MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

placebo

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Some of you will remember the saga of the British Chiropractic Association suing my friend and co-author Simon Singh (eventually losing the case, lots of money and all respect). One of the ‘hot potatoes’ in this case was the question whether chiropractic is effective for infant colic. This question is settled, I thought: IT HAS NOT BEEN SHOWN TO WORK BETTER THAN A PLACEBO.

Yet manipulators have not forgotten the defeat and are still plotting, it seems, to overturn it. Hence a new systematic review assessed the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants.

The authors reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). The inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. The authors included the following types of peer-reviewed studies in our search: RCTs, prospective cohort studies, observational studies, case–control studies, case series, questionnaire surveys and qualitative studies.

Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study. Only 5 studies were rated as high quality: four RCTs (low risk of bias) and a qualitative study.

The authors found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect).

Reduction in crying: RCTs mean difference.

The risk of reported adverse events was low (only 8 studies mentioned adverse effects at all, meaning that the rest were in breach of research and publication ethics): seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed.

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

The aim of this three-armed, parallel, randomized exploratory study was to determine, if two types of acupuncture (auricular acupuncture [AA] and traditional Chinese acupuncture [TCA]) were feasible and more effective than usual care (UC) alone for TBI–related headache. The subjects were previously deployed Service members (18–69 years old) with mild-to-moderate TBI and headaches. The interventions explored were UC alone or with the addition of AA or TCA. The primary outcome was the Headache Impact Test (HIT). Secondary outcomes were the Numerical Rating Scale (NRS), Pittsburgh Sleep Quality Index, Post-Traumatic Stress Checklist, Symptom Checklist-90-R, Medical Outcome Study Quality of Life (QoL), Beck Depression Inventory, State-Trait Anxiety Inventory, the Automated Neuropsychological Assessment Metrics, and expectancy of outcome and acupuncture efficacy.

Mean HIT scores decreased in the AA and TCA groups but increased slightly in the UC-only group from baseline to week 6 [AA, −10.2% (−6.4 points); TCA, −4.6% (−2.9 points); UC, +0.8% (+0.6 points)]. Both acupuncture groups had sizable decreases in NRS (Pain Best), compared to UC (TCA versus UC: P = 0.0008, d = 1.70; AA versus UC: P = 0.0127, d = 1.6). No statistically significant results were found for any other secondary outcome measures.

The authors concluded that both AA and TCA improved headache-related QoL more than UC did in Service members with TBI.

The stated aim of this study (to determine whether AA or TCA both with UC are more effective than UC alone) does not make sense and should therefore never have passed ethics review, in my view. The RCT followed a design which essentially is the much-lamented ‘A+B versus B’ protocol (except that a further groups ‘C+B’ was added). The nature of such designs is that there is no control for placebo effects, the extra time and attention, etc. Therefore, such studies cannot fail but generate positive results, even if the tested intervention is a placebo. In such trials, it is impossible to attribute any outcome to the experimental treatment. This means that the positive results are known before the first patient has been enrolled; hence they are an unethical waste of resources which can only serve one purpose: to mislead us. It also means that the conclusions drawn above are not correct.

An alternative and in my view more accurate conclusion would be this one: both AA and TCA had probably no effect; the improved headache-related QoL was due to the additional attention and expectation in the two experimental groups and is unrelated to the interventions tested in this study.

In our new book, MORE HARM THAN GOOD, we discuss that such trials are deceptive to the point of being unethical. Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.

This is the title of an editorial by Alan Schmukler. You probably remember him; I have featured him before, for instance here, here, and here. This is what was recently on Schmukler’s mind (I have added a few references referring to comments of mine added below):

England’s National Health Service (NHS) is proposing that NHS doctors no longer be permitted to prescribe homeopathic remedies [1]… They claim lack of evidence for effectiveness. Anyone who’s been remotely conscious the last 10 years will see this as a pretext. Homeopathy is practiced by board certified physicians in clinics and hospitals around the world [2]. The massive Swiss review of homeopathy, found it effective, safe and economical, and the Swiss incorporated homeopathy into their national health care system [3]…

The reason given for banning homeopathy and these nutrients is a lie. Why would the NHS ban safe, effective and affordable healing methods? [4] Without these methods, all that is left are prescription drugs. Apparently, someone at the  NHS has an interest in pushing expensive prescription drugs [5], rather than safer and cheaper alternatives. That someone, also wishes to deny people freedom of choice in medicine [6]. I say “someone”, because organizations don’t make decisions, people do. Who is that someone?  In looking for a suspect, we might ask, who is the chief executive of the organization? Who introduced this plan and is promoting it? Who at the NHS has the political clout?  Who was it that recently declared: “Homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work”.

The quote is from Simon Stevens, NHS England’s chief executive. He got the job in 2014, after ten years as a top executive at UnitedHealth, the largest health insurance company in America. His past work experiences and current activities show that he favors privatization [7]. That would make him an odd choice to run a healthcare system based on socialized medicine. In fact, he has been moving the NHS towards privatization and the corporate, profit based American model. [8] The last thing a privatizer in healthcare would want, are non-proprietary medicines, for which you can’t charge exorbitant fees [9]. Banning homeopathy on the NHS is just one small part of a larger plan to maximize corporate profits by letting corporations own and control the health care system [10].  Before they can do this, they have to eliminate alternative methods of treatment.

Personally, I think Schmukler is wrong – here is why:

1 The current argument is not about what doctors are permitted to do, but about what the NHS should do with our tax money.

2 Argumentum ad populum

3 Oh dear! Anyone who uses this report as evidence must be desperate – see for instance here.

4 Why indeed? Except highly dilute homeopathic remedies are pure placebos.

5 Maybe ‘someone’ merely wants to use effective medications rather than placebos.

6 Freedom of choice is a nonsense, if it is not guided by sound evidence – see here.

7 No, that’s Jeremy Hunt! But in any case privatisation might be more profitable with homeopathy – much higher profit margins without any investment into R&D.

8 No, this is Hunt again!

9 Homeopathic remedies are ideal for making vast profits: no research, no development, no cost for raw material, etc., etc.

10 I am sure Boiron et al would not mind stepping into the gap.

I very much look forward to the next outburst of Alan Schmukler and hope he will manage to think a bit clearer by then.

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.

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