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

back pain

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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!!!

Spanish colleagues and I just published an article entitled “Is Osteopathic Manipulative Treatment Clinically Superior to Sham or Placebo for Patients with Neck or Low-Back Pain? A Systematic Review with Meta-Analysis”. Here is its abstract:

The aim of this systematic review and meta-analysis was to compare whether osteopathic manipulative treatment (OMT) for somatic dysfunctions was more effective than sham or placebo interventions in improving pain intensity, disability, and quality of life for patients with neck pain (NP) or low-back pain (LBP). Methods: A systematic review and meta-analysis was carried out. Searches were conducted in PubMed, Physiotherapy Evidence Database, Cochrane Library, and Web of Science from inception to September 2024. Studies applying a pragmatic intervention based on the diagnosis of somatic dysfunctions in patients with NP or LBP were included. The methodological quality was assessed with the PEDro scale. The quantitative synthesis was performed using random-effect meta-analysis calculating the standardized mean difference (SMD) with RevMan 5.4. The certainty of evidence was evaluated using GRADEPro. Results: Nine studies were included in the qualitative synthesis, and most of them showed no superior effect of OMTs compared to sham or placebo in any clinical outcome. The quantitative synthesis reported no statistically significant differences for pain intensity (SMD = −0.15; −0.38, 0.08; seven studies; 1173 patients) or disability (SMD = −0.09; −0.25, 0.08; six studies; 1153 patients). The certainty of evidence was downgraded to moderate, low, or very low. Conclusions: The findings of this study reveal that OMT is not superior to sham or placebo for improving pain, disability, and quality of life in patients with NP or LBP.

As always, it seems important to stress that our review has several limitations. Firstly, the searches were conducted in the most relevant databases; however, some studies not indexed in these sources may have been missed. Secondly, the diverse NP and LBP diagnosis, as well as the lack of data reported by some studies, complicates the interpretation of the results and may weaken our conclusion. Thirdly, the primary studies pragmatically applied interventions based on diagnoses of various somatic dysfunctions, resulting in a high degree of heterogeneity among the treatments applied.

Despite these limitations, it is fair to say, I think, that OMT is not nearlly as solidly supported by reliable evidence as most osteopaths try to make us believe. In essence, this means that, if you suffer from NP or LBP, you best concult a proper doctor or physiotherapist.

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.

Cauda equina syndrome (CES) is a lumbosacral surgical emergency that has been associated with chiropractic spinal manipulation (CSM) in numerous case reports. However, identifying if there is a potential causal effect is complicated by the heightened incidence of CES among those with low back pain (LBP). This study‘s hypothesis was that there would be no increase in the risk of CES in adults with LBP following CSM compared to a propensity-matched cohort following physical therapy (PT) evaluation without spinal manipulation over a three-month follow-up period.

A query of a United States network (TriNetX, Inc.) was conducted, searching health records of more than 107 million patients attending academic health centers, yielding data ranging from 20 years prior to the search date (July 30, 2023). Patients aged 18 or older with LBP were included, excluding those with pre-existing CES, incontinence, or serious pathology that may cause CES. Patients were divided into two cohorts:

  • (1) LBP patients receiving CSM,
  • (2) LBP patients receiving PT evaluation without spinal manipulation.

Propensity score matching controlled for confounding variables associated with CES.

67,220 patients per cohort (mean age 51 years) remained after propensity matching. CES incidence was 0.07% (95% confidence intervals [CI]: 0.05–0.09%) in the CSM cohort compared to 0.11% (95% CI: 0.09–0.14%) in the PT evaluation cohort, yielding a risk ratio and 95% CI of 0.60 (0.42–0.86; p = .0052). Both cohorts showed a higher rate of CES during the first two weeks of follow-up.

The authors concluded that the present study involving over 130,000 propensity-matched patients found that CSM is not a risk factor for CES. The incidence of CES in both CSM and PT evaluation cohorts aligns with previous estimates of CES incidence among patients with LBP, indicating a heightened risk of CES compared to asymptomatic individuals regardless of intervention. Moreover, these findings underscore the increased CES incidence within the first two weeks after either CSM or PT evaluation, emphasizing the need for clinicians’ vigilance in identifying and emergently referring patients with CES for surgical evaluation. Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.

This is an interesting and well-reported investigation. Its particular strength is the huge sample size. Its weakness, on the other hand, is the fact that, despite the researchers best efforts, the two groups might not have been entirely comparable and that there could be a host of relevant factors that the propensity matching was unable to control for.

It is, I think, to the credit of the authors that they abstain from overrating their results and correctly emphasize in their conclusions that: Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.

“Is Chiropractic Worth the Taxpayer’s Expense?” is the interesting question asked in this article by Ikenna Idika Ogbu from the Department of Neurosurgery, University Hospitals of North Midlands, UK and Chandrasekaran Kaliaperumal from the Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, UK. Here is the abstract:

Chiropractic remains a service provided outside the NHS in the United Kingdom and the argument for inclusion has been ongoing since the 90’s. There are significant patient-reported benefits from chiropractic backed by evidence in specific use-cases as cervicogenic headaches and there are significant potential cost-savings from the inclusion of chiropractic as an NHS service. The evidence, however, does not particularly favour the use case of chiropractic, especially in the context of Low Back Pain (LBP) and the benefits of chiropractic are unclear. Considering the potential cost-savings for the NHS and the society, there should be consideration for its inclusion. However, the evidence will need to be clearer to argue for inclusion of chiropractic in the NHS spectrum of services, especially for spinal services.

So, the authors confirm that, even for back pain, “the benefits of chiropractic are unclear”, and in the next sentence they advocate “consideration for its inclusion.”

Does that make sense?

No!

Let’s be clear: the least expensive way to proceed in the short term is usually to do nothing. No treatment is invariably less expensive than treatment! Yet, this logic obviously does not account for the two most important factors in this equation: risk and benefit.

  • Not treating a condition can cause prolonged, needless suffering.
  • Not treating a condition can cause significant follow-up costs.
  • Treating it can cause adverse effects and additional suffering.
  • Adverse effects can cause significant follow-up costs.
  • Treating the condition effectively will result in less suffering.
  • Treating the condition effectively will result in less follow-up costs.

It follows that we should treat health problems:

  1. effectively,
  2. with few risks of side-effects,
  3. as cheaply as possible.

It also follows that costs are by no means the only factor in this complex equation. Cost-effectiveness without effectiveness is not possible. Moreover, cost-effectiveness withoout an acceptable degree of safety is unlikely.

In the case of chiropractic, we have hardly reliable proof of effectiveness or safety. And this means that, before we can consider chiropractic to be paid for from public money, we first need solid evidence for its safey and efficacy – each for the relevant health problem to be treated. Once we have reliable data about all this – AND ONLY THEN – might we consider including chiropractic into the public healthcare budget.

In other words, the above cited paper is naive and ill-informed to the extreme.

 

 

Several years ago, I reported on the range of conditions which, according to homeopaths, “respond best to homeopathic treatment” (basically any condition imaginable). To remind you, here is the list again:

ENT and bronchial problems

  • Ear infections,
  • rhinitis,
  • sinusitis,
  • pharyngitis,
  • tonsillitis,
  • tracheitis,
  • bronchitis,
  • asthma.

Digestive problems

  • Stomach complaints
  • acidity,
  • heartburn,
  • fullness,
  • poor digestion,
  • flatulence,
  • duodenal ulcer,
  • diarrhoea,
  • constipation,
  • nausea,
  • vomiting,
  • canker sores.

Cardiovascular problems

Osteoarticular complaints

All types of muscle and/or joint pain due to arthrosis or arthritis:

  • neck pain,
  • shoulder pain,
  • elbow pain,
  • wrist pain,
  • Back pain,
  • sciatica,
  • knee pain,
  • ankle pain,
  • Sprains,
  • contractures etc.

Traumas

Urological disorders

Gynaecological problems

Dermatological problems

  • Eczema, hives,
  • Acne vulgaris, acne rosacea,
  • Recurrent boils, verucas, plantar warts,
  • Molluscum contagiosum,
  • Herpes simple and zoster
  • Psoriasis

Neurological disorders

  • Headaches and migraines.
  • Eye problems
  • Conjunctivitis,
  • blepharitis,
  • styes, dacryocistitis,
  • uveitis.

Behavioural and psychiatric disorders

  • Anxiety,
  • depression,
  • stress,
  • mental fatigue,
  • Pediatric problems,
  • Ear infections,
  • tonsillitis,
  • bronchitis,
  • asthma,
  • diarrhoea,
  • vomiting,
  • skin complaints,
  • canker sores,
  • teething problems,
  • sleep disorders,
  • educational attainment issues,
  • behavioural issues.

Endocrine disorders

  • Obesity,
  • hypothyroidism,
  • hyperthyroidism,
  • Depleted immune defences,
  • Recurrent infections affecting the throat,
  • sinuses, nose, ears,
  • connective tissue, larynx,
  • bronchial tubes,
  • lungs,
  • skin,
  • bladder etc.

Palliative care

For the treatment of the diverse symptoms that appear over the course of the illness. Homeopathy can improve the patient’s general wellbeing and counteract the side effects of other treatments.

These are just a few examples, but the list could be endless – it is important to stress that homeopathy is very effective in pathologies that are difficult to establish or those with contradictory or paradoxical symptoms.

In recurrent illnesses, homeopathic medicines can boost the defences and help to regulate the sufferer’s body in order to prevent further relapses.

Homeopathy is an excellent preventive medicine.

_______________________

You will notice that SCIATICA is on the list.

Would they really be as daft as to use homeopathy for sciatica?

Not only that, they would even conduct a study on the subject. Here is this recently published trial:

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings.

So, homeopathy does not work for sciatica.

Surprise, surprise!

Why not?

Simple: because homeopathy does not work for any condition.

This study aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.

WalkBack was a two-armed, randomised clinical trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)

Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group).

The authors concluded that an individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.

Rigorous clinical trials of excercise therapy are difficult to conceive and conduct because of a range of methodological issues. For instance, there is no obvious placebo and thus it is hardly possible to control for placebo effects. Nonetheless, the benefits of exercise therapy for back pain is undoubted. As previously discussed on this blog, a recent systematic review concluded that “the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance.”

I have always been convinced of the health benefits of excercise. In fact, 40 years ago, when I did my inaugural lecture at the University of Munich (LMU), excercise was its topic and I concluded that, if exercise were a pharmaceutical product, it would out-sell any drug. The new study only confirms my view. It adds to our knowledge by suggesting that exercise also reduces the risk of recurrences.

Forget about spinal manipulation, acupuncture, etc., despite the undeniable weaknesses in the evidence, exercise is by far the most promissing treatment for back pain

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