Monthly Archives: April 2015
In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.
According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.
The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.
The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
So why do I think this is ‘positively barmy’?
The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:
- a placebo effect
- the natural history of the condition
- regression to the mean
- other treatments which the patients took but did not declare
- the empathic encounter with the physician
- social desirability
To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.
In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!
On this blog, we have discussed the Alexander Technique before; it is an educational method promoted for all sorts of conditions, including neck pain. The very first website I found when googling it stated the following: “Back and neck pain can be caused by poor posture. Alexander Technique lessons help you to understand how to improve your posture throughout your daily activities. Many people, even those with herniated disc or pinched nerve, experience relief after one lesson, often permanent relief after five or ten lessons.”
Sounds too good to be true? Is there any good evidence?
The aim of this study, a randomized controlled trial with 3 parallel groups, was to test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. A total of 72 patients (65 females, 40.7±7.9 years) with chronic, non-specific neck pain were recruited. They received 5 sessions of the Alexander Technique, while the control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each.
The primary outcome measure at week 5 was neck pain intensity quantified on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. The results show no group differences for pain intensity for the Alexander Technique compared to local heat. An exploratory analysis revealed the superiority of the Alexander Technique over guided imagery. Significant group differences in favor of the Alexander Technique were also found for physical quality of life. Adverse events were mild and mainly included slightly increased pain and muscle soreness.
The authors concluded that Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment.
I am impressed with these conclusions: this is how results should be interpreted. The primary outcome measure failed to yield a significant effect, and therefore such a negative conclusion is the only one that can be justified. Yet such clear words are an extreme rarity in the realm of alternative medicine. Most researchers in this area would, in my experience, have highlighted the little glimpses of the possibility of a positive effect and concluded that this therapeutic approach may be well worth a try.
In my view, this article is a fine example for demonstrating the difference between true scientists (who aim at testing the effectiveness of interventions) and pseudo-scientists (who aim at promoting their pet therapy). I applaud the authors of this paper!
Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.
A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.
Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.
The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.
I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?
One of my last posts prompted a comment informing us that Dr Dixon has just put himself forward as a candidate for the presidency of ‘THE ROYAL COLLEGE OF GENERAL PRACTITIONERS’ (RCGP) of the UK. This must be big news in the small world of alternative medicine and deserves further discussion.
Dr Dixon works in Cullompton Devon, where, according to one website, he has introduced over 20 complementary therapists alongside the normal GP services that would be expected anywhere. Patients have to pay for therapies such as healing, massage, acupuncture, or herbal medicine but at a reduced fee. The practice has its own organic and herb gardens and is next to a Boots store that stocks many of the remedies.
The RCGP’s announcement describes him with the following words:
Dr Dixon is NHS Alliance chairman, and has been a GP since 1984 at the College Surgery in Cullompton, Devon. He is acting president of NHS Clinical Commissioners, set up to represent CCGs after their creation in 2012, and has held a number of NHS advisory posts.
THE TELEGRAPH once listed Dr Dixon amongst the top ‘health gurus’ of Britain and commented: A trustee of the Prince’s Foundation for Integrated Medicine, the soothingly avuncular Dixon is one of the most persuasive advocates of complementary medicine, as well as one of its most dynamic practitioners. His new venture is an integrated health centre in Cullompton, Devon (opening in January), where practitioners of massage, homeopathy, acupuncture and so on will have rooms alongside his conventional GP’s surgery. If he’s good enough for Prince Charles…
Flattering as they may be for Dr Dixon, I don’t think that these descriptions do him justice. They fail to stress that he has, since over 20 years, been fighting tirelessly for integrating unproven alternative therapies into the NHS. He even presided over Prince Charles’ FOUNDATION FOR INTEGRATED MEDICINE when it had to be closed down amidst allegations of fraud and money laundering. He now heads the successor organisation, THE COLLEGE OF MEDICINE, and is involved in uncounted similar initiatives promoting outright quackery. Examples include:
Dixon is a medical advisor to ‘YES TO LIFE’, an organisation advocating unproven treatments for cancer.
Dixon is a practitioner of spiritual healing.
Dixon advocates Johrei healing despite the fact that he was involved in a study we did which failed to show that it is effective.
Dixon is an advocate of homeopathy.
Dixon created the Culm Valley Integrated Centre for Health which offers unproven treatments such as homeopathy, neurolinguistic programming, Bowen technique, aromatherapy and, of course, healing.
Dixon is a patron of ‘THE QUIET MIND CENTRE’ which offers unproven treatments such as healing, reflexology, kinesiology, shiatsu, Indian head massage, zero balancing, and craniosacral therapy.
Dixon encourages GPs to use alternative medicine.
Dixon advocates the statutory regulation of Chinese herbalists.
Dixon is a ‘key lecturer’ at the BRITISH COLLEGE OF INTEGRATIVE MEDICINE.
Further revealing comments on Dr Dixon can be found here and here and here.
Finally, I recently published a short excerpt from my recent book ‘A SCIENTIST IN WONDERLAND’ in which Dr Dixon played a prominent role. I am hopeful that many GPs will read it.
Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.
Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.
A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.
Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.
More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.
The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.
Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.
Today I would like to share with you an interesting little exchange that I had a few days ago on TWITTER. Someone who I perhaps should but did not know sent me the following tweet apparently ‘out of the blue’:
“…remember that asthma trial whose results you faked?”
It was clear that the study he referred to was our trial published in THORAX 12 years ago. I found this allegation so absurd that I re-tweeted his tweet, and a third party responded to him by asking: “any evidence for this?”
His answer: ” Yes, I was involved with the study which severely breached its protocols. It should have been abandoned not published”
My reply to this: “Involved as what? I do not recall any breach of protocol”
His next tweet: “Pity, I do. Maybe it’s because you only added your name to the paper”
My response: “Stop telling lies and find a good libel lawyer”
Over the years, I got used to all sorts of attacks, but I feel that this one is quite special. It accuses me first of faking research, then of breaching research protocols, and finally of false authorship of a research paper. To someone whose entire reputation relies on his credibility as a scientist, such very public and entirely false claims are, of course, hugely damaging. I asked myself: Is this libel? Is it defamation? Is it actionable?
Looking for answers, I found an interesting website which explains the relevant English law in some detail:
“A defamatory statement is one which is false and causes damage to a person’s reputation or otherwise does them harm. Libel is the term given to defamation in a permanent form such as in print…
For a person to bring a claim of defamation, the following must apply:
- The statement has to have been made to somebody other than the claimant. It is not defamation if the statement is not heard by anyone but the claimant.
- The statement has to be in words
- The statement may damage the person’s reputation by making people who hear or read the statement think worse of them.
- The statement may expose the claimant to contempt, disliking, hatred or ridicule.
- The statement may cause the claimant to be shunned by society or avoided by people
- The statement must be clearly applicable to the claimant, although they do not necessarily have to be named (e.g. “the head of London Metropolitan Police Force” would be sufficient without explicitly naming the claimant).
- If someone claims that a person has made defamatory statements about them, the onus is on the person who made the statements to prove that the statements are true.”
Subsequently, I tried to find out the identity of my attacker. He is Tony Pinkus who turns out to be the director of Ainsworth Homeopathic Pharmacy, 36 New Cavendish St London W1G 8UF. This fact makes my little exchange much more interesting and exciting. In my view, it begs the following questions:
- Should I ask Ainsworth for an apology?
- Or Pinkus?
- Or perhaps I should sue Ainsworth for libel?
- Or Pinkus?
- Or should I sue both?
Not being a lawyer, I wonder whether any of my readers might advise me. In addition, I will send this post to Ainsworth and will keep you posted about their reply.
One of the UK’s most ardent promoters of outright unproven and disproven therapies must be Dr Michael Dixon. He has repeatedly and deservedly received a mention on this blog. Steven Novella even called him once a ‘pyromaniac in a field of (integrative) straw men’. This is because Steven felt that Dixon uses phony arguments to promote dodgy therapies. If you find this hard to believe (after all Dixon is a GP who heads important organisations such as the NHS Alliance and the College of Medicine), just look at him dabbling in spiritual healing. Unusual, to say the least, I’d say. If you want to learn more about the strange Dr Dixon, you should read my memoir where he makes several remarkable appearances.
I always delight when I stumble over something that one of my former co-workers (yes, Dixon and I did collaborate for many years) has said to the press. This is why an otherwise silly article in the Daily Mail (yes, I know!) caught my attention; here is the relevant section: Dr Mike Dixon, a GP in Cullompton, Devon, and chairman of the College of Medicine, says he is a ‘fan’ of herbal medicines because they are ‘safe, help to encourage self-care by patients and, in cases such as mint and aloe vera, can be grown by the patients themselves, making them virtually free’.
As I already pointed out, Dixon does tend to promote bizarre concepts. The generalisation that herbal remedies are safe is not just bizarre, it also put the public at risk. One does not need to search long to find an article that makes this clear:
Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.
Dixon once told me that GPs do not any longer read scientific papers. I think, however, that he should start doing so before the next time he misinform the public and endangers the health of vulnerable people.
Many experts have argued that the growing popularity of alternative medicine (AM) mandates their implementation into formal undergraduate medical education. Most medical students seem to feel a need to learn about AM. Yet little is known about the student-specific need for AM education. The objective of this paper was address this issue, specifically the authors wanted to assess the self-reported need for AM education among Australian medical students.
Thirty second-year to final-year medical students participated in semi-structured interviews. A constructivist grounded theory methodological approach was used to generate, construct and analyse the data.
The results show that these medical students generally held favourable attitudes toward AM but had knowledge deficits and did not feel adept at counselling patients about AMs. All students were supportive of integrating AM into education, noting its importance in relation to the doctor-patient encounter, specifically with regard to interactions with medical management. Students recognised the need to be able to effectively communicate about AMs and advise patients regarding safe and effective AM use.
The authors of this survey concluded that Australian medical students expressed interest in, and the need for, AM education in medical education regardless of their opinion of it, and were supportive of evidence-based AMs being part of their armamentarium. However, current levels of AM education in medical schools do not adequately enable this. This level of receptivity suggests the need for AM education with firm recommendations and competencies to assist AM education development required. Identifying this need may help medical educators to respond more effectively.
One might object to such wide-reaching conclusions based on a sample size of just 30. However, there are several similar surveys from other parts of the world which seem to paint a similar picture: most medical students clearly do want to learn about AM. But this issue raises several important questions:
- How can this be squeezed into the already over-full curriculum?
- Should students learn about AM or should they learn how to practice AM?
- Who should teach this subject?
In my view, students should learn the essentials about AM but not how to do this or that therapy. Most deans of medical schools seem to agree with me on that particular point.
The question as to who should teach students about AM is, however, much more contentious. Most conventional medical instructors have no interest in and/or no knowledge of the subject. Consequently, there is a tendency for medical schools to delegate AM by hiring a few alternative practitioners to cover AM. Thus we see homeopaths teaching medical students all (well, almost all) about homeopathy, acupuncturists teaching acupuncture, herbalists teaching herbal medicine etc. To many observers, this might sound right and reasonable – but I beg to differ resolutely.
Most alternative practitioners who I have met (and these were many over the last 20 years) are clearly not capable of teaching their own subject in a way that befits a medical school. They have little or no idea about the nature of scientific evidence and usually lack the slightest hint of critical analysis. Thus a homeopaths might teach homeopathy such that students get the impression that it is well grounded in evidence, for instance. Students who have been taught in this fashion are not likely to advise their future patients responsibly on the subject in question: THE TEACHING OF NONSENSE IS BOUND TO RESULT IN NONSENSICAL PRACTICE!
In my view, AM is an ideal subject to acquaint medical students with the concepts of critical thinking. In this respect, it offers an almost opportunity for medical schools to develop much-needed skills in their students. Sadly, however, this is not what is currently happening. All too often, medical school deans find themselves caught between the devil and the deep blue sea. In the end, they tend to delegate the subject of AM to people who are not competent and should not be let loose on impressionable students.
I fear that progress and care of future patients are bound to suffer.
The task of UK Clinical Commissioning Groups (CCGs) is to ensure NHS funds are spent as effectively and responsibly as possible. This is particularly important in the current financial climate, as NHS budgets are under enormous pressure. For that reason, The Good Thinking Society (GTS, a pro-science charity) invited Liverpool CCG to reconsider whether the money (~ £ 30,000 pa) they spend on homeopathy represents good service to the public. Recently the CCG agreed to make a fresh decision on this contentious issue.
The GTS would prefer to see limited NHS resources spent on evidence-based medicine rather than on continued funding of homeopathy which, as readers of this blog will know, has repeatedly failed to demonstrate that it is doing more good than harm. It is encouraging to see Liverpool CCG take a first step in the right direction by agreeing to properly consider the best evidence and expertise on this issue.
Supporters of homeopathy frequently cite the concept of patient choice and claim that, if patients want homeopathy, they should have it free on the NHS. The principle is obviously important, but it is crucial that this choice is an informed one. The best evidence has conclusively shown that homeopathy is not an effective treatment, and to continue to offer ineffective treatments under the guise of patient choice raises troubling questions about the important concept of informed choice, and indeed of informed consent as well as medical ethics.
The GTS were represented by Salima Budhani and Jamie Potter of Bindmans LLP. Salima said: “This case underlines the necessity of transparent and accountable decision making by the controllers of health budgets, particularly in the light of the current financial climate in the NHS. CCGs have legal obligations to properly consider relevant evidence, as well as the views of experts and residents, in deciding how precious NHS resources are to be spent. It is essential that commissioning decisions are rational and evidence-based. Liverpool CCG’s decision to reconsider its position on the funding of homeopathy in these circumstances is to be welcomed.
“Our client has also called upon the Secretary of State for Health to issue guidance on the funding of homeopathy on the NHS. Public statements by the Secretary of State indicate that he does not support ongoing funding, yet he has so far declined to ask NICE to do any work on this issue. The provision of such guidance would be of significant benefit to CCGs in justifying decisions to terminate funding.”
Commenting on their decision, a Liverpool CCG spokesperson said: “Liverpool CCG currently resources a small homeopathy contract to the value of £30,000 per year that benefits a small number of patients in the city who choose to access NHS homeopathy care and treatment services. The CCG has agreed with the Good Thinking Society to carry out further engagement with patients and the general public to inform our future commissioning intentions for this service.”
Over the last two decades, prescriptions fulfilled in community pharmacies for homeopathy on the NHS in England have fallen by over 94% and homeopathic hospitals have seen their funding reallocated. This reduction indicates that the majority of doctors and commissioning bodies have acted responsibly by terminating funding for homeopathic treatments.
The GTS are currently fundraising in order to fund further legal challenges – donate now to support our campaign at justgiving.com/Good-Thinking-Society-Appeal/.
As I grew up in Germany, it was considered entirely normal that I was given homeopathic remedies when ill. I often wondered whether, with the advent of EBM, this has changed. A recent paper provides an answer to this question.
In this nationwide German survey, data were collected from 3013 children on their utilization of medicinal products, including homeopathic and other alternative remedies.
In all, 26% of the reported 2489 drugs were from the realm of alternative medicine. The 4-week prevalence for homeopathy was 7.5%. Of the drugs identified as alternative, 53.7% were homeopathic remedies, and 30.8% were herbal drugs. Factors associated with higher medicinal use of alternative remedies were female gender, residing in Munich, and higher maternal education. A homeopathy user utilized on average homeopathic remedies worth EUR 15.28. The corresponding figure for herbal drug users was EUR 16.02, and EUR 18.72 for overall medicinal CAM users. Compared with data from 4 years before, the prevalence of homeopathy use had declined by 52%.
The authors concluded that CAM use among 15-year-old children in the GINIplus cohort is popular, but decreased noticeably compared with children from the same cohort at the age of 10 years. This is possibly mainly because German health legislation normally covers CAM for children younger than 12 years only.
The survey shows that homeopathy is still a major player in the health care of German children. From the point of view of a homeopath, this makes a lot of sense: children are supposed to respond particularly well to homeopathy. But is that really true? The short answer is NO.
Our systematic review of all relevant studies tells it straight: The evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.
In other words, the evidence is very much at odds with the practice. This begs the question, I think, HOW SHOULD WE INTERPRET THIS DISCREPANCY?
A few possibilities come into mind, and I would be grateful to hear from my readers which they think might be correct:
- Homeopathy is used as a ‘benign placebo’ [clinicians know that most paediatric conditions are self-limiting and thus prefer to give placebos rather than drugs that can cause adverse effects].
- Doctors prescribe homeopathy mainly because the kids’ parents insist on them.
- Doctors believe that homeopathic remedies are more than just placebos [in which case they are clearly ill-informed].
- German doctors do not believe in scientific evidence and prefer to rely on their intuition.
- This high level of homeopathy usage misleads the next generation into believing in quackery.
- It amounts to child abuse and should be stopped.
