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

pseudo-science

We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.

Here is the full and unaltered abstract of the study:

Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.

END OF QUOTE

My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!

My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.

In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.

Reflexology is an alternative therapy that is subjectively pleasant and objectively popular; it has been the subject on this blog before (see also here and here). Reflexologists assume that certain zones on the sole of our feet correspond to certain organs, and that their manual treatment can influence the function of these organs. Thus reflexology is advocated for all sorts of conditions, including infant colic.

The aim of this new study was to explore the effect of reflexology on infantile colic.

A total of 64 babies with colic were included in this study. Following a paediatrician’s diagnosis, two groups (study and control) were created. Socio-demographic data (including mother’s age, educational status, and smoking habits of parents) and medical history of the baby (including gender, birth weight, mode of delivery, time of the onset breastfeeding after birth, and nutrition style) were collected. The Infant Colic Scale (ICS) was used to estimate the colic severity in the infants. Reflexology was applied to the study group by the researcher and their mother 2 days a week for 3 weeks. The babies in the control group did not receive reflexology. Assessments were performed before and after the intervention in both groups.

The results show that the two groups were similar regarding socio-demographic background and medical history. While there was no difference between the groups in ICS scores before application of reflexology, the mean ICS score of the study group was significantly lower than that of control group at the end of the intervention.

The authors concluded that reflexology application for babies suffering from infantile colic may be a promising method to alleviate colic severity.

The authors seem to attribute the outcome to specific effects of reflexology.

However, they are mistaken!

Why?

Because their study does not control for the non-specific effects of the intervention.

Reflexology has not been shown to work for anything (“the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition“), and there is plenty of evidence to show that holding the baby, massaging it, cuddling it, rocking it or doing just about anything with it will have an effect, e. g.:

This trial of massage treatment for infantile colic showed statistically significant or clinically relevant effect in comparison with the rocking group.

The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not…

…kangaroo care for infants with colic is a promising intervention…

I think, in a way, this is rather good news; we do not need to believe in the hocus-pocus of reflexology in order to help our crying infants.

Amongst all the implausible treatments to be found under the umbrella of ‘alternative medicine’, Reiki might be one of the worst, i. e. least plausible and outright bizarre (see for instance here, here and here). But this has never stopped enthusiasts from playing scientists and conducting some more pseudo-science.

This new study examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical centre. It was designed as a retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. Hospitalized patients requesting or referred to the healing arts team received either a massage or reiki session and completed pre- and post-therapy symptom questionnaires. Differences between pre- and post-sessions in pain, nausea, fatigue, anxiety, depression, and overall well-being were recorded using an 11-point Likert scale.

Patients reported symptom relief with both reiki and massage therapy. Reiki improved fatigue and anxiety  more than massage. Pain, nausea, depression, and well being changes were not different between reiki and massage encounters. Immediate symptom relief was similar for cancer and non-cancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms.

The authors concluded that reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Don’t I just adore this little addendum to the conclusions, “controlled trials should be considered to validate the data” ?

The thing is, there is nothing to validate here!

The outcomes are not due to the specific effects of Reiki or massage; they are almost certainly caused by:

  • the extra attention,
  • the expectation of patients,
  • the verbal or non-verbal suggestions of the therapists,
  • the regression towards the mean,
  • the natural history of the condition,
  • the concomitant therapies administered in parallel,
  • the placebo effect,
  • social desirability.

Such pseudo-research only can only serve one purpose: to mislead (some of) us into thinking that treatments such as Reiki might work.

What journal would be so utterly devoid of critical analysis to publish such unethical nonsense?

Ahh … it’s our old friend the Journal of Alternative and Complementary Medicine

Say no more!

Osteopathy is an odd alternative therapy. In many parts of the world it is popular; the profession differs dramatically from country to country; and there is not a single condition for which we could say that osteopathy out-performs other options. No wonder then that osteopaths would be more than happy to find a new area where they could practice their skills.

Perhaps surgical care is such an area?

The aim of this systematic review was to present an overview of published research articles within the subject field of osteopathic manipulative treatment (OMT) in surgical care. The authors evaluated peer-reviewed research articles published in osteopathic journals during the period 1990 to 2017. In total, 10 articles were identified.

Previous research has been conducted within the areas of abdominal, thoracic, gynecological, and/or orthopedic surgery. The studies included outcomes such as pain, analgesia consumption, length of hospital stay, and range of motion. Heterogeneity was identified in usage of osteopathic techniques, treatment duration, and occurrence, as well as in the osteopath’s experience.

The authors concluded that despite the small number of research articles within this field, both positive effects as well as the absence of such effects were identified. Overall, there was a heterogeneity concerning surgical contexts, diagnoses, signs and symptoms, as well as surgical phases in current interprofessional osteopathic publications. In this era of multimodal surgical care, the authors concluded, there is an urgent need to evaluate OMT in this context of care and with a proper research approach.

This is an odd conclusion, if there ever was one!

The facts are fairly straight forward:

  • Osteopaths would like to expand into the area of surgical care [mainly, I suspect, because it would be good for business]
  • There is no plausible reason why OMT should be beneficial in this setting.
  • Osteopaths are not well-trained for looking after surgical patients.
  • Physiotherapists, however, are and therefore there is no need for osteopaths on surgical wards.
  • The evidence is extremely scarce.
  • The available trials are of poor quality.
  • Their results are contradictory.
  • Therefore there is no reliable evidence to show that OMT is effective.

The correct conclusion of this review should thus be as follows:

THE AVAILABLE EVIDENCE FAILS TO SHOW EFFECTIVENESS OF OMT. THEREFORE THIS APPROACH CANNOT BE RECOMMENDED.

End of story.

The UK ‘COLLEGE OF MEDICINE’ has recently (and very quietly) renamed itself; it now is THE COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMIH). This takes it closer to its original intentions of being the successor of the PRINCE OF WALES FOUNDATION FOR INTEGRATED MEDICINE (PWFIM), the organisation that had to be shut down amidst charges of fraud and money-laundering. Originally, the name of COMIH was to be COLLEGE OF INTEGRATED HEALTH (as opposed to disintegrated health?, I asked myself at the time).

Under the leadership of Dr Michael Dixon, OBE (who also led the PWFIM into its demise), the COMIH pursues all sots of activities. One of them seems to be publishing ‘cutting-edge’ articles.

A recent and superb example is on the fascinating subject of ‘holistic dentistry‘:

START OF QUOTE

Professor Sonia Williams … explores how integrated oral health needs to consider the whole body, not just the dentition…

Complementary and alternative approaches can also be considered as complementary to ‘mainstream’ care, with varying levels of evidence cited for their benefit.

Dental hypnosis (British Society of Medical and Dental Hypnosis) can help support patients including those with dental phobia or help to reduce pain experience during treatment.

Acupuncture in dentistry (British Society of Dental Acupuncture) can, for instance, assist with pain relief and allay the tendency to vomit during dental care.  There is also a British Homeopathic Dental Association.

For the UK Faculty of General Dental Practitioners, holistic dentistry refers to strengthening the link between general and oral health.

For some others, the term also represents an ‘alternative’ form of dentistry, which may concern itself with the avoidance and elimination of ‘toxic’ filling materials, perceived potential harm from fluoride and root canal treatments and with treating dental malocclusion to put patients back in ‘balance’.

In the USA, there is a Holistic Dental Association, while in the UK, there is the British Society for Mercury-free Dentistry. Unfortunately the evidence base for many of these procedures is weak.

Nevertheless, pressure to avoid mercury in dental restorative materials is becoming mainstream.

In summary, integrated health and care in dentistry can mean different things to different people. The weight of evidence supports the contention that the mouth is an integral part of the body and that attention to the one without taking account of the other can have adverse consequences.

END OF QUOTE

Do I get this right? ‘Holistic dentistry’ in the UK means the recognition that my mouth belongs to my body, and the adoption of a few dubious treatments with w ‘weak’ evidence base?

Well, isn’t this just great? I had no idea that my mouth belongs to my body. And clearly the non-holistic dentists in the UK are oblivious to this fact as well. I am sooooooo glad we got this cleared up.

Thanks COMIH!!!

And what about the alternative treatments used by holistic dentists?

The British Society of Medical and Dental Hypnosis (Scotland) inform us on their website that a trained medical and dental hypnotherapists can help you to deal with a large variety of challenges that you face in your everyday life e.g.

Asthma Migraines
Anxiety & Stress Smoking Cessation
Dental Problems Insomnia
Weight Problems Psychosexual Disorders
Depression Pain Management
Irritable Bowel  And many other conditions

I hasten to add that, for most of these conditions, the evidence fails to support the claims.

The British Society of Dental Acupuncture claim on their website that the typical conditions that may be helped by acupuncture are:

  • TMJ (jaw joint) problems
  • Facial pain
  • Muscle spasm in the head and neck
  • Stress headaches & Migraine
  • Rhinitis & sinusitis
  • Gagging
  • Dry mouth problems
  • Post-operative pain
  • Dental anxiety

I hasten to add that, for most of these conditions, the evidence fails to support the claims.

The British Homeopathic Dental Association claim on their website that studies have shown improved bone healing around implants with Symphytum and reduced discomfort and improved healing time with ulcers and beneficial in oral lichen planus.

I hasten to add that none of these claims are not supported by sound evidence.

The COMIH article is entitled “The mouth reflects whole body health – but what does integrated care mean for dentists?’ So, what does it mean? Judging from this article, it means an amalgam (pun intended) of platitudes, bogus claims and outright nonsense.

Pity that they did not change their name to College of Medicine and Integrated Care – I could have abbreviated it as COMIC!

Since many months, I have noticed a proliferation of so-called pilot studies of alternative therapies. A pilot study (also called feasibility study) is defined as a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Here I submit that most of the pilot studies of alternative therapies are, in fact, bogus.

To qualify as a pilot study, an investigation needs to have an aim that is in line with the above-mentioned definition. Another obvious hallmark must be that its conclusions are in line with this aim. We do not need to conduct much research to find that even these two elementary preconditions are not fulfilled by the plethora of pilot studies that are currently being published, and that proper pilot studies of alternative medicine are very rare.

Three recent examples of dodgy pilot studies will have to suffice (but rest assured, there are many, many more).

Foot Reflexotherapy Induces Analgesia in Elderly Individuals with Low Back Pain: A Randomized, Double-Blind, Controlled Pilot Study

The aim of this study was to evaluate the effects of foot reflexotherapy on pain and postural balance in elderly individuals with low back pain. And the conclusions drawn by its authors were that this study demonstrated that foot reflexotherapy induced analgesia but did not affect postural balance in elderly individuals with low back pain.

Effect of Tai Chi Training on Dual-Tasking Performance That Involves Stepping Down among Stroke Survivors: A Pilot Study.

The aim of this study was to investigate the effect of Tai Chi training on dual-tasking performance that involved stepping down and compared it with that of conventional exercise among stroke survivors. And the conclusions read: These results suggest a beneficial effect of Tai Chi training on cognition among stroke survivors without compromising physical task performance in dual-tasking.

The Efficacy of Acupuncture on Anthropometric Measures and the Biochemical Markers for Metabolic Syndrome: A Randomized Controlled Pilot Study.

The aim of this study was to evaluate the efficacy [of acupuncture] over 12 weeks of treatment and 12 weeks of follow-up. And the conclusion: Acupuncture decreases WC, HC, HbA1c, TG, and TC values and blood pressure in MetS.

It is almost painfully obvious that these studies are not ‘pilot’ studies as defined above.

So, what are they, and why are they so popular in alternative medicine?

The way I see it, they are the result of amateur researchers conducting pseudo-research for publication in lamentable journals in an attempt to promote their pet therapies (I have yet to find such a study that reports a negative finding). The sequence of events that lead to the publication of such pilot studies is usually as follows:

  • An enthusiast or a team of enthusiasts of alternative medicine decide that they will do some research.
  • They have no or very little know-how in conducting a clinical trial.
  • They nevertheless feel that such a study would be nice as it promotes both their careers and their pet therapy.
  • They design some sort of a plan and start recruiting patients for their trial.
  • At this point they notice that things are not as easy as they had imagined.
  • They have too few funds and too little time to do anything properly.
  • This does, however, not stop them to continue.
  • The trial progresses slowly, and patient numbers remain low.
  • After a while the would-be researchers get fed up and decide that their study has enough patients to stop the trial.
  • They improvise some statistical analyses with their results.
  • They write up the results the best they can.
  • They submit it for publication in a 3rd class journal and, in order to get it accepted, they call it a ‘pilot study’.
  • They feel that this title is an excuse for even the most obvious flaws in their work.
  • The journal’s reviewers and editors are all proponents of alternative medicine who welcome any study that seems to confirm their belief.
  • Thus the study does get published despite the fact that it is worthless.

Some might say ‘so what? no harm done!’

But I beg to differ: these studies pollute the medical literature and misguide people who are unable or unwilling to look behind the smoke-screen. Enthusiasts of alternative medicine popularise these bogus trials, while hiding the fact that their results are unreliable. Journalists report about them, and many consumers assume they are being told the truth – after all it was published in a ‘peer-reviewed’ medical journal!

My conclusions are as simple as they are severe:

  • Such pilot studies are the result of gross incompetence on many levels (researchers, funders, ethics committees, reviewers, journal editors).
  • They can cause considerable harm, because they mislead many people.
  • In more than one way, they represent a violation of medical ethics.
  • The could be considered scientific misconduct.
  • We should think of stopping this increasingly common form of scientific misconduct.

In recent days, journalists across the world had a field day (mis)reporting that doctors practising integrative medicine were doing something positive after all. I think that the paper shows nothing of the kind – but please judge for yourself.

The authors of this article wanted to determine differences in antibiotic prescription rates between conventional General Practice (GP) surgeries and GP surgeries employing general practitioners (GPs) additionally trained in integrative medicine (IM) or complementary and alternative medicine (CAM) (referred to as IM GPs) working within National Health Service (NHS) England.

They conducted a retrospective study on antibiotic prescription rates per STAR-PU (Specific Therapeutic group Age–sex weighting Related Prescribing Unit) using NHS Digital data over 2016. Publicly available data were used on prevalence of relevant comorbidities, demographics of patient populations and deprivation scores. setting Primary Care. Participants were 7283 NHS GP surgeries in England. The association between IM GPs and antibiotic prescribing rates per STAR-PU with the number of antibiotic prescriptions (total, and for respiratory tract infection (RTI) and urinary tract infection (UTI) separately) as outcome. results IM GP surgeries (n=9) were comparable to conventional GP surgeries in terms of list sizes, demographics, deprivation scores and comorbidity prevalence.

Statistically significant fewer total antibiotics  were prescribed at NHS IM GP surgeries compared with conventional NHS GP surgeries. In contrast, the number of antibiotics prescribed for UTI were similar between both practices.

The authors concluded that NHS England GP surgeries employing GPs additionally trained in IM/CAM have lower antibiotic prescribing rates. Accessibility of IM/CAM within NHS England primary care is limited. Main study limitation is the lack of consultation data. Future research should include the differences in consultation behaviour of patients self-selecting to consult an IM GP or conventional surgery, and its effect on antibiotic prescription. Additional treatment strategies for common primary care infections used by IM GPs should be explored to see if they could be used to assist in the fight against antimicrobial resistance.

The study was flimsy to say the least:

  • It was retrospective and is therefore open to no end of confounders.
  • There were only 9 surgeries in the IM group.

Moreover, the results were far from impressive. The differences in antibiotic prescribing between the two groups of GP surgeries were minimal or non-existent. Finally, the study was financed via an unrestricted grant of WALA Heilmittel GmbH, Germany (“approx. 900 different remedies conforming to the anthroposophic understanding of man and nature”) and its senior author has a long track record of publishing papers promotional for anthroposophic medicine.

Such pseudo-research seems to be popular in the realm of CAM, and I have commented before on similarly futile projects. The comparison, I sometimes use is that of a Hamburger restaurant:

Employees by a large Hamburger chain set out to study the association between utilization of Hamburger restaurant services and vegetarianism. The authors used a retrospective cohort design. The study population comprised New Hampshire residents aged 18-99 years, who had entered the premises of a Hamburger restaurant within 90 days for a primary purpose of eating. The authors excluded subjects with a diagnosis of cancer. They measured the likelihood of  vegetarianism among recipients of services delivered by Hamburger restaurants compared with a control group of individuals not using meat-dispensing facilities. They also compared the cohorts with regard to the money spent in Hamburger restaurants. The adjusted likelihood of being a vegetarian was 55% lower among the experimental group compared to controls. The average money spent per person in Hamburger restaurants were also significantly lower among the Hamburger group.

To me, it is obvious that such analyses must produce a seemingly favourable result for CAM. In the present case, there are several reasons for this:

  1. GPs who volunteer to be trained in CAM tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  2. Education in CAM would only re-inforce this notion.
  3. Similarly, patients electing to consult IM GPs tend to be in favour of ‘natural’ treatments and oppose synthetic drugs such as antibiotics.
  4. Such patients might be less severely ill that the rest of the patient population (the data from the present study do in fact imply this to be true).
  5. These phenomena work in concert to generate less antibiotic prescribing in the IM group.

In the final analysis, all this finding amounts to is a self-fulfilling prophecy: grocery shops sell less meat than butchers! You don’t believe me? Perhaps you need to read a previous post then; it concluded that physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

What is upsetting with the present paper, in my view, are the facts that:

  • a reputable journal published this junk,
  • the international press has a field-day reporting this study implying that CAM is a good thing.

The fact is that it shows nothing of the kind. Imagine we send GPs on a course where they are taught to treat all their patients with blood-letting. This too would result in less prescription of antibiotics, wouldn’t it? But would it be a good thing? Of course not!

True, we prescribe too much antibiotics. Nobody doubts that. And nobody doubts that it is a big problem. The solution to this problem is not more CAM, but less antibiotics. To realise the solution we do not need to teach GPs CAM but we need to remind them of the principles of evidence-based practice. And the two are clearly not the same; in fact, they are opposites.

 

An announcement (it’s in German, I’m afraid) proudly declaring that ‘homeopathy fulfils the criteria of evidence-based medicine‘ caught my attention.

Here is the story:

In 2016, Dr. Melanie Wölk, did a ‘Master of Science’* at the ‘Donau University’ in Krems, Austria investigating the question whether homeopathy follows the rules of evidence-based medicine (EBM). She arrived at the conclusion that YES, IT DOES! This pleased the leading Austrian manufacturer of homeopathics (Dr Peithner) so much and so durably that, on 23 March 2018, he gave her a ‘scientific’ award (the annual Peithner award) for her ‘research’.

So far so good.

Her paper is unpublished, or at least not available on Medline; therefore, I am unable to evaluate it directly. All I know about it from the announcement is that she did her ‘research at the ‘Zentrum für Traditionelle Chinesische Medizin und Komplementärmedizin‘ of the said university. A quick Medline search revealed that this unit has never published anything, not a single paper, it seems! Disappointed I search for Dr. Christine Schauhuber, the leader of the unit; and again I find no Medline-listed publications in her name. My interim conclusion is thus that this institution might not be at the cutting edge of science.

But what do we know about Dr. Melanie Wölk’s award-winning master thesis *?

The announcement tells us that she investigated all RCTs published between 2010 and 2016. In addition, she evaluated:

On that basis, she arrived at her positive verdict – not just tentatively, but without doubt (“Das Ergebnis steht fest”).

Dr Peithner, the owner of the company and awarder of the prize, was quoted stating that this is a very important piece of work for homeopathy; it shows yet again what we see in our daily routine, namely that homeopathics are effective. Wölk’s investigation demonstrates furthermore that high-quality trials of homeopathy do exist, and that it is time to end the witch-hunt aimed at discrediting an effective therapy. Conventional medicine and homeopathy ought to finally work hand in hand – for the benefit of our patients. (“Für die Homöopathie ist das eine sehr wichtige Arbeit, die wieder zeigt, was wir in der ärztlichen Praxis täglich erleben, nämlich dass homöopathische Arzneimittel wirken. Wölks Untersuchung zeigt weiters deutlich, dass es sehr wohl hochqualitative Homöopathie-Studien gibt und es an der Zeit ist, die Hexenjagd zu beenden, mit der eine wirksame medizinische Therapie diskreditiert werden soll. Konventionelle Medizin und Homöopathie sollten endlich Hand in Hand arbeiten – zum Wohle der Patientinnen und Patienten.”)

I do hope that Dr Wölk uses the prize money (by no means a fortune; see photo) to buy some time for publishing her work (one of my teachers, all those years ago, used to say ‘unpublished research is no research’) so that we can all benefit from it. Until it becomes available, I should perhaps mention that the description of her methodology (publications between 2010 and 2016 [plus a few other papers that nicely fitted the arguments?]; including one Linde review and not his more recent re-analysis [see above]) does not inspire me to think that Dr Wölk’s research was anywhere near rigorous, systematic or complete. In the same vein, I am tempted to point out that the Swiss report is probably the very last document I would select, if I wanted to generate an objective picture about the value of homeopathy.

Taking all this into account, I conclude that we seem to be dealing here with a

  • pseudo-prize (given by a commercial firm to further its business) for a piece of
  • pseudo-research (the project seems to have been aimed to white-wash homeopathy) into
  • pseudo-medicine (a treatment that has been tested extensively but has not been shown to work beyond placebo).

*Wölk, Melanie: Eminenz oder Evidenz: Die Homöopathie auf dem Prüfstand der Evidence based Medicine. Masterarbeit zur Erlangung des akademischen Abschlusses Master of Science im Universitätslehrgang Natural Medicine. Donau-Universität Krems, Department für Gesundheitswissenschaften und Biomedizin. Krems, Mai 2016.

Reiki is a Japanese technique administered by “laying on hands” and is based on the idea that an unseen “life force energy” flows through us and is what causes us to be alive. If one’s “life force energy” is low, then we are more likely to get sick or feel stress, and if it is high, we are more capable of being happy and healthy (because it is such a clear-cut case of nonsense, we have discussed Reiki regularly; see for instance here, here, here, here, here, here, and here).

But nonsense does not stop researchers from conducting trials. In this new clinical trial, conducted in Physiotherapy Clinic of Khatam Al-Anbia Hospital in Iran, 60 patients with pain due to inter-vertebral disc herniation (IVDH) were randomly assigned to one of three groups.

  1. The Reiki group received three 15-minute Reiki sessions on consecutive days by a master of Reiki plus Indomethacin and Methocarbamol (as in group 3).
  2. The physiotherapy group underwent 7 to 10 sessions of physiotherapy of 60 to 90 minutes (heat therapy, TENS, pelvic traction, and physical exercises) plus Indomethacin and Methocarbamol (as in group 3).
  3. The drug group received Indomethacin capsules 75 mg and Methocarbamol tablets 500 mg every 8 hours daily for one week.

The severity of pain and the activities of daily living (ADL) were measured using visual analogue scales (VAS) and ADL-Instrumental ADL questionnaire before and after the intervention. A significant difference was found in pain intensity and ADL improvement between Reiki and the drug therapy. No significant difference between the Reiki and physiotherapy groups were noted.

The authors concluded that Reiki and physiotherapy are effective methods in managing pain and improving ADL in patients with IVDH; however, Reiki is more cost-effective and faster treatment method than physiotherapy.

This RCT seems fairly well-panned and conducted, and its results are straight forward. My only problem with it is how the findings are interpreted.

The study design was such that there was no blinding or control for placebo effects. Therefore, the observed outcomes can be interpreted in more than one way. In my view, by far the most plausible explanation is that Reiki (being an exotic, impressive intervention that generates plenty of expectation) produced a powerful placebo effect. Physiotherapy (being entirely normal and routine), on the other hand, was only marginally successful. It is regrettable that the authors do not even consider this interpretation of their results. They should have remembered that a clinical trial test the null-hypothesis (the experimental treatment is not better that the comparator) which can be rejected only, if there is no other reasonable explanation for the results produced.

If I am correct, the conclusions should be re-written as follows:

The addition of Reiki to drug treatment generated better outcomes than drug therapy alone. Physiotherapy was only marginally effective. The effects of Reiki are most likely not due to the treatment per se but to a classical placebo response.

The plethora of dodgy meta-analyses in alternative medicine has been the subject of a recent post – so this one is a mere update of a regular lament.

This new meta-analysis was to evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). (Call me pedantic, but I prefer meta-analyses that evaluate the evidence FOR AND AGAINST a therapy.) Electronic databases were searched to identify RCTs of acupuncture for LDH, and 30 RCTs involving 3503 participants were included; 29 were published in Chinese and one in English, and all trialists were Chinese.

The results showed that acupuncture had a higher total effective rate than lumbar traction, ibuprofen, diclofenac sodium and meloxicam. Acupuncture was also superior to lumbar traction and diclofenac sodium in terms of pain measured with visual analogue scales (VAS). The total effective rate in 5 trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Two trials showed a superior effect of acupuncture in VAS scores compared with ibuprofen or mannitol plus dexamethasone, respectively.

The authors from the College of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong, China, concluded that acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.

Why do I call this meta-analysis ‘dodgy’? I have several reasons, 10 to be exact:

  1. There is no plausible mechanism by which acupuncture might cure LDH.
  2. The types of acupuncture used in these trials was far from uniform and  included manual acupuncture (MA) in 13 studies, electro-acupuncture (EA) in 10 studies, and warm needle acupuncture (WNA) in 7 studies. Arguably, these are different interventions that cannot be lumped together.
  3. The trials were mostly of very poor quality, as depicted in the table above. For instance, 18 studies failed to mention the methods used for randomisation. I have previously shown that some Chinese studies use the terms ‘randomisation’ and ‘RCT’ even in the absence of a control group.
  4. None of the trials made any attempt to control for placebo effects.
  5. None of the trials were conducted against sham acupuncture.
  6. Only 10 studies 10 trials reported dropouts or withdrawals.
  7. Only two trials reported adverse reactions.
  8. None of these shortcomings were critically discussed in the paper.
  9. Despite their affiliation, the authors state that they have no conflicts of interest.
  10. All trials were conducted in China, and, on this blog, we have discussed repeatedly that acupuncture trials from China never report negative results.

And why do I find the journal ‘dodgy’?

Because any journal that publishes such a paper is likely to be sub-standard. In the case of ‘Acupuncture in Medicine’, the official journal of the British Medical Acupuncture Society, I see such appalling articles published far too frequently to believe that the present paper is just a regrettable, one-off mistake. What makes this issue particularly embarrassing is, of course, the fact that the journal belongs to the BMJ group.

… but we never really thought that science publishing was about anything other than money, did we?

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