MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pseudo-science

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Yesterday, I wrote about a new acupuncture trial. Amongst other things, I wanted to find out whether the author who had previously insisted I answer his questions about my view on the new NICE guideline would himself answer a few questions when asked politely. To remind you, this is what I wrote:

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

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

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

…Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:

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

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

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

So, here is my interpretation of this study:

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

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

I would be most interested to hear what you think about it [if you want to see the full article, please send me an email].

The ‘ALT MED HALL OF FAME’ is filling up very nicely. Remember: so far, I have honoured the following individuals for (almost) never publishing anything else but positive results (in brackets are the main alternative therapies of each researcher and the countries where they are currently based):

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)

Today, I am about to admit another female to our club of alt med elite (the group was in danger of getting a bit too male-dominated) : Prof Nicola Robinson from the School of Health and Social Care, London South Bank University, UK. She may not be known to many of my readers; therefore I better provide some extra information. Her own institution wrote her up as follows:

Professor Nicola Robinson joined London South Bank University in March 2011 as Professor of Traditional Chinese Medicine and Integrated Health. Previously she was Professor of Complementary Medicine, University of West London. Professor Robinson’s former posts include; Consultant Epidemiologist Brent and Harrow Health Authority, Senior lecturer in Primary Healthcare University College London, Lecturer at Charing Cross and Westminster Hospital Medical School and Research Fellow at the London School of Hygiene and Tropical Medicine.

She graduated from Leicester University with a BSc (Hons) in Biological Sciences, and her PhD from Manchester University was in Immunology. She has been a registered acupuncturist since 1982. In 1985 Nicola was awarded an RD Lawrence Fellowship by Diabetes UK and in 1993 she was given an Honorary Membership of the Faculty of Public Health Medicine for her contribution to epidemiology and health services research. 

In 2004, Nicola was awarded a Winston Churchill Traveling Fellowship to visit China, to explore educational and research initiatives in Traditional Chinese Medicine at various universities and hospitals. Nicola has a keen interest in complementary medicine and its assimilation and integration into mainstream health care and has been involved in various research initiatives with professional groups. 

Nicola has written over 200 scientific articles in peer reviewed journals, prepared scientific reports and presented research at local, national and international conferences. She is the Editor in Chief of the European Journal of Integrative Medicine (Elsevier) as well as being on the editorial boards of other scientific journals. She has had considerable research experience in various aspects of public health that has covered a wide range of subject arenas including: complementary medicine, cancer, patient public engagement, mental health, diabetes, coronary heart disease, HIV, cystic fibrosis and psychosocial aspects of disease. She has various research links in China and has had successfully supervised both Chinese and UK PhD students.

As always, I conducted a Medline search for ‘Robinson N, alternative medicine’, which generated 50 articles. I excluded those articles that were not on alternative medicine (probably from someone by the same name) and those that had no abstract with conclusions about the value of alternative medicine. Of the rest, I included the most recent 10 papers. Below I show these articles with the appropriate links and the conclusion (in bold).

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

Hu XY, Chen NN, Chai QY, Yang GY, Trevelyan E, Lorenc A, Liu JP, Robinson N.

Chin J Integr Med. 2015 Oct 26. [Epub ahead of print]

Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details.

Complementary therapy provision in a London community clinic for people living with HIV/AIDS: a case study.

Lorenc A, Banarsee R, Robinson N.

Complement Ther Clin Pract. 2014 Feb;20(1):65-9. doi: 10.1016/j.ctcp.2013.10.003. Epub 2013 Oct 15

Complementary Ttherapies may provide important support and treatment options for HIV disease, but cost effectiveness requires further evaluation.

A review of the use of complementary and alternative medicine and HIV: issues for patient care.

Lorenc A, Robinson N.

AIDS Patient Care STDS. 2013 Sep;27(9):503-10. doi: 10.1089/apc.2013.0175. Review

Clinicians, particularly nurses, should consider discussing CAM with patients as part of patient-centered care, to encourage valuable self-management and ensure patient safety.

Meditative movement for respiratory function: a systematic review.

Lorenc AB, Wang Y, Madge SL, Hu X, Mian AM, Robinson N.

Respir Care. 2014 Mar;59(3):427-40. doi: 10.4187/respcare.02570. Epub 2013 Jul 23. Review

The available evidence does not support meditative movement for patients with CF, and there is very limited evidence for respiratory function in healthy populations. The available studies had heterogeneous populations and provided inadequate sampling information, so clinically relevant conclusions cannot be drawn. Well powered, randomized studies of meditative movement are needed.

Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study.

Huang W, Taylor A, Howie J, Robinson N.

J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.

This pilot study suggests that TCA could reduce stress and increase the morning rise of the cortisol profile; however, this was not distinguishable from the effect of attention only.

The evidence for Shiatsu: a systematic review of Shiatsu and acupressure.

Robinson N, Lorenc A, Liao X.

BMC Complement Altern Med. 2011 Oct 7;11:88. doi: 10.1186/1472-6882-11-88. Review.

Evidence is improving in quantity, quality and reporting, but more research is needed, particularly for Shiatsu, where evidence is poor. Acupressure may be beneficial for pain, nausea and vomiting and sleep.

Autogenic Training as a behavioural approach to insomnia: a prospective cohort study.

Bowden A, Lorenc A, Robinson N.

Prim Health Care Res Dev. 2012 Apr;13(2):175-85. doi: 10.1017/S1463423611000181. Epub 2011 Jul 26

This study suggests that AT may improve sleep patterns for patients with various health conditions and reduce anxiety and depression, both of which may result from and cause insomnia. Improvements in sleep patterns occurred despite, or possibly due to, not focusing on sleep during training. AT may provide an approach to insomnia that could be incorporated into primary care.

Traditional and complementary approaches to child health.

Robinson N, Lorenc A.

Nurs Stand. 2011 May 25-31;25(38):39-47.

Health visitors had greater knowledge and understanding of TCA than practice nurses or nurse practitioners, often informed by patients and personal experience. Health visitors reported that they discussed TCA with families using a culturally competent and family-centred approach to explain the advantages and disadvantages of TCA. This is probably made possible by their ongoing, close relationship with parents in the home environment and their focus on child health. Other primary care nurses were reluctant to engage with patients on TCA because of concerns about liability, lack of information and practice and policy constraints. Practice nurses and nurse practitioners may be able to improve their holistic and patient-centred practice by learning from health visitors’ experience, particularly cultural differences and safety issues. Nurses and their professional bodies may need to explore how this can be achieved given the time-limited and focused nature of practice-based consultations.

A case study exploration of the value of acupuncture as an adjunct treatment for patients diagnosed with schizophrenia: results and future study design.

Ronan P, Robinson N, Harbinson D, Macinnes D.

Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):503-14

The study indicates that patients diagnosed with schizophrenia would benefit from acupuncture treatment alongside conventional treatment.

An investigation into the effectiveness of traditional Chinese acupuncture (TCA) for chronic stress in adults: a randomised controlled pilot study.

Huang W, Howie J, Taylor A, Robinson N.

Complement Ther Clin Pract. 2011 Feb;17(1):16-21. doi: 10.1016/j.ctcp.2010.05.013. Epub 2010 Jun 19

This pilot study suggests that TCA may be successful in treating the symptoms of stress, through a combination of specific and non-specific effects; but may not relate directly to how a person perceives their stress.

I think we have here a very clear case: Prof Robinson has investigated a range of very different alternative therapies for vastly different conditions. She drew 9 positive and one negative conclusions. This renders her ‘Trustworthiness Index’ truly remarkable. I am therefore confident that we all can agree to admit her to the ALT MED HALL OF FAME.

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?

 

In 2008, I published a paper entitled ‘CHIROPRACTIC, A CRITICAL EVALUATION’ where I reviewed most aspects of this subject, including the historical context. Here is the passage about the history of chiropractic. I believe it is relevant to much of the current discussions about the value or otherwise of chiropractic.

The history of chiropractic is “rooted in quasi-mystical concepts.”  Bone-setters of various types are part of the folk medicine of most cultures, and bone-setting also formed the basis on which chiropractic developed.

The birthday of chiropractic is said to be September 18, 1895. On this day, D.D. Palmer manipulated the spine of a deaf janitor by the name of Harvey Lillard, allegedly curing him of his deafness. Palmer’s second patient, a man suffering from heart disease, was also cured. About one year later, Palmer opened the first school of chiropractic. There is evidence to suggest that D.D. Palmer had learned manipulative techniques from Andrew Taylor Still, the founder of osteopathy. He combined the skills of a bone-setter with the background of a magnetic healer and claimed that “chiropractic was not evolved from medicine or any other method, except that of magnetic.” He coined the term “innate intelligence” (or “innate”) for the assumed “energy” or “vital force,” which, according to the magnetic healers of that time, enables the body to heal itself. The “innate” defies quantification. “Chiropractic is based on a metaphysical epistemology that is not amenable to positivist research or experiment.”

The “innate” is said to regulate all body functions but, in the presence of “vertebral subluxation,” it cannot function adequately. Chiropractors therefore developed spinal manipulations to correct such subluxations,  which, in their view, block the flow of the “innate.” Chiropractic is “a system of healing based on the premise that the body requires unobstructed flow through the nervous system of innate intelligence.” Anyone who did not believe in the “innate” or in “subluxations” was said to have no legitimate role in chiropractic.

“Innate intelligence” evolved as a theological concept, the representative of Universal Intelligence ( = God) within each person. D.D. Palmer was convinced he had discovered a natural law that pertained to human health in the most general terms. Originally, manipulation was not a technique for treating spinal or musculoskeletal problems, it was a cure for all human illness: “95% of all diseases are caused by displaced vertebrae, the remainder by luxations of other joints.” Early chiropractic pamphlets hardly mention back pain or neck pain, but assert that, “chiropractic could address ailments such as insanity, sexual dysfunction, measles and influenza.” D.D. Palmer was convinced that he had “created a science of principles that has existed as long as the vertebra.” Chiropractors envision man as a microcosm of the universe where “innate intelligence” determines human health as much as “universal intelligence” governs the cosmos; the discovery of the “innate intelligence” represents a discovery of the first order, “a reflection of a critical law that God used to govern natural phenomena.”

Early chiropractic displayed many characteristics of a religion. Both D.D. Palmer and his son, B.J. Palmer, seriously considered establishing  chiropractic as a religion. Chiropractic “incorporated vitalistic concepts of an innate intelligence with religious concepts of universal intelligence,” which substituted for science. D.D. Palmer declared that he had discovered the answer to the timeworn question, “What is life?” and added that chiropractic made “this stage of existence much more efficient in its preparation for the next step – the life beyond.”

Most early and many of today’s chiropractors agree: “Men do not cure. It is that inherent power (derived from the creator) that causes wounds to heal, or a part to be repaired. The Creator…uses the chiropractor as a tool…chiropractic philosophy is truly the missing link between Religion or Power of the various religions.” Today, some chiropractors continue to relate the “innate” to God. Others, however, warn not to “dwindle or dwarf chiropractic by making a religion out of a technique.”

Initially, the success of chiropractic was considerable. By 1925, more than 80 chiropractic schools had been established in the United States. Most were “diploma mills” offering an “easy way to make money,” and many “were at one another’s throats.” Chiropractors believed they had established their own form of science, which emphasized observation rather than experimentation, a vitalistic rather than mechanistic philosophy, and a mutually supportive rather than antagonist relationship between science and religion. The gap between conventional medicine and chiropractic thus widened “from a fissure into a canyon.” The rivalry was not confined to conventional  medicine; “many osteopaths asserted that chiropractic was a bastardized version of osteopathy.”

Rather than arguing over issues such as efficacy, education, or professional authority, the American Medical Association insisted that all competent health care providers must have adequate knowledge of the essential subjects such as anatomy, physiology, pathology, chemistry, and bacteriology. By that token, the American Medical Association claimed, chiropractors were not fit for practice. Some “martyrs,” including D.D. Palmer himself, went to jail for practicing medicine without a licence.

Chiropractors countered that doctors were merely defending their patch for obvious financial reasons (ironically, chiropractors today often earn more than conventional doctors), that orthodox science was morally corrupt and lacked open-mindedness. They attacked the “germo-anti-toxins-vaxiradi-electro-microbioslush death producers” and promised a medicine “destined to the grandest and greatest of this or any age.”

Eventually, the escalating battle against the medical establishment was won in “the trial of the century.” In 1987, sections of the U.S. medical establishment were found “guilty of conspiracy against chiropractors,” a decision which was upheld by the U.S. Supreme Court in 1990. In other countries, similar legal battles were fought, usually with similar outcomes. Only rarely did they not result in the defeat of the “establishment:” In 1990, a Japanese Ministry of Health report found that chiropractic is “not based on the knowledge of human anatomy but subjective and unscientific.”

These victories came at the price of “taming” and “medicalizing” chiropractic. In turn, this formed the basis of a conflict within the chiropractic profession – the dispute between “mixers” and “straights” – a conflict which continues to the present day.

The “straights” religiously adhere to D.D. Palmer’s notions of the “innate intelligence” and view subluxation as the sole cause and manipulation as the sole cure of all human disease. They do not mix any non-chiropractic techniques into their therapeutic repertoire, dismiss physical examination (beyond searching for subluxations) and think medical diagnosis is irrelevant for chiropractic. The “mixers” are somewhat more open to science and conventional medicine, use treatments other than spinal manipulation, and tend to see chiropractors as back pain specialists. Father and son Palmer warned that the “mixers” were “polluting and diluting the sacred teachings” of chiropractic. Many chiropractors agreed that the mixers were “bringing discredit to the chiropractic.”

The “straights” are now in the minority but nevertheless exert an important influence. They have, for instance, recently achieved election victories within the British General Chiropractic Council. Today, two different chiropractic professions exist side by sided “one that wishes to preserve the non-empirical, non-positivist, vitalist foundations (the straights) and the other that wishes to be reckoned as medical physicians and wishes to utilize the techniques and mechanistic viewpoint of orthodox medicine (the mixers).” The International Chiropractic Association represents the “straights” and the American Chiropractic Association the “mixers.”

(for references, see the original article)

While over on my post about the new NICE GUIDELINES on acupuncture for back pain, the acupuncturists’ assassination attempts of my character, competence, integrity and personality are in full swing, I have decided to employ my time more fruitfully and briefly comment on a new piece of acupuncture research.

This new Italian study was to determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer.

A total of 190 women with breast cancer were randomly assigned to two groups. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints.

The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses.

Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P < .05).

The authors concluded that acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

This hardly needs a comment, as I have been going on about this study design many times before: the ‘A+B versus B’ design can only produce positive findings. Any such study concluding that ‘acupuncture (or whatever other intervention) is effective’ can therefore not be a legitimate test of a hypothesis and ought to be categorised as pseudo-science. Sadly, this problem seems more the rule than the exception in the realm of acupuncture research. That’s a pity really… because, if there is potential in acupuncture at all, this sort of thing can only distract from it.

I think the JOURNAL OF CLINICAL ONCOLOGY, its editors and reviewers, should be ashamed of having published such misleading rubbish.

Yes, I think he does deserve to join this fast-expanding club which, so far, consists of the following people:

Simon Mills

Gustav Dobos

Claudia Witt

George Lewith

John Licciardone

They have been admitted mostly because they have demonstrated that they exclusively or mostly publish positive results about alternative medicine. Therefore, their ‘TRUSTWORTHYNESS INDEX’ is remarkable.

With Peter Fisher, things are a little different, and in a way much more convincing. He also has a remarkable publication record, of course. As the Queen’s homeopath, he is a stark defender of homeopathy. He has just under 100 Medline-listed articles in this area, and, if I am not mistaken, only one of them cast any doubt on the effectiveness of homeopathy.

Peter is also the long-term editor of the journal HOMEOPATHY, and he used this position to fire me from its editorial board. Furthermore, he has been shown to have an unusual attitude towards telling the truth. But the decider for his admission to THE ALT MED HALL OF FAME was the following recent interview for NATURALLYSAVVY where he shows himself as a fierce defender of science, evidence-based medicine and critical thinking:

Andrea Donsky: I understand you arrived yesterday from England. I’m curious what you take for jetlag?

Peter Fisher: We have a traditional combination that we use for jetlag, which is arnica montana, and cocculus indicus. So arnica is something that is traditionally used for bruises, and cocculus is used for sleep problems. So arnica and cocculus combined, 6CH every hour or two, helps with jetlag.

Andrea Donsky: I read about the incredible work you do as an Integrative Medicine Doctor so I thought we would start today’s interview with having you explain what that means.

Peter Fisher: Simply put, it means the best of both worlds: the best of conventional, and the best of complementary medicine. There is also a much longer and more complicated definition, but essentially it’s integrating complementary medicine in care packages to avoid some of the worst excesses of conventional medicines, like over-drugging, and excess use of medication.

Andrea Donsky: I know you don’t see patients with the common cold or flu, but if you did, what would be your protocol?

Peter Fisher: I’ve done quite a lot of research on the flu. It’s quite clear that conventional treatments don’t work all that well, and may even prolong the flu. Most of the conventional treatments push the symptoms down [suppress them] and actually prolong the illness.

Andrea Donsky: So something like Oscillococcinum would be a perfect thing to recommend to people.

Peter Fisher: Yes, and other homeopathic combinations that can speed up the resolution, relieve the symptoms, and make the flu go away quicker.

Andrea Donsky: Tell me a little bit about the European way of practicing medicine. I remember hearing that in Europe doctors prescribe homeopathy alongside medication. Is this true?

Peter Fisher: It varies widely between countries. In France, Germany, and increasingly in Spain, it is the case, but not so much in the UK. A lot of doctors do incorporate it in their practice and they integrate homeopathy when it seems appropriate, but they also use antibiotics and other drugs when they feel it is appropriate.

Andrea Donsky: Do you often approach these skeptics and say: “Listen, you are wrong because there is research behind it!”

Peter Fisher: I will debate with anybody, anytime. The trouble is, skeptics don’t like that because they always lose. I’ve been involved in a series of debates with “so called” skeptics. But many well-known skeptics avoid me because they lose the debate. What they prefer to do is to blog, or tweet, so they can make nasty sneering public remarks and you can’t come back at them. If it’s a proper debate, I say my piece, you say your piece, there’s somebody there to make sure that it’s fair play, and that could be in a journal, it could be in a lower court, I don’t care. There was a big court case in the U.S. that was resolved in September where that happened. An allegation was made that false claims were being made for homeopathic medicines and they lost the case…homeopathy won!

Andrea Donsky: Tell us how you came to be a physician to Her Majesty the Queen.

Peter Fisher: There’s a long tradition of the Royal Family having a homeopathic physician. It actually goes back 150 years to Queen Victoria and her beloved Prince Albert. The founder of our hospital was Prince Albert’s father’s doctor. There has been an official homeopathic physician treating the Royal Family since the 1930s. It’s been me since 2001.

Andrea Donsky: It is nice to hear that the Royal Family is open to integrative medicine. Do you just treat the Queen, or the whole family? I read that Prince Charles eats organic and has an organic garden so I am assuming he is quite open to it as well.

Peter Fisher: I treat the entire family. I think Kate and Will are too young and healthy so they don’t need medicine. But the Prince of Wales, Prince Charles, is very friendly, and he is more than willing to stick his neck out to actually say things. He has spoken at the World Health Assembly, which is the AGN of the World Health Organization. So he’s really quite fond of integrative medicine.

Andrea Donsky: I think that’s incredible. As a conventionally trained physician, how did you become interested in homeopathy?

Peter Fisher: At the end of the Cultural Revolution I went to visit China. I was a medical student at the time, and I remember the moment when it became clear to me. I was in the operating room of a small Chinese provincial town and there was a woman lying on the operating table with her entire abdomen open, fully conscious talking to the anesthetist with three needles in her left ear.

Andrea Donsky: Acupuncture needles?

Peter Fisher: Yes.

Andrea Donsky: That’s amazing.

Peter Fisher: The needles were connected to a little electrical box. I thought, “That doesn’t happen. They didn’t tell us about this at Cambridge.” I went to the best medical school, Cambridge, a very elite medical school, and I just thought, “This can’t happen. This doesn’t happen.” That experience is what made me think that there was more to medicine than what we were taught in medical school. Then a few years later, I became ill myself. I was still a medical student so I went to see a very distinguished professor at my medical school who made a precise diagnosis and said, “Tough, nothing can be done.” So my friends suggested I try homeopathy, and I did, and it helped. So it snowballed from there.

Andrea Donsky: Oftentimes we need to see things for ourselves and/or experience it to believe it.

Peter Fisher: Yes. I got almost obsessed by it, you know. In many ways as a scientific thing it shouldn’t work. I mean I do understand to that extent where the skeptics are coming from. There does appear to be a good reason why it can’t possibly work, and yet it does.

Andrea Donsky: Can you define what homeopathy is and how it works?

Peter Fisher: Homeopathy is based on the idea of like curing like. So you give a very small dose of something that could cause a similar illness if given an enlarged dose. Some people say it’s like holding a mirror up to nature. You’re saying to the body, “OK, this is what your problem is, this is what the disease is.” The idea is that the body has very strong self-healing capabilities; it is strong, but sometimes it can be stupid like when it comes to autoimmune diseases. In that case it is actually the body’s defensive mechanism being misdirected.

Andrea Donsky: Can you explain the difference between a single remedy and a combination?

Peter Fisher: A single remedy is one remedy and a combination is multiple. Broadly speaking, there are two kinds of homeopathy. One is the so-called “keynote prescribing way,” where you prescribe for one or two keynote symptoms like a cold, sore throat, or runny nose.Then there is “constitutional medicine” where you are not so much treating the disease, but rather the person. So for example, if someone has insomnia, muscular aches and pains or even a cold and/or flu, they can take a combination of two, three, four, or even five different homeopathic medicines, which will likely cover the symptoms. This is more for self-treatment, rather than doctor prescribed.

Andrea Donsky: That makes sense. I like that there is a role in homeopathy for both self (like for the common cold) and expert prescribing.

Peter Fisher: Yes. It is one thing if someone has a short-term health issue, but it is another thing if they have a chronic complicated, multi-faceted issue. I mean one of the interesting things about homeopathy is the idea of treating the person, and not the disease

I AM CONFIDENT THAT THE MAJORITY OF MY READERS AGREE TO ADMIT DR FISHER TO THE ALT MED HALL OF FAME.

Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.

The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.

They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.

Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).

Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.

The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.

This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.

The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.

clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.

I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.

If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.

This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.

There can, of course, be several reasons for the evidence being not positive:

  • there can be a paucity of data
  • the results might be contradictory
  • the trials might be open to bias
  • some of the primary data might look suspicious

In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.

I am pleased to report that my ‘ALTERNATIVE MEDICINE HALL OF FAME’ is growing steadily. So far, this elite club includes:

Gustav Dobos

Claudia Witt

George Lewith

John Licciardone

Time, I think, to elect another member. I was fascinated to read what the COLLEGE OF MEDICINE (I have published about this organisation before, for instance, here) writes about a former co-worker of mine, Simon Mills (those who have read my memoir will know more about him and about my struggle to disassociate me and my work from him and his activities):

Simon Mills is a member of the College of Medicine Council. He is a Cambridge graduate in medical sciences who has since 1977 been a herbal practitioner and natural therapist in Exeter. In that time he has led the main organizations for herbal medicine in the UK (the British Herbal Medicine Association, the College of Practitioners of Phytotherapy, and National Institute of Medical Herbalists) and served on Government and House of Lords committees. Since 1997 he has been Secretary of ESCOP, the lead herbal scientific network in Europe, that produces defining monographs on herbal medicines for the European Medicines Agency. He has also written award-winning seminal herbal medicine textbooks, notably with Kerry Bone the two editions of Principles and Practice of Phytotherapy and the Essential Book of Herbal Safety. He has long been involved in academic work having co-founded the world’s first University centre for complementary health in Exeter (1987), the first integrated health course at a UK medical school at the Peninsula Medical School in Exeter (2000) and the first masters degree programme in herbal medicine in the USA (2001). He has published in many peer-reviewed scientific journals including full clinical trials with herbal medicines, and has supervised 10 successful doctorate theses. Simon is currently building a new role for healthcare practitioners as ‘health guides. With health workbooks, training programmes, community projects and websites.

It was new to me that he has ‘published in many peer-reviewed scientific journals’, so I did a Medline search and found a total of 14 articles. Most of these were comments, letters etc. I decided to identify the first 10 papers that drew some sort of conclusions about the value of alternative therapies. This is what I found (as usual, I have copied the conclusions in bold):

Short-term study on the effects of rosemary on cognitive function in an elderly population.

Pengelly A, Snow J, Mills SY, Scholey A, Wesnes K, Butler LR.

J Med Food. 2012 Jan;15(1):10-7. doi: 10.1089/jmf.2011.0005. Epub 2011 Aug 30.

The positive effect of the dose nearest normal culinary consumption points to the value of further work on effects of low doses over the longer term.

Continuous PC6 wristband acupressure for relief of nausea and vomiting associated with acute myocardial infarction: a partially randomised, placebo-controlled trial.

Dent HE, Dewhurst NG, Mills SY, Willoughby M.

Complement Ther Med. 2003 Jun;11(2):72-7.

Continuous 24-h PC6 acupressure therapy as an adjunct to standard antiemetic medication for post-MI nausea and vomiting is feasible and is well accepted and tolerated by patients. In view of its benefits, further studies are worthwhile using earlier onset of treatment.

Effect of a proprietary herbal medicine on the relief of chronic arthritic pain: a double-blind study.

Mills SY, Jacoby RK, Chacksfield M, Willoughby M.

Br J Rheumatol. 1996 Sep;35(9):874-8.

It is concluded that Reumalex has a mild analgesic effect in chronic arthritis at a level appropriate to self-medication.

Yes, there were just three such papers; perhaps the College of Medicine’s description is just a trifle misleading? As all of these arrived at positive conclusions, I think Mr Mills nevertheless deserves a place in my ALTERNATIVE MEDICINE’S HALL OF FAME.

Reiki is one of the most popular types of ‘energy healing’. Reiki healers believe to be able to channel ‘healing energy’ into patients’ body thus enabling them to get healthy. If Reiki were not such a popular treatment, one could brush such claims aside and think “let the lunatic fringe believe what they want”. But as Reiki so effectively undermines consumers’ sense of reality and rationality, I feel I should continue informing the public about this subject – despite the fact that I have already reported about it several times before, for instance here, here, here, here, here and here.

A new RCT, published in a respected journal looks interesting enough for a further blog-post on the subject. The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioural therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. The researchers from Canada, Malaysia and Australia recruited 188 adolescent depressed adolescents. They were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after 12 weeks of treatments/wait list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (p<.001) and the wait-list control (p<.001). Reiki also showed greater decreases in CDI scores across treatment relative to the wait-list control condition (p=.031).  Male participants showed a smaller treatment effects for Reiki than did female participants. The authors concluded that both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki.

I find it most disappointing that these days even respected journals publish such RCTs without the necessary critical input. This study may appear to be rigorous but, in fact, it is hardly worth the paper it was printed on.

The results show that Reiki produced worse results than CBT. That I can well believe!

However, the findings also suggest that Reiki was nevertheless “effective in reducing the symptoms of depression”, as the authors put it in their conclusions. This statement is misleading!

It is based on the comparison of Reiki with doing nothing. As Reiki involves lots of attention, it can be assumed to generate a sizable placebo effect. As a proportion of the patients in the wait list group are probably disappointed for not getting such attention, they can be assumed to experience the adverse effects of their disappointment. The two phenomena combined can easily explain the result without any “effectiveness” of Reiki per se.

If such considerations are not fully discussed and made amply clear even in the conclusions of the abstract, it seems reasonable to accuse the journal of being less than responsible and the authors of being outright misleading.

As with so many papers in this area, one has to ask: WHERE DOES SLOPPY RESEARCH END AND WHERE DOES SCIENTIFIC MISCONDUCT BEGIN?

My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:

Claudia Witt

George Lewith

John Licciardone

But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.

For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:

SYSTEMATIC REVIEW COMPARING DIFFERENT YOGA STYLES (2016)

RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.

SYSTEMATIC REVIEW OF YOGA FOR WEIGHT LOSS (2016)

Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)

…there is published, positive level I evidence for a number of CAM treatment forms.

SYSTEMATIC REVIEW OF MINDFULNESS FOR PSYCHOSES (2016)

Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.

RCT OF CABBAGE LEAF WRAPS FOR OSTEOARTHOSIS (2016)

Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.

SYSTEMATIC REVIEW OF HERBAL MEDICINES FOR COUGH (2015)

This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.

SYSTEMATIC REVIEW OF DIETARY APPROACHES FOR METABOLIC SYNDROME (2016)

Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.

SYSTEMATIC REVIEW OF MIND BODY MEDICINE FOR CORONARY HEART DISEASE (2015)

In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.

CRANIOSACRAL THERAPY (CST) FOR BACK PAIN (2016)

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

REVIEW OF INTEGRATED MEDICINE FOR BREAST CANCER (2015)

Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.

Amazed?

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

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