conflict of interest
The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).
The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.
The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.
I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?
But why do SCAM-fans not get it?
Why do we see trial after trial and review after review ignoring this simple and obvious fact?
I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!
But that’s cheating!
And isn’t cheating unethical?
My answer is YES!
(If you want to read a more detailed answer, please read our in-depth analysis here)
Here is the abstract of a paper that makes even the most senior assessor of quackery shudder:
The purpose of this report is to describe the manipulation under anesthesia (MUA) treatment of 6 infants with newborn torticollis with a segmental dysfunction at C1/C2.
Six infants aged 4 1/2 to 15 months previously diagnosed with newborn torticollis were referred to a doctor of chiropractic owing to a failure to respond adequately to previous conservative therapies. Common physical findings were limited range of motion of the upper cervical spine. Radiographs demonstrated rotational malpositions and translation of atlas on axis in all 6 infants, and 1 had a subluxation of the C1/C2 articulation.
Interventions and Outcome:
Selection was based on complexity and variety of different clinical cases qualifying for MUA. Treatment consisted of 1 mobilization and was performed in the operating room of a children’s hospital by a certified chiropractic physician with the author assisting. Along with the chiropractor and his assistant, a children’s anesthesiologist, 1 to 2 operating nurses, a children’s radiologist, and in 1 case a pediatric surgeon were present. Before the mobilization, plain radiographs of the cervico-occipital area were taken. Three infants needed further investigation by a pediatric computed tomography scan of the area because of asymmetric bony conditions on the plain radiographs. Follow-up consultations at 2, 3, 5, or 6 weeks were done. Patient records were analyzed for restriction at baseline before MUA compared with after MUA treatment for active rotation, passive rotation, and passive rotation in full flexion of the upper cervical spine. All 3 measurements showed significant differences. The long-term outcome data was collected via phone calls to the parents at 6 to 72 months. The initial clinical improvements were maintained.
These 6 infants with arthrogenic newborn torticollis, who did not respond to previous conservative treatment methods, responded to MUA.
After reading the full text, I see many very serious problems and questions with this paper; here are 14 of the most obvious ones.
1. A congenital torticollis (that’s essentially what these kids were suffering from) has a good prognosis and does not require such invasive treatments. There is thus no plausible reason to conduct a case series of this nature.
2. A retrospective case series does not allow conclusions about therapeutic effectiveness, yet in the article the author does just that.
3. The same applies to her conclusions about the safety of the interventions.
4. It is unclear how the 6 cases were selected; it seems possible or even likely that they are, in fact, 6 cases of many more treated over a long period of time.
5. If so, this paper is hardly a ‘retrospective case series’; at best it could be called a ‘best case series’.
6. The X-rays or CT scans are unnecessary and potentially harmful.
7. The anaesthesia is potentially very harmful and unjustifiable.
8. The outcome measure is unreliable, particularly if performed by the chiropractor who has a vested interest in generating a positive result.
9. The follow-up by telephone is inadequate.
10. The range of the follow-up period (6-72 months) is unacceptable.
11. The exact way in which informed consent was obtained is unclear. In particular, we would need to know whether the parents were fully informed about the futility of the treatment and its considerable risks.
12. The chiropractor who administered the treatments is not named. Why not?
13. Similarly, it is unclear why the other healthcare professionals involved in these treatments are not named as co-authors of the paper.
14. It is unclear whether ethical approval was obtained for these treatments.
The author seems inexperienced in publishing scientific articles; the present one is poorly written and badly constructed. A Medline research reveals that she has only one other publication to her name. So, perhaps one should not be too harsh in judging her. But what about her supervisors, the journal, its reviewers, its editor and the author’s institution? The author comes from the Department of Chiropractic Medicine, Medical Faculty University, Zurich, Switzerland. On their website, they state:
The Faculty of Medicine of the University of Zurich is committed to high quality teaching and continuing research-based education of students in health care professions. Excellent and internationally recognised scientists and clinically outstanding physicians are at the Faculty of Medicine devoted to patients and public health, to teaching, to the support of young researchers and to academic medicine. The interaction between research and teaching, and their connection to clinical practice play a central role for us…
The Faculty of Medicine of the University of Zurich promotes innovative research in the basic fields of medicine, in the clinical application of knowledge, in personalised medicine, in health care, and in the translational connection between all these research areas. In addition, it encourages the cooperation between primary care and specialised health care.
It seems that, with the above paper, the UZH must have made an exception. In my view, it is a clear case of scientific misconduct and child abuse.
I have just given two lectures on so-called alternative medicine (SCAM) in France.
Why should that be anything to write home about?
Perhaps it isn’t; but during the last 25 years I have been lecturing all over the world and, even though I live partly in France and speak the language, I never attended a single SCAM-conference there. I have tried for a long time to establish contact with French SCAM-researchers, but somehow this never happened.
Eventually, I came to the conclusion that, although the practice of SCAM is hugely popular in this country, there was no or very little SCAM-research in France. This conclusion seems to be confirmed by simple Medline searches. For instance, Medline lists just 171 papers for ‘homeopathy/France’ (homeopathy is much-used in France), while the figures for Germany and the UK are 490 and 448.
These are, of course, only very rough indicators, and therefore I was delighted to be invited to participate for the first time in a French SCAM-conference. It was well-organised, and I am most grateful to the organisers to have me. Actually, the meeting was about non-pharmacological treatments but the focus was clearly on SCAM. Here are a few impressions purely on the SCAM-elements of this conference.
Already the title of the conference, ‘Non-pharmacological Interventions: Integrative, Preventive, Complementary and Personalised Medicines‘, contained a confusing shopping-list of terms. The actual lectures offered even more. Clear definitions of these terms were not forthcoming and are, as far as I can see, impossible. This meant that much of the discussion lacked focus. In both my presentations, I used the term ‘alternative medicine’ and stressed that all such umbrella terms are fairly useless. In my view, it is therefore best to name the precise modality (acupuncture, osteopathy, homeopathy etc.) one wants to discuss.
The term that seemed to dominate the conference was ‘INTEGRATIVE MEDICINE’ (IM). I got the impression that it was employed uncritically by some for bypassing the need for proper evaluation of any specific SCAM. The experts seemed to imply that, because IM is the politically and socially correct approach, there is no longer a need for asking whether the treatments to be integrated actually generate more good than harm. I got the impression that most of these researchers were confusing science with promotion.
The discussions regularly touched upon research methodology – but they did little more than lightly touch it. People tended to lament that ‘conventional research methodology’ was inadequate for assessing SCAM, and that we therefore needed different methods and even paradigms. I did not hear any reasonable explanations in what respect the ‘conventional methodology’ might be insufficient, nor did I understand the concept of an alternative science or paradigm. My caution that double standards in medicine can only be detrimental, seemed to irritate and fell mostly on deaf ears.
My own research agenda has always been the efficacy and safety of SCAM; and I still have no doubt that these are the issues that need addressing more urgently than any others. My impression was that, during this conference, the researchers seemed to aim in entirely different directions. One speaker even explained that, if a homeopath is fully convinced of the assumptions of homeopathy, he is entirely within the ethical standards to treat his patients homeopathically, regardless of the fact that homeopathy is demonstrably wrong. Another speaker claimed that there is no doubt any longer about the efficacy of acupuncture; the research question therefore must be how to best implement it in routine healthcare. And yet another expert tried to explain TCM with quantum physics. I have, of course, heard similar nonsense before during such conferences, but rarely did it pass without objection or debate.
The lack of research funding was bemoaned repeatedly. Most researchers seemed to think that they needed dedicated funding streams for SCAM to take account of the need of softer methodologies and the unique nature of SCAM. The argument that there should be only one set of standards for spending scarce research funds – scientific rigor and relevance – was not one shared by the French SCAM enthusiasts. The US example was frequently cited as the one that we ought to follow. In my view, the US example foremost shows impressively that a ring-fenced funding stream for SCAM is a wasteful mistake.
To my surprise I learnt during a conference presentation that there is such a thing as the ‘Collège Universitaire de Médecines Intégratives et Complémentaires‘ (How could I have been unaware of it all those years? Why did I never see any of their published work? Why did they never contact me and cooperate?). Its president is Prof Jacques Kopferschmitt from the University of Strasbourg, and many French Universities are members of this organisation. Here is the abstract of Kopferschmitt’s lecture on the topic of this College:
The multitude of complementary therapies or non-pharmacological interventions (NPIs) first requires pedagogical semantic harmonization to bring down the historical tensions that persist. If users often remain very or too seduced, it is not the same with health professionals! Behind the words, there are concepts that disturb because between efficiency and efficiency the nuances are subtle. However, nothing really stands in the way of modern western medicine, but there are really gaps that we could fill in the face of the growing scale of chronic diseases, the prerogative of the Western world. The need for a university investment in verification, validation and certification is essential in the face of the diversity of offers. The main beneficiaries are health professionals who need to invest in an integrative approach, particularly in France. The CUMIC promotes a different vision of efficiency and effectiveness with a broader vision of multidisciplinary evaluation, which we will discuss the main targets.
Kopferschmitt is Professor of Medical Therapy, which introduced him to a pluralism of approach to health concerns, including innovative by the introduction of the CT in the first and second cycle of medical studies. He is responsible for the teaching of Acupuncture, Auriculotherapy and hypnosis clinic. He is vice President of the Groupe d’Évaluation des Thérapies complémentaires Personnalisées (GETCOP). By founding the association of complementary Therapies at the University hospitals of Strasbourg he coordinates the introduction, teaching and research in both in Hospital and in University, who was organized many seminars on CT. He currently chairs the French University of Integrative and Complementary Medicine College (CUMIC).
This sounded odd to me; however, it got truly bizarre after I looked up what SCAM-research Kopferschmitt or any of the other officers of the College have published. I could not find a single SCAM-article authored by him/them.
Altogether I found the conference enjoyable and was pleased to meet many interesting and very kind people. But I often felt like having arrived on a different planet. Many of the discussions, lectures, ideas, comments, etc. reminded me of 1993, the year I had arrived in the UK to start our research in SCAM. What is more, I fear that French experts involved in real science might feel the same about those colleagues who seem to engage themselves in SCAM research with more enthusiasm than expertise, scientific rigour or track record. The planet I had landed on was one where critical thinking was yet to be discovered, I felt.
Who am I to teach others what to do?
Yes, I do hesitate to give advice – but, after all, I have researched SCAM for 25 years and published more on the subject that any researcher on the planet; and I too was once more of a SCAM-enthusiast as is apparent today. So, for what it’s worth, here is some hopefully constructive advice that crossed my mind while driving home through the beautiful French landscape:
- Sort out the confusion in terminology and define your terms as accurately as you can.
- Try to focus on the research questions that are justifiably the most important ones for improving healthcare.
- Do not attempt to re-invent the wheel.
- Once you have identified a truly relevant research question, read up what has already been published on it.
- While doing this, differentiate between rigorous research and fluff that does not meet this criterion.
- Remember to abandon your own prejudices; research is about finding the truth and not about confirming your beliefs.
- Avoid double standards like the pest.
- Publish your research in top journals and avoid SCAM-journals that nobody outside SCAM takes seriously.
- If you do not have a track record of publishing articles in top journals, please do not pretend to be an expert.
- Involve sceptics in discussions and projects.
- Remember that criticism is a precondition of progress.
I sincerely hope that this advice is not taken the wrong way. I certainly do not mean to hurt anyone’s feelings. What I do want is foremost that my French colleagues don’t have to repeat all the mistakes we did in the UK and that they are able to make swift progress.
Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.
This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015.
Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3.
The results show a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone. This trend persisted until day 5. The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone.
The authors concluded that these results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.
The design of the study is not able to control for placebo effects. Therefore, the question raised by this study is the following: can an objective parameter like the platelet count be influenced by placebo? The answer is clearly YES.
Why do researchers go to the trouble of conducting such a trial, while omitting both randomisation as well as placebo control? Without such design features the study lacks rigour and its results become meaningless? Why can researchers of Dengue fever run a trial without reporting symptomatic improvements? Could the answer to these questions perhaps be found in the fact that the authors are affiliated to the ‘Central Council for Research in Homoeopathy, New Delhi?
One could argue that this trial – yet another one published in the journal ‘Homeopathy’ – is a waste of resources and patients’ co-operation. Therefore, one might even argue, such a study might be seen as unethical. In any case, I would argue that this study is irrelevant nonsense that should have never seen the light of day.
Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.
The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.
Sounds more than a little weird?
Yes, I agree.
Perhaps we need some real evidence.
The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).
Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.
The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:
- The theory on which PPT is based is not plausible (to put it mildly).
- It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
- The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
- The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
- Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
- The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.
So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.
As you can imagine, I get quite a lot of ‘fan-post’. Most of the correspondence amounts to personal attacks and insults which I usually discard. But some of these ‘love-letters’ are so remarkable in one way or another that I answer them. This short email was received on 20/3/19; it belongs to the latter category:
You have been trashing homeopathy ad nauseum for so many years based on your limited understanding of it. You seem to know little more than that the remedies are so extremely dilute as to be impossibly effective in your opinion. Everybody knows this and has to confront their initial disbelief.
Why dont you get some direct understanding of homeopathy by doing a homeopathic proving of an unknown (to you) remedy? Only once was I able to convince a skeptic to take the challenge to do a homeopathic proving. He was amazed at all the new symptoms he experienced after taking the remedy repeatedly over several days.
Please have a similar bravery in your approach to homeopathy instead of basing your thoughts purely on your speculation on the subject, grounded in little understanding and no experience of it.
THIS IS HOW I RESPONDED
Dear Mr …
thank you for this email which I would like to answer as follows.
Your lines give the impression that you might not be familiar with the concept of critical analysis. In fact, you seem to confuse my criticism of homeopathy with ‘trashing it’. I strongly recommend you read up about critical analysis. No doubt you will then realise that it is a necessary and valuable process towards generating progress in healthcare and beyond.
You assume that I have limited understanding of homeopathy. In fact, I grew up with homeopathy, practised homeopathy as a young doctor, researched the subject for more than 25 years and published several books as well as over 100 peer-reviewed scientific papers about it. All of this, I have disclosed publicly, for instance, in my memoir which might interest you.
The challenge you mention has been taken by me and others many times. It cannot convince critical thinkers and, frankly, I am surprised that you found a sceptic who was convinced by what essentially amounts to little more than a party trick. But, as you seem to like challenges, I invite you to consider taking the challenge of the INH which even offers a sizable amount of money, in case you are successful.
Your final claim that my thoughts are based purely on speculation is almost farcically wrong. The truth is that sceptics try their very best to counter-balance the mostly weird speculations of homeopaths with scientific facts. I am sure that, once you have acquired the skills of critical thinking, you will do the same.
Best of luck.
This paper notes that, according to the World Naturopathic Federation (WNF), the naturopathic profession is based on two fundamental philosophies of medicine (vitalism and holism) and seven principles of practice (healing power of nature; treat the whole person; treat the cause; first, do no harm; doctor as teacher; health promotion and disease prevention; and wellness). The philosophy, theory, and principles are translated to clinical practice through a range of therapeutic modalities. The WNF has identified seven core modalities: (1) clinical nutrition and diet modification/counselling; (2) applied nutrition (use of dietary supplements, traditional medicines, and natural health care products); (3) herbal medicine; (4) lifestyle counselling; (5) hydrotherapy; (6) homeopathy, including complex homeopathy; and (7) physical modalities (based on the treatment modalities taught and allowed in each jurisdiction, including yoga, naturopathic manipulation, and muscle release techniques).
The ‘scoping’ review was to summarize the current state of the research evidence for whole-system, multi-modality naturopathic medicine. Studies were included, if they met the following criteria:
- Controlled clinical trials, longitudinal cohort studies, observational trials, or case series involving five or more cases presented in any language
- Human studies
- Multi-modality treatment administered by a naturopath (naturopathic clinician, naturopathic physician) as an intervention
- Non-English language studies in which an English title and abstract provided sufficient information to determine effectiveness
- Case series in which five or more individual cases were pooled and authors provided a summative discussion of the cases in the context of naturopathic medicine
- All human research evaluating the effectiveness of naturopathic medicine, where two or more naturopathic modalities are delivered by naturopathic clinicians, were included in the review.
- Case studies of five or more cases were included.
Thirty-three published studies with a total of 9859 patients met inclusion criteria (11 US; 4 Canadian; 6 German; 7 Indian; 3 Australian; 1 UK; and 1 Japanese) across a range of mainly chronic clinical conditions. A majority of the included studies were observational cohort studies (12 prospective and 8 retrospective), with 11 clinical trials and 2 case series. The studies predominantly showed evidence for the efficacy of naturopathic medicine for the conditions and settings in which they were based. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.
The authors concluded that to date, research in whole-system, multi-modality naturopathic medicine shows that it is effective for treating cardiovascular disease, musculoskeletal pain, type 2 diabetes, polycystic ovary syndrome, depression, anxiety, and a range of complex chronic conditions. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.
Where to start?
There are many issues here to choose from:
- The definition of naturopathy used in this review may be the one of the WHF, but it has little resemblance to the one used elsewhere. German naturopathic doctors, for instance, would not consider homeopathy to be a naturopathic treatment. They would also not, like the WNF does, subscribe to the long-obsolete humoral theory of disease. The only German professional organisation that is a member of the WNF is thus not one of naturopathic doctors but one of Heilpraktiker (the notorious German lay-practitioner created by the Nazis during the Third Reich).
- A review that includes observational studies and even case series, while drawing far-reaching conclusions on therapeutic effectiveness is, in my view, little more than embarrassing pseudo-science. Such studies are unable to differentiate between specific and non-specific therapeutic effects and therefore can tell us nothing about the effectiveness of a treatment.
- A review on a subject such as naturopathy (an approach which, after all, originated in Europe) that excludes studies not published in English (and without an English abstract providing sufficient information to determine effectiveness) is likely to be incomplete.
- The authors call their review a ‘scoping review’; they nevertheless draw conclusions not about the scope but the effectiveness of naturopathy.
- Many of the studies included in this review do, in fact, not comply with the inclusion criteria set by the review-authors.
- The review does not assess or even comment on the risks of naturopathic treatments.
- Several of the included studies are not investigations of naturopathy but of approaches that squarely fall under the umbrella of integrative or alternative medicine.
- Of the 33 studies included, only 5 were RCTs, and none of these was free of major limitations.
- None of the RCTs have been independently replicated.
- There is a remarkable absence of negative trials suggestion a strong influence of bias.
- The review lacks any trace of critical thinking.
- The authors are affiliated to institutions of naturopathy but declare no conflicts of interest.
- No funding source was named but it seems that it was supported by the WNF; their primary goal is to promote and advance the naturopathic profession.
- The review appeared in the notorious Journal of Complementary and Alternative Medicine.
Prof Dwyer, the founding president of the Australian ‘Friends of Science in Medicine’, said the study damaged Southern Cross University’s reputation. “At the heart of this is the credibility of Southern Cross University,” he said. “There’s been a stand-off between SCU and the rest of the scientific community in Australia for a number of years and there have been challenges to whether they are really upholding the highest standards of evidence-based medicine.” Professor Dwyer also raised questions about the university’s credibility late last year when it accepted a $10 million donation from vitamin company Blackmore’s to establish a National Centre for Naturopathic Medicine.
My conclusion of naturopathy, as defined by the WNF, is that it is an obsolete form of quackery steeped in concepts of vitalism that should be abandoned sooner rather than later. And my conclusion about the new review agrees with Prof Dwyer’s judgement: it is an embarrassment to all concerned.
A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.
The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.
Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.
Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.
In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.
Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)
About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:
- SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
- If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
- Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
- Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
- Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
- Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
- Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
- Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
- The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
- The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.
After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.
Osteopathy is a tricky subject:
- Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
- Yet many osteopaths use them also for a myriad of non-spinal conditions.
- Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
- The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
- Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.
A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints. Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.
Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.
In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.
The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”
Some of the most obvious weaknesses of this review include the following:
- In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
- In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
- Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
- One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
- The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.
Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.
Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.
A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.
The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.
Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.
The endpoints of the study were:
- quality of life,
- psychological distress,
- satisfaction level,
- adherence rate.
The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).
The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.
The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.
Are the authors’ conclusions correct?
I think not!
Here are some reasons for my judgement:
- The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
- There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
- There was no randomisation, and therefore the two groups were probably not comparable.
- Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
- There was no attempt to control for placebo effects.
- The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.
In conclusion, this study fails to show that yoga has any value in primary care.
Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).