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

charlatan

Infant colic is a sensitive subject for chiropractors in the UK. In case you forgot, here is why. Consequently, the subject has featured regularly on this blog – and now there is new evidence:

A systematic review and meta-analysis were conducted on infantile colic studies that used SO-CALLED alternative medicine (SCAM) techniques as interventions. The outcome measures were hours spent crying and/or sleeping. The authors used the PubMed, Physiotherapy Evidence Database, Cochrane Library, Embase, Web of Science, Scopus, Osteopathic Medicine Digital Database, and Google Scholar databases from inception to 11 November 2022.

The methodological quality of the randomized control trials ranged from fair to high. The authors focused on five studies with 422 babies using the following interventions: cranial, visceral, or structural osteopathy or chiropractic manipulation or mobilization. These treatments failed to decrease the crying time (mean difference -1.08, 95% CI -2.17 to 0.01, I2 = 92%) and to increase the sleeping time (mean difference 1.11, 95% CI -0.20 to 2.41; I2: 91%), compared with no intervention. The quality of the evidence was rated as very low for both outcome measures.The authors concluded that osteopathy and chiropractic treatment failed to reduce the crying time and increase sleeping time in babies with infantile colic, compared to no additional intervention.The 5 included studies were the following:

  • Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: A pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012;35(8):600–7.
  • Castejón-Castejón M, Murcia-González MA, Todri J, Lena O, Chillón-Martínez R. Treatment of infant colic with craniosacral therapy. A randomized controlled trial. Complement Ther Med. 2022;71(February 2021).
  • Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001;84(2):138–41.
  • Holm LV, Jarbøl DE, Christensen HW, Søndergaard J, Hestbæk L. The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial. Chiropr Man Ther. 2021;29(1):1–11.
  • Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract. 2006;12(2):83–90.

This means that, in recent years, several new studies have emerged. I find this surprising: there is no plausible mechanism of action and the previous reviews were negative.

Why flog a dead horse?

But – come to think of it – this is a question one might ask about most of the research into cranial, visceral, or structural osteopathy or chiropractic manipulation or mobilization.

It is not only practitioners of so-called alternative medicine (SCAM) who can be fraudulent charlatans. The study of medicine does not protect you from joining in. Here is an impressive case in point:

It has been reported that a former doctor convicted of fraudulently submitting nearly $120 million in claims related to the 1-800-GET-THIN Lap-Band surgery business has been sentenced to seven years in federal prison.

Julian Omidi, 58, of West Hollywood was sentenced Monday by U.S. District Court Judge Dolly M. Gee. The judge also imposed a five-year probation period on Surgery Center Management LLC, an Omidi-controlled Beverly Hills-based company. In the coming weeks, Gee is expected to hold a separate hearing to decide on restitution and forfeiture in the case, along with setting a fine for the Beverly Hills company.

The 1-800-GET-THIN billboards once dominated the Los Angeles landscape with claims of a one-hour procedure and an easy insurance verification process. But a federal jury in December 2021 found that the business was a criminal scheme that bilked millions from several insurance providers, including the Tricare healthcare program for military service members.

“Mr. Omidi made millions at the expense of the multiple victim companies he defrauded, and he violated his oath to ‘do no harm’ by callously misleading patients about the need for a sleep study and subsequent weight loss surgery,” said Donald Alway, the assistant director in charge of the FBI’s Los Angeles field office.

Omidi controlled several entities in the GET-THIN network. Prosecutors say Omidi incentivized employees to ensure patients underwent sleep studies and then falsified the results to show that patients had obstructive sleep apnea to help them qualify for insurance coverage for the weight loss surgery. Those results were then filed with insurance companies to pre-approve the Lap-Band weight-loss surgeries. The 1-800-GET-THIN business received approximately $41 million for those procedures, according to prosecutors. While not all patients were approved to receive the surgery, prosecutors say GET-THIN would bill the patient roughly $15,000 for each sleep study, totaling $27 million in payments from insurance providers.

Omidi and his Beverly Hills-based company, Surgery Center Management, were found guilty of 28 counts of wire fraud, three counts of mail fraud, and one count of conspiracy to commit money laundering. Omidi was also found guilty of two counts of making false statements relating to healthcare matters, one count of aggravated identity theft, and two counts of money laundering after a 48-day trial in downtown Los Angeles.

“As found by the jury, the defendant Julian Omidi deliberately and repeatedly acted with an eye towards business and profits, rather than in the interest of GET-THIN’s medical patients, by inducing patients to undergo medical treatment premised on fraud rather than medical necessity, including surgeries that carry significant risks and life-long health impacts,” said U.S. Atty. Martin Estrada. A series of Los Angeles Times columns from 2010 to 2014 detailed how five patients died after they received Lap-Band surgeries at clinics affiliated with 1-800-GET-THIN. During a 2009 inspection, the Department of Health and Human Services found unsanitary conditions, inoperative scrub sinks, one-time-only equipment being reused, and several other deficiencies. The inspector shut down the clinic for a day, but further action was not taken at the time.

Omidi’s medical license was revoked in 2009, and he was arrested. In 2014, federal agencies seized more than $110 million from the 1-800-GET-THIN network in securities and funds.

______________________________

This is a spectacular case, of course. Yet, I fail to see how it differs in principle from the many instances we see on a daily basis in the realm of SCAM. Let me give you just a few examples:

  • A chiropractor diagnoses subluxation and subsequently treats his patient with a series of spinal manipulations.
  • A naturopath uses iridology to diagnose a weakness of the liver and subsequently treats it with herbal remedies.
  • An acupuncturist diagnoses a blockage of chi and follows it up with a series of acupuncture sessions.
  • A Heilpraktiker employs bioresonance to diagnose an intoxication which he then treats with a detox program.

The strategy is always the same:

  1. Charlatans use bogus diagnostic methods.
  2. They make bogus diagnoses with them.
  3. They then start expensive and often dangerous treatments.
  4. They make good money by defrauding the system.

Could someone please explain what the difference in principle is between the case of the fraudulent surgeon and the average SCAM practitioner?

Social media platforms are frequently used by the general public to access health information, including information relating to complementary and alternative medicine (CAM). The aim of this study was to measure how often naturopathic influencers make evidence-informed recommendations on Instagram, and to examine associations between the level of evidence available or presented, and user engagement.

A retrospective observational study using quantitative content analysis on health-related claims made by naturopathic influencers with 30 000 or more followers on Instagram was conducted. Linear regression was used to measure the association between health-related posts and the number of Likes, and Comments.

A total of 494 health claims were extracted from eight Instagram accounts, of which 242 (49.0%) were supported by evidence and 34 (6.9%) included a link to evidence supporting the claim. Three naturopathic influencers did not provide any evidence to support the health claims they made on Instagram. Posts with links to evidence had fewer Likes (B=-1343.9, 95% CI=-2424.4 to -263.4, X=-0.1, P=0.02) and fewer Comments (B=-82.0, 95% CI=-145.9 to -18.2, X=-0.2, P=0.01), compared to posts without links to evidence. The most common areas of health were claims relating to ‘women’s health’ (n=94; 19.0%), and ‘hair, nail, and skin’ (n=74; 15.0%).

The authors concluded that this study is one of the first to look at the evidence available to support health-related claims by naturopathic influencers on Instagram. Our findings indicate that around half of Instagram posts from popular naturopathic influencers with health claims are supported by high-quality evidence.

At first sight, these findings amazed me; I would have thought that the percentage of supported claims was lower. As it turned out, I was not far off: in the paper, the authors differentiate the results into more categories and state that ” of those with evidence clearly available, approximately 10% of health claims were underpinned by high-quality evidence such as systematic reviews of randomised controlled trials.”

Even though interesting, the study has significant limitations. The authors are well aware of them and explain:

A key limitation was relying on the 10 most relevant retrieved articles in PubMed, rather than conducting an extensive search for evidence, when not provided alongside the claim. It is possible we did not identify existing evidence to support some of the claims; however, it would not have been feasible to construct a comprehensive search strategy and screen articles for every health claim made. Our search strategy served as a proxy measure for the evidence to support the claim and it is unlikely that the 10 most relevant articles on PubMed would systematically fail to identify existing supporting evidence.

The risk of subjectivity in the extraction of interventional health claims from Instagram posts and conversion into a PICO is another limitation. The subjectivity of data extraction was minimised using standards which included extracting specific terms used by the naturopathic influencer to perform database searches on PubMed. If not explicitly stated, the intended target audience of the health claims were made using educated guesses based on the intervention and outcome promoted in the claim. For the claim to be considered supported by evidence, study participants must match the intended audience of the health claim on Instagram(e.g., postmenopausal women, athletes). When the study with the highest level of evidence were inconclusive due to reasons such as inadequate cohort size, conflicting results for different cohort (e.g., male vs. females), heterogeneity between studies and poor quality of studies, it was concluded that the evidence did not support the health claim. When there was considerable uncertainty related to the health intervention or outcome, it was excluded from the study.

So, in the end, I guess, it boils down to whether you are an optimist or a pessimist:

About half of the claims made by prominent naturopaths are supported by at least a bit of evidence.

About half of the claims made by prominent naturopaths are not supported by evidence.

I came across an article entitled “Consent for Paediatric Chiropractic Treatment (Ages 0-16)“. Naturally, it interested me. Here is the full paper; I have only inserted a few numbers in square brackets which refer to my comments below:

By law, all Chiropractors are required to inform you of the risks and benefits of chiropractic spinal manipulation and the other types of care we provide. Chiropractors use manual therapy alongside taking a thorough history, and doing a neurological, orthopaedic and chiropractic examination to both diagnose and to treat spinal, cranial and extremity dysfunction.  This may include taking joints to the end range of function, palpating soft tissues (including inside the mouth and the abdomen), mobilisation, soft tissue therapy and very gentle manipulation [1]. Our Chiropractors have been educated to perform highly specific types of bony or soft tissue manipulation and we strive to follow a system of evidence-based care [2].  At the core of our belief system is “Do No Harm”. We recognise that infants and children are not tiny adults.  The force of an adjustment used in a child is at least less than half of what we might use with a fully grown adult.  Studies by Hawk et al (2016) and Marchand (2013) agreed that Chiropractors use 15 – 35 x less force in the under 3-month age group when compared to medical practitioners doing manipulation (Koch, 2002) [3].  We also use less force in all other paediatrics groups, especially when compared to adults (Marchand, 2013). In addition to using lower force, depth, amplitude and speed in our chiropractic adjustments [4], we utilise different techniques. We expect all children under the age of 16 years to be accompanied by a responsible adult during appointments unless prior permission to treat without a consenting adult e.g., over the age of 14 has been discussed with the treating chiropractor.

Risks

  • Research into chiropractic care for children in the past 70 years has shown it to have a low risk of adverse effects (Miller, 2019) [5]. These effects tend to be mild and of short duration e.g., muscular or ligament irritation. Vorhra et al (2007) found the risk of severe of adverse effects (e.g. fracture, quadriplegia, paraplegia, and death) is very, very rare and was more likely to occur in individuals where there is already serious underlying pathology and missed diagnosis by other medical profession [6].  These particular cases occurred more than 25 years ago and is practically unheard of now since research and evidence-based care has become the norm [7].
  • The most common side effect in infants following chiropractic treatment includes fussiness or irritability for the first 24 hours, and sleeping longer than usual or more soundly. (Miller and Benfield, 2008) [8]
  • In older children, especially if presenting with pain e.g., in the neck or lower back, the greatest risk is that this pain may increase during examination due to increasing the length of involved muscles or ligaments [9]. Similarly, the child may also experience pain, stiffness or irritability after treatment (Miller & Benfield, 2008) [10].  Occasionally children may experience a headache.[11] We find that children experience side effects much less often than adults.[12]

Benefits

  • Your child might get better with chiropractic care. [13] If they don’t, we will refer you on [14].
  • Low risk of side effects and very rare risk of serious adverse effects [15].
  • Drug-free health care. We are not against medication, but we do not prescribe [16].
  • Compared with a medical practitioner, manual therapy carried out by a chiropractor is 20 x less likely to result in injury (Koch et al 2002, Miller 2009).[17]
  • Children do not often require long courses of treatment (>3 weeks) unless complicating factors are present.[18]
  • Studies have shown that parents have a high satisfaction rate with Chiropractic care [19].
  • Physical therapies are much less likely to interfere with biomedical treatments. (McCann & Newell 2006) [20]
  • You will have a better understanding of diagnosis of any complain and we will let you know what you can do to help.[21]

We invite you to have open discussions and communication with your treating chiropractor at all times.  Should you need any further clarification please just ask.

References

  • Hawk, C. Shneider, M.J., Vallone, S and Hewitt, E.G. (2016) – Best practises recommendations for chiropractic care of children: A consensus update. JMPT, 39 (3), 158-168.
  • Marchand, A. (2013) – A Proposed model with possible implications for safety and technique adaptations for chiropractic spinal manipulative therapy for infants and children.   JMPT, 5, 1-14
  • Koch L. E., Koch, H, Graumann-Brunnt, S. Stolle, D. Ramirez, J.M., & Saternus, K.S. (2002) – Heart rate changes in response to mild mechanical irritation of the high cervical cord region in infants. Forensic Science International, 128, 168-176
  • Miller J (2019) – Evidence-Based Chiropractic Care for Infants: Rational, Therapies and Outcomes. Chapter 11: Safety of Chiropractic care for Infants p111. Praeclarus Press
  • Vohra, S. Johnston, B.C. Cramer, K, Humphreys, K. (2007) – Adverse events associated with paediatric spinal manipulation: A Systematic Review. Pediatrics, 119 (1) e275-283
  • Miller, J and Benfield (2008) – Adverse effects of spinal manipulative therapy in children younger than 3 years: a retrospective study in a chiropractic teaching clinic. JMPT Jul-Aug;31(6):419-23.
  • McCann, L.J. & Newell, S.J. (2006). Survey of paediatric complementary and alternative medicine in health and chronic disease. Archives of Diseases of Childhood, 91, 173-174
  • Corso, M.,  Cancelliere, C. ,  Mior., Taylor-Vaise, A.   Côté, P. (2020) – The safety of spinal manipulative therapy in children under 10 years: a rapid review. Chiropractic Manual therapy 25: 12

___________________________________

  1.  “taking joints to the end range of function” (range of motion, more likely) is arguably not “very gently”;
  2.  “we strive to follow a system of evidence-based care”; I do not think that this is possible because pediatric chiropractic care is hardy evidence-based;
  3.  as a generalizable statement, this seems to be not true;
  4.  ” lower force, depth, amplitude and speed”; I am not sure that there is good evidence for that;
  5.  research has foremost shown that there might be significant under-reporting;
  6.  to blame the medical profession for diagnoses missed by chiropractors seems odd;
  7.  possibly because of under-reporting;
  8.  possibly because of under-reporting;
  9.  possibly because of under-reporting;
  10.  possibly because of under-reporting;
  11.  possibly because of under-reporting;
  12.  your impressions are not evidence;
  13. your child might get even better without chiropractic care;
  14. referral rates of chiropractors tend to be low;
  15. possibly because of under-reporting;
  16. chiropractors have no prescription rights but some lobby hard for it;
  17. irrelevant if we consider the intervention useless and thus obsolete;
  18. any evidence for this statement?;
  19. satisfaction rates are no substitute for real evidence;
  20. that does not mean they are effective, safe, or value for money;
  21. this is perhaps the strangest statement of them all – do chiropractors think they are the optimal diagnosticians for all complaints?

_____________________________________

According to its title, the paper was supposed to deal with consent for chiropractic pediatric care. It almost totally avoided the subject and certainly did not list the information chiropractors must give to parents before commencing treatment.

Considering the arguments that the article did provide has brought me to the conclusion that chiropractors who treat children are out of touch with reality and seem in danger of committing child abuse.

The claim that homeopathy has a role in oncology does not seem to go away. Some enthusiasts say it can be used as a causal therapy, while others insist it might be a helpful symptomatic adjuvant. Almost all oncologists agree that homeopathy has no place at all in cancer care.

Who is right?

This systematic review included clinical studies from 1800 until 2020 to evaluate evidence of the effectiveness of homeopathy on physical and mental conditions in patients during oncological treatment.

In February 2021 a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find studies concerning use, effectiveness, and potential harm of homeopathy in cancer patients.

From all 1352 search results, 18 studies with 2016 patients were included in this SR. The patients treated with homeopathy were mainly diagnosed with breast cancer. The therapy concepts included single and combination homeopathic remedies (used systemically or as mouth rinses) of various dilutions. The outcomes assessed were:

  • the influence on toxicity of cancer treatment (mostly hot flashes and menopausal symptoms),
  • the time to drain removal in breast cancer patients after mastectomy,
  • survival,
  • quality of life,
  • global health,
  • subjective well-being,
  • anxiety and depression,
  • safety and tolerance.

The included studies reported heterogeneous results: some studies described significant differences in quality of life or toxicity of cancer treatment favoring homeopathy, whereas others did not find an effect or reported significant differences to the disadvantage of homeopathy or side effects caused by homeopathy. The majority of the studies had low methodological quality.

The authors concluded that, the results for the effectiveness of homeopathy in cancer patients are heterogeneous, mostly not significant and fail to show an advantage of homeopathy over other active or passive comparison groups. No evidence can be provided that homeopathy exceeds the placebo effect. Furthermore, the majority of the included studies shows numerous and severe methodological weaknesses leading to a high level of bias and are consequently hardly reliable. Therefore, based on the findings of this SR, no evidence for positive effectiveness of homeopathy can be verified.

This could not be clearer. Some might argue that, of course, homeopathy cannot change the natural history of cancer, but it might improve the quality of life of those patients who believe in it via a placebo response. I would still oppose this notion: there are many effective treatments in the supportive treatment of cancer, and it seems much better to use those options and tell patients the truth about homeopathy.

This meta-analysis aimed “to provide better evidence of the efficacy of manual therapy (MT) on adolescent idiopathic scoliosis (AIS)”.

All RCTs of MT for the management of patients with AIS were included in the present study. The treatment difference between the experimental and control group was mainly MT. The outcomes consisted of the total effective rate, the Cobb angle, and Scoliosis Research Society-22 (SRS-22) questionnaire score. Electronic database searches were conducted from database inception to July 2022, including the Cochrane Library, PubMed, Web of Science, Embase, Wanfang Data, CNKI, and VIP. The pooled data were analyzed using RevMan 5.4 software.

Four RCTs with 213 patients in the experimental groups were finally included. There are 2 studies of standalone MT in the experimental group and 3 studies of MT with identical conservative treatments in the control group. Three trials reported the total effective rate and a statistically significant difference was found (P = 0.004). Three trials reported Cobb angle; a statistical difference was found (P = 0.01). Then, sensitivity analysis showed that there was a significant difference in the additional MT subgroup (P < 0.00001) while not in the standalone MT subgroup (P = 0.41). Three trials reported SRS-22 scores (P = 0.55) without significant differences.

The authors concluded that there is insufficient data to determine the effectiveness of spinal manipulation limited by the very low quality of included studies. High-quality studies with appropriate design and follow-up periods are warranted to determine if MT may be beneficial as an adjunct therapy for AIS. Currently, there is no evidence to support spinal manipulation.

The treatment of idiopathic scoliosis depends on the age, curve size, and progression of the condition. Therapeutic options include observation, bracing, physiotherapy, and surgery. They do NOT include MT because it is neither a plausible nor effective solution to this problem. It follows that further studies are not warranted and should be discouraged.

And, even if you disagree with me here and feel that further studies might be justified, let me remind you that proper research is never aimed at providing better evidence that a therapy works (as the authors of this odd paper seem to think); it must be aimed at testing whether it is effective!

Austrian doctors recently received a notice in their mailbox about a postgraduate training event that is remarkable, to say the least.

The Vienna Medical Association is organizing a postgraduate training course on “Complementary Medical Homeopathy for Post- and Long Covid“. The date for the event is 20.4.2023. Registration for it is via the Association’s “Department of Complementary and Integrative Medicine”.

In case you ask, what is wrong with such a course? There is no scientific evidence that homeopathy has a specific, positive effect in long/post covid. Therefore the announced event has about the same validity as a lecture series for:

  • BUNGEE JUMPING FOR DIABETES

or

  • DOUGHNUT EATING FOR CORONARY HEART DISEASE

or

  • CIGARETTE SMOKING IN CANCER PREVENTION

While relevant pseudomedicine training courses have in the past been organized by the relevant Austrian SCAM-organizations, the Vienna Medical Association itself is now joining the ranks of the organizers of pseudomedicine training courses. Whereas pseudomedicine has so far been the domain of physicians in private practice in Austria, it now appears to be promoted by the Vienna Medical Association in hospitals as well.

The Vienna Medical Association boldly claims that MEDICAL ETHICS IS THE BASIS OF OUR WORK. Well guess what, guys: teaching nonsense is not very ethical!

The ‘tasks and goals’ of the Association’s  ‘Department for Complementary and Integrative Medicine’ of the Vienna Medical Association are explained on their website:

The aim of our department is to represent doctors with additional diplomas in the medical association and to inform about the value of their special therapeutic approaches better than previously – particularly in cases of serious side effects of conventional therapies.

In the sense of conveying up-to-date, high-quality, medical, and complementary education and training in complementary medicine, our department aims to publish relevant articles and announcements of dates of the respective professional societies in the chamber’s own media.

Practice-oriented introductory lectures or study groups on the following topics are also planned topics:

  • medical homeopathy,
  • psychosomatic relaxation therapy (bipolar harmonising abdominal breathing, autogenic training),
  • acupuncture,
  • regulation therapy based on skin resistance measurements at acupuncture points,
  • TCM,
  • herbal therapy, etc.

“Up-to-date, high-quality, medical, and complementary education and training in complementary medicine” – oh really? If the Association’s “Department of Complementary and Integrative Medicine” is truly interested in this, I herewith offer to give a free lecture series for them that would teach them the high-quality evidence truly shows.

Meanwhile, as there is no good evidence that homeopathy is an effective therapy for post/long Covid, the question of whether the ‘Vienna Medical Association’ has taken leave of its senses, must be answered in the affirmative.

I am pleased to announce that our regular contributors ‘DC‘ as well as ‘mimi‘ both correctly guessed the person responsible for the quote about informed consent that was the subject of yesterday’s post. Congratulations to both; that certainly wasn’t easy!

The quote is by Karl Brandt.

Who was Karl Brandt?

Brandt was a young and evidently gifted doctor when, during a series of coincidences, he became a member of Hitler’s ‘inner circle’ and acted as one of Hitler’s personal physicians (originally, he had wanted to join the team of Albert Schweitzer!). Hitler liked the good-looking, ambitious Brandt and thus gave him greater and greater responsibilities and power. Amongst other things, Brandt managed to become in charge of the German euthanasia program which killed about 70 000 patients who the Nazis considered to be ‘useless eaters’ and unworthy of their support. It had the cynical purpose of freeing up hospital beds for the war and cleansing the German gene pool. Brandt also was responsible for many of the unspeakably cruel and immoral medical experiments in the concentration camps.

After the war, Brandt was put on trial in Nuremberg. The trial became known as the ‘Doctors’ Trail‘. Twenty of the 23 defendants were medical doctors (Viktor BrackRudolf Brandt, and Wolfram Sievers were Nazi officials). They were accused of having been involved in Nazi human experimentation and mass murder under the guise of euthanasia. Brandt insisted that he had never done anything wrong, had followed orders, and had been guided by the highest morals, solid medical ethics, and his determination to do the very best for the German people.

During his interrogations, he stated the sentences that fascinated me when I first read it: ” On the one hand, there are experiments that are carried out for or with someone on a voluntary basis; on the other hand, there are those that take place against the will of the person concerned. A further subdivision indicates whether they are particularly dangerous or comparatively harmless and without any potential for danger. A further distinction must be made as to whether the result of the experiment is important or whether it is merely a ridiculous game played by a scientifically educated person. These six criteria form a kind of guideline that enables one to say YES or NO from a medical point of view.”

The quote is cited in the book by Ulf Schmidt which is extremely well-researched and worth reading for anyone with an interest in the subject. In my view, it gives a unique insight into the thinking of someone who clearly was bright yet power-hungry, scrupulous and deeply immoral:

  • experiments “against the will of the person concerned” always were unlawful, immoral, and unethical according to the guidelines that existed at the time;
  • “particularly dangerous” experiments should have never been considered;
  • research that is merely a “ridiculous game played by a scientifically educated person” is pseudoscience and not ethical.

Brandt tried to present himself as the ‘honest’, upright Nazi who did what he did because of a deep conviction and because he wanted the best. He seemed to have fooled others and possibly even himself. Several influential personalities rallied to his support. Yet, the judges at Nuremberg did neither believe his version of events nor were they inclined to pardon his behavior. Brandt was found guilty of:

  • War crimes: performing medical experiments, without the subjects’ consent, on prisoners of war and civilians of occupied countries, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts. Also planning and performing the mass murder of prisoners of war and civilians of occupied countries, stigmatized as aged, insane, incurably ill, deformed, and so on, by gas, lethal injections, and diverse other means in nursing homes, hospitals, and asylums during the Euthanasia Program and participating in the mass murder of concentration camp inmates;
  • Crimes against humanity: committing crimes also on German nationals;
  • Membership in a criminal organization, the SS. The charges against him included special responsibility for, and participation in, Freezing, MalariaLOST GasSulfanilamide, Bone, Muscle and Nerve Regeneration and Bone Transplantation, Sea-Water, Epidemic Jaundice, Sterilization, and Typhus Experiments.

Brandt was executed on 2 June 1948.

The discussions around informed consent at the Nuremberg ‘doctors trial’ brought this subject into a renewed focus and eventually led to the formulation of the now famous ‘Nuremberg Code‘.

A German newspaper reported the experience of two journalists who went undercover to consult several practitioners of so-called alternative medicine to receive treatment for Hodgkin lymphoma. Here are several passages from their important article (my translation, my bolding)

… Doctor Uwe Reuter invites us in. He is sitting behind an iMac on which he sometimes shows me pictures of his therapies. He is around 50, tall and lean, his face looks particularly serious through frameless glasses. I tell him my story. He listens attentively, and then it seems for a while as if he can’t decide what to advise me. Finally, he has it: I should first do a “diagnostic series” in his clinic, three or even better five days, for about 1000 Euros. This would include “electromagnetic measurements” for the “energy balance of individual organs”. Only then can he determine which therapy might be indicated in my case. “Hypnosis, homeopathy, vitamin B17 infusions” will probably play a role, says Reuter, and a “fever therapy” in which I will be injected with dead bacteria.

“In addition to chemotherapy or alone?”, I ask. The doctor says he can’t make this decision for me, I should make it from my “inside”. I have to understand that my illness does not come from the outside and that therapies only have a supporting effect – the healing “has to come from within”.

… In the end, Reuter suggests postponing chemotherapy for a quarter of a year and using his therapy to “push aside everything that prevents healing” – toxins, distractions, and fears. The cost? Around 10,000 Euros for the entire therapy…

[Next doctor is] the well-known alternative doctor Klaus Maar in Düsseldorf…  His wrinkled face is dominated by a large nose, his hair is enviably thick and black for a man of his age. “Well,” he says in his comforting voice, “why don’t you describe what happened to you?” I am nervous. Will he believe that I am terminally ill? I stammer and tell my story. He listens to me, looks at me, answers calmly, and takes his time – and attention that few orthodox doctors can afford today, which is one of the reasons that drive people into the arms of alternative healers.

Finally, Maar advises a “heat therapy” in which the tumor is heated locally. Yet Klaus Maar is still one of the more serious healers. He does not directly advise against chemotherapy, but warns about the side effects. In the end, he recommends postponing it for a fortnight and starting the 8,000-euro heat treatment as soon as possible. “But don’t delay, don’t blame me and say I delayed the chemotherapy,” Maar says. I guess that’s his way of hedging his bets: If he were to successfully dissuade me from chemotherapy, my family could sue him one day. I come across such phrases again and again.

… next visit; the alternative practitioner Ursula Stoll specializes in “Germanic New Medicine”. Ryke Geerd Hamer, a former doctor, founded this doctrine in the early 1980s as a reaction to “Jewish” orthodox medicine. No wonder it enjoys great popularity in völkisch circles. Hamer’s abstruse and dangerous theories led to the withdrawal of his license. He continued to practice illegally, however, and several of his patients died… Even Ursula Stoll thinks he was crazy – but not his theory…  Stoll practices in Öhringen, an idyllic little town north of Stuttgart, in her nondescript detached house. She wears a white shirt and horn-rimmed glasses, her brown hair pinned back in a plait, an accurate governess with a stern look.

As I tell her about my suffering, she quickly interrupts me: “What is cancer?” she asks. We have to get rid of the term. There is no such thing as cancer. All I have is a swelling of the lymph nodes in my neck. That’s all. The cause: a self-deprecation of a professional nature. In my case, there is also an existential fear, and like a fish on land, I store water in my body in order to survive. Hence the swollen lymph nodes. Metastases? There are none. The medical report? She skims over it casually and asks: Did you sweat when you were sick? Did the sweat smell? Did it have a color? Where exactly was the itch?

I tell her about the lecture I gave and that my boss didn’t like. Yes! That could be the reason for the cancer. She says my symptoms are a reaction to this slight, my body is trying to heal itself, but the first chemotherapy interrupted and disrupted the process. Her advice to beat the cancer: I should move back in with my parents, life as a single person is too much for me, Berlin is a terrible city anyway… I ask again about chemotherapy. “I personally wouldn’t do it,” she says, “and for my children and my parents I would decide the same.” There it is again, this nappy-soft formulation with which the healers evade their legal responsibility. One more question: isn’t it dangerous to forego chemotherapy? The alternative practitioner Ursula Stoll: “Humans can withstand a lot.”

… Since the spiritual healers Wolfgang Bittscheidt and Teresa Schuhl were favorably discussed on German TV, their practice in Siegburg near Bonn has enjoyed great popularity: appointments are made only months in advance. When we are asked into the treatment room, it is dark, the blinds are half closed. A candle burns on the dark wooden desk. Teresa Schuhl is blond, has blue eyes, and seems cool and aloof, gesticulating strangely with her hands. She whispers more than she speaks; I have to lean forward to understand her. Her advice? “If you were my son right now, I would say, hands off chemo!” For herself, she would decide the same. “One possibility is vitamin B17. Have you heard of it?”

I have heard of it. The so-called vitamin B17 is in fact not a vitamin at all, but a toxic substance, related to prussic acid. It is currently experiencing a boom in the alternative scene and has no proven benefit for cancer. Several people have died from overdoses.

Schuhl is now poking around in my spiritual life and in the relationship between me and my parents. She also suspects a trauma behind my cancer. “The thyroid represents the hormonal. The balance between male and female. Do you know where you belong? Male or female?” What is she trying to say?

“I come from Tajikistan,” he says, “where they say: sickness is a sacred time. When you are sick, God talks to you. He tells you what life really is. What we live is not life, it’s shit. Sickness asks us to make a change.” He continues, “Death is the most beautiful thing there is. Like a trip to the Caribbean. Why are we afraid of it? On this tortured planet here?”

After this introduction, my head is spinning, but now the actual treatment begins. I lie down on a couch. Schuhl runs her hands over my stomach and holds my shoulder. At the same time, she says prayers. She changes into the extinct Aramaic that is sometimes used in Christian services. Then she leaves me alone. Later, her partner, a licensed doctor, recommends that I read up on vitamin B17, come to them once a month and light a candle in a church in Cologne. I walk out of the practice befuddled…

The practitioners protect themselves legally. They make the patients sign contracts stating that the patient has been informed about orthodox medicine and that they reject it willy-nilly, even though the information is often not worth mentioning. What would be the solution?

… The doctor Achim Schuppert in Bonn suspects mobile phone radiation as the cause of my tumor and wants to measure my magnetic aura. It was important to him to “exclude electrosmog as a possible damaging factor”, he writes later.

Lothar Hollerbach, who runs an alternative practice in a Heidelberg city villa, gives a philosophical lecture: “We are spiritual beings and only for a short time in a mobile home we call a body.” Every crisis is a lesson, he says, but perhaps that lesson is for the next life. One of the things he recommends to me for recovery is Rudolf Steiner‘s lectures. How many patients has he successfully treated? He doesn’t count them, Hollerbach waves off. And after all, it’s not just about surviving. Some of his patients could have led a totally different life “in the next incarnation”. For those who long for death – his practice is highly recommended…

… The “medical director” Elke Tegel, a blonde alternative practitioner, leads me through the bright house, shows me the “inner world travel room” where traumatic situations are processed, the room for “healing music“, and also the impressive machine for “high-frequency therapy“, in which electrical energy is supplied to the cells. Costs: 13670 Euros for five weeks.

Cancer, says the alternative practitioner, is “suppressed anger and suppressed resentment”; Hodgkin’s lymphoma in particular is about guilt. She asks: “Where do you feel guilty? Guilty of being a man?” Later she advises a “biological chemotherapy” of highly concentrated vitamin C. This, she says, is far superior to conventional chemo. She confuses my well-treatable Hodgkin’s lymphoma with the fundamentally different non-Hodgkin’s lymphoma. And justifies herself: “With us, it’s not about diagnosis, that’s not of interest.” …

________________________

What I like about this report is that they exposed both doctors and non-medically trained practitioners, i.e. Heilpraktiker. We see yet again that the study of medicine does not protect people from becoming dangerous charlatans. Yet, there are important differences between doctors and Heilpraktiker:

  1. Only a very small proportion of doctors would treat Hodgkin lymphoma with ineffective quackery, whereas the proportion with Heilpraktiker would, I guess, be not far from 100%.
  2. Doctors will get struck off for such behavior, whereas this happens to Heilpraktiker as good as never.

 

 

 

Sure, the LP is dangerous nonsense, but this begs the question of whether so-called alternative medicine (SCAM) has anything to offer for patients suffering from ME/CFS. If the LP story tells us anything, then it must be this: we should not trust single trials, particularly if they seem dodgy. In other words, we should look at systematic reviews that synthesize ALL clinical trials and evaluate them critically.

To locate this type of evidence I conducted several Medline searches and found several recent systematic reviews that address the issue:

Systematic review (2001)

Context: A variety of interventions have been used in the treatment and management of chronic fatigue syndrome (CFS). Currently, debate exists among health care professionals and patients about appropriate strategies for management.

Objective: To assess the effectiveness of all interventions that have been evaluated for use in the treatment or management of CFS in adults or children.

Data sources: Nineteen specialist databases were searched from inception to either January or July 2000 for published or unpublished studies in any language. The search was updated through October 2000 using PubMed. Other sources included scanning citations, Internet searching, contacting experts, and online requests for articles.

Study selection: Controlled trials (randomized or nonrandomized) that evaluated interventions in patients diagnosed as having CFS according to any criteria were included. Study inclusion was assessed independently by 2 reviewers. Of 350 studies initially identified, 44 met inclusion criteria, including 36 randomized controlled trials and 8 controlled trials.

Data extraction: Data extraction was conducted by 1 reviewer and checked by a second. Validity assessment was carried out by 2 reviewers with disagreements resolved by consensus. A qualitative synthesis was carried out and studies were grouped according to type of intervention and outcomes assessed.

Data synthesis: The number of participants included in each trial ranged from 12 to 326, with a total of 2801 participants included in the 44 trials combined. Across the studies, 38 different outcomes were evaluated using about 130 different scales or types of measurement. Studies were grouped into 6 different categories. In the behavioral category, graded exercise therapy and cognitive behavioral therapy showed positive results and also scored highly on the validity assessment. In the immunological category, both immunoglobulin and hydrocortisone showed some limited effects but, overall, the evidence was inconclusive. There was insufficient evidence about effectiveness in the other 4 categories (pharmacological, supplements, complementary/alternative, and other interventions).

Conclusions: Overall, the interventions demonstrated mixed results in terms of effectiveness. All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies. Interventions which have shown promising results include cognitive behavioral therapy and graded exercise therapy. Further research into these and other treatments is required using standardized outcome measures.

Systematic review (2011)

Introduction: Chronic fatigue syndrome (CFS) affects between 0.006% and 3% of the population depending on the criteria of definition used, with women being at higher risk than men.

Methods and outcomes: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for chronic fatigue syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results: We found 46 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antidepressants, cognitive behavioural therapy (CBT), corticosteroids, dietary supplements, evening primrose oil, galantamine, graded exercise therapy, homeopathy, immunotherapy, intramuscular magnesium, oral nicotinamide adenine dinucleotide, and prolonged rest.

Systematic review (2011)

Background: Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population.

Methods: Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded.

Results: A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium.

Conclusions: The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.

Systematic review (2014)

Background: There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China.

Objective: To evaluate the effectiveness and safety of TCM for CFS.

Methods: The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results.

Results: 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder’s fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell’s fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events.

Conclusions: TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.

Systematic review (2017)

Background: As the etiology of chronic fatigue syndrome (CFS) is unclear and the treatment is still a big issue. There exists a wide range of literature about acupuncture and moxibustion (AM) for CFS in traditional Chinese medicine (TCM). But there are certain doubts as well in the effectiveness of its treatment due to the lack of a comprehensive and evidence-based medical proof to dispel the misgivings. Current study evaluated systematically the effectiveness of acupuncture and moxibustion treatments on CFS, and clarified the difference among them and Chinese herbal medicine, western medicine and sham-acupuncture.

Methods: We comprehensively reviewed literature including PubMed, EMBASE, Cochrane library, CBM (Chinese Biomedical Literature Database) and CNKI (China National Knowledge Infrastructure) up to May 2016, for RCT clinical research on CFS treated by acupuncture and moxibustion. Traditional direct meta-analysis was adopted to analyze the difference between AM and other treatments. Analysis was performed based on the treatment in experiment and control groups. Network meta-analysis was adopted to make comprehensive comparisons between any two kinds of treatments. The primary outcome was total effective rate, while relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.

Results: A total of 31 randomized controlled trials (RCTs) were enrolled in analyses. In traditional direct meta-analysis, we found that in comparison to Chinese herbal medicine, CbAM (combined acupuncture and moxibustion, which meant two or more types of acupuncture and moxibustion were adopted) had a higher total effective rate (RR (95% CI), 1.17 (1.09 ~ 1.25)). Compared with Chinese herbal medicine, western medicine and sham-acupuncture, SAM (single acupuncture or single moxibustion) had a higher total effective rate, with RR (95% CI) of 1.22 (1.14 ~ 1.30), 1.51 (1.31-1.74), 5.90 (3.64-9.56). In addition, compared with SAM, CbAM had a higher total effective rate (RR (95% CI), 1.23 (1.12 ~ 1.36)). In network meta-analyses, similar results were recorded. Subsequently, we ranked all treatments from high to low effective rate and the order was CbAM, SAM, Chinese herbal medicine, western medicine and sham-acupuncture.

Conclusions: In the treatment of CFS, CbAM and SAM may have better effect than other treatments. However, the included trials have relatively poor quality, hence high quality studies are needed to confirm our finding.

Systematic review (2022)

Objectives: This meta-analysis aimed to assess the effectiveness and safety of Chinese herbal medicine (CHM) in treating chronic fatigue syndrome (CFS). Methods: Nine electronic databases were searched from inception to May 2022. Two reviewers screened studies, extracted the data, and assessed the risk of bias independently. The meta-analysis was performed using the Stata 12.0 software. Results: Eighty-four RCTs that explored the efficacy of 69 kinds of Chinese herbal formulas with various dosage forms (decoction, granule, oral liquid, pill, ointment, capsule, and herbal porridge), involving 6,944 participants were identified. This meta-analysis showed that the application of CHM for CFS can decrease Fatigue Scale scores (WMD: -1.77; 95%CI: -1.96 to -1.57; p < 0.001), Fatigue Assessment Instrument scores (WMD: -15.75; 95%CI: -26.89 to -4.61; p < 0.01), Self-Rating Scale of mental state scores (WMD: -9.72; 95%CI:-12.26 to -7.18; p < 0.001), Self-Rating Anxiety Scale scores (WMD: -7.07; 95%CI: -9.96 to -4.19; p < 0.001), Self-Rating Depression Scale scores (WMD: -5.45; 95%CI: -6.82 to -4.08; p < 0.001), and clinical symptom scores (WMD: -5.37; 95%CI: -6.13 to -4.60; p < 0.001) and improve IGA (WMD: 0.30; 95%CI: 0.20-0.41; p < 0.001), IGG (WMD: 1.74; 95%CI: 0.87-2.62; p < 0.001), IGM (WMD: 0.21; 95%CI: 0.14-0.29; p < 0.001), and the effective rate (RR = 1.41; 95%CI: 1.33-1.49; p < 0.001). However, natural killer cell levels did not change significantly. The included studies did not report any serious adverse events. In addition, the methodology quality of the included RCTs was generally not high. Conclusion: Our study showed that CHM seems to be effective and safe in the treatment of CFS. However, given the poor quality of reports from these studies, the results should be interpreted cautiously. More international multi-centered, double-blinded, well-designed, randomized controlled trials are needed in future research.

What does all that tell us?

Disappointingly, it tells me that SCAM has preciously little to offer for ME/CFS patients.

But what about the TCM treatments? Aren’t the above reviews quite positive TCM?

Yes, they are but I nevertheless recommend taking them with a healthy pinch of salt.

Why?

Because we have seen many times before that, for a range of reasons, Chinese researchers of TCM draw false positive conclusions. That may sound unfair, harsh, or even racist, but I think it’s true. If you disagree, please show me a couple of systematic reviews of TCM for any human disease by Chinese researchers that have drawn negative conclusions.

And what is my advice to patients suffering from ME/CSF?

I think the best I can offer is this: be very cautious about the many claims made by SCAM enthusiasts; if it sounds too good to be true, it probably is!

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

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

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

Archives
Categories