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

musculoskeletal problems

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The objective of this paper, as stated by its authors, was to develop an evidence-based clinical practice guideline (CPG) through a broad-based consensus process on best practices for chiropractic management of patients with chronic musculoskeletal (MSK) pain.

Using systematic reviews identified in an initial literature search, a steering committee of experts in research and management of patients with chronic MSK pain drafted a set of recommendations. Additional supportive literature was identified to supplement gaps in the evidence base. A multidisciplinary panel of experienced practitioners and educators rated the recommendations through a formal Delphi consensus process using the RAND Corporation/University of California, Los Angeles, methodology.

The Delphi process was conducted January–February 2020. The 62-member Delphi panel reached consensus on chiropractic management of five common chronic MSK pain conditions:

  • low-back pain (LBP),
  • neck pain,
  • tension headache,
  • osteoarthritis (knee and hip),
  • fibromyalgia.

Recommendations were made for non-pharmacological treatments, including:

  • acupuncture,
  • spinal manipulation/mobilization,
  • other manual therapy;
  • low-level laser (LLL);
  • interferential current;
  • exercise, including yoga;
  • mind–body interventions, including mindfulness meditation and cognitive behavior therapy (CBT);
  • lifestyle modifications such as diet and tobacco cessation.

Recommendations covered many aspects of the clinical encounter, from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral. Appropriate referral and comanagement were emphasized.

Therapeutic recommendations for low back pain:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence.
  • Exercise
  • Yoga/qigong (which may also be considered “mind–body” interventions)
  • Lifestyle advice to stay active; avoid sitting; manage weight if obese; and quit smoking
  • Spinal manipulation/mobilization
  • Massage
  • Acupuncture
  • LLL therapy
  • Transcutaneous electrical nerve stimulation (TENS) or interferential current may be beneficial as part of a multimodal approach, at the beginning of treatment to assist the patient in becoming or remaining active.
  • Combined active and passive: multidisciplinary rehabilitation
  • CBT
  • Mindfulness-based stress reduction

Therapeutic recommendations for neck pain:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan for maximum therapeutic effect. The following are recommended, based on current evidence.
  • Exercise (range of motion and strengthening).
  • Exercise combined with manipulation/mobilization.
  • Spinal manipulation and mobilization
  • Massage
  • Low-level laser
  • Acupuncture
  • These modalities may be added as part of a multimodal treatment plan, especially at the beginning, to assist the patient in becoming or remaining active:
  • Transcutaneous nerve stimulation (TENS), traction, ultrasound, and interferential current.
  • Yoga
  • Qigong

Therapeutic recommendations for tension headache:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan for maximum therapeutic effect. The following are recommended, based on current evidence:
  • Reassurance that TTH does not indicate presence of a disease.
  • Advice to avoid triggers.
  • Exercise (aerobic).
  • Spinal manipulation
  • Acupuncture
  • Cold packs or menthol gels
  • Combined active and passive
  • CBT
  • Relaxation therapy
  • Biofeedback
  • Mindfulness Meditation

Therapeutic recommendations for knee osteoarthritis:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence:
  • Exercise
  • Manual therapy
  • Ultrasound
  • Acupuncture, using “high dose” (greater treatment frequency, at least 3 × week)
  • LLL therapy

Therapeutic recommendations for hip osteoarthritis:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence
  • Exercise
  • Manual therapy

Therapeutic recommendations for fibromyagia:

  • Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence:
  • Exercise (aerobic and strengthening)
  • Advice on healthy lifestyle
  • Education on the condition
  • Spinal manipulation
  • Myofascial release
  • Acupuncture
  • LLL therapy
  • multidisciplinary rehabilitation
  • CBT
  • mindfulness meditation
  • yoga
  • Tai chi,
  • Qigong

The authors concluded that these evidence-based recommendations for a variety of conservative treatment approaches to the management of common chronic MSK pain conditions may advance consistency of care, foster collaboration between provider groups, and thereby improve patient outcomes.

This paper is an excellent example of a pseudo-scientific process resulting in unreliable outcomes.

  • The Delphi process was conducted some 4 years ago
  • Because of the truly weird inclusion criteria, the findings are based essentially on just 3 systematic reviews.
  • Anyone who has ever tried to conduct a consensus excercise knows that the outcome will almost entirely depend on who is chosen to sit on the panel. So, all you have to do to obtain pro-chiro recommendations is to select a few pro-chiro ‘experts’ who then write the recommendations!
  • A “best practices for chiropractic management” may sound reasonable but, looking at the therapeutic recommendation, one easily realizes that the authors cast their nets so wide that the result has little to do with what differentiates chiropractic from Physiotherapists or osteopaths.

It is therefore not surprising that the recommendations are laughably unreliable: can, for instance, anyone explain to me why “advice on healthy lifestyle and education on the condition” are recommended for fibromyalgia but not for any other condition?

This paper is, in my view, chiropractic pseudo-science at its most ridiculous!

All it really does is it tries to legitimise all sorts of therapies as part of the chiropractic toolbox. My advice to patients is to:

  • consult a physio if you need exercise therapy or LLL or manual therapy or ultrasound or interferential current or TENS or cold packs or massage;
  • consult a clinical psychologist if you need CBT, or mindfulness, biofeedback;
  • consult a doctor if you want rehab or education or lifestyle advice or reassurance;
  • etc. etc.

And please avoid chiropractors who pretend they can do all of the above, while merely wanting to manipulate your neck.

Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.

Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.

We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.

Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.

We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain. 

Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?

Guest post by Catherine de Jong

Academic circles have reacted with surprise to the announcement on 12 November of the appointment of chiropractor Sidney Rubinstein as endowed professor at the Vrije Universiteit Amsterdam. The website of the Dutch Chiropractors Association (NCA)  states:

“On 1 August 2024, Mr. Sidney Rubinstein was appointed professor by special appointment at the chair “Optimizing Management of Musculoskeletal Health” at the Vrije Universiteit in Amsterdam. In addition to his work as a chiropractor in his own practice, Rubinstein has been working at the Vrije Universiteit for a long time. In addition to treating patients, he has always focused on research and development within chiropractic and musculoskeletal (MSK) disorders.”

Chiropractic is an alternative method of treatment. There is no scientific evidence for clinically relevant positive treatment outcomes. For that reason, chiropractic is not mentioned as a treatment option in the guidelines of general practitioners and medical specialists in the Netherlands. Both the profession and the education are not recognized in the Netherlands. On the website of the NVAO (Dutch-Flemish Academic Organization, www.nvao.net), chiropractic does not appear as an accredited program. There is now plenty of research, especially case reports, on the damage that treatment by a chiropractor can cause, such as cerebral infarctions due to arterial dissection of carotid arteries due to cracking of the neck by chiropractors.

On June 20, 2008, the website of Medisch Contact (magazine of KNMG, Dutch Society of Medical Doctors) stated: “First Dutch chiropractor gets his PhD: Sidney Rubinstein will be the first chiropractor in the Netherlands to obtain a PhD today. Rubinstein states that most of the side effects of chiropractic are harmless and temporary.”

This dissertation, for which Sidney Rubinstein obtained his doctorate at VU Amsterdam, was substandard and was criticized in a letter sent to the same journal. The subsequent correspondence with, among others, the supervisor can be read here. In short, a dissertation that VU Amsterdam cannot be proud of.

The Cochrane database contains two reviews published by Rubinstein on chiropractic, or Spinal Manipulative Therapy (SMT) for acute and chronic back pain, respectively. The conclusion was the same in both cases: In summary, SMT appears to be no better or worse than other existing therapies for patients with acute/chronic low‐back pain. In a 2013 update (Spinal manipulative therapy for acute low back pain: an update of the Cochrane review. Spine 2013; 38(3): E158-77), Rubinstein comes to the same conclusion: SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Rubinstein himself has concluded years ago that chiropractic or SMT has no greater effect than other treatments (like standard physiotherapy), but still it needs to be researched again and again?

At the end of the news item on the NCA’s website, the truth is revealed: the NCA subsidizes half of the chair! The members of this organization (there are now more than 500 chiropractors in the Netherlands) have diligently raised the money for this chair. Since its foundation in 1896 by the grocer/magnetizer D.D. Palmer, chiropractic has had every chance to prove its usefulness, but it has not succeeded. That Rubinstein can change that situation is, of course, extremely unlikely.

This appointment is therefore in fact a political publicity stunt for a still pointless alternative treatment. It will do both the practice of Sidney Rubinstein and that of other chiropractors a lot of good that there is now a professor of chiropractic in the Netherlands.

The other half of the chair is paid for by the university. This means that public money that could have been better spent is now going to be wasted on research into an alternative treatment that we already know is useless, by a researcher who has already shown that there is no added value of treatment by a chiropractor.

A substandard dissertation and a purchased chair, but Sidney Rubinstein can call himself a professor. With the appointment of chiropractor Sidney Rubinstein as endowed professor at VU Amsterdam, the university is jeopardizing its good name and contributing to the unjustified elevation of Sidney Rubenstein’s status and his pointless method of treatment, chiropractic.
Can this appointment really be reconciled with the scientific norms and values that VU Amsterdam wants to uphold?

This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.

The authors selected from a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics) 18–63 years old malignant breast cancer survivors who were experiencing pain and were ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.

Among 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.

The authors concluded that, although adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.

Oh, dear!

Which institutions support such nonsense?

  • School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA.
  • School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA.
  • College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
  • Integrative Medicine Program, Departments of Supportive Care Medicine and Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
  • School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA. [email protected].
  • School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA. [email protected].

And which journal is not ashamed to publish it?

It’s the BMC Med!

The conclusion is, of course, quite wrong.

Please let me try to formulate one that comes closer to what the study actually shows:

This study failed to show that a ‘real world impact’ of acupuncture exists. Since the authors were dissatisfied with a negative result, subsequent data dredging was undertaken until some findings emerged that were in line with their expectations. Sadly, no responsible scienctist will take this paper seriously.

Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:

Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.

The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.

Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture

  • relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
  • improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
  • improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).

There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).

The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.

What should we make of this paper?

In case you are in a hurry: NOT A LOT!

In case you need more, here are a few points:

  • many trials were of poor quality;
  • there was evidence of publication bias;
  • there was considerable heterogeneity within the studies.

The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.

Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.

Dishonest researchers?

Biased reviewers?

Incompetent editors?

Truly unbelievable!!!

In consideration of these points, let me rephrase the conclusions:

The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.

PS

I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!

_________________________

Now – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:

BMJ Open has retracted this article.1 After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.

I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:

WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?

Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.

  • Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
  • Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
  • Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
  • Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
  • Editors who repeatedly make such mistakes should be dismissed.

I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!

The aim of this article was to review the use of homeopathy in rheumatic diseases (RDs). PubMed and Embase databases were examined for literature on homeopathy and RDs between 1966 and April 2023. 15 articles were included.

The diseases treated were

  • osteoarthritis (n=3),
  • rheumatoid arthritis (n=3),
  • ankylosing spondylitis (n=1),
  • hyperuricemia (n=1),
  • tendinopathy (n=1).

The age of the patients varied from 31 to 87 years, and male gender ranged from 56.7% to 100%. The homeopathic treatments varied from a fixed medicine to an individualized homeopathy.

Most studies (9/15) demonstrated improvements after homeopathy. Side effects were not seen or minimal and were comparable to those of the placebo groups.

The authors concluded that this review shows homeopathy is a promising and safe therapy for RD treatment. However, the data needs to be reproduced in future more extensive studies, including other rheumatic conditions.

This paper amounts to an insult of its readership!

Not only is it badly written but also [and more importantly] it is missing almost everything that makes a systematic review. Despite this the authors claim that it “adhered to PRISMA standards”. This is certainly not true.

Amongst the missing items, the most important ones are probably the evaluation of the methodological quality of the inclued primary studies as well as a critical assessment of the evidence. The authors concede that their paper has limitations: “the number of participants was low. Second, a few RDs were evaluated: osteoarthritis, rheumatoid arthritis, fibromyalgia, hyperuricemia, ankylosing spondylitis, and
tendinopathy.”

When reading this, I asked myself: are they clueless or dishonest?

In my view, the authors (from Brasil and Israel) and peer-reviewers of this paper should be ashamed of such shoddy work and the editors of the journal publishing this nonsense should withdraw the paper asap.

 

Chiropractic is a complementary medicine that has been growing increasingly in different countries over recent decades. It addresses the prevention, diagnosis and treatment of the neuromusculoskeletal system disorders and their effects on the whole body health.

This review aimed to evaluate the effectiveness of chiropractic in the treatment of different diseases. To gather data, scientific electronic databases, such as Cochrane, Medline, Google Scholar, and Scirus were searched and all systematic reviews in the field of chiropractic were obtained. Reviews were included if they were specifically concerned with the effectiveness of chiropractic treatment, included evidence from at least one clinical trial, included randomized studies and focused on a specific disease. The articles were excluded if:

  • – they were concerned with a combination of chiropractic and other treatments (not specifically chiropractic treatment);
  • – they lacked at least one clinical trial;
  • – they lacked at least one randomized study;
  • – and they studied chiropractic in the treatment of multiple diseases.

The research data including the article’s first author’s name, type of disease, intervention type, number and types of research used, meta-analysis, number of participants, and overall results of the study, were extracted, studied and analyzed.

Totally, 23 chiropractic systematic reviews were found, and 11 articles met the defined criteria. The results showed the influence of chiropractic on improvement of neck pain, shoulder and neck trigger points, and sport injuries. In the cases of asthma, infant colic, autism spectrum disorder, gastrointestinal problems, fibromyalgia, back pain and carpal tunnel syndrome, there was no conclusive scientific evidence. There is heterogeneity in some of the studies and also limited number of clinical trials in the assessed systematic reviews. Thus, conducting comprehensive studies based on more reliable study designs are highly recommended.

The authors stressed that three points should be emphasized. Firstly, there is a discrepancy between the development of chiropractic in different countries of the world and the quality and quantity of studies regarding the effectiveness and safety of chiropractic in treatment of diseases. Secondly, some of the systematic reviews regarding the effectiveness of chiropractic in treatment of diseases had a minimum quality of research methodology and were not useful for evaluation. Some of the excluded articles are examples of this problem. Finally, a limited number of studies (11 systematic review articles and 10 diseases) had the required criteria and were assessed in the study.

Assessment and analysis of the studies showed the impact of chiropractic on improvement of some upper extremity conditions including shoulder and neck trigger points, neck pain and sport injuries. In the case of asthma, infant colic and other studied diseases, further clinical trials with larger sample sizes and high quality research methodology are recommended.

So, is chiroprctic of proven effectiveness for any disease?

The conditions for which there is tentatively positive evidence (btw: most rely on my research!!!) are arguably not diseases but symptoms of undelying conditions. Therefore, the answer to my question above is:

NO.

This prospective, community-based, active surveillance study aimed to report the incidence of moderate, severe, and serious adverse events (AEs) after chiropractic (n = 100) / physiotherapist (n = 50) visit in offices throughout North America between October-2015 and December-2017.

Three content-validated questionnaires were used to collect AE information: two completed by the patient (pre-treatment [T0] and 2-7 days post-treatment [T2]) and one completed by the provider immediately post-treatment [T1]. Any new or worsened symptom was considered an AE and further classified as mild, moderate, severe or serious.

From the 42 participating providers (31 chiropractors; 11 physiotherapists), 3819 patient visits had complete T0 and T1 assessments. The patients were on average 50±18 years of age and 62.5% females. Neck/back pain was the most common presenting condition (70.0%) with 24.3% of patients reporting no condition/preventative care.

From the patients visits with a complete T2 assessment (n = 2136 patient visits, 55.9%), 21.3% reported an AE, of which:

  • 7.9% were mild,
  • 6.2% moderate,
  • 3.7% severe,
  • 1.5% serious,
  • 2.0% had missing severity rating.

The most common symptoms reported with moderate or higher severity were:

  • discomfort/pain,
  • stiffness,
  • difficulty walking,
  • headache.

 

The authors concluded that this study provides valuable information for patients and providers regarding incidence and severity of AEs following patient visits in multiple community-based professions. These findings can be used to inform patients of what AEs may occur and future research opportunities can focus on mitigating common AEs.

They also note that:

  • The incidence of AEs reported in their study was lower than the 30%-50% reported in a recent scoping review of 250 observational and experimental studies of manual treatments of the spine.
  • A similar prospective clinic-based survey collected data from 4712 encounters from Norwegian chiropractors found that 55% of these encounters had an AE.
  • A clinical trial of chiropractic care for patients with neck pain found that 30% reported an AE.
  • The Scandinavian College of Naprapathic Manual Medicine collected AE information from 767 patients and found that 51% of those who had at least 3 SMT treatments reported an AE.

The authors did not mention our systematic review:

The aim of this systematic review was to summarize the evidence about the risks of spinal manipulation. Articles were located through searching three electronic databases (MEDLINE, EMBASE, Cochrane Library), contacting experts (n =9), scanning reference lists of relevant articles, and searching departmental files. Reports in any language containing data relating to risks associated with spinal manipulation were included, irrespective of the profession of the therapist. Where available, systematic reviews were used as the basis of this article. All papers were evaluated independently by the authors. Data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

Whatever the true rate of AEs turns out to be, one thing is very clear: it is unacceptably high, particularly if we consider that the benefits of spinal manipulations are doubtful and at best small.

 This study evaluated efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis. It was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial that took place in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020.

The patients received

  • 2 g/d of krill oil (n = 130)
  • or matching placebo (n = 132) for 24 weeks.

The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks.

Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo).

The authors concluded that, among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population.

This is a rigorous and well-presented study. Apart from the ineffectiveness of krill, it confirms two issues very clearly:

  • Placebo effects plus regression to the mean can lead to symptomatic improvements.
  • Adverse effects occur even with placebo therapy.

Krill is a small crustacean consumed by whales, penguins and other sea creatures. It is a source of omega 3 fatty acids. The alleged benefits of krill supplements include anti-inflammatory effects. So, it could theoretically help reducing the inflammation that is part of knee osteoarthritis.

A review including five trials with 700 patients using krill oil for knee pain was recently published. Results showed no significant difference between krill oil and placebo for knee pain, knee stiffness, and lipid profiles. However, krill oil demonstrated a significant small effect in improving knee physical function. Trial sequential analysis provided certainty that krill oil enhances knee physical function compared to placebo and indicated no improvement in knee pain, but the findings for knee stiffness need to be confirmed by further research. The authors concluded that krill oil supplementation did not significantly improve knee pain, stiffness, or lipid profile, although it may help knee physical function. Based on these findings, krill oil supplementation is not yet justified for knee pain.

The two papers should settle the issue: KRILL IS NOT EFFECTIVE FOR KNEE OSTEOARTHRITIS. Will this stop the many manufacturers of krill supplements selling their products to gullible consumers? I would not hold my breath.

Yesterday, I was sent this OfS press release and asked to comment:

Approval of proposed new name for AECC University College UKPRN: 10000163

The Office for Students (OfS) has approved the use of the word ‘university’ in the provider’s change of name from ‘AECC University College’ to ‘Health Sciences University’.

The Higher Education and Research Act 2017 amended relevant legislation to give the OfS the power to consent to the use of the word university in a registered higher education provider’s name. In consenting to the inclusion of the word ’university’ in any name, the OfS has regard to the need to avoid names which are, or may be, confusing.1

The OfS has published guidance for registered higher education providers that wish to use either ‘university’ or ‘university college’ title as part of their name. This states that we will consult on a provider’s proposed new name and assess the extent to which the proposed name is, or may be, confusing or misleading.2

AECC University College applied to the OfS for approval to use the word university in its proposed new name ‘Health Sciences University’ in June 2023. We consulted on the provider’s proposed new name and received 98 responses.3 Considering the responses:

• We took the view that the provider’s proposed new name did not appear to be like any other registered English higher education provider’s name because of similarity that could cause potential confusion or be misleading.

• We agreed with some consultation responses which stated that the proposed name could be potentially misleading, for the following reasons:

o Several respondents raised concerns that the proposed name implies a scope of offering that does not match the reality of the provider’s offering.

o Several respondents raised concerns that the proposed name may suggest that the provider is the sole provider of health sciences provision in the region and/or the UK. Respondents stated that the proposed name offers a broader portfolio than the provider has in reality, and therefore the name is anti-competitive, given other providers may offer a broader scope of provision in the relevant disciplines.

• We concluded, however, that issues raised by respondents during the consultation are unlikely to cause any detriment or harm as they could be mitigated by the university’s requirement to comply with its legal obligations under consumer protection law. This means that the university must ensure that students have clear information to enable them to make informed decisions about whether they want to study there. Information would include, for example, what is meant by the term ‘health sciences’ and clear and visible communication regarding the breadth and depth of courses offered.

• Therefore, we decided to approve the proposed new name of ‘Health Sciences University’.

1 See https://www.legislation.gov.uk/ukpga/2017/29/part/1/crossheading/powers-in-relation-to-university title/enacted.
2 See ‘Regulatory Advice 13: How to apply for university college or university title’ available at:
www.officeforstudents.org.uk/publications/regulatory-advice-13-how-to-apply-for-university-college-and university-title/.
3 Available at: www.officeforstudents.org.uk/publications/proposed-new-name-for-aecc-university-college/.

_________________________________

A few years ago, I was invited to visit the ‘AECC’ and give a lecture to its students. Here is the post I published about this weird experience:

As I said, yesterday, I was asked (by ‘The Times Higher’) to comment on the above press release. Here is the comment I provided; I hope they publish it:

The change from ‘AECC University College’ to ‘Health Sciences University’ is an intriguing construct emphasizing the academic status by using the term ‘university’, while hiding the true content of the institution: AECC stands for ‘Anglo-European College of Chiropractic‘; in other words, the institution is a school of chiropractic, a form of treatment that is as far from science as bungee jumping and has never convincingly demonstrated to generate more good than harm. I wonder what might be next – a ‘Health Science University for Pole Dancing’ perhaps?

Subsequently, the journalist came back to me with two further questions which I answered:

Q1: Do you think it is concerning that the OfS has allowed it to use this title?

A: This title will almost inevitably mislead consumers who might assume that, if they are granted university status, chiropractic must be backed by strong evidence for efficacy and safety.

Q2: What do you worry will be the consequences?

A: Patients who are misled in this way are in danger of wasting their money, of delaying their recovery, or of suffering significant harm.

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