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

pain

This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.

A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.

The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.

As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:

  • regression towards the mean;
  • natural history of the condition;
  • success of patient blinding;
  • social desirability.

To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.

In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.

The ‘University College of Osteopathy’ announced a proposal to merge with the AECC University College (AECC UC).  Both institutions will seek to bring together the two specialist providers to offer a “unique inter-disciplinary environment for education, clinical practice and research in osteopathy, chiropractic, and across a wide range of allied health and related disciplines”.

The partnership is allegedly set to unlock significant opportunities for growth and development by bringing together the two specialist institutions’ expertise and resources across two locations – in Dorset and central London.

As a joint statement, Chair of the Board of Governors at AECC UC, Jeni Bremner and Chair of the Board of Governors at UCO, Professor Jo Price commented:

“We believe the proposed merger would further the institutional ambitions for both of our organisations and the related professional groups, by allowing us to expand our educational offering, grow student numbers and provide a unique inter-disciplinary training environment, providing students the opportunity to be immersed in multi-professional practice and research, with exposure to and participation in multi-disciplinary teams.

“There is also an exciting and compelling opportunity to expedite the development of a nationally unique, and internationally-leading MSK Centre of Excellence for Education and Research, developed and delivered across our two sites.”

The announcement is accompanied by further uncritical and promotional language:

Established as the first chiropractic training provider in Europe, AECC UC has been at the forefront of evidence-based chiropractic education, practice and research for more than 50 years. The institution is on an exciting journey of growth and development, having expanded and diversified its academic portfolio and activity beyond its traditional core offering of chiropractic across a broad range of allied health courses and apprenticeships, working closely with NHS, local authority and other system partners across Dorset and the south-west. The proposed merger with UCO would allow AECC UC to enhance the breadth and depth of its offer to support the expansion and development of the health and care workforce across a wider range of partners.

Now in its 106th year, UCO is one of the UK’s leading providers of osteopathic education and research with an established reputation for creating highly-skilled, evidence-informed graduates. UCO research is recognised as world-leading, delivering value to the osteopathic and wider health care community.

Sharon Potter, Acting Vice-Chancellor of UCO, said:

“As an institution that has long been at the forefront of osteopathic education and research, we are committed to ensuring further growth and development of the osteopathic profession.

“UCO has been proactively considering options to future-proof the institution. Following a review of strategic options, UCO is delighted by the proposed merger, working closely with AECC UC to ensure that UCO and osteopathy thrives as part of the inter-professional health sciences landscape, both academically and clinically. There is significant congruence between UCO and AECC UC in our strong aligned values, commitment to and delivery of excellent osteopathic education, clinical care and research, and opinion leadership.

“AECC UC has a strong track record of respecting the differences in professions, evidenced by the autonomy across the 10 different professional groups supported by the institution. The merger will not only mean we are protecting UCO through preserving its osteopathic heritage and creating a sustainable future, but that our staff and students can collaborate with other professional groups such as physiotherapy, chiropractic, sport rehabilitation, podiatry and diagnostic imaging, in a multidisciplinary MSK and rehabilitation environment unlike anywhere else in the UK.”

Professor Lesley Haig, Vice-Chancellor of AECC UC, commented:

“Preserving the heritage of UCO and safeguarding its future status as the flagship osteopathy training provider in the UK will be critical, just as it has been to protect the chiropractic heritage of the AECC brand. UCO is seen as synonymous with, and reflective of, the success of the osteopathy profession and we fully recognise and respect the important role that UCO plays not only as a sector-leading provider of osteopathic education, research and clinical care, but as the UK’s flagship osteopathy educational provider.

“Overall it is clear that UCO and AECC UC already have a common values base, similar understanding of approaches to academic and clinical delivery, and positive relationships upon which a future organisational structure and opportunities can be developed. It’s an exciting time for both institutions as we move forward in partnership to create something unique and become recognised nationally and internationally as a centre of excellence.”

The proposed merger would continue the already founded positive relations between the institutions, where regular visits, sharing of good practice, and collaborative research work are already taking place. Heads of terms for the potential merger have now been agreed and both institutions are entering into the next phase of discussions, which will include wide consultation with staff, students and other stakeholders to produce a comprehensive implementation plan.

__________________________________

In case this bonanza of platitudes and half-truths has not yet overwhelmed you,  I might be so bold as to ask 10 critical questions:

  1. What is an “evidence-based chiropractic education”? Does it include the messages that 1) subluxation is nonsense, 2) chiropractic manipulations can cause harm, 3) there is little evidence that they do more good than harm?
  2. How  an an “expansion and development of the health and care workforce” be anticipated on the basis of the 3 points I just made?
  3. What does the term “evidence-informed graduates” mean? Does it mean they are informed that you teach them nonsense but instruct them to practice this nonsense anyway?
  4. Do “options to future-proof the institution” include the continuation of misleading the public about the value of chiropractic/osteopathy?
  5. Does the”delivery of excellent osteopathic education, clinical care and research, and opinion leadership” account for the fact that the evidence for osteopathy is weak at best and for most conditions negative?
  6. By “preserving its osteopathic heritage”, do you intend to preserve also the reputation of your founding father, Andrew Taylor Still, who did many dubious things. In 1874, for instance, he was excommunicated by the Methodist Church because of his “laying on of hands”; specifically, he was accused of trying to emulate Jesus Christ, labelled an agent of the Devil, and condemned as practicing voodoo. Or do you prefer to white-wash the osteopathic heritage?
  7. You also want “to protect the chiropractic heritage”; does that mean you aim at white-washing the juicy biography of the charlatan who created chiropractic, DD Palmer, as well?
  8. “UCO and AECC UC already have a common values base” – what are they? As far as I can see, they mainly consist in hiding the truth about the uselessness of your activities from the public.
  9. How do you want to “recognised nationally and internationally as a centre of excellence”? Might it be a good idea to begin by critically assessing your interventions and ask whether they do more good than harm?
  10. Crucially, what is really behing the merger that you are trying to sell us with such concentrated BS?

This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.

PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.

The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.

The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.

I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?

Let’s look at the facts related to this review:

  • Craniosacral therapy (CST) is utterly implausible.
  • Only 4 RCTs were found.
  • They were of poor quality.
  • They were published mostly by people who want to promote CST.
  • Therefore the overall statistically significant effect is most likely a false-positive result.
  • This means that the conclusion should be much more straight forward.

I suggest something along the following lines:

A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.

 

Charles III is about to pay his first visit to France, his second visit to any state. Earlier this year, he has already visited Germany. Originally, France had been first on his list but the event was cancelled in view of the violent protests that rocked the country at the time. Now he is definitely expected and the French are exited. I am currently in France and have been asked to give several interviews on the king’s love affair with so-called alternative medicine (SCAM).

The French have long been fascinated by our royal family which seems a bit odd considering what they did to their own. Now that Charles and Camilla are about to appear with an entourage of about 50 servants between them, the press is full with slightly bemused reports and comments:

Since childhood, Charles has been accustomed to a luxurious, gilded life, which is reproduced on every trip outside the royal palaces, to ensure maximum service, comfort and security… The new king always travels with his private secretary, Sir Clive Alderton, his press advisor, his steward, his doctor, his personal valets, his security guards, and his private chauffeur, Tim Williams… And, of course, his regular osteopath to relieve his lower back. Since he’s had a lot of falls playing polo, Charles regularly suffers from back pain…”.

Really, just an osteopath?

What about all the other SCAM-practitioners whose businesses Charles so regularly supported in the past:

  • · Acupuncture
  • · Aromatherapy
  • · Ayurveda
  • · Chiropractic
  • · Detox
  • · Gerson therapy
  • · Herbal medicine
  • · Homeopathy
  • · Iridology
  • · Marma massage
  • · Massage therapy
  • · Pulse diagnosis
  • · Reflexology
  • · Tongue diagnosis
  • · Traditional Chinese Medicine
  • · Yoga

Will they not be disappointed?

I do wonder who Charles’ osteopath and doctor are. Are they competent? I am sure they both must be well-informed and evidence-based experts. If that is the case, they will have, of course, told Charles that osteopathy is hardly an optimal solution for an injured back.

In any case, now I am concerned about the royal back and therefore urgently recommend that HIS MAJESTY reads some of my previous posts on the subject, e.g.:

Let’s hope all goes well here in France, and please let’s not be so akward as to ask about the environmental aspects – we all know how worried Charles truly is about not just his health but also the health of the planet – of moving such an entourage for a two-day visit.

PS

Charles flew in a private jet from London to Paris and took his Bentley with him.

This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.

The interventions were:

  • curcumin alone (C),
  • omeprazole alone (O),
  • curcumin plus omeprazole (C+O).

Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.

Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.

A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.

The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.

This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:

This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.

Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.

The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.

However, I am far less impressed.

Why?

Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:

We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.

Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.

PS

Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.

This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).

In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.

CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.

The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.

To understand this  study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:

Movement system impairment-based treatment

The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].

Cognitive functional therapy

Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages: [1] making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs [2] exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and [3] lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.

I must admit that I am not fully convinced.

Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show  CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.

My conclusion:

we need not just more but better evidence.

This study aimed to compare the effectiveness of three distinct interventions – Yoga, Naturopathy, and Conventional medical management – in alleviating pain, reducing disability, enhancing spinal mobility, and improving the quality of life in individuals with low back pain. Ninety participants were recruited and randomly divided into three groups.

  • The first group (group 1) received Yoga,
  • the second group (group 2) received Naturopathy treatments,
  • the third group served as the control and received conventional medications.

Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI), Flexion Test-Finger to Floor Test (FTFT) results, and Quality of Life (QOL) were assessed at baseline and after a 10-day intervention period for all groups.

Overall comparisons between the groups, utilizing ANOVA, revealed marked differences in pain severity, disability index, daily functional capacity, and Quality of Life (QoL) improvements following respective interventions. Substantial improvements were also noted within the yoga and naturopathic medicine groups across multiple variables.

The authors concluded that the results of this comparative analysis emphasize the effectiveness of Yoga, Naturopathy, and Conventional Medical Treatment in managing low back pain. All three interventions demonstrated significant improvements in pain intensity, disability, spinal mobility, and quality of life. This study contributes valuable insights into the diverse therapeutic approaches for low back pain management, highlighting the potential of holistic and alternative treatments to enhance patients’ well-being.

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This is a remarkably poor study. Its flaws are too numerous to account for them all here. Let me focus on just a three that stand out.

  1. All we learn about the 3 treatment regimen is this (and it clearly not enough to do an independent replication of this trial):

Yoga Group:

Participants in the Yoga Group underwent a specifically designed integrated approach of Yoga therapy (IAYT) for back pain, incorporating relaxation techniques, spinal movements, breathing exercises, pranayama, and deep relaxation techniques. The intervention was conducted by qualified yoga instructors at SDM College of Naturopathy and Yogic Sciences.

Naturopathy Group:

Participants in the Naturopathy Group received neutral spinal baths and partial massages. The spinal bath was administered at Government Yoga & Nature Cure Out Patient Center, Puttur, and massages were performed by trained naturopathy therapists.

Conventional Medicine Group:

Participants in the Conventional Medicine Group received standard medical treatments for low back pain as recommended by orthopedic physicians from S.D.M Medical College, Dharward

  1. As an equivalence trial, the sample size of this study is far too small. This means that its findings are most likely caused by coincidence and not by the interventions applied.
  2. There was no attempt of blinding the patients. Therefore, the results – if they were otherwise trustworthy – would be dominated by expectations and not by the effects of the treatments.

Altogether, this study is, I think, a good example for the fact that

poor research often is worse than no research at all.

The case of a 91-year old male patient developing acute neuropathic pain along the sciatic nerve distribution following spinal manipulation has been reported. Manipulative treatment with an Activator Adjusting Instrument (AAI) had been performed. During this treatment, three applications of the AAI were administered. The applications were bilateral (1) over the sacroiliac joint, (2) gluteal area, and (3) paraspinal region just above the iliac crest.

Within 24 hours, the patient developed severe 10/10 pain originating from the left gluteal area at the site of one of the activator deployments with radiation all the way down his left leg to the foot. He was able to maintain distal left leg strength and sensation. Subsequently, the patient developed insomnia, confusion, and adrenal gland dysfunction in response to changes in steroids, gabapentin, and other drugs, thus highlighting some nuances of managing elderly patients with back pain.

Relief was achieved with subsequent physical therapy techniques aimed at relaxing the patient’s deep gluteal muscles, raising the hypothesis of temporary injury to the deep gluteal muscles, with painful contractions resulting in gluteal region pain as well as sciatic nerve inflammation as the nerve passed through that region.

The authors concluded that this clinical case illustrates some of the perils and risks of spinal manipulation, particularly in the elderly, and the need for careful patient selection.

The authors of this (stranely incomplete) case report discuss whether any manipulation was truly necessary or indicated as part of his initial chiropractic treatment plan. They state that, given that complications associated with similar practices are not often reported in the literature, this case highlights important considerations to be made in the elderly given the potential impact of transient/permanent neuropathic pain in that population subset.

Somehow, I doubt that we can be certain that the patient improved due to the physical therapy and not due to the drugs he received. Moreover, I question the authors’ repeated assertions that such adverse effects of chiropractic spinal manipulation are truly rare. Here is a section from our own 2002 systematic review of the subject:

A systematic review of five prospective investigations of the risks of spinal manipulation concluded that mild-to moderate transient adverse reactions occur in approximately half of patients who undergo spinal manipulation. The largest of these studies involved 1058 patients who received a total of 4712 treatments from 102 chiropractors in Norway. At least one adverse reaction was reported by 55% (n 580) of patients. About one quarter (n 1174) of treatments resulted in at least one adverse reaction. The most common reaction reported was local discomfort. Eighty-five percent (n 824) of reactions were described as “mild or moderate” and 1% (n 14) as “unbearable.” Seventy-four percent (n 1052) of reactions disappeared within 24 hours. No serious, permanent complications of spinal manipulation were reported, but follow-up was not described. These results were confirmed by a similar study in Sweden with 625 patients and a smaller one (68 patients) from the United Kingdom …

Non-life-threatening adverse effects after spinal manipulations are not rare – they are merely rarely reported!

Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.

A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.

Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.

The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.

Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. Image result for systematic review, cartoon

How can this be?

Systematic reviews are supposed to generate reliable evidence!

How can we explain the contradiction?

There are several differences between the two papers:

  • One was published in a SCAM journal and the other one in a mainstream medical journal.
  • One was authored by Chinese researchers, the other one by an international team.
  • One included 17, the other one 23 RCTs.
  • One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.

The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:

  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].

What lesson can we learn from this confusion?

Perhaps that Tuina is effective for neck pain?

No!

What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.

What we do learn – yet again – is that

  1. Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
  2. Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.

 

This systematic review with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.Image result for death by neck manipulation

RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.

A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).

The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.

Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:

Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.

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