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

malpractice

1 2 3 6

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

___________________________________________________

Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

The U.S. Food and Drug Administration posted warning letters to 4 US companies producing homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio.

Please allow me to copy the FDA’s announcement unaltered and without comment:

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits. We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues. One company that continues to concern us because of the low quality of their operation and the threat their products pose to consumers is King Bio. Despite previous actions we’ve taken, our concerns remain. The warning letter we’re sending is a formal notice to King Bio outlining a number of ongoing, serious violations with their manufacturing operations that must be corrected,” said FDA Commissioner Scott Gottlieb, M.D. “Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated. These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer. In addition to our concerns with contamination, some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm. That’s why we’ve proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labeled as homeopathic. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. The actions we’ve taken recently, and over the course of the past year are further warning to all companies that these types of products must be manufactured and labeled appropriately. We’re working to finalize our draft guidance in the coming months to help ensure that products that reach consumers are not harmful to their health.”

Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labeled 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. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.

The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homeopathic drug products; results revealed inordinately high microbiological contamination. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drugs. The microbiological contamination of the water system led, in part, to a voluntary recall of more than 900 potentially homeopathic drug products manufactured by King Bio. Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.

King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.

Today, the FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations.

  • Red Mountain Incorporated, Oakland Park, Fla.warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
  • Tec Laboratories Incorporated, Albany, Ore.warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system
  • B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, Indiawarning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.

The FDA has taken similar actions this year, including a warning letter to Nutra Pharma Corp., Boca Raton, Fla.; as announced earlier this month, the FDA issued a warning letter regarding the company illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain; the agency also alerted consumers to this health fraud scam. In February, the FDA issued a warning letter to Pure Source LLC, Doral, Fla. for distributing drugs made with contaminated raw materials.

In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public. We expect to finalize this guidance soon.

The FDA encourages healthcare 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.

 

A series of article in The Times yesterday (to which I had made several minor contributions) focussed on the dangers of homeoprophylaxis/homeopathic vaccinations. Sadly, the paper is behind a paywall. I therefore will try to summarise some of the relevant points.

A courageous Times-reporter went under cover to extract some of the anti-vaccination views from a lay homeopath. This particular homeopath happened to charge £330 from customers who want to protect themselves or their family from infectious diseases (£130 for a homeopathic remedy kit, plus £200 for the compulsory instructions via skype that automatically come with the kit). Here are some of the most obvious porkies uttered by that homeopath:

  • Only 30% of healthcare professionals get vaccinated.
  • Rubella is a very mild disease.
  • Cancer patients don’t get fever.
  • Measles mainly kills children with severe disease.
  • Anything which messes with natural immunity could contribute to autism.
  • Health officials devised a seven-step recipe to scare consumers into vaccinating their kids.
  • Fevers should be celebrated.

This new undercover research by the Times is reminiscent of our own investigation of 2002. At the time, we contacted 168 homoeopaths, of whom 104 (72%) responded, 27 (26%) withdrawing their answers after debriefing. We also contacted 63 chiropractors, of whom 22 (44%) responded, six (27%) withdrawing their responses after debriefing.  Only 3% of professional homoeopaths and 25% of the chiropractors advised in favour of the MMR vaccination. Almost half of the homoeopaths and nearly a fifth of the chiropractors advised against it. (This tiny and seemingly insignificant study almost cost me my job: some homeopaths complained to my peers at Exeter University who then, in their infinite wisdom, conducted a most unpleasant investigation into my allegedly ‘unethical’ research; full details of this amazing story are provided in my memoir.)

But perhaps you think that homeoprophylaxis might be effective after all? In this case, you would be mistaken! As discussed a couple of weeks ago, a recent study demonstrated that such treatments are ineffective. Its authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

The Times article stated that about half of all new parents have been exposed to anti-vaxx propaganda. Consequently, global measles cases have risen by 300% in the first three months of this year compared to last year. Faced with measles outbreaks across the world, it is hard to deny that homeopaths who promote homeopathic vaccinations are a significant risk to public health.

The Times considered the issue sufficiently important to add an editorial. Its opening sentence sums up the issue well, I think: The evidence supporting claims that homeopathic remedies offer an effective alternative to the measles vaccine can be summarised in one word: zero. And its concluding sentences are even clearer: Tobacco companies are obliged to carry prominent public health warnings on their products. Homeopaths should too.

If one agrees with this sentiment, I suggest, we also consider the same for some:

  1. chiropractors;
  2. doctors of anthroposophical medicine;
  3. naturopaths;
  4. doctors practising integrative medicine.

And furthermore I suggest we disregard the many pro-vaccination statements by the professional organisations of these clinicians – they are nothing but semi-transparent fig-leaves and a politically-correct lip services which they neither enforce nor even truly mean.

 

Spinal manipulation has regularly been associated with serious complications, most commonly strokes due to arterial dissections. But there are several other possibilities as well.

A new and unusual case report a serious complication after spinal manipulation has just been published:

A 54-year-old Indian gentleman, presented to hospital with exertional dyspnoea and chest heaviness for the past 6 months which had increased in the last 6 days. Dyspnoea increased on lying down. He was diagnosed as pneumonia on the basis of X-ray and chest CT scan, received treatment for the same and responded to the therapy.

However, breathlessness and hypercapnia persisted. He had unexplained hypercapnia for which extensive investigations were carried out. Neurological and cardiac assessments were essentially normal. On revisit clinical examination, he was found to have paradoxical diaphragmatic movement with respiration. Ultrasound of chest detected no diaphragmatic movement. Detailed history elicited that patient was fond of neck massage and neck cracking wherein his barber would bend his neck with jerk to either side after a haircut.

After considering all possible aetiologies, the authors concluded that this was a case of diaphragm palsy induced by barber neck manipulation, leading to Type-2 respiratory failure. The fact that the vital clues to the diagnosis were elicited by detailed history and thorough examination reinforces that history and clinical examination for doctors shall remain a very important tool for clinical diagnosis.

My chiropractor friends will be relieved, no doubt, to read that, in this incident, a barber rather than a chiropractor caused this unusual incident. Putting my tongue slightly in the direction of my cheek, the story shows me one thing: one does not necessarily have to be a graduate of a chiro-school to cause severe complications with neck manipulations. Occasionally, osteopaths, physiotherapists, doctors and even barbers are capable of the same feast.

Bleach can be a useful product – but not as a medicine taken by mouth or for injection.

A 39-year-old man with a fracture of the right acetabulum underwent open reduction and internal fixation with a plate under general anaesthesia. At closure, the surgeons injected 0.75% ropivacaine into the subcutaneous tissue of the incision wound for postoperative analgesia. Soon after injection, subcutaneous emphysema at the injection site and a sudden decrease in end-tidal CO2 tension with crude oscillatory ripples during the alveolar plateau phase were observed. Shortly thereafter, it was found that the surgeons had mistakenly injected hydrogen peroxide instead of ropivacaine. Fortunately, the patient recovered to normal status after 10 minutes. After the surgery, the patient was carefully observed for suspected pulmonary embolism and discharged without complications.

A team from Morocco reported the case of a massive embolism after hydrogen peroxide use in the cleaning of infected wound with osteosynthesis material left femoral done under spinal anaesthesia in a young girl of 17 years admitted after to the ICU intubated ventilated. She was placed under mechanical ventilation with vasoactive drugs for ten hours and then extubated without neurological sequelae.

Tunisian doctors reported 2 cases of embolic events with neurological signs. The first, during a pleural cleaning with hydrogen peroxide after cystectomy of a pulmonary hydatic cyst at the right upper lobe. The second case, after a pleural washing during the treatment of hepatitic hydatidosis complicated by a ruptured cyst in the thorax.

Canadian anaesthetists reported a case of suspected oxygen venous embolism during lumbar discectomy in the knee-prone position after use of H2O2. Immediately after irrigation of a discectomy wound with H2O2, a dramatic decrease of the PETCO2, blood pressure and oxygen saturation coincident with ST segment elevation occurred suggesting a coronary gas embolism. Symptomatic treatment was initiated immediately and the patient recovered without any sequelae.

Indian nephrologists reported a case of chlorine dioxide poisoning presenting with acute kidney injury.

A 1-year-old boy presented to the emergency department with vomiting and poor complexion after accidentally ingesting a ClO2-based household product. The patient had profound hypoxia that did not respond to oxygen therapy and required endotracheal intubation to maintain a normal oxygen level. Methemoglobinemia was suspected based on the gap between SpO2 and PaO2, and subsequently increased methemoglobin at 8.0% was detected. The patient was admitted to the paediatric intensive care unit for further management. After supportive treatment, he was discharged without any complications. He had no cognitive or motor dysfunction on follow up 3 months later.

The medical literature is littered with such case-reports. They give us a fairly good idea that the internal use of bleach is not a good idea. In fact, it has caused several deaths. Yet, this is precisely what some SCAM practitioners are advocating.

Now one of them is in court for manslaughter. “If I am such a clear and present danger and a murderer, I should be in jail by now,” said doctor Shortt, who despite a criminal investigation, is still treating patients in his office on the outskirts of Columbia, S.C. Shortt got his medical degree 13 years ago on the Caribbean island of Montserrat. Being a “longevity physician” didn’t seem to bother anyone until one of his patients wound up dead. Shortt gave her an infusion of hydrogen peroxide. Katherine Bibeau, a medical technologist and a mother of two, had been battling multiple sclerosis for two years, and was looking for any treatment that might keep her out of a wheelchair. According to her husband, doctor Shortt said hydrogen peroxide was just the thing. “He had said that there was other people who had been in wheelchairs, and had actually gone through treatment and were now walking again.” It didn’t worry the Bibeaus that Shortt wasn’t affiliated with any hospital or university – and that insurance didn’t cover most of his treatments. “He was a licensed medical doctor in Carolina,” says Bibeau. “So I put my faith in those credentials.” According to Shortt’s own records, the patient subsequently complained of “nausea,” “leg pain,” and later “bruises” with no clear cause. “She went Tuesday, she went Thursday. And by 11 o’clock on Sunday, she died,” says Mr Bibeau. Shortt never told him or his wife about any serious risks. “Even if it wasn’t effective, it should not have been harmful.”

Shortt has been putting hydrogen peroxide in several of his patients’ veins, because he believes it can effectively treat illnesses from AIDS to the common cold. “I think it’s an effective treatment for the flu,” says Shortt, who also believes that it’s effective for multiple sclerosis, Lyme disease, and “as adjunctive therapy” for heart disease. “Things that involve the immune system, viruses, bacteria, sometimes parasites.”

He’s not the only physician using this treatment. Intravenous hydrogen peroxide is a SCAM touted as a cure the medical establishment doesn’t want you to know about. There even is an association that claims to have trained hundreds of doctors how to administer it. The theory is that hydrogen peroxide releases extra oxygen inside the body, killing viruses and bacteria.

Natural News, for instance, tells us that cancer has a rival that destroys it like an M-60 leveling a field of enemy soldiers. It’s called “hydrogen peroxide,” and the “lame-stream,” mainstream media will tell you how “dangerous” it is at 35%, but they won’t tell you that you can drip a couple drops in a glass of water each day and end cancer. Yes, it’s true.

And hydrogen peroxide is not the only bleach that found its way into the realm of SCAM.

Perhaps even worse (if that is possible), the Genesis II Church of Health and Healing promote MMS as a miracle cure. It consists of chlorine dioxide, a powerful bleach that has been banned in several countries around the world for use as a medical treatment. The ‘Church’ claim that MMS cures 95% of all diseases in the world by making adults and children, including infants, drink industrial bleach. The group is inviting members to attend what they call their “effective alternative healing”.

The organizer of the event, Tom Merry, has publicized it by telling people that learning how to consume the bleach “could save your life, or the life of a loved one sent home to die”. The “church” is asking attendants of the meeting to “donate” $450 each, or $800 per couple, in exchange for receiving membership to the organization as well as packages of the bleach, which they call “sacraments”. The chemical is referred to as MMS, or “miracle mineral solution or supplement”, and participants are promised they will acquire “the knowledge to help heal many people of this world’s terrible diseases”.

Fiona O’Leary, a tireless and courageous campaigner for putting an end to a wide variety of mistreatments of children and adults, whose work helped to get MMS banned in Ireland, said she was horrified that the Genesis II Church, which she called a “bleach cult”, was hosting a public event in Washington.

In Fiona’s words: “ Its experimentation and abuse”. I do agree and might just add this: selling bleach for oral or intravenous application, while pretending it is an effective medicine, seems criminal as well.

Chiropractic spinal manipulative therapy (CSMT) for migraine?

Why?

There is no good evidence that it works!

On the contrary, there is good evidence that it does NOT work!

A recent and rigorous study (conducted by chiropractors!) tested the efficacy of chiropractic CSMT for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3). The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment. The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was sustained throughout the RCT. The authors concluded that the effect of CSMT observed in our study is probably due to a placebo response.

One can understand that, for chiropractors, this finding is upsetting. After all, they earn a good part of their living by treating migraineurs. They don’t want to lose patients and, at the same time, they need to claim to practise evidence-based medicine.

What is the way out of this dilemma?

Simple!

They only need to publish a review in which they dilute the irritatingly negative result of the above trial by including all previous low-quality trials with false-positive results and thus generate a new overall finding that alleges CSMT to be evidence-based.

This new systematic review of randomized clinical trials (RCTs) evaluated the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.

The searches identified 6 RCTs eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. The results showed that spinal manipulation reduced migraine days with an overall small effect size as well as migraine pain/intensity.

The authors concluded that spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Bob’s your uncle!

Perhaps not perfect, but at least the chiropractic profession can now continue to claim they practice something akin to evidence-based medicine, while happily cashing in on selling their unproven treatments to migraineurs!

But that’s not very fair; research is not for promotion, research is for finding the truth; this white-wash is not in the best interest of patients! I hear you say.

Who cares about fairness, truth or conflicts of interest?

Christine Goertz, one of the review-authors, has received funding from the NCMIC Foundation and served as the Director of the Inter‐Institutional Network for Chiropractic Research (IINCR). Peter M. Wayne, another author, has received funding from the NCMIC Foundation and served as the co‐Director of the Inter‐Institutional Network for Chiropractic Research (IINCR)

And who the Dickens are the  NCMIC and the IINCR?

At NCMIC, they believe that supporting the chiropractic profession, including chiropractic research programs and projects, is an important part of our heritage. They also offer business training and malpractice risk management seminars and resources to D.C.s as a complement to the education provided by the chiropractic colleges.

The IINCR is a collaborative effort between PCCR, Yale Center for Medical Informatics and the Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School. They aim at creating a chiropractic research portfolio that’s truly translational. Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic Christine Goertz, DC, PhD (PCCR) is the network director. Peter Wayne, PhD (Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School) will join Anthony J. Lisi, DC (Yale Center for Medical Informatics and VA Connecticut Healthcare System) as a co-director. These investigators will form a robust foundation to advance chiropractic science, practice and policy. “Our collective efforts provide an unprecedented opportunity to conduct clinical and basic research that advances chiropractic research and evidence-based clinical practice, ultimately benefiting the patients we serve,” said Christine Goertz.

Really: benefiting the patients? 

You could have fooled me!

Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.

This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.

Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:

  • vitamins and minerals (89 practitioners, 127 recommendations),
  • probiotics (110 practitioners, 110 recommendations),
  • essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
  • homeopathics (56 practitioners, 66 recommendations),
  • botanicals (29 practitioners, 31 recommendations),
  • other NHPs (33 practitioners, 34 recommendations).

Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:

  • 596 total indications for probiotics,
  • 318 indications for essential fatty acids,
  • 138 indications for vitamin D,
  • 71 indications for multi-vitamins.

Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless  and potentially harmful children.

In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.

Is this a Canadian phenomenon? If you think so, read this abstract:

AIM:

This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).

METHOD:

AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.

RESULTS:

Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.

CONCLUSIONS:

Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.

This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and  who prescribe or recommend treatments of unknown value, usually without the children needing them.

Why are regulators not more concerned about this obvious abuse?

The aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.

Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.

The authors of this review come from:

  • the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
  • the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
  • the Homoeopathy University Jaipur, Jaipur, India;
  • the Central Council of Homeopathy, Hooghly,
  • the Central Council of Homeopathy, Howrah, India

They state that they have no conflicts of interest.

The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:

  • According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
  • The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
  • The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
  • The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
  • Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
  • Several of the included studies are not of homeopathy but of isopathy.
  • The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
  • Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
  • No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
  • Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
  • The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.

Confusion?

Incompetence?

Scientific misconduct?

Fraud?

YOU DECIDE!

The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.

A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.

The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.

The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.

A survey with a response rate of 10%?

An investigation published 9 years after it has been conducted?

Who at the AECC is responsible for controlling the quality of the research output?

Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?

But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.

I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.

This clearly begs the question: is it not time to stop these charlatans?

What do you think?

Whenever there are discussions about homeopathy (currently, they have reached fever-pitch both in France and in Germany), one subject is bound to emerge sooner or later: its cost. Some seemingly well-informed person will exclaim that USING MORE HOMEOPATHY WILL SAVE US ALL A LOT OF MONEY.

The statement is as predictable as it is wrong.

Of course, homeopathic remedies tend to cost, on average, less than conventional treatments. But that is beside the point. A car without an engine is also cheaper than one with an engine. Comparing the costs of items that are not comparable is nonsense.

What we need are proper analyses of cost-effectiveness. And these studies clearly fail to prove that homeopathy is a money-saver.

Even researchers who are well-known for their pro-homeopathy stance have published a systematic review of economic evaluations of homeopathy. They included 14 published assessments, and the more rigorous of these investigations did not show that homeopathy is cost-effective. The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.

Probably the most meaningful study in this area is an investigation by another pro-homeopathy research team. Here is its abstract:

OBJECTIVES:

This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.

METHODS:

Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache.

RESULTS:

Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients.

CONCLUSION:

The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.

A recent analysis confirms this situation. It concluded that patients who use homeopathy are more expensive to their health insurances than patients who do not use it. The German ‘Medical Tribune’ thus summarised the evidence correctly when stating that ‘Globuli are m0re expensive than conventional therapies’. This quote mirrors perfectly the situation in Switzerland which as been summarised as follows: ‘Globuli only cause unnecessary healthcare costs‘.

But homeopaths (perhaps understandably) seem reluctant to agree. They tend to come out with ever new arguments to defend the indefensible. They claim, for instance, that prescribing a homeopathic remedy to a patient would avoid giving her a conventional treatment that is not only more expensive but also has side-effects which would cause further expense to the system.

To some, this sounds perhaps reasonable (particularly, I fear, to some politicians), but it should not be reasonable argument for responsible healthcare professionals.

Why?

Because it could apply only to the practice of bad and unethical medicine: if a patient is ill and needs a medical treatment, she does certainly not need something that is ineffective, like homeopathy. If she is not ill and merely wants a placebo, she needs assurance, compassion, empathy, understanding and most certainly not an expensive and potentially harmful conventional therapy.

To employ the above analogy, if someone needs transport, she does not need a car without an engine!

So, whichever way we twist or turn it, the issue turns out to be quite simple:

WHITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS!

1 2 3 6
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Categories