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

critical thinking

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In Germany, homeopathy had a free ride for a very long time. In recent years, however, several doctors, pharmacists, scientists, etc. have started opposing the fact that the public has to pay for ineffective treatments such as homeopathics. As a consequence, homeopaths have begun to fight back. The weapons they chose are often not the most subtle. Now they seem to have reached a new low; the Board of the German Central Association of Homeopathic Physicians (DZVhÄ) has sent an open letter to the Board of the German Society of Internal Medicine (DGIM) and to the participating colleagues of the 127th Congress of the DGIM from April 17 – 20, 2021 in an attempt to stop an invited lecture of a critic of homeopathy.

Here is my translation of the letter:

Dear colleagues on the board of the DGIM,

We were very surprised to read that an ENT colleague will speak on homeopathy at the 127th Congress of Internal Medicine. Dr. Lübbers is known up and down the country as a media-active campaigner against homeopathy. His “awakening experience” he had, according to his own account, when he had to fish homeopathic pills out of the ear of a child with otitis, since then he is engaged – no: not for better education, in the mentioned case of the parents or other users – against the method homeopathy (which was certainly not “guilty” of the improper application!).

It has surely not escaped you that in all media again and again only a small handful of self-proclaimed “experts” – all from the clique of the skeptic movement! – are heard on the subject of homeopathy. A single (!) fighter against homeopathy is a physician who completed her training in homeopathy and practices for a time as a homeopath. All the others come from non-medical and other occupational groups. In contrast, there are several thousand medical colleagues throughout Germany who stand on the ground of evidence-based medicine, have learned conventional medicine, implement it in their practices, and have completed a recognized continuing education program in homeopathy.

In the German Central Association of Homeopathic Physicians – the oldest medical professional association in Germany – 146 qualified internists are currently registered as members, in addition to numerous other medical specialists, all of whom are actively practicing medicine.

Question: Why does the German Society for Internal Medicine invite an ENT specialist, of all people, who lectures on homeopathy without any expertise of his own? Why not at least a specialist colleague in internal medicine? Or even a colleague who could report on the subject from her own scientific or practical experience? For example, on the topic of “hyperaldosteronism,” would you also invite a urologist or orthodontist? And if so, why?

Dear Board of Directors of the DGIM: As an honorary board member of the German Central Association of Homeopathic Physicians e.V.. (DZVhÄ) – and a specialist in internal medicine – I am quite sure that we could immediately name several colleagues with sufficient expertise as homeopathically trained and experienced internists, if you are really interested in a solid and correct discourse on the subject of homeopathy. Under the above-mentioned circumstances, there is, of course, rather the suspicion that it should not be about, but rather exclusively against homeopathy.

If it is planned for a later congress, e.g. in 2022, to deal again with the topic of homeopathy in a truly professionally well-founded and possibly even more balanced form: please contact us at any time! As medical colleagues, we are very interested in a fair and unprejudiced professional discourse.

Yours sincerely

Dr. med. Ulf Riker, Internist – Homeopathy – Naturopathy

2nd chairman DZVhÄ / 1st chairman LV Bayern

________________

What are Riker and the DZVhÄ trying to say with this ill-advised, convoluted, and poorly written letter?

Let me try to put his points a little clearer:

  • They are upset that the congress of internists invited a non-homeopath to give a lecture about homeopathy.
  • The person in question, Dr. Lübbers, is an ENT specialist and, like all other German critics of homeopathy (apart from one, Dr. Grams), does not understand homeopathy.
  • There are thousands of physicians who do understand it and are fully trained in homeopathy.
  • They would therefore do a much better job in providing a lecture.
  • So, would the German internists please invite homeopaths for their future meetings?

And what is Riker trying to achieve?

  • It seems quite clear that he aims to prevent criticism of homeopathy.
  • He wishes to replace it with pro-homeopathy propaganda.
  • Essentially he wants to stifle free speech, it seems to me.

To reach these aims, he does not hesitate to embarrass himself by sending and making publicly available a very stupid letter. He also behaves in a most unprofessional fashion and does not mind putting a few untruths on paper.

Having said that, I will admit that they are in good company. Hahnemann was by all accounts a most intolerant and cantankerous chap himself. And during the last 200 years, his followers have given ample evidence that critical thinking has remained an alien concept for them. Consequently, such behavior seems not that unusual for German defenders of homeopathy. In recent times they have:

Quite a track record, wouldn’t you agree?

But, I think, attempting to suppress free speech beats it all and must be a new low in the history of homeopathy.

 

Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science. The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.

The purpose of this study was to evaluate the effects of energy healing (EH) therapy prior to and following posterior surgical correction for adolescent idiopathic scoliosis (AIS) compared to controls.

Patients were prospectively randomized to one of two groups: standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions. The outcomes included visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay. For the experimental group, VAS was assessed pre- and post-EH session.

Fifty patients were enrolled-28 controls and 22 EH patients. The controls had a median of 12 levels fused vs. 11 in the EH group (p = 0.04). Pre-operative thoracic and lumbar curve magnitudes were similar (p > 0.05). Overall VAS pain scores increased from pre- to post-operative (p < 0.001), whereas the VAS anxiety scores decreased immediately post-operative (p < 0.001). The control and pre-EH assessments were statistically similar. Significant decreases in VAS pain and anxiety scores from pre to post-EH assessments were noted for the EH group. Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11). The median days to discharge were four in the controls and three in the EH group (p = 0.07).

The authors concluded that EH therapy resulted in a decrease in patient’s pre-operative anxiety. Offering this CAM modality may enhance the wellbeing of the patient and their overall recovery when undergoing posterior surgical correction for AIS.

I am getting tired of explaining that this trial design tells us as good as nothing about the effects of the tested therapy per se. As we have discussed ad nauseam on this blog, A+B is always more than B alone. Such trials appear to be rigorous and fool many people, but they are unable to control for context effects, like placebo or attention. Therefore, I need to re-write the conclusions:

The placebo effect and the extra attention associated with EH therapy resulted in a decrease in patients’ pre-operative anxiety. EH itself is most likely bar any effect. Further studies in this area are not required.

Absurd claims about spinal manipulative therapy (SMT) improving immune function have increased substantially during the COVID-19 pandemic. Is there any basis at all for such notions?

The objective of this systematic review was to identify, appraise, and synthesize the scientific literature on the efficacy and effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes in patients with infectious disease and to examine the association between SMT and selected immunological, endocrine, and other physiological biomarkers.

A literature search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Index to Chiropractic Literature, the Cochrane Central Register of Controlled Trials, and Embase was conducted. Randomized clinical trials and cohort studies were included. Eligible studies were critically appraised, and evidence with high and acceptable quality was synthesized using the Synthesis Without Meta-Analysis guideline.

A total of 2593 records were retrieved; after exclusions, 50 full-text articles were screened, and 16 articles reporting the findings of 13 studies comprising 795 participants were critically appraised. No clinical studies were located that investigated the efficacy or effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes among patients with infectious disease. Eight articles reporting the results of 6 high- and acceptable-quality RCTs comprising 529 participants investigated the effect of SMT on biomarkers. Spinal manipulative therapy was not associated with changes in lymphocyte levels or physiological markers among patients with low back pain or participants who were asymptomatic compared with sham manipulation, a lecture series, and venipuncture control groups. Spinal manipulative therapy was associated with short-term changes in selected immunological biomarkers among asymptomatic participants compared with sham manipulation, a lecture series, and venipuncture control groups.

The authors concluded that no clinical evidence was found to support or refute claims that SMT was efficacious or effective in changing immune system outcomes. Although there were limited preliminary data from basic scientific studies suggesting that SMT may be associated with short-term changes in immunological and endocrine biomarkers, the clinical relevance of these findings is unknown. Given the lack of evidence that SMT is associated with the prevention of infectious diseases or improvements in immune function, further studies should be completed before claims of efficacy or effectiveness are made.

I fully agree with the data as summarised in this paper. Yet, I find the conclusions a bit odd. The authors of this paper are chiropractors who declare the following conflicts of interest: Dr Côté reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation, travel expenses from the World Federation of Chiropractic, and personal fees from the Canadian Chiropractic Protective Association outside the submitted work. Dr Cancelliere reported receiving grants from the Canadian Chiropractic Research Foundation outside the submitted work. Dr Mior reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Association and the Ontario Chiropractic Association outside the submitted work. Dr Hogg-Johnson reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation outside the submitted work. No other disclosures were reported. The research was supported by funding from the College of Chiropractors of British Columbia to Ontario Tech University, the Canada Research Chairs program (Dr Côté), and the Canadian Chiropractic Research Foundation (Dr Cancelliere).

Would authors independent of chiropractic influence have drawn the same conclusions? I doubt it! While I do appreciate that chiropractors published these negative findings prominently, I feel the conclusions could easily be put much clearer:

There is no clinical evidence to support claims that SMT is efficacious or effective in changing immune system outcomes. Further studies in this area are not warranted.

Battlefield Acupuncture (BFA) – I presume the name comes from the fact that it is so simple, it could even be used under combat situations – is a form of ear acupuncture developed 20 years ago by Dr Richard Niemtzow. BFA employs gold semipermanent needles that are placed at up to 5 specific sites in one or both ears.  The BFA needles are small conical darts that pierce the outer ear in designated locations and remain in place until they fall out typically within 3–4 days.

The US Defense and Veterans Center for Integrative Pain Management and the Veterans Health Administration National Pain Management Program Office recently completed a 3-year acupuncture education and training program, which deployed certified BFA trainers for the Department of Defense and Veterans Administration medical centers. Over 2800 practitioners were thus trained to provide BFA. The total costs amounted to $ 5.4 million.

This clearly begs the question:

DOES IT WORK?

 This review aims to investigate the effects and safety of BFA in adults with pain. Electronic databases were searched for randomized controlled trials (RCTs) published in English evaluating efficacy and safety of BFA in adults with pain, from database inception to September 6, 2019. The primary outcome was pain intensity change, and the secondary outcome was safety. Nine RCTs were included in this review, and five trials involving 344 participants were analyzed quantitatively. Compared with no intervention, usual care, sham BFA, and delayed BFA interventions, BFA had no significant improvement in the pain intensity felt by adults suffering from pain. Few adverse effects (AEs) were reported with BFA therapy, but they were mild and transitory.

The authors of this review concluded that BFA is a safe, rapid, and easily learned acupuncture technique, mainly used in acute pain management, but no significant efficacy was found in adult individuals with pain, compared with the control groups. Given the poor methodological quality of the included studies, high-quality RCTs with rigorous evaluation methods are needed in the future.

And here are my comments:

  • SAFE? Impossible to tell on the basis of 344 patients.
  • RAPID? True, but meaningless, as it does not work.
  • EASILY LEARNT? True, it’s simple and seems ever so stupid.
  • NO SIGNIFICANT EFFICACY? That I can easily believe.

I am amazed that anyone would fall for an idea as naive as BFA. That it should be the US military is simply hilarious, in my view. I am furthermore baffled that anyone recommends more study of such monumental nonsense.

Why, oh why?

Acupuncture is far-fetched (to put it mildly). Ear acupuncture is positively ridiculous. BFA seems beyond ridiculous and must be the biggest military hoax since general Grigory Aleksandrovich Potemkin painted façades to fool Catherine the Great into thinking that an area was far richer than it truly was.

 

Low back pain must be one of the most frequent reasons for patients to seek out some so-called alternative medicine (SCAM). It would therefore be important that the information they get is sound. But is it?

The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM. The investigators searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. They used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.

Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.

The authors concluded that despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.

In the past, I have conducted several similar surveys, for instance, this one:

Background: Low back pain (LBP) is expected to globally affect up to 80% of individuals at some point during their lifetime. While conventional LBP therapies are effective, they may result in adverse side-effects. It is thus common for patients to seek information about complementary and alternative medicine (CAM) online to either supplement or even replace their conventional LBP care. The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM.

Methods: We searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. We used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.

Results: Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.

Conclusion: Despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.

Or this one:

Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.

Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,

Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

The findings were invariably disappointing and confirmed those of the above paper. As it is nearly impossible to do much about this lamentable situation, I can only think of two strategies for creating progress:

  1. Advise patients not to rely on Internet information about SCAM.
  2. Provide reliable information for the public.

Both describe the raison d’etre of my blog pretty well.

Recently, I came across a newspaper asking: “Which vaccine do you trust most?” It turned out that there was a clear favourite according to public opinion. In the present climate of heated debates about COVID vaccines, this seems to make sense.

Or doesn’t it?

What determines public opinion?

There are probably many determinants, but most are dominated by what the public is being told about a subject. If, for instance, the press incessantly reports bad things about a certain vaccine and mostly good news about another, public opinion will reflect exactly that.

What I am trying to point out is this: the man and woman in the street have no expertise in vaccines. They mostly think what they are being told about them. So, public opinion is largely determined by journalists who write about the subject. If then a newspaper presents the public opinion about a vaccine, it is all but a foregone conclusion. The paper might as well just repeat what they have been telling their readers. By presenting a ‘public opinion’ about vaccines they actually go one step further: they amplify their own opinion by pretending it is not of their making but that of the public.

All this seems fairly obvious, once you start thinking about it.

So, why do I go on about it?

If this phenomenon occurs with vaccines, it also occurs with other issues, for instance, so-called alternative medicine (SCAM). We often hear that the public is in favour of this or that type of SCAM. It is supposed to convince us and politicians that SCAM is good. If thousands or even millions are in favour of it, it must be good! Who am I to disagree with the public?

But, as we have just seen with the example of the vaccines, public opinion is merely a reflection of what the press tells people. The man and the woman in the street are not competent to reliably estimate the risk-benefit ratios of St John’s wort, Arnica, glucosamine, acupuncture, etc. etc. They can judge such issues as little as they can judge the risk-benefit balance of a vaccine. They rely on information from the outside, and that information usually reaches them by the press.

What am I aiming at?

Public opinion sounds impressive, and in the realm of SCAM, it often determines much. If the public opinion is in favour of homoeopathy, for instance, politicians are likely to lend their support to it. Yet, public opinion is just OPINION! It cannot be used as an indicator for the efficacy or safety of medical interventions, and it cannot be the reason for using or rejecting them.

It follows, I think, that journalists have a huge responsibility to inform the public correctly on SCAM (and any other matter). On this blog, we have seen numerous instances of journalists who could have done better, e.g.:

Public opinion, it seems to me, can only be meaningful, if the information fed to the public is sound. And when it comes to SCAM, this condition is often not met.

 

 

Previous studies have shown inconclusive results of homeopathy in the treatment of warts. A team of Indian homeopaths aimed to assess the feasibility of a future definitive trial, with a preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in the treatment of cutaneous warts.

A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of warts; the secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.

Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all > 0.05, Mann-Whitney U tests) with small effect sizes-both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported.

The Indian homeopaths draw the following conclusion: As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.

INCONCLUSIVE?

No, the findings are not inconclusive at all! Read the results again: they confirm that homeopathy is a placebo therapy.

So, why is this trial worth writing about?

Surely, we did not expect anything else than a negative outcome from such a study?!

No, we didn’t.

But there is still something quite remarkable about this study: I have previously noted that virtually all studies of homeopathy by Indian researchers report positive results. AND THIS ONE DOESN’T!!!

Alright, it tries to hide the fact that the findings were negative, but this already seems to be a step in the right direction. So, well done, my Indian friends!!!

Perhaps one day, you will be able to admit that homeopathy is a placebo therapy?

 

 

The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.

The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.

Here are 6 results that I found noteworthy:

  • Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
  • Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
  • Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
  • Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
  • Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
  • Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.

Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:

  • Do you believe in the concept of subluxation?
  • Do you treat conditions other than spinal problems?
  • How frequently do you use spinal manipulations?
  • How often do you see adverse effects of spinal manipulation?
  • Do you obtain informed consent from all patients?
  • How often do you refer patients to medical doctors?
  • Do you advise in favour of vaccinations?
  • Do you follow the rules of evidence-based medicine?
  • Do you offer advice about prescribed medications?
  • Which supplements do you recommend?
  • Do you recommend maintenance treatment?

I wonder why they were not included.

 

Osteopathic manipulative treatment (OMT) is frequently recommended by osteopaths for improving breastfeeding. But does it work?

This double-blind randomised clinical trial tested whether OMT was effective for facilitating breastfeeding. Breastfed term infants were eligible if one of the following criteria was met:

  • suboptimal breastfeeding behaviour,
  • maternal cracked nipples,
  • maternal pain.

The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.

One hundred twenty-eight mother-infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breastfed at 1 month vs 39 of 59 (66%) in the control group. After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44. No adverse effects were reported in either group.

The authors concluded dryly that OMT did not improve exclusive breastfeeding at 1 month.

This is a rigorous trial with clear and expected results. It was conducted in cooperation with a group of 7 French osteopaths, and the study was sponsored by the ‘Société Européenne de Recherche en Osthéopathie Périnatale et Pédiatrique’, the ‘Fonds pour la Recherche en Ostéopathie’ and ‘Formation et Recherche Ostéopathie et Prévention’. The researchers need to be congratulated on publishing this trial and expressing the results so clearly despite the fact that the findings were not what the osteopaths had hoped for.

Three questions come to my mind:

  1. Is any of the many therapeutic recommendations of osteopaths valid?
  2. Why was it ever assumed that OMT would be effective?
  3. Do we really have to test every weird assumption before we can dismiss it?

The authors of this study claim that, in the aging brain, reduction in the pulsation of cerebral vasculature and fluid circulation causes impairment in the fluid exchange between different compartments and lays a foundation for the neuroinflammation that results in Alzheimer disease (AD). The knowledge that lymphatic vessels in the central nervous system play a role in the clearance of brain-derived metabolic waste products opens an unprecedented capability to increase the clearance of macromolecules such as amyloid β proteins. However, currently, there is no pharmacologic mechanism available to increase fluid circulation in the aging brain.

Based on these considerations, the authors conducted a study to demonstrate the influence of an osteopathic cranial manipulative medicine (OCMM) technique, specifically, compression of the fourth ventricle, on spatial memory and changes in substrates associated with mechanisms of metabolic waste clearance in the central nervous system using the naturally aged rat model of AD.

The rats in the OCMM group received the CV4 technique every day for 7 days for 4 to 7 minutes at each session. Rats were anesthetized with 1.5% to 3% isoflurane throughout the procedure. Rats in the UT group were also anesthetized to nullify any influence of isoflurane in spatial learning. During the CV4 procedure, the operator applied mechanical pressure over the rat’s occiput, medial to the junction of the occiput and temporal bone and inferior to the lambdoid suture to place tension on the dural membrane around the fourth ventricle. This gentle pressure was applied to resist cranial flexion with the aim of improving symmetry in the cranial rhythmic impulse (CRI), initiating a rhythmic fluctuation of the CSF, and improving mobility of the cranial bones and dural membranes. This rhythmic fluctuation is thought to be primarily due to flexion and extension that takes place at the synchondrosis between the sphenoid and basiocciput. The treatment end point was achieved when the operator identified that the tissues relaxed, a still point was reached, and improved symmetry or fullness of the CRI was felt. Currently, there is no quantitative measure for the pressure used in this treatment.

The results showed a significant improvement in spatial memory in 6 rats after 7 days of OCMM sessions. Live animal positron emission tomographic imaging and immunoassays revealed that OCMM reduced amyloid β levels, activated astrocytes, and improved neurotransmission in the aged rat brains.

The authors concluded that these findings demonstrate the molecular mechanism of OCMM in aged rats. This study and further investigations will help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.

If there ever was an adventurous, over-optimistic extrapolation, this must be it!

Even assuming that all of the findings can be confirmed and replicated, they would be a very far shot from rendering OCMM an evidence-based treatment for AD:

  • Rats are not humans.
  • Aged rats do not have AD.
  • OCMM is not a plausible treatment.
  • An animal study is not a clinical trial.

I am at a complete loss to see how the findings of this bizarre animal experiment might help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.

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