MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pseudo-science

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Amidst the current controversy of chiropractic spinal manipulation for new-born babies, the previous director of Chiropractor’s Association of Australia NSW, Alex Fielding, published an interesting article. In it, he declared:

  1. I do not condone the chiropractic treatment of children for non-musculoskeletal conditions it is simply not our place. There is little to no evidence for it and it should not be done. If a chiro is report them to AHPRA.
  2. There is no evidence for “subluxation” it simply has not been shown to exist by any credible source.
  3. Chiropractic does not equal spinal manipulative therapy (SMT) or adjustment. We are trained to assess and treat musculoskeletal conditions, use exercise rehab, various forms of manual therapy including SMT, give sound evidence based advice and refer to better suited health professionals in the appropriate circumstance. To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT.

Here I only want to comment on his last point. I think it is important, not least because we hear it ad nauseam. As soon as there emerges new evidence to show that SMT does little for back or neck pain or is ineffective for non-spinal conditions, chiropractors insist that they do so much more than just SMT, and therefore any such findings do not ever lend themselves to a verdict about chiropractic care.

In my view, this argument is a bit like ‘wanting the cake and eat it’ (chiros want to be different from physios by adhering to SMT, but they don’t want to be judged by the uselessness of SMT). It begs the following questions:

  1. What other modalities do chiros use?
  2. For which conditions do they use them?
  3. What is the evidence for or against them?
  4. In what percentage of patients do chiros use SMT?

The last question may be the most important one. I am not aware of data from ‘down under’ but, in the UK, the percentage is close to 100%. This is why I often call SMT the ‘hallmark therapy of chiropractors’. No other profession employ it more frequently. It is the treatment that defines the chiropractic profession.

If the evidence for SMT is flimsy or negative or non-existent, it seems not unreasonable to voice doubts about the profession that uses it most. The fact that chiropractors also administer other modalities – most of which, by the way, have a shaky evidence-base too – is simply a smoke-screen used to mislead us.

An example might make this a bit clearer. Imagine a surgeon who takes out the tonsils of every patient he sees, regardless of any tonsillitis or other tonsil-related condition (historically, this fad once existed; tonsillectomy was even used to treat depression). This surgeon also does all sorts of other things: he prescribes pain-killers, gives antibiotics, orders bed-rest, gives life-style advice etc. etc. Yet he is a charlatan because his hallmark intervention is not effective and even puts patients at unnecessary risks.

I know, the analogy is not perfect, but it makes the point: chiropractors refuse to be judged by the uselessness of SMT. Yet it is what defines them and they continue using SMT pretty much regardless of the evidence. Fielding pleads: To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT. I’d say there is no good evidence for SMT nor for chiropractic care that includes SMT.

My advice for chiropractors therefore is: abandon SMT and become physiotherapists. This will make you a bit better grounded in evidence, but at least you would have rid yourself of the Palmer-cult with all the BS that comes with it.

The current issues of ‘homeopathy 4 everyone’ (April 2016) carries several articles on homeoprophylaxis, the use of homeopathic remedies for the prevention of mostly infectious diseases promoted by homeopathy as a safe and effective alternative to immunizations. They are worth reading – but watch your blood pressure! Here I will give you a flavour by citing from one of these articles:

“…As I have been teaching about Homeoprophylaxis (“HP”) throughout the United States and in Europe, some things have become unmistakably clear.  One is the ever increasing desire of people to know that there is a nontoxic alternative when it comes to disease prevention.  Another is a profound misunderstanding or, perhaps better said, a lack of education among many regarding HP…

The effectiveness of HP is being shown fairly consistently to be about 90%1, which is comparable to any vaccine.  With this in mind, too, those who utilize homeoprophylaxis work to help their clients understand fundamentally that disease is generally not to be feared—that disease-causing pathogens are a necessary part of our environment and that the body generally becomes healthier once it has been exposed to a disease and has worked its way through it…

My passion regarding spreading the word and helping people learn about homeoprophylaxis led to my becoming the co-founder/director of the first international conference of its type in the world—Homeoprophylaxis: A Worldwide Choice, which took place in Dallas, Texas, USA in October, 2015.  Isaac Golden was our keynote speaker…

Frequently seen is the protocol Isaac Golden utilizes. This is a once monthly method, where one single remedy/nosode is introduced at potency.  If following, for example, a pediatric regimen that lists several nosodes, it will be the next month that either a larger dose of that same nosode is taken, or the next nosode is introduced.  For pediatric HP, this is cycled through until all nosodes in the protocol are taken, the higher potency being started after the lower potency is completed. A booklet is provided to the clientele to keep track of these…

Ultimately, homeoprophylaxis has been in use since the days of Hahnemann.  What is apparent when one considers the entire picture, noting the meticulous studies that have been and are yet being done as well as the current increasing demand of people worldwide— perhaps especially parents— for a nontoxic alternative for disease prevention, it truly makes sense to be promoting  homeoprophylaxis.  Our children are the most vulnerable in our society and deserve our utmost attention and concern.  Not every practitioner needs to utilize HP.  However, because there are many who do, support of this should be encouraged.  It is an alternative people deserve to know about so that they can make an educated choice, and health for our society, especially our children, can be promoted.”

END OF QUOTE

By now, you are probably wondering who wrote this article. It was Cathy Lemmon, BA, C.HP, D.Psc,  Co-Founder/Director of Homeoprophylaxis: A Worldwide Choice for Disease Prevention, she is also working on future conferences for the promotion of HP. She has studied HP with Isaac Golden of Australia and Ravi Roy and Carola Lage-Roy of Germany. She also has certificates in homeopathic treatment of vaccine injury as well as, through the ARHF in the Netherlands, treatment of epidemics and trauma. She completed studies at the School of Homeopathy and is completing specialized homeopathic studies through Gesundes Bewußtsein in Germany as well as post-graduate work in homeopathy through the College of Practical Homeopathy in London.

With all these ‘qualifications’, she has obviously escaped any education in real science and evidence-based medicine; if not she would know that her views are not just wrong but also dangerous. To Be clear:

  • Homeoprophylaxis is not biologically plausible.
  • There is no evidence that it works.
  • The concept misleads people to think that conventional immunizations are superfluous.
  • This has the potential to kill thousands.

Osteopathy is a confusing subject about which I have reported regularly on this blog (for instance here and here).

Recently, I came across a good article where someone had assessed 100 websites by UK osteopaths. The findings are impressive:

57% of websites in the survey published the ‘self-healing’ claim

70% publicised the fact they offered cranial therapy;

61% made a claim to treat one or more specific ailments not related to the musculoskeletal system;

48% of practitioners also personally offered another CAM therapy;

71% of all sites surveyed located in a setting where other CAM was immediately available.

In total, 93% of the randomly selected websites checked at least one, often more, of the criteria for pseudoscientific claims. The author concluded that quackery is far from existing only on the fringe of osteopathic practice.

In a previous article, the author had stated that “there’s some (not strong) evidence that manual therapy may have some benefit in the case of lower back pain.” This evidence for the assumption that osteopathy works for back pain seems to rely heavily on one researcher: Licciardone JC. He comes from ‘The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth‘. which also is the flag-ship of research into osteopathy with plenty of funds and a worldwide reputation.

In 2005, he and his team published a systematic review/meta-analysis of RCTs which concluded that “osteopathic manipulative therapy (OMT) significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.”

This is the article cited regularly to support the statement that osteopathy is an effective therapy for back pain. As the paper is now over 10 years old, we clearly need a more up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for chronic non-specific low back pain (CNSLBP) was recently published by an Australian team. A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

In other words, there seems to be an overt contradiction between the conclusions of Licciardone JC and those of the Australian team. Why? we may well ask. Perhaps the Osteopathic Research Center is not in the best position to be impartial? In order to check them out, I decided to have a closer look at their publications.

This team has published around 80 articles mostly in very low-impact osteopathic journals. They include several RCTs, and I decided to extract the conclusions of the last 10 papers reporting RCTs. Here they are:

RCT No 1 (2016)

Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions.

RCT No 2 (2016)

The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP.

RCT No 3 (2014)

Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

RCT No 4 (2014)

These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.

RCT No 5 (2013)

The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

RCT No 6 (2013)

The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

RCT No 7 (2012)

This study found associations between IL-1β and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.

RCT No 8 (2010)

Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.

RCT No 8 (2004)

The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.

RCT No 9 (2003)

Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

RCT No 10

Sorry, there is no 10th paper reporting an RCT.

Most of the remaining articles listed on Medline are comments and opinion papers. Crucially, it would be erroneous to assume that they conducted a total of 9 RCTs. Several of the above cited articles refer to the same RCT.

However, the most remarkable feature, in my view, is that the conclusions are almost invariably positive. Whenever I find a research team that manages to publish almost nothing but positive findings on one subject which most other experts are sceptical about, my alarm-bells start ringing.

In a previous blog, I have explained this in greater detail. Suffice to say that, according to my theory, the trustworthiness of the ‘Osteopathic Research Center’ is nothing to write home about.

What, I wonder, does that tell us about the reliability of the claim that osteopathy is effective for back pain?

For many years, I have been impressed with the high quality and originality of chiropractic research. Here is the abstract of a particularly remarkable, new investigation.

The purpose of this study was to compare characteristics, likelihood to use, and actual use of chiropractic care for US survey respondents with positive and negative perceptions of doctors of chiropractic (DCs) and chiropractic care.

From a 2015 nationally representative survey of 5422 adults (response rate, 29%), we used respondents’ answers to identify those with positive and negative perceptions of DCs or chiropractic care. We used the χ2 test to compare other survey responses for these groups.

Positive perceptions of DCs were more common than those for chiropractic care, whereas negative perceptions of chiropractic care were more common than those for DCs. Respondents with negative perceptions of DCs or chiropractic care were less likely to know whether chiropractic care was covered by their insurance, more likely to want to see a medical doctor first if they were experiencing neck or back pain, less likely to indicate that they would see a DC for neck or back pain, and less likely to have ever seen a DC as a patient, particularly in the recent past. Positive perceptions of chiropractic care and negative perceptions of DCs appear to have greater influence on DC utilization rates than their converses.

CONCLUSION:

We found that US adults generally perceive DCs in a positive manner but that a relatively high proportion has negative perceptions of chiropractic care, particularly the costs and number of visits required by such care. Characteristics of respondents with positive and negative perceptions were similar, but those with positive perceptions were more likely to plan to use-and to have already received-chiropractic care.

END OF ABSTRACT

I bet you are dying to learn who the authors of this impressive article are. Here is the full list and their affiliations:
Weeks WB1, Goertz CM2, Meeker WC3, Marchiori DM4.

  • 1Chair, Clinical and Health Services Research Program, Palmer Center for Chiropractic Research, Davenport, IA; Professor, The Geisel School of Medicine at Dartmouth, The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, NH. Electronic address: wbw@dartmouth.edu.
  • 2Vice Chancellor, Research and Health Policy, Palmer College of Chiropractic, Palmer Center for Chiropractic Research, Davenport, IA.
  • 3President, Palmer College of Chiropractic West Campus, San Jose, CA.
  • 4Chancellor, Palmer College of Chiropractic, Davenport, Iowa.

 

Not just inexperienced novices then! The authors belong to the crème de la crème of the chiropractic establishment and research!!!

In comparison, I feel like a mere beginner. But let me nevertheless try to design my own study along similar lines. It is so brilliant that I might even get the Nobel Prize for it. Here we go:

The purpose of my study would be to compare characteristics, likelihood to use, and actual use of spectacles for survey respondents with positive and negative perceptions of spectacles and opticians***. From a nationally representative survey of about 5000 adults, I would use the respondents’ answers to identify those with positive and negative perceptions of spectacles and opticians. My results would show that positive perceptions of opticians are more common than those for spectacles, whereas negative perceptions of spectacles are more common than those for opticians. Respondents with negative perceptions of opticians or spectacles were less likely to know whether spectacles were covered by their insurance, more likely to want to see a medical doctor first, if they were experiencing poor eye-sight, less likely to indicate that they would see an optician for poor eye-sight, and less likely to have ever seen an optician as a patient, particularly in the recent past. Positive perceptions of spectacles and negative perceptions of opticians appear to have greater influence on optician utilization rates than their converses. From these data, I would conclude that my sample generally perceive opticians in a positive manner but that a relatively high proportion has negative perceptions of spectacles, particularly the costs and number of visits required for getting them. Characteristics of respondents with positive and negative perceptions were similar, but those with positive perceptions were more likely to plan to use – and to have already received – care from opticians.

*** instead of opticians and spectacles, I might also opt for other things like

  • acupuncturists and needles,
  • aroma-therapists and essential oils,
  • herbalists and herbs,
  • fast food restaurants and hamburgers,
  • politicians and politics,
  • priests and religion,
  • etc., etc.

YOU MUST AGREE, THIS DESERVES A NOBEL PRIZE!

I thank the authors of the above paper for having inspired me with their ground-breaking science. In case they receive a Nobel Prize before I do, I congratulate them on their extraordinary achievement in designing, conducting and publishing this truly cutting-edge investigation.

I just came across this article which I find remarkable in several ways. Here is the abstract:

OBJECTIVE:
The purpose of this report is to describe 2 patients with coronary artery disease presenting with musculoskeletal symptoms to a chiropractic clinic.
CLINICAL FEATURES:
A 48-year-old male new patient had thoracic spine pain aggravated by physical exertion. A 61-year-old man under routine care for low back pain experienced a secondary complaint of acute chest pain during a reevaluation.
INTERVENTION AND OUTCOME:
In both cases, the patients were strongly encouraged to consult their medical physician and were subsequently diagnosed with coronary artery disease. Following their diagnoses, each patient underwent surgical angioplasty procedures with stenting.
CONCLUSION:
Patients may present for chiropractic care with what appears to be musculoskeletal chest pain when the pain may be generating from coronary artery disease necessitating medical and possibly emergency care.

I FIND THIS REMARKABLE FOR AT LEAST 3 REASONS:

  1. I don’t remember coming across the term ‘medical physician’ before. It is clear what the author meant by it. But it is also quite clear that such phraseology is nonsensical. My Oxford Dictionary defines ‘physician’ as: “A person qualified to practise medicine, especially one who specializes in diagnosis and medical treatment as distinct from surgery.” Therefore, a ‘medical physician’ would be ‘a medical person qualified to practise medicine.’ This begs the question why this term is used in a chiro-journal. The answer is probably quite simple: they want to arrive at a point where we all accept that there are two types of physicians: medical and chiropractic. But, using again my dictionary, this would be not just a little confusing. A chiropractic physician would be ‘a chiropractor qualified to practice medicine.’ And for that you need to go not to chiro-college but to medical school.
  2. The two case reports are remarkable in themselves, I find. They show that “patients may present for chiropractic care with what appears to be musculoskeletal chest pain when the pain may be generating from coronary artery disease necessitating medical and possibly emergency care.” The remarkable thing about this is that such basic knowledge ever merited a mention and publication in a journal. It should be clear to anyone who is in healthcare! I even know shop assistants who have called an ambulance because a customer suffered from what might have been misdiagnosed as a muscular problem in the left arm but was in truth due to coronary hear disease. The fact that chiros and editors of their journals feel that it worthy of publication seems a bit worrying and begs the question: how many other elementary things about the human body (known even to shop assistants) are unknown to the average chiro?
  3. Lastly, I must praise the chiro-profession for the progress they now seem to start making. About 120 years ago, DD Palmer, the founding father of chiropractic, famously treated a man with coronary heart disease by adjusting his spine. The author of the above article did not do that! Yes, progress was painfully slow, but the above article seems to indicate that at least some chiros have come around to agreeing with real physicians that the Palmer-gospel is based on little more than wishful thinking.

A nice way to conclude this year’s ‘homeopathy awareness week’, I think, is to review some of the more important homeopathy-related events from across the world that have been reported (on this blog) in the past 12 months.

  1. A few weeks ago, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”
  2. On January 30, a group of experts from all walks of life met in Freiburg to discuss ways of informing the public responsibly and countering the plethora of misinformation that Germans are regularly exposed to on the subject of homeopathy. They founded the ‘Information Network Homeopathy‘ and decided on a range of actions.
  3. Earlier that month, the Nobel laureate Venkatraman Ramakrishnan called homeopathy ‘bogus’. “They (homeopaths) take arsenic compounds and dilute it to such an extent that just a molecule is left. It will not make any effect on you. Your tap water has more arsenic. No one in chemistry believes in homeopathy. It works because of placebo effect,” he was quoted saying.
  4. We have confirmed that Dana Ulman (the ‘spokesman’ for homeopathy in the US) fails to understand science or medicine. He excels in producing one fallacy after the next. If he were on a mission to give homeopathy a bad name, he would be doing a sterling job!
  5. I identified Prof Frass as one of the most magical of all homeopathy researchers: he never fails to produce a positive result with his placebos.
  6. In an interview,  Christian Boiron, the general manager of the world’s largest producer of homeopathics, carried the debate about homeopathy to a new level of stupidity. He pointed out that “Il y a un Ku Klux Klan contre l’homéopathie” My translation: THERE IS A KU KLUX KLAN AGAINST HOMEOPATHY.
  7. In a similar vein, Dr Michael Dixon, advisor to Prince Charles, defended homeopathy by stating that omitting it from the NHS “would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference. It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy.”
  8. The Hungarian Academy of Sciences statement proposing the same scientific standards for homeopathic drug registration as for normal drugs Members of the Section of Medical Sciences of the Hungarian Academy of Sciences (HAS) voted unanimously on 9 November 2015 for supporting the earlier proposal of the Royal Swedish Academy of Sciences. The Swedish statement requested that the homeopathic remedies should go through the same efficacy trials as normal drugs should.
  9. The US Federal Trade Commission (FTC) announced that they are considering whether advertisements for homeopathic products have any evidence to back the numerous claims that are being made for them. A meeting took place on 21 September, and the first details have emerged.
  10. A legal challenge  in the UK failed to produce the results homeopaths had hoped for. Honor Watt, 73 had sued Lothian Health Board after the authority stopped in June 2013 to provide homeopathic treatments to patients. Ms Watt’s lawyers decided to challenge the board’s decision in the Court of Session claiming the health board acted illegally. There is reason to believe that Ms Watt was assisted by a professional organisation of homeopathy ( the judgement mentions that the Board’s submission stated that ‘the real force behind the petition was a charity, not the petitioner’). The case went to court and the judge, Lord Uist, ruled that the health board had acted legally. He therefore refused to overturn the board’s original decision. In a written judgement issued on Friday, Lord Uist confirmed that the health board acted correctly: “It is clear to me from an examination of the relevant documents that the board was from the outset consciously focusing on its PSED.”
  11. The first International Conference on Homeoprophylaxis announce its guest speaker: ex-doctor Andrew Wakefield.
  12. The Royal Pharmacy Society’s Chief Scientist Professor Jayne Lawrence has blogged on the history of homeopathy and asked why, even in the face of the lack of evidence, people are still actively seeking homeopathic treatment today. Jayne layed down a challenge to the profession: “… are we ready to remove homeopathy from the shelves of pharmacies?And here are the relevant passages from Jayne Lawrence’s post:…it is easy to see why homeopathy, with its use of ultralow doses of the treatment material, became so popular so quickly, despite the fact that a clinical trial performed as early as 1835 showed that homeopathy as a method of treatment was wholly ineffective.…for homeopathy to work as claimed, we would have to completely revise our understanding of science. Any scientific evidence claiming to support homeopathy has either been shown to be flawed or not repeatable under controlled conditions. Furthermore, systematic reviews of modern clinical trials have supported the first early clinical trial showing that homeopathy has no more clinical effect than a placebo…The public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”
  13. And finally, there is this impressive graph (published not by me but) by the formidable Nightingale Collaboration. It speaks for itself, I think:

The decline of homeopathy in the NHS 2015

NO, ONE CANNOT SAY THAT IT WAS A GOOD YEAR FOR HOMEOPATHY – BUT, PLEASE, LET THAT NOT SPOIL YOUR CELEBRATORY MOOD.

One of the things about alternative medicine that I find most regrettable is the fact that researchers in this area abuse science for their very own promotional aims. This phenomenon is so very common, in my view, that many of the individuals involved in it are no longer aware of it. Science, they seem to think, is a tool for marketing products or for popularising the idea that alternative medicine is the best thing since sliced bread.

To support this bold statement, I could show you virtually hundreds of articles. But this might bore your socks off, and instead I will focus on just one paper which has just been published and makes my point in an exemplary fashion.

The new clinical investigation was performed to confirm the benefit of complementary medicine in patients with breast cancer undergoing adjuvant hormone therapy (HT). A total of 1561 patients were treated according to international guidelines. They suffered from arthralgia and mucosal dryness induced by the adjuvant HT. In order to reduce the side-effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. Outcomes were documented before and four weeks after complementary treatment. Validation was carried-out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely poor tolerability). A total of 1,165 patients suffering from severe side-effects (symptom scores >3) were enrolled in this investigation.

Overall, 62.6% of patients (729 out of 1,165) suffering from severe arthralgia and 71.7% of patients (520 out of 725) with severe mucosal dryness significantly benefited from the oral combination product. Mean scores of symptoms declined from 4.83 before treatment to 3.23 after four weeks of treatment for arthralgia and from 4.72 before treatment to 2.99 after four weeks of treatment for mucosal dryness, the primary aims of the present investigation. The reduction of side-effects of HT was statistically significant after four weeks.

The authors concluded that this investigation confirms studies suggesting a benefit of complementary treatment with the combination of sodium selenite, proteolytic enzymes and L. culinaris lectin in patients with breast cancer.

Where should I start?

  • This ‘investigation’ was nothing other than a survey.
  • There was no control group, and we therefore cannot tell whether the patients would not have done just a well or even better without taking this supplement.
  • No objective outcome measure was included.
  • What happened to the ~400 patients who were not included in the analyses?
  • Even the authors admit that their aim was “to confirm the benefit of complementary medicine…”, and it goes without saying that, with such an aim in mind, any scientific rigor is not welcome.
Science, I had always assumed, is a means of generating progress. This sort of pseudoscience can only generate the opposite. The sad thing is that, in alternative medicine, pseudoscience of this nature seems to dominate the scene. The victims here are we all: as the false-positive findings accumulate, the overall evidence is being distorted and wrong therapeutic decisions become inevitable.

The website of the Brighton and Hove News informs us that the Brighton charity Rockinghorse is paying for a Reiki healer to treat young patients at the Royal Alexandra Children’s Hospital in Kemp Town. They claim that studies suggest that Reiki can relieve symptoms of chronic and acute illness, manage stress levels and aid relaxation and sleep. Rockinghorse has provided funding for an initial three years to therapists from Active LightWorks who have already been treating patients at the Alex as volunteers since 2012. The funding will allow the therapists to double the amount of time that they are able to offer treatments from five hours a week to ten.

One of the HDU patients to receive Reiki therapy is eight-month-old Blake Mlotshwa. He suffered a serious infection when he was 18 days old which led to him having two thirds of his bowel removed. Blake is unable to absorb the food and nutrients that he needed to grow and his condition remains critical. The reiki therapists are working with his doctors and nurses to help keep him as comfortable as possible.

Ali Walters, a Reiki therapist, said: “It is wonderful to be able to give both the children and parents an opportunity to relax and unwind. So often parents tell me they are delighted that during treatment their child drops off to sleep or they see their child become more calm and comfortable. I am delighted that Rockinghorse is now funding our work so we can provide more therapists and treatments to support the critical care that is provided in HDU.”

Kamal Patel, paediatric consultant at the Alex, said: “The reiki treatment has improved sleep, fear, anxiety, distress and pain for children on our Paediatric Critical Care Unit over and above what we can achieve through modern medicine. To have such a fantastic team of people offering reiki really helps our patients get better quicker.”

Yes, we have discussed Reiki several times already on this blog. For instance, I quoted the Cochrane review aimed at evaluating the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.

Literature searches were conducted in the Cochrane Register of Controlled Trials (CENTRAL – all years), the Cochrane Depression, Anxiety and Neurosis Review Group’s Specialised Register (CCDANCTR – all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014.

Randomised trials were considered in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner. The two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified.

The researchers found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students. These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively.

The findings did not show any evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduced the certainty of the evidence.

The authors of this Cochrane review concluded that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

On a different blog post, I concluded that “we do not need a trained Reiki master, nor the illusion of some mysterious ‘healing energy’. Simple companionship without woo or make-believe has exactly the same effect without undermining rationality. Or, to put it much more bluntly: REIKI IS NONSENSE ON STILTS.”

Perhaps someone should tell the guys at Rockinghorse that they are funding nonsense?

Perhaps the charity should have been responsible enough to do a quick search on the evidence BEFORE they committed their funds?

Perhaps the consultant pediatrician should be sent to a refresher course in evidence-based medicine?

So many ‘perhapses’ – and only one certainty: THIS CHARITY IS WASTING ITS FUNDS ON OFFENSIVE NONSENSE.

I must have stated this a thousand times – but I will do it again: A HOMEOPATHIC REMEDY MIGHT BE HARMLESS, BUT MANY HOMEOPATHS AREN’T!

As to prove my point, US homeopaths are about to host a conference where it is made quite obvious. The National Center for Homeopathy (NHC) is a non-profit organization in the US dedicated to “promoting health through homeopathy by advancing the use and practice of homeopathy.” The NCH is also the host organization for the Joint American Homeopathic Conference (JAHC). This event offers an afternoon of homeopathic learning for those interested in understanding more about the use of homeopathy on 9 April this year.

“We host a conference every year for practitioners and serious students but we also know there are a lot of people who’d like to learn more about homeopathy. So we created this special afternoon for interested beginners called Homeopathy Academy for Moms Live! Though we find moms and dads increasingly interested in using homeopathic remedies for their families, we created this event for all novice users,” explains NCH Executive Director Alison Teitelbaum. “People are interested in homeopathy because it’s safe, has no side effects, is inexpensive and, best of all, natural.”

Interested attendees to the introductory workshop receive:

1. Two 2-hour workshops taught by renowned homeopathic instructors that are guaranteed to increase your understanding, skill level, and confidence in using homeopathy at home for yourself and your family
2. Access to our one-of-a-kind holistic Marketplace – where close to 40 exhibitors and vendors will be showcasing and selling their natural, holistic, and homeopathic products and services.

Pre-registration rate of $35 is available until March 23 and then $50 thereafter.

A few clicks away, I found a NHC website which might disclose more clearly what the moms are about to be taught. Here are a few highlights:

Based on a thorough review of the literature, I believe strongly that the decreased incidence of these serious diseases is linked to improved sanitation and hygiene as well as to the introduction of vaccinations.  However, I am deeply concerned about the catastrophic rise of chronic diseases like asthma, autism, and behavioral disorders. Much more research into the possible relationship between vaccinations and these epidemic problems needs to be done.

At present, there is little data to support or reject any such association.

If your state permits exemption to vaccination, you may decide to withhold vaccinations from your child based on the simple philosophical decision that you do not wish to inject foreign bacterial/viral matter into your healthy child. Given that the infectious diseases for which people get vaccinated are exceedingly rare in the U.S., it is unlikely that your child would suffer the consequences of one of them. Be aware, however, that in some cities it is becoming routine to remove unvaccinated children from schools whenever there is a child with an infectious disease for which the majority are vaccinated. In the case of chickenpox, this could result in a child being removed from school two or four weeks a year, without recourse….

Do not accept the bland reassurances of health professionals or public health authorities that your child will be safe if vaccinated. There is no question that vaccines have the potential to undermine immune function in some children who receive them. Many vaccine investigators agree that the increase in asthma, diabetes, autism, and some autoimmune diseases is directly attributed to vaccine use in children. Educate yourself about disease incidence, vaccine effectiveness, and vaccine adverse effects before you agree to any vaccinations…

Don’t be bullied by the medical profession. Do make a decision and try not to let it plague you–move on and enjoy your baby! Also, don’t forget that if you are breastfeeding, your baby will get a lot of immunity from you and it would be unnecessary to vaccinate quite so early in their life…

All vaccines are artificial disease products, accompanied with preservatives of varying potential toxicity. Their introduction into the body is a serious proposition…

NOW, WHO FEELS LIKE PERPETUATING THE MYTH OF HOMEOPATHY BEING HARMLESS?

Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”

The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.

The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”

Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.

In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.

I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.

 

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