When sceptics claim that no positive trials of homeopathy exist, they are clearly mistaken. The truth is that there are plenty of them! But many, if not most are of such poor quality that it is safe to suspect they are false-positives. Here is a recent example of this type of scenario.
This new study investigated the clinical effectiveness of a homeopathic add-on therapy in children with upper respiratory tract infections (URTI). It was designed as a randomized, controlled, multi-national clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. IFC tablets contain a fixed combination of 6 homeopathic single substances (Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuanha D3, and Phosphorus D5). IFC was administered according to the following schedule: 8 tablets/day during the first 72 hours, 3 tablets/day during the following 96 hours. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
A total of 261 paediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, their symptoms resolved significantly earlier, they had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less during the entire URTI episode.
Days until symptom resolution (WURSS-21 item 1) in both treatment groups.
The light grey (IFC-group) and dark grey (ST-group) lines are polynomial fit curves. The dashed line estimates the between-group difference in the number of days after which 50% of patients had symptom resolution.
Between-group differences (IFC − ST) with 95% confidence intervals in the proportion of patients without fever during the observational period.
A difference (%) greater than zero indicates a higher proportion without fever in the IFC-group. Day 1 = Baseline.
The authors concluded that IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use.
On the one hand, this study has many features of a rigorous trial. I am sure that homeopaths will praise its quality, sample size, clever statistical analyses, etc. etc. The trial will therefore be cited by enthusiasts as a poof for homeopathy’s effectiveness and for homeopaths’ laudable research efforts.
On the other hand, one only needs to apply a minimum of critical thinking to find that it has been designed such that it cannot possibly generate a negative result. In fact, the paper turns out to be much more of a marketing exercise than a research effort.
The homeopathic remedy was given as an add-on therapy according to a fairly tedious ritual. It is safe to assume that this ritual created expectations on the parents’ side. These expectations alone suffice to account for the small group differences which seemingly favour homeopathy. The study follows the infamous ‘A+B versus B’ design which (as we have discussed ad nauseam on this blog) is extremely likely to generate false positive findings.
Why do researchers nevertheless plan, conduct and publish such studies (in the case of the paper discussed here, they even published their findings twice! Their previous paper included a larger group of patients of all ages and concluded that the homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated.)? The answer can be found, I think, in the small print at the end of the paper:
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Robert van Haselen has received a consultancy fee from the Deutsche Homöopathie-Union. Manuela Thinesse-Mallwitz received a fee from the Deutsche Homöopathie-Union for coordinating the study. Vitaliy Maidannyk received a fee from the Deutsche Homöopathie-Union for coordinating the study. Stephen L. Buskin is a member of the Advisory Board of the Deutsche Homöopathie-Union. Stephan Weber received a fee from the Deutsche Homöopathie-Union for contributing to the study. Thomas Keller received a fee from the Deutsche Homöopathie-Union for contributing to the study. Julia Burkart is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid. Petra Klement is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Deutsche Homöopathie-Union, Karlsruhe, Germany. Deutsche Homöopathie-Union manufactures the homeopathic medicinal product used in this study and provided the publication fee.
I REST MY CASE
Two of my recent posts directly related to the German ‘Heilpraktiker’ (here and here) and to the risks which this profession poses to public health in Germany. As this is a very German phenomenon, it might be time to provide some explanations to my non-German readers.
The German ‘Heilpraktiker’ (literally translated: healing practitioner) is perhaps best understood by its fascinating history. When the Nazis came to power in 1933, German health care was dominated by lay practitioners who were organised in multiple organisations struggling for recognition. The Nazis felt the need to re-organise this situation to bring it under their control. At the same time, the Nazis promoted their concept of ‘Neue Deutsche Heilkunde’ (New German Medicine) which entailed the integration – perhaps more a shot-gun marriage – of conventional and alternative medicine. I have published about the rather bizarre history of the ‘New German Medicine’ in 2001:
The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker‘ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.
The Nazis thus offered to grant all alternative practitioners official recognition by establishing them under the newly created umbrella of ‘Heilpraktiker’. To please the powerful lobby of conventional doctors, they decreed that the ‘Heilpraktiker’ was barred from educating a second generation of this profession. Therefore, the Heilpraktiker was destined to become extinct within decades.
Several of the Nazi rulers were staunch supporters of homeopathy and other forms of alternative medicine. They hoped that alternative medicine would soon have become an established part of ‘New German Medicine’. For a range of reasons, this never happened.
After the war, the Heilpraktiker went to court and won the right to educate their own students. Today they are a profession that uses homeopathy extensively. The German Heilpraktiker has no mandatory medical training; a simple test to show that they know the legal limits of their profession suffices for receiving an almost unrestricted licence for practicing medicine as long as they want.
You may not believe me – many readers of my blog seem to think that I spend my time spinning the truth – therefore let me show you an article by another author on the same subject:
In Germany, the naturopathic practitioner, the “Heilpraktiker”, is allowed to practice medicine, like medically trained physicians. The German heilpraktiker, a specific German phenomenon embedded in the country’s history, practices medicine without being obliged to undertake any medical teaching or training. Anybody 25 years old or older, with a secondary school certificate, and free of disease can participate in a test, conducted by the local health authorities to “exclude danger to the health of the nation.” In the case of failure, this test can be repeated ad libitum. Having passed this test, the heilpraktiker is allowed to practice the whole realm of medicine, except for gynecology, dentistry, prescription of medication, and healing infectious diseases. There is no more state control during the heilpraktiker’s working life, except in those practices applying invasive methods, such as infusions, injections, oxygen therapy, and acupuncture. These practices are inspected by the public health department based on the Infection Protection Act. Although several cases of fatal errors in treatment are known, the greatest risk in the heilpraktiker’s practice is the omission of proper diagnostics and therapies, which is risk by omission. In this paper, the history of the heilpraktiker in Germany as well as the task of the Public Health Departments in testing the candidates are shown. The data of 345 tests from 2004-2007 in the Rhein-Main area are presented, with 53% of the participants failing. Concerning the hygiene control visits, a concept for hygiene was lacking in 79% of 109 practices, while in 49% a concept for cleaning and disinfection was also missing. In 60% of the practices, a dispenser for hand disinfection was lacking. Recommended improvements were quickly performed in most practices. In conclusion, the current legal regulation, i.e., testing the candidates only once before practicing for a lifetime, does not sufficiently protect the population against danger caused by false diagnostics and (invasive) therapy of the heilpraktiker. Considering the population’s increasing interest and use of complementary and alternative medicine (CAM) with a heilpraktiker being frequently consulted, there are growing concerns in health services, regarding (1) how to regulate CAM professions and natural health procedures, (2) how to incorporate safe CAM into school medicine, and (3) how best to protect the public from a wide range of possible CAM-conventional medicine interactions.
We investigated to what extent psychiatric inpatients consult Heilpraktiker, i.e. non-academically trained providers of complementary and alternative medicine (CAM), which diagnostic and therapeutic methods Heilpraktiker employ, how patients assess Heilpraictikers’ professional competence, CAM in general and issues of satisfaction for those who have had experience with Heilpraktiker. Four hundred and seventy three patients admitted to a psychiatric university department during a 9-month period filled out a questionnaire developed for this investigation. About one third of the patients had consulted a Heilpraktiker, a quarter of these for their current psychiatric illness. Women were in the majority. Patients with the highest secondary school education consulted Heilpraktiker less often. There was considerable ‘customer loyalty’ towards Heilpraktiker. Largely the same diagnostic and treatment methods were employed for mental illness as for somatic complaints. Except for iridology, exotic or dangerous methods played a secondary role. Patients generally revealed a very positive attitude toward Heilpraktiker and CAM, although methods were rated differently. CAM enjoyed greater appreciation among women and patients who had consulted Heilpraktiker. Patients with personal experience were, on the whole, very satisfied with the professional competence, with the atmosphere in the practice and staff concern for the patient’s well-being. Degree of satisfaction correlated closely with frequency of consultation. More patients with neurotic disorders considered the cost unreasonable than others, despite comparatively frequent visits. Psychiatric patients seek out Heilpraktiker to a considerable degree. Especially those who have relevant experience rank Heilpraktiker highly, in particular due to their ‘psychotherapeutic’ attitude, but professional competence is also valued. Methods of CAM received mixed reviews from patients but are generally seen in a positive light. It is recommended that doctors collecting case history data on their patients also ask about experience with alternative practitioners and treatments.
Unsurprisingly, there are numerous reports of Heilpraktiker doing harm to their patients. However, such cases hardly ever get reported in the medical literature. Because there is no effective post-marketing surveillance system in this area, the frequency of harm is essentially unknown.
In my view, it is high time that German officials cast a critical eye on this sector. The incidents mentioned above seem to confirm the urgency of this view.
A thorough report by the Australian group ‘friends of science in medicine’ has just been published. It casts considerable doubt about the therapeutic value of acupuncture. As I think it is a report well worth reading, I reproduce (with the permission of the authors) a large section below:
What could be the mechanisms by which acupuncture might work?
The proponents of acupuncture have postulated possible mechanisms involving neurovascular bundles, trigger points, connective tissue fascial planes, electrical impedance, migration of nuclear tracers, and other factors. These studies are flawed, inconclusive, contradict one another, and have not been replicated. However, interest in acupuncture, particularly for analgesia, has been related to the ‘gate control’ theory (R. Melzack and P.D. Wall, “Pain mechanisms: a new theory”). According to this theory, the activation of large sensory fibres (touch pressure and vibration) inhibits transmission of nociceptive (pain recognising) pathways carried by small unmyelinated nerve fibres. This was postulated to occur in the spinal cord and might explain the effect of ‘rubbing’ the skin to reduce acute pain, the use of ‘counter irritants’, defined by the USA FDA as “externally applied substances that cause irritation or mild inflammation of the skin for the purpose of relieving pain in muscles, joints and viscera distal to the site of application”. It has been suggested that acupuncture could act as a counter irritant. Interest grew, in the 1970s, with the discovery of brain endogenous opioid peptides, which mimic the actions of morphine on pain. These discoveries triggered extensive research, both in China and around the world, on the involvement of endogenous opioid peptides and a plethora of many neuropeptides and purines in acupunctureinduced analgesia (H.M. Langevin et al., “Mechanical signaling through connective tissue: A mechanism for the therapeutic effect of acupuncture,” N. Goldman et al., “Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture,” Z.Q. Zhao “Neural mechanism underlying acupuncture analgesia”.) The discovery of novel neurotransmitters capable of affecting nociception gave extra impetus to explain some analgesic responses to sensory stimulation (e.g. mini-review on “Acupuncture and endorphins” in Neuroscience Letters). However while the concept that sensory stimulation affects pain sensation is well established, efforts to date have not established that this phenomenon is responsible for acupuncture induced analgesia. Although acupuncture is supposed to be a very specific intervention involving skin penetration with needles and manipulation (twirling), many studies include a plethora of other interventions, assumed to be, to a lesser or greater degree, equivalent. These include acupressure, electro-acupuncture, transcutaneous nerve electrical stimulation (TENS), laser acupuncture, tiny gold beads implanted under the skin, and injection of homeopathic remedies into acupoints. Electro-acupuncture, manipulated by passing electric currents through implanted needles, is widely used and allows a more objective control over stimulating parameters. Electro-acupuncture appears to be able to activate or deactivate a variety of brain regions and promote the release of endogenous opioid peptides, which are responsible for mediating its analgesic effects. Other non-penetrating methods include stimulation with sound, pressure, heat (moxibustion, sometimes with deliberate burn injury), electromagnetic frequencies (laser stimulation, capsicum plaster, an acu-stimulation device such as Electro-acupuncture of Voll [EAV]), chemical (capsicum plaster and Sweet Bee Venom Pharmaco-puncture), vacuum (cupping), color, waving hands over acupoints, and striking the appropriate meridian on an acupuncture doll with a metal hammer (Tong Ren). Even some forms of bloodletting are thought to involve activation of acupuncture points. Because of the aforementioned scientific studies on the neuroscience of nociception, acupuncture seemed to gain somewhat more plausibility than other forms of alternative medicine. Acupuncture has even been said to have positive effects on animals’ cognitive functions.
Acupuncture and the proven principles of Brain Science
Any hypothesis on the mechanism of action of acupuncture and equivalent interventions needs to be placed within the well established, proven principles of the brain sciences. Brain activity is due to the activity of billions of nerve cells, each generating small electrical currents which carry signals from one end to the other of each nerve cell; and, due to communication through the release of small amounts of chemicals, called neurotransmitters, with other nerve cells and with muscle and glands. These electrical and chemical aspects of the nervous system represent the most important foundations of modern brain science. This principle of organisation and function of the nervous system became well-established by the middle of the 20th Century, thanks to the research of the Australian neuroscientist, Sir John Eccles, Nobel prize-winner in Medicine because of this discovery. Since then, a plethora of neurotransmitter substances have been identified in the brain and in peripheral organs. Amongst these are endogenous opioids, as mentioned above, and other neuropeptides; these are recognised as important potential modulators of brain function. Not surprisingly, the idea that activating sensory inputs might affect central neural circuits and that, in particular, acupuncture might well work for analgesia, has triggered extensive research. While there is evidence for the release by various sensory stimuli, including manual acupuncture, of some endogenous opioids and other endogenous chemical mediators potentially capable of modifying pain stimuli, there is little evidence that this is a specific effect related to any anatomical organisation which could correspond to the ‘meridians’ of TCM. In most cases, any physical or chemical sensory stimulus is likely to result in the release of some endogenous anti-nociceptive substances. The highest quality studies have shown that it doesn’t matter where you insert the needles (acupoints or non-acupoints), and that it doesn’t matter whether the skin is penetrated (in one study, touching the skin with a toothpick worked just as well). The one thing that does seem to matter is whether the patient believes in acupuncture.
It is becoming increasingly clear that the brain processes underlying the physiological ‘placebo effect’ in reducing pain perception share similar neurochemical mechanisms with the sensory stimulation caused by acupuncture and other sensory stimulations. Thus the placebo effect is likely to explain many of the subjective improvements of many interventions, including acupuncture. This similarity explains, in part, why it has been so difficult, in practice, to perform satisfactory clinical trials to test the effectiveness of acupuncture separate from the placebo effect. Another myth is that acupuncture must be effective because it works on animals, and they wouldn’t respond to a placebo. But animals can’t talk to tell us to how they feel; their owners must interpret their responses by observing the animal’s behaviour, and the owners are susceptible to suggestion. They might inadvertently influence the animal’s behavior by giving it more attention or treating it differently in some way. They might be convinced that they see a change in the animal’s behavior and think that it means the animal feels better.
Using acupuncture for its placebo effect
Recently, the weight of evidence has convinced some acupuncturists that acupuncture works no better than placebo, but they still advocate using it for its placebo effect. Medical ethicists universally condemn using placebos intentionally since it amounts to lying and can destroy trust in the doctor/patient relationship. In reality, placebos don’t do much; their effects tend to be small in magnitude and short in duration. Patients who use them might defer or reject necessary effective treatment. Placebos can waste time and money, and harm can result when patients are deluded into thinking they are getting better when they really are not. One study found that patients with asthma had the same positive subjective responses to placebos as to an asthma inhaler; but objectively, only the patients in the asthma inhaler group had improvements in lung function. The response to placebos was no better than that of patients in a no-treatment control group. This could have serious consequences, since difficulty in perceiving the severity of an asthma attack is a risk factor for asthma-related death.
Is there clinical evidence for effectiveness of acupuncture in clinical medicine?
The proponents of acupuncture, whether as part of holistic TCM or as a separate technique, advertise that acupuncture can cure a wide range of diseases. Acupuncture has been claimed to be effective for addiction (such as alcoholism), allergies, asthma, bronchitis, carpal tunnel syndrome, chemotherapy-induced nausea and vomiting, constipation, depression, diarrhoea, endometriosis, facial tics, fibromyalgia, gastro-esophageal reflux, headaches, high blood pressure, infertility, irregular menstrual cycles, kidney infections, memory problems, multiple sclerosis, pre-menstrual syndrome, polycystic ovarian syndrome, low back pain, menopausal symptoms, menstrual cramps, osteoarthritis, pain of various natures, pharyngitis, post-operative nausea and vomiting, psychological disorders such as anxiety, sciatica, sensory disturbances, sinusitis, spastic colon (often called irritable bowel syndrome), stroke rehabilitation, tendonitis, tennis elbow, tinnitus, urinary problems such as incontinence, sports injuries, sprains, strains, ulcers, and whiplash.
Acupuncture trials and pitfalls
Clinical research on acupuncture is inherently difficult. The practice of acupuncture is not standardised, and some studies of ‘acupuncture’ are actually of electro-acupuncture, ear acupuncture, or other variants. It’s next to impossible to do double-blind studies, so confounding factors cannot be eliminated. The best studies use a retractable needle in a sheath, so that the patient can’t tell whether the skin has been penetrated or only touched by the needle. The results are highly variable: it’s easy to find studies to support a belief in acupuncture, but it’s even easier to find studies showing that it doesn’t work. The rationale for acupuncture’s acceptance in some aspects of clinical medicine, particularly in emergency medicine and pain clinics, has begun to crumble on closer examination of the evidence, mostly because of the excessively variable nature of the interventions involved in various studies which did not clarify the nature of the sham interventions used and any placebo effects. Recent reviews of the effectiveness of acupuncture on pain in general are rather damning. There have, over several decades, been several thousand acupuncture studies. After all this clinical research, acupuncture has not been clearly demonstrated to be effective for any indication. In short it is more than reasonable to suggest that acupuncture doesn’t work being no more than “a theatrical placebo”. Traditional Chinese acupuncture is no better for treating menopausal symptoms than a ‘sham’ version using blunt needles, according to a University of Melbourne study, published in the Annals of Internal Medicine, involving 327 Australian women over 40 who had at least seven moderately hot flushes daily. Half were given ten sessions of standard Chinese medicine acupuncture, where thin needles were inserted into the body at specific points. The others had their skin stimulated with blunt-tipped needles, which had a milder effect without penetrating the skin. After eight weeks of treatment, both had led to a 40% improvement in the severity and frequency of hot flushes; this was sustained six months later. However, there was no statistical difference between the two therapies. The authors said that both groups might have improved as a result of the placebo effect or because attending a clinic to talk about symptoms helped. The authors also noted that hot flushes tended to improve spontaneously with time adding “This was a large and rigorous study, and we are confident there is no additional benefit from inserting needles compared with stimulation from pressuring the blunt needles without skin penetration for hot flushes.” The most positive results from acupuncture have been for pain and post-operative nausea and vomiting (PONV). But even for those, the evidence is unconvincing. For PONV, the most recent meta-analysis indicated a small effect of P6 acupoint stimulation, but it mixed studies of acupuncture with electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure. There were questionable randomisation procedures, incomplete data, and the conclusion of the reviewers (that P6 acupoint stimulation “prevented PONV”) was not justified by the data. There is a lot of ‘noise’ in the data from these studies, but there doesn’t appear to be any ‘signal‘ mixed with the ‘noise’. It has been shown that the analgesic benefits of acupuncture are partially mediated through placebo effects related to the acupuncturist’s behavior. It is becoming increasingly clear that any reported benefits of acupuncture are largely due to the surrounding ritual, the beliefs of patient and practitioner, and the other nonspecific effects of treatment, not to the needles themselves. The team studying PONV also examined ‘Acupuncture for pelvic and back pain in pregnancy: a systematic review’. They concluded “limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy”. A systematic review of acupuncture for various pain conditions found a mix of negative, positive and inconclusive results. Out of 57 systematic reviews, there were only 4 pain conditions for which more than one systematic review reached the same conclusion: in 3 cases, they agreed that it was ineffective, and in only one (neck pain) was it agreed that it was effective. That finding is suspect, because it doesn’t make sense that a treatment could relieve pain only in one part of the body but not elsewhere. Over the past 10-15 years the Cochrane collaboration has addressed the efficacy of acupuncture for many of these indications. When clinical trials have been performed properly, lack or insufficient evidence of effectiveness for acupuncture was demonstrated in most cases. The following is a list, not exhaustive, of such trials. In thirty trials for depression, with 2,812 participants, manual and electro acupuncture were compared with medication; they found no difference between the two groups. A review by the Cochrane Collaboration on the question ‘Do acupuncture and related therapies help smokers who are trying to quit’ “did not find consistent evidence that active acupuncture or related techniques increased the number of people who could successfully quit smoking”. A study by RMIT researchers in 2016 showed that acupuncture is no better than placebo for menopausal symptoms such as hot flashes. A Cochrane Collaboration study (2014) demonstrated no effects on functional dyspepsia. A similar lack of effect on rheumatoid arthritis was demonstrated in 2005. Even proponents of acupuncture from the team at the RMIT in Melbourne, in their attempt to prove that acupuncture is effective in a “range of health conditions”, admitted, “No solid conclusion of which design is the most appropriate sham control of Ear-acupuncture/ear-acupressure could be drawn in this review”. Very clear experimental work performed by a University of Melbourne team on one of the projects funded by the NH&MRC on laser acupuncture, “Acupuncture for Chronic Knee Pain published A Randomized Clinical Trial on chronic knee pain”, showed that neither needle nor laser acupuncture significantly improved pain and concluded that their findings did not support acupuncture for these patients. A paper in Obstetrics & Gynecology in 2008 “Acupuncture to Induce Labor: A Randomized Controlled Trial” concluded “Two sessions of manual acupuncture, using local and distal acupuncture points, administered 2 days before a scheduled induction of labor did not reduce the need for induction methods or the duration of labor for women with a post-term pregnancy”.
Trials not performed sufficiently well and therefore “need to be repeated”
Despite the several decades of significant funding for, and research on, acupuncture and, in general, on alternative medicines in Australia and around the world, far too often the conclusion from clinical trials is “more research is needed”. The excuses given in the numerous reviews, mostly by the proponents, are insufficient numbers of patients or trials or insufficient control subjects. The reality is more likely due to the reality that there is an absence of effectiveness. For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”. In a review, “Pain Research in Complementary and Alternative Medicine in Australia: A Critical Review”, the authors concluded that, because of the poor design and execution of research papers on pain and alternative medicines, “The quantity and the quality of CAM pain research in Australia is inconsistent with the high utilization of the relevant CAM therapies by Australians. A substantial increase in government funding is required. Collaborative research examining the multimodality or multidisciplinary approach is needed”. It has been claimed that surgery can be performed using only acupuncture anesthesia. A widely publicised picture of a patient allegedly undergoing open-heart surgery under acupuncture anesthesia appears to be a fake: it shows her with an open chest cavity that would make her lungs collapse, she is not on a respirator and a heartbypass machine does not appear to be in use. Also, the incision is in the wrong place for the procedure being described, and the photo is curious in other respects (such as the position of the patient’s head). A recent BBC video of surgery on a conscious patient anaesthetised with acupuncture was similarly misleading. Researchers at the Centre for Complementary Medicine Research at the University of Western Sydney, commenting on studies of acupuncture for menstrual problems stated, “Five systematic reviews were included, and six RCTs. The symptoms of the menopause and of dysmenorrhea have been subject to greater clinical evaluation through RCTs, and the evidence summarised in systematic reviews, than any other reproductive health complaint. The evidence for acupuncture to treat dysmenorrhea and menopause remains unclear, due to small study populations and the presence of methodological bias. For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”. Many other studies by the Cochrane Collaboration concluded that there was insufficient evidence for recommending the use of acupuncture for the conditions investigated, as listed as follow: ADHD in children and adolescents (2011); autism spectrum disorders (ASD) (2011); Bell’s palsy (2010); cancer-related pain (2015); glaucoma (2013); depression (2010); dysphagia in acute stroke (2008); tennis elbow (2002); ‘fibromyalgia’ (2013); induction of labour (2013); menopausal hot flushes (2013); mumps (2014); nearsightedness in children (2011); hypoxic ischemic encephalopathy in newborn babies (2013); pain in endometriosis (2011); period pain (2011); chronic asthma (1999); urinary incontinence (2013); stroke rehabilitation (2006); uterine fibroids (2010); labour pains (2011); vascular dementia (2007); nausea and vomiting in early pregnancy (2015); obesity (2015). Even TENS appears to give insufficient evidence for improving dementia (2003).
Reasonable trials with evidence for small effects.
A Cochrane study on acupuncture and dry needling for low back pain, based on 35 randomised clinical trials in 2005, reported a very small effect. Another Cochrane study in 2009 suggested that acupuncture should be considered a treatment option for migraine prophylaxis, despite finding that “there was no evidence of an effect of true acupuncture over sham interventions”. A Cochrane study in 2006 found moderate evidence for a small improvement in chronic neck pain while a review in 2009 suggested that there was benefit from the use of acupuncture to treat Tension-type headache Almost all trials of alternative medicines seem to end up with the conclusion “more research is needed”. After more than 3,000 trials, we should recognise that the need for more trials is dubious…
Acupuncture has been studied for decades and the evidence that it can provide clinical benefits continues to be weak and inconsistent. There is no longer any justification for more studies. There is already enough evidence to confidently conclude that acupuncture doesn’t work. It is merely a theatrical placebo based on pre-scientific myths. All health care providers who accept that they should base their treatments on scientific evidence whenever credible evidence is available, but who still include acupuncture as part of their health interventions, should seriously revise their practice. There is no place for acupuncture in Medicine.[the original report is fully referenced]
Politeness means showing consideration for others and observing accepted social rules. Those who know me personally would probably confirm that I am a fairly polite person. And I had always hoped that politeness might also become a feature of how all of us deal with each other on this blog. Sadly this has not proven to be so.
Don’t get me wrong, I am not trying to say that I am blameless. Firstly I see all the comments before they get posted, and secondly I too have been rather the opposite of polite at times. How come?
My excuse is that I too often let myself get carried away. From my perspective, the typical exchange ending in impoliteness develops as follows:
- My post is formulated such that it provokes some strong reaction. I know, I do this all the time, and I cannot promise that I will not do it in the future. This is because I believe – and experience tells me that I am correct – that one has to provoke in order to get some reaction.
- The person I provoked posts a comment that challenges me or someone else to respond. The nature of the comment is often such that it comes close to a personal attack. For instance, someone might state that I was fired from my Exeter post, that I am paid by the pharmaceutical industry, that I don’t know my subject, etc.
- Often, I do not respond at all to this sort of thing. But sometimes I conclude that facts need to be corrected, and regrettably, I correct them with more provocation.
- This then gets up the nose of the commenter and he or she feels hurt and points out that the discourse has become less than polite – which, of course, is correct.
This is not to excuse anyone or anything; it is just to show how things happen.
The way I see it, there is a bit of a conundrum here: if I write a post without any provocation [which I have done often], there will be no feedback or comments at all [which also happens occasionally]. If I use the method of deliberately provoking people, things can easily escalate. The secret is obviously to get the dose right.
So, when I get it wrong, do blame me!
Politeness is undoubtedly desirable and we should all aim to be polite on this blog and elsewhere. At the same time, we should remember that politeness is not a virtue; it is simply following rules without requiring any moral judgment. Politeness is an artifice. The essence of politeness is form; the essence of virtue is character. A polite bastard is still a bastard! And an impolite man of virtue is still a man of virtue.
Impoliteness may be hurtful but the truth is sometimes hurtful too. And there is a danger in going too far in both directions; exaggerated politeness is close to insincerity. If it were a choice between politeness and truth, I would always opt for the latter.
But luckily this is rarely the case; one can usually have both!
Why am I rambling on about such an issue? Because I want to appeal to all who write and comment here – not least myself – that politeness is a very good thing and enables a better exchange than we sometimes had on this blog. So, lets not escalate things again, let’s understand little provocations for what they are meant to be: a stimulus to have an open, challenging but nevertheless polite debate.
Guest post by Frank Van der Kooy
Some serious flaws in the scientific reporting of two acupuncture clinical trials, for the treatment of infertility and allergic rhinitis, were recently published on this blog. The overly positive way in which the researchers made their mostly negative results public, was also of concern. Both these studies were published by the researcher of the year, Prof Caroline Smith, of the National Institute of Complementary Medicine (NICM), Australia. The stream of comments and discussions that followed made me think of another commonly overlooked aspect when it comes to acupuncture clinical trials. Conflict of interest! In both these studies the authors declared to have no conflicts of interest and in other studies by this author this also seems to be the case. The question can be asked: If you are a practicing acupuncturist who runs a clinical trial of acupuncture, isn’t that, by default, a serious conflict of interest? The intention of this article is not an in-depth discussion of what a conflict of interest is, but rather to compare medical doctors with acupuncturists turned researchers. Let me explain.
Some medical doctors (GPs, surgeons etc.) decide to leave their practice after practicing 10-20 years to become full time researchers (and visa versa). Universities accept these people with open arms because they bring with them a wealth of knowledge regarding the practical side of medicine and healthcare in general. They are thus seen as an asset to any medical research project including clinical trials. Can the same be said about an acupuncturist? They also bring with them years of experience and thus they should also be a major asset to any acupuncture clinical trial. But I am afraid not!
Why? Medical doctors have a multitude of tools (drugs, surgical procedures, diagnostic tools etc.) at their disposal to treat all types of medical conditions. When will their background constitute a conflict of interest? When they publish a positive clinical trial of a specific medical intervention in which they have a vested interest. e.g owning shares in the company producing the medical intervention (financial interest) or if they have been staunch supporters of this intervention during their years of practice (emotional interest). Just imagine that you have prescribed a specific intervention to hundreds of patients over a long period of time, and you swore by it, and now you have to face them with a negative clinical trial result – that will be difficult. The former is easy to declare whilst the latter might be slightly more difficult.
Doctors also tend to focus on a specific disease e.g. cancer and will perform research with the existing tools at their disposal but also try to find new tools in order to improve the risk-benefit profile of the disease treatment. Thus, for a doctor there is the possibility that they might run into a conflict of interest, but due to the multitude of medical interventions out there this is by no means a given.
What about acupuncture practitioners turned researchers? An acupuncturist only has one tool at their disposal to treat all medical conditions. I can hear them say; but we stick needles in different places and depths etc. depending on the medical condition! Yes, but the fact remains that they can only stick needles into people – and that is a single intervention. So is this by default a conflict of interest? I would argue, yes, it is like having only one drug to treat all medical conditions. If you have treated hundreds of patients for various medical conditions with acupuncture and now suddenly you publish a negative clinical trial, you will not only be red faced when you run into your former patients – who paid for your evidence based acupuncture treatment – they might even sue you for misleading them. As an acupuncturist, you cannot allow the single tool that you have to be ineffective, otherwise people might start to question acupuncture. The fact that they have to protect acupuncture means that an acupuncturist will by default have a conflict of interest – no matter what medical condition they aim to treat.
If you have been emotionally and financially invested in acupuncture as a cure-all for 10-20 years, it will be very difficult, if not impossible, to publish a negative result as an acupuncture researcher.
Another aspect is that the acupuncture fraternity is a very tight knit community, where negative results are frowned upon because of everyone’s financial and emotional interests. Surely they will expel you from this community, if you publish negative results?
So how do acupuncture researchers go about running clinical trials? An example: Professors Smith and Bensoussan, both at the NICM, are currently registered as practicing acupuncturists. This means that they can legally practice acupuncture and, because they have been active for decades, they are also well known in the acupuncture fraternity. It is unknown, whether they are still actively practicing in their own practice or part-time in someone else’s practice, or if they have a financial stake in their former or someone else’s practice. Based on the fact that they are still registered as active acupuncturists, I can conclude that they do have an emotional and/or financial interest in the positive outcome of their acupuncture clinical trials.
Because of this inherent conflict of interest, and due to current strict clinical trial regulations, which makes it quite difficult (although not impossible) to fabricate or falsify data, they go for the next best thing – which is the design of their clinical trial e.g. the A+B versus A design. But it doesn’t stop there. As soon as a clinical trial fails to give a positive result, the results will be inflated to make it sound positive.
Why? Because they must prevent themselves from cognitive dissonance, they need to protect the single tool that they have, they must keep the acupuncture fraternity happy and they have to protect themselves against potential lawsuits from former (current) patients or a decrease in patient numbers (and thus financial income). On top of that – how would the media and the public react to an acupuncture clinical trial if the lead researcher declare that they have their own acupuncture clinic? Surely these factors together amount to a conflict of interest and should be declared as such?
So what, in this context, is the main difference between a doctor and an acupuncturist? A doctor has a multitude of medical interventions. He or she might have a conflict of interest, if they work on a specific intervention in which they have a vested interest. An acupuncturist only has one intervention and therefore they have a vested interest by default – which they never seem to declare!
The Swiss interior ministry has yesterday announced its intention to elevate quackery to the same level as conventional medicine.
The 5 therapies were named as
- holistic medicine,
- herbal medicine,
- traditional Chinese medicine
No, this is not an early April fools joke! It might merely a sign that this country is in dire need of some critical thinking.
The 5 therapies will acquire the same status as conventional medicine by May 2017. After being rejected in 2005 by the authorities for lack of scientific proof of their efficacy, complementary and alternative medicines made a comeback in 2009 when two-thirds of Swiss backed their inclusion on the constitutional list of paid health services. As a result of the vote, these treatments are covered by basic compulsory insurance as part of six-year trial period from 2012-2017, during which their efficacy would be examined. The ministry has come to the conclusion that it is impossible to verify the efficacy of these therapies in their entirety. It has therefore opted to accept them on par with other medical disciplines. It plans to continue allowing reimbursements of treatment costs by compulsory health insurance, provided they are administered by certified medical professionals. However, as is the practice for conventional medicine, certain controversial practices under these complementary therapies will be subjected to further scrutiny. The ministry has initiated a consultation process – open until June 30, 2016 – on the proposed modification of the regulations.
There are a few interesting things here:
- What on earth is ‘holistic medicine’? It seems to be an umbrella term under which any type of quackery can be included.
- The lack of proof of efficacy – which since 20015 has only increased – is over-ruled by a popular vote.
- The ministry has come to the conclusion that it is impossible to verify the efficacy of these therapies in their entirety. What does that mean? From a scientific point of view, it means science cannot show that these treatment work, BECAUSE THEY DON’T! But I suspect they did not want to say that. What did they want to say then?
- holidays for citizens who feel ‘under the weather’,
- distance healing,
- botox therapy for wrinkled faces,
- hair transplants,
- pet ownership,
- free champagne for low blood pressure,
Sorry, I just realized that all of the above are already included in the category of HOLISTIC MEDICINE.
Whenever I write something critical about an alternative therapy, chances are that I get hate mail, sometimes lots of it (and much of it is hilarious). It usually centres around themes such as:
- Ernst is bought by ‘Big Pharma’.
- Ernst is incompetent.
- Ernst is a lousy scientist.
- Ernst is a liar.
- Ernst has an axe to grind.
However, one theme that comes up more often than any other is, I think, the allegation of my ‘lack of qualifications’. Here is an example posted as a comment to my recent article on acupuncture in THE SPECTATOR:
“Ernst’s appointment as a professor at the University of the Penisula, his apparent ‘qualifications’ in Complementary Medicine (including homeopathy as well as what he says here about acupuncture) are controversial to say the least and he lacks qualifications in evidence-based medicine too.”[This particular quote is quite funny; the author not only was wrong about my qualifications but also re-named the University of Exeter ‘The University of the Penisula’ – begging the penetrating questions, who is Ula? And what has his penis to do with my professorship?]
If I have the time and the patience, I do like to respond even to the weirdest of attacks.
Because my attackers often claim that a non-response amounts to an ‘admission of guilt’ on my part. Yet, all too often, this strategy turns out to be a mistake, and the whole thing quickly degrades even further.
In the above-mentioned instance, I replied: “I never said that I had formal qualifications in acupuncture or homeopathy. I learnt these things as doctors learn most other techniques: initially by studying them and subsequently applying them, first with supervision and later independently. I once wrote as a footnote to a critical article on homeopathy: ‘CONFLICTS OF INTEREST: I AM A TRAINED HOMEOPATH’. Only a moron could miss that this was tongue in cheek. Moreover, it was correct: I was trained during several months working in a homeopathic hospital. It seems that this is the origin of all these false allegations against me. To accuse me of having no qualifications in these areas is, I think, akin to me accusing you of having no degree in particle physics.”
Rather than carefully considering what I had written, my attacker answered by bringing up a new lie: “You are not and were not a registered medical doctor in the UK at the time but were a professor of Complementary Medicine. (fact or ad hominem attack?) If this is so you deserve to be congratulated on a superb interview to get the job with your only ‘qualification’ being picking up a bit of knowledge here and there on CAM as a doctor.”[One has to excuse the confusing language of the commentator who seems far too overwhelmed with emotion and excitement to express things clearly. What was meant, I think (mostly from previous, similar attacks), was the allegation that I was not even a GMC-registered physician when I took up the Exeter job.]
I have only little hope that it will deter future attacks of this nature but, for the sake of honesty, integrity and transparency, I will (yet again) try to clarify the situation regarding my ‘lack of qualifications’.
- There is nothing controversial about my qualifications.
- I have never claimed to hold qualifications that I did not earn.
- I have no formal ones in alternative medicine, and I have never said otherwise.
- I am not even sure that such qualifications existed when I was in my ‘qualifying years’ (late 1970s).
- As for any degrees in EBM, they certainly all came in after that time (even the term ‘EBM’ was invented only later).
- If you are qualified as a doctor, you do not need to have any extra qualifications to practice alternative medicine.
- Neither does one need them to research alternative medicine.
- As I stated many times before, I have received training in several forms of alternative medicine.
- I consider myself competent to research most areas of alternative medicine.
- I have been registered with the GMC since the late 1970s.
- When it became clear that this registration was no longer needed to conduct the research I did at Exeter, I cancelled it to save the considerable annual expense.
- I have also published a full memoir entitled ‘A SCIENTIST IN WONDERLAND’ where the background to many of these issues is discussed in more detail.
All that I need to say now to future ad hominem attackers: PLEASE FIND A DIFFERENT LINE OF ATTACK; THIS ONE IS GETTING BORING AND MERELY DISPLAYS YOUR IGNORANCE.
At this time of the year, journalists like to review what has happened during the previous year. I am not a journalist, just an alt med researcher, and I don’t want to review the 10 most important events but the non-events, that is 10 relevant things that should have happened in the realm of alt med but unfortunately didn’t happen. Needless to say: my choice is subjective, personal and highly biased.
Here we go, in no particular order:
In 2014, the WHO published the WHO TRADITIONAL MEDICINE STRATEGY 2014 – 2023. Amazingly, it has all the hallmarks of a promotional document that lacks critical input: “The strategy aims to support Member States in developing proactive policies and implementing action plans that will strengthen the role TM plays in keeping populations healthy.” In my view, those officials within the WHO who are capable of critical assessment should have spotted the danger of this strategy and, by 2015, have managed to withdraw this shameful paper, as it can only discredit this otherwise reputable organisation.
After suing my friend Simon Singh and losing the case, lots of money and even more reputation, the BCA and the chiropractic profession at large should have not only apologised to Simon but also taken more decisive actions to ensure that chiropractors around the world stop misleading the public about what they can contribute to human health. Sadly this blog has shown more than once that bogus claims still abound and chiropractors are still unable to criticise even the most extreme excesses of quackery in their ranks.
The International Council for Homeopathy (ICH) “is the international professional platform representing professional homeopaths and the practice of homeopathy around the world. ICH presently consists of 31 professional associations of homeopaths from 28 countries in four continents, and aims eventually to have member associations in all continents. Through networking and dialogue, members of ICH engage in the promotion and evaluation of the status of homeopathy in every part of the world; with emphasis on the development of international guidelines promoting freedom of access to the highest possible standard of homeopathic care.” With such high, self-declared aims, the ICH would have been in the ideal position to inform its members that the most transparent and thorough investigation of homeopathy concluded that “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.” Sadly, homeopaths all over the world prefer to go into a state of denial and carry on as before – to the detriment of public health worldwide.
Peter Fisher, the homeopath of the Queen, has been shown to have published an important lie about me. In the interest of honesty, of his reputation and that of homeopathy, he should have retracted it and apologised. The fact that he has chosen to remain silent is, I think, a telling tale about the standards of truth in homeopathy.
Prince Charles is one of the most prominent promoters of INTEGRATED MEDICINE. He may not have the wit to understand the issues involved but he certainly has access to the best advisors money can buy. By now, he should have realised that the yes-men he has been using are not up to the job of providing reasonable advice on alt med. Therefore he should have recruited proper experts who would have told him that adding unproven treatments to evidence-based medicine is not going to be an improvement. Sadly, Charles’ promotion of quackery continues unabated.
Christian Boiron, the General Manager of the world’s largest manufacturer of homeopathic remedies, ‘BOIRON’, recently stated that the critics of homeopathy are like the Ku Klux Klan. This embarrassing statement reflects a level of stupidity and arrogance that can only be harmful to his firm and homeopathy in general. The fact that it was not withdrawn does not bode well for either of them.
Dan Ullman is one of the tireless [and tiresome] entrepreneurs in US homeopathy. I recently dedicated a blog-post to him where he commented copiously and was subsequently shown to be wrong on many issues. This would have been the right moment for him to give up selling bogus drugs and misleading literature. Unfortunately, the comments did not offer any hope that fanatics like him can be brought to their senses. This sad course of events suggests, I fear, that homeopathic delusions of this nature are too severe to cure.
During these discussions, one commentator provided disturbing suspicions that one of the recent ‘flag-ship’ evidence for homeopathy might be fraudulent. The author of the paper in question, who had been a keen participant of the discussions, should have responded and argued his case. Instead his comments on this blog abruptly stopped, a fact that most experts might interpret as an admission of guilt.
My Vice Chancellor at Exeter, Steve Smith, should have read 2015 my memoire, which suggests that he behaved less than honourably, and he should then have responded to it. Instead, Exeter opted to ignore not only my book but also the award of the John Maddox Prize 2015. It is up to the reader to decide how this non-action ought to be interpreted.
The ‘INTERNATIONAL PHARMACEUTICAL FEDERATION’ has the slogan ‘advancing pharmacy worldwide’ in their logo. Therefore it seems to be the right organisation to remind pharmacists across the globe that they are not shopkeepers but a healthcare profession with ethical codes and moral responsibilities. Therefore they should have reminded community pharmacists, pharmacy chains and other interested parties that selling disproven remedies like homeopathy, Bach Flower Remedies, ineffective cough syrups etc. is a violation of pharmacists’ codes of ethics.
Any post about non-events and missed opportunities is a somewhat frustrating affaire. At the same time, it also offers hope: perhaps 2016 will see (some of) them happening?
I had thought that I know most alternative therapies. However, Shujing massage was new to me. It seems to be a massage technique from Traditional Chinese Medicine (TCM) along the Yin/Yang concept; a bit like Shiatsu perhaps.
Does it work?
This study might easily be the first to address this question. It was aimed at comparing the efficacy on insomnia between shujing massage therapy and medication with estazolam.
Eighty patients with insomnia were randomized into a shujing massage therapy group and a medication group. The massage was applied along the gallbladder meridian on the temporal area. Pressing and kneading manipulations were performed at Yangbai (GB 14), Benshen (GB 13), Toulinqi (GB 15), Zhengying (GB 17), Chengling (GB 18), Shuaigu (GB 8), and Fengchi (GB 20), etc. one minute at each acupoint. In the medication group, 1 mg estazolam was administered orally half an hour before sleep. The treatments were given once every day in both groups. After one month, the sub-scores and the total score of the Pittsburgh sleep quality index scale (PSQI) and the clinical efficacy were compared between the two groups.
After the intervention, the each sub-score of PSQI was improved as compared with that before treatment in the patients of the two groups. The differences in sleep time and the time for falling into sleep were not significant between the two groups. In the shujing massage group, the scores of sleep quality, sleep efficiency, sleep disturbance and daytime dysfunction, as well as the total score were all lower than those in the medication group. The response rate was 92.1% (35/38) in the shujing massage group and 84. 2% (32/38) in the medication group.
The Chinese authors concluded that Shujing massage therapy achieves the superior efficacy on insomnia compared with the oral administration of estazolam.
Sadly, this study is less conclusive as TCM-enthusiasts may think:
- the study was not blind; therefore placebo-effects might have produced a false-positive result;
- any massage is relaxing; therefore the effect could be entirely unrelated to TCM-philosophy;
- it is likely that the regular ritual of a massage has a beneficial effect on sleep;
- before we agree with these findings, we should insist on an independent confirmation via a more rigorous study.
I think that, before we accept the ‘efficacy’ of this TCM-treatment, we should see much more convincing evidence.
This is a true gem which I found on Medline. The article was published 91 years ago by Holburt Jacob Waring (1866 – 1953) in the BMJ. I hope you enjoy it.
This article does not need a comment, I think. Its author was one of the most prominent surgeons of his time. Apparently he was known and feared for his outspokenness. I think I understand why.