MD, PhD, FMedSci, FSB, FRCP, FRCPEd

quackery

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The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”

This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.

The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).

As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:

Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.

The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.

In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.

The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, thisthis, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.

“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”

We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.

Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.

There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!

Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…

Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”

My question is short and simple: IGNORANCE OR FRAUD?

 

Yes, yes, yes, I know: we have too few women in our ‘ALT MED HALL OF FAME’. This is not because I have anything against them (quite the contrary) but, in alternative medicine research, the boys by far outnumber the girls, I am afraid.

You do remember, of course, you has previously been admitted to this austere club of excellence; only two women so far. Here is the current list of members to remind you:

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

If you study the list carefully, you will also notice that, until now, I have totally ignored the chiropractic profession. This is a truly embarrassing omission! When it comes to excellence in research, who could possibly bypass our friends, the chiropractors?

Today we are going to correct these mistakes. Specifically, we are going to increase the number of women by 50% (adding one more to the previous two) and, at the same time, admit a deserving chiropractor to the ALT MED HALL OF FAME.

Cheryl Hawk is currently the Executive Director of Northwest Center for Lifestyle and Functional Medicine, University of Western States, Portland, USA. Previously she worked as Director of Clinical Research at the Logan University College of Chiropractic, Chesterfield, USA, and prior to that she was employed at various other institutions. Since many years she has been a shining light of chiropractic research. She is certainly not ‘small fry’ when it comes to the promotion of chiropractic.

Cheryl seems to prefer surveys as a research tool over clinical trials, and it was therefore not always easy to identify those of her 67 Medline-listed articles that reported some kind of evaluation of the value of chiropractic. Here are, as always, the 10 most recent papers where I could extract something like a data-based conclusion (in bold) from the abstract.

Best Practices for Chiropractic Care of Children: A Consensus Update.

Hawk C, Schneider MJ, Vallone S, Hewitt EG.

J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):158-68

All of the seed statements in this best practices document achieved a high level of consensus and thus represent a general framework for what constitutes an evidence-based and reasonable approach to the chiropractic management of infants, children, and adolescents.

Clinical Practice Guideline: Chiropractic Care for Low Back Pain.

Globe G, Farabaugh RJ, Hawk C, Morris CE, Baker G, Whalen WM, Walters S, Kaeser M, Dehen M, Augat T.

J Manipulative Physiol Ther. 2016 Jan;39(1):1-22

The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.

The Role of Chiropractic Care in the Treatment of Dizziness or Balance Disorders: Analysis of National Health Interview Survey Data.

Ndetan H, Hawk C, Sekhon VK, Chiusano M.

J Evid Based Complementary Altern Med. 2016 Apr;21(2):138-42.

The odds ratio for perceiving being helped by a chiropractor was 4.36 (95% CI, 1.17-16.31) for respondents aged 65 years or older; 9.5 (95% CI, 7.92-11.40) for respondents reporting head or neck trauma; and 13.78 (95% CI, 5.59-33.99) for those reporting neurological or muscular conditions as the cause of their balance or dizziness.

US chiropractors’ attitudes, skills and use of evidence-based practice: A cross-sectional national survey.

Schneider MJ, Evans R, Haas M, Leach M, Hawk C, Long C, Cramer GD, Walters O, Vihstadt C, Terhorst L.

Chiropr Man Therap. 2015 May 4;23:16.

American chiropractors appear similar to chiropractors in other countries, and other health professionals regarding their favorable attitudes towards EBP, while expressing barriers related to EBP skills such as research relevance and lack of time. This suggests that the design of future EBP educational interventions should capitalize on the growing body of EBP implementation research developing in other health disciplines. This will likely include broadening the approach beyond a sole focus on EBP education, and taking a multilevel approach that also targets professional, organizational and health policy domains.

Chiropractic identity, role and future: a survey of North American chiropractic students.

Gliedt JA, Hawk C, Anderson M, Ahmad K, Bunn D, Cambron J, Gleberzon B, Hart J, Kizhakkeveettil A, Perle SM, Ramcharan M, Sullivan S, Zhang L.

Chiropr Man Therap. 2015 Feb 2;23(1):4

The chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.

Do informed consent documents for chiropractic clinical research studies meet readability level recommendations and contain required elements: a descriptive study.

Twist E, Lawrence DJ, Salsbury SA, Hawk C.

Chiropr Man Therap. 2014 Dec 10;22(1):40

These results strongly suggest that chiropractic clinical researchers are not developing ICDs at a readability level congruent with the national average acceptable level. The low number of elements in some of the informed consent documents raises concern that not all research participants were fully informed when given the informed consent, and it may suggest that some documents may not be in compliance with federal requirements. Risk varies among institutions and even within institutions for the same intervention.

Feasibility of using a standardized patient encounter for training chiropractic students in tobacco cessation counseling.

Hawk C, Kaeser MA, Beavers DV.

J Chiropr Educ. 2013 Fall;27(2):135-40.

This active learning exercise appeared to be a feasible way to introduce tobacco counseling into the curriculum.

Consensus process to develop a best-practice document on the role of chiropractic care in health promotion, disease prevention, and wellness.

Hawk C, Schneider M, Evans MW Jr, Redwood D.

J Manipulative Physiol Ther. 2012 Sep;35(7):556-67

This living document provides a general framework for an evidence-based approach to chiropractic wellness care.

Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey.

Ndetan H, Evans MW Jr, Hawk C, Walker C.

J Altern Complement Med. 2012 Apr;18(4):347-53.

C/OM is primarily used for back and neck pain, which is increasing in prevalence in children. Teens are more likely to use it than are younger children.

The role of chiropractic care in older adults.

Dougherty PE, Hawk C, Weiner DK, Gleberzon B, Andrew K, Killinger L.

Chiropr Man Therap. 2012 Feb 21;20(1):3.

Given the utilization of chiropractic services by the older adult, it is imperative that providers be familiar with the evidence for and the prudent use of different management strategies for older adults.

I am pleased to say that Prof Hawk gave me no problems at all; her case is clear: she is a champion of using research as a means for promoting chiropractic, has published many papers in this vein, clearly prefers the journals of chiropractic that nobody other than chiropractors ever access, and has an impeccable track record when it comes to avoiding negative conclusions which could harm chiropractic in any way.

Very well done indeed!

WELCOME, PROF HAWK, TO THE ‘ALT MED HALL OF FAME’.

 

You have to excuse me, if I keep coming back to this theme: so-called ‘alternative cancer cures’ are truly dangerous. I have tried to explain this already many times, for instance here, here and here. And it is by no means just alternative therapists who make a living of such quackery. Sadly qualified medical doctors are often involved as well. As to prove my point, here is a tragic story that broke yesterday:

Former Miss New Hampshire, Rachel Petz Dowd, lost her battle with cancer on Sunday 12 June 2016 — a battle she fought publicly through personal writings in a blog in hopes of helping others on a similar journey toward healing. The singer/songwriter and mother of three from Auburn died about a month after traveling to Mexico for an aggressive form of alternative cancer treatment. She turned 47 last week. Dowd was diagnosed with stage 2 triple negative breast cancer in May 2014. The diagnosis led her to create a blog called “Rachel’s Healing” to document what she hoped would be a journey back to health. “I hope my readers can gain something from my journey and that they find their own personal way to combat this disease impacting too many women today,” she wrote. Dowd used the blog to share her experiences with traditional and natural medicine during her cancer fight.

On 5/3/16 Mrs Dowd wrote on her blog: “Well after some careful consideration and looking at different clinics and hospitals we’ve made a decision. Will be going to the CMN Hospital on the Yuma, Arizona border*. For 28 days of treatments. It’s not a day clinic but a full hospital servicing over the past 30 years. There’s a special wing dedicated to alternative cancer care and the treatment list is impressive.  Many treatments that are not available in this country. We feel this would be the best course of care daily for 28 days and then at the end of the 4 weeks I intend my immune system to be back on-line. I will be doing a stem cell boost of my bone marrow the last week. I know of a women, Shannon Knight, from The Truth About Cancer documentary, who had stage 4 metastasized into locations of her bones and her lungs and she came out of there completely cured. Her oncologist said it was nothing short of a miracle, but she said no it was just clean hard work!  She said no it was just clean the hard, aggressive treatments that only attack cancer, boost and prime your immune system, become a whole, healthy being once again:) It is possible and I am planning on being one of the exceptions like Shannon!”

  • The hospital is across the US border in Mexico; it is run by medically qualified personnel.

The hospital [“CMN Hospital’s facility is only 14 blocks away once you cross the border to begin your alternative cancer treatment”] has a website where they tell a somewhat confusing story about their treatment plans; here is a short but telling excerpt:

CMN’s protocols are individualized and comprehensive. You will benefit from oxidative therapies, IV minerals selenium and bicarbonate IV vitamins such as vitamin B-17 and IV vitamin C. Far infrared and others including MAHT, Cold Laser Therapy, Hyperbaric Oxygen Therapy and Ozone Therapy are a daily part of your protocol. Ultraviolet Blood Irradiation is effective in destroying pathogens in your blood and slows the growth of cancer cell growth. CMN’s Stem cell therapy and Dendritic cell therapy are just two of the advanced cancer treatments applied to patients.”

And here is what they say about three therapies as examples of treatments that have discussed before on this blog: vitamin C, Laetrile and Essiac.

IV Vitamin C If large amounts of vitamin C are presented to cancer cells, large amounts will be absorbed. In these unusually large concentrations, the antioxidant vitamin C will start behaving as a pro-oxidant as it interacts with intracellular copper and iron. This chemical interaction produces small amounts of hydrogen peroxide. Because cancer cells are relatively low in an intracellular anti-oxidant enzyme called catalase, the high dose vitamin C induction of peroxide will continue to build up until it eventually lyses the cancer cell from the inside out!

IV Vitamin B17 / Laetrile Also known as amygdaline, Vitamin B-17 is a molecule made up of four parts: -2 parts Glucose -1 part Benzaldahyde-1 part Hydrogen Cyanide. Laetrile is found in at least 1200 different plants, including apricots, peaches, apple seeds, lentils, cashews, brown rice, millet, and alfalfa. Commercial preparations of laetrile are obtained from the kernels of apricots, peaches and bitter almonds. The body requires an enzyme called beta-glucosidase in order to process laetrile and release the cyanide. Studies have shown that cancer cells contain more of this enzyme than normal cells, which allows for a higher release of cyanide at tumor sites. Another enzyme known as rhodanese is important in this process. Normal healthy cells contain rhodanese which protects them from the activated cyanide. Most cancer cells are deficient in this enzyme, leaving them vulnerable to the poison. Tumor destruction begins once the cyanide is released within the malignancies, meaning laetrile therapy is selectively toxic to cancer cells while remaining non-toxic to normal cells.

Essiac Tea / Order Original Essiac Tea Essiac, given its name by Rene Caisse (“caisse” spelt backwards), consists of four main herbs that grow in the wilderness of Ontario, Canada. The original formula is believed to have its roots from the native Canadian Ojibway Indians. The four main herbs that make up Essiac are Burdock Root, Slippery Elm Inner Bark, Sheep Sorrel and Indian Rhubarb Root. Essiac tea helps release toxins that build up in fat and tissues into the blood stream where they can be filtered and excreted by the liver and kidneys.  Cleaning the body of toxins and impurities frees up the immune system to focus on killing cancer cells and protecting the body.

 

I think I will abstain from further comments, firstly because I want to avoid getting sued by these people and secondly because it seems all too depressingly obvious.

Britt Marie Hermes is a most remarkable woman. She is an ex-naturopath who has the courage to speak out against all that is wrong with naturopathy. On her website she writes:

I used to be a naturopathic doctor. For 3 years, I practiced naturopathic medicine, licensed in Washington and Arizona. I earned my degree at Bastyr University and then completed a one-year naturopathic residency in a private clinic. I stayed at this clinic until I moved to Tucson.

Naturopathic medicine is not what I was led to believe. I discovered that the profession functions as a system of indoctrination based on discredited ideas about health and medicine, full of anti-science rhetoric with many ineffective and dangerous practices.

I left the profession of naturopathic medicine to pursue an education in biomedical research. Since my departure, I have been working to understand my former biases within naturopathic medicine. I am now exploring the ethics and evidence, or lack thereof, of naturopathic education and practice. I hope I can convey the message that naturopathy must be highly scrutinized, as its proponents have a seemingly on-going history of deceit, exploitation, and medical fraud.

Her articles are a rich source of fascinating material about naturopathy, and I warmly recommend you read her criticisms; you will not find better-informed comments easily. Recently, she went one step further and started a petition against US naturopaths’ plight to call themselves ‘doctors’. It seems that this was one step too far for the mighty ‘BIG NATUROPATHY’.

Forbes Magazine reported that, on May 26th, 5 days after Hermes launched her petition, the AANP retaliated [the AANP is the leading naturopaths’ organization in the U.S., the American Association of Naturopathic Physicians]. The subject line of an email sent to all AANP membership:  “AANP Needs Your Help – Stop Britt’s Change.org Petition.”

“We need your help to stop this petition… This petition violates these [Change.org] policies:

  • Breaks the law – this is defamatory and libelous content
  • Impersonates others;  Britt Marie Hermes is not from the United States
  • Terms of service – does not abide by the law or respect the rights of others

Naturopaths found Britt Marie so threatening that they started a website entitled ‘BRITT MARIE HERMES FACT CHECK. Here they indulge in blatant character assassination:

Britt Marie Hermes Fact Check was established to provide an unbiased analysis of the claims that Britt Marie Hermes (Britt Marie Deegan) has made, and is making, about Naturopathic Medicine, its educational system, and its practitioners. For the past year she promoted herself as an expert on Naturopathic Medicine, having left the profession because of her unsuccessful time as a practitioner. It’s clear that she has an agenda against the profession while claiming to be an expert. She has consistently lied, and left out important facts when discussing aspects of the Naturopathic Medicine, its educational system and its practitioners. Accusations have been made that she is being paid by the pharmaceutical industry, although they haven’t been substantiated. What is clear, is that she was unsuccessful during her short time as a practitioner and now has an agenda against the profession.

This looks suspiciously like the dirt some alternative medicine fans have been throwing at me, I thought, and I asked Britt Marie (who I once had the pleasure of meeting in person) to comment – and she very kindly did:

I find it amusing to be accused of being an unsuccessful practitioner of naturopathic medicine. I graduated with high grades from Bastyr. I landed a highly competitive naturopathic residency. Had I remained in practice, I would currently be eligible to take the naturopathic pediatrics “board-certification” exam offered by the American Association of Naturopathic Pediatrics.

I was making decent money at my practices in Seattle and Tucson. By all accounts, I was a successful naturopathic doctor. My bosses at the Tucson clinic had even asked me if I were interested in becoming their business partner!

I walked away from my practice because my boss was committing a federal crime by importing and administering a non-FDA approved medication to his cancer patients. I decided to leave naturopathic medicine for good after a former president of the American Association of Naturopathic Physicians urged me not to report my boss’s criminal activity to the authorities.

These wounds still hurt. I lost dozens of friends. I lost eight years of my life. I lost my livelihood. The ND degree does not have any value in the academic community. It is a tarnish on my permanent record. It would have been in my financial interest to move to another practice and continue being a “successful” naturopath.

The problem with naturopaths is that they measure success by how much money one collects from patients, yet they fail to understand that naturopathic services are quackery. So by their logic, being a successful naturopath is dependent upon profiting by fooling patients and fooling oneself. If others want to describe me as an unsuccessful naturopath, then the term “success” has no useful meaning.

I am not employed to write about anything in particular about naturopathic medicine or with any particular tone. I am an independent blogger who wants to share my insights. I created my own opinions on naturopathic medicine by looking at the profession critically. This kind of task is fundamental to the scientific process that I only learned after leaving naturopathy and engaging with the academic community.

Naturopaths want to be recognized as primary care physicians in the U.S. and Canada. This is a big deal, and we all should be skeptical. This profession is claiming to have established a comprehensive medical education that trains competent medical practitioners, who somehow predominately rely upon unproven methods at best and debunked ones at worst.

Naturopaths essentially want to be allowed to take shortcuts in medical training. Instead of attending medical school, naturopaths attend naturopathic programs with low acceptance standards and faculty who are not qualified to teach medical topics. Instead of passing a standardized and peer-reviewed medical licensing exam, naturopaths have created their own secretive licensing exam that tests on homeopathy and other dubious treatments. What little real medical standards that seem to be tested on the exam have been botched, like the one question in which a child is gasping for air and the correct answer on how to treat is to give a homeopathic remedy.

Naturopaths have called me a liar, but have been unable to identify any specific fabrications. They say I am omitting facts and evidence, but they cannot show what information I allegedly missed. It seems that for naturopaths the only way to deal with legitimate criticism, is to undermine my integrity.

My blog harbors no hidden agenda. I write to prevent students from being duped into thinking they are being adequately trained as a primary care physicians in naturopathic programs. I write to protect patients from the poorly trained practitioners that these programs produce. I write because I have seen both worlds, and the naturopathic one is terrifying.

To this, I have nothing to add – except a big THANK YOU to Britt Marie for her courage, honesty and tenacity.

Seasonal allergic rhinitis (hay fever) is a common condition which can considerably reduce the quality of life of sufferers. Homeopathy is often advocated – but does it work?

A new study was meant to be an “assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting.”

The investigator performed a ‘clinical observational study’ of eight patients from his private practice using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and 4 weeks of individualized homeopathic treatment which was given as an add-on to conventional treatments.

The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and 4 weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively.

The author concluded as follows: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.

It is hard to name the things that are most offensively wrong here; the choice is too large. Let me just list three points:

  • The study design is not matched to the research question.
  • The implication that homeopathy had anything to do with the observed outcome is unwarranted.
  • The conclusion that the results might lend themselves to develop a pilot study is meaningless.

The question whether homeopathy is an effective therapy for hay fever has been tested before, even in RCTs. It seems therefore mysterious why one needs to revert to tiny observational studies in order to plan a pilot, and even less for an assessment of effectiveness.

There are few conditions which are more time-dependent than hay fever. Any attempt of testing the effectiveness of medical interventions without a control group seems therefore not just questionable but wasteful. Clinical studies absorb resources; even if the author was happy to waste his time, he should not assume that he can freely waste the time, effort and availability of his patients.

Two final points, if I may:

  • An observational study of homeopathy for hay-fever without a control group might be utterly useless but it is still an investigation that requires certain things. As far as I can see, this study did not even have ethics approval nor is there a mention of informed consent. Strictly speaking, this makes it an unethical study.
  • If we allow research of this nature to take place and be published, we give clinical research a bad name and undermine the confidence of the public in science.

I am puzzled how such a paper could pass peer review and how an Elsevier journal could even consider publishing it.

The question whether pharmacists should sell unproven alternative medicines will not go away. On this blog, we have discussed it repeatedly, for instance here, here and here. The Australian Journal of Pharmacy’s latest poll shows that readers have their suspicions about the validity of naturopathic medicines, with a whopping 544 voters choosing the option, “No, there’s no evidence they work” at the time of writing.

This constitutes 65% of readers who took part in the poll. A significant minority – 193 readers, with 23% of the vote – said that pharmacies should stock these medicines as they are legitimate products. Five per cent said that while they questioned their efficacy, pharmacy should stock them; and 3% said they were unsure, but the public wanted them.

Taree pharmacist and member of Friends in Science and Medicine Ian Carr, who has spoken to the AJP several times in the last couple of weeks as debate has continued about the subject of naturopathy in pharmacy, said he was surprised and pleased at the strength of the No vote. “I looked at [the poll] on the first day, and there was definitely a majority saying these things have no evidence, but there was still above 30% saying yes, they were legitimate products,” Carr told the AJP. “That’s been dwarfed by a lot of people who’ve looked in, and it’s interesting to have that many people vote. “I’m glad that it seems to be becoming recognised that there’s a need for the evidence base in these things, and the difference between having a naturopathic product or supplement on the shelf, and having somebody there charging for their time, as a naturopath, dispensing advice without knowing the patient’s background and without an intervention by a registered pharmacist.” He encouraged pharmacists concerned about the validity of naturopathy to consider what products and services they offer.

Where naturopaths are used, they should at least be expected to keep a record of products and advice dispensed, he says, similar to protocols around blood pressure and blood glucose monitoring. “If there’s going to be an insistence that naturopaths remain, that’s the way I’d like to see it: that the pharmacy has good records and oversight of what they’re doing. I think, given our connection to the PBS and the fact that we as pharmacists are looking for a more serious role as part of the health care team generally, and having a more active and integrative role, we would be silly to fritter it away on peripheries like naturopathy. I personally see the opportunities in evidence-based medicine and what flows from that, rather than trying to make up dollars. We’re more likely to lose control of pharmacy if we don’t guard it jealousy.”

One of the suppliers of CAM products to pharmacies responded to the article by stating the following:

“The complementary and alternative medicine (CAMs) sector and its role in healthcare management continues to be hotly debated by the media. Rather than dissuade this debate, we actively encourage this discussion, as it shines a light on many issues which need to be addressed. Of priority is the point that not all complementary and alternative medicine products are equal. As in many media articles, an incredibly wide spectrum of products are grouped under the label of ‘CAMs’. Products with specific clinical evidence, high-quality manufacturing processes and transparency on the sourcing of ingredients are not clearly identified from products without these qualities. Consumers and healthcare professionals are unable to distinguish this difference due to a lack of clear labelling. We agree with calls for CAMs products to be more thoroughly assessed, beyond being simply classified as ‘safe’. Healthcare professionals and consumers deserve this information and are indeed asking for it. Consumers are aware of the impact of their choices and that their demand drives industry change. History is littered with recent examples where consumer awareness has changed the marketplace for the better. Consumer-driven change in the CAMs industry IS possible, it just needs to be supported. The Australian CAMs industry needs to increase healthcare professional and consumer education on the importance of evidence-based CAM products; on what ‘evidence-based’ means and what this difference delivers… Healthcare professionals are key to helping their patients understand that not all CAMs or natural medicine products are equal… It takes time to change the way people see CAMs and natural medicines – but it is of inherent value for the consumer. Something, we believe, is integral to the future of the industry.”

The arguments are clearest, if we focus on a specific type of alternative medicine and spell out what precisely we are talking about. The one that comes to mind is, of course, homeopathy. In my view, there is no good reason why pharmacists should sell homeopathic remedies. It is comforting to know that the Chief Scientist of the UK Royal Pharmaceutical Society, Professor Jayne Lawrence, agrees; she stated about a year ago that “the public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”

And what has changed since?

Nothing, as far as I can see – but please correct me, if I am wrong.

I think it is important that we remind the community pharmacists everywhere that they have their very own codes of ethics and that they need to adhere to them. If they don’t, they tacitly agree that they are not really healthcare professionals but mere shop-keepers.

I have previously reported about the issue of homeopathy on the NHS in Liverpool here. Since then, the NHS Liverpool Clinical Commissioning Group (CCG) has conducted a consultation on whether to continue funding. Personally, I think such polls are a daft waste of resources.

Why?

I will explain in a moment; first read the (slightly shortened) summary:

In November 2015, NHS Liverpool CCG Governing Body stated a preference to decommission the homeopathy service and commenced the consultation exercise with the intent to ascertain how the public felt about it. This report was written by the Centre for Public Health, Liverpool John Moores University, and includes independent analysis of the consultation activities.

The consultation ran from 13th November – 22nd December 2015. The two main methods used were 1) a survey available online and in paper format. It was completed by 743 individual respondents and, of those who provided a valid postcode, 68% (323 individuals) lived within the Liverpool CCG area, 2) a small consultation event held on 4th December 2015 facilitated by Liverpool John Moores University. The event was attended by 29 individuals, the majority of whom were patients and staff from the Liverpool Medical Homeopathic Service. Eighteen of the participants at this event resided in Liverpool.

Two thirds of survey respondents (66%; 380 respondents) said they would never use homeopathy services in the future. The reasons for this included the lack of evidence and scientific basis of homeopathy; negative personal experiences of homeopathy; and believing it was an inappropriate use of NHS funding. Those who would be likely to use it in the future (28%) felt they wanted to be able to choose an alternative to conventional medicine; felt it was value for money for the NHS; appreciated the time, care and holistic consultation; and discussed their own positive experiences. Sixty six per cent of survey respondents (111) who had used homeopathy in the past reported an excellent or good experience. Those who reported a positive experience (66%) felt that homeopathy had improved their health where conventional medicine had not, and participants valued that the homeopathic practitioner had treated their emotional as well as their physical needs. Those who reported a below average or poor experience (31%) felt homeopathy had not improved their medical condition and some felt they had been misled and had not been told the remedy contained no active ingredients.

At the consultation event, the majority of the 29 participants were homeopathy service users and they described a positive experience of homeopathy and the ability to choose ‘holistic’ and non-pharmaceutical treatment. Participants also questioned what services they could use if they were unable to access homeopathy on the NHS and were concerned and angry about the service potentially being decommissioned. A small number of participants at this event agreed with the view that there is a lack of evidence regarding efficacy and felt it was an inappropriate use of NHS funds that would be better spent on other, more effective services.

Of the survey respondents, 73% (541 individuals) chose the option to stop funding all homeopathy services; when including only Liverpool residents in the analysis this decreased to 64%.  Twenty three per cent of survey respondents (170 individuals) wanted to continue to fund homeopathy services in Liverpool (either at current levels or to increase the budget); when only including Liverpool residents this proportion increased slightly to 30%. At the end of the consultation event the participants in the room (29 individuals) were asked to vote on their preferred funding option; twenty two participants (76%) wanted to continue the service and increase the maximum funding limit; three participants (14%) wanted to stay with the current situation and three participants (10%) wanted to stop funding the service.

There was some tension in what those in the consultation saw as acceptable and appropriate evidence about the effectiveness of homeopathy. Many participants in the survey and at the event reported their positive experience or anecdotal evidence as “proof” that homeopathy is effective.  There was a low understanding about how scientific research is conducted or evaluated. The NHS try to base funding decisions on rigorous, high-quality, unbiased, peer-reviewed research, however, the CCG is required to account of all evidence, including patient experience, when funding or discontinuing services.

Across the survey and the consultation event there was some confusion about what types of treatment come under the heading of “homeopathy”, with participants making reference to a range of herbal remedies and supplements. Iscador (a mistletoe extract) may be, in some cases, provided as a complementary treatment for patients with cancer, however, this is not a homeopathic remedy. There was also discussion (in the event and in the survey responses) about other herbal remedies and supplements.

END OF SUMMARY

So, why do I not think highly about exercises of this kind?

In general, surveys are tricky and often very dodgy research tools. Particularly in alternative medicine, they are as popular as they are useless. The potential problems arise from the way the methodology is often applied. For instance, sampling is crucial. If, like in the present case, no rigorous sampling techniques are applied, the results will inevitably be unreliable in reflecting the views of a population.

The findings of the survey above could easily be little more than a reflection of which camp had a better PR. Homeopaths usually are very good on such occasions at persuading others for homeopathy. In this case, the results show that, despite their best efforts, the overall vote was not positive for homeopathy. What we don’t know is whether this is a reflection on the ‘will of the people’. It could be that the public is much more against funding nonsense than this poll suggests.

I would also argue that letting people vote about the availability of medical interventions is nonsensical. The value of healthcare technologies is not determined by such ‘beauty contests’; the value depends on the scientific evidence, and that is not readily evaluated by non-experts. Imagine: next we might vote for or against bone-marrow transplants; who has the expertise to cast such a vote?

Oh yes, and the ‘small consultation’ – what was that supposed to be. Probably just an exercise in political correctness. Nobody in their right mind can have expected any meaningful insight coming from it.

Finally, I dispute that ‘patients’ experience’ is the same as ‘evidence’, as the summary above seems to claim. This is just nonsense. evidence is something entirely different from experience.

But politicians will disregard all this. They will say ‘the public has decided’ and will stop funding homeopathy on the NHS in Liverpool. More by coincidence than by design, this survey went into the right direction. Now one can only hope that the rest of the country will follow suit – on evidence, not on dodgy pseudo-evidence from surveys.

This post is dedicated to Mel Koppelman.

Those who followed the recent discussions about acupuncture on this blog will probably know her; she is an acupuncturist who (thinks she) knows a lot about research because she has several higher qualifications (but was unable to show us any research published by herself). Mel seems very quick in lecturing others about research methodology. Yesterday, she posted this comment in relation to my previous post on a study of aromatherapy and reflexology:

Professor Ernst, This post affirms yet again a rather poor understanding of clinical trial methodology. A pragmatic trial such as this one with a wait-list control makes no attempt to look for specific effects. You say “it is quite simply wrong to assume that this outcome is specifically related to the two treatments.” Where have specific effects been tested or assumed in this study? Your statement in no way, shape or form negates the author’s conclusions that “aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions.” Effectiveness is not a measure of specific effects.

I am most grateful for this comment because it highlights an issue that I had wanted to address for some time: The meanings of the two terms ‘efficacy and effectiveness’ and their differences as seen by scientists and by alternative practitioners/researchers.

Let’s start with the definitions.

I often use the excellent book of Alan Earl-Slater entitled THE HANDBOOK OF CLINICAL TRIALS AND OTHER RESEARCH. In it, EFFICACY is defined as ‘the degree to which an intervention does what it is intended to do under ideal conditions. EFFECTIVENESS is the degree to which a treatment works under real life conditions. An EFFECTIVENESS TRIAL is a trial that ‘is said to approximate reality (i. e. clinical practice). It is sometimes called a pragmatic trial’. An EFFICACY TRIAL ‘is a clinical trial that is said to take place under ideal conditions.’

In other words, an efficacy trial investigates the question, ‘can the therapy work?’, and an effectiveness trial asks, ‘does this therapy work?’ In both cases, the question relate to the therapy per se and not to the plethora of phenomena which are not directly related to it. It seems logical that, where possible, the first question would need to be addressed before the second – it does make little sense to test for effectiveness, if efficacy has not been ascertained, and effectiveness without efficacy does not seem to be possible.

In my 2007 book entitled UNDERSTANDING RESEARCH IN COMPLEMENTARY AND ALTERNATIVE MEDICINE (written especially for alternative therapists like Mel), I adopted these definitions and added: “It is conceivable that a given therapy works only under optimal conditions but not in everyday practice. For instance, in clinical practice patients may not comply with a therapy because it causes adverse effects.” I should have added perhaps that adverse effects are by no means the only reason for non-compliance, and that non-compliance is not the only reason why an efficacious treatment might not be effective.

Most scientists would agree with the above definitions. In fact, I am not aware of a debate about them in scientific circles. But they are not something alternative practitioners tend to like. Why? Because, using these strict definitions, many alternative therapies are neither of proven efficacy nor effectiveness.

What can be done about this unfortunate situation?

Simple! Let’s re-formulate the definitions of efficacy and effectiveness!

Efficacy, according to some alternative medicine proponents, refers to the therapeutic effects of the therapy per se, in other words, its specific effects. (That coincides almost with the scientific definition of this term – except, of course, it fails to tell us anything about the boundary conditions [optimal or real-life conditions].)

Effectiveness, according to the advocates of alternative therapies, refers to its specific effects plus its non-specific effects. Some researchers have even introduced the term ‘real-life effectiveness’ for this.

This is why, the authors of the study discussed in my previous post, could conclude that “aromatherapy massage and reflexology are simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on their data, neither aromatherapy nor reflexology has been shown to be effective. They might appear to be effective because patients expected to get better, or patients in the no-treatment control group felt worse for not getting the extra care. Based on studies of this nature, giving patients £10 or a box of chocolate might also turn out to be “simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on these definitions of efficacy and effectiveness, there are hardly any limits to bogus claims for any old quackery.

Such obfuscation suits proponents of alternative therapies fine because, using such definitions, virtually every treatment anyone might ever think of can be shown to be effective! Wishful thinking, it seems, can fulfil almost any dream, it can even turn the truth upside down.

Or can anyone name an alternative treatment that cannot even generate a placebo response when administered with empathy, sympathy and care? Compared to doing nothing, virtually every ineffective therapy might generate outcomes that make the treatment look effective. Even the anticipation of an effect alone might do the trick. How often have you had a tooth-ache, went to the dentist, and discovered sitting in the waiting room that the pain had gone? Does that mean that sitting in a waiting room is an effective treatment for dental pain?

In fact, some enthusiasts of alternative medicine could soon begin to argue that, with their new definition of ‘effectiveness’, we no longer need controlled clinical trials at all, if we want to demonstrate how effective alternative therapies truly are. We can just do observational studies without a control group, note that lots of patients get better, and ‘Bob is your uncle’!!! This is much faster, saves money, time and effort, and has the undeniable advantage of never generating a negative result.

To most outsiders, all this might seem a bit like splitting hair. However, I fear that it is far from that. In fact, it turns out to be a fairly fundamental issue in almost any discussion about the value or otherwise of alternative medicine. And, I think, it is also a matter of principle that reaches far beyond alternative medicine: if we allow various interest groups, lobbyists, sects, cults etc. to use their own definitions of fundamentally important terms, any dialogue, understanding or progress becomes almost impossible.

“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

On this blog, I have repeatedly tried to explain why integrative (or integrated) medicine is such a deceptive nonsense; see for instance here, here and here. Today, I have reason to make another attempt: The International Congress on Integrative Medicine & Health.

In 2012, I published an analysis of the ‘3rd European Congress of Integrated Medicine’ which had taken place in December 2010 in Berlin (in Europe they call it ‘integrated’ and in the US ‘integrative’ medicine). For this purpose, I simply read all the 222 abstracts and labelled them according to their contents. The results showed that the vast majority were on unproven alternative therapies and none on conventional treatments.

The abstracts from the International Congress on Integrative Medicine & Health (ICIMH, Green Valley Ranch Resort, Las Vegas, Nevada, USA, May 17–20, 2016) which were just published provide me with the opportunity to check whether this situation has changed. There were around 400 abstracts, and I did essentially the same type of analysis (attributing one subject area to each abstract). And what a tedious task this was! I spotted just two articles of interest, and will report about them shortly.

This time I also assessed whether the conclusions of each paper were positive (expressing something favourable about the subject at hand), negative (expressing something negative about the subject at hand) or neither of the two (surveys, for instance, rarely show positive or negative results).

Here are the results: mind-body therapies were the top subject with 49 papers, followed by acupuncture (44), herbal medicine (37), integrative medicine (36), chiropractic and other manual therapies (26), TCM (19), methodological issues (16), animal and other pre-clinical investigations (15) and Tai Chi (5). The rest of the abstracts were on a diverse array of other subjects. There was not a single paper on a conventional therapy and only 4 focussed on risk assessments.

The 36 articles on integrative medicine deserve perhaps a special mention. The majority of these papers were about using alternative therapies as an add-on to conventional care. They focussed on the alternative therapies used and usually concluded that this ‘integration’ was followed by good results. None of these papers discussed integrative medicine and its assumptions critically, and none of these investigations cast any doubt about the assumption that integrative medicine is a positive thing.

I should also mention that my attributions of the subject areas were not always straight forward. I allowed myself only one subject per paper, but there were, of course, many that could be categorised in more than one subject area ( for instance, a paper on an herbal medicine might be in that category, or in TCM or in pre-clinical). So I tried to attribute the subject that seemed to dominate the abstract in question.

My analysis according to the direction of the conclusions was equally revealing: I categorised 260 papers as positive, 5 as negative and 116 as neither of the two. That means for every negative result there were 52 positive ones. I find this most remarkable.

Essentially, my two analyses of conference abstracts published 6 years apart show the same phenomenon: on the ‘scientific level’, integrative medicine is not about the ‘best of both worlds’ (i. e. the best alternative medicine has to offer integrated with the best conventional medicine offers) – the slogan by which advocates of integrative medicine usually try to ‘sell’ their dubious approach to us. It is almost exclusively about alternative therapies which advocates of integrative medicine aim to smuggle into mainstream healthcare. Critical analysis seems to be unwelcome in this area, and – perhaps worse of all – in the last 6 years, there does not seem to have been any improvement.

And that’s just on the ‘scientific level’, as I said. If you wonder what is happening on the ‘practical level’, you will find that, in the realm of integrative medicine, every quackery under the sun is being promoted at often exorbitant prices to the often gullible and always unsuspecting public. If you don’t believe me, search for ‘integrative medicine clinic’ on the Internet; I promise, you will be surprised!

Personally, I am sometimes amused by the sheer idiocy of all this, but more often I am enraged and ask myself:

  • Why are we allowing quackery to make such a spectacular come-back?
  • Why is hardly anyone voicing strong objections?
  • Is it not our ethical duty to do something about it and try to prevent the worse?

 

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