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

spinal manipulation

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Spinal manipulation therapy (SMT) is widely used worldwide to treat musculoskeletal and many other conditions. The evidence that it works for any of them is weak, non-existent, or negative. What is worse, SMT can – as we have discussed so often on this blog –  cause adverse events some of which are serious, even fatal.

Spinal epidural hematoma (SEH) caused by SMT is a rare emergency that can cause neurological dysfunction. Chinese researchers recently reported three cases of SEH after SMT.

  1. The first case was a 30-year-old woman who experienced neck pain and numbness in both upper limbs immediately after SMT. Her symptoms persisted after 3 d of conservative treatment, and she was admitted to our hospital. Magnetic resonance imaging (MRI) demonstrated an SEH, extending from C6 to C7.
  2. The second case was a 55-year-old man with sudden back pain 1 d after SMT, numbness in both lower limbs, an inability to stand or walk, and difficulty urinating. MRI revealed an SEH, extending from T1 to T3.
  3. The third case was a 28-year-old man who suddenly developed symptoms of numbness in both lower limbs 4 h after SMT. He was unable to stand or walk and experienced mild back pain. MRI revealed an SEH, extending from T1 to T2.

All three patients underwent surgery after failed conservative treatment and all recovered to ASIA grade E on day 5, 1 wk, and day 10 after surgery, respectively. All patients returned to normal after 3 mo of follow-up.

The authors concluded that SEH caused by SMT is very rare, and the condition of each patient should be evaluated in full detail before operation. SEH should be diagnosed immediately and actively treated by surgery.

These cases might serve as an apt reminder of the fact that SMT (particularly SMT of the neck) is not without its dangers. The authors’ assurance that SEH is VERY RARE is a little puzzling, in my view (the paper includes a table with all 17 previously published cases). There is, as we often have mentioned, no post-marketing surveillance, surgeons only see those patients who survive such complications long enough to come to the hospital, and they publish such cases only if they feel like it. Consequently, the true incidence is anyone’s guess.

As pointed out earlier, the evidence that SMT might be effective is shaky for most indications. In view of the potential for harm, this can mean only one thing:

The risk/benefit balance for SMT is not demonstrably positive.

In turn, this leads to the conclusion that patients should think twice before having SMT and should inquire about other therapeutic options that have a more positive risk/benefit balance. Similarly, the therapists proposing SMT to a patient have the ethical and moral duty to obtain fully informed consent which includes information about the risk/benefit balance of SMT and other options.

These days, I live in France (some of my time) and I am often baffled by the number of osteopaths and the high level of acceptance of osteopathy in this country. The public seems to believe everything osteopaths claim and even most doctors have long given up to object to the idiocies they proclaim.

The website of the Institute of Osteopathy in Renne is but one of many examples. The Institute informed us as follows (my translation):

In addition to back pain, the osteopath can act on functional disorders of the digestive, neurological, cardiovascular systems or conditions related to ear, nose and throat. Osteopaths can promote recovery in athletes, relieve migraines, musculoskeletal disorders such as tendonitis, or treat sleep disorders. Less known for its preventive aspect, osteopathy also helps maintain good health. It can be effective even when everything is going well because it will prevent the appearance of pain. Osteopathy is, in fact, a manual medicine that allows the rebalancing of the major systems of the body, whatever the age of the patient and his problems. The osteopath looks for the root cause of your complaint in order to develop a curative and preventive treatment.

Who are osteopathic consultations for?

Osteopathic consultations at the Institute of Osteopathy of Rennes-Bretagne are intended for the following types of patients and pathologies

BABY / CHILD

GERD (gastric reflux), plagiocephaly (cranial deformities), recurrent ENT disorders (sinusitis, ear infections…), digestive, sleep and behavioural disorders, motor delay, following a difficult birth…

ADULT

Prevention, comfort treatment of osteoarthritis, musculoskeletal pain, functional abdominal pain, digestive disorders, headaches, dizziness, postural deficiency, facial pains…

PREGNANT WOMAN

Musculoskeletal pain (lumbago, back pain), digestive disorders, preparation for childbirth, post-partum check-up.

COMPANY

Prevention and treatment of MSDs (musculoskeletal disorders) linked to workstation ergonomics, stress, pain due to repetitive movements, poor posture at work, etc.

ADOLESCENT

Scoliosis, prevention of certain pathologies linked to growth, fatigue, stress, follow-up of orthodontic treatment.

SPORTSMAN

Musculoskeletal pain, tendonitis, osteopathic preparation for competition, osteopathic assessment according to the sport practised, repetitive injury.

In case you are not familiar with the evidence for osteopathy, let me tell you that as good as none of the many claims made in the above text is supported by anything that even resembles sound evidence.

So, how can we explain that, in France, osteopathy is allowed to thrive in a virtually evidence-free space?

In France, osteopathy started developing in the 1950s. In 2002, osteopathy received legislative recognition in France, and today, it is booming; between 2016 and 2018, 3589 osteopaths were trained in France. Osteopaths can be DO doctors, DO physiotherapists, DO nurses, DO midwives, DO chiropodists, or even DO dentists.

Thus, in 2018, and out of a total of 29,612 professionals practising osteopathy, there were 17,897 osteopaths DO and 11,715 DO health professionals. The number of professionals using the title of osteopath has roughly tripled in 8 years (11608 in 2010 for 29612 in 2018). There are currently around 30 osteopathic schools in France. About 3 out of 5 French people now consult osteopaths.

But this does not answer my question why, in France, osteopathy is allowed to thrive in a virtually evidence-free space! To be honest, I do not know its answer.

Perhaps someone else does?

If so, please enlighten me.

 

 

The aims of this bibliometric analysis are to describe the characteristics of articles published on the efficacy of osteopathic interventions and to provide an overall portrait of their impacts in the scientific literature. A bibliometric analysis approach was used. Articles were identified with searches using a combination of relevant MeSH terms and indexing keywords about osteopathy and research designs in MEDLINE and CINAHL databases. The following indicators were extracted: country of the primary author, year of publication, journals, impact factor of the journal, number of citations, research design, participants’ age group, system/body part addressed, primary outcome, indexing keywords and types of techniques.

A total of 389 articles met the inclusion criteria. The number of empirical studies doubled every 5 years, with the United States, Italy, Spain, and the United Kingdom being the most productive countries. Twenty-three articles were cited over 100 times. Articles were published in 103 different indexed journals, but more than half (53.7%) of articles were published in one of three osteopathy-focused readership journals. Randomized control trials (n = 145; 37.3%) and case reports (n = 142; 36.5%) were the most common research designs. A total of 187 (48.1%) studies examined the effects of osteopathic interventions using a combination of techniques that belonged to two or all of the classic fields of osteopathic interventions (musculoskeletal, cranial, and visceral).

The authors concluded that this bibliometric analysis shows that publications about efficacy of osteopathy are relatively recent and have increased at a rapid pace over the last three decades. More than half of these publications are published in three osteopathic journals targeting a limited, disciplinary-focused readership. Our results highlight important needs for large efficacy and effectiveness trials, as well as study designs to further understanding of the mechanisms of action of the techniques being investigated. Finally, this bibliometric analysis can assist to identify osteopathy techniques and populations where further clinical research is required.

What the authors fail to state is that their analysis discloses osteopathy to be an area of utter unimportance. Less than 400 studies in 52 years is a dismal result. The fact that they were mostly published in journals of no impact makes it even worse. Twenty-three articles were cited more than 100 times; this is dismal! To put it in perspective, I have ~250 articles that were cited more than 100 times. Does that suggest that my work has made about 10 times more impact than the entire field of osteopathy?

A substantial number of patients globally receive spinal manipulative therapy (SMT) to manage non-musculoskeletal disorders. However, the efficacy and effectiveness of these interventions to prevent or treat non-musculoskeletal disorders remain controversial.

A Global Summit of international chiropractors and scientists conducted a systematic review of the literature to determine the efficacy and effectiveness of SMT for the primary, secondary and tertiary prevention of non-musculoskeletal disorders. The Global Summit took place on September 14-15, 2019 in Toronto, Canada. It was attended by 50 chiropractic researchers from 8 countries and 28 observers from 18 chiropractic organizations. Participants met the following criteria: 1) chiropractor with a PhD, or a researcher with a PhD (not a chiropractor) with research expertise in chiropractic; 2) actively involved in research (defined as having published at least 5 peer-reviewed papers over the past 5 years); and 3) appointed at an academic or educational institution. In addition, a small group of researchers who did not meet these criteria were invited. These included three chiropractors with a strong publication and scientific editorial record who did not have a PhD (SMP, JW, and HS) and two early career researchers with expertise within the area of chiropractic and pseudoscience (ALM, GG). Participants were invited by the Steering Committee using purposive and snowball sampling methods. At the summit, participants critically appraised the literature and synthesized the evidence.

They searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and the Index to Chiropractic Literature from inception to May 15, 2019, using subject headings specific to each database and free text words relevant to manipulation/manual therapy, effectiveness, prevention, treatment, and non-musculoskeletal disorders. Eligible for review were randomized controlled trials published in English. The methodological quality of eligible studies was assessed independently by reviewers using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for randomized controlled trials. The researchers synthesized the evidence from articles with high or acceptable methodological quality according to the Synthesis without Meta-Analysis (SWiM) Guideline. The final risk of bias and evidence tables were reviewed by researchers who attended the Global Summit and 75% (38/50) had to approve the content to reach consensus.

A total of 4997 citations were retrieved, and 1123 duplicates were removed, and 3874 citations were screened. Of those, the eligibility of 32 articles was evaluated at the Global Summit and 16 articles were included in the systematic review. The synthesis included 6 randomized controlled trials with acceptable or high methodological quality (reported in 7 articles). These trials investigated the efficacy or effectiveness of SMT for the management of

  • infantile colic,
  • childhood asthma,
  • hypertension,
  • primary dysmenorrhea,
  • migraine.

None of the trials evaluated the effectiveness of SMT in preventing the occurrence of non-musculoskeletal disorders. A consensus was reached on the content of all risk of bias and evidence tables. All randomized controlled trials with high or acceptable quality found that SMT was not superior to sham interventions for the treatment of these non-musculoskeletal disorders.

Six of 50 participants (12%) in the Global Summit did not approve the final report.

The authors concluded that our systematic review included six randomized clinical trials (534 participants) of acceptable or high quality investigating the efficacy or effectiveness of SMT for the treatment of non-musculoskeletal disorders. We found no evidence of an effect of SMT for the management of non-musculoskeletal disorders including infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. This finding challenges the validity of the theory that treating spinal dysfunctions with SMT has a physiological effect on organs and their function. Governments, payers, regulators, educators, and clinicians should consider this evidence when developing policies about the use and reimbursement of SMT for non-musculoskeletal disorders.

I would have formulated the conclusions much more succinctly:

As has already been shown repeatedly, there is no sound evidence that SMT is effective for non-musculoskeletal conditions.

Two chiropractors conducted a retrospective review of publicly available data from the California Board of Chiropractic Examiners. Their aim was to determine categories of offense, experience, and gender of disciplined doctors of chiropractic (DC) in California and compare them with disciplined medical physicians in California.

Retrospective reviews of publicly available data from the California Board of Chiropractic Examiners.

The DC disciplinary categories, in descending order, were

  • fraud (44%),
  • sexual boundary issues (22%),
  • other offences (13%),
  • abuse of alcohol or drugs (10%),
  • negligence or incompetence (6%),
  • poor supervision (2%),
  • mental impairment (.3%).

The authors concluded that the professions differ in the major reasons for disciplinary actions. Two thirds (67%) of the doctors of chiropractic were disciplined for fraud and sexual boundary issues, compared with 59% for negligence and substance misuse for medical physicians. Additional study in each profession may reveal methods to identify causes and possible intervention for those who are at high risk.

The two authors of this paper should be congratulated for their courage to publish such a review. These figures seem shocking. But I think that in reality some of them might be far higher. Take the important matter of competence, for instance. If you consider it competent that chiropractors treat conditions other than back pain, you might arrive at the above-mentioned figure of 6%. If you consider this as incompetent, as I do, the figure might be one order of magnitude higher (for more on unprofessional conduct by chiropractors see here).

The abstract of the paper does not provide comparisons to the data related to the medical profession. Here they are; relative to doctors, chiropractors are:

  • 2x more likely to be involved in malpractice,
  • 9x more likely to be practising fraud,
  • 2x more likely to transgress sexual boundaries.

The frequency of fraud is particularly striking. Come to think of it, however, it is not all that amazing. I have said it before: chiropractic is in my view mostly about money.

It has been reported that B.C.’s chiropractors are deeply divided about the future of their profession, disagreeing on everything from false advertising to the use of routine X-rays.

Chiropractors attending an extraordinary general meeting of the College of Chiropractors of B.C. were split nearly down the middle on a series of non-binding resolutions addressing actions the College has taken in recent years. By the narrowest of margins, with at most 54% support, the members voted in favor of the college’s moves to limit the use of diagnostic X-rays and ban claims that aren’t supported by scientific evidence. The question that remains is who represents the bulk of the profession in B.C. — chiropractors advocating for what they describe as evidence-based practice targeting the musculoskeletal system, or “vitalists” who argue that chiropractic treatment can help with everything from immunity to brain function.

The modernizers see it as “a deliberate attempt to take over the college by a small group of chiropractors with no respect or knowledge of regulation … funded by organizations out of the province and out of the country,” Victoria chiropractor Clark Konczak told the virtual meeting.

At issue was a series of policies the college introduced in the wake of what Konczak called “the smoothie episode.” He was referring to a video posted on Facebook in 2017 by the then-vice chair of the college’s board, Avtar Jassal, in which he falsely suggested fruit smoothies are better than vaccines at preventing the flu.

Earlier this year, the college introduced amendments that bar chiropractors from performing routine and repeat X-rays, saying radiography is only scientifically supported when there are red flags that something is seriously wrong. The policy change on X-rays was the flashpoint in the long-simmering tension within the profession. A group of chiropractors has filed a petition in B.C. Supreme Court, alleging the college is preventing them from providing “safe, ethical, and effective care to their patients.” Their legal action has backing from national and international vitalistic organizations. During the recent meeting, a group of chiropractors argued unsuccessfully for the new X-ray policy to be tossed. Some suggested that chiropractors who don’t perform X-rays as a matter of routine are actually harming their patients. Another extraordinary general meeting has been called for July 20 to vote on resolutions calling for the removal of four college board members.

As I have often pointed out, chiropractic is all about money. The ‘chiro-wars’ have been going on for quite a while now, and they are by no means confined to B. C. or Canada. In a nutshell, they suggest to me that a significant proportion of chiropractors prefer money to progress.

Vertebral artery dissections (VAD) are a rare but important cause of ischemic stroke, especially in younger patients. Many etiologies have been identified, including motor vehicle accidents, cervical fractures, falls, physical exercise, and, as I have often discussed on this blog, cervical chiropractic manipulation. The goal of this study was to investigate the subgroup of patients who suffered a chiropractor-associated injury and determine how their prognosis compared to other-cause VAD.

The researchers, neurosurgeons from Chicago, conducted a retrospective chart review of 310 patients with vertebral artery dissections who presented at their institution between January 2004 and December 2018. Variables included demographic data, event characteristics, treatment, radiographic outcomes, and clinical outcomes measured using the modified Rankin Scale.

Overall, 34 out of our 310 patients suffered a chiropractor-associated injury. These patients tended to be younger (p = 0.01), female (p = 0.003), and have fewer comorbidities (p = 0.005) compared to patients with other-cause VADs. The characteristics of the injuries were similar, but chiropractor-associated injuries appeared to be milder at discharge and at follow-up. A higher proportion of the chiropractor-associated group had injuries in the 0-2 mRS range at discharge and at 3 months (p = 0.05, p = 0.04) and no patients suffered severe long-term neurologic consequences or death (0% vs. 9.8%, p = 0.05). However, when a multivariate binomial regression was performed, these effects dissipated and the only independent predictor of a worse injury at discharge was the presence of a cervical spine fracture (p < 0.001).

The authors concluded that chiropractor-associated injuries are similar to VADs of other causes, and apparent differences in the severity of the injury are likely due to demographic differences between the two populations.

The authors of the present paper are clear: “chiropractic manipulations are a risk factor for vertebral artery dissections.” This fact is further supported by a host of other investigations. For instance, the Canadian Stroke Consortium found that 28% of strokes following cervical artery dissection were preceded by chiropractic neck manipulation. Dziewas et al. obtained a similar rate in patients with vertebral artery dissections. Many chiropractors are in denial; however, this is merely due to their overt conflicts of interest.

My conclusions from the accumulated evidence are this:

Spinal manipulations of the upper spine should not be routinely used for any condition. Patients who nevertheless insist on having them must be made aware of the risks and give informed consent.

This systematic review assessed the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.

Different databases were screened up to 20 August 2020. Randomized controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effects (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analyzed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Most of the trials were of chiropractic manipulation. Very low evidence quality suggests clinically insignificant pain improvement in favor of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation is the most recognized technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

The optimal therapy for back pain does not exist or has not yet been identified; there are dozens of different approaches but none has been found to be truly and dramatically effective. Manual therapies like chiropractic and osteopathy are often used, and some data suggest that they are as good (or as bad) as most other options. This review confirms what we have discussed many times previously (e.g. here), namely that the small positive effect of MT, or specifically spinal manipulation, is largely due to placebo.

Considering this information, what is the best treatment for back pain sufferers? The answer seems obvious: it is a therapy that is as (in)effective as all the others but causes the least harm or expense. In other words, it is not chiropractic nor osteopathy but exercise.

My conclusion:

avoid therapists who use spinal manipulation for back pain.

The purpose of this study was to describe changes in opioid-therapy prescription rates after a family medicine practice included on-site chiropractic services. It was designed as a retrospective analysis of opioid prescription data. The database included opioid prescriptions written for patients seeking care at the family medicine practice from April 2015 to September 2018. In June 2016, the practice reviewed and changed its opioid medication practices. In April 2017, the practice included on-site chiropractic services. Opiod-therapy use was defined as the average rate of opioid prescriptions overall medical providers at the practice.

There was a significant decrease of 22% in the average monthly rate of opioid prescriptions after the inclusion of chiropractic services (F1,40 = 10.69; P < .05). There was a significant decrease of 32% in the prescribing rate of schedule II opioids after the inclusion of chiropractic services (F2,80 = 6.07 for the Group × Schedule interaction; P < .05). The likelihood of writing schedule II opioid prescriptions decreased by 27% after the inclusion of chiropractic services (odds ratio, 0.73; 95% confidence interval, 0.59-0.90). Changes in opioid medication practices by the medical providers included prescribing a schedule III or IV opioid rather than a schedule II opioid (F6,76 = 29.81; P < .05) and a 30% decrease in the daily doses of opioid prescriptions (odds ratio, 0.70; 95% confidence interval, 0.50-0.98).

The authors concluded that this study demonstrates that there were decreases in opioid-therapy prescribing rates after a family medicine practice included on-site chiropractic services. This suggests that inclusion of chiropractic services may have had a positive effect on prescribing behaviors of medical physicians, as they may have been able to offer their patients additional nonpharmaceutical options for pain management.

The authors are correct in concluding the inclusion of chiropractic services MAY have had a positive effect. And then again, it may not!

Cause and effect cannot be established by correlation alone.

CORRELATION IS NOT CAUSATION!

And even if the inclusion of chiropractic services caused the positive effect, it would not prove that chiropractic is effective in the management of pain. It would only mean that the physicians had an option that helped them to write fewer opioid prescriptions. Had they hired a crystal healer or a homeopath or a faith healer or any other practitioner of an ineffective therapy, the findings might have been very similar.

The long and short of it is this: if we want to use fewer opioids, there is only one way to achieve it: we must prescribe less.

 

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.

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