MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

pseudo-science

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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.

An impressive 17% of US chiropractic patients are 17 years of age or younger. This figure increases to 39% among US chiropractors who have specialized in paediatrics. Data for other countries can be assumed to be similar. But is chiropractic effective for children? All previous reviews concluded that there is a paucity of evidence for the effectiveness of manual therapy for conditions within paediatric populations.

This systematic review is an attempt to shed more light on the issue by evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

  • attention deficit hyperactivity disorder (ADHD),
  • autism,
  • asthma,
  • cerebral palsy,
  • clubfoot,
  • constipation,
  • cranial asymmetry,
  • cuboid syndrome,
  • headache,
  • infantile colic,
  • low back pain,
  • obstructive apnoea,
  • otitis media,
  • paediatric dysfunctional voiding,
  • paediatric nocturnal enuresis,
  • postural asymmetry,
  • preterm infants,
  • pulled elbow,
  • suboptimal infant breastfeeding,
  • scoliosis,
  • suboptimal infant breastfeeding,
  • temporomandibular dysfunction,
  • torticollis,
  • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

  • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
  • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
  • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
  • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
  • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

  1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
  2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
  3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

And why do the authors of this new review arrive at such dramatically different conclusion? I am not sure. Could it perhaps have something to do with their affiliations?

  • Palmer College of Chiropractic,
  • Canadian Memorial Chiropractic College,
  • Performance Chiropractic.

What do you think?

“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.

Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:

  • kreatinin,
  • turmeric,
  • Ashwagandha,
  • citicoline,
  • lycopene,
  • vitamin D3.

Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.

The therapeutic claims made for the product are numerous:

  • it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
  • it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
  • it will improve cognitive function,
  • it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
  • it will improve quality of life,
  • it will improve sleep (reducing insomnia by 70%),
  • it will improve immunity,
  • it will reduce inflammation,
  • it will improve your memory,
  • it will improve osteoporosis (reduce risk of osteoporosis by 37%).

These claims are backed up by 197 clinical trials, we are being told.

If true, this would be truly sensational – but is it true?

I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.

I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?

The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”

It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!

Having the choice, I might think again.

I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:

  • Vitamin C (it has over 61 000 Medline listed articles to its name),
  • Vitanin E (it has over 42 000 Medline listed articles to its name),
  • Collagen (it has over 210 000 Medline listed articles to its name),
  • Coffee (it has over 14 000 Medline listed articles to its name),
  • Aloe vera (it has over 3 000 Medline listed articles to its name).

I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.

But this would be wrong, misleading, even bogus!!!, I hear you object.

On the one hand, I agree.

On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.

 

 

 

 

*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).

In a previous post, I have tried to explain that someone could be an expert in certain aspects of homeopathy; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the research of homeopathy.

But can anyone really be an expert in homeopathy in a more general sense?

Are homeopaths experts in homeopathy?

OF COURSE THEY ARE!!!

What is he talking about?, I hear homeopathy-fans exclaim.

Yet, I am not so sure.

Can one be an expert in something that is fundamentally flawed or wrong?

Can one be an expert in flying carpets?

Can one be an expert in quantum healing?

Can one be an expert in clod fusion?

Can one be an expert in astrology?

Can one be an expert in telekinetics?

Can one be an expert in tea-leaf reading?

I am not sure that classical homeopaths can rightfully called experts in classical homeopathy (there are so many forms of homeopathy that, for the purpose of this discussion, I need to focus on the classical Hahnemannian version).

An expert is a person who is very knowledgeable about or skilful in a particular area. An expert in any medical field (say neurology, gynaecology, nephrology or oncology) would need to have sound knowledge and practical skills in areas including:

  • organ-specific anatomy,
  • organ-specific physiology,
  • organ-specific pathophysiology,
  • nosology of the medical field,
  • disease-specific diagnostics,
  • disease-specific etiology,
  • disease-specific therapy,
  • etc.

None of the listed items apply to classical homeopathy. There are no homeopathic diseases, homeopathy is largely detached from knowledge in anatomy, physiology and pathophysiology, homeopathy disregards the current knowledge of etiology, homeopathy does not apply current criteria of diagnostics, homeopathy offers no rational mode of action for its interventions.

An expert in any medical field would need to:

  • deal with facts,
  • be able to show the effectiveness of his methods,
  • be part of an area that makes progress,
  • benefit from advances made elsewhere in medicine,
  • would associate with other disciplines,
  • understand the principles of evidence-based medicine,
  • etc.

None of these features apply to a classical homeopath. Homeopaths substitute facts for fantasy and wishful thinking, homeopaths cannot rely on sound evidence regarding the effectiveness of their therapy, classical homeopaths are not interested in progressing their field but religiously adhere to Hahnemann’s dogma, homeopaths do not benefit from the advances made in other areas of medicine, homeopaths pursue their sectarian activities in near-complete isolation, homeopaths make a mockery of evidence-based medicine.

Collectively, these considerations would seem to indicate that an expert in homeopathy is a contradiction in terms. Either you are an expert, or you are a homeopath. To be both seems an impossibility – or, to put it bluntly, an ‘expert’ in homeopathy is an adept in nonsense and a virtuoso in ignorance.

Crohn’s disease (CD) is an inflammatory bowel disease characterized by recurring flares altered by periods of inactive disease and remission, affecting physical and psychological aspects and quality of life (QoL). The aim of this study was to determine the therapeutic benefits of soft non-manipulative osteopathic techniques in patients with CD.

A randomized controlled trial was performed. It included 30 individuals with CD who were divided into 2 groups: 16 in the experimental group (EG) and 14 in the control group (CG). The EG was treated with the 6 manual techniques depicted below. All patients were advised to continue their prescribed medications and diets. The intervention period lasted 30 days (1 session every 10 days). Pain, global quality of life (GQoL) and QoL specific for CD (QoLCD) were assessed before and after the intervention. Anxiety and depression levels were measured at the beginning of the study.

A significant effect was observed of the treatment in both the physical and task subscales of the GQoL and also in the QoLCD but not in pain score. When the intensity of pain was taken into consideration in the analysis of the EG, there was a significantly greater increment in the QoLCD after treatment in people without pain than in those with pain. The improvements in GQoL were independent from the disease status.

The authors concluded that soft, non-manipulative osteopathic treatment is effective in improving overall and physical-related QoL in CD patients, regardless of the phase of the disease. Pain is an important factor that inversely correlates with the improvements in QoL.

Where to begin?

Here are some of the most obvious flaws of this study:

  1. It was far too small for drawing any far-reaching conclusions.
  2. Because the sample size was so small, randomisation failed to create two comparable groups.
  3. Sub-group analyses are based on even smaller samples and thus even less meaningful.
  4. The authors call their trial a ‘single-blind’ study but, in fact, neither the patients nor the therapists (physiotherapists) were blind.
  5. The researchers were physiotherapists, their treatments were mostly physiotherapy. It is therefore puzzling why they repeatedly call them ‘osteopathic’.
  6. It also seems unclear why these and not some other soft tissue techniques were employed.
  7. The CG did not receive additional treatment at all; no attempt was thus made to control for placebo effects.
  8. The stated aim to determine the therapeutic benefits… seems to be a clue that this study was never aimed at rigorously testing the effectiveness of the treatments.

My conclusion therefore is (yet again) that poor science has the potential to mislead and thus harm us all.

Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.

Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.

The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.

There are numerous problems with this study:

  • The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
  • A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
  • For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
  • If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
  • The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
  • The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
  • Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.

My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.

Excellent journals always publish excellent science!

If this is what you believe, you might want to read a study of chiropractic just published in the highly respected SCIENTIFIC REPORTS.

The objective of this study was to investigate whether a single session of chiropractic care could increase strength in weak plantar flexor muscles in chronic stroke patients. Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes were recorded in 12 chronic stroke patients, with plantar flexor muscle weakness, using a randomized controlled crossover design. Outcomes were assessed pre and post a chiropractic care intervention and a passive movement control. Repeated measures ANOVA was used to asses within and between group differences. Significance was set at p < 0.05. Following the chiropractic care intervention there was a significant increase in strength (F (1,11) = 14.49, p = 0.002; avg 64.2 ± 77.7%) and V-wave/Mmax ratio (F(1,11) = 9.67, p = 0.009; avg 54.0 ± 65.2%) compared to the control intervention. There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention. There were no other significant differences. Plantar flexor muscle strength increased in chronic stroke patients after a single session of chiropractic care. An increase in V-wave amplitude combined with no significant changes in H-reflex parameters suggests this increased strength is likely modulated at a supraspinal level. Further research is required to investigate the longer term and potential functional effects of chiropractic care in stroke recovery.

In the article we find the following further statements (quotes in bold, followed by my comments in normal print):

  • Data were collected by a team of researchers from the Centre for Chiropractic Research at the New Zealand College of Chiropractic. These researchers can be assumed to be highly motivated in generating a positive finding.
  • The entire spine and both sacroiliac joints were assessed for vertebral subluxations, and chiropractic adjustments were given where deemed necessary, by a New Zealand registered chiropractor. As there is now near-general agreement that such subluxations are a myth, the researchers treated a non-existing entity.
  • The chiropractor did not contact on a segment deemed to be subluxated during the control set-up and no adjustive thrusts were applied during any control intervention. The patients therefore were clearly able to tell the difference between real and control treatmentsParticipants were not checked for blinding success.
  • Maximum isometric plantarflexion force was measured using an isometric strain gauge. Such measurements crucially depend on the motivation of the patient.
  • The grant proposal for this study was reviewed by the Australian Spinal Research Foundation to support facilitation of funding from the United Chiropractic Association. Does this not mean the researchers had a conflict of interest?
  • The authors declare no competing interests. Really? They were ardent subluxationists supported by the United Chiropractic Association, an organisation stating that chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation, and subscribes to to the obsolete concept of vitalism: we ascribe to the idea that all living organisms are sustained by an innate intelligence, which is both different from and greater than physical and chemical forces. Further, we believe innate intelligence is an expression of universal intelligence.

So, in essence, what we have here is an under-powered study sponsored by vitalists and conducted by subluxationists treating a mythical entity with dubious interventions without controlling for patients’ expectation pretending their false-positive findings are meaningful.

I cannot help wondering what possessed the SCIENTIFIC REPORTS to publish such poor science.

Acupuncture is all over the news today. The reason is a study just out in BMJ-Open.

The aim of this new RCT was to investigate the efficacy of a standardised brief acupuncture approach for women with moderate-tosevere menopausal symptoms. Nine Danish primary care practices recruited 70 women with moderate-to-severe menopausal symptoms. Nine general practitioners with accredited education in acupuncture administered the treatments.

The acupuncture style was western medical with a standardised approach in the pre-defined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group received no acupuncture but was offered treatment after 6 weeks. Outcomes were the differences between the two groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.

Thirty-six patients received the intervention, and 34 were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes, day-and-night sweats, general sweating, menopausal-specific sleeping problems, emotional symptoms, physical symptoms and skin and hair symptoms compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent three weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.

The authors concluded that the standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.

The only thing that I find amazing here is the fact the a reputable journal published such a flawed trial arriving at such misleading conclusions.

  • The authors call it a ‘pragmatic’ trial. Yet it excluded far too many patients to realistically qualify for this characterisation.
  • The trial had no adequate control group, i.e. one that can account for placebo effects. Thus the observed outcomes are entirely in keeping with the powerful placebo effect that acupuncture undeniably has.
  • The authors nevertheless conclude that ‘acupuncture treatment produced a fast and clinically relevant reduction’ of symptoms.
  • They also state that they used this design because no validated sham acupuncture method exists. This is demonstrably wrong.
  • In my view, such misleading statements might even amount to scientific misconduct.

So, what would be the result of a trial that is rigorous and does adequately control for placebo-effects? Luckily, we do not need to rely on speculation here; we have a study to demonstrate the result:

Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.

Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.

Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)

Setting: Community in Australia.

Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.

Interventions:10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.

Measurements: 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.

Results: 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 were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.

Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.

Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

My conclusion from all this is simple: acupuncture trials generate positive findings, provided the researchers fail to test it rigorously.

In 2004, my team published a review analysing the diversity of so-called alternative medicine (SCAM) research published in one single year (2002) across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. In total 652 abstracts of articles were assessed. Germany and the UK were the only two European countries to publish in excess of 100 articles in that year (Germany: 137, UK: 183). The majority of articles were non-systematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various SCAM modalities and investigated the safety of CAM. We concluded that important national differences exist in terms of the nature of SCAM research. This raises important questions regarding the reasons for such differences.

One striking difference was the fact that, compared to the UK, Germany had published far less research on SCAM that failed to report a positive result (4% versus 14%). Ever since, I have wondered why. Perhaps it has something to do with the biggest sponsor of SCAM research in Germany: THE CARSTENS STIFTUNG?

The Carstens Foundation (CF) was created by the former German President, Prof. Dr. Karl Carstens and his wife, Dr. Veronica Carstens. Karl Carstens (1914-1992) was the 5th President of federal Germany, from 1979 to 1984. Veronica Carstens (1923-2012) was a doctor of Internal Medicine with an interest in natural medicine and homeopathy in particular. She is quoted by the CF stating: „Der Arzt und die Ärztin der Zukunft sollen zwei Sprachen sprechen, die der Schulmedizin und die der Naturheilkunde und Homöopathie. Sie sollen im Einzelfall entscheiden können, welche Methode die besten Heilungschancen für den Patienten bietet.“ (Future doctors should speak two languages, that of ‘school medicine’ [Hahnemann’s derogatory term for conventional medicine] and that of naturopathy and homeopathy. They should be able to decide on a case by case basis which method offers the best chances of a cure for the patient.***)

Together, the two Carstens created the CF with the goal of sponsoring SCAM in Germany. More than 35 million € have so far been spent on more than 100 projects, fellowships, dissertations, an own publishing house, and a patient societyNatur und Medizin” (currently ~23 000 members) with the task of promoting SCAM. Projects the CF proudly list as their ‘milestones’ include: 

  • an outpatient clinic of natural medicine for cancer
  • a project ‘Natural medicine and homeopathy for children and adolescents’.

The primary focus of the CF clearly is homeopathy, and it is in this area where their anti-science bias gets most obvious. I do invite everyone who reads German to have a look at their website and be amazed at the plethora of misleading claims.

Their expert for all things homeopathic is Dr Jens Behnke (‘Referent für Homöopathieforschung bei der Karl und Veronica Carstens-Stiftung: Evidenzbasierte Medizin, CAM, klinische Forschung, Grundlagenforschung’). He is not a medical doctor but has a doctorate from the ‘Kulturwissenschaftlichen Fakultät der Europa-Universität Viadrina’ entitled ‘Wissenschaft und Weltanschauung. Eine epistemologische Analyse des Paradigmenstreits in der Homöopathieforschung’ (Science and world view. An epistemological analysis of the paradigm-quarrel in homeopathy research). His supervisor was Prof Harald Walach who has long been close to the CF.

Behnke claims to be an expert in EBM, clinical research and basic research but, intriguingly, he has not a single Medline-listed publication to his name. So, we only have his dissertation to assess his expertise.

The very 1st sentence of his dissertation is noteworthy, in my view: Die Homöopathie ist eine Therapiemethode, die seit mehr als 200 Jahren praktiziert wird und eine beträchtliche Zahl an Heilungserfolgen vorzuweisen hat (Homeopathy is a therapeutic method, that is being used since more than 200 years and which is supported by a remarkable number of therapeutic successes). In essence, the dissertation dismisses the scientific approach for evaluating homeopathy as well as the current best evidence that shows homeopathy to be ineffective.

Behnke dismisses my own research on homeopathy without even considering it. He first claims to have found an error in one of my systematic reviews and then states: Die Fragwürdigkeit der oben angeführten Methoden rechtfertigt das Übergehen sämtlicher Publikationen dieses Autors im Rahmen dieser Arbeit. Wenn einem Wissenschaftler die aufgezeigte absichtliche Falschdarstellung aufgrund von Voreingenommenheit nachgewiesen werden kann, sind seine Ergebnisse, wenn überhaupt, nur nach vorheriger systematischer Überprüfung sämtlicher Originalpublikationen und Daten, auf die sie sich beziehen, verwertbar. Essentially, he claims that, because he has found one error, the rest cannot be trusted and therefore he is entitled to reject the lot.

In the same dissertation, we read the following: Ernst konstatiert in allen … Arbeiten zur Homöopathie ausnahmslos, dass es keinerlei belastbare Hinweise auf eine Wirksamkeit homöopathischer Arzneimittel über Placeboeffekte hinaus gebe (Ernst states in all publications on homeopathy without exception that no solid suggestions exist at all for an effectiveness of homeopathic remedies). However, it is demonstrably wrong that all of my papers arrive at a negative judgement of homeopathy’s effectiveness; here are three that spring into my mind:

So, applying Behnke’s own logic outlined above, one should argue that, because I have found one error in his research, the rest of what Behnke will (perhaps one day be able to) publish cannot be trusted and therefore I am entitled to reject the lot.

That would, of course, be tantamount to adopting the stupidity of one’s own opponents. So, I will certainly not do that; instead, I will wait patiently for the sound science that Dr Behnke (and indeed the CF) might eventually produce.

 

***phraseology that is strikingly similar to that of Rudolf Hess on the same subject.

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

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