MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

critical thinking

The subject of placebo is a complex but fascinating one, particularly for those interested in alternative medicine. Most sceptics believe that alternative therapies rely heavily, if not entirely, on the placebo effect. Some alternative practitioners, when unable to produce convincing evidence that their treatment is effective, seem to have now settled to admitting that their therapy works (mostly or entirely) via a placebo effect. They the hasten to add that this is perfectly fine, because it is just an explanation as to how it works – a mechanism of action, in other words. Causing benefit via a placebo effect still means, they insist, that their therapy is effective.

In a previous post, I have tried to demonstrate that this belief is erroneous and where the notion comes from. It originates, I believe, from a mistaken definition of ‘effectiveness’: for many alternative practitioners ‘effectiveness’ encompasses the specific plus the non-specific (e. g. placebo) effects of their therapy. In real medicine, ‘effectiveness’ is the degree to which a treatment works under real life conditions.

The ‘alternative’ definition is, of course, incorrect but alternative practitioners stubbornly refuse to acknowledge this fact. Here are just two reasons why it cannot be right:

  • If it were correct, it would be hardly conceivable to think of a treatment that is NOT effective. Applied with empathy and compassion, virtually all treatments – however devoid of specific effects – will produce a placebo effect. Thus they will all be effective, and the term would be superfluous because ‘treatment’ would automatically mean ‘effective’. An ineffective treatment would, in other words, be a contradiction in terms.
  • If it were correct, any pharmaceutical or devices company could legally market ineffective drugs or gadgets and rightly claim (or even prove) that they are effective. Any such therapy could very easily be shown to generate a placebo-effect under the right circumstances; and as long as this is the case, it would be certifiably effective.

I do sympathise with alt med enthusiasts who find this hard or even impossible to accept. They see almost every day how their placebo-therapy benefits their patients. (It seems worth remembering that not just the placebo phenomenon but several other factors are involved in such outcomes – take, for instance, the natural history of the disease and the regression towards the mean.) And they might think that my arguments are nothing but a devious attempt do away with the beneficial power of the placebo.

The truth, however, is that nobody wants to do anything of the sort; we all want to help patients as much as possible, and that does, of course, include the use of the placebo effect. In clinical practice, we usually want to maximise the placebo effect where possible. But for this goal, we do not require placebo therapies. If we administer a specifically effective therapy with compassion, we undoubtedly also generate a placebo response. In addition, our patients would benefit from the specific effects of the prescribed therapy. Both elements are essential for an optimal therapeutic response, and I don’t know any conventional healthcare professionals who do not aim at this optimal outcome.

Giving just placebos will not normally generate an optimal outcome, and therefore it cannot truly be in the interest of the patient. It is also ethically problematic because it usually entails a degree of deception of the patient. Moreover, placebo effects are unreliable and usually of short duration. Foremost, they do not normally cure a disease; they may alleviate symptoms but they almost never tackle their causes. These characteristics hardly make placebos an acceptable choice for routine clinical practice.

The bottom line is clear and simple: a drug that is not better than placebo can only be classified as being ineffective. The same applies to all non-drug therapies. Double standards are not acceptable in healthcare. And the demonstration of a placebo effect does not turn an ineffective therapy into an effective one.

I know that many alternative practitioners do not agree with this line of thought – so, let’s hear their counter-arguments.

This post is dedicated to Mel Koppelman.

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

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

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

Let’s start with the definitions.

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

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

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

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

What can be done about this unfortunate situation?

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

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

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

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

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

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

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

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

Alternative medicine has no shortage of research that suggests it to be effective. Almost invariably, however, one finds – when looking a bit more carefully at such investigations – that the positive conclusions are not warranted by the data. Here is an excellent, recent example:

This new study, authored by two Turkish nurses, was an RCT where the patients were randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in group 1 for 30 minutes. Reflexology was administered to both feet of subjects in group 2 for 40 minutes during weekly home visits. The subjects of group 3, the control group, received no intervention.

Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks.

Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05).

The authors concluded that aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.

I am sure that most readers have spotted the snag: the two interventions generated better outcomes than no therapy. It is quite simply wrong to assume that this outcome is specifically related to the two treatments. Both of these treatments are fairly agreeable and generate expectations, involve touch, attention and care. In my view, it is these latter factors which together have caused the better outcomes. And this is, of course, entirely unrelated to any specific effects of the two therapies.

This might well be trivial, but if such sloppy conclusions pollute the literature to the extend that they currently do in the realm of alternative medicine, it becomes important.

Acupuncture, like most other alternative therapies, is particular popular for indications that are

  1. chronic,
  2. associated with a high burden of suffering,
  3. not easily treatable with conventional therapies,
  4. are frequently resolved without any intervention.

Infertility or subfertility tick most of these boxes. It is therefore not surprising that acupuncturists the world over claim that acupuncture can cure infertility. But is this claim based on evidence or on wishful thinking?

The objective of this new study was to find out. Specifically, the authors wanted to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles, and increased fertility awareness.

In a pragmatic randomised controlled trial, with the A+B versus B design, sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%) compared to 40% of the lifestyle only participants. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group.

The authors concluded that the acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.

The first sentences of the authors’ discussion are, I think, revealing: The main findings were that this acupuncture intervention, compared to lifestyle only, resulted in significant increases in fertility awareness and quality of life measures in relation to wellbeing; it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings provide preliminary evidence that the acupuncture intervention is acceptable and is not inert and that acupuncture dose may have a significant influence on outcomes. 

In my view, the main findings of this study are entirely different. Let me propose alternatives:

  • In alternative medicine, if you did a lousy study, you can just call it a ‘pilot study’ and all is forgiven.
  • The infamous A+B vs B design continues to be popular for those who cannot bring themselves to publishing negative findings.
  • It works perfectly for subjective parameters but less convincingly for objective ones, such as pregnancy rates.
  • Doing such research on infertility is good for the cash flow of acupuncturists.
  • Making women aware of fertility increases (surprise, surprise!) fertility awareness.

No need to be so cynical!, some will think. After all, the results showed that women receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group. True! But there was no statistically significant difference between these two figures. And that means, the difference was a chance finding (which has no place in an abstract) which probably has no relevance whatsoever.

Or perhaps I am wrong?

I am told to always keep an open mind!

So, let’s keep our minds open to some truly alternative explanations. How about this one: regular acupuncture increases the rate of adultery, which, in turn, decreases the time to conception.

Makes sense, doesn’t it? Has anyone a better idea?

AROMATHERAPY is one of the most popular alternative therapies. The experience is usually pleasant enough, but what are the risks? None!!! At least this is what the therapists would claim. But is this true? Perhaps not. According to a recent press-release, the risks might be considerable.

Officials with the Tennessee Poison Control Center (TPC) are warning that they are seeing an increasing number of toxic exposures, mostly involving children, to essential oils used in aromatherapy. The TPC says the number of essential oil exposures doubled between 2011 and 2015, and 80 percent of those cases involved children. The primary route of poisoning is by ingestion, but also occurs with excessive or inappropriate application to the skin. Children are at risk because their skin easily absorbs oils and because they may try to ingest essential oils from the container.

“Tea tree oil is commonly cited, and most of those cases are accidental ingestions by children.” said Justin Loden, PharmD, certified specialist in Poison Information (CSPI) at TPC. Most essential oils have a pleasant smell but bitter taste, so children easily choke on them and aspirate the oil to their lungs, Loden said.

Several essential oils such as camphor, clove, lavender, eucalyptus, thyme, tea tree, and wintergreen oils are highly toxic. All of the oils produce oral and throat irritation, nausea, and vomiting when ingested. Most essential oils either produce central nervous system (CNS) stimulation, which results in agitation, hallucinations, delirium, and seizures or CNS depression, which results in lethargy and coma. Other toxic effects include painless chemical burns, hypotension, acute respiratory distress syndrome, acute liver failure, severe metabolic acidosis, and cerebral edema depending on which essential oil is in question.

Tennessee Poison Center Tips for using essential oils

  • Safely using and storing essential oils is extremely important
  • Use essential oil products ONLY for their intended purpose.
  • Use only the amount stated on the label/guide.
  • Do not swallow an essential oil unless the label says to do so.
  • Do not use a product on the skin unless the label says to do so.
  • Do not leave the product out (i.e. as a pesticide) unless the label says to do so.
  • If you have bottles of essential oils at home, keep them locked up, out of sight and reach of children and pet at all times. Children act fast, so do poisons.

Many will think that this is alarmist – but I don’t. In fact, in 2012, I published a systematic review aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. No, it was not funded by ‘BIG PHARMA’ but by THE ROYAL COLLEGE OF PHYSICIANS, LONDON.

Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects.

At the time, we concluded that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.

I might add – before the therapists start making comments – that, yes, aromatherapy is still dimensions safer than many conventional treatments. But remember: the value of a therapy is not determined by its safety but by the risk/benefit balance! And what are the proven benefits of aromatherapy, I ask you.

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. What other treatments did each group of patients receive?
  9. 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. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. 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 or just poor science?

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.

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?

 

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.

 

12998_2016_96_Fig3_HTMLThe 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!

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