MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pain

For this blog, I am constantly on the lookout for ‘positive news’ about alternative medicine. Admittedly, I rarely find any.

All the more delighted I was when I found this new study aimed to analyse the association between dietary long-chain n-3 polyunsaturated fatty acids (PUFAs) and incidence of rheumatoid arthritis (RA) in middle-aged and older women.

Data on diet were collected in 1987 and 1997 via a self-administered food-frequency questionnaire (FFQ). The risk of RA associated with dietary long-chain n-3 PUFAs and fish intake was estimated using Cox proportional hazard regression models, adjusted for age, cigarette smoking, alcohol intake, use of aspirin and energy intake.

The results show that, among 32 232 women born 1914–1948, 205 RA cases were identified during a mean follow-up of 7.5 years. An intake of dietary long-chain n-3 PUFAs (FFQ1997) of more than 0.21 g/day (lowest quintile) was associated with a 35% decreased risk of developing RA compared with a lower intake. Long-term intake consistently higher than 0.21 g/day (according to both FFQ1987 and FFQ1997) was associated with a 52% decreased risk. Consistent long-term consumption (FFQ1987 and FFQ1997) of fish ≥1 serving per week compared with<1 was associated with a 29% decrease in risk.

The authors concluded that this prospective study of women supports the hypothesis that dietary intake of long-chain n-3 PUFAs may play a role in aetiology of RA.

These are interesting findings which originate from a good investigation and which are interpreted with the necessary caution. As all epidemiological data, this study is open to a number of confounding factors, and it is therefore impossible to make firm causal inferences. The results thus do not led themselves to clinical recommendation, but they are an indication that more definitive research is warranted, all the more so since we have plausible mechanisms to explain the observed findings.

A most encouraging development for alternative medicine, one could conclude. But is this really true? Most experts would be surprised, I think, to find that PUFA-consumption should fall under the umbrella of alternative medicine. Remember: What do we call alternative medicine that works? It is called MEDICINE!

Reflexology? Isn’t that an alternative therapy? And as such, a physiotherapist would not normally use it, most of us might think.

Well, think again! Here is what the UK Chartered Society of Physiotherapists writes about reflexology:

Developed centuries ago in countries such as China, Egypt and India, reflexology is often referred to as a ‘gentle’ and ‘holistic’ therapy that benefits both mind and body. It centres on the feet because these are said by practitioners to be a mirror, or topographical map, for the rest of the body. Manipulation of certain pressure, or reflex, points is claimed to have an effect on corresponding zones in the body. The impact, say reflexologists, extends throughout – to bones, muscles, organs, glands, circulatory and neural pathways. The head and hands can also be massaged in some cases. The treatment is perhaps best known for use in connection with relaxation and relief from stress, anxiety, pain, sleep disorders, headaches, migraine, menstrual and digestive problems. But advocates say it can be used to great effect far more widely, often in conjunction with other treatments.

Reflexology, or Reflex Therapy (RT) as some physiotherapists prefer to call it, clearly is approved by the UK Chartered Society of Physiotherapists. And what evidence do they have for it?

One hundred members of the Association of Chartered Physiotherapists in Reflex Therapy (ACPIRT) participated in an audit to establish a baseline of practice. Findings indicate that experienced therapists use RT in conjunction with their professional skills to induce relaxation (95%) and reduce pain (86%) for patients with conditions including whiplash injury and chronic pain. According to 68% of respondents, RT is “very good,” “good” or “as good as” orthodox physiotherapy practices. Requiring minimal equipment, RT may be as cost effective as orthodox physiotherapy with regards to duration and frequency of treatment.

But that’s not evidence!!! I hear you grumble. No, it isn’t, I agree.

Is there good evidence to show that RT is effective?

I am afraid not!

My own systematic review concluded that the best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.

Does that mean that the Chartered Society of Physiotherapists promotes quackery?

I let my readers answer that question.

An international team of researchers wanted to determine the efficacy of laser and needle acupuncture for chronic knee pain. They conducted a Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists.

The treatments consisted of A) no acupuncture (control group, n = 71), B) needle (n = 70), C) laser (n = 71), and D) sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial.

Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data.

At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events.

The authors drew the following conclusions: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients.

This is one of the methodologically best acupuncture studies that I have seen so far.

  • its protocol has been published when the trial started thus allowing maximum transparency
  • it is adequately powered
  • it has a very clever study-design
  • it minimizes bias in all sorts of ways
  • it tests acupuncture for a condition that it is widely used for
  • it even manages to blind acupuncturists by using one treatment arm with laser acupuncture

The results show quite clearly that acupuncture does have mild effects on pain and function that entirely rely on a placebo response.

Will acupuncturists learn from this study and henceforward stop treating knee-patients? Somehow I doubt it! The much more likely scenario is that they will claim the trial was, for this or that reason, not valid. Acupuncture, like most of alternative medicine, seems unable to revise its dogma.

Many proponents of alternative medicine seem somewhat suspicious of research; they have obviously understood that it might not produce the positive result they had hoped for; after all, good research tests hypotheses and does not necessarily confirm beliefs. At the same time, they are often tempted to conduct research: this is perceived as being good for the image and, provided the findings are positive, also good for business.

Therefore they seem to be tirelessly looking for a study design that cannot ‘fail’, i.e. one that avoids the risk of negative results but looks respectable enough to be accepted by ‘the establishment’. For these enthusiasts, I have good news: here is the study design that cannot fail.

It is perhaps best outlined as a concrete example; for reasons that will become clear very shortly, I have chosen reflexology as a treatment of diabetic neuropathy, but you can, of course, replace both the treatment and the condition as it suits your needs. Here is the outline:

  • recruit a group of patients suffering from diabetic neuropathy – say 58, that will do nicely,
  • randomly allocate them to two groups,
  • the experimental group receives regular treatments by a motivated reflexologist,
  • the controls get no such therapy,
  • both groups also receive conventional treatments for their neuropathy,
  • the follow-up is 6 months,
  • the following outcome measures are used: pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities,
  • the results show that the reflexology group experience more improvements in all outcome measures than those of control subjects,
  • your conclusion: This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

Mission accomplished!

This method is fool-proof, trust me, I have seen it often enough being tested, and never has it generated disappointment. It cannot fail because it follows the notorious A+B versus B design (I know, I have mentioned this several times before on this blog, but it is really important, I think): both patient groups receive the essential mainstream treatment, and the experimental group receives a useless but pleasant alternative treatment in addition. The alternative treatment involves touch, time, compassion, empathy, expectations, etc. All of these elements will inevitably have positive effects, and they can even be used to increase the patients’ compliance with the conventional treatments that is being applied in parallel. Thus all outcome measures will be better in the experimental compared to the control group.

The overall effect is pure magic: even an utterly ineffective treatment will appear as being effective – the perfect method for producing false-positive results.

And now we hopefully all understand why this study design is so very popular in alternative medicine. It looks solid – after all, it’s an RCT!!! – and it thus convinces even mildly critical experts of the notion that the useless treatment is something worth while. Consequently the useless treatment will become accepted as ‘evidence-based’, will be used more widely and perhaps even reimbursed from the public purse. Business will be thriving!

And why did I employ reflexology for diabetic neuropathy? Is that example not a far-fetched? Not a bit! I used it because it describes precisely a study that has just been published. Of course, I could also have taken the chiropractic trial from my last post, or dozens of other studies following the A+B versus B design – it is so brilliantly suited for misleading us all.

On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.

The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).

Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.

Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.

The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.

This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don't have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.

The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.

No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.

Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.

For every condition which is not curable by conventional medicine there are dozens of alternative treatments that offer a cure or at least symptomatic relief. Multiple sclerosis (MS) is such a disease. It is hard to find an alternative therapy that is not being promoted for MS.

Acupuncture is, of course, no exception. It is widely promoted for treating MS symptoms and many MS patients spend lots of money hoping that it does. The US ‘National MS Society’, For instance claim that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression. There is no evidence, however, that acupuncture can reduce the frequency of MS exacerbations or slow the progression of disability. And the ‘British Acupuncture Council’ state that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression.

Such claims seem a little over-optimistic; let’s have a look what the evidence really tells us.

The purpose of this brand-new review was to assess the literature on the effectiveness of acupuncture for treating MS. A literature search resulted in 12 peer-reviewed articles on the subject that examined the use of acupuncture to treat MS related quality of life, fatigue, spasticity, and pain. The majority of the studies were poorly designed-without control, randomization, or blinding. Description of the subjects, interventions, and outcome measures as well as statistical analysis were often lacking or minimal.

The authors concluded that although many of the studies suggested that acupuncture was successful in improving MS related symptoms, lack of statistical rigor and poor study design make it difficult to draw any conclusions about the true effectiveness of this intervention in the MS population. Further studies with more rigorous designs and analysis are needed before accurate claims can be made as to the effectiveness of acupuncture in this population.

And what about other alternative therapies? Our own systematic review of the subject included 12 randomized controlled trials: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2). But the evidence was not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem.

That was some time ago,  and it is therefore reasonable to ask: has the evidence changed? Thankfully, the ‘American Academy of Neurology’ has just published the following guidelines entitles complementary and alternative medicine in multiple sclerosis:

Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.

Interestingly, on yesterday it was announced that the NHS in Wales has just made available a cannabis-based spray for MS-sufferers (I should mention that most cannabis-based preparations are not full plant extracts and thus by definition not herbal but conventional medicines).

It would be wonderful, if other alternative therapies were of proven benefit to MS-sufferers. But sadly, this does not seem to be the case. I think it is better to be truthful about this than to raise false hopes of desperate patients.

There must be well over 10 000 clinical trials of acupuncture; Medline lists ~5 000, and many more are hidden in the non-Medline listed literature. That should be good news! Sadly, it isn’t.

It should mean that we now have a pretty good idea for what conditions acupuncture is effective and for which illnesses it does not work. But we don’t! Sceptics say it works for nothing, while acupuncturists claim it is a panacea. The main reason for this continued controversy is that the quality of the vast majority of these 10 000 studies is not just poor, it is lousy.

“Where is the evidence for this outraging statement???” – I hear the acupuncture-enthusiasts shout. Well, how about my own experience as editor-in-chief of FACT? No? Far too anecdotal?

How about looking at Cochrane reviews then; they are considered to be the most independent and reliable evidence in existence? There are many such reviews (most, if not all [co-]authored by acupuncturists) and they all agree that the scientific rigor of the primary studies is fairly awful. Here are the crucial bits of just the last three; feel free to look for more:

All of the studies had a high risk of bias

All included trials had a high risk of bias…

The studies were not judged to be free from bias…

Or how about providing an example? Good idea! Here is a new trial which could stand for numerous others:

This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of Quervain’s tendosynovitis (no, you do not need to look up what condition this is for understanding this post). Thirty patients were treated in two groups. The acupuncture group received 5 acupuncture sessions of 30 minutes duration. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. Thus there were short-term improvements of pain and function in both groups.

The authors drew the following conclusions: Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain’s tenosynovitis.

The flaws of this study are exemplary and numerous:

  • This should have been a study that compares two treatments – the technical term is ‘equivalence trial – and such studies need to be much larger to produce a meaningful result. Small sample sizes in equivalent trials will always make the two treatments look similarly effective, even if one is a pure placebo.
  • There is no gold standard treatment for this condition. This means that a comparative trial makes no sense at all. In such a situation, one ought to conduct a placebo-controlled trial.
  • There was no blinding of patients; therefore their expectation might have distorted the results.
  • The acupuncture group received more treatments than the injection group; therefore the additional attention might have distorted the findings.
  • Even if the results were entirely correct, one cannot conclude from them that acupuncture was effective; the notion that it was similarly ineffective as the injections is just as warranted.

These are just some of the most fatal flaws of this study. The sad thing is that similar criticisms can be made for most of the 10 000 trials of acupuncture. But the point here is not to nit-pick nor to quack-bust. My point is a different and more serious one: fatally flawed research is not just a ‘poor show’, it is unethical because it is a waste of scarce resources and, even more importantly, an abuse of patients for meaningless pseudo-science. All it does is it misleads the public into believing that acupuncture might be good for this or that condition and consequently make wrong therapeutic decisions.

In acupuncture (and indeed in most alternative medicine) research, the problem is so extremely wide-spread that it is high time to do something about it. Journal editors, peer-reviewers, ethics committees, universities, funding agencies and all others concerned with such research have to work together so that such flagrant abuse is stopped once and for all.

We all know, I think, that chronic low back pain (CLBP) is common and causes significant suffering in individuals as well as cost to society. Many treatments are on offer but, as we have seen repeatedly on this blog, not one is convincingly effective and some, like chiropractic, is associated with considerable risks.

Enthusiasts claim that hypnotherapy works well, but too little is known about the minimum dose needed to produce meaningful benefits, the roles of home practice and hypnotizability on outcome, or the maintenance of treatment benefits beyond 3 months. A new trial was aimed at addressing these issues.

One hundred veterans with CLBP participated in a randomized, four parallel group study. The groups were (1) an eight-session self-hypnosis training intervention without audio recordings for home practice; (2) an eight-session self-hypnosis training intervention with recordings; (3) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls; and (4) an eight-session active (biofeedback) control intervention.

Participants in all four groups reported significant pre- to post-treatment improvements in pain intensity, pain interference and sleep quality. The three hypnotherapy groups combined reported significantly more pain intensity reduction than the control group. There was no significant difference among the three hypnotherapy groups. Over half of the participants who received hypnotherapy reported clinically meaningful (≥30%) reductions in pain intensity, and they maintained these benefits for at least 6 months after treatment. Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome.

The authors conclude that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment. If replicated in other patient samples, the findings have important implications for the application of hypnosis treatment for chronic pain management.

Even though this trial has several important limitations, I do agree with the authors: these results would be worth an independent replication – not least because self-hypnosis is cheap and does not carry great risks. What would be interesting, in my view, are studies that compare several alternative LBP therapies (e.g. chiropractic, osteopathy, acupuncture, massage, various form of exercise and hypnotherapy) in terms of cost, risks, long-term effectiveness and patients’ preference. I somehow feel that the results of such comparative trials might overturn the often issued recommendations for spinal manipulation, i.e. chiropractic or osteopathy.

What is the best treatment for the millions of people who suffer from chronic low back pain (CLBP)? If we are honest, no therapy has yet been proven to be overwhelmingly effective. Whenever something like that happens in medicine, we have a proliferation of interventions which all are promoted as effective but which, in fact, work just marginally. And sure enough, in the case of CLBP, we have a constantly growing list of treatments none of which is really convincing.

One of the latest additions to this list is PILATES.

Pilates? What is this ? One practitioner describes it as follows: In Pilates, we pay a lot of attention to how our body parts are lined up in relation to each other, which is our alignment. We usually think of our alignment as our posture, but good posture is a dynamic process, dependent on the body’s ability to align its parts to respond to varying demands effectively. When alignment is off, uneven stresses on the skeleton, especially the spine, are the result. Pilates exercises, done with attention to alignment, create uniform muscle use and development, allowing movement to flow through the body in a natural way.

For example, one of the most common postural imbalances that people have is the tendency to either tuck or tilt the pelvis. Both positions create weaknesses on one side of the body and overly tight areas on the other. They deny the spine the support of its natural curves and create a domino effect of aches and pains all the way up the spine and into the neck. Doing Pilates increases the awareness of the proper placement of the spine and pelvis, and creates the inner strength to support the natural curves of the spine. This is called having a neutral spine and it has been the key to better backs for many people.

Mumbo-jumbo? Perhaps; in any case, we need evidence! Is there any at all? Surprisingly, the answer is yes. Recently, someone even published a proper systematic review.

This systematic review was aimed at evaluating the effectiveness of Pilates exercise in people with chronic low back pain (CLBP).

A search for RCTs was undertaken in 10 electronic. Two independent reviewers did the selection of evidence and evaluated the quality of the primary studies. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs could be included.

The methodological quality of RCTs ranged from “poor” to “excellent”. A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.

The authors drew the following conclusions: Pilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.

So, Pilates can be added to the long list of treatments that work for CLBP, albeit not convincingly better than most other therapies on offer. Does that mean these options are all as good or as bad as the next? I don’t think so.

Let’s assume chiropractic/osteopathic manipulations, massage and various forms of exercise are all equally effective. How do we decide which is more commendable than the next? We clearly need to take other important factors into account:

  • cost
  • risks
  • acceptability for patients
  • availability

If we use these criteria, it becomes instantly clear that chiropractic and osteopathy are not favourites in this race for the most commendable CLBP-treatment. They are neither cheap nor free of risks. Massage is virtually risk-free but not cheap. This leaves us with various forms of exercise, including Pilates. But which exercise is better than the next? At present, we do not know, and therefore the last two factors are crucial: if people love doing Pilates and if they easily stick with it, then Pilates is fine.

I am sure chiropractors will (yet again) disagree with me but, to me, this logic could hardly be more straight forward.

There is some (albeit not compelling) evidence to suggest that chiropractic spinal manipulation might be effective for treating non-specific back pain. But what about specific back pain, such as the one caused by a herniated disc? Some experts believe that, in patients suffering from such a condition, manipulations are contra-indicated (because the latter can cause the former), while others think that manipulation might be an effective treatment option (although the evidence is far from compelling). Who is correct? The issue can only be resolved with data from well-designed clinical investigations. A new trial might therefore enlighten us.

The stated purposes of this study were:

  1. to evaluate patients with low-back pain (LBP) and leg pain due to magnetic resonance imaging-confirmed disc herniation treated with high-velocity, low-amplitude spinal manipulation in terms of their short-, medium-, and long-term outcomes of self-reported global impression of change and pain levels
  2. to determine if outcomes differ between acute and chronic patients using.

The researchers conducted a ‘prospective cohort outcomes study‘ with 148 patients with LBP, leg pain, and physical examination abnormalities with concordant lumbar disc herniations. Baseline numerical rating scale (NRS) data for LBP, leg pain, and the Oswestry questionnaire were obtained. The specific lumbar spinal manipulation was dependent upon whether the disc herniation was intraforaminal or paramedian as seen on the magnetic resonance images and was performed by a chiropractor. Outcomes included the patient’s global impression of change scale for overall improvement, the NRS for LBP, leg pain, and the Oswestry questionnaire at 2 weeks, 1, 3, and 6 months, and 1 year. The proportion of patients reporting “improvement” on the patient’s global impression of change scale was calculated for all patients and for acute vs chronic patients. Pre-treatment and post-treatment NRS scores were compared using the paired t test. Baseline and follow-up Oswestry scores were compared using the Wilcoxon test. Numerical rating scale and Oswestry scores for acute vs chronic patients were compared using the unpaired t test for NRS scores and the Mann-Whitney U test for Oswestry scores.

Significant improvements for all outcomes at all time points were reported. At 3 months, 91% of patients were “improved”, and 88% were “improved” after 1 year. Acute patients improved faster by 3 months than did chronic patients. 81.8% of chronic patients 89.2% felt “improved” at 1 year. No adverse events were reported.

The researchers concluded that a large percentage of acute and importantly chronic lumbar disc herniation patients treated with chiropractic spinal manipulation reported clinically relevant improvement.

Does this new study meaningfully contribute to our knowledge about the effectiveness of chiropractic manipulation for back pain caused by herniated discs? The short answer to this question is NO.

A longer answer might be that the report does tell us something relevant about the quality of this research project. We know from countless studies that ~50% of patients experience adverse effects after spinal manipulations by a chiropractor. This means that any report claiming that NO ADVERSE EFFECTS WERE REPORTED is puzzling to a degree that we have to seriously question its quality or even honesty. In this context, it is relevant to mention that a recent review of the evidence concluded that a cause-effect relationship exists between the manipulative treatment and the development of disc herniation.

The positive outcomes reported in this new study could, of course, be due to a range of factors which are unrelated to the manipulations administered by the chiropractors:

  1. placebo-effects
  2. natural history of disc herniation
  3. regression towards the mean
  4. other treatments employed by the patients
  5. social desirability

To be able to say with any degree of certainty that the manipulations had anything to do with the observed positive outcomes would require an entirely different study-design. Should we assume that this is not known in the world of chiropractic? Or should we consider that chiropractors shy away from rigorous research because they fear its results?

The term prospective cohort outcomes study, seems to be a chiropractic invention (cohort studies are by definition prospective, and observational studies are usually prospective). It seems that, behind this long and impressive word, one can easily hide the fact that this study design fails to make the slightest attempt of controlling for non-specific effects; the term sounds scientific – but when we analyse what it means, we discover that this methodology is little more than a self-serving consumer survey. Most scientists would call such an investigation quite simply an OBSERVATIONAL STUDY.

I think it is time that chiropractors start doing proper research which actually does answer some of the many open questions regarding spinal manipulation.

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