MD, PhD, FMedSci, FSB, FRCP, FRCPEd

alternative medicine

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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].

While looking up an acupuncturist who has recently commented on this blog trying to teach me how to do science and understand research methodology, I was impressed that he, Dr John McDonald, PhD, has just published a clinical trial. Not many acupuncturists do that, you know, and I very much applaud this action, which even seems to have earned him his PhD! McDonald is understandably proud of his achievement – all the more because the study arrived at positive conclusions. This is what he wrote about it:

…So, in a nutshell, acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis which produces lasting changes in the immune system and hence improvements in symptoms and quality of life.    Dr John McDonald

Fascinating! I quickly looked up the paper. Here it is:

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.

These conclusions seem to be based on the data of the study. But they are oddly out of line with the above statement made by McDonald about his trial. What could be the reason for this discrepancy? Could it be that he behaves ‘scientifically’ correct when under the watchful eye of numerous co-authors from the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia, the Health Innovations Research Institute and School of Health Sciences, RMIT University, Melbourne, Victoria, Australia, and the Stanford University, Palo Alto, California? And could it be that he is a little more ‘liberal’ when on his own? A mere speculation, of course, but it would be nice to know.

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”?

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.

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)

It has long been argued that chiropractic spinal manipulations are mere placebo interventions. Yet few controlled trials have assessed the efficacy of spinal manipulative therapy (SMT). No high quality trials have been performed to test the efficacy and effectiveness of Graston Technique® (GT), an instrument-assisted soft tissue therapy.

The objective of this trial was to determine the efficacy of SMT and GT compared to sham therapy for the treatment of non-specific thoracic spine pain.

People with non-specific thoracic pain were randomly allocated to one of three groups: SMT, GT, or a placebo (de-tuned ultrasound). GT is a popular soft-tissue technique in the United States and becoming more popular in other developed countries. GT is an instrument-assisted soft-tissue therapy involving the use of hand-held stainless steel instruments. The promoters of the GT claim that the instruments resonate in the clinician’s hands allowing the clinician to isolate soft-tissue “adhesions and restrictions”, and treat them precisely. Each participant received up to 10 supervised treatment sessions at Murdoch University chiropractic student clinic over a 4 week period.

The two outcome measures were self-administered instruments. Participants were given blank questionnaires in a package by a research assistant following their first treatment. Participants were instructed to complete the instruments at each assessment time point. After completion of the forms the participant posted them back to the Murdoch University Chiropractic Clinic. Research assistants remained blind to the outcome data for the entire study period. The participants and treatment providers were not blinded to the treatment allocation as it was clear that the groups were receiving different treatments. Participants in the placebo group were blinded to their placebo allocation until follow-up was complete at 12 months. Participants were surveyed for the adequacy of the placebo blinding at the end of the study.

Treatment outcomes were measured at baseline, 1 week, and at one, three, six and 12 months. Primary outcome measures included a modified Oswestry Disability Index, and the Visual Analogue Scale (VAS). Treatment effects were estimated with intention to treat analysis and linear mixed models.

One hundred and forty three participants were randomly allocated to the three groups (SMT = 36, GT = 63 and Placebo = 44). Baseline data for the three groups did not show any meaningful differences. Results of the intention to treat analyses revealed no time by group interactions, indicating no statistically significant between-group differences in pain or disability at 1 week, 1 month, 3 months, 6 months, or 12 months. There were significant main effects of time (p < 0.01) indicating improvements in pain and disability from baseline among all participants regardless of intervention. No significant adverse events were reported.

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The authors concluded that this study indicates that there is no difference in outcome at any time point for pain or disability when comparing SMT, Graston Technique® or sham therapy for thoracic spine pain, however all groups improved with time. These results constitute the first from a fully powered randomised controlled trial comparing SMT, Graston technique® and a placebo.

Some people claim that there is little wrong with placebo therapy, as long as it helps patients. This is not what I think, but even the proponents of this argument would agree that the placebo used in this way has to be safe. As SMT is by no means free of adverse effects, the argument cannot be applied here.

Other people will argue that this is about SMT and not chiropractic implying that I am conducting a vendetta against the poor chiropractors. I would disagree: we have just learnt that 93% of chiropractors consider SMT as their primary treatment. Yes, osteopaths and physiotherapists also use SMT but certainly not to this extent. Thus this discussion is mostly about chiropractic, and the onus is on chiropractors to demonstrate beyond doubt that SMT does more good than harm.

The true significance of this study is, I think, that the chiropractic profession now must convince us that spinal manipulation has any usefulness at all. They will have to conduct rigorous trials along the lines of this study to test for which condition these interventions generate outcomes that are significantly better than those achievable by sham.

Until such data are available, it would be wise, I think, to consider all therapeutic claims made for chiropractic unproven and bogus.

WATCH THIS SPACE!

Ad hominem attacks, I have previously pointed out, are victories of reason over unreason. And they are used frequently by supporters of alternative medicine!

If you doubt it, see for yourself.

I recently posted a comment on new Nice guidelines. It generated lots of comments, and mostly they were rational discussions of the issues involved. This changed abruptly when, on 16 May, Mel’s comment started a new, concerted wave of discussion at a time when the usual debate had already subsided. In the course of this new and heated debate, I was repeatedly accused of being rude.

As I have stated repeatedly on this blog, I try to keep rudeness out of the comments as much as I can. Therefore, the claim surprised me and today I reviewed the entire comment section selecting all potential ad hominem attacks. Here are the results:

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS AGAINST ME

Peter Deadman on Tuesday 17 May 2016 at 12:55 Edward Ernst, I always thought you were a bully and a fraud. You’re very macho when it comes to slapping down people who may have experiential reasons for supporting acupuncture and other therapies but don’t have the skill to challenge you on the clinical evidence. Now as soon as somebody does, you back off, cry ‘enough’, say you can’t possibly comment till some undetermined future date and generally act like a wuss. I say put up or shut up. I’d prefer the former because it would be good to see you eat crow but I lean towards the latter because of the substantial harm you are causing and the beautiful silence that would ensue if you did indeed go quiet.

tonto on Tuesday 17 May 2016 at 13:19 You appear as weak in your arguments, as some pendulum swinging, new age dowser, who vainly holds sticks to their guns, not because they can back their position up with scientific evidence, but because it is what they “believe”.

Jill Onyett on Tuesday 17 May 2016 at 14:29 …an unfortunate creature too keen on the sound of his own voice.

Tracey Phillips on Tuesday 17 May 2016 at 13:16 …to date you have been fairly opinionated …

Peter Deadman on Tuesday 17 May 2016 at 16:34  I made an ad hominem response because your blog is all about you as a person. You are constantly rude to others and bypass or ignore responses that you don’t like. It’s you who makes it hominem.

Peter Deadman on Tuesday 17 May 2016 at 16:52 You are hyper-emotional, extremely biased, hostile and contemptuous of anyone you think ‘beneath you’. You gloat over people’s real or imagined inconsistencies and generally come across as a nasty piece of work.

Peter Deadman on Tuesday 17 May 2016 at 19:30 How can such a childish provocateur remain in his post. It demeans the University and it’s time they let him go.

Kylee Junghans on Wednesday 18 May 2016 at 08:42 …you, kind Sir, with your rhetoric and tantrums, are exhibiting a prime example of confirmation bias.

Peter Deadman on Wednesday 18 May 2016 at 08:48 [Ernst] professes a scholarly detachment, a commitment to evidence and an open mind, but in fact is deeply biased… He clearly loves his childish provocative stance and is as far from a disinterested observer as it’s possible to be. I wouldn’t waste my time or breath on him if he didn’t have an influence that far exceeds his worth.

Carol Cooke on Wednesday 18 May 2016 at 09:27 I have followed this discussion with interest. Some of the rudest and most discourteous posts I can see are from Mr Ernst himself. But I get that, I imagine you seek to maintain a bold and authoritative tone simply by dismissing others. Being a bit controversial in your discourse has obviously served you well in that you have built a media profile on it.

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS BY MYSELF

Edzard on Wednesday 18 May 2016 at 09:18 “it is also difficult to get a man to read something, when he is foaming from his mouth”.

I know, this is not really ‘ad hominem’ but I could not find anything more dramatic. Surely, some will disagree this me here, and I do invite them to cite my rudeness from this threat, if they spot it. You are more than welcome!

CONCLUSION

You may think this is a bit trivial, but I disagree. The main reason I did this little exercise is to demonstrate a point which I think is important and carries a relevant lesson for future comments and discussions:

  • WHEN I OR ANYONE ELSE DEFENDING RATIONALITY GET AGGRESSED, WE NATURALLY TEND TO RESPOND SLIGHTLY MORE FORCEFULLY.
  • SUBSEQUENTLY, THE OTHER SIDE OFTEN REACTS BY ATTACKING US PERSONALLY.
  • THIS OFTEN LEADS TO AN ESCALATION OF TONE.
  • EVENTUALLY THE OTHER SIDE CLAIMS WITH INDIGNATION THAT WE ARE THE ONES DOING THE PERSONAL ATTACKS.
  • IT IS A TACTIC THAT IS EFFECTIVE BUT DISHONEST, IN MY VIEW.
  • THE LESSON IS SIMPLE: DO NOT LET YOURSELF GET PROVOKED INTO ISSUING AD HOMINEM ATTACKS, BE POLITE AND PATIENT.

I know this sounds simpler than it is, and I am far from being immune to the problem, but we owe it to reason to give it a try.

 

Anyone who really wants to get an insight into the ‘homeopathic mind-set’ should read the regular newsletter ‘HOMEOPATHY 4 EVERYONE’. Its current issue is focussed on cardiology. An article on coronary heart disease, a condition that kills about 40% of the population, informs us how homeopaths tackle this killer-disease:

If anything permanent is to be accomplished by treatment, a most careful examination of the individual case must be made. Not the attack alone, but the habits of the patient, his family history and environments must all be studied in every possible light. In the management, each case must be considered separately and the causes that excite an attack sought after. Many of these patients already have recognized the cause in their own case and often it is some irregularity of diet, exercise or mental condition. Many times it is not an easy matter to control the mental state, as the worry and strain of business life presses upon many of these patients, and is responsible for many cases of arterial degeneration that give rise to apoplexy, Bright ‘s disease, aneurysm or angina pectoris. The age and occupation of the patient, and the condition of the vascular system should be taken into consideration.

Following an attack the condition of the heart may require absolute rest, from a day to a week or more; this is especially true if the attacks are precipitated by a slight degree of exercise, which shows that the heart is not able to propel the blood under anything but normal conditions. Under no condition should quick movements and strong emotions be associated. Steady quiet exercise as walking upon level ground is beneficial. If the cardiac weakness is such as to forbid this, massage, or the resistance exercise of the Schott’s method may be tried. This exercise should not follow immediately after a meal.

But this is not all. There are plenty more papers on life-threatening cardiac conditions. Take the article on pericarditis for instance. This is how homeopaths are told how to treat this medical emergency:

Remedies that may be indicated are as follows: If traumatic, Arnica. For the inflammatory outset, Aconite or Vera- trum viride. The anguish of Aconite distinguishes its inflammation from that attending the stupor of Veratrum. For the pain Bryonia or Spigelia. They may be indicated in this order, Bryonia for the first stage and Spigelia for the subsequent myalgia. In these cases there may be met with indications for Belladonna (its flushed face), Arsenicum (dyspnoea on lying down), Digitalis (its weak pulse), Cactus (severe myalgia) or Kali carb (stitching pains). General symptoms may call for Colchicum, Aesculus, Kali iod., Cimicifuga, Kahnia, Squilla

A further article tackles diseases of the blood vessels. The article on thrombosis informs the homeopath that

Thrombosis is a blocking of the local circulation either spontaneously, after injuries or from slow and imperfect circulation forming a clot. In thrombosis the part becomes pale and edematous. The remedies are Aconite for first stage. Hamamelis, Lachesis or Lycopodium may be indicated. If suppuration threatens Sulphur or Hepar.  Rest and a supporting diet.

The same article also tells us how to treat aneurysms:

Select the remedy carefully. Lycopodium 12 has cured aneurism of the carotid (Hughes). If the attack is due to a sudden strain or injury, Arnica; if from fear or fright, Aconite; if from syphilis, Mercurius, Kali hydr. or Nitric acid; if from alcoholism, Arsenicum or Nux vomica; if from fatty degeneration, Phosphorus; if from fibrous inflammation and degeneration, Bryonia; if there is great arterial excitement and delirium, Veratrum viride; if circulation sluggish, Digitalis. Secale has cured aneurism. Consult Carbo veg., Spigelia. See Heart Therapeutics.

After reading the entire issue, I was not sure whether this wasn’t a hoax. Are we supposed to laugh or to cry? Personally I did giggle a lot while reading this. But if I imagine for a minute that some homeopaths might take this seriously, I am not far from crying.

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.

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