MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

fraud

We have repeatedly discussed the journal ‘Evidence-Based Complementary and Alternative Medicine’ (see for instance here and here). The journal has recently done something remarkable and seemingly laudable: it retracted an article titled “Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A Prospective Clinical Study” due to concerns about the ethics, authorship, quality of reporting, and misleading conclusions.***

Aradeep and Ashim Chatterjee own and manage the Critical Cancer Management Research Centre and Clinic (CCMRCC), the private clinic to which they are affiliated. The methods state “The study protocol was approved by the Institutional Review Board (IRB approval Number: 2001–05) of the CCMRCC” in 2001, but a 2014 review of Psorinum therapy said CCMRCC was founded in 2008. The study states “The participants received the drug Psorinum along with allopathic and homeopathic supportive treatments without trying conventional or any other investigational cancer treatments”; withholding conventional cancer treatment raises ethical concerns.

We asked the authors and their institutions for documentation of the ethics approval, the study protocol, and a blank copy of the informed consent form. However, the corresponding author, Aradeep Chatterjee, was reported to have been arrested in June 2017 for allegedly practising medicine without the correct qualifications and his co-author and father Ashim Chatterjee was reported to have been arrested in August; the Chatterjees and their legal representative did not respond to our queries. The co-authors Syamsundar Mandal, Sudin Bhattacharya, and Bishnu Mukhopadhyay said they did not agree to be authors of the article and were not aware of its submission; co-author Jaydip Biswas did not respond.

A member of the editorial board noted that although the discussion stated that “The limitation of this study is that it did not have any placebo or treatment control arm; therefore, it cannot be concluded that Psorinum Therapy is effective in improving the survival and the quality of life of the participants due to the academic rigours of the scientific clinical trials”, the abstract was misleading because it implied Psorinum therapy is effective in cancer treatment. The study design was described as a “prospective observational clinical trial”, but it cannot have been both observational and a clinical trial.

(*** while I wrote this blog (13/3/18) the abstract of this paper was still available on Medline without a retraction notice)

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In case you wonder what ‘psorinum therapy’ is, this website explains:

A cancer specialist and Psorinum clinical researcher, Aurodeep Chaterjee, believes Psorinum Therapy is less time consuming and more economical for treatment of cancer. ‘The advantage of this treatment is that the patient can continue this treatment while staying home and the hospitalization is less required,’ said Chaterjee. He added that it’s an immunotherapy treatment in which the medicine is in liquid form and the technique of consumption is oral.

Though no chemo or radiation sessions are required in it but they can be used parallel to it depending upon the stage of the cancer. He claimed that more than 30 types of cancers could be treated from this therapy. Some of them include gastrointestinal cancer, liver cancer, gall bladder cancer, ovarian cancer, stomach cancer, etc. The process requires two months duration in which the patient has to undergo 12 cycles and the cost is just Rs 5000. Moli Rapoor 55, software engineer from USA who is suffering from ovarian cancer said on Thursday (June 20) that after three chemo cycles when her cancer did not cure after being diagnosed in 2008, she decided to take up Psorinum therapy.

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I am sorry, but the retraction of such a paper is far less laudable than it seems – it should not have been retracted, but it should have never been published in the first place. There are multiple points where the reviewers’ and editors’ alarm bells should have started ringing loud and clear. Take, for instance, this note at the end of the paper:

Funding

Dr. Rabindranath Chatterjee Memorial Cancer Trust provided funding for this study.

Conflict of Interests

The authors declare that they have no conflict of interests.

I think that this should have been a give-away, considering the names of the authors: Chatterjee A1, Biswas J, Chatterjee A, Bhattacharya S, Mukhopadhyay B, Mandal S.

What this story shows, in my view, is that the journal ‘Evidence-Based Complementary and Alternative Medicine’ (EBCAM) operates an unacceptably poor system of peer-review, and is led by an editor who seems to shut both eyes when deciding about publication or rejection. And why would an editor shut his/her eyes to abuse? Perhaps the journal’s interesting business model provides an explanation? Here is what I wrote about it previously:

What I fail to understand is why so many researchers send their papers to this journal. In 2015, EBCAM published just under 1000 (983 to be exact) papers. This is not far from half of all Medline-listed articles on alternative medicine (2056 in total).

To appreciate these figures – and this is where it gets not just puzzling but intriguing, in my view – we need to know that EBCAM charges a publication fee of US$ 2500. That means the journal has an income of about US$ 2 500 000 per annum!

END OF QUOTE

To put it in a nutshell: in healthcare, fraud and greed can cause enormous harm.

The ‘best homeopathy doctor in Delhi‘  is so ‘marvellous’ that he and his colleagues offer homeopathic treatment for HIV/AIDS:

START OF QUOTE

Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350.  Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.

At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.

END OF QUOTE

When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.

It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:

1st paper

Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.

Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.

This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.

2nd paper (I am a co-author of this one)

The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.

3rd paper (author is our old friend Dana Ullman!)

Homeopathic medicine developed significant popularity in the nineteenth century in the United States and Europe as a result of its successes treating the infectious disease epidemics during that era. Homeopathic medicine is a medical system that is specifically oriented to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune and defense system rather than directly attacking the microbial agents.

To review the literature referenced in MEDLINE and in nonindexed homeopathic journals for placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different theoretical and methodological approach to treating people with the viral infection.

A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy homeopathic treatment was provided. A separate body of preliminary research was conducted using homeopathic doses of growth factors. Two randomized double-blinded, placebo-controlled studies were conducted with a total of 77 people with AIDS who used only natural therapies over a 8-16-week period. Two other studies were conducted over a 2.5-year period with 27 subjects in an open-label format.

The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, with the approval of the Ministry of Health and Family Welfare, Government of India. The second body of studies was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.

The first study found no statistically significant improvement in CD4 T-lymphocytes, but did find statistically significant pretest and post-test results in subjects with stage III AIDS, in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads.

As a result of the growing number of people with drug-resistant HIV infection taking structured treatment interruptions, homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy.

4th paper

In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.

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So, what does this collective evidence tell us?

I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.

Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine. Take for instance this recently published trial of homeopathy.

The objective of this study was to investigate the usefulness of classical homeopathy for the prevention of recurrent urinary tract infections (UTI) in patients with spinal cord injury (SCI). Patients were admitted to this trial, if they had chronic SCI and had previously suffered from at least three UTI/year. They were treated either with a standardized prophylaxis alone, or with a standardized prophylaxis in combination with homeopathy. The number of UTIs, general and specific quality of life (QoL), and satisfaction with homeopathic treatment were assessed prospectively over the period of one year. Ten patients were in the control group and 25 patients received adjunctive homeopathic treatment. The median number of self-reported UTI in the homeopathy group decreased significantly, whereas it remained unchanged in the control group. The domain incontinence impact of the KHQ improved significantly, whereas the general QoL did not change. The satisfaction with homeopathic care was high.

The authors concluded that adjunctive homeopathic treatment lead to a significant decrease of UTI in SCI patients. Therefore, classical homeopathy could be considered in SCI patients with recurrent UTI.

Where to begin?

Here are just some of the most obvious flaws of and concerns with this study:

  1. There is no plausible rationale to even plan such a study.
  2. The sample size was far too small for allowing generalizable conclusions.
  3. There was no adequate randomisation and patients were able to chose the homeopathy option.
  4. The study seems to lack objective outcome measures.
  5. The study design did not allow to control for non-specific effects; therefore, it seems likely that the observed outcomes are unrelated to the homeopathic treatments but are caused by placebo and other non-specific effects.
  6. Even if the study had been rigorous, we would need independent replications before we draw such definitive conclusions.
  7. Two of the authors are homeopaths, and it is in their clinics that the study took place.
  8. Some of the authors have previously published a very similar paper – except that this ‘case series’ included no control group at all.
  9. The latter paper seems to have been published more than once.
  10. Of this paper, one of the authors claimed that ” the usefulness of classical homeopathy as an adjunctive measure for UTI prophylaxis in patients with NLUTD due to SCI has been demonstrated in a case series”. He seems to be unaware of the fact that a case series cannot possible lend itself to demonstrate this.
  11. I do wonder: did they just add a control group to their case series thus pretending it became a controlled clinical trial?

What strikes me most with such pseudo-research is its abundance and the naivety – or should I call it ignorance? – of the enthusiasts who conduct it. Most of them, I am fairly sure do not mean to do harm; but by Jove they do!

 

Yesterday, I saw a Tweet stating:

Homeopath in Cornwall specialising in Women’s Health #fertility #naturalconception #pcos #pms

It was followed by a list of specific indications:

  • Pregnancy
  • Infertility
  • PCOS
  • PMS
  • Fibroids
  • Depression
  • Anxiety and much more…

I responded to this Tweet by tweeting:

Homeopath in Cornwall specialising in misleading women

Minutes later I received a response from a homeopathy-fan:

That could be called libel Edzard. I would be careful.

So, should I be careful, and if so why?

Reading the thinly veiled threat, I wasn’t exactly shaking in my boots with fear (I was deeply involved in helping Simon Singh in his defence against the BCA’s libel action), but I nevertheless wanted to be sure of my position and conducted some ‘rough and ready’ searches for recent evidence to suggesting that homeopathy is effective for any of the conditions mentioned above. Here is what I found:

  • Pregnancy. Yes, there is an RCT! It concluded that “homeopathy does not appear to prevent excessive body mass gain in pregnant women…” And another one concluding that “neither Pentazocine, or Chamomilla recutita offer substantial analgesia during labor.”
  • Infertility. No RCT or other sound evidence.
  • PCOS. Nothing
  • PMS. No clinical trials.
  • Fibroids. No clinical trials
  • Depression. Even leading homeopaths seem to agree that there is no good evidence.
  • Anxiety. Again, I could not find any sound evidence.

Don’t get me wrong, these statements are not based on full systematic reviews; that would take a while and hardly seems worth it. (If you want a good systematic review, I recommend this one; it concluded: “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.“) But my quick glance at the evidence is enough, I think, to justify my statement that the above claims by a homeopath are misleading. In fact, I believe that I could have used much stronger terminology without the slightest risk of being sued.

PERHAPS NEXT TIME!

Yesterday, a press-release about our new book has been distributed by our publisher. As I hope than many regular readers of my blog might want to read this book – if you don’t want to buy it, please get it via your library – I decided to re-publish the press-release here:

Governments must legislate to regulate and restrict the sale of complementary and alternative therapies, conclude authors of new book More Harm Than Good.

Heidelberg, 20 February 2018

Commercial organisations selling lethal weapons or addictive substances clearly exploit customers, damage third parties and undermine genuine autonomy. Purveyors of complementary and alternative medicine (CAM) do too, argue authors Edzard Ernst and Kevin Smith.

The only downside to regulating such a controversial industry is that regulation could confer upon it an undeserved stamp of respectability and approval. At best, it can ensure the competent delivery of therapies that are inherently incompetent.

This is just one of the ethical dilemmas at the heart of the book. In all areas of healthcare, consumers are entitled to expect essential elements of medical ethics to be upheld. These include access to competent, appropriately-trained practitioners who base treatment decisions on evidence from robust scientific research. Such requirements are frequently neglected, ignored or wilfully violated in CAM.

“We would argue that a competent healthcare professional should be defined as one who practices or recommends plausible therapies that are supported by robust evidence,” says bioethicist Kevin Smith.

“Regrettably, the reality is that many CAM proponents allow themselves to be deluded as to the efficacy or safety of their chosen therapy, thus putting at risk the health of those who heed their advice or receive their treatment,” he says.

Therapies covered include homeopathy, acupuncture, chiropractic, iridology, Reiki, crystal healing, naturopathy, intercessory prayer, wet cupping, Bach flower therapy, Ukrain and craniosacral therapy. Their inappropriate use can not only raises false hope and inflicts financial hardship on consumers, but can also be dangerous; either through direct harm or because patients fail to receive more effective treatment. For example, advice given by homeopaths to diabetic patients has the potential to kill them; and when anthroposophic doctors advise against vaccination, they can be held responsible for measles outbreaks.

There are even ethical concerns to subjecting such therapies to clinical research. In mainstream medical research, a convincing database from pre-clinical research is accumulated before patients are experimented upon. However, this is mostly not possible with CAM. Pre-scientific forms of medicine have been used since time immemorial, but their persistence alone does not make them credible or effective. Some are based on notions so deeply implausible that accepting them is tantamount to believing in magic.

“Dogma and ideology, not rationality and evidence, are the drivers of CAM practice,” says Professor Edzard Ernst.

Edzard Ernst, Kevin Smith
More Harm than Good?
1st ed. 2018, XXV, 223 p.
Softcover $22.99, €19,99, £15.99 ISBN 978-3-319-69940-0
Also available as an eBook ISBN 978-3-319-69941-7

END OF PRESS RELEASE

As I already stated above, I hope you will read our new book. It offers something that has, I think, not been attempted before: it critically evaluates many aspects of alternative medicine by holding them to the ethical standards of medicine. Previously, we have often been asking WHERE IS THE EVIDENCE FOR THIS OR THAT CLAIM? In our book, we ask different questions: IS THIS OR THAT ASPECT OF ALTERNATIVE MEDICINE ETHICAL? Of course, the evidence question does come into this too, but our approach in this book is much broader.

The conclusions we draw are often surprising, sometimes even provocative.

Well, you will see for yourself (I hope).

Sipjeondaebo-tang is an East Asian herbal supplement containing Angelica root (Angelicae Gigantis Radix), the rhizome of Cnidium officinale Makino (Cnidii Rhizoma), Radix Paeoniae, Rehmannia glutinosa root (Rehmanniae Radix Preparata), Ginseng root (Ginseng Radix Alba), Atractylodes lancea root (Atractylodis Rhizoma Alba), the dried sclerotia of Poria cocos (Poria cocos Sclerotium), Licorice root (Glycyrrhizae Radix), Astragalus root (Astragali Radix), and the dried bark of Cinnamomum verum (Cinnamomi Cortex).

But does this herbal mixture actually work? Korean researchers wanted to find out.

The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.

The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.

From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.

Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!

As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.

This level of scientific misconduct is remarkable, even for the notoriously poor 

I strongly suggest that:

  1. The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
  2. The paper is withdrawn because it can only mislead vulnerable patients.

Difficulties breastfeeding?

Some say that Chinese herbal medicine offers a solution.

This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.

At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.

The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.

To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:

  • All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
  • The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
  • The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
  • As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
  • There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
  • Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.

I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.

It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics:  CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or flawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…

We probably all heard about the horrific stories related to Larry Nassar who, on January 24, 2018, was sentenced to 40 to 175 years in a Michigan state prison after pleading guilty to the sexual assault of numerous minors and US gymnasts. But few of us, I think, had any idea that these stories also relate to alternative medicine. This is an excerpt from an article in the LOS ANGELES TIMES.

… McKayla Maroney, the Olympic gold medalist who says she was paid $1.25 million by the United States Olympic Committee and USA Gymnastics to stop her from speaking out, put it flatly: “Dr. Nassar was not a doctor.”

No wonder the survivors chose to crush that word. “Doctor” was Nassar’s supreme and founding lie. It notarized him as a professional pledged to heal, and launched his 20-year child-molestation spree, gaining him a sturdy disguise, a complicity network, access to victims and a savage sense of entitlement.

What allowed Nasser to use the honorific? In 1993, he received a doctorate in osteopathic medicine from Michigan State University. MSU, of course, went on to protect and pay Nassar, the almighty and trusted doctor, as a faculty member for 20 years. Lou Anna Simon, MSU’s president, resigned this week amid charges that the university covered for Nassar and enabled him. USA Gymnastics, where Nassar also passed as a doctor, is similarly accused of giving safe harbor to a known criminal, while hushing and deceiving his victims. Under pressure, the group announced this week that the entire USAG board would resign.

Osteopathic medicine focuses on the joints, muscles and spine. Historically, though, osteopathy — its original name — was closely associated with a set of esoteric massage styles that some researchers now consider ineffective or worse. For its part, MSU’s College of Osteopathic Medicine still teaches these unusual manipulations — a special “benefit” unique to osteopathic medicine — describing them as a form of “hands-on diagnosis and treatment.”

Some historical context: Andrew Taylor Still, the founder of osteopathy, wrote of his medical discoveries in 1897: “I could twist a man one way and cure flux … shake a child and stop scarlet fever … cure whooping cough in three days by a wring of the child’s neck.”

Modern osteopathic medicine uses none of these techniques to treat infections — or anything else. But the specter of violence and child abuse that Still conjured in his early writings continues to haunt the fringes of osteopathic medicine. These practices include intravaginal manipulation. Fisting. This was the “medical procedure” Nassar performed on so many young girls.

According to his victims, Nassar’s attention wasn’t on their hamstrings or ACLs; instead, he focused on their anuses, breasts and vaginas. In January 2017, one victim spelled it out in her complaint: “Nassar digitally penetrated Plaintiff Jane A. Doe’s vagina multiple times without prior notice and without gloves or lubricant.” Other victims describe Nassar’s forcing his “dry fingers” into their anuses and vaginas. The violent fisting was excruciating. “I’d want to scream,” said Kassie Powell, an MSU pole vaulter. As Amy Labadie, a gymnast, put it: “My vagina was sore during my competition because of this man.”

Then came the gaslighting. When the girls blew the whistle, Nassar and his enablers tirelessly reasserted his privileges as a doctor. “We were manipulated into believing that Mr. Nassar was healing us as any normal doctor is supposed to do,” Capua testified. Just last year, the American Osteopathic Assn. released a statement to MLive.com, the Michigan news service, saying that intravaginal manipulations are indeed an approved, if rare, osteopathic treatment for pelvic pain…

END OF EXCERPT

I feel sick and am speechless.

But before my detractors point it out: yes, such monserous transgressions do occur in conventional healthcare too. And no, I am not implying that all osteopaths are criminal perverts.

Brace yourself: the wonders of homeopathy seem to be without limits. You can even increase the height of your children with homeopathy!

This website explains in some detail:

SBL Rite-Hite Tablets growth promoter homeopathic medicine is indicated for children who do not grow or develop satisfactorily, suffer feeble digestion & imperfect assimilation, anemia, lack of concentration, poor memory. A clinically proven homeopathy research product from SBL that aids proper physical development of growing children to gain proper body size in terms of height and girth

SBL’s Rite-Hite is a homeopathic medicine for height increase in children. It is a clinically established proven formulation which contains well balanced homeopathic medicines. Rite-Hite helps to achieve the optimal balance of factors like genetics, hormonal balance, nutritional status and general health and thereby promotes optimal growth…

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Blooume16 GRO T Drops. Homeopathy grow tall medicine-Buy online
Wheezal WL14 Grow Tall drops – Homeopathy height increase medicine

Action of individual Ingredients in Rite-Hite:
Baryta carbonica: For children who are mentally and physically backward, do not grow and develop swollen abdomen, loss of memory.
Silicea: For imperfect assimilation and consequent defective nutrition. Children who are slow walking.
Natrum Muriaticum: Great emaciation; losing flesh while eating well. Anaemia

Calcarea Phosphorica: For anemic children who are peevish with feeble digestion, it is excellent for tardy dentition troubles and promote growth of healthy bones. It also covers abdominal flatulence in children, mild inflammation of tonsils, colic or soreness around navel, diarrhea with undigested food in stools.

END OF QUOTES

In my view this is plain and obvious child abuse (I don’t need to go into showing that none of the claims are plausible/evidence-based because it is painfully obvious). Some of the clinical scenarios are indicative of a severely sick child, for instance:

  • mentally and physically backward, do not grow and develop swollen abdomen, loss of memory;
  • anaemic children who are peevish with feeble digestion;
  • losing flesh while eating well, anaemia.

To not take such children to a doctor or hospital and instead lose valuable time with homeopathy is criminal neglect and unethical abuse. No question about that!

I can only hope that no parent will ever fall for it.

Recently, I was asked about the ‘Dorn Method’. In alternative medicine, it sometimes seems that everyone who manages to write his family name correctly has inaugurated his very own therapy. It is therefore a tall order to aim at blogging about them all. But that’s been my goal all along, and after more than 1 000 posts, I am still far from achieving it.

So, what is the Dorn Method?

A website dedicated to it provides some first-hand information. Here are a few extracts (numbers in brackets were inserted by me and refer to my comments below):

START OF QUOTE

Developed by Dieter Dorn in the 1970’s in the South of Germany, it is now fast becoming the widest used therapy for Back Pain and many Spinal Disorders in Germany (1).

The Dorn Method ist presented under different names like Dornmethod, Dorntherapy, Dorn Spinal Therapy, Dorn-Breuss Method, Dorn-XXname-method and (should) have as ‘core’ the same basic principles.

There are many supporters of the Dorn Method (2) but also Critics (see: Dorn controversy) and because it is a free (3) Method and therefore not bound to clear defined rules and regulations, this issue will not change so quickly.

The Method is featured in numerous books and medical expositions (4), taught to medical students in some universities (5), covered by most private medical insurances (6) and more and more recognized in general (7).

However because it is fairly new and not developed by a Medical Professional it is often still considered an alternative Healing Method and it is meant to stay FREE of becoming a registered trademark, following the wish of the Founder Dieter Dorn (†2011) who did NOT execute his sole right to register this Method as the founder, this Method must become socalled Folk Medicine.

As of now only licensed Therapists, Non Medical Practitioners (in Germany called Heilpraktiker (Healing Practitioners with Government recognition) (8), Physical Therapists or Medical Doctors are authorized to practice with government license, but luckily the Dorn Method is mainly a True Self Help Method therefore all other Dorn Method Practitioners can legally help others by sharing it in this way (9).

What conditions can be treated with the Dorn Method? Every disease, even up to the psychological domain can be treated (positively influenced) unless an illness had already led to irreversible damages at organs (10). The main areas of application are: Muscle-Skeletal Disorders (incl. Back Pain, Sciatica, Scoliosis, Joint-Pain, Muscular Tensions, Migraines etc.)

END OF QUOTE

My brief comments:

  1. This is a gross exaggeration.
  2. Clearly another exaggeration.
  3. Not ‘free’ in the sense of costing nothing, surely!
  4. Yet another exaggeration.
  5. I very much doubt that.
  6. I also have difficulties believing this statement.
  7. I see no evidence for this.
  8. We have repeatedly discussed the Heilpraktiker on this blog, see for instance here, here and here.
  9. Sorry, but I fail to understand the meaning of this statement.
  10. I am always sceptical of claims of this nature.

By now, we all are keen to know what evidence there might be to suggest that the Dorn Method works. The website of the Dorn Method claims that there are 4 different strands of evidence:

START OF QUOTE

1. A new form of manual therapy and self help method which is basically unknown in conventional medicine until now, with absolutely revolutionary new knowledge. It concerns for example the manual adjustment of a difference in length of legs as a consequence of a combination of subluxation of the hip-joint (subluxation=partly luxated=misaligned) and a subluxation of the joints of sacrum (Ilio-sacral joint) and possible knee and ankle joints. The longer leg is considered the ‘problem’-leg and Not the shorter leg as believed in classical medicine and chiropractic.

2. The osteopathic knowledge that there is a connection of each vertebra and its appropriate  spinal segment to certain inner organs. That means that when there are damages at these structures, disturbances of organic functions are the consequence, which again are the base for the arising of diseases.

3. The knowledge of the Chinese medicine, especially of acupuncture and meridian science that the organic functions are stirred and leveled, also among each other, via the vegetative nervous system

4. The natural-scientific  knowledge of anatomy, physiology, physics, chemistry and other domains.

END OF QUOTE

One does not need to be a master in critical thinking to realise that these 4 strands amount to precisely NOTHING in terms of evidence for the Dorn Method. I therefore conducted several searches and have to report that, to the best of my knowledge, there is not a jot of evidence to suggest that the Dorm Method is more than hocus-pocus.

In case you wonder what actually happens when a patient – unaware of this lack of evidence – consults a clinician using the Dorn Method, the above website provides us with some interesting details:

START OF QUOTE

First the patients leg length is controlled and if necessary corrected in a laying position. The hip joint is brought to a (more or less) 90 degree position and the leg is then brought back to its straight position while guiding the bones back into its original place with gentle pressure.

picture link to dorn therapy pictures

This can be done by the patient and it is absolutely safe, easy and painless!

The treatment of Knees and Ankles should then follow with the same principals: Gentle pressure towards the Joint while moving it from a bended to a more straight position.

After the legs the pelvis is checked for misalignment and also corrected if necessary in standing position.

Followed by the lumbar vertebrae and lower thoracic columns, also while standing upright.

Then the upper thoracic vertebrae are checked, corrected if necessary, and finally the cervical vertebrae, usually in a sitting position.

The treatment often is continued by the controlling and correction of other joints like the shoulders, elbow, hands and others like the jaw or collarbone.

END OF QUOTE

Even if we disregard the poor English used throughout the text, we cannot possibly escape the conclusion that the Dorn Method is pure nonsense. So, why do some practitioners practice it?

The answer to this question is, of course, simple: There is money in it!

“Average fees for Dorn Therapy sessions range from about 40€ to 100€ or more…  Average fees for Dorn Method Seminars range from about 180€ to 400€ in most developed countries for a two day basic or review or advanced training.”

SAY NO MORE!

 

 

 

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