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

Monthly Archives: December 2019

Recently, we discussed the findings of a meta-analysis which concluded that walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.

At the time, I commented that

this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.

My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

Now, there is new evidence that seems to confirm what I wrote. An international team of researchers requested individual participant data (IPD) from high-quality randomised clinical trials of patients suffering from persistent low back pain. They conducted descriptive analyses and one-stage IPD meta-analysis. They received IPD for 27 trials with a total of 3514 participants.

For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up.

Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care.

But you cannot dismiss so-called alternative medicine (SCAM), just like that, I hear my chiropractic and other manipulating friends exclaim – at the very minimum, we need direct comparisons of the two approaches!!!

Alright, you convinced me; here you go:

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with chronic low back pain (CLBP). Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review. Only three RCTs met the inclusion criteria. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term. The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Convinced?

No?

But I am!

Exercise is preferable to chiropractic and other manipulating SCAMs because:

  1. It is cheaper.
  2. It is safer.
  3. It is readily available to anyone.
  4. And you don’t have to listen to the bizarre and often dangerous advice many chiros offer their clients.

Here is a so-called alternative medicine (SCAM) that might be new to you – it certainly was to me: etiopathy. Founded in 1963 by the French Christian Trédaniel, etiopathy is a method of reasoning to determine the causes of a health problem and remove them acting on them. Etiopathy seems particularly popular in France, but is now slowly making inroads also elsewhere.

What is it?

This article explains it quite well:

Etiopathy is an alternative medicine which aims to treat everyday ailments without medication, using only manual techniques. Although it has been around for many years, the discipline is only just beginning to find its feet. It is a recognised health profession in several European countries, although there are not many practitioners.

The word etiopathy comes from the Greek word “aïtia”, which means “cause” and “pathos”, which means “suffering”. In short, etiopathy prioritises trying to find the cause for a pathology rather than getting rid of its symptoms.

The ethos of etiopathy is that the only way to prevent a problem from recurring is to treat it at the cause. According to this approach, if we don’t go back to the true source of the problem, patients run the risk of relapse.

The emphasis on diagnosis in etiopathy allows practitioners to treat the majority of common pathologies, thanks to an exclusively manual treatment approach, involving massage of particular points and thus avoiding medication and side effects. Obviously, an etiopath will immediately refer the patient on if they feel that the support of another health professional is required.

Etiopathy can be used to complement classic medical treatment, to help treat fairly benign problems such as:

  • joint problems (sprains, strains, tendonitis, carpal tunnel syndrome, tarsal tunnel syndrome, etc.)
  • respiratory or ENT problems (asthma, colds, coughs, sinusitis, rhinitis, rhinopharyngitis, etc.)
  • vertebral problems (neuralgia, torticollis, lumbago, chronic lower back pain, etc.)
  • problems during pregnancy (nausea, vomiting, sciatica) and preparation for giving birth
  • digestive problems (bloating, aerophagia, gastro-oesophageal reflux, constipation, diarrhea, etc.)
  • urinary problems (cystitis, prostate problems, incontinence, etc.)
  • gynaecological problems (painful periods, infertility, menopause, organ prolapse, etc.)
  • circulation problems (palpitations, tightness in the chest, heavy legs, Raynaud’s syndrome, etc.)
  • general health problems (migraines, insomnia, anxiety, shingles, etc.)

The goal of etiopathy is to reduce the risk of developing chronic problems or to find a natural solution to avoid surgical intervention.

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Big claims indeed!

But what about plausibility?

What about the evidence?

None!

Naught!

Zero!

Zilch!

Zippo!

Conclusion: etiopathy is a SCAM like many others – plenty of hot air, fantasy and hype combined with an absence of science, evidence and  data.

Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.

Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.

The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.

I have to admit, I have problems with these conclusions.

  1. Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone.  By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life.  This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
  2.  I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.

To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.

FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.

This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.

Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.

MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.

SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.

A total of 182 participants were randomized. The short‐term and long‐term groups demonstrated significant improvements in back disability (ODI score –3.9 [95% confidence interval (95% CI) –5.8, –2.0] versus ODI score –6.3 [95% CI –8.2, –4.4]) and neck disability (NDI score –7.3 [95% CI –9.1, –5.5] versus NDI score –9.0 [95% CI –10.8, –7.2]) after 36 weeks, with no difference between groups (back ODI score 2.4 [95% CI –0.3, 5.1]; neck NDI score 1.7 [95% CI 0.8, 4.2]). The long‐term management group experienced greater improvement in neck pain at week 36, in self‐efficacy at weeks 36 and 52, and in functional ability, and balance.For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.

FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.

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I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.

Having mentioned the report on chiropractic for children by SAVER CARE VICTORIA (SCV) several times before, I now better reveal its contents. Here are important excerpts from it, but I encourage everyone to read the full document:

Review of evidence of harm

An extensive search was undertaken to identify evidence of harm sustained by children who had received spinal manipulation. This included a literature review by Cochrane Australia, capture of patient complaints and practitioner notification data from Australian complaints and regulatory agencies, capture of Australian insurance claim data from the primary insurers for registered chiropractors, and stakeholder feedback from both online consultations. This extensive search identified very little evidence of patient harm occurring in Australia. In particular, there were no patient complaints or practitioner notifications that arose from significant harm to a child following spinal manipulation.

Three individual case reports were the only evidence of serious harm identified. Each of these reports related to spinal manipulative techniques performed outside of Australia and not limited to chiropractors. The practices described in these reports are not reflective of Australian chiropractic techniques. This does not mean spinal manipulation in children is not associated with any risk of any adverse effects. An extensive literature review did identify transient or minor adverse events but the prevalence was very low, albeit possibly more common in very young children.

There are two principle reasons why the search did not find strong evidence of harm in Australia. First, it is unlikely that spinal manipulation, as defined within the scope of the review, is a technique that is being routinely applied in Australia to young children or those with an immature spine. Second, skilled chiropractic care requires the practitioner to modify the force applied based on the age and developmental stage of the child. This means that children, particularly very young children, under the care of an Australian chiropractor are not likely to be receiving high impact manipulations.

Nonetheless, it is clear that spinal manipulation in children is not wholly without risk. Any risk associated with care, no matter how uncommon or minor, must be considered in light of any potential or likely benefits. This is particularly important in younger children, especially those under the age of 2 years in whom minor adverse events may be more common.

Review of evidence of effectiveness

SCV commissioned Cochrane Australia to undertake a systematic review of the effectiveness and safety of spinal manipulation of children under 12 years for any condition or symptom, irrespective of the profession providing treatment.

The major finding of this review is that the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia.

Specifically, the comprehensive review of the literature failed to identify any strong evidence for the effectiveness of spinal manipulation for a variety of conditions for which children are widely offered chiropractic manipulations. These conditions included colic, enuresis, back/neck pain, headache, asthma, otitis media, cerebral palsy, hyperactivity and torticollis.

There was low certainty (weak) evidence that spinal manipulation may be beneficial for modestly reducing crying time in children with colic, or for reducing the number of wet nights in children with enuresis. For both conditions the evidence was also consistent with either no or worsening effects.

For the other conditions – headache, asthma, otitis media, cerebral palsy, hyperactivity, and torticollis – there was no evidence that spinal manipulation was effective.

Based on this review of effectiveness, spinal manipulation of children cannot be recommended for:

  • headache
  • asthma
  • otitis media
  • cerebral palsy
  • hyperactivity disorders
  • torticollis.

The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.

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As pointed out repeatedly, one reason for not finding many reports of adverse effects might be very simple: UNDER-REPORTING! In any case, no good evidence for benefit + a finite risk = a negative risk/benefit balance. And a negative risk/benefit balance, of course, means that we should advise against chiropractic spinal manipulation for children. I am pleased to report that SCV agree; their 1st recommendation is: spinal manipulation … should not be provided to children under 12 years of age.

Tiger Balm (TB) ointments are Chinese topical remedies, often used for pain relief available as over-the-counter medications. TB is clearly popular, but does it work? The aim of this systematic review was to find out by assessing the efficacy, safety and tolerability of TB ointments.

A total of 12 studies were included (five on TB ointments efficacy, whereas seven on their safety and tolerability). Two cases of dermatitis and one of cheilitis likely ascribable to the use of TB ointments have been reported. Based on available studies, it might be estimated that around 4% [95% CI, 3%-5%] of patients with history of contact skin allergy could be positive if patch tested with TB ointments, therefore caution is recommended in the use of TB among these subjects.

The authors concluded that, according to retrieved evidence, TB ointments might be useful for the management of pain due to tension headache, and they seem capable of increasing leg blood flow if combined with massage. Considering available evidence on topical products with camphor, TB ointments shouldn’t be used in children, as well as in pregnant or lactating women. Chronic use, large amounts of balm, and the application on damaged skin must be avoided too. Further studies are recommended.

I had to laugh out loud when reading these conclusions:

  1.  That TB MIGHT be useful is hardly worth writing home about. A systematic review should tell us whether there is any good evidence THAT it is useful.
  2.  That TB seems capable of increasing leg blood flow is also nonsense. Firstly, anything increases blood flow IF COMBINED WITH MASSAGE. Secondly, why would anyone want to increase leg blood flow? Ahh of course: if you have leg ischaemia, e. g. in intermittent claudication. But then increasing blood flow of the skin of the leg is likely to be counter-productive, as this would shunt blood away from the already oxygen-starved muscles.

So, what evidence is there that TB might be effective? It turns out that there is all of ONE small randomised clinical trial that is over 20 years old which delivers a positive result. In view of this, I find it hard to resist re-writing the conclusions as follows:

TB IS A CHINESE REMEDY THAT CAN CAUSE ADVERSE EFFECTS AND FOR WHICH THERE IS NO GOOD EVIDENCE OF EFFICACY. ITS RISK/BENEFIT BALANCE IS THEREFORE NOT DEMONSTRABLY POSITIVE.

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