MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

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This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.

Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn  (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).

The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that  homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.

I have seen many odd studies in my time, but this must be one of the oddest?

  • What is the rationale for assuming that homeopathy might affect body weight?
  • Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
  • Why try to turn a clearly negative result into a finding that is (at least partly) positive?

The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).

Are they for real?

I suppose they are: they are real pseudo-scientific promoters of quackery!

WARNING: THIS POST IS NOT ABOUT ALTERNATIVE MEDICINE

My first ever scientific paper, a spin-off from my MD thesis, was published exactly 40 years ago. Since then, I have written many more articles. Readers of this blog might think that they are all on alternative medicine, but that is not the case. My most cited paper is (I think) one which combined my research in haemorheology with that in epidemiology. Yet, I would not consider it to be my most important article.

So, what is my most important publication?

It is one that relates to the history of medicine.

How come?

In 1990, I was appointed as chair of Rehabilitation Medicine at the University of Vienna. On the occasion of the official opening of the new 2000-bed university hospital in Vienna, I was asked to say a few words and thought that a review of the history of my department might be a fitting subject. But I was wrong. What I discovered while researching it turned out to be totally unfitting for the event; in fact, it contributed to my decision to leave Vienna in 1993. I did, however, summarize my findings in an article – and it is this paper that I consider my most important publication. Here is its abstract:

Misguided by the notion that the decline of the German race would be prevented by purifying “Aryan blood” and eliminating foreign, particularly Jewish, influences, the Nazis evicted all Jews from universities within their growing empire during the Third Reich. The Medical Faculty of Vienna suffered more than any other European faculty from “race hygiene.” Within weeks of the Nazi annexation of Austria in 1938, 153 of the Faculty’s 197 members were dismissed. By far the most frequent reason for dismissal was Jewish origin. Most victims managed to emigrate, many died in concentration camps, and others committed suicide. The “cleansing” process encountered little resistance, and the vacant posts were quickly filled with persons known not for their medical expertise but for their political trustworthiness. It was in this climate that medical atrocities could be committed. After the collapse of the Third Reich, most members of the Faculty were burdened with a Nazi past. Most remained in office, and those who had to leave were reinstituted swiftly. The Jews evicted in 1938 were discouraged from returning. These events have significantly–and with long-lasting effects–damaged the quality of a once-leading medical school. This story needs to be told to honor its victims and to fortify us so that history does not repeat itself.

As I pointed out in my memoir, it “was not published until 1995, by which time I was no longer at the University of Vienna but had left Austria and gone joyfully back to the U.K. to take up my post at the University of Exeter. When the paper was published, it had a considerable impact and important consequences. On the one hand, I received a torrent of hate-mail and threats, and was even accused by the more sensationalistic elements of the Austrian press of having stolen considerable amounts of money from my department at the University of Vienna – an entirely fabricated story, of course, and so ridiculous that I couldn’t even take it seriously enough to instigate legal action.”

So, what else happened as a consequence of the paper?

The answer is ‘lots’.

The Nazi-dean of the medical faculty in 1938, Eduard Pernkopf,  became the author of one of the world’s best anatomical atlas. Here is a short excerpt from a website on Pernkopf and his work which outlines some of the consequences of my paper:

START OF QUOTE

Following Dr. Edzard Ernst’s, revelations in the Annals of Internal Medicine (1995) about the source of Pernkopf’s “models,” Yad Vashem (the Holocaust Authority in Israel) requested that the Universities of Vienna and Insbruck conduct an independent inquiry to determine who the subjects in Pernkopf’s Atlas were and how they died. The request from Yad Vashem was initially denied; but the issue did not end. The following year, a letter by Dr. Seidelman and Dr. Howard Israel, an oral surgeon at Columbia University published in JAMA (November, 1996) in which they stated: “The abuses of medicine perpetrated during the Hitler regime pervaded the entire medical profession of the Third Reich including the academic elite. One legacy of the tragic era endures today through the continued publication of a critically acclaimed atlas, Pernkopf Anatomy…” Their letter prompted a report by the New York Times (1996).

In 1997, Alfred Ebenbauer, the rector of the University of Vienna, wrote to JAMA indicating that an investigation had been initiated and that preliminary findings indicated that the anatomy department had indeed, routinely received corpses of executed persons, among them renowned dissidents, and “brain preparations derived from children under the euthanasia program in psychiatric institutes were still stored there…” For the first time, he acknowledged publicly systematic suppression and even denial of the university’s Nazi past and its failure to conduct relevant investigations. Ebenbauer explained that this attitude had changed because of ‘‘increasing pressure from abroad’’ and a new political atmosphere in Austria (Ethics and Access…Pernkopf atlas, Bulletin of the Medical Library Association 2001; Hildebrandt, 2006).

Penkopf_Atlas Human Anatomy_neck-shoulderThe final report of University of Vienna investigation found that at least 1,377 bodies of executed victims (guillotined or shot by the Gestapo at a rifle range); about 7,000 bodies of fetuses and children; and “8 victims of Jewish origin” had been received by the Anatomy Institute. A statement for users of Pernkop’s Atlas sent out by the U of V to all libraries states: “it is therefore within the individual user’s ethical responsibility to decide whether and in which way he wishes to use this book.” (Hildebrandt, 2006). Hildebrandt states: “the influx of bodies from executions increased so much during the NS [Nazi] regime that the rooms of the anatomy institute were sometimes overfilled and executions had to be postponed because of this.” However, she notes that the true numbers are not known because of incomplete documentation.

Howard M. Spiro, M.D., director of Yale’s Program for Humanities in Medicine and professor of internal medicine, was among the noted speakers at the convocation in Vienna marking (1998) the 60th anniversary of the dismissal of Jewish faculty members from the Vienna Medical School. In his address The Silence of Words, Dr. Spiro said, “the things that we avoid and don’t talk about are the matters that mean the most to us. The shame that has no vent in words makes other organs weep.” Dr. Spiro acknowledged that current officials of the University of Vienna are attempting to recover information that has either been hidden or destroyed and trying to locate former faculty who were interned and exiled. “There is a new generation that has taken over, and they are not afraid to look into these atrocities.”

It is now understood that many of the incredibly detailed illustrations in Pernkopf’s atlas depicted the bodies of victims of Nazi terror.

END OF QUOTE

Why do I bring this up again today?

For two reasons: firstly, I have been invited to give two lecture about these events in recent weeks. Secondly and much more importantly, we seem to live in times when the threat of fascism in several countries has again become worrisomely acute, and I think reminding people of my conclusion drawn in 1995 might not be a bad idea:

This story needs to be told to honor its victims and to fortify us so that history does not repeat itself.

WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):

The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.

The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.

Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”

The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.

People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.

END OF QUOTE

And what is wrong with this article?

The answer is quite a lot:

  1. The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
  2. The research itself is not described in a way that it would be possible to evaluate.
  3. The sample size of what seems to have been a case-control study was tiny.
  4. The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
  5. I was not able to find the publication on Medline, based on the information given.

Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.

 

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.”

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