MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

A press-release from a company based in Germany recently caught my attention. I here present only the most relevant sections from this document:

Natural remedies like medicinal mushrooms also called vitality mushrooms haven proven helpful in prevention and as a support in the therapy, of diabetes type 2. This could be shown by long-time observational studies in naturopathy, for example by MykoTroph – Institute for Medicinal Mushrooms. Medicinal mushroom Coprinus has regenerating effects on the pancreas; it also helps the sensitization of the receptors responsible for the absorption of insulin and claims to have a blood sugar lowering effect.

Medicinal mushroom Maitake has positive effects on the fat metabolism and the sensitivity of insulin receptors. Diabetes type 2 is often linked to circulation problems, vascular diseases and hypertension. Therefore, regular monitoring of the blood pressure, blood lipids, triglycerides and body weight is highly important. The intake of Maitake can help ‒ even in a preliminary stage ‒ to get a grip on these determining factors.

Within the scope of a holistic therapy of diabetes type 2 with metabolic syndrome, the combined intake of medicinal mushrooms and Nopal juice (prickly pear) can be very reasonable. Nopal juice has a lowering effect on the glycemic index of ingested food. The consequence is a slower release of carbohydrates in the intestines and is therefore favorable for a healthy level of blood sugar…

Medicinal mushrooms are available as mushroom powder capsules. According to observational studies of MykoTroph – Institute for Medicinal Mushrooms, especially mushroom powder derived from the whole mushroom has proven effective. Only if the mushroom powder is derived from the whole mushroom, the powder will contain all of the effective ingredients of medicinal mushrooms. It should also be taken care that the mushrooms are from certified organic production. For further information, please visit us on http://www.mykotroph.com
a Japanese study participants comprised 726 Japanese T2DM outpatients free of history of CVD. Life styles were analyzed using self-reported questionnaires. The relationship between dietary patterns, identified by factor analysis, and potential risk factors for CVD was investigated by linear and logistic regression analyses….The “Seaweeds, Vegetables, Soy products and Mushrooms” pattern, characterized by high consumption of seaweeds, soy products and mushrooms, was associated with lower use of diabetes medication and healthier lifestyles.

END OF QUOTE

These are claims that could be relevant to millions of diabetic patients worldwide – but are they true?

The study cited above did indeed show an association; but an association is not necessarily a causal relationship! So what evidence is there fore a causal relationship between mushroom-consumption and diabetes? The answer is: frustratingly little.

A Cochrane review concluded that “evidence from a small number of randomised controlled trials does not support the use of G lucidum [Ganoderma lucidum (also known as lingzhi or reishi)] for treatment of cardiovascular risk factors in people with type 2 diabetes mellitus. Future research into the efficacy of G lucidum should be placebo-controlled and adhere to clinical trial reporting standards.”

The authors of another Cochrane review concluded that “our review did not find sufficient evidence to justify the use of G. lucidum as a first-line treatment for cancer. It remains uncertain whether G. lucidum helps prolong long-term cancer survival. However, G. lucidum could be administered as an alternative adjunct to conventional treatment in consideration of its potential of enhancing tumour response and stimulating host immunity. G. lucidum was generally well tolerated by most participants with only a scattered number of minor adverse events. No major toxicity was observed across the studies. Although there were few reports of harmful effect of G. lucidum, the use of its extract should be judicious, especially after thorough consideration of cost-benefit and patient preference. Future studies should put emphasis on the improvement in methodological quality and further clinical research on the effect of G. lucidum on cancer long-term survival are needed. An update to this review will be performed every two years.”

A further study determined whether a supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes. It was designed as a clinical randomized, double-blind, placebo-controlled trial. Diabetic patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. At the end of the study, the subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index than the control group (n = 31). The plasma adiponectin concentration increased by 20% in the ABM group after 12 weeks of treatment, but decreased 20% among those taking the placebo. The authors concluded that “ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.”

On the basis of all this evidence, it seems fair to conclude that mushrooms have little or no effect on diabetes.

And what about the above press-release?

Diabetes is a serious condition that can be well-controlled with diet, exercise and drugs. Many diabetics are nevertheless fed up with taking drugs throughout their entire life and would only be too happy to exchange them for ‘something natural’. Therefore patients might try mushrooms or other natural ‘cures’, if they are promoted in this way. However, this decision could prove fatal (examples of such tragedies abound).

In view of these considerations, I find such promotion irresponsible, unethical and outright dangerous.

Dietary and herbal supplements (DHS) are currently popular. They are being promoted as being natural and therefore safe – an assumption that is clearly wrong: some DHS can contain toxic substances or they might cause interactions with drugs or other DHS.

This study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. It was designed as a cross-sectional survey of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use. It also assessed whether DHS consumption was documented in patients’ medical files. Statistical analysis was used to delineate DHS users at risk for adverse events associated with interactions with conventional drugs or other DHS.

The results show that about half of all patients took DHS. In 17 (3.7%) of the 458 DHS users, an adverse event may have been caused by DHS-drug-DHS interactions. According to the Drug Interaction Probability Scale, 14 interactions “probably” caused the adverse events, and 11 “possibly” caused them. Interactions occurred more frequently in older patients (p = 0.025, 95% CI: 2.26-19.7), patients born outside Israel (p = 0.025, 95% CI: 0.03-0.42), those with ophthalmologic (p = 0.032, 95% CI: 0.02-0.37) or gastrointestinal (p = 0.008, 95% CI: 0.05-0.46) comorbidities, and those using higher numbers of DHS (p < 0.0001, 95% CI: 0.52-2.48) or drugs (p = 0.027, 95% CI: 0.23-3.77).

The authors concluded that approximately one in 55 hospitalizations in this study may have been caused by adverse events associated with DHS-drug-DHS interactions. To minimize the actual occurrence of adverse events, medical staff education regarding DHS should be improved.

This seems to be a good study and it generated interesting findings on an important topic.

Why do I have nevertheless a problem with it?

The answer is simple but not pleasant: very similar results have been published almost simultaneously in more than one journal. The link above is to an article in the BR J CLIN PHARMACOL of October this year. The following text is from the abstract of an article in INTERN EMERG MED also of October this year:

Of 927 patients who agreed to answer the questionnaire, 458 (49.4 %) reported the use of 89 different DHS. Potential DHS-DHS interactions were identified in 12.9 % of DHS users. Three interactions were associated with the actual occurrence of adverse events. Patients at risk of DHS-DHS interactions included females (p = 0.026) and patients with greater numbers of concomitant medications (p < 0.0001) and of consumed DHS (p < 0.0001). In 88.9 % of DHS users, DHS use was not reported in medical files and only 18 % of the DHS involved in interactions were documented. Potential DHS-DHS interactions are common in inpatients, and may lead to hospitalization or worsen existing medical conditions. The causal relationship between potential interactions and actual adverse events requires further study.

END OF QUOTE

And to my surprise, I also found a third article also from the October issue of INTERN EMERG MED reporting on this survey. Here is part of its abstract:

DHS users were determined via a questionnaire. The Natural Medicine database was used to search for potential DHS-drug interactions for identified DHS, and the clinical significance was evaluated using Lexi-interact online interaction analysis. Medical files were assessed for documentation of DHS use. Univariate and multivariate logistic regression analyses were used to characterize potential risk factors for DHS-drug interactions. Of 927 patients consenting to answer the questionnaire, 458 (49 %) reported DHS use. Of these, 215 (47 %) had at least one potential interaction during hospitalization (759 interactions). Of these interactions, 116 (15 %) were potentially clinically significant. Older age [OR = 1.02 (1.01-1.04), p = 0.002], males [OR = 2.11 (1.35-3.29), p = 0.001] and increased number of used DHS [OR = 4.28 (2.28-8.03), p < 0.001] or drugs [OR = 1.95 (1.17-3.26), p = 0.011] were associated with potential interactions in DHS users. Physicians documented only 16.5 % of DHS involved in these interactions in patients’ medical files. In conclusion, a substantial number of inpatients use DHS with potential interactions with concomitant medications. Medical staff should be aware of this, question patients on DHS usage and check for such interactions.

END OF QUOTE

What is the difference between the three articles? The first one in INTERN EMERG MED authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potential DHS-DHS interactions among inpatients”. The second one in INTERN EMERG MED also authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potentially dangerous interactions of DHS with prescribed medications among inpatients”. Finally the one in BR J CLIN PHARMACOL also authored by Levy I, Attias S, Ben-Arye E, Goldstein L, Schiff E  assessed in addition the interactions between DHS and prescription drugs.

Dual publications are usually considered to be a violation of research ethics. Publication of different aspects of one single data-set in multiple articles is called ‘salami-slicing’ and is often considered to be poor form.

My question to you, the reader of this post, is: What type of scientific misconduct do we have here?

Homeopathic remedies are being marketed and sold as though they are medicines, yet highly diluted preparations contain nothing and do nothing. This means consumers are constantly mislead into believing that they are drugs. This situation seems to be changing dramatically in the US, and hopefully – led by the American example – elsewhere as well.

It has been reported that the US Federal Trade Commission issued a statement which said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

The ‘Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs’ makes it clear that “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.”

However, an [over-the-counter] homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. In other words, if no evidence for efficacy exists, companies must advertise this fact clearly on their labelling, and also disclose that claims are today rejected by the majority of the scientific community. Failure to do this will be considered a violation of the FTC Act.

“This is a real victory for reason, science, and the health of the American people,” said Michael De Dora, public policy director for The Center for Inquiry in a statement issued in response to the new act. “The FTC has made the right decision to hold manufacturers accountable for the absolutely baseless assertions they make about homeopathic products.”

The new regulation will make sure that customers are informed explicitly about whether the product they purchase at a pharmacy has any scientific basis. This is important because homeopathic remedies aren’t just ineffective, but they can be dangerous too. The FDA is currently investigating the deaths of 10 babies who were given homeopathic teething tablets that contained deadly nightshade.

“Consumers can’t help but be confused when snake oil is placed on the same pharmacy shelves as real science-based medicine, and they throw away billions of dollars every year on homeopathy based on its false promises,” said De Dora. “The dangers of homeopathy are very real, for when people choose these deceptive, useless products over proven, effective medicine, they risk their health and the health of their families.”

These are clear words indeed; the new regulation is bound to make a dramatic change for homeopathy in the US. The winner will undoubtedly the consumer who can no longer be so openly and shamelessly misled as before. The FTC has set an example for other national regulators who will hopefully follow suit.

On 25 and 26 May of this year I wrote two posts about an acupuncture trial that, in my view, was dodgy. To refresh your memory, here is the relevant part of the 2nd post:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

…the trial itself raises a number of questions:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

END OF QUOTE

This and the previous post created lots of discussion and comments. However, the question whether the study in question amounted to scientific misconduct was never satisfactorily resolved. Therefore, I decided to write to the editor of ‘Ann Allergy Asthma Immunol‘ where the trial had been published. He answered by saying I would need to file an official complaint for him to address the issue. On 13 June, I therefore sent him the following email:

Thank you for your letter of 3/6/2016 suggesting I make a formal complaint about the paper entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I herewith wish to file such a complaint.

The article in question reports an RCT of acupuncture for persistent allergic rhinitis. It followed a parallel group design with 3 groups receiving the following interventions:

1.       Acupuncture

2.       Sham-acupuncture

3.       No treatment

There was a plethora of outcome measures and time points on which they were measured. A broad range of parameters was defined as primary endpoints.

The conclusion reached by the authors essentially was that acupuncture affected several outcome measures in a positive sense, thus supporting the notion that acupuncture is efficacious [“Symptoms and quality of life improved significantly and were still continuing to improve 4 weeks after treatment ceased.”] This conclusion, however, is misleading and needs correcting.

The main reasons for this are as follows:

·         Despite the fact that the authors did many dozens of statistical tests for significance, they did not correct for this multiplicity of tests. Consequently, some or most of the significant results are likely to be false positive.

·         Many of the positive results of this paper were not obtained by comparing one group to another but by doing before/after comparisons within one group. This approach defies the principle of a controlled clinical trial. For doing intra-group comparisons, we obviously do not need any control group at all. The findings from intra-group comparisons are prominently reported in the paper, for instance in the abstract, giving the impression that they originate from inter-group comparisons. One has to read the paper very carefully to find that, when inter-group comparisons were conducted, their results did NOT confirm the findings from the reported intra-group comparisons. As this is the case for most of the symptomatic endpoints, the impression given is seriously misleading and needs urgent correction.

On the whole, the article is a masterpiece of obfuscation and misrepresentation of the actual data. I urge you to consider the harm than can be done by such a misleading publication. In my view, the best way to address this problem is to withdraw the article.

I look forward to your decision.

Regards

E Ernst

END OF QUOTE

I had to send several reminders but my most recent one prompted the following response dated 7/11/ 2016:

Dear Professor Ernst,
Thank you for your patience while we worked through the process of considering your complaints levied on the article entitled ‘EFFECT OF ACUPUNCTURE ON HOUSE DUST MITE…’ [ Ann Allergy Asthma Immunol 2016] by McDonald et al. I considered the points that you made in your previous letter, sought input from our editorial team (including our biostatistics editor) , our publisher and the authors themselves. I sent the the  charges ( point by point) anonymously to the authors and allowed them time to respond which they did. I had their responses reviewed by selected editors and , as a result of this process, have decided not to pursue any corrective or punitive action based upon the following :
 
  1. Our editorial team recognizes that this is not the best clinical trial we have published in the Annals of Allergy, Asthma and Immunology. However, neither is is the worst. As in most published research studies, there are always things that could have been done better to make it a stronger paper. Never-the-less, the criticism falls fall short of any sort of remedy that would include withdrawal of the manuscript.
  2. Regarding your accusation that the multiple positive endpoint resulted in the authors making specific therapeutic claims, our assessment is that no specific therapeutic claim was made but rather the authors maintained that the data support the value of acupuncture in improving symptoms and quality of life in patients with AR. We do not believe there was overreach in those statements.
  3. The authors’ stated intent was to show immune changes associated with clinical markers of improvement in the active acupuncture group compared to controls. The authors maintain (and our editors agree) that their data assessments were primarily based upon three statistical tests not “dozens” (as stated in your original letter of complaint).  The power analysis and sample size calculations were presented to us and deemed adequate , making the probability of a type I error quite low.
  4. The authors acknowledge in their paper that there could be limitations to their data interpretation based upon potential disparities between intra- and intergroup comparisons. The editors felt their transparency was adequately disclosed.
In summary, as editor-in-chief of the Annals of Allergy, Asthma and Immunology, I did not find sufficient merit in your charges to initiate any corrective or punitive action for this manuscript. I understand you will strongly disagree with this decision and I regret that. However, in the final analysis, my primary intent is to preserve the objectivity, fairness, and integrity of our journal and its review process. I believe I have accomplished that in this instance.
 
Sincerely
END OF QUOTE
This seems to settle the issue: the study in question does not involve scientific misconduct!
Or does it?
I would be grateful for the view of the readers of this post.

I have published many articles on the risks of various alternative treatments (see for instance here, here, here, here, here and here) – not because I am alarmist but because I have always felt very strongly that, for a researcher into alternative medicine, the most important issue must be to make sure users of these therapies are as safe as possible. Usually I differentiated between direct and indirect risks. The former relate to the risks of the treatment and include, for instance, liver damage caused by a herbal remedy or stroke due to neck manipulation. The latter are mainly due to the poor, often irresponsible advice given by many therapists.

A recent article adopted the same terminology when reviewing the risks of alternative medicine specifically for cancer patients. As the indirect risks are often neglected, I will here quote the relevant section of this paper in full:

…Health care physicians and oncology experts have an ethical responsibility to initiate the communication regarding the use of complementary therapies with cancer patients. However, according to data obtained from this literature review, oncology doctors and physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation. This passive attitude was linked to a lack of sufficient scientific evidence for positive outcomes of complementary therapies found in high quality randomized controlled trials (RCTs). Oncology nurses, on the other hand, sometimes actively promote complementary modalities that they find to correspond with their vision of holistic care.

According to the included studies, complementary providers often differ from conventional health care providers in their understanding of treatment concepts, philosophies and diagnostic procedures. This leads to different models of disease causality (cells, blood, nerves vs. energy, vital force, meridians) and treatment philosophy (reductionism vs. holism). As many complementary providers are philosophically oriented towards personal and spiritual growth, patients may feel guilty if the disease continues to advance despite the patients’ best spiritual and mental efforts. According to Broom and colleagues, such philosophies may also give patients false hope of recovery.

Another indirect risk connected to the combination of conventional and complementary treatment in cancer care is the lack of regulation and standardized education in many countries. Currently, there are, for example, no standard training requirements for complementary providers working in cancer care or any other health care setting in the EU. According to Mackareth et al., complementary providers in England need specific training to learn how to practice safely.

Moreover, there is a need for common medical terminology to bridge the communication gap between health care providers working outside the conventional health care system. Common medical terminology may reduce the existing communication gap between conventional and complementary providers about mutual patients. To minimize communication gap between physicians, oncology experts and complementary providers, a medical complementary record should include a treatment plan with conventional and complementary diagnosis, explanation of terminology, possible treatment interactions, description of the complementary treatment plan and goals. If possible, the quality of any complementary supplement given should be reported.

END OF QUOTE

As I said, I find it important to discuss the indirect risks of alternative medicine, and I am therefore pleased that the authors of this article addressed them. At the same time, I find their text remarkably tame.

Why are they not more open and forceful about what, after all, amounts to a serious public health issue? The answer might be simpler than expected: most of them are affiliated with the ‘National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway’. Could it be that open warnings about outright quackery is not what suits this unit?

So, what might be an open and frank approach to discussing the indirect risks of alternative medicine? In my view, it should make several points abundantly clear and transparent:

  • Alternative practitioners (APs) are usually not trained to advise patients responsibly, particularly in cases serious disease.
  • The training of APs is often inadequate and sometimes resembles more to brain-washing than to proper education.
  • Consequently, APs often woefully over-estimate what their therapy can achieve.
  • The patients of APs are often desperate and ready to believe even the tallest tales.
  • APs have a huge conflict of interest – in order to make a living they need to treat as many patients as possible and are therefore not motivated to refer them to more suitable care.
  • APs are frequently in denial when it comes to the risks of their treatments.
  • APs are not educated such that they understand the full complexities of serious illness.
  • As a result, APs far too often misguide their patients to make tragically wrong choices thus putting their health at serious risk.
  • In most countries, the regulators turn a blind eye to this huge problem.

These are by no means trivial  points, and they have nothing to do with a ‘turf war’ between conventional and alternative medicine. They relate to our ethical duty to keep our patients as safe as we can. It has been estimated that, in oncology alone, 1 – 5% of deaths are due to patients opting to have alternative instead of conventional treatments. This amounts to an unbearably high absolute number of patients dying prematurely due to the indirect risks of alternative medicine.

It is high time, I think, that we tackle this issue systematically and seriously.

Being exposed to a lot of gibberish in the comments’ section, some of my readers are probably wondering how much it takes to get blocked from commenting here. The ‘rules’ for this blog have been set out quite clearly from the start:

I do like clearly expressed views and intend to be as outspoken as politeness allows. I hope that commentators will do the same, no matter whether they agree or disagree with me. Yet a few, simple, principles should be observed by everyone commenting on my blog.

All posts have to be in English.

Libellous statements are not allowed.

Comments must be on topic.

Nothing published here should be taken as medical advice.

All my statements are comments in a legal sense.

Conflicts of interest should always be disclosed.

I will take the liberty of stopping the discussion on any particular topic, if I feel that enough has been said and things are getting boring or repetitive.

I will not post comments which are overtly nonsensical or in such poor English that I cannot understand them.

I will prevent commentators from monopolizing the discussion.

In the past, many of us  – I included – have broken these rules. I felt that this was regrettable yet tolerable and let it pass. Nevertheless, I would like to take this opportunity to remind myself and everyone else to try their best to be polite, even when responding to someone who might seem utterly unhinged.

In the past, some commentators got banned for being consistently and intolerably offensive. The ‘rules’, however, fail to state when this should happen. So, let me try to explain it now: I take the liberty of blocking someone when he or she has repeatedly insults others without contributing meaningfully to the debate, particularly if there is no sign or hope of improvement.

These things are perhaps best explained by using an example.

So, here is one:

I am today blocking ‘zet1’ from making further comments on this blog.

As I take this step, I am already regretting it a little bit: zet1 has been a reliable, daily source of amusement for me, and I suspect others had to laugh just as much as I did about his ramblings – I assume zet1 is a male person. His comments are full of unintended humour, I find. Others may have enjoyed getting a glimpse at the sick mind of a fanatic believer in alternative medicine. Others again might have found zet1 an interesting study of increasingly paranoid behaviour.

Why then am I blocking him?

He  has insulted just about everyone who does not share his bizarre creed; he has consistently posted utter nonsense; he does not contribute to any meaningful discussion; he seems far too deluded to ever make any sense whatsoever; he shows no signs of improvement. In case you feel that my judgement is too harsh, here are some excerpts from his recent comments:

 

Edzard Bastard… Yes, the seno doggy style!

Mojo, as you knows tour “skeptical activism” is part of the problem: fraud.

Ernst is clearly a fraud with extreme bias and severe conflicts of interests!

Not data little liar?

Tell me more zeno. tell me more. Can you need the help of Björn? Coward.

Fraud in NHMRC

Fraud in Evidence Check report

Caroline Watt the schizoid pseudoskeptic and paranormal “believer” against homeopathy.
Ernst the UFO pseudobeliever and modern Clinton propagandist.
Tracey Brown the corporate manager L & Reskin, Syngenta and Monsanto cofunder in Genetic Literacy.
David Gorski, H Hall and S. Novella the others…

The true Amaz!ing believers and gangster team of pseudoskepticsm, LOL!

The lack of coherence, fraud, links with industrial interests or ghost pseudoGNO (example: Nightingale Collaboration) or ex-“quacks”, is an strong indication of your biased propaganda. In the future, Ernst will appear as the boss of pseudoskeptical incoherence and big international fraud.

END OF QUOTES

Yes, this is hilariously funny comedy gold – and, in a way, we will miss him for that. On the other hand, it is unproductive and I feel increasingly embarrassed to give someone the opportunity to make such a fool of himself.

And this is what it really takes to get evicted from this blog.

 

 

Chiropractors have been shown to over-use X-rays (a worry about which I cautioned almost 20 years ago) and to refer for lumbar radiography inconsistent with the current clinical guidelines for low back pain. It is unknown whether this is due to lack of adherence with, or a lack of awareness of relevant guidelines. The aim of this study was to clarify this issue; more specifically, the authors wanted to determine Australian chiropractors’ awareness of, and reported adherence to, radiographic guidelines for low back pain.

An online survey was distributed to Australian chiropractors from July to September, 2014. Survey questions assessed demographic, chiropractic practice and radiographic usage characteristics, awareness of radiographic guidelines for low back pain and the level of agreement with current guidelines. Results were analysed with descriptive statistics and logistic regression analysis.

A total of 480 surveys were completed online. Only 49.6 % of the responders reported awareness of radiographic guidelines for low back pain. Chiropractors reported a likelihood of referring for radiographs for low back pain: in new patients (47.6 %); to confirm biomechanical pathologies (69.0 %); to perform biomechanical analysis (37.5 %); or to screen for contraindications (39.4 %). Chiropractors agreed that radiographs for low back pain could be useful for: acute low back pain (54.0 %); screening for contraindications (55.8 %); or to confirm diagnosis and direct treatment (61.3 %). Poorer adherence to current guidelines was seen, if the chiropractor referred to in-house radiographic facilities, practiced a technique other than diversified technique or was unaware or unsure of current radiographic guidelines for low back pain.

The authors of this paper concluded that only 50 % of Australian chiropractors report awareness of current radiographic guidelines for low back pain. A poorer awareness of guidelines is associated with an increase in the reported likelihood of use, and the perceived usefulness of radiographs for low back pain, in clinical situations that fall outside of current guidelines. Therefore, education strategies may help to increase guideline knowledge and compliance.

I am tempted to rephrase the last sentence: EDUCATION STRATEGIES MAY HELP TO INCREASE THE KNOWLEDGE THAT RESPONSIBLE HEALTHCARE PROFESSIONALS SHOULD WORK PRIMARILY FOR THE BENEFIT OF THEIR PATIENTS RATHER THAN FOR THE BENEFIT OF THEIR BANK ACCOUNTS.

In my view, this investigation confirms that:

  • chiropractors still grossly over-use X-rays (it probably is fair to assume that the responders of this survey were relatively guideline-conform compared to non-responders; if that were true, the true figures of X-ray overuse would be even higher)
  • they use X-rays for spurious reasons;
  • they are ill-informed about the existing evidence;
  • they have not abandoned the myth of ‘subluxation’, i. e. ‘biomechanical pathologies’.

Of course, the data are from Australia, and chiros elsewhere might claim that they are more guideline-conform than their Australian colleagues. But, in their discussion section, the authors of the present paper point out that “three previous studies have quantitatively assessed the adherence of registered chiropractors to radiographic guidelines for the management of low back pain (LBP). Two surveys performed in Canada with 26 and 32 responses respectively found that 63 and 59 % would use radiography for acute LBP without indicators of potential pathology and 68 and 66 % thought that radiography was useful in the evaluation of acute LBP.”

Are you or a family member ill?

No need to call a doctor or other healthcare professional!

Homeopathy DIY is the answer. The website of the NATIONAL CENTER FOR HOMEOPATHY tells you how and gives you concrete advice for specific conditions – at closer inspection, it turns out to be an instruction for killing off your entire family:

START OF QUOTE

It’s easy to get started using homeopathy at home. You don’t need to be an expert in anatomy, physiology, or pharmacology. You only need to be able to observe your and your family’s symptoms and any changes you might see in those symptoms. By using the information on this site you can quickly learn enough about homeopathy to use it at home to care for yourself and your family to address minor illnesses and injuries that don’t necessarily need a doctor’s care.

Asthma Attack

Asthma attacks occur for a variety of reasons. You can help treat asthma attacks with homeopathic remedies based on the type of attack that it is.

  • Arsenicum album: anxiety, restlessness, unable to lie down because of feeling of suffocation shortly after midnight.
  • Carbo vegetabilis: asthma attach occurs after long, spasmodic coughing spell with gagging or vomiting; patient feels worst after eating or talking; worse in the evening.
  • Ipecacuanha: sudden onset of wheezing and feeling of suffocation; coughs constantly, but unable to bring up mucus; feeling of weight on chest.
  • Nux vomica: attack often follows stomach upset with much belching; patient very irritable.

Bleeding

  • Arnica: injury, shock.
  • China: loss of blood.
  • Carbo vegetabilis: steady oozing of dark blood; cold breath, cold limbs; cold, clammy sweat; air hunger.
  • Ipecac: gushes of bright red blood, nausea, cold sweat.
  • Sabina: threatened abortion and uterine hemorrhage.
  • Phosphorus: profuse nosebleed, especially after vigorous blowing, or any hemorrhage; when small wounds bleed profusely.

Chicken Pox

Chicken pox can be uncomfortable and painful (for both the child and the parent) and the only way to deal with it is to wait for it to run its course. However, homeopathy can help speed up the healing process – and quickly calm the itch and irritation of this childhood illness.

Let’s look at the handful of remedies that are often called for in cases of chicken pox:

  • Aconite: Early cases, with restlessness, anxiety and high fever.
  • Antimonium tart: Delayed or receding, blue or pustular eruptions. Drowsy, sweaty and relaxed; nausea. Tardy eruption, to accelerate it. Associated with bronchitis, especially in children.
  • Belladonna: Severe headache: face flushed; hot skin. Drowsiness with inability to sleep.
  • Mercurius: To be used should vesicles discharge pus.
  • Rhus toxicodendron: Intense, annoying itching. Generally the only remedy required; under its action the disease soon disappears.
  • Sulphur: like with Rhus toxicodendron, rash is extremely annoying; very thirsty and hungry but takes more than can eat.

Croup

Croup can be very scary for parents… your child awakens at night coughing and gasping for air. Homeopathy works very well for these young patients.

There are a number of great homeopathic remedies to consider first when you confront this condition late some night:

  • Aconite: This remedy should always be given at the first; it will often prove to be the only one needed, if given right, unless some other remedy is strongly, indicated. Aconite will be called for if there is a high fever, skin dry, much restlessness and distress. Cough and loud breathing during inspiration. Every expiration ends with a hoarse hacking cough.
  • Arsenicum album: For croup with suffocative attacks at night; especially after midnight; croup before or after rashes or hives; patient cannot breath through nose; complaints with much restlessness and thirst, but for less quantity of water; aggravation after drinking.
  • Bromine: Spasms of the larynx, suffocative cough, horse whistling, croupy sound with great effort; rattling breathing; gasping; impeded respiration, heat of the face, much rattling in larynx when coughing.
  • Hepar sulph: If there is a rattling, choking cough, becoming worse particularly in the morning part of the night. Patient tends to be chilly. Cough can be worse from cold drafts or cold room – better warm moist air.
  • Spongia: The cough is dry and silibant; or it sounds like a saw driven through a pine board, each cough corresponding to a thrust of the saw.

Ebola

…The good news is that a small international team of experienced and heroic homeopaths have arrived in West Africa, and are currently on the ground working hard to examine patients, work out the “genus epidemicus,” and initiate clinical trials. This work is being done alongside the current conventional supportive measures and treatments already in place. We applaud and congratulate this team’s dedication and courage in joining the front lines in treating Ebola with homeopathy. The answer to whether homeopathic medicine has an important role in the Ebola epidemic could be forthcoming quite soon.

Flu

The flu can come on suddenly and stop you in your tracks – but there are many homeopathic remedies that can help bring relief and shorten the duration of the flu.

The following are some remedies that can bring relief during the flu:

  • Arsenicum album: great prostration with extreme chilliness and a thirst for frequent sips of warm drinks. The eyes and nose stream with watery, acrid discharges. Feels irritable and anxious.
  • Baptista: gastric flu with vomiting and diarrhea. Comes on suddenly. Feels sore and bruised all over. Profuse perspiration with a high fever and extreme thirst. Feels (and looks) dazed and sluggish.
  • Bryonia: flu comes on slowly. Aching pains in all the joints are worse for the slightest motion. Painful dry cough that makes the head hurt. Extreme thirst at infrequent intervals. Feels intensely irritable and wants to be alone.
  • Eupatorium perfoliatum: the pains are so severe it feels as if the bones are broken. The muscles ache and feel sore and bruised as well. A bursting headache with sore, aching eyeballs. The nose runs with much sneezing, and the chest feels sore and raw. Thirsty for cold water even though it brings on violent chills in the small of the back.
  • Ferrum phosphoricum: a fever develops, a flu is likely but the symptoms aren’t clearly developed yet (and Aconite didn’t help). Take 3 doses every 2-4 hours.
  • Gelsemium: flu comes on slowly especially when the weather changes from cold to warm. The muscles feel weak and achy. There’s a great feeling of heaviness everywhere-the head (which aches dully), limbs, eyelids, etc. No thist at all. Fever alternative with chills and shivers that run up and down the spine. Feels (and looks) apathetic, dull, and drowsy.
  • Mercurius solubilis: fever with copious, extremely offensive perspiration that doesn’t provide any relief (unlike most feverish sweats). The breath smells bad, there’s more salivation than normal and an extreme thirst.
  • Nux vomica: gastric flu with vomiting and diarrhea. The limbs and back ache a great deal. The nose runs during the day and is stopped up at night. Fever with chills and shivering especially after drinking. Very chilly and sensitive to the slightest draught of air or uncovering. Feels extremely impatient and irritable.
  • Pyrogenium: serious flu with severe pains in the back and the limbs and a terrible, bursting headache. Feels beaten and bruised all over. Very restless and feels better on beginning to move. Chills in the back and the limbs with a thumping heart.
  • Rhus toxicodendron: flu in cold, damp weather. Great restlessness: aching and stiffness in the joints is worse for first motion, it eases with continued motion and then they feel weak and have to rest after which they stiffen and have to move again. Pains are better for warmth. Feels anxious and weepy.
At the first sign of a flu Oscillococcinum® can also be taken right at the very beginning of feeling ill but before any symptoms have developed.

Hand, Foot, and Mouth Disease

Hand, foot, and mouth disease (HFM) starts with a fever and shortly after, the spots appear. The spots are more like blisters and can show up on the soles of the feet, palms of the hands, and/or inside the mouth and back of the throat. The blisters in the mouth can be very painful, especially when your little one is trying to swallow or eat.

A child also might:

  • develop fever, muscle aches, or other flu-like symptoms.
  • become irritable or sleep more than usual.
  • begin drooling (due to painful swallowing).
  • gravitate toward cold fluids.

Try the following remedies when HFM makes an appearance in your house.

  • Mercurius solubis: Mouth sores can be very severe, and the person is very sensitive to hot and cold; may have a fever before getting the blisters and may alternate between getting too hot with perspiration and becoming chilled at night; becoming too hot or too cold makes the person worse in general; blisters tend to be more painful at night; one of the characteristic symptoms of Mercurius is the tendency to drool or to have an excess of saliva in the mouth; the breath may be quite offensive with pus visible on the tonsils or elsewhere in the mouth.
  • Antimonium tart: Chill stage of fever: gooseflesh and icy cold skin; heat stage of fever: clings to those around and wants to be carried; does not want to be touched or looked at; thirstless despite the dry parched tongue; wweat stage of fever: profuse, cold, clammy or sticky; dry, cracked, parched tongue with whitish discoloration in the centre; tongue tip and sides clean, moist and red; thrush; may crave apples or apple juice.
  • Borax: Refuses to talk during fever; desire for cold drinks and cold food during fever; great heat and dryness of mouth with white ulcers (aphthae); white fungus-like growth; tender; ulcers bleed on touch and eating; painful red blisters on tongue; sore mouth prevents infants from nursing; fear of downward motion; startle easily; very sensitive to sudden noises.

Measles

While measles is probably best known for its full-body rash, the first symptoms of the infection are usually a hacking cough, runny nose, high fever, and red eyes that can be very sensitive to light. Characteristic markers of measles are Koplik’s spots, small red spots with blue-white centers that appear inside the mouth. The rash first appears on the face and then moves downwards and from the face downward.

  • Euphrasia: Lots of mucus; a mouthful hawked up on cough; clears the throat frequently; cough during the day only and worse in the morning; better lying down; eyes – burning, watery and sensitive to light; eyelids burning, red and swollen; wind and light aggravate; nose – bland, watery unlike the watery discharge of the eyes which burns; throat might be sore with burning pain.
  • Pulsatilla: thirstless; clinging and weepy; warm rooms and becoming warm aggravate; open air ameliorates; low fever and the itchy skin/eruptions are worse for heat; eruptions itching and worse for warmth with white or yellow discharge.
  • Apis: eruptions painful, burning, hot, stinging with swelling where the skin looks shiny/puffy; thirstless; itching better for cold applications and worse for heat, especially heat of bed; if rash is slow to develop or is suppressed; better in general for fresh air, better with cold drinks.
  • Bryonia: Rash/eruptions slow to come out or suppressed; warmth of the bed ameliorates; dryness and dislike of movement; headache has pain behind the eyeballs, bursting and violent, worse for moving; better for cold compresses and pressure; thirsty for large quantities of water all at once; motion aggravates; grumpy bear remedy – want to be left alone; throbbing/pulsating pains; dryness throughout all mucous membranes.

END OF QUOTE

I have only selected conditions that are potentially serious. Originally, I had intended to include all of them in this post, but half way through I gave up: there were just too many.

I am sure that most readers of the above advice would have – like I did – first have giggled a bit and then have felt increasingly angry and eventually slightly depressed: this glimpse into the way homeopaths think is revealing and frightening in equal measure.

I already hear the apologists say: This is unnecessarily alarmist; homeopathic remedies are safe, much safer than conventional medicines. My answer to these two points are as follows:

  1. Homeopathy does not normally harm patients via its remedies but by neglect: it is a non-treatment; and a non-treatment of a serious condition is always life-threatening.
  2. Sure, real medicines have risks, but they also have benefits. Responsible healthcare practitioners use those treatments where the benefits outweigh the risks.

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

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

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

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

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

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

The risks of consulting a chiropractor have regularly been the subject of this blog (see for instance here, here and here). My critics believe that I am alarmist and have a bee in my bonnet. I think they are mistaken and believe it is important to warn the public of the serious complications that are being reported with depressing regularity, particularly in connection with neck manipulations.

It has been reported that the American model Katie May died earlier this year “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck” This is the conclusion drawn by the L.A. County Coroner.

katie-may-ist-mit-34-jahre-gestorben

According to Wikipedia, Katie tweeted on January 29, 2016, that she had “pinched a nerve in [her] neck on a photoshoot” and “got adjusted” at a chiropractor. She tweeted on January 31, 2016 that she was “going back to the chiropractor tomorrow.” On the evening of February 1, 2016, May “had begun feeling numbness in a hand and dizzy” and “called her parents to tell them she thought she was going to pass out.” At her family’s urging, May went to Cedars Sinai Hospital; she was found to be suffering a “massive stroke.” According to her father, she “was not conscious when we got to finally see her the next day. We never got to talk to her again.” Life support was withdrawn on February 4, 2016.

Katie’s death certificate states that she died when a blunt force injury tore her left vertebral artery, and cut off blood flow to her brain. It also says the injury was sustained during a “neck manipulation by chiropractor.” Her death is listed as accidental.

Katie’s family is said to be aware of the coroner’s findings. They would not comment on whether they or her estate would pursue legal action.

The coroner’s verdict ends the uncertainty about Katie’s tragic death which was well and wisely expressed elsewhere:

“…The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke four or five days later… Thus, it seems to be jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” … Her two chiropractic manipulations might well have either worsened an existing intimal tear or caused a new one that led to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.”

My conclusions are as before and I think they need to be put as bluntly as possible: avoid chiropractors – the possible risks outweigh the documented benefits – and if you simply cannot resist consulting one: DON’T LET HIM/HER TOUCH YOUR NECK!

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