MD, PhD, FMedSci, FSB, FRCP, FRCPEd

systematic review

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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?

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.

On this blog, I have repeatedly pleaded for a change of the 2010 NICE guidelines for low back pain (LBP). My reason was that it had become quite clear that their recommendation to use spinal manipulation and acupuncture for recurrent LBP was no longer supported by sound evidence.

Two years ago, a systematic review (authored by a chiropractor and published in a chiro-journal) concluded that “there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP.” A the time, I wrote a blog explaining that “whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently)  is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of chronic LBP – and consequently consulting a chiropractor should not be the first choice for chronic LBP patients.”

Three years ago, a systematic review of acupuncture for LBP (published in a TCM-journal) concluded that the effect of acupuncture “is likely to be produced by the nonspecific effects of manipulation.” At that time I concluded my blog-post with this question: Should NICE be recommending placebo-treatments and have the tax payer foot the bill? Now NICE have provided an answer.

The new draft guideline by NICE recommends various forms of exercise as the first step in managing low back pain. Massage and manipulation by a physiotherapist should only be used alongside exercise; there is not enough evidence to show they are of benefit when used alone. Moreover, patients should be encouraged to continue with normal activities as far as possible. Crucially, the draft guideline no longer recommends acupuncture for treating low back pain.

NICE concluded that the evidence shows that acupuncture is not better than sham treatment. Paracetamol on its own is no longer recommended either, instead non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin should be tried first. Talking therapies are recommended in combination with physical therapies for patients who had no improvement on previous treatments or who have significant psychological and social barriers to recovery.

Professor Mark Baker, clinical practice director for NICE, was quoted stating “Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”

Good news for us all, I would say:

  • good news for patients who now hear from an accepted authority what to do when they suffer from LBP,
  • good news for society who does no longer need to spend vast amounts of money on questionable therapies,
  • good news for responsible clinicians who now have clear guidance which they can show and explain to their patients.

Not so good news, I admit, for acupuncturists, chiropractors and osteopaths who just had a major source of their income scrapped. I have tried to find some first reactions from these groups but, for the moment, they seemed to be stunned into silence – nobody seems to have yet objected to the new guideline. Instead, I found a very recent website where chiropractic is not just recommended for LBP therapy but where patients are instructed that, even in the absence of pain, they need to see their chiropractor regularly: “Maintenance chiropractic care is well supported in studies for controlling chronic LBP.”

NEVER LET THE TRUTH GET IN THE WAY OF YOUR CASH-FLOW…they seem to conclude.

Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”

The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”

This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”

How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.

On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.

Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”

RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.

Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.

I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.

After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.

WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.

The current ‘Acupuncture Awareness Week’ is perhaps a good occasion to look beyond acupuncture for humans. The ‘Chi Institute’ is an organisation that teaches TCM for animals. There you can specialise in all sorts of intriguing things that a critical mind would have never thought about. Take acupuncture for horses, for instance; on their website, the Institute informs us that:

The Equine Acupuncture Program…certifies students in veterinary acupuncture with an emphasis on horses. The program begins with an overview of fundamental aspects of Chinese Medicine, including Ying-Yang and Five Elements theory, which serve as a foundation for case diagnosis and treatment presented later in the class. A variety of acupuncture techniques are taught, including electro-acupuncture and moxibustion, in addition to conventional “dry” needling. Students of the program learn acupuncture points on large animals only, and horses are used for practice in the wet labs.

The program is presented in five sessions (two online and three on-site) over a period of six months. Online sessions are composed of lectures that students can stream at their own convenience. Afternoon wet-labs of on-site sessions give students the opportunity to learn acupuncture points on live animals in small lab groups of five to six students per instructor. A spring class and a fall class are held each year. Equine Acupuncture is offered to licensed veterinarians and veterinary school junior/senior students only.

Major Topics: 

  • Traditional Chinese Veterinary Medicine (TCVM) Principles: Five Elements, Yin-Yang, Eight Principles, Zang-Fu Physiology and Pathology, Meridians and Channels
  • Scientific Basis of Acupuncture
  • 200 Transpositional Equine Acupuncture Points (hands-on, wet-lab demos)
  • 70 Classical Equine Acupuncture Points (hands-on, wet-lab demos)
  • How to needle acupuncture points in horses
  • TCVM Diagnostic Systems, including Tongue and Pulse Diagnosis
  • How to integrate acupuncture into your practice
  • How to use veterinary acupuncture to diagnose and treat:
      1. Musculoskeletal conditions, lameness and neurological disorders
      2. Cardiovascular diseases and respiratory disorders
      3. Gastrointestinal disorders and behavioral problems
      4. Dermatological problems and immune-mediated diseases
      5. Renal & urinary disorders and reproductive disorders
  • Veterinary acupuncture techniques:
      1. Dry needle (conventional needling)
      2. Aqua-acupuncture (point injection)
      3. Electro-acupuncture
      4. Hemo-acupuncture
      5. Moxibustion

But is there not something missing, I asked myself when I read this. What about the evidence? What about the question whether there is any proof that any of this works?
As it happens, some time ago, we looked into this by conducting a systematic review. Here is our abstract ( I should mention that the first author of this paper was a vet who was very fond of acupuncture):

Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

What a pity that the pupils of the above course are not being told that THERE IS NO COMPELLING EVIDENCE that any of the tings they are about to learn has any value…but that would be bad for business, wouldn’t it? And we cannot have a bit of evidence jeopardize a nice little earner, can we?

Samuel Hahnemann, the founder of homeopathy, gave a lecture on the subject of veterinary homeopathy in the mid-1810s. Ever since, homeopathy has been used for treating animals. Von Boennighausen, a Dutch lawyer and early convert to homeopathy, was one of the first influential proponents of veterinary homeopathy.

However, veterinary medical schools tended to take a very dim view of homoeopathy, and the number of veterinary homeopaths initially remained small. In the 1920ies, veterinary homoeopathy was revived in Germany. Members of the “Studiengemeinschaft für tierärztliche Homöopathie” (Study Group for Veterinary Homoeopathy), which was founded in 1936 and had Nazi support, started to investigate this approach.

Today, veterinary homeopathy is popular, not least because of the general boom in alternative medicine. Prince Charles has become one of its most prominent advocate. In his book HARMONY, he writes:

“…one of the big arguments used against homeopathy is that it does not really work medically. The criticism is that people simply believe they feel they are going to feel better and so they think they are better. They have responded to the so-called ‘placebo effect’. It is for this reason that critics of homeopathy argue that it is a trick of the mind and its remedies are nothing more than sugar pills. What none of those who take this view ever seem to acknowledge is that these remedies also work on animals, which are surely unlikely to be influenced by the placebo effect. I certainly remember that when I started to introduce homeopathic remedies on the Duchy Home Farm, farm staff who had no view either way reported that the health of an animal that had been treated had improved so I wonder what it is that prevents the medical profession from even considering the evidence that now exists of trials of homeopathic treatments carried out on animals? It is not the quackery they claim it to be. Or if it is, then I have some very clever cows in my shed!”

[I do love this quote; it so very clearly shows the frightfully muddled thinking of this man.]

In many countries, veterinary homeopaths have their own professional organisations. In other countries, however, veterinarians are banned from practicing homeopathy. In the UK, only veterinarians are allowed to use homeopathy on animals, but ironically anyone regardless of background can use it on human patients. In the US, homeopathic vets are organised in the Academy of Veterinary Homeopathy.

But what do homeopathic vets treat? One website informs us that the conditions frequently treated are: arthritis, lameness, cruciate rupture, chronic diarrhoea, atopy, allergy, autoimmune disorders (auto-immune), periodic ophthalmia (moon blindness, moonblindness, recurrent uveitis, recurrent ophthalmia, ERU), head shaking (headshaking, head-shaking), hip dysplasia, COPD, sweet itch, laminitis, corneal ulcer, elbow dysplasia, RAO, DJD, OCD, bone cysts, pasteurellosis (pasteurella), chlamydia, cryptosporidia, pneumonia, meningitis, mastitis, ringworm, epilepsy, pyoderma, eczema, dermatitis, eosinophilic myositis, eosinophilic granuloma, rodent ulcer, miliary eczema (miliary dermatitis), kidney problems, liver problems (hepatopathy), cystitis.

Now I can almost hear you shout: WHERE IS THE EVIDENCE???

May I refer you to a previous post on the matter?

It discussed a review aimed to assess risk of bias and to quantify the effect size of homeopathic interventions compared with placebo for each eligible peer-reviewed trial. Judgement in 7 assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise reliable evidence, if its risk of bias was low or was unclear in specified domains. A trial was considered to be free of vested interest, if it was not funded by a homeopathic pharmacy.

The 18 RCTs found by the researchers were disparate in nature, representing 4 species and 11 different medical conditions. Reliable evidence, free from vested interest, was identified in only two trials:

  1. homeopathic Coli had a prophylactic effect on porcine diarrhoea (odds ratio 3.89, 95 per cent confidence interval [CI], 1.19 to 12.68, P=0.02);
  2. individualised homeopathic treatment did not have a more beneficial effect on bovine mastitis than placebo intervention (standardised mean difference -0.31, 95 per cent CI, -0.97 to 0.34, P=0.35).

The authors conclusions are clear: Mixed findings from the only two placebo-controlled RCTs that had suitably reliable evidence precluded generalisable conclusions about the efficacy of any particular homeopathic medicine or the impact of individualised homeopathic intervention on any given medical condition in animals.

…homeopaths…will try to claim that [the review] was a biased piece of research conducted, most likely, by notorious anti-homeopaths who cannot be trusted. So who are the authors of this new publication?

They are RT Mathie from the British Homeopathic Association and J Clausen from one of Germany’s most pro-homeopathic institution, the ‘Karl und Veronica Carstens-Stiftung’.

At this stage, some of my readers are quite angry, I imagine. They might wonder how to protect defenceless animals from homeopathic quacks. But how?

Simple! Just sign the petition to ban veterinary homeopathy! I mean it – please do!!!

In 2009, we published a systematic review of studies testing acupuncture as a treatment of menopausal hot flushes. We searched the literature using 17 databases from inception to October 10, 2008, without language restrictions. We only included randomized clinical trials (RCTs) of acupuncture versus sham acupuncture. Their methodological quality was assessed using the modified Jadad score. In total, six RCTs could be included. Four RCTs compared the effects of acupuncture with penetrating sham acupuncture on non-acupuncture points. All of these trials failed to show specific effects on menopausal hot flush frequency, severity or index. One RCT found no effects of acupuncture on hot flush frequency and severity compared with penetrating sham acupuncture on acupuncture points that are not relevant for the treatment of hot flushes. The remaining RCT tested acupuncture against non-penetrating acupuncture on non-acupuncture points. Its results suggested favourable effects of acupuncture on menopausal hot flush severity. However, this study was too small to generate reliable findings. At the time, we concluded that sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes. We also argued that more rigorous research is warranted.

It seems that such research has just become available.

The aim of a brand-new study – a stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists were blinded to treatment allocation), parallel, randomized, sham-controlled trial with equal allocation – was to assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal hot flushes (HFs). It was funded by the Australian National Health and Medical Research Council.

Women older than 40 years were recruited; they had to be in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. These patients received 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat ‘kidney yin deficiency’ or they got the same amount of non-insertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

In total, 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment period were 15.36 in the acupuncture group and 15.04 in the sham group. No serious adverse events were reported.

The authors concluded that Chinese medicine acupuncture was not superior to non-insertive sham acupuncture for women with moderately severe menopausal HFs.

The trial has several strengths: it includes a large sample size and the patients were adequately blinded to eliminate the effects of expectations. It was published in a top journal, and we can therefore assume that it was properly peer-reviewed. Combined with the evidence from our previous systematic review, this indicates that acupuncture has no effect beyond placebo.

In other words: ACUPUNCTURE IS NOTHING BUT A THEATRICAL PLACEBO.

One does not need to be a clairvoyant to predict that acupuncturists will now find what they perceive as a flaw in the new study and claim that its results were false-negative. Subsequently they will probably conduct their own trial which, because it is wide open to bias, will generate the finding they were hoping for.

This sequence of poor quality positive and high quality negative studies could go on ad infinitum.

This begs the question: how can such wasteful pseudo-research be stopped?

In theory, applications to ethics committees for research that is not aimed at answering open and important questions should get rejected. In practice, however, this is unlikely to happen. In my experience, the main reason preventing such actions is that, when it comes to alternative medicine, ethics committees tend to be too lenient (attempting to be ‘politically correct’), too uninterested (thinking that alternative medicine is not really a serious area of research) and too uninformed (failing to insist on a rigorous assessment of the already available evidence).

Many cancer patients use mistletoe extracts either hoping to cure their cancer or to alleviate its symptoms. The evidence that mistletoe treatment (MT) can achieve either of these goals is mixed but, on the whole, however, it is not positive. Our own systematic review of 2003 concluded that ‘rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy’. The more recent Cochrane review concurred: ‘The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak.’

Patients’ experiences of side effects and the acceptability, tolerability, and perceived benefits of MT have not been assessed critically. The aim of this new article was to systematically review and synthesise the results of qualitative studies of cancer patients’ experiences of using MT.

Electronic searches were conducted in MEDLINE, Embase, PsychLIT, CINAHL, and AMED to identify all qualitative studies of MT. Articles were screened independently by two reviewers and critically appraised using the Critical Appraisal Skills Programme tool. A thematic synthesis of the findings was carried out.

One hundred and seventy-three papers were identified; 156 were excluded at initial screening. Seventeen papers were read in full, 14 of which were excluded. Three articles about patients’ experiences of MT alongside conventional treatment were included in the synthesis, either as a monotherapy (two articles) or as part of a package of anthroposophic treatment (one article). Patients reported demonstrable changes to their physical, emotional, and psychosocial well-being following MT, as well as a reduction in chemotherapy side effects. Self-reported side effects from MT were few, and the studies suggest good adherence to the therapy. Self-injection gave patients a sense of empowerment through involvement in their own treatment.

The authors concluded that ‘given the variation in context of MT delivery across the articles, it is not possible to ascribe changes in patients’ quality of life specifically to MT.’

This might be a polite way of saying that there is no good evidence to suggest that MT positively affects patients’ experiences of side effects and the acceptability, tolerability, and perceived benefits.

Mistletoe is, of course, the ‘flagship’ intervention of Rudolf Steiner’s anthroposophical medicine. About a century ago, his idea was simple (or should this be ‘simplistic’?): the mistletoe plant is a parasite that lives off host trees sapping its resources until, eventually, it might even kill its host – just like cancer threatening the life of a human being. It follows, according to the homeopathy-inspired Steiner and the many followers of his cult that mistletoe is an effective cancer therapy.

Despite the weirdness of this concept and the largely negative evidence, MT is hugely popular as a cancer cure, particularly in German-speaking countries. The question I ask myself is this: ISN’T IT TIME THAT THIS NONSENSE STOPS?

What a question, you might say. And you would be right, it’s a most awkward one, so much so that I cannot answer it for myself.

I NEED YOUR HELP.

Here is the story:

Ten years ago, with the help of S Lejeune and an EU grant, my team conducted a Cochrane review of Laertrile. To do the ‘ground work’, we hired an Italian research assistant, S Milazzo, who was supervised mainly by my research fellow Katja Schmidt. Consequently, the review was published under the names of all main contributors: Milazzo, Ernst, Lejeune, Schmidt.

In 2011, an update was due for which the help of Dr Markus Horneber, the head of a German research team investigating alt med in relation to cancer, was recruited. By then, Milazzo and Schmidt had left my unit and, with my consent, Horneber, Milazzo and Schmidt took charge of the review. I was then sent a draft of their update and did a revision of it which consisted mostly in checking the facts and making linguistic changes. The article was then published under the following authorship: Milazzo S, Ernst E, Lejeune S, Boehm K, Horneber M (Katja had married meanwhile, so Boehm and Schmidt are the same person).

A few days ago, I noticed that a further update had been published in 2015. Amazingly, I had not been told, asked to contribute, or informed that my name as co-author had been scrapped. The authors of the new update are simply Milazzo and Horneber (the latter being the senior author). Katja Boehm had apparently indicated that she did no longer want to be involved; I am not sure what happened to Lejeune.

I know Markus Horneber since donkey’s years and had co-authored several other papers with him in the past, so I (admittedly miffed about my discovery) sent him an email and asked him whether he did not consider this behaviour to amount to plagiarism. His reply was, in my view, unhelpful in explaining why I had not been asked to get involved and Horneber asked me to withdraw the allegation of plagiarism (which I had not even made) – or else he would take legal action (this was the moment when I got truly suspicious).

Next, I contacted the responsible editor at the Cochrane Collaboration, not least because Horneber had claimed that she had condoned the disputed change of authorship. Her reply confirmed that “excluding previous authors without giving them a chance to comment is not normal Cochrane policy” and that she did, in fact, not condone the omission of my name from the list of co-authors.

The question that I am asking myself (not for the first time, I am afraid – a similar, arguably worse case has been described in the comments section of this post) is the following: IS THIS A CASE OF PLAGIARISM OR NOT? In the name of honesty, transparency and science, it requires an answer, I think.

Even after contemplating it for several days, I seem to be unable to find a conclusive response. On the one hand, I did clearly not contribute to the latest (2015) update and should therefore not be a co-author. On the other hand, I feel that I should have been asked to contribute, in which case I would certainly have done so and remained a co-author.

For a fuller understanding of this case, I here copy the various sections of the abstracts of the 2011 update (marked OLD) and the 2015 update without my co-authorship (marked NEW):

 

OLD

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

NEW

Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.

OBJECTIVES:

OLD

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

NEW

To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.

SEARCH METHODS:

OLD

We searched the following databases: CENTRAL (2011, Issue 1); MEDLINE (1951-2011); EMBASE (1980-2011); AMED; Scirus; CancerLit; CINAHL (all from 1982-2011); CAMbase (from 1998-2011); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

NEW

We searched the following databases: CENTRAL (2014, Issue 9); MEDLINE (1951-2014); EMBASE (1980-2014); AMED; Scirus; CINAHL (all from 1982-2015); CAMbase (from 1998-2015); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.

SELECTION CRITERIA:

OLD

Randomized controlled trials (RCTs) and quasi-RCTs.

NEW

Randomized controlled trials (RCTs) and quasi-RCTs.

DATA COLLECTION AND ANALYSIS:

OLD

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

NEW

We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.

MAIN RESULTS:

OLD

We located over 200 references, 63 were evaluated in the original review and an additional 6 in this update. However, we did not identify any studies that met our inclusion criteria.

NEW

We located over 200 references, 63 were evaluated in the original review, 6 in the 2011 and none in this update. However, we did not identify any studies that met our inclusion criteria.

AUTHORS’ CONCLUSIONS:

OLD

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

NEW

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

END OF ABSTRACT

I HOPE THAT YOU, THE READER OF THIS POST, ARE NOW ABLE TO TELL ME:

HAVE I BEEN PLAGIARISED?

P S

After the response from the Cochrane editor, I asked Horneber whether he wanted to make a further comment because I was thinking to blog about this. So far, I have not received a reply.

Some time ago, when we published our systematic review about the adverse effects associated with homeopathic remedies, there was an outcry of critics stating that it is not rational to claim, on the one hand, that homeopathic remedies are so dilute that they contain nothing and therefore do nothing and, on the other hand, that homeopathic remedies can cause side-effects. These people should, of course, have known better, but I admit it can be a little confusing. So, let me explain.

Every homeopathic remedy starts as a ‘mother tincture’. That is the undiluted stock prepared according to a homeopathic pharmacopoeia. The mother tincture is then diluted and shaken to give the first ‘potency’. Depending on the potency scale, this could be a ‘C1’ (1:100) or ‘D1’ (1:10). The resulting potency can be potentised again to give the second potency which can be potentised again to give the third potency. And this process of ‘serial dilution’ can be continued ad infinitum (the most common potency is the C30 which is a dilution of 30 times 1 : 100).

All of these remedies are by definition homeopathic, of course; even a mother tincture is strictly speaking a homeopathic remedy.

Now imagine we have a highly toxic stock, for instance, arsenic. This is by no means an extreme example, as many substances used in homeopathy are poisonous. A ‘D1’ of arsenic is both effective and dangerous: it is effective for killing rats and other unwanted creatures, and it is dangerous should a patient take it.

So, now we understand better why homeopathic remedies can, contrary to a common myth, cause direct adverse effects (in addition to the scenario outlined above, they can also be contaminated or adulterated, of course). We also realise that the ‘experts’ who protested against our review of side-effects of homeopathic remedies were either ignorant or stupid or both. Most importantly, we understand, I hope, that when we speak or write about the ineffectiveness of homeopathic remedies, we of course mean those that are too dilute to have any effect at all – and these are certainly the vast majority.

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