Updated Edition!
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:
- Advise patients not to rely on Internet information about SCAM.
- 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.:
- “Scientists have shown how homeopathy works” – journalists’ obsession with ‘balance’
- ACUPUNCTURE: journalists, be aware of your responsibility not to mislead the public
- “Chiropractic treatments are too dangerous…” A TALE OF POOR JOURNALISM (by the Daily Mail)
- SUCCESS: my first official complaint about a newspaper article
- Recklessly stupid TCM-promotion by the ‘Daily Mail’
- Beware of the alkaline diet and the claims made for it! A plea for journalistic accuracy
- Ear-candles, a TV-doctor, THE DAILY MAIL, and journalistic ‘balance’
- Irresponsible promotion of quackery even by the ‘respectable’ press
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 p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 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.
The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:
Recommendations: Acupuncture for chronic primary pain
Consider a single course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:
- is delivered in a community setting and
- is delivered by a band 7 (equivalent or lower) healthcare professional with appropriate training and
- is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries) or
- is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.
_____________________________
Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.
Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.
An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).
Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.
_______________________________
Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
______________END OF QUOTES____________
I will leave this here without a comment for the moment and look forward to reading what you think about this.
The use of so-called alternative medicine (SCAM) is common among breast cancer patients, but less is known about whether SCAM influences breast cancer survival. The primary aim of this recent study from Tunesia was to determine the impact of self-use of herbs on the overall survival of women with breast cancer.
The researchers conducted a prospective study including 110 patients with breast cancer. All patients were questioned about their usage of herbal remedies. The demographic data and the overall survival of the patients were then analyzed.
The average age was 51 years (30-80 years old). In total, 37 had metastatic disease (33.6%), and 48 patients had taken plant-based treatments (43.6%). Of those women, 19 patients consumed Graviola (39.6%) and 29 Alenda (60.4%). Overall survival rates at 3 years and at 5 years were 96.2% and 82.4% in the absence of herbal medicine usage versus 78.5% and 78.5% in the presence of herbal medicine use (p = 0.015).
The authors concluded that self-medication with Graviola or Alenda may be associated with an increase of death risk in patients with breast cancer. Further studies are needed to confirm these results.
This is only a small and not very rigorous case-control study. In itself, it would be far from conclusive. What renders it relevant, however, is the fact that its findings do by no means stand alone. We have seen several times on this blog that SCAM use can shorten the life of cancer patients, e.g.:
- More evidence that SCAM-use is associated with shorter survival of cancer patients
- Patients who received CM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of CCT.
- The use of CAM had significantly associated with delay in presentation and resolution of diagnosis.
- CAM did not provide any definite survival benefit, CAM users reported clinically significant worse health-related quality of life.
So, perhaps it is true? Perhaps using SCAM is not such a good idea, if you are suffering from cancer!
The mechanisms of such detrimental effects are not difficult to imagine. They might include direct effects on the cancer, interactions with prescribed drugs, delay of cancer diagnosis, or less strict adherence to the anti-cancer treatments.
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:
- Is any of the many therapeutic recommendations of osteopaths valid?
- Why was it ever assumed that OMT would be effective?
- 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.
