ is a specific system of medical care, devised by Dr Samuel Hahnemann in the nineteenth century, and comprises two distinct dimensions: (i) the establishment of a constructive therapeutic relationship between an empathic homeopath and a patient. This may provide benefit due to the non-specific effects of condolence, counselling, and care – and should be a component of the practice of all doctors in any event; (ii) the homeopathically prepared (HP) remedies that are generally prescribed. To avoid confusion, these two dimensions should not be conflated.

HP remedies may be obtained over the counter, prescribed by lay homeopaths and even given out by dentists and nurses on the grounds that “30C homeopathic arnica helps bruising”. The US Federal Trades Commission has stated that “The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted…accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.” (FTC Policy statement 2017).

Special focus should be brought to bear on the ethical, intellectual and professional obligations of those doctors registered as medical practitioners by the GMC and practicing homeopathy in the UK. Some homeopaths may intend taking advantage of gullible and vulnerable patients. Here I take it that those practitioners who prescribe homeopathic remedies sincerely do believe they have worthwhile effects, but I contend such practice generally fails to comply with ethical and professional standards as set down by the GMC. That is to be deprecated.

Systems to regulate medical practice in the British Isles have been devised since the middle ages. In 1518, Thomas Linacre founded the College of Physicians – based on systems he had seen in Europe. From 1704, the Society of Apothecaries licensed its members to prescribe and dispense medicines, and developed the profession of general practice. In order to protect the public from charlatans, quacks and fraudsters more effectively, the Medical Act of 1858 established formal statutory regulation of doctors by the General Medical Council. Registrants who are not deemed fit to practice may be struck off the register. They can still practice, but not as registered medical practitioners. They can still use the title ‘doctor’ (as can anyone), but not for fraudulent purposes.

Dr Samuel Hahnemann qualified in Saxony in 1781 and was a good doctor, but he became disillusioned with many of the practices and practitioners of his day. He wrote about his fellow doctors: “Precious and fragile human life, so easily destroyed, was frequently placed in jeopardy at the hands of these perverted people, especially since bleedings, emetics, purges, blistering plaster, fontanels, setons, caustics and cauterisations were used.” In 1796 he wrote to a friend, “I renounced the practice of medicine that I might no longer incur the risk of doing injury, and I engaged in chemistry exclusively and in literary occupations.”

Hahnemann went on to develop his own alternative system of health care, which he styled ‘Homoeopathy’. Published as the Organon of the Healing Arts in 1810, Hahnemann set out an idiosyncratic medical system based on identifying ‘remedies’ which in large doses, could produce symptoms comparable to those suffered by the patient. The remedies he prescribed were prepared with serial dilutions so that no active principle remained. Today’s homeopaths hold that a remedy’s ‘vital force’, ‘healing energy’ or ‘memory’ provides therapeutic benefit. That may be the case, but the consensus of informed scientific and medical opinion is that any effects of ‘homeopathy’ are as a result of contextual placebo effects. The remedies themselves cannot and do not have any effect. England’s Chief Medical Officer has described homeopathy’s principles as ‘rubbish’. The government’s Chief Scientific Adviser, Sir Mark Walport has said he would tell ministers, “My view, scientifically, is absolutely clear: homeopathy is nonsense. The most it can have is a placebo effect.” Simon Stevens, CEO of the NHS, when interviewed on Radio 4 said he agrees with Sir Mark – yet failed to explain why he had not included homeopathic remedies in the 2017 list of NHS proscribed medicines. That stance is being reviewed.

The GMC states, “Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected.” Those standards are set down in the GMC’s Good Medical Practice which advises, “Serious or persistent failure to follow this guidance will put your registration at risk.” The GMC standards are coherent with those of the American Medical Association’s Principles of Medical Ethics (2016).

In précis, the most relevant and important GMC standards are:

  • Make the care of your patient your first concern.
  • Give patients the information they want or need in a way they can understand.
  • Be honest and open and act with integrity.
  • Never abuse your patients’ trust in you or the public’s trust in the profession.
  • You are personally accountable for your professional practice and must always be prepared to justify your decisions and actions.
  • You must  prescribe drugs or treatment only when you are satisfied that the drugs or treatment serve the patient’s needs.                                                                                                                                             
  • You must provide effective treatments based on the best available evidence.
  • You must be satisfied that you have consent or other valid authority before you carry out any examination, investigation or provide treatment.
  • You must make good use of the resources available to you.

I contend that medical practitioners who prescribe homeopathic remedies regularly fail to meet these standards. They know perfectly well that the best available evidence indicates no support for the assertion that homeopathic remedies ‘serve the patient’s needs’, except as placebos; that the treatments have no specific effects; that the remedies are placebos; and that resources are wasted by expenditure on these ineffective remedies. Medical homeopaths invariably do not give patients this information; they fail to obtain properly informed consent; they do not justify their decisions and actions rationally; and they may be obtaining financial advantage by misrepresentation to insurance companies or the NHS. This is an abuse of the public’s trust in the medical profession.

The issue of informed consent is particularly important. GMC guidance states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

The GMC states that, “in order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options… risks can take a number of forms, but will usually be: side effects; complications; failure of an intervention to achieve the desired aim.” The risk of wasting money on ineffective remedies, whether NHS or private, and of delaying treatment known to be effective should also be discussed.

Homeopaths acknowledge that after ministration of remedies, some patients experience ‘aggravations’ – a worsening of symptoms, but they advise this is evidence that the remedy is ‘working’. Medical consensus is more likely to suggest ‘aggravations’ are evidence of an underlying psychological component to the patient’s condition. Suggestions that remedies themselves have any effect, good or bad, is misrepresentation and may be fraud. Offering patients sugar pills with a claim the pills have therapeutic effects means lying to them, and is an abuse of trust.

Homeopaths’ system of diagnosis and prescription of remedies requires them to have beliefs for which there is no plausible evidence base. The Oxford Dictionary defines ‘belief’ as “assent to a proposition, statement or fact, especially on the grounds of testimony or authority, or in the absence of proof or conclusive evidence.” It might be acceptable to practice ‘homeopathy’ as a counselling modality, providing the practitioner complies with the GMC standard that, “You must not express your personal beliefs to patients in ways that exploit their vulnerability or are likely to cause them distress.”

Homeopaths are invariably non-compliant in obtaining fully informed consent. Such a failing is an abuse of patients’ trust in the medical profession. Doctors might be determined to be unfit to practice unless they clearly justify their prescriptions, and identify the evidence that supports them. All these issues should also be explored during the doctor’s annual appraisal, without which a registered medical practitioner will not be licensed to practice. Even registration without a licence requires compliance with the standards. Appraisal can be carried out by non-homeopaths, as the issue is not the assessment of the standard of ‘homeopathic practice’, but compliance with GMC standards of good medical practice.

If a medical homeopath wishes to be GMC compliant, they must properly inform patients about contentious issues. I suggest that consent should be obtained along the lines: “I propose prescribing you a remedy comprising sugar pills impregnated with a solution which has been diluted to such an extent that a sphere of water the size of the Earth’s average radius to the Sun would probably contain no more than one molecule of the original substance. Nevertheless, my clinical experience suggests to me that this remedy will improve your condition. You need to understand that colleagues who practise conventional evidence-based scientific medicine regard my belief as implausible and the methods I use as ‘alternative.’ I believe the remedy will help you, but I have no evidence accepted by the majority of doctors that the intervention I propose will achieve the desired effects. I do not believe that taking a homeopathic remedy will delay any other treatment which might reasonably help your condition and I invite you to take this remedy with understanding of the issues I have outlined.” A copy of the consent should be placed in the patient’s records.

Those who defend the right of registered medical practitioners to prescribe HP remedies do so with arguments fatally holed by a myriad of logical fallacies. Some arguments are (with fallacies in parenthesis):

  • “Homeopathy has been used for over two hundred years” (appeal to tradition and argument from ignorance);
  • “It has become very popular and is what patients want (appeal to popularity);
  • “Homeopathy has the capacity to help patients” (red herring, because present consideration is about the value of HP remedies, not relationships);
  • “Remedies are cheap” (red herring);
  • “Homeopathy does not do any harm” (irrelevant and a red herring);
  • “Pharmaceuticals have side effects” (tu quoque and red herring);
  • “The Royal Family use it” (appeal to irrelevant authority);
  • “The remedies enhance the doctor/patient relationship (straw man);
  • “Science does not know everything” (red herring and false dichotomy);
  • “Those who oppose us don’t understand homeopathy” (argumentum ad hominem and ‘poisoning the well’);
  • “I have the evidence of patients’ anecdotes and testimonials” (pseudoscience, confirmation bias and cherry picking);
  • “Homeopathic doctors are caring people” (red herring and straw man);
  • “I’ve got much evidence of  patients taking remedies and getting better” (post hoc ergo propter hoc – ‘after this, therefore because of this’ – confusion of coincidence with causation).

The latter most perverse fallacy is the foundation of homeopathic practice, based on identifying a remedy whereby ‘like cures like’ – a principle based on post hoc fallacy for which there is no scientifically credible evidence.

Unless and until medical homeopaths understand the intellectual environment in which they practice, are prepared to properly inform their patients, and obtain consent for treatment having done so, they should not prescribe homeopathic remedies. Fortunately, there is no evidence that patients who are prescribed HP remedies by empathic GMC registered homeopaths have any different outcomes from those prescribed pure sugar pills – even if they are told they are placebos. However, trust in the medical profession can only be maintained if deceptive practices are set aside and full explanations for proposed interventions are offered. Given the scientific consensus, patients have to face up to the fact that to the highest degree of probability, HP remedies have no value. Regrettably, too many patients and even homeopaths are in denial. Medical homeopaths should continue to serve their patients with care, compassion and intellectual honesty, but if they are to comply with the standards required for GMC registration, they should not prescribe homeopathically prepared remedies.

I have mentioned the German alt med phenomenon of the ‘Heilpraktiker’ before. For instance, a year ago I wrote this:

…The German ‘Heilpraktiker’ (literally translated: healing practitioner) is perhaps best understood by its fascinating history. When the Nazis came to power in 1933, German health care was dominated by lay practitioners who were organised in multiple organisations struggling for recognition. The Nazis felt the need to re-organise this situation to bring it under their control. At the same time, the Nazis promoted their concept of ‘Neue Deutsche Heilkunde’ (New German Medicine) which entailed the integration – perhaps more a shot-gun marriage – of conventional and alternative medicine. I have published about the rather bizarre history of the ‘New German Medicine’ in 2001:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker‘ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

The Nazis thus offered to grant all alternative practitioners official recognition by establishing them under the newly created umbrella of ‘Heilpraktiker’. To please the powerful lobby of conventional doctors, they decreed that the ‘Heilpraktiker’ was barred from educating a second generation of this profession. Therefore, the Heilpraktiker was destined to become extinct within decades.

Several of the Nazi rulers were staunch supporters of homeopathy and other forms of alternative medicine. They hoped that alternative medicine would soon have become an established part of ‘New German Medicine’. For a range of reasons, this never happened.

After the war, the Heilpraktiker went to court and won the right to educate their own students. Today they are a profession that uses homeopathy extensively. The German Heilpraktiker has no mandatory medical training; a simple test to show that they know the legal limits of their profession suffices for receiving an almost unrestricted licence for practicing medicine as long as they want…

END OF QUOTE

Since about two years, a group of German scientists, clinicians and various other experts (I was a member of the panel), led by a prominent ethicist, worked on a document that was published this week. Here are its conclusions (in German):

Medizinische Parallelwelten mit radikal divergierenden Qualitätsstandards, wie sie aktuell im deutschen Gesundheitswesen in Form von Doppelstandards bei Ergebnisbewertung und Qualitäts kontrolle bestehen, sind für eine aufgeklärte Gesellschaft nicht akzeptabel. Bei Heilpraktikern stehen aufgrund ihrer ungenügenden, kaum regulierten Ausbildung die Qualifikationen und Tätigkeitsbefugnisse in einem eklatanten Missverhältnis. Heilpraktiker bieten schwer punktmäßig alternativ­ oder komplementärmedizinische Verfahren an, die in den meisten Fällen wissenschaftlich unhaltbar sind. Dies führt zu einer Gefährdung von Patienten. Abhilfe verspricht nur ein gleichzeitiges Vorgehen auf mehreren Ebenen:

(1.) eine einheitliche Bewertung der Patientendienlichkeit in allen Bereichen der Medizin;

(2.) ein verstärktes Engagement für die Erfordernisse einer gelingenden Kommunikation mit Patienten;

(3.) eine verstärkte Förderung wissenschaftstheoretischer Kompetenzen in Ausbildung und Studium gesundheitsbezogener Berufe; sowie

(4.) eine Abschaffung des Heilpraktikerwesens oder eine radikale Anhebung und Sicherstellung des Kompetenzniveaus von Heilpraktikern.

Wir haben uns hier auf die Reform des Heilpraktikerwesens konzentriert und dafür zwei Lösungsvorschläge skizziert: Wir empfehlen entweder die gänzliche Abschaffung des Heilpraktikerberufs oder dessen Ablösung durch die Einführung spezialisierter „Fach­Heilpraktiker“ als Zusatzqualifikation für bestehende Gesundheitsfachberufe. Für die Übergangsphase empfehlen wir eine gesetzliche Beschränkung des Heilpraktikerwesens auf weitgehend gefahrlose Tätigkeiten. Auf diese Weise ließen sich die Gefahren für Patienten reduzieren und die Patientenversorgung langfristig wesentlich verbessern.

END OF QUOTE

Essentially, we are saying that, the Heilpraktiker has introduced two hugely different quality standards into the German healthcare system. In the interest of the patient and of good healthcare, this double standard must be addressed. We are demanding the profession of the Heilpraktiker either is completely abolished, or is reformed such that it no longer poses a threat to public health in Germany. Our document makes concrete suggestions for such reforms.

Our suggestions have already received lots of attention in Germany, and we are therefore hopeful that they will be taken seriously, start a much-needed debate and eventually bring about progress.

This press-release caught my eye today. It relates to an article that does not seem to be available yet (at least when I looked it was not on Medline). As it is highly relevant to issues that we have repeatedly discussed on this blog, let me quote the important sections of the press-release instead:

To investigate alternative medicine use and its impact on survival compared to conventional cancer treatment, the researchers studied 840 patients with breast, prostate, lung, and colorectal cancer in the National Cancer Database (NCDB) — a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The NCDB represents approximately 70% of newly diagnosed cancers nationwide. Researchers compared 280 patients who chose alternative medicine to 560 patients who had received conventional cancer treatment.

The researchers studied patients diagnosed from 2004 to 2013. By collecting the outcomes of patients who received alternative medicine instead of chemotherapy, surgery, and/or radiation, they found a greater risk of death. This finding persisted for patients with breast, lung, and colorectal cancer. The researchers concluded that patients who chose treatment with alternative medicine were more likely to die and urged for greater scrutiny of the use of alternative medicine for the initial treatment of cancer.

We now have evidence to suggest that using alternative medicine in place of proven cancer therapies results in worse survival,” said lead author Dr. Skyler Johnson. “It is our hope that this information can be used by patients and physicians when discussing the impact of cancer treatment decisions on survival.”

Dr. Cary Gross, co-author of the study, called for further research, adding, “It’s important to note that when it comes to alternative cancer therapies, there is just so little known — patients are making decisions in the dark. We need to understand more about which treatments are effective — whether we’re talking about a new type of immunotherapy or a high-dose vitamin — and which ones aren’t, so that patients can make informed decisions.”

END OF QUOTE

Regular readers of my blog will not be surprised; we have discussed similar findings before:

Korean researchers evaluated whether complementary/alternative medicine (CAM) -use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”

A Norwegian study examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”

This study from the US was aimed at determining whether CAM use impacts on the prognosis of breast cancer patients. Health Eating, Activity, and Lifestyle (HEAL) Study participants (n = 707) were diagnosed with stage I-IIIA breast cancer. Participants completed a 30-month post-diagnosis interview including questions on CAM use (natural products such as dietary and botanical supplements, alternative health practices, and alternative medical systems), weight, physical activity, and comorbidities. Outcomes were breast cancer-specific and total mortality, which were ascertained from the Surveillance Epidemiology and End Results registries in Western Washington, Los Angeles County, and New Mexico. Cox proportional hazards regression models were fit to data to estimate hazard ratios (HR) and 95 % confidence intervals (CI) for mortality. Models were adjusted for potential confounding by socio-demographic, health, and cancer-related factors. Among the 707 participants, 70 breast cancer-specific deaths and 149 total deaths were reported. 60.2 % of participants reported CAM use post-diagnosis. The most common CAM were natural products (51 %) including plant-based estrogenic supplements (42 %). Manipulative and body-based practices and alternative medical systems were used by 27 and 13 % of participants, respectively. No associations were observed between CAM use and breast cancer-specific (HR 1.04, 95 % CI 0.61-1.76) or total mortality (HR 0.91, 95 % CI 0.63-1.29). The authors concluded that CAM use was not associated with breast cancer-specific mortality or total mortality. Randomized controlled trials may be needed to definitively test whether there is harm or benefit from the types of CAM assessed in HEAL in relation to mortality outcomes in breast cancer survivors.

MY CONCLUSION:

Some forms of CAM might be effective in supportive or palliative care of cancer patients. However, if it is used or recommended as a cancer therapy, our alarm bells should start ringing.

 

PS

I just found the new article; here is its abstract:

There is limited available information on patterns of utilization and efficacy of alternative medicine (AM) for patients with cancer. We identified 281 patients with nonmetastatic breast, prostate, lung, or colorectal cancer who chose AM, administered as sole anticancer treatment among patients who did not receive conventional cancer treatment (CCT), defined as chemotherapy, radiotherapy, surgery, and/or hormone therapy. Independent covariates on multivariable logistic regression associated with increased likelihood of AM use included breast or lung cancer, higher socioeconomic status, Intermountain West or Pacific location, stage II or III disease, and low comorbidity score. Following 2:1 matching (CCT = 560 patients and AM = 280 patients) on Cox proportional hazards regression, AM use was independently associated with greater risk of death compared with CCT overall (hazard ratio [HR] = 2.50, 95% confidence interval [CI] = 1.88 to 3.27) and in subgroups with breast (HR = 5.68, 95% CI = 3.22 to 10.04), lung (HR = 2.17, 95% CI = 1.42 to 3.32), and colorectal cancer (HR = 4.57, 95% CI = 1.66 to 12.61). Although rare, AM utilization for curable cancer without any CCT is associated with greater risk of death.

The Gerson therapy, CANCER RESEARCH UK correctly informs us, is an alternative therapy which means it is usually used instead of conventional cancer treatment. It aims to rid the body of toxins and strengthen the body’s immune system. There is no scientific evidence that Gerson therapy can treat cancer. In fact, in certain situations Gerson therapy can be very harmful to your health. The diet should not be used instead of conventional cancer treatment.

I would go two steps further:

  • I would avoid the treatment at all cost.
  • I would distrust anyone who promotes it.

Like this article about Gerson therapy and its coffee enemas, for instance:

START OF QUOTE

…The Gerson Institute, along with many other high-profile alternative practitioners, prescribes coffee enemas to their patients up to five times per day in order to assist the liver in its mammoth task of detoxification and encouraging healthy bile production, which can further assist in breaking down toxins and cleansing the body.

It might sound a little wacky (and more than a little uncomfortable!), but the continuing popularity of coffee enemas suggests that it may be worth giving them a go if you’re suffering from stubborn health problems or planning on starting a detox diet…

Here are some of the reasons why you might want to try a coffee enema for yourself:

Eliminate toxins

You’ve probably already guessed by now that helping the liver to eliminate toxins from the body is the main reason why coffee enemas are so popular these days. The fact is, we live in an increasingly toxic world, surrounding ourselves in machines that spew forth toxic fumes, food that introduces increasing levels of harmful chemicals and excesses of vitamins and minerals, and chronic stress which tricks our bodies into retaining toxins rather than expelling them.

Eventually, something’s gotta give — it’s either your liver or the toxins (hint: it’s usually the liver). Liver failure is often accompanied by other serious health conditions, with anything from diabetes to cancer as possible outcomes. Coffee enemas bypass the digestive acids of the stomach, thereby delivering higher concentrations of caffeine to the colonic walls and stimulating greater bile secretion. This greatly helps the liver break down and eliminate toxins, a process which is marked by reduced gastrointestinal and liver pain, and a clearing of those Herxheimer symptoms.

Promote a healthy digestive tract

Over time, our digestive system can start to get a bit “down in the dumps” (pun intended). Bits of food waste can accumulate in the colon, along with toxins and other harmful compounds that stick to the colonic walls and can begin to degrade the overall health of your digestive tract. Coffee enemas, by stimulating bile secretion, help to purge the colon of that accumulated debris. This is helped by the physical flushing of fluids through the colon in the opposite direction, along with the enema encouraging greater peristalsis. Peristalsis refers to the wave-like contractions that help to move your food from one end to the other. More peristalsis means more movement of food wastes… and toxins.

Ease bloating and stomach pain

Bloating, gas and stomach pain are usually signs that your digestive system is underperforming. This is often due to a lack of bile secretion, poor food transit time and an overloaded liver… all of which are improved via coffee enemas! By using coffee enemas, you’re likely to see a marked improvement in your digestive issues, with less bloating, upset stomachs and gas.

Improve mood

Hundreds of recent studies have found a strong link between the gut and our mood. That link, referred to as the gut-brain axis, proves that a healthy gut is associated with a healthy state of mind. When your digestive system (and therefore gut) is overloaded with toxins, you’re bound to feel depressed and constantly suffering from negative emotions. Clearing up your toxin problem with a regular coffee enema should help to improve your mood and alleviate depression.

Treat candida

Candida is one of the biggest problems facing Americans today. It’s a stubborn form of yeast that resides in the gut (along with the mouth and, er, lady bits) and wreaks havoc with your immune system. Not only that, candida overgrowth contributes to insatiable sugar cravings, which in turn causes the overgrowth to establish itself more firmly.

Coffee enemas may selectively flush out candida overgrowths in the gut while preserving the beneficial bacteria that we rely on to break down food and support healthy immune function. Many people report a significant reduction in their symptoms of candida with regular coffee enema flushing.

END OF QUOTE

The article where these quotes come from is entitled ‘5 REASONS TO TRY COFFEE ENEMAS’. I think it is only fair for me to respond by writing a (much shorter) comment entitled

5 REASONS TO AVOID COFFEE ENEMAS

  1. None of the claims made above is supported by good evidence.
  2. Enemas with or without coffee are far from pleasant.
  3. Enemas are not risk-free.
  4. Such treatments cost money which could be used for something sensible.
  5. Coffee taken via the other end of the digestive tract is a much nicer experience.

On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that

  • mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
  • serious adverse effects are being reported regularly;
  • the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
  • the consequences can be permanent neurological deficits and even deaths;
  • under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
  • there is no system to accurately monitor the risks;
  • chiropractors are in denial of these problems.

Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.

The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%  of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

In my previous post, I reported that the NHS has included homeopathy and herbal medicine on the list of medications that might no longer get reimbursed. The news was reported by most newspapers in the UK. All of the papers correctly quote NHS England giving their reasons for black-listing homeopathy and herbal remedies. Some papers also quote critics of homeopathy providing short ‘sound bites’ and opinions. None of the articles bother to explain in any detail why homeopathy is so ridiculously implausible or how strong the evidence against it has become. In this post, I intend to analyse some of this press coverage by copying those excerpts from the newspaper articles which I find odd or misleading and by adding short comments by myself.

THE DAILY MAIL claimed that homeopathic remedies are treatments using heavily diluted forms of plants, herbs and minerals. This is factually incorrect; think of remedies like X-ray! The Mail also quoted Don Redding, director of policy at National Voices, stating: ‘Whilst some treatments are available to purchase over the counter, that does not mean that everyone can afford them. There will be distinct categories of people who rely on NHS funding for prescriptions of remedies that are otherwise available over the counter. Stopping such prescriptions would break with the principle of an NHS “free at the point of use” and would create a system where access to treatments is based on a person’s ability to pay.’  This argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE INDEPENDENT cited Professor Helen Stokes-Lampard, chair of the Royal College of GPs, who said: “If patients are in a position that they can afford to buy over the counter medicines and products, then we would encourage them to do so rather than request a prescription – but imposing blanket policies on GPs, that don’t take into account demographic differences across the country, or that don’t allow for flexibility for a patient’s individual circumstances, risks alienating the most vulnerable in society.” Again, this argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE DAILY TELEGRAPH also reported the quote from Don Redding, Director of Policy at National Voices which I cited above.

THE DAILY MIRROR quoted The Royal Pharmaceutical Society claiming that such a move raised “serious concerns” for poorer Brits. RPS England Board Chair Sandra Gidley said: “A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. “Those on low incomes will be disproportionately affected.” THE MIRROR also reported what had to say and added that the NHS constitution states that: “Access to NHS services is based on clinical need, not an individual’s ability to pay; NHS services are free of charge, except in limited circumstances sanctioned by parliament.”

THE NEWS & STAR repeated the above quote from The Royal Pharmaceutical Society.

THE GUERNSEY PRESS repeated what RPS England board chair Sandra Gidley said: “We would encourage people with minor health problems to self-care with the support of a pharmacist and to buy medicines where appropriate and affordable to the individual. However, expecting everyone to pay for medicines for common conditions will further increase health inequalities and worsen the health of patients who cannot afford them. A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. Those on low incomes will be disproportionately affected. They should not be denied treatment because of an inability to pay.”

THE TIMES also quoted the RPS and Don Redding misleadingly (see above and below) and concluded their article by citing Cristal Summer, chief executive of the British Homeopathic Association saying: Patients will be prescribed more expensive conventional drugs in place of homeopathy, which defeats the object of the exercise. The NHS also claims it wants to reduce the amount of prescription drugs patients take, then stops offering complementary therapies which can help achieve this. This clearly ignores the fact that ‘the object of the exercise’ for any health service must be to provide effective treatments and avoid placebo therapies like homeopathy. 

THE SUN quoted The Royal Pharmaceutical Society saying such a move raised “serious concerns” for poorer Brits. But it said banning NHS-funded homeopathy was long overdue. THE SUN continued by citing John O’Connell, Chief Executive of the TaxPayers’ Alliance: “The NHS are absolutely right to look at removing homeopathy from their approved prescription list and it’s astonishing that it hasn’t happened sooner.”

METRO pointed out that actress Gwyneth Paltrow, ex-Beatle Paul McCartney and world record sprinter Usain Bolt are all known to swear by homeopathic remedies.

Generally speaking, the newspaper coverage was not bad, in my view. The exception evidently is THE TIMES (see above). Several other articles also have a slight whiff of false balance, introducing seemingly rational counter-arguments where none exist. Even though the headlines invariably focus on homeopathy, some of the quotes used by the papers are clearly about other medicines black-listed. This seems particularly obvious with the quotes by the RPS. Many readers might thus be misled into thinking that there is opposition by reputable organisations to the ban on homeopathy. None of the articles that I read quoted a homeopath at the end saying something like  WE KNOW OF MANY PATIENTS WHOSE LIVES WERE SAVED BY HOMEOPATHY. JUST BECAUSE WE DON’T UNDERSTAND HOW IT WORKS DOES NOT MEAN IT DOES NOT WORK. A BAN WOULD PUT PUBLIC HEALTH AT RISK.

Only a few years ago, this type of conclusion to an article on homeopathy would have been inevitable! Could it be that UK journalists (with the exception of those at THE TIMES?) are slowly learning?

 

The Daily Star reported that 9 children have died in Tripura Para of Sitakunda during the last week. At least 46 other children in the remote hilly area are suffering from the same unidentified disease which has not yet been identified. The children aged between one and 12 suffer from fever and other symptoms include body rash, breathing problems, vomiting and blood in stool.

None of the fatalities was taken to a hospital, and two of them were treated homeopathically. The three-year-old Rupali had fever and a rash all over her body for three days. “We took her to a man who practices homeopathy. He lives some two kilometres away. He had given Rupali some medicines”, said her uncle. Asked why they did not take the child to a hospital, Pradip said the next health complex was 15 kilometres away from their home. Besides, they did not have money to buy medicines which would have been prescribed by doctors.

Shimal Tripura was also among the children who died. His father Biman Tripura said the two-year-old boy had been suffering from fever for six days. Shimal was also taken to a local man who practices homeopathy.

“The disease could not be identified immediately,” said a spokesperson. Asked whether the disease could be transmitted by mosquitoes, he said, “It does not seem so. If it was, then why only children were being affected?” A medical team from the Institute of Epidemiology, Disease Control and Research in Dhaka was dispatched for Sitakunda, he said, adding that the local primary school was shut down to prevent the spread of the disease.

I have often pointed out that homeopathy can be deadly – not usually via its remedies (highly diluted homeopathic have no effects whatsoever) but via homeopaths who do not know what they are doing. It seems that here we have yet further tragic cases to confirm this point. Nine children were reported to have died. Two of them received homeopathic remedies and 7 seemed to have had no treatment at all. This looks like a very sad statistic indicating that homeopathy is as bad as no treatment at all.

Isn’t it wonderful when your long-held views are confirmed by someone with influence?

This, of course, is a rhetorical question – I can tell you: it is wonderful!

Matthew Stanbrook, MD PhD recently published an editorial in CMAJ which I find delightful; let me present you a few quotes from it:

The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…

In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.

…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…

…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.

The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.

END OF QUOTES

This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year ­revealed a review of pharmacy regulation, headed by Stephen King from the Productivity ­Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant ­evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”

“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily ­accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homo­eopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”

AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.

In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”

Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”

So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.

Hurray!!!

When, I ask myself, are the UK, the US and other countries following suit?

 

I was surprised to receive this email yesterday: “Hello Edzard Ernst, You may remember I got in touch last week regarding losing a loved one to the ravages of drugs or alcohol. I just wanted to remind you that Narconon is here to help. For over fifty years Narconon drug and alcohol rehabilitation centres have been successfully reversing the tide of addiction for men and woman from all walks of life. The Narconon programme has saved them from the misery of addiction, and the potential of an early grave. We not only address the cause of the addiction, we resolve them…”

The email was signed by a man from ‘Narconon International’. First I thought someone has been counting the empty bottles in my bin, then I read it again and noticed the word ‘NARCONON’ and remembered that I once wrote about it. A quick search located my article from THE GUARDIAN 2012:

Imagine a therapy that “enables an individual to rid himself of the harmful effects of drugs, toxins and other chemicals that lodge in the body and create a biochemical barrier to spiritual well-being“. If you were told that the treatment was entirely natural and had already “enabled hundreds of thousands to free themselves from the harmful effects of drugs and toxins and so achieve spiritual gains”, wouldn’t you be tempted to try it?

Who doesn’t want a body free of nasty chemicals? And who wouldn’t be delighted at the chance to counter a growing threat to an “advancement in mental … wellbeing”?

These claims are being made for the “Purification Rundown” (“Purif” for short) and the closely related Narconon detox programmes, which mainly consist of regular exercise, sauna and nutrition, with industrial doses of vitamins and minerals added for good measure. Some of the claims are quite specific: the Purif programme is supposed to increase your IQ, reduce the level of cancer-causing agents in your body, and even enable you to lose weight easily and quickly. The Narconon programme is more specifically targeted at drug and alcohol dependency and is claimed to have an impressive success rate of 75%.

Both programmes were developed by L Ron Hubbard (1911-1986) and are currently marketed by the Church of Scientology. The CoS is not generally known to be an organisation that promotes healthcare programmes. Hubbard, the pulp-fiction writer who founded the CoS, portrayed himself somewhat over-optimistically as a pioneer, innovator and nuclear physicist.

He taught his followers that, at their core, humans contain a “thetan”. After creating the universe, thetans accidentally became trapped in physical bodies and, through scientology, we can restore the immortal, omnipotent, god-like powers of the “thetan” within us. Weird stuff that is the preserve of Hollywood eccentrics, you might think, but perhaps the CoS’s detox-ventures are an attempt to conquer new territory?

A typical course of treatment lasts several weeks and consists of many hours of exercise and sauna every day. This regimen is supplemented with megadoses of vitamins and minerals, which can cause problems. Niacin, one vitamin that is given in high doses as part of the regimen, can be particularly dangerous. The US National Institutes of Health warns that at high doses it can cause “liver problems, gout, ulcers of the digestive tract, loss of vision, high blood sugar, irregular heartbeat, and other serious problems.” It should not be taken by people who already have liver damage.

Seven fatalities of people undergoing the Narconon programme are currently being investigated in Oklahoma, although the CoS says these deaths are not connected with the treatment regimen itself.

Whatever the truth regarding these deaths, a review of the evidence about the treatment regimen’s effectiveness – carried out by the Norwegian Knowledge Centre for the Health Services in 2008 – found no good evidence that the Narconon programme works:

There is currently no reliable evidence for the effectiveness of Narconon as a primary or secondary drug prevention program. This is partly due to the insufficient research evidence about Narconon and partly due to the non-experimental nature of the few studies that exist.

The claim that such detox treatments eliminate toxins from the body is, of course, easily testable. All we would need to do is define what toxin we are talking about and measure the change in levels of that toxin compared with a control group of volunteers who did not receive the detox.

But such studies are not available. Why? Do the marketing men believe in their own claims? Maybe they feel that profits and evidence are like fire and water? Or possibly the thetans have an aversion to science?

If you think that the Purif, Narconon or any other form of alternative detox eliminates toxins, you might be mistaken. Most clients have lost some money, many have lost their ability to think straight, some may even have lost their lives. But there is no reliable evidence that they have actually lost any toxins.

END OF MY 2012 ARTICLE

In 2012, I found no evidence to suggest that NARCONON works. Now, I looked again and found this article reporting a non-randomised, controlled study:

“In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. After informed parental consent, approximately 1000 Oklahoma and Hawai’i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program also produced changes in knowledge, attitudes and perception of risk. The eight-module Narconon curriculum has thorough grounding in substance abuse etiology and prevention theory. Incorporating several historically successful prevention strategies this curriculum reduced drug use among youths.”

The question arises: would I send anyone to the NARCONON programme?

My answer is NO!

Not because the trial is lousy (which it is) and not because the programme is too expensive (which it is); I would not send anyone to any institution that has even the slightest links to Scientology.

 

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