MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

placebo

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Some doctors use homeopathy, and for proponents of homeopathy this has always been a strong argument for its effectiveness. They claim that someone who has studied medicine would not employ a therapy that does not work. I have long felt that this view is erroneous.

This article goes some way in finding out who is right. It was aimed at describing the use of homeopathy by physicians working in outpatient care, factors associated with prescribing homeopathy, and the therapeutic intentions and attitudes involved.

All physicians working in outpatient care in the Swiss Canton of Zurich in the year 2015 (n = 4072) were approached. Outcomes of the survey were:

  • association of prescribing homeopathy with medical specialties;
  • intentions behind prescriptions;
  • level of agreement with specific attitudes;
  • views towards homeopathy including explanatory models,
  • rating of homeopathy’s evidence base,
  • the endorsement of indications,
  • reimbursement of homeopathic treatment by statutory health insurance providers.

The participation rate was 38%, mean age 54 years, 61% male, and 40% specialised in general internal medicine. Homeopathy was prescribed at least once a year by 23% of the respondents. Medical specialisations associated with prescribing homeopathy were: no medical specialisation (OR 3.9; 95% CI 1.7-9.0), specialisation in paediatrics (OR 3.8 95% CI 1.8-8.0) and gynaecology/obstetrics (OR 3.1 95% CI 1.5-6.7).

Among prescribers, only 50% clearly intended to induce specific homeopathic effects, only 27% strongly adhered to homeopathic prescription doctrines, and only 23% thought there was scientific evidence to prove homeopathy’s effectiveness. Seeing homeopathy as a way to induce placebo effects had the strongest endorsement among prescribers and non-prescribers of homeopathy (63% and 74% endorsement respectively). Reimbursement of homeopathic remedies by statutory health insurance was rejected by 61% of all respondents

The authors concluded that medical specialties use homeopathy with significantly varying frequency and only half of the prescribers clearly intend to achieve specific effects. Moreover, the majority of prescribers acknowledge that effectiveness is unproven and give little importance to traditional principles behind homeopathy. Medical specialties and associated patient demands but also physicians’ openness towards placebo interventions may play a role in homeopathy prescriptions. Education should therefore address not only the evidence base of homeopathy, but also ethical dilemmas with placebo interventions.

These data suggest than many doctors use homeopathy as a placebo. And this is what I had always suspected. Certainly I did often employ it in this way when I still worked as a clinician. The logic of doing so is quite simple: there are many patients where, after running all necessary tests, you conclude that there is nothing wrong with them. You try your best to get the message across but it is not accepted by the patient who clearly wants to have a prescription for something. In the end, due to time pressure etc., you give up and prescribe a homeopathic remedy hoping that the placebo effect, regression towards the mean and the natural history of the condition will do the trick.

And often they do!

I do know that this is hardly good medicine and arguably even not entirely ethical, but it is the reality. If I found myself in the same situation again, I am not sure that I would not do something similar.

Guest post by Richard Rawlins MB BS MBA FRCS

Doctors who are registered medical practitioners (RMPs) must comply with the standards of practice set down by the General Medical Council. ‘Homeopathy’ is a specific system of medical care, devised by Dr Samuel Hahnemann in the nineteenth century, and comprises two distinct dimensions: (i) the establishment of a constructive therapeutic relationship between an empathic homeopath and a patient. This may provide benefit due to the non-specific effects of condolence, counselling, and care – and should be a component of the practice of all doctors in any event; (ii) the homeopathically prepared (HP) remedies that are generally prescribed. To avoid confusion, these two dimensions should not be conflated.

HP remedies may be obtained over the counter, prescribed by lay homeopaths and even given out by dentists and nurses on the grounds that “30C homeopathic arnica helps bruising”. The US Federal Trades Commission has stated that “The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted…accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.” (FTC Policy statement 2017).

Special focus should be brought to bear on the ethical, intellectual and professional obligations of those doctors registered as medical practitioners by the GMC and practicing homeopathy in the UK. Some homeopaths may intend taking advantage of gullible and vulnerable patients. Here I take it that those practitioners who prescribe homeopathic remedies sincerely do believe they have worthwhile effects, but I contend such practice generally fails to comply with ethical and professional standards as set down by the GMC. That is to be deprecated.

Systems to regulate medical practice in the British Isles have been devised since the middle ages. In 1518, Thomas Linacre founded the College of Physicians – based on systems he had seen in Europe. From 1704, the Society of Apothecaries licensed its members to prescribe and dispense medicines, and developed the profession of general practice. In order to protect the public from charlatans, quacks and fraudsters more effectively, the Medical Act of 1858 established formal statutory regulation of doctors by the General Medical Council. Registrants who are not deemed fit to practice may be struck off the register. They can still practice, but not as registered medical practitioners. They can still use the title ‘doctor’ (as can anyone), but not for fraudulent purposes.

Dr Samuel Hahnemann qualified in Saxony in 1781 and was a good doctor, but he became disillusioned with many of the practices and practitioners of his day. He wrote about his fellow doctors: “Precious and fragile human life, so easily destroyed, was frequently placed in jeopardy at the hands of these perverted people, especially since bleedings, emetics, purges, blistering plaster, fontanels, setons, caustics and cauterisations were used.” In 1796 he wrote to a friend, “I renounced the practice of medicine that I might no longer incur the risk of doing injury, and I engaged in chemistry exclusively and in literary occupations.”

Hahnemann went on to develop his own alternative system of health care, which he styled ‘Homoeopathy’. Published as the Organon of the Healing Arts in 1810, Hahnemann set out an idiosyncratic medical system based on identifying ‘remedies’ which in large doses, could produce symptoms comparable to those suffered by the patient. The remedies he prescribed were prepared with serial dilutions so that no active principle remained. Today’s homeopaths hold that a remedy’s ‘vital force’, ‘healing energy’ or ‘memory’ provides therapeutic benefit. That may be the case, but the consensus of informed scientific and medical opinion is that any effects of ‘homeopathy’ are as a result of contextual placebo effects. The remedies themselves cannot and do not have any effect. England’s Chief Medical Officer has described homeopathy’s principles as ‘rubbish’. The government’s Chief Scientific Adviser, Sir Mark Walport has said he would tell ministers, “My view, scientifically, is absolutely clear: homeopathy is nonsense. The most it can have is a placebo effect.” Simon Stevens, CEO of the NHS, when interviewed on Radio 4 said he agrees with Sir Mark – yet failed to explain why he had not included homeopathic remedies in the 2017 list of NHS proscribed medicines. That stance is being reviewed.

The GMC states, “Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected.” Those standards are set down in the GMC’s Good Medical Practice which advises, “Serious or persistent failure to follow this guidance will put your registration at risk.” The GMC standards are coherent with those of the American Medical Association’s Principles of Medical Ethics (2016).

In précis, the most relevant and important GMC standards are:

  • Make the care of your patient your first concern.
  • Give patients the information they want or need in a way they can understand.
  • Be honest and open and act with integrity.
  • Never abuse your patients’ trust in you or the public’s trust in the profession.
  • You are personally accountable for your professional practice and must always be prepared to justify your decisions and actions.
  • You must  prescribe drugs or treatment only when you are satisfied that the drugs or treatment serve the patient’s needs.                                                                                                                                             
  • You must provide effective treatments based on the best available evidence.
  • You must be satisfied that you have consent or other valid authority before you carry out any examination, investigation or provide treatment.
  • You must make good use of the resources available to you.

I contend that medical practitioners who prescribe homeopathic remedies regularly fail to meet these standards. They know perfectly well that the best available evidence indicates no support for the assertion that homeopathic remedies ‘serve the patient’s needs’, except as placebos; that the treatments have no specific effects; that the remedies are placebos; and that resources are wasted by expenditure on these ineffective remedies. Medical homeopaths invariably do not give patients this information; they fail to obtain properly informed consent; they do not justify their decisions and actions rationally; and they may be obtaining financial advantage by misrepresentation to insurance companies or the NHS. This is an abuse of the public’s trust in the medical profession.

The issue of informed consent is particularly important. GMC guidance states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

The GMC states that, “in order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options… risks can take a number of forms, but will usually be: side effects; complications; failure of an intervention to achieve the desired aim.” The risk of wasting money on ineffective remedies, whether NHS or private, and of delaying treatment known to be effective should also be discussed.

Homeopaths acknowledge that after ministration of remedies, some patients experience ‘aggravations’ – a worsening of symptoms, but they advise this is evidence that the remedy is ‘working’. Medical consensus is more likely to suggest ‘aggravations’ are evidence of an underlying psychological component to the patient’s condition. Suggestions that remedies themselves have any effect, good or bad, is misrepresentation and may be fraud. Offering patients sugar pills with a claim the pills have therapeutic effects means lying to them, and is an abuse of trust.

Homeopaths’ system of diagnosis and prescription of remedies requires them to have beliefs for which there is no plausible evidence base. The Oxford Dictionary defines ‘belief’ as “assent to a proposition, statement or fact, especially on the grounds of testimony or authority, or in the absence of proof or conclusive evidence.” It might be acceptable to practice ‘homeopathy’ as a counselling modality, providing the practitioner complies with the GMC standard that, “You must not express your personal beliefs to patients in ways that exploit their vulnerability or are likely to cause them distress.”

Homeopaths are invariably non-compliant in obtaining fully informed consent. Such a failing is an abuse of patients’ trust in the medical profession. Doctors might be determined to be unfit to practice unless they clearly justify their prescriptions, and identify the evidence that supports them. All these issues should also be explored during the doctor’s annual appraisal, without which a registered medical practitioner will not be licensed to practice. Even registration without a licence requires compliance with the standards. Appraisal can be carried out by non-homeopaths, as the issue is not the assessment of the standard of ‘homeopathic practice’, but compliance with GMC standards of good medical practice.

If a medical homeopath wishes to be GMC compliant, they must properly inform patients about contentious issues. I suggest that consent should be obtained along the lines: “I propose prescribing you a remedy comprising sugar pills impregnated with a solution which has been diluted to such an extent that a sphere of water the size of the Earth’s average radius to the Sun would probably contain no more than one molecule of the original substance. Nevertheless, my clinical experience suggests to me that this remedy will improve your condition. You need to understand that colleagues who practise conventional evidence-based scientific medicine regard my belief as implausible and the methods I use as ‘alternative.’ I believe the remedy will help you, but I have no evidence accepted by the majority of doctors that the intervention I propose will achieve the desired effects. I do not believe that taking a homeopathic remedy will delay any other treatment which might reasonably help your condition and I invite you to take this remedy with understanding of the issues I have outlined.” A copy of the consent should be placed in the patient’s records.

Those who defend the right of registered medical practitioners to prescribe HP remedies do so with arguments fatally holed by a myriad of logical fallacies. Some arguments are (with fallacies in parenthesis):

  • “Homeopathy has been used for over two hundred years” (appeal to tradition and argument from ignorance);
  • “It has become very popular and is what patients want (appeal to popularity);
  • “Homeopathy has the capacity to help patients” (red herring, because present consideration is about the value of HP remedies, not relationships);
  • “Remedies are cheap” (red herring);
  • “Homeopathy does not do any harm” (irrelevant and a red herring);
  • “Pharmaceuticals have side effects” (tu quoque and red herring);
  • “The Royal Family use it” (appeal to irrelevant authority);
  • “The remedies enhance the doctor/patient relationship (straw man);
  • “Science does not know everything” (red herring and false dichotomy);
  • “Those who oppose us don’t understand homeopathy” (argumentum ad hominem and ‘poisoning the well’);
  • “I have the evidence of patients’ anecdotes and testimonials” (pseudoscience, confirmation bias and cherry picking);
  • “Homeopathic doctors are caring people” (red herring and straw man);
  • “I’ve got much evidence of  patients taking remedies and getting better” (post hoc ergo propter hoc – ‘after this, therefore because of this’ – confusion of coincidence with causation).

The latter most perverse fallacy is the foundation of homeopathic practice, based on identifying a remedy whereby ‘like cures like’ – a principle based on post hoc fallacy for which there is no scientifically credible evidence.

Unless and until medical homeopaths understand the intellectual environment in which they practice, are prepared to properly inform their patients, and obtain consent for treatment having done so, they should not prescribe homeopathic remedies. Fortunately, there is no evidence that patients who are prescribed HP remedies by empathic GMC registered homeopaths have any different outcomes from those prescribed pure sugar pills – even if they are told they are placebos. However, trust in the medical profession can only be maintained if deceptive practices are set aside and full explanations for proposed interventions are offered. Given the scientific consensus, patients have to face up to the fact that to the highest degree of probability, HP remedies have no value. Regrettably, too many patients and even homeopaths are in denial. Medical homeopaths should continue to serve their patients with care, compassion and intellectual honesty, but if they are to comply with the standards required for GMC registration, they should not prescribe homeopathically prepared remedies.

This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:

  1. low frequency manual acupuncture (LF-MA),
  2. high frequency manual acupuncture (HF-MA),
  3. low frequency electro acupuncture (LF-EA)
  4. and high frequency electro acupuncture (HF-EA).

A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.

During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.

The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.

Let me explain:

  • acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
  • the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
  • acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?

The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.

Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.

It used to be called ‘good bedside manners’. The term is an umbrella for a range of attitudes and behaviours including compassion, empathy and conveying positive messages. What could be more obvious than the assumption that good bedside manners are better than bad ones?

But as sceptics, we need to doubt obvious assumptions! Where is the evidence? we need to ask. So, where is the evidence that positive messages have any clinical effects? A meta-analysis has tackled the issue, and the results are noteworthy.

The researchers aimed to estimate the efficacy of positive messages for pain reduction. They included RCTs of the effects of positive messages. Their primary outcome measures were differences in patient- or observer reported pain between groups who were given positive messages and those who were not. Of the 16 RCTs (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was −0.31 (95% CI −0.61 to −0.01, P = 0.04, I² = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size −0.17, 95% CI −0.54 to 0.19, P = 0.36, I² = 84%). The authors concluded that care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high quality studies to confirm (or falsify) our result.

The 1st author of this paper published a comment in which he stated that our recent mega-study with 12 randomized trials confirmed that doctors who use positive language reduce patient pain by a similar amount to drugs. Other trials show that positive messages can:

• help Parkinson’s patients move their hands faster,
• increase ‘peak flow’ (a measure of how much air is breathed) in asthma patients,
• improve the diameter of arteries in heart surgery patients, and
• reduce the amount of pain medication patients use.

The way a positive message seems to help is biological. When a patient anticipates a good thing happening (for example that their pain will go away), this activates parts of the brain that help the body make its own drugs like endorphins. A positive doctor may also help a patient relax which can also improve health.

I am not sure that this is entirely correct. When the authors excluded the methodologically weak and therefore unreliable studies, the effect was no longer significant. That is to say, it was likely due to chance.

And what about the other papers cited above? I am not sure about them either. Firstly, they do not necessarily show that positive messages are effective. Secondly, there is just one study for each claim, and one swallow does not make a summer; we would need independent replications.

So, am I saying that being positive as a clinician is ineffective? No! I am saying that the evidence is too flimsy to be sure. And possibly, this means that the effect of positive messages is smaller than we all thought.

This double-blind RCT aimed to test the efficacy of self-administered acupressure for pain and physical function in adults with knee osteoarthritis (KOA).

150 patients with symptomatic KOA participated and were randomized to

  1. verum acupressure,
  2. sham acupressure,
  3. or usual care.

Verum and sham, but not usual care, participants were taught to self-apply acupressure once daily, five days/week for eight weeks. Assessments were collected at baseline, 4 and 8 weeks. The numeric rating scale (NRS) for pain was administered during weekly phone calls. Outcomes included the WOMAC pain subscale (primary), the NRS and physical function measures (secondary). Linear mixed regression was conducted to test between group differences in mean changes from baseline for the outcomes at eight weeks.

Compared with usual care, both verum and sham participants experienced significant improvements in WOMAC pain, NRS pain and WOMAC function at 8 weeks. There were no significant differences between verum and sham acupressure groups in any of the outcomes.

The authors concluded that self-administered acupressure is superior to usual care in pain and physical function improvement for older people with KOA. The reason for the benefits is unclear and placebo effects may have played a role.

Another very odd conclusion!

The authors’ stated aim was to TEST THE EFFICACY OF ACUPRESSURE. To achieve this aim, they rightly compared it to a placebo (sham) intervention. This comparison did not show any differences between the two. Ergo, the only correct conclusion is that acupressure is a placebo.

I know, the authors (sort of) try to say this in their conclusions: placebo effects may have played a role. But surely, this is more than a little confusing. Placebo effects were quite evidently the sole cause of the observed outcomes. Is it ethical to confuse the public in this way, I wonder.

 

 

The aim of this pragmatic study was “to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.”

Patients with allergic asthma were included in a controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months plus routine care, or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1–7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0–100). Outcome parameters were assessed at baseline and at 3 and 6 months.

A total of 1,445 patients were randomized and included in the analysis (184 patients randomized to acupuncture plus routine care and 173 to routine care alone, and 1,088 in the nonrandomized acupuncture plus routine care group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5–1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0–4.0]; mental 4.0 [2.1–6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.

The authors concluded that in patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

We have been over this so many times (see for instance here, here and here) that I am almost a little embarrassed to explain it again: it is fairly easy to design an RCT such that it can only produce a positive result. The currently most popular way to achieve this aim in alternative medicine research is to do a ‘A+B versus B’ study, where A = the experimental treatment, and B = routine care. As A always amounts to more than nothing – in the above trial acupuncture would have placebo effects and the extra attention would also amount to something – A+B must always be more than B alone. The easiest way of thinking of this is to imagine that A and B are both finite amounts of money; everyone can understand that A+B must always be more than B!

Why then do acupuncture researchers not get the point? Are they that stupid? I happen to know some of the authors of the above paper personally, and I can assure you, they are not stupid!

So, why?

I am afraid there is only one reason I can think of: they know perfectly well that such an RCT can only produce a positive finding, and precisely that is their reason for conducting such a study. In other words, they are not using science to test a hypothesis, they deliberately abuse it to promote their pet therapy or hypothesis.

As I stated above, it is fairly easy to design an RCT such that it can only produce a positive result. Yet, it is arguably also unethical, perhaps even fraudulent, to do this. In my view, such RCTs amount to pseudoscience and scientific misconduct.

Acupuncture is little more than a theatrical placebo! If we confront an acupuncture fan with this statement, he/she is bound to argue that there are some indications for which the evidence is soundly positive. One of these conditions, they would claim, is nausea and vomiting. But how strong are these data? A new study sheds some light on this question.

The objective of this RCT was to evaluate if consumption of antiemetics and eating capacity differed between patients receiving verum acupuncture, sham acupuncture, or standard care only during radiotherapy. Patients were randomized to verum (n = 100) or sham (n = 100) acupuncture (telescopic blunt sham needle) (12 sessions) and registered daily their consumption of antiemetics and eating capacity. A standard care group (n = 62) received standard care only.

The results show that more patients in the verum and the sham acupuncture group did not need any antiemetic medications, as compared to the standard care group after receiving 27 Gray dose of radiotherapy. More patients in the verum and the sham acupuncture group were capable of eating as usual, compared to the standard care group. Patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.

The authors concluded that patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.

I find these conclusions odd because they seem to state that acupuncture was more effective than standard care. Subsequently – almost as an afterthought – they mention that its effects are brought about by nonspecific effects. This is grossly misleading, in my view.

The study was designed as a comparison between real and sham acupuncture, and the standard care group was not a randomised comparison group. Therefore, the main result and conclusion has to focus on the comparison between verum and sham acupuncture. This comparison shows that the two did not produce different result. Therefore, the study shows that acupuncture was not effective.

A much more reasonable conclusion would have been: THIS STUDY FAILED TO FIND SIGNIFICANT EFFECTS OF ACUPUNCTURE BEYOND PLACEBO.

‘Country News’ just published an article about our heir to the throne. Here is an excerpt:

The Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

The prince made these comments to experts at a summit at the Royal Society in London as part of a global battle against the growing threat of antibiotic resistance. ‘‘In fact, it was one of the reasons I converted my farming operation to an organic, or agro-ecological, system over 30 years ago, and why incidentally we have been successfully using homeopathic — yes, homeopathic — treatments for my cattle and sheep as part of a program to reduce the use of antibiotics,’’ Prince Charles said. Calling for ‘‘urgent and coherent’’ global action, he said antibiotics were being overused. ‘‘It must be incredibly frustrating to witness the fact that, as has been pointed out by many authorities, antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, as a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.’’

The prince continued: ‘‘I find it difficult to understand how we can continue to allow most of the antibiotics in farming, many of which are also used in human medicine, to be administered to healthy animals… Could we not devise more effective systems where we reserve antibiotics for treating animals where the use is fully justified by the seriousness of the illness?’’

END OF EXCERPT

Charles seems to have a few reasonable points her. Sadly he then spoils it all by not being able to resist his passion for quackery.

  • Yes, we have over-used antibiotics both in human and in veterinary medicine.
  • Yes, this has now gone so far that it now endangers our health.
  • Yes, it is a scandal that so little has happened in this respect, despite us knowing about the problem for many years.
  • No, homeopathy is not the solution to any of the above!!!

The Prince claims he has been ‘successfully using homeopathy’. This is nonsense, and he should know it. Highly diluted homeopathic remedies are pure placebos, and to use placebos for sick animals cannot be a good idea. For those who need the evidence for these (all too obvious) statements, here it is:

A recent systematic review assessed the efficacy of homeopathy in cattle, pigs and poultry. Only peer-reviewed publications dealing with homeopathic remedies, which could possibly replace or prevent the use of antibiotics in the case of infective diseases or growth promotion in livestock were included. Search results revealed a total number of 52 trials performed within 48 publications fulfilling the predefined criteria. Twenty-eight trials were in favour of homeopathy, with 26 trials showing a significantly higher efficacy in comparison to a control group, whereas 22 showed no medicinal effect. Cure rates for the treatments with antibiotics, homeopathy or placebo varied to a high degree, while the remedy used did not seem to make a big difference. No study had been repeated under comparable conditions. Consequently, the use of homeopathy cannot claim to have sufficient prognostic validity where efficacy is concerned. When striving for high therapeutic success in treatment, the potential of homeopathy in replacing or reducing antibiotics can only be validated if evidence of efficacy is confirmed by randomised controlled trials under modified conditions.

If we want to reduce antibiotics, we need to stop using them for situations where they are not necessary, and we must improve husbandry such that antibiotics are not required for disease prevention. To a large extent this is a question of educating those who are responsible for administering antibiotics. Education has to be rational and evidence-based. Homeopathy is irrational and believe-based.

Yet again, Prince Charles’ views turn out to be a hindrance to progress.

God save the Queen!

A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).

The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”

The authors were, of course, well advised to be so atypically cautious:

  • Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
  • Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
  • The effect size of the benefit is tiny and of doubtful clinical relevance.

My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.

So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.

Prof Walach has featured on this blog before, for instance here, and here. He is a psychologist by training and a vocal and prominent advocate of several bogus treatments, including homeopathy. He also is the editor in chief of the journal ‘Complementary Medicine Research’ and regularly uses this position to sing the praise of homeopathy. There is a degree of mystery about his affiliation: he informed me about 10 months ago that he has left his post at the Europa Universität Viadrina, Frankfurt/Oder (“Dass ich als “ehemaliger Professor” geführt werde liegt daran, dass ich  Ende Januar aufgehört habe. Meine Stelle ist ausgelaufen und ich habe
sie nicht mehr verlängert.”). Yet all, even his recent papers still carry this address.

His latest article is entitled ‘The future of homeopathy’ is no exception. It is remarkable not just because of the mysterious affiliation but also – and mostly – because of its content. Here is my translation of a brief passage from this paper [I added some numbers in square brackets which refer to footnotes below].

START OF MY TRANSLATION

It is entirely undisputed that homeopathy with its therapeutic principles runs against the mainstream of science; and in this, Weymayr [1] is correct. However, to build on this fact a veritable research prohibition, such as the ‘scientability-concept’ suggests, is not just wrong from a science theoretical perspective, but… also discloses a dogmatic and unscientific stance.

If we see things soberly, homeopathy is – from a science theory point of view – an anomaly: empiric data prove that effects appear regularly and more and more frequently [2].  This is being demonstrated with meta-analyses of placebo-controlled clinical trials. And this also shows with our own provings, which conform well with the newly developed standards as well as with the newer provings. Effects are furthermore noted with such frequency in animal and plant-based studies. Contrary to often voiced statements, there are also models which produce replicated effects – for instance the model of children with ADHD which is currently being replicated. Repeatedly high quality pilot studies emerge, such as the one by Gassmann et al., which show that unexpected effects also appear with higher potencies, documented with objective methods. Homeopathy proves itself as useful in large pragmatic trials of which we, however, have far too few. And let’s not forget: homeopathy is pragmatically useful. Even though aggravations do occur occasionally during homeopathic treatments, the claim that homeopathy is dangerous is a careless interpretation of the data. [3]

In what way is homeopathy an anomaly? I have already years ago argued that the signature of the data does not suggest that we are dealing with a classical local effect. This would be an effect which would conform with the usual criterion of causality and would thus be stable, regular and more and more evident with improved experimentation. It is unnecessary to repeat this argument [4] for the purpose of this editorial. But precisely the question of the classic causal effect is the controversy. And exactly this is the issue used by the new wave of critic of homeopathy which is openly aimed at the demise of homeopathy. This situation occurs because also the homeopaths are victims of the misapprehension  that homeopathy is based on a classic causal process. But this assumption is most likely wrong, and homeopaths would be well-advised on the one side to point to the empiric evidence, and on the other side to practice theoretical chastity making clear that, for the time being, we have not a clue how homeopathy functions. This is the typical situation when a scientific anomaly occurs…

My prognosis would be: if we stop to misunderstand homeopathy as a classic causal phenomenon and instead view and research it as a non-classical phenomenon, homeopathy would have a chance and science would get richer by a new category of phenomena. This approach will prompt criticism, because it renders the world more complex rather than simpler. But this cannot be changed. Perhaps a new era of therapeutics might even emerge which does not abolish the molecular paradigm but makes it appear as one of several possibilities. [5]

END OF MY TRANSLATION

For those of you who can read German, here is the original text with references:

Dass die Homöopathie mit ihren therapeutischen Prinzipien dem Hauptstrom der Wissenschaft immer schon zuwiderlief, ist völlig unbestritten, und darin hat Weymayr recht. Aber auf dieser Tatsache ein regelrechtes «Forschungsverbot» aufbauen zu wollen, wie es das Szientabilitätskonzept vorsieht, das ist nicht nur wissenschaftstheoretisch absolut falsch, wie wir in einer Replik gezeigt haben [2], sondern offenbart auch eine dogmatische und unwissenschaftliche Einstellung.

Wenn man die Sache nüchtern sieht, ist die Homöopathie – wissenschaftstheoretisch betrachtet – eine Anomalie [3]: Empirische Daten belegen, dass immer wieder und insgesamt häufiger als zufällig erwartet Effekte auftreten. Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf. Entgegen oft gehörten Äußerungen gibt es durchaus auch Modelle, die replizierte Effekte ergeben – etwa das Modell homöopathischer Behandlung von Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätssyndrom [17,18], das gerade repliziert wird [19]. Immer wieder gibt es qualitativ hochwertige Pilotstudien, wie die unlängst publizierte von Gassmann et al. [20], die zeigen, dass unerwartete Effekte auch unter höheren Potenzen und dokumentiert mit objektiven Methoden zu beobachten sind. Homöopathie erweist sich in großen pragmatischen Studien, von denen es allerdings viel zu wenige gibt, als nützlich [21,22,23]. Und nicht zu vergessen: Homöopathie ist pragmatisch hilfreich [24,25,26,27]. Zwar kommt es bei homöopathischer Behandlung gelegentlich zu einer Erstverschlimmerung [28,29], aber die Behauptung, Homöopathie sei gefährlich [30], ist eine fahrlässige Interpretation der Daten [31].

Inwiefern ist die Homöopathie dann eine Anomalie? Ich habe schon vor Jahren argumentiert, dass die Signatur der Daten in der Homöopathie nicht dafür spricht, dass wir es mit einem klassischen, lokalen Effekt zu tun haben [32]. Das wäre ein Effekt, der dem gewöhnlichen Kriterium der Kausalität entspräche und somit stabil, regelmäßig und bei immer besserer Experimentierkunst immer deutlicher hervorträte. Dieses Argument jetzt wieder aufzurollen, ist im Rahmen eines Editorials müßig. Aber genau die Frage nach einem klassisch-kausalen Effekt ist letztlich der Stein des Anstoßes. Und genau diesen Anstoß nimmt nun die neue Welle der Homöopathiekritik, die erklärtermaßen auf die Abschaffung der Homöopathie abzielt, zu ihrem Anlass. Diese Situation ergibt sich, weil auch die Homöopathen dem Selbstmissverständnis aufsitzen, Homöopathie sei ein klassisch-kausaler Prozess. Das ist höchstwahrscheinlich falsch, und die Homöopathie wäre gut beraten, einerseits auf die empirischen Befunde hinzuweisen und auf der anderen Seite theoretische Enthaltsamkeit zu üben und klarzulegen, dass wir vorläufig keinerlei Ahnung haben, wie Homöopathie funktioniert. Das ist die typische Situation, wenn eine wissenschaftliche Anomalie vorliegt…

Meine Prognose wäre: Wenn wir aufhören, die Homöopathie als klassisches Phänomen misszuverstehen, und sie stattdessen als ein mögliches nichtklassisches Phänomen betrachten und beforschen, dann hat die Homöopathie eine Chance und die Wissenschaft wird um eine neue Kategorie von Phänomenen reicher. Dieser Ansatz wird Kritik hervorrufen, denn er macht die Welt eher komplexer als einfacher. Aber das lässt sich nicht ändern. Vielleicht kann sogar eine neue Ära der Therapie beginnen, die das molekulare Paradigma nicht abschafft, aber als eine von mehreren Möglichkeiten erscheinen lässt.


Rather than commenting on this text in full detail, I simply want to provide a few explanations [they refer to the numbers in square brackets inserted by me into my translation] in order to facilitate understanding. I hope, however, that my readers will comment as much as they feel like.

1) Weymayr argued that certain fields lack plausibility to a degree that they do not merit being investigated. Here is an abstract of an article by him:

Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.

2) A scientific anomaly is “something which cannot be explained by currently accepted scientific theories. Sometimes the new phenomenon leads to new rules or theories, e.g., the discovery of x-rays and radiation.

3) Even a minimal amount of critical thinking leads to the conclusion that the claims made about homeopathy in this paragraph are mostly not true or exaggerated. On this blog, there is plenty of evidence to contradict Walach on all the points he made here.

4) Walach’s argument is detailed in this article:

Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, ‘information’ or ‘energy’ is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung’s notion of synchronicity and make some predictions following this analysis.

5) In a nutshell, Walach seems to be saying:

  • the empirical evidence for homeopathy is strong;
  • nobody understands the mechanisms by which the effects of homeopathy are brought about;
  • if we all claim that homeopathy is a ‘scientific anomaly’ which operates according to Jung’s notion of synchronicity, the discrepancy between strong evidence and lack of plausible explanation disappears and everyone can be happy.

This is wrong for the following reasons, in my view:

  • the evidence is not strong but negative or extremely weak;
  • we understand very well that the effects of homeopathy are due to non-specific effects;
  • therefore there is no need for a new paradigm;
  • Jung’s notion of synchronicity is pure speculation and not applicable to therapeutics.

In summary, Prof Walach would do well to stop philosophising about homeopathy, read up about critical analysis, fine-tune his BS-detector and familiarise himself with Occam’s razor.

 

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