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

back pain

This study allegedly evaluated the efficacy of osteopathic manipulative therapy (OMT) compared to that of the Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) for patients with chronic LBP.

It included 68 participants of both genders, aged 30 to 60, with chronic LBP. Participants were randomly assigned to one of two parallel groups, each with 34 members. The OMT group received, as a direct technique, a high-velocity/low-amplitude (HVLA) impulse, and as indirect techniques, strain counterstrain (SCS), myofascial release (MFR), and visceral mobilization therapy (VMT). The KEOMT group received lumbar segmental traction and lumbar segmental mobilization-flexion and gliding therapy grade 3. The participants in both groups received 10 treatments, two per week for five weeks. The primary outcome was pain severity, using a numeric pain rating scale (NPRS). The secondary outcome was the measurement of functional disability, using the Oswestry Disability Index (ODI).

The OMT and KEOMT both decreased pain and disability; however, the changes on the NPRS and ODI postintervention were statistically greater for the OMT group compared to the KEOMT group (P < .05).

The authors concluded that the OMT was better at reducing pain and improving quality of life. It reduced functional disability more than KEOMT in patients with chronic LBP.

The Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) concept is a treatment and training system based upon a comprehensive biomechanical evaluation of the arthro-neuro-muscular system and an individual’s functional abilities. This system of diagnosis and patient management applies to both patients with acute, subacute and chronic conditions of the spine and extremities and to athletes seeking to improve performance. It offers a reliable and practical approach that focuses on optimal physical health and function.

Has the KEOMT concept been tested and shown to be effective for LBP?

No!

So, what we have here is an equivalence trial of two manual techniques. As such it is FAR too small to yield a meaningful result. If the findings were meaningful, would they show that OMT is effective?

No!

As we have no proof that KEOMT does not impede recovery from LBP, the result could merely be due to the fact that OMT does not influence the natural history of LBP, while KEOMT has a detrimental effect.

Last question: which journal publishes such rubbish?

Ahh, it’s the remarkable Alternative therapies in health and medicine. That explains a lot!

 

This trial investigated the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. It was designed as a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk, and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization.

The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations.

The authors concluded that the OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.

I have no access to the full paper (if someone can send me the paper, I would update my post accordingly), but from reading the abstract, it seems the reported findings are based on within-group changes. The whole point of having a control group is to compare verum and control. The other point of importance is that it would have been crucial to verify whether patients were able to tell the verum from the sham intervention. If patients were able to tell, they would no longer be blinded and the placebo effect would have not been accounted for. A third point of relevance might be that the study seems tiny and far too small for drawing general conclusions about the value of OVM.

_________________________

I have now seen the protocol of the paper – thanks for making it available – and might add the following points to the discussion:

  • The sham treatment consisted of  “light touches over the different parts of the abdomen, without any deep mobilization or movement. The osteopath applied her hands over the same points with the
    same duration as in OVM to give the patient the perception of being treated.” It is likely that patients in the control group could have guessed that they were sham-treated.
  • The stats issue cannot be resolved on the basis of just the protocol.
  • “To assess patients’ blinding to treatment allocation, patients are asked post treatment (six weeks after
    the start of treatment) to report which study treatment they think that they received (OVM/SOVM). The effect of their reports on outcome will be examined in explorative analysis.” As I have no

access to the results, I still do not know whether blinding was successful.

Lumbosacral Radicular Syndrome (LSRS) is a condition characterized by pain radiating in one or more dermatomes (Radicular Pain) and/or the presence of neurological impairments (Radiculopathy). So far, different reviews have investigated the effect of HVLA (high-velocity low-amplitude) spinal manipulations in LSRS. However, these studies included ‘mixed’ population samples (LBP patients with or without LSRS) and treatments other than HVLA spinal manipulations (e.g., mobilisation, soft tissue treatment, etc.). Hence, the efficacy of HVLAT in LSRS is yet to be fully understood.

This review investigated the effect and safety of HVLATs on pain, levels of disability, and health-related quality of life in LSRS, as well as any possible adverse events.

Randomized clinical trials (RCTs) published in English in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE, PEDro, and Web of Science were identified. RCTs on an adult population (18-65 years) with LSRS that compared HVLATs with other non-surgical treatments, sham spinal manipulation, or no intervention were considered. Two authors selected the studies, extracted the data, and assessed the methodological quality through the ‘Risk of Bias (RoB) Tool 2.0’ and the certainty of the evidence through the ‘GRADE tool’. A meta-analysis was performed to quantify the effect of HVLA on pain levels.

A total of 308 records were retrieved from the search strings. Only two studies met the inclusion criteria. Both studies were at high RoB. Two meta-analyses were performed for low back and leg pain levels. HVLA seemed to reduce the levels of low back (MD = -1.48; 95% CI = -2.45, -0.50) and lower limb (MD = -2.36; 95% CI = -3.28, -1.44) pain compared to other conservative treatments, at three months after treatment. However, high heterogeneity was found (I² = 0.0%, p = 0.735). Besides, their certainty of the evidence was ‘very low’. No adverse events were reported.

The authors stated that they cannot conclude whether HVLA spinal manipulations can be helpful for the treatment of LSRS or not. Future high-quality RCTs are needed to establish the actual effect of HVLA manipulation in this disease with adequate sample size and LSRS definition.

Chiropractors earn their living by applying HVLA thrusts to patients suffering from LSRS. One would therefore have assumed that the question of efficacy has been extensively researched and conclusively answered. It seems that one would have assumed wrongly!

Now that this is (yet again) in the open, I wonder whether chiropractors will, in the future, tell their patients while obtaining informed consent: “I plan to give you a treatment for which sound evidence is not available; it can also cause harm; and, of course, it will cost you – I hope you don’t mind.”

An explanatory sequential mixed methods study with three separate phases was conducted in Danish patients with lumbar radiculopathy receiving a standardized chiropractic care package (SCCP). Lumbar radiculopathy is pain and other neurological symptoms caused by the pinching of nerve roots where they leave your spinal cord in the lumbar region.

Phase one of the study was a quantitative analysis based on a survey in a prospective cohort of patients with lumbar radiculopathy in an SCCP from 2018 to 2020. Patients rated their satisfaction with the examination, information, treatment effect, and overall management of their problem on a 0–10 scale. In phase two, six semi-structured interviews conducted in 2021 were used to gain further explanatory insights into the findings from phase one. Data were analyzed using systematic text condensation. In phase three, the quantitative and qualitative data were merged in a narrative joint display to obtain a deeper understanding of the overall results.

Here I am only interested in the patients’ perception of the treatment effect. Of 303 eligible patients, 238 responded to the survey. Of these, 50% were very satisfied with the treatment effect.

The authors stated that patients in their study expected a rapid and persistent decrease in symptoms, which, unfortunately, does not match the prognosis of lumbar radiculopathy. Although the prognosis is considered good, the improvement happens gradually and often with fluctuating pain patterns, and it is not unusual to have milder symptoms for three months or longer.

So, only half of the patients who had chosen to consult chiropractors for their lumbar radiculopathy were very satisfied with the treatment results. In most patients, the symptoms decreased only gradually often with fluctuating pain patterns, and the authors comment that symptoms frequently last for three months or longer with a SCCP.

Impressive?

Might I point out that what is being described here looks to me very much like the natural history of lumbar radiculopathy? About 90% of patients with back pain caused by disc herniation see improvements within three months without therapy. Are the authors aware that their observational study is in accordance with the notion that the SCCP does nothing or very little to help patients suffering from lumbar radiculopathy?

Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualized approach that targets unhelpful pain-related cognitions, emotions, and behaviors that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects.

This study aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.

RESTORE was a randomized, three-arm, parallel-group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. The researchers recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study’s questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralized adaptive schedule to

  • usual care,
  • CFT only,
  • CFT plus biofeedback.

The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked.

Between Oct 23, 2018, and Aug 3, 2020, the researchers assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, they randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; –AU$5276 [–10 529 to –24) and –8211 (–12 923 to –3500).

The authors concluded that CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care.

This is a well-designed and well-reported study. It shows that CFT is better than usual care. The effect sizes are not huge and seem similar to many other treatments for chronic LBP, including the numerous so-called alternative medicine (SCAM) options that are available.

Faced with a situation where we have virtually dozens of therapies of similar effectiveness, what should we recommend to patients? I think this question is best and most ethically answered by accounting for two other important determinants of usefulness:

  1. risk
  2. cost.

CFT is both low in risk and cost. So is therapeutic exercise. We would therefore need a direct comparison of the two to decide which is the optimal approach.

Until we have such a study, patients might just opt for one or both of them. What seems clear, meanwhile, is this: SCAM does not offer the best solution to chronic LBP. In particular, chiropractic, osteopathy, or acupuncture – which are neither low-cost nor risk-free – are, contrary to what some try so very hard to convince us of, sensible options.

This single-blind, randomized, clinical trial was aimed at determining the long-term clinical effects of spinal manipulative therapy (SMT) or mobilization (MOB) as an adjunct to neurodynamic mobilization (NM) in the management of individuals with Lumbar Disc Herniation with Radiculopathy (DHR).

Forty participants diagnosed as having a chronic DHR (≥3 months) were randomly allocated into two groups with 20 participants each in the SMT and MOB groups.

Participants in the SMT group received high-velocity, low-amplitude manipulation, while those in the MOB group received Mulligans’ spinal mobilization with leg movement. Each treatment group also received NM as a co-intervention, administered immediately after the SMT and MOB treatment sessions. Each group received treatment twice a week for 12 weeks.

The following outcomes were measured at baseline, 6, 12, 26, and 52 weeks post-randomization; back pain, leg pain, activity limitation, sciatica bothersomeness, sciatica frequency, functional mobility, quality of life, and global effect. The primary outcomes were pain and activity limitation at 12 weeks post-randomization.

The results indicate that the MOB group improved significantly better than the SMT group in all outcomes (p < 0.05), and at all timelines (6, 12, 26, and 52 weeks post-randomization), except for sensory deficit at 52 weeks, and reflex and motor deficits at 12 and 52 weeks. These improvements were also clinically meaningful for neurodynamic testing and sensory deficits at 12 weeks, back pain intensity at 6 weeks, and for activity limitation, functional mobility, and quality of life outcomes at 6, 12, 26, and 52 weeks of follow-ups. The risk of being improved at 12 weeks post-randomization was 40% lower (RR = 0.6, CI = 0.4 to 0.9, p = 0.007) in the SMT group compared to the MOB group.

The authors concluded that this study found that individuals with DHR demonstrated better improvements when treated with MOB plus NM than when treated with SMT plus NM. These improvements were also clinically meaningful for activity limitation, functional mobility, and quality of life outcomes at long-term follow-up.

Yet again, I find it hard to resist playing the devil’s advocate: had the researchers added a third group with sham-MOB, they would have perhaps found that this group would have recovered even faster. In other words, this study might show that SMT is no good for DHR (which I find unsurprising), but it does NOT demonstrate MOB to be an effective therapy.

Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.

The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.

Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.

Acute LBP

Paracetamol

There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).

NSAIDs

There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).

Muscle relaxants and benzodiazepines

There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).

Opioids

None of the included Cochrane Reviews aimed to identify evidence for acute LBP.

Antidepressants

No evidence was identified by the included reviews for acute LBP.

Chronic LBP

Paracetamol

No evidence was identified by the included reviews for chronic LBP.

NSAIDs

There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).

Muscle relaxants and benzodiazepines

There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).

Opioids

There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).

There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).

There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).

Antidepressants

There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).

The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.

This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.

This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.

If you think that scanning through dozens of new scientific articles every week is a dry and often somewhat tedious exercise, you are probably correct. But every now and then, this task is turned into prime entertainment by some pseudoscientists trying to pretend to be scientists. Take, for instance, the latest homeopathy study by Indian researchers with no less than 9 seemingly impressive affiliations:

  • 1Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
  • 2Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, India.
  • 3Department of Homoeopathy, State Homoeopathic Dispensary, Karaila, Pratapgarh, Uttar Pradesh, India.
  • 4Department of Homoeopathy, State Homoeopathic Dispensary, Tulsipur, Shrawasti, Uttar Pradesh, India.
  • 5Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
  • 6State Homoeopathic Dispensary, Mangalbari Rural Hospital, Matiali Block, Jalpaiguri, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India.
  • 7Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India.
  • 8Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Village and Post Office: Gouripur (South), Police Station Bishnupur, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India.
  • 9Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.

Now that I have whetted your appetite, here is their study:

Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in lumbar spondylosis (LS) is unknown. In this double-blind, randomized, placebo-controlled trial, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS. It was conducted at the National Institute of Homoeopathy, West Bengal, India.

Patients were randomized to receive IHMs or placebos; standardized concomitant care was administered in both groups. The Oswestry low back pain and disability questionnaire (ODQ) was used as the primary outcome measure; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) served as secondary outcome measures. They were measured at baseline and every month for 3 months. Intention-to-treat analyses (ITT) were used to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired t-tests at different time points.

Enrolment was stopped prematurely because of time restrictions; 55 patients had been randomized (verum: 28; control: 27); 49 could be analyzed by ITT (verum: 26; control: 23).

The results are as follows:

  • Inter-group differences in ODQ (F 1, 47 = 0.001, p = 0.977), RMQ (F 1, 47 = 0.190, p = 0.665) and SF-MPQ total score (F 1, 47 = 3.183, p = 0.081) at 3 months were not statistically significant.
  • SF-MPQ total score after 2 months (p = 0.030) revealed an inter-group statistical significance, favoring IHMs against placebos.
  • Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months (p = 0.002) and 3 months (p = 0.007).
  • Rhus Toxicodendron, Sulphur, and Pulsatilla nigricans were the most frequently indicated medicines.

The authors concluded that owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.

Now that I (and hopefully you too) have recovered from laughing out loud, let me point out why this paper had me in stitches:

  • The trial was aborted not because of a “time limit” but because of slow recruitment, I presume. The question is why were not more patients volunteering? Low back pain with LS is extremely common. Could it be that patients know only too well that homeopathy does not help with low back pain?
  • If a trial gets aborted because of very low patient numbers, it is probably best not to publish it or at least not to evaluate its results at all.
  • If the researchers insist on publishing it, their paper should focus on the reason why it did not succeed so that others can learn from their experience by avoiding their mistakes.
  • However, once the researchers do run statistical tests, they should be honest and conclude clearly that, because the primary outcome measure showed no inter-group difference, the study failed to demonstrate that the treatment is effective.
  • The trial did not “remain inconclusive”; it was squarely negative.
  • The editor of the journal HOMEOPATHY should know better than to publish such nonsense.

A final thought: is it perhaps the ultimate proof of homeopathy’s ‘like cures like’ assumption to use sound science (i.e. an RCT), submit it to the homeopathic process of endless dilutions and succussions, and – BINGO – generate utter nonsense?

Hypericum perforatum (St John’s wort) is often recommended as a remedy to relieve pain caused by nerve damage. This trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo.

The study was designed as a randomized double-blind, monocentric, placebo-controlled clinical trial with inpatients undergoing surgery for lumbar sequestrectomy. Homeopathic treatment was compared to placebo, both in addition to usual pain management. The primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception.

The results show that the change in pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed.

The authors concluded that this is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction.

For a number of reasons, this is a remarkably mysterious and quite hilarious study:

  1. Hypericum is recommended as an analgesic for neuropathic pain.
  2. According to the ‘like cures like’ axiom of homeopathy, it therefore must increase pain in such situations.
  3. Yet, the authors of this trial mounted an RCT to see whether it reduces pain.
  4. Thus they either do not understand homeopathy or wanted to sabotage it.
  5. As they are well-known pro-homeopathy researchers affiliated with a university that promotes homeopathy (Witten/Herdecke University, Herdecke, Germany), both explanations are highly implausible.
  6. The facts that the paper was published in a pro-SCAM journal (J Integr Complement Med), and the study was sponsored by the largest German firm of homeopathics (Deutsche Homoeopathische Union) renders all this even more puzzling.
  7. However, these biases do explain that the authors do their very best to mislead us by including some unwarranted ‘positive’ findings in their overall conclusions.

In the end, none of this matters, because the results of the study reveal that firstly the homeopathic ‘law of similars’ is nonsense, and secondly one homeopathic placebo (i.e. Hypericum C200) produces exactly the same outcomes as another, non-homeopathic placebo.

Osteopathy is currently regulated in 12 European countries: Cyprus, Denmark, Finland, France, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Portugal, Switzerland, and the UK. Other countries such as Belgium and Norway have not fully regulated it. In Austria, osteopathy is not recognized or regulated. The Osteopathic Practitioners Estimates and RAtes (OPERA) project was developed as a Europe-based survey, whereby an updated profile of osteopaths not only provides new data for Austria but also allows comparisons with other European countries.

A voluntary, online-based, closed-ended survey was distributed across Austria in the period between April and August 2020. The original English OPERA questionnaire, composed of 52 questions in seven sections, was translated into German and adapted to the Austrian situation. Recruitment was performed through social media and an e-based campaign.

The survey was completed by 338 individuals (response rate ~26%), of which 239 (71%) were female. The median age of the responders was 40–49 years. Almost all had preliminary healthcare training, mainly in physiotherapy (72%). The majority of respondents were self-employed (88%) and working as sole practitioners (54%). The median number of consultations per week was 21–25 and the majority of respondents scheduled 46–60 minutes for each consultation (69%).

The most commonly used diagnostic techniques were: palpation of position/structure, palpation of tenderness, and visual inspection. The most commonly used treatment techniques were cranial, visceral, and articulatory/mobilization techniques. The majority of patients estimated by respondents consulted an osteopath for musculoskeletal complaints mainly localized in the lumbar and cervical region. Although the majority of respondents experienced a strong osteopathic identity, only a small proportion (17%) advertise themselves exclusively as osteopaths.

The authors concluded that this study represents the first published document to determine the characteristics of the osteopathic practitioners in Austria using large, national data. It provides new information on where, how, and by whom osteopathic care is delivered. The information provided may contribute to the evidence used by stakeholders and policy makers for the future regulation of the profession in Austria.

This paper reveals several findings that are, I think, noteworthy:

  • Visceral osteopathy was used often or very often by 84% of the osteopaths.
  • Muscle energy techniques were used often or very often by 53% of the osteopaths.
  • Techniques applied to the breasts were used by 59% of the osteopaths.
  • Vaginal techniques were used by 49% of the osteopaths.
  • Rectal techniques were used by 39% of the osteopaths.
  • “Taping/kinesiology tape” was used by 40% of osteopaths.
  • Applied kinesiology was used by 17% of osteopaths and was by far the most-used diagnostic approach.

Perhaps the most worrying finding of the entire paper is summarized in this sentence: “Informed consent for oral techniques was requested only by 10.4% of respondents, and for genital and rectal techniques by 21.0% and 18.3% respectively.”

I am lost for words!

I fail to understand what meaningful medical purpose the fingers of an osteopath are supposed to have in a patient’s vagina or rectum. Surely, putting them there is a gross violation of medical ethics.

Considering these points, I find it impossible not to conclude that far too many Austrian osteopaths practice treatments that are implausible, unproven, potentially harmful, unethical, and illegal. If patients had the courage to take action, many of these charlatans would probably spend some time in jail.

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