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

pain

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Fibromyalgia (FM) is one of the most frequent generalized pain disorders. It accounts for a sizable proportion of healthcare costs. Despite extensive research, the etiology (the ‘root cause’) of FM remains unknown – except, of course, to SCAM practitioners!

Most types of SCAM are said to be effective for FM (while the evidence for such claims is less than solid).

And almost every one of them claims to treat the ‘root cause’ of the condition. Which must mean that they are able to tackle its etiology, usually some disturbance of the ‘vital force’ or ‘energy’ flow. To patients, this sadly sounds impressive.

But what, if the etiology of FM is something entirely different?

New research shows that most (if not all) patients with FM belong to a distinct population that can be segregated from a control group by their glycated haemoglobin A1c (HbA1c) levels, a surrogate marker of insulin resistance (IR). This was demonstrated by analysing the data after introducing an age stratification correction into a linear regression model. This strategy showed highly significant differences between FM patients and control subjects (p < 0.0001 and p = 0.0002, for two separate control populations, respectively).

A subgroup of FM patients meeting criteria for pre-diabetes or diabetes (patients with HbA1c values of 5.7% or greater) who had undergone treatment with metformin showed dramatic improvements of their widespread myofascial pain. This was shown comparing pre and post-treatment numerical pain rating scale (NPRS). Response to metformin plus standard treatment (ST) was followed by complete resolution of the pain (report of 0 of 10 in the NPRS) in 8 of 16 patients who had been treated with metformin (50%), a degree of improvement never observed before in such a large proportion of FM patients subjected to any available treatment. In contrast, patients treated with ST alone improved, but complete resolution of pain was generally not observed. Interestingly, some patients responded only to metformin and not to ST with NSRIs or membrane stabilizing agents. Importantly, there was a long-term retention of the analgesic effect of metformin.

The authors concluded that these findings suggest a pathogenetic relationship between FM and IR, which may lead to a radical paradigm shift in the management of this disorder.

From my perspective, these findings also suggest that all the many SCAMs allegedly claiming to tackle the ‘root cause’ of FM have been barking up the wrong tree. In fact, all these claims of SCAM practitioners about treating the ‘root causes’ can easily be disclosed as a simple (and sadly effective) marketing gimmick. Six years ago, I even challenged the world of SCAM to name a single treatment that treats the ‘root cause’ of any disease. As yet, nobody has come forward with a convincing suggestion.

I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:

Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.

I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.

So, let’s try again.

Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.

Dr Geer published a short article explaining the nature of naprapathy:

Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.

What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:

1st study (2007)

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

RESULTS:

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

DISCUSSION:

This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

2nd study (2010)

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

RESULTS:

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

CONCLUSIONS:

Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

3rd study (2016)

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

RESULTS:

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

CONCLUSION:

The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

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I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:

Anxiety
Back Disorders
Back Pain
Cervical Radiculopathy
Cervical Spondylolisthesis
Cervical Sprain
Cervicogenic Headache
Chronic Headache
Chronic Neck Pain
Cluster Headache
Cough Headache
Depressive Disorders
Fibromyalgia
Headache
Hip Arthritis
Hip Injury
Hip Muscle Strain
Hip Pain
Hip Sprain
Joint Clicking
Joint Pain
Joint Stiffness
Joint Swelling
Knee Injuries
Knee Ligament Injuries
Knee Sprain
Knee Tendinitis
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Lumbar Sprain
Muscle Diseases
Musculoskeletal Pain
Neck Pain
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Shoulder Disorders
Shoulder Injuries
Shoulder Pain
Sports Injuries
Sports Injuries of the Knee
Stress
Tendonitis
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Toe Injuries

Odd, I’d say! Did all this change my mind about naprapathy? Not really.

But nobody – except perhaps Dr Greer – can say I did not try.

And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.

My friend Roger, the homeopath, alerted me to the ‘Self-Controlled Energo Neuro Adaptive Regulation‘ (SCENAR). He uses it in his practice and explains:

The scenar uses biofeedback; by stimulating the nervous system, it is able to teach the body to heal itself. The device sends out a series of signals through the skin and measures the response. Each signal is only sent out when a change, in response to the previous signal, is recorded in the electrical properties of the skin. Visible responses include reddening of the skin, numbness, stickiness (the device will have the feeling of being magnetically dragged), a change in the numerical readout and an increase in the electronic clattering of the device.

The C-fibres, which comprise 85% of all nerves in the body, react most readily to the electro-stimulation and are responsible for the production of neuropeptides and other regulatory peptides. A TENS unit will only stimulate the A & B-fibres for temporary relief.

The body can get accustomed to a stable pathological state, which may have been caused by injury, disease or toxicity. The Scenar catalyses the process to produce regulatory peptides for the body to use where necessary, by stimulation of C-fibres  . It is these neuropeptides that in turn reestablish the body’s natural physiological state and are responsible for the healing process. As these peptides last up to several hours, the healing process will continue long after the treatment is over. The large quantity of neuropeptides and C-fibres in the Central Nervous System can also result in the treatment on one area aiding with other general regulatory processes, like chemical imbalances, correcting sleeplessness, appetite and behavioral problems.

Sounds like science fiction?

Or perhaps more like BS?

But, as always, the proof of the pudding is in the eating. Roger explains:

What conditions can Scenar treat?
In the UK, the devices are licensed by the British Standards Institute for pain relief only. Likewise the FDA has approved the Scenar for pain relief. However, because of the nature of the device, viz., stimulating the nervous system, the Russian experience is that Scenar affects all the body systems in a curative manner.

The Russian experience suggests that it can be effective for a very broad range of diseases, including diseases of the digestive, cardio-vascular, respiratory, musculo-skeletal, urinary, reproductive and nervous systems. It is also useful for managing ENT diseases, eye diseases, skin conditions and dental problems. It has also been found beneficial in burns, fractures, insect bites, allergic reactions, diseases of the blood and disorders involving immune mechanisms; endocrine, nutritional and metabolic disorders; stress and mental depression, etc.

It is known to give real relief from many types of pain. It does so because it stimulates the body to heal the underlying disease causing the pain!

Another SCENAR therapist is much more specific. He tells us that SCENAR is effective for:

  • Sports and other injuries
  • Musculoskeletal problems
  • Issues with circulation
  • Respiratory diseases
  • Digestive disorders
  • Certain infections
  • Immune dysfunctions

Perhaps I was a bit hasty; perhaps the SCENAR does work after all. It is certainly offered by many therapists like Roger. They cannot all be charlatans, or can they?

Time to do a proper Medline search and find out about the clinical trials that have been done with the SCENAR. Disappointingly, I only found three relevant papers; here they are:

Study No 1

A new technique of low-frequency modulated electric current therapy, SCENAR therapy, was used in treatment of 103 patients with duodenal ulcer (DU). The influence of SCENAR therapy on the main clinical and functional indices of a DU relapse was studied. It was shown that SCENAR therapy, which influences disturbed mechanisms of adaptive regulation and self-regulation, led to positive changes in most of the parameters under study. Addition of SCENAR therapy to the complex conventional pharmacotherapy fastened ulcer healing, increased the effectiveness of Helicobacter pylori eradication, and improved the condition of the gastroduodenal mucosa.

Study No 2

Administration of artrofoon in combination with SCENAR therapy to patients with localized suppurative peritonitis in the postoperative period considerably reduced plasma MDA level, stabilized ceruloplasmin activity, and increased catalase activity in erythrocytes compared to the corresponding parameters in patients receiving standard treatment in combination with SCENAR therapy.

Study No 3

The author recommends a self-control energoneuroadaptive regulator (SCENAR) as effective in the treatment of neurogenic dysfunction of the bladder in children with nocturnal enuresis. This regulator operates according to the principles of Chinese medicine and may be used in sanatoria and at home by the children’s parents specially trained by physiotherapist.

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While the quantity of the ‘studies’ is lamentable, their quality seems quite simply unacceptable.

We are thus left with two possibilities: either the SCENAR is more or less what its proponents promise and the science has for some strange reason not caught up with this reality; or the reality is that SCENAR is a bogus treatment used by charlatans who exploit the gullible public.

I know which possibility I favour – how about you?

Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.

The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.

Sounds more than a little weird?

Yes, I agree.

Perhaps we need some real evidence.

The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).

Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.

The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.

I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:

  • The theory on which PPT is based is not plausible (to put it mildly).
  • It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
  • The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
  • The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
  • Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
  • The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.

So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.

Osteopathy is a tricky subject:

  • Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
  • Yet many osteopaths use them also for a myriad of non-spinal conditions.
  • Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
  • The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
  • Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.

A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints.  Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.

Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.

In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.

The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”

Some of the most obvious weaknesses of this review include the following:

  • In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
  • In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
  • Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
  • One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
  • The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.

Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.

Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.

Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.

Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.

The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.

There are numerous problems with this study:

  • The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
  • A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
  • For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
  • If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
  • The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
  • The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
  • Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.

My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.

Chiropractors believe that their spinal manipulations bring about a reduction in pain perception, and they often call this ‘manipulation-induced hypoalgesia’ (MIH). It is unknown, however, whether MIH following high-velocity low-amplitude spinal manipulative therapy is a specific and clinically relevant treatment effect.

This systematic review was an effort in finding out.

The authors investigated changes in quantitative sensory testing measures following high-velocity low-amplitude spinal manipulative therapy in musculoskeletal pain populations, in randomised controlled trials. Their objectives were to compare changes in quantitative sensory testing outcomes after spinal manipulative therapy vs. sham, control and active interventions, to estimate the magnitude of change over time, and to determine whether changes are systemic or not.

Fifteen studies were included. Thirteen measured pressure pain threshold, and 4 of these were sham-controlled. Change in pressure pain threshold after spinal manipulative therapy compared to sham revealed no significant difference. Pressure pain threshold increased significantly over time after spinal manipulative therapy (0.32 kg/cm2, CI 0.22–0.42), which occurred systemically. There were too few studies comparing to other interventions or for other types of quantitative sensory testing to make robust conclusions about these.

The authors concluded that they found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.

An odd conclusion, if there ever was one!

A more straight forward conclusion might be this:

MIH is yet another myth to add to the long list of bogus claims made by chiropractors.

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

Carpal tunnel syndrome (CTS) is caused by the tendons in the wrist getting too tight and thus putting pressure on the nerves that run beneath them. The symptoms can include:

  • pain in fingers, hand or arm,
  • numb hands,
  • tingling or ‘pins and needles’,
  • a weak thumb or difficulty gripping.

These symptoms often start slowly and they can come and go but often get worse over time. They are usually worse at night and may keep patients from having a good night’s sleep.

The treatments advocated for CTS include painkillers, splints and just about every alternative therapy one can think of, particularly acupuncture. Acupuncture may be popular, but does it work?

This new Cochrane review was aimed at assessing the evidence for acupuncture and similar treatments for CTS. It included 12 studies with 869 participants. Ten studies reported the primary outcome of overall clinical improvement at short‐term follow‐up (3 months or less) after randomisation. Most studies could not be combined in a meta‐analysis due to heterogeneity, and all had an unclear or high overall risk of bias. Only 7 studies provided information on adverse events.

The authors (two of them are from my former Exeter team) found that, in comparison with placebo or sham-treatments, acupuncture and laser acupuncture have little or no effect in the short term on symptoms of CTS. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity.

The authors concluded that high‐quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very‐low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.

This last point is one that I made very often: most trials of acupuncture fail to report adverse effects. This is doubtlessly unethical (it gives a false-positive overall impression about acupuncture’s safety). And what can you do with studies that are unethical? My answer is simple: bin them!

Most of the trials were of poor or very poor quality. Such studies tend to generate false-positive results. And what can you do with studies that are flimsy and misleading? My answer is simple: bin them!

So, what can we do with acupuncture trials of CTS? … I let you decide.

But binning the evidence offers little help to patients who suffer from chronic, progressive CTS. What can those patients do? Go and see a surgeon! (S)he will cure you with a relatively simply and safe operation; in all likelihood, you will never look back at dubious treatments.

For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.

The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.

The comparisons showed that there were no differences between the two groups at any time point.

(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)

The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!

Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):

  • Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
  • The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
  • The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.

Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.

So sorry, my homeopathic friends!

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