MD, PhD, FMedSci, FSB, FRCP, FRCPEd

causation

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Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”

The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.

The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”

Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.

In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.

I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.

 

Lots of people are puzzled how healthcare professionals – some with sound medical training – can become convinced homeopaths. Having done part of this journey myself, I think I know one possible answer to this question. So, let me try to explain it to you in the form of a ‘story’ of a young doctor who goes through this development. As you may have guessed, some elements of this story are autobiographical but others are entirely fictional.

Here is the story:

After he had finished medical school, our young and enthusiastic doctor wanted nothing more than to help and assist needy patients. A chain of coincidences made him take a post in a homeopathic hospital where he worked as a junior clinician alongside 10 experienced homeopaths. What he saw impressed him: despite of what he had learnt at med school, homeopathy seemed to work quite well: patients with all sorts of symptoms improved. This was not his or anybody else’s imagination, it was an undeniable fact.

As his confidence and his ability to think clearly grew, the young physician began to wonder nevertheless: were his patients’ improvements really due to the homeopathic remedies, or were these outcomes caused by the kind and compassionate care he and the other staff provided?

To cut a long story short, when he left the hospital to establish his own practice, he certainly knew how to prescribe homeopathics but he was not what one might call a convinced homeopath. He decided to employ homeopathy in parallel with conventional medicine and it turned out that he made less and less use of homeopathy as the months went by.

One day, a young women consulted him; she had been unsuccessfully trying to have a baby for two years and was now getting very frustrated, even depressed, with her childlessness. All tests on her and her husband had not revealed any abnormalities. A friend had told her that homeopathy might help, and see had therefore made this appointment to consult a doctor who had trained as a homeopath.

Our young physician was not convinced that he could help his patient but, in the end, he was persuaded to give it a try. As he had been taught by his fellow homeopaths, he conducted a full homeopathic history to find the optimal remedy for his patient, gave her an individualised prescription and explained that any effect might take a while. The patient was delighted that someone had given her so much time, felt well-cared for by her homeopaths, and seemed full of optimism.

Months passed and she returned for several further consultations. But sadly she failed to become pregnant. About a year later, when everyone involved had all but given up hope, her periods stopped and the test confirmed: she was expecting!

Everyone was surprised, not least our doctor. This outcome, he reasoned, could not possibly be due to placebo, or the good therapeutic relationship he had been able to establish with his patient. Perhaps it was just a coincidence?

In the small town where they lived, news spread quickly that he was able to treat infertility with homeopathy. Several other women with the same problem liked the idea of having an effective yet risk-free therapy for their infertility problem. The doctor thus treated several infertile women, about 10, during the next months. Amazingly most of them got pregnant within a year or so. The doctor was baffled, such a series of pregnancies could not be a coincidence, he reasoned.

Naturally, the cases that were talked about were the women who had become pregnant. And naturally, these were the patients our doctor liked to remember. Slowly he became convinced that he was indeed able to treat infertility homeopathically – so much so that he published a case series in a homeopathic journal about his successes.

In a way, he had hoped that, perhaps, someone would challenge him and explain where he had gone wrong. But the article was greeted nationally with much applause by his fellow homeopaths, and he was even invited to speak at several conferences. In short, within a few years, he made himself a name for his ability to help infertile women.

Patients now travelled from across the country to see him, and some even came from abroad. Our physician had become a minor celebrity in the realm of homeopathy. He also, one has to admit, had started to make very good money; most of his patients were private patients. Life was good. It almost goes without saying that all his former doubts about the effectiveness of homeopathic remedies gradually vanished into thin air.

Whenever now someone challenged his findings with arguments like ‘homeopathics are just placebos’, he surprised himself by getting quite angry. How do they dare doubt my data, he thought. The babies are there, to deny their existence means calling me a liar!

OUR DOCTOR HAD BECOME AN EVANGELICALLY CONVINCED HOMEOPATH, AND NO RATIONAL ARGUMENT COULD DISSUADE HIM.

And what arguments might that be? Isn’t he entirely correct? Can dozens of pregnancies be the result of a placebo effect, the therapeutic relationship or coincidence?

The answer is NO! The babies are real, very real.

But there are other, even simpler and much more plausible explanations for our doctor’s apparent success rate: otherwise healthy women who don’t get pregnant within months of trying do very often succeed eventually, even without any treatment whatsoever. Our doctor struck lucky when this happened a few times after the first patient had consulted him. Had he prescribed non-homeopathic placebos, his success rate would have been exactly the same.

As a clinician, it is all too easy and extremely tempting not to adequately rationalise such ‘success’. If the ‘success’ then happens repeatedly, one can be in danger of becoming deluded, and then one almost automatically ‘forgets’ one’s failures. Over time, this confirmation bias will create an entirely false impression and often even a deeply felt conviction.

I am sure that this sort of thing happens often, very often. And it happens not just to homeopaths. It happens to all types of quacks. And, I am afraid, it also happens to many conventional doctors.

This is how ineffective treatments survive for often very long periods. This is how blood-letting survived for centuries. This is how millions of patients get harmed following the advice of their trusted physicians to employ a useless or even dangerous therapy.

HOW CAN THIS SORT OF THING BE STOPPED?

The answer to this most important question is very simple: health care professionals need to systematically learn critical thinking early on in their education. The answer may be simple but its realisation is unfortunately not.

Even today, courses in critical thinking are rarely part of the medical curriculum. In my view, they would be as important as anatomy, physiology or any of the other core subjects in medicine.

We all hope that serious complications after chiropractic care are rare. However, this does not mean they are unimportant. Multi-vessel cervical dissection with cortical sparing is an exceptional event in clinical practice. Such a case has just been described as a result of chiropractic upper spinal manipulation.

Neurologists from Qatar published a case report of a 55-year-old man who presented with acute-onset neck pain associated with sudden onset right-sided hemiparesis and dysphasia after chiropractic manipulation for chronic neck pain.

Magnetic resonance imaging revealed bilateral internal carotid artery dissection and left extracranial vertebral artery dissection with bilateral anterior cerebral artery territory infarctions and large cortical-sparing left middle cerebral artery infarction. This suggests the presence of functionally patent and interconnecting leptomeningeal anastomoses between cerebral arteries, which may provide sufficient blood flow to salvage penumbral regions when a supplying artery is occluded.

The authors concluded that chiropractic cervical manipulation can result in catastrophic vascular lesions preventable if these practices are limited to highly specialized personnel under very specific situations.

Chiropractors will claim that they are highly specialised and that such events must be true rarities. Others might even deny a causal relationship altogether. Others again would claim that, relative to conventional treatments, chiropractic manipulations are extremely safe. You only need to search my blog using the search-term ‘chiropractic’ to find that there are considerable doubts about these assumptions:

  • Many chiropractors are not well trained and seem mostly in the business of making a tidy profit.
  • Some seem to have forgotten most of the factual knowledge they may have learnt at chiro-college.
  • There is no effective monitoring scheme to adequately record serious side-effects of chiropractic care.
  • Therefore the incidence figures of such catastrophic events are currently still anyone’s guess.
  • Publications by chiropractic interest groups seemingly denying this point are all fatally flawed.
  • It is not far-fetched to fear that under-reporting of serious complications is huge.
  • The reliable evidence fails to demonstrate that neck manipulations generate more good than harm.
  • Until sound evidence is available, the precautionary principle leads most critical thinkers to conclude that neck manipulations have no place in routine health care.

The randomized, placebo-controlled, double-blind trial is usually the methodology to test the efficacy of a therapy that carries the least risk of bias. This fact is an obvious annoyance to some alt med enthusiasts, because such trials far too often fail to produce the results they were hoping for.

But there is no need to despair. Here I provide a few simple tips on how to mislead the public with seemingly rigorous trials.

1 FRAUD

The most brutal method for misleading people is simply to cheat. The Germans have a saying, ‘Papier ist geduldig’ (paper is patient), implying that anyone can put anything on paper. Fortunately we currently have plenty of alt med journals which publish any rubbish anyone might dream up. The process of ‘peer-review’ is one of several mechanisms supposed to minimise the risk of scientific fraud. Yet alt med journals are more clever than that! They tend to have a peer-review that rarely involves independent and critical scientists, more often than not you can even ask that you best friend is invited to do the peer-review, and the alt med journal will follow your wish. Consequently the door is wide open to cheating. Once your fraudulent paper has been published, it is almost impossible to tell that something is fundamentally wrong.

But cheating is not confined to original research. You can also apply the method to other types of research, of course. For instance, the authors of the infamous ‘Swiss report’ on homeopathy generated a false positive picture using published systematic reviews of mine by simply changing their conclusions from negative to positive. Simple!

2 PRETTIFICATION

Obviously, outright cheating is not always as simple as that. Even in alt med, you cannot easily claim to have conducted a clinical trial without a complex infrastructure which invariably involves other people. And they are likely to want to have some control over what is happening. This means that complete fabrication of an entire data set may not always be possible. What might still be feasible, however, is the ‘prettification’ of the results. By just ‘re-adjusting’ a few data points that failed to live up to your expectations, you might be able to turn a negative into a positive trial. Proper governance is aimed at preventing his type of ‘mini-fraud’ but fortunately you work in alt med where such mechanisms are rarely adequately implemented.

3 OMISSION

Another very handy method is the omission of aspects of your trial which regrettably turned out to be in disagreement with the desired overall result. In most studies, one has a myriad of endpoints. Once the statistics of your trial have been calculated, it is likely that some of them yield the wanted positive results, while others do not. By simply omitting any mention of the embarrassingly negative results, you can easily turn a largely negative study into a seemingly positive one. Normally, researchers have to rely on a pre-specified protocol which defines a primary outcome measure. Thankfully, in the absence of proper governance, it usually is possible to publish a report which obscures such detail and thus mislead the public (I even think there has been an example of such an omission on this very blog).

4 STATISTICS

Yes – lies, dam lies, and statistics! A gifted statistician can easily find ways to ‘torture the data until they confess’. One only has to run statistical test after statistical test, and BINGO one will eventually yield something that can be marketed as the longed-for positive result. Normally, researchers must have a protocol that pre-specifies all the methodologies used in a trial, including the statistical analyses. But, in alt med, we certainly do not want things to function normally, do we?

5 TRIAL DESIGNS THAT CANNOT GENERATE A NEGATIVE RESULT

All the above tricks are a bit fraudulent, of course. Unfortunately, fraud is not well-seen by everyone. Therefore, a more legitimate means of misleading the public would be highly desirable for those aspiring alt med researchers who do not want to tarnish their record to their disadvantage. No worries guys, help is on the way!

The fool-proof trial design is obviously the often-mentioned ‘A+B versus B’ design. In such a study, patients are randomized to receive an alt med treatment (A) together with usual care (B) or usual care (B) alone. This looks rigorous, can be sold as a ‘pragmatic’ trial addressing a real-fife problem, and has the enormous advantage of never failing to produce a positive result: A+B is always more than B alone, even if A is a pure placebo. Such trials are akin to going into a hamburger joint for measuring the calories of a Big Mac without chips and comparing them to the calories of a Big Mac with chips. We know the result before the research has started; in alt med, that’s how it should be!

I have been banging on about the ‘A+B versus B’ design often enough, but recently I came across a new study design used in alt med which is just as elegantly misleading. The trial in question has a promising title: Quality-of-life outcomes in patients with gynecologic cancer referred to integrative oncology treatment during chemotherapy. Here is the unabbreviated abstract:

OBJECTIVE:

Integrative oncology incorporates complementary medicine (CM) therapies in patients with cancer. We explored the impact of an integrative oncology therapeutic regimen on quality-of-life (QOL) outcomes in women with gynecological cancer undergoing chemotherapy.

PATIENTS AND METHODS:

A prospective preference study examined patients referred by oncology health care practitioners (HCPs) to an integrative physician (IP) consultation and CM treatments. QOL and chemotherapy-related toxicities were evaluated using the Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, at baseline and at a 6-12-week follow-up assessment. Adherence to the integrative care (AIC) program was defined as ≥4 CM treatments, with ≤30 days between each session.

RESULTS:

Of 128 patients referred by their HCP, 102 underwent IP consultation and subsequent CM treatments. The main concerns expressed by patients were fatigue (79.8 %), gastrointestinal symptoms (64.6 %), pain and neuropathy (54.5 %), and emotional distress (45.5 %). Patients in both AIC (n = 68) and non-AIC (n = 28) groups shared similar demographic, treatment, and cancer-related characteristics. ESAS fatigue scores improved by a mean of 1.97 points in the AIC group on a scale of 0-10 and worsened by a mean of 0.27 points in the non-AIC group (p = 0.033). In the AIC group, MYCAW scores improved significantly (p < 0.0001) for each of the leading concerns as well as for well-being, a finding which was not apparent in the non-AIC group.

CONCLUSIONS:

An IP-guided CM treatment regimen provided to patients with gynecological cancer during chemotherapy may reduce cancer-related fatigue and improve other QOL outcomes.

A ‘prospective preference study’ – this is the design the world of alt med has been yearning for! Its principle is beautiful in its simplicity. One merely administers a treatment or treatment package to a group of patients; inevitably some patients take it, while others don’t. The reasons for not taking it could range from lack of perceived effectiveness to experience of side-effects. But never mind, the fact that some do not want your treatment provides you with two groups of patients: those who comply and those who do not comply. With a bit of skill, you can now make the non-compliers appear like a proper control group. Now you only need to compare the outcomes and BOB IS YOUR UNCLE!

Brilliant! Absolutely brilliant!

I cannot think of a more deceptive trial-design than this one; it will make any treatment look good, even one that is a mere placebo. Alright, it is not randomized, and it does not even have a proper control group. But it sure looks rigorous and meaningful, this ‘prospective preference study’!

While some chiropractors now do admit that upper neck manipulations can cause severe problems, many of them simply continue to ignore this fact. It is therefore important, I think, to keep alerting both consumers and chiropractors to the risks of spinal manipulations. In this context, a new article seems relevant.

Danish doctors reported a critical case of bilateral vertebral artery dissection (VAD) causing embolic occlusion of the basilar artery (BA) in a patient whose symptoms started after chiropractic Spinal manipulative therapy (cSMT). The patient, a 37-year-old woman, presented with acute onset of neurological symptoms immediately following cSMT in a chiropractic facility. Acute magnetic resonance imaging (MRI) showed ischemic lesions in the right cerebellar hemisphere and occlusion of the cranial part of the BA. Angiography demonstrated bilateral VADs. Symptoms remitted after endovascular therapy, which included dilatation of the left vertebral artery (VA) and extraction of thrombus from the BA. After 6 months, the patient still had minor sensory and cognitive deficits.

The authors concluded that, in severe cases, VAD may be complicated by BA thrombosis, and this case highlights the importance of a fast diagnostic approach and advanced intravascular procedure to obtain good long-term neurological outcome. Furthermore, this case underlines the need to suspect VAD in patients presenting with neurological symptoms following cSMT.

I can already hear the excuses of the chiropractic fraternity:

  • this is just a case report,
  • the risk is very rare,
  • some investigations even deny any risk at all,
  • the risk of many conventional treatments is far greater.
However, these excuses are lame for a number of reasons:
  • as there are no functioning monitoring systems, nobody can tell with certainty how big the risk truly is,
  • the precautionary principle in health care compels us to take even the slightest of suspicions of harm seriously,
  • the risk/benefit principle compels us to ask whether the demonstrable benefits of neck manipulations outweigh its suspected risks.

The last point is perhaps the most important: AS FAR AS I CAN SEE, THERE IS NO INDICATION FOR NECK MANIPULATIONS FOR WHICH THE BENEFIT IS SUFFICIENTLY CERTAIN TO JUSTIFY ANY SUCH RISKS.

Chiropractors and osteopaths have long tried to convince us that spinal manipulation and mobilisation are the best we can do when suffering from neck pain. But is this claim based on good evidence?

This recent update of a Cochrane review was aimed at assessing the effects of manipulation or mobilisation alone compared with those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up, and when appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes.

Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). They also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies.

Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain were included in this assessment.

Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). The authors calculated pooled risk ratios (RRs) and standardised mean differences (SMDs).

Fifty-one trials with a total of 2920 participants could be included. The findings are diverse. Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up. Cervical manipulation versus another active treatment: For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up. Thoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality). Thoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain. Mobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control. Mobilisation versus another active treatment: For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality).

Confused? So am I!

In my view, these analyses show that the quality of most studies is wanting and the evidence is weak – much weaker than chiropractors and osteopaths try to make us believe. It seems to me that no truly effective treatments for neck pain have been discovered and that therefore manipulation/mobilisation techniques are as good or as bad as most other options.

In such a situation, it might be prudent to first investigate the causes of neck pain in greater detail  and subsequently determine the optimal therapies for each of them. Neck pain is a SYMPTOM, not a disease! And it is always best to treat the cause of a symptom rather than pretending we know the cause as chiropractors and osteopaths often do.

The authors of the Cochrane review seem to agree with this view at least to some extent. They conclude that although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.

The call for further research is, of course, of no help for patients who are suffering from neck pain today. What would I recommend to them?

My advice is to be cautious:

  • Consult your doctor and try to get a detailed diagnosis.
  • See a physiotherapist and ask to be shown exercises aimed at reducing the pain and preventing future episodes.
  • Do these exercises regularly, even when you have no pain.
  • Make sure you do whatever else might be needed in terms of life-style changes (ergonomic work place, correct sleeping arrangements, etc.).
  • If you are keen on seeing an alternative practitioner for manual therapy, consult a osteopath rather than a chiropractor; the former tend to employ techniques which are less risky than the latter.
  • Avoid both chiropractors and long-term medication for neck pain.

The authors of a recent paper inform us that Reiki is a Japanese system of energy healing that has been used for over 2 500 years. It involves the transfer of energy from the practitioner to the receiver, which promotes healing, and can be done by either contact or non-contact methods. Both the receiver and the practitioner may feel the energy in various forms (warmth, cold, tingling, vibration, pulsations and/or floating sensations). Reiki can also be self-administered if one is a Reiki practitioner. Reiki is mainly used to address stress, anxiety, and pain reduction while also promoting a sense of well-being and improving quality of life.

Such statements should make us weary: what is presented here as fact is nothing more than conjecture – and very, very implausible conjecture too. Anyone who writes stuff like this in the introduction of a scientific paper is, in my view, unlikely to be objective and could be well on the way to present some nasty piece of pseudo-science.

But I am, of course, pre-judging the issue; let’s have a quick look at the article itself.

The purpose of this study was to determine the effects of a 20-week structured self-Reiki program on stress reduction and relaxation in college students. Students were recruited from Stockton University and sessions were conducted in the privacy of their residence. Twenty students completed the entire study consisting of 20 weeks of self-Reiki done twice weekly. Each participant completed a Reiki Baseline Credibility Scale, a Reiki Expectancy Scale, and a Perceived Stress Scale (PSS) after acceptance into the study. The PSS was completed every four weeks once the interventions were initiated. A global assessment questionnaire was completed at the end of the study. Logs summarizing the outcome of each session were submitted at the end of the study.

With the exception of three participants, participants believed that Reiki is a credible technique for reducing stress levels. Except for two participants, participants agreed that Reiki would be effective in reducing stress levels. All participants experienced stress within the month prior to completing the initial PSS. There was a significant reduction in stress levels from pre-study to post-study. There was a correlation between self-rating of improvement and final PSS scores. With one exception, stress levels at 20 weeks did not return to pre-study stress levels.

The authors concluded that this study supports the hypothesis that the calming effect of Reiki may be achieved through the use of self-Reiki.

QED – my suspicions were fully confirmed. This study shows precisely nothing, and it certainly does not support any hypothesis regarding Reiki.

If we recruited 20 volunteers who were sufficiently gullible to believe that watching an ice-cube slowly melting in the kitchen sink, or anything else that we can think of, has profound effects on their vital energy, or chi, or karma, or anything else, we would almost certaily generate similar results.

My conclusion is therefore very different from those of the original authors: THIS STUDY SUPPORTS THE HYPOTHESIS THAT GULLIBLE PEOPLE CAN BE EASILY MISLEAD ABOUT BOGUS THERAPIES WITH PSEUDO-SCIENTIFIC STUDIES BY IRRESPONSIBLE WOULD-BE SCIENTISTS.

One of the most common claims of alternative practitioners is that they take a holistic approach to health care. And it is this claim which attracts many consumers. It also makes conventional medicine look bad, reductionist and inhuman, as it implies that mainstream medicine is non-holistic.

The claim can be easily disclosed to be a straw man, because all good medicine was, is and always will be holistic. Moreover, the claim amounts to a falsehood, because much of alternative medicine is everything but holistic. I will try to explain what I mean using the recent example of acupuncture for neck pain, but I could have used almost any other alternative treatment and any other human complaint/condition/disease:

  • chiropractic for back pain;
  • homeopathy for asthma;
  • energy healing for depression;
  • aromatherapy for jet lag;
  • etc. etc.

The recent trial found that adding acupuncture to usual care yields a slightly better outcome than usual care alone. This is hardly a big deal; adding a good cup of tea and a compassionate chat to usual care might have done a similar thing. Acupuncturists, however, will say that their holistic approach is successful.

How holistic is acupuncture?

A ‘Western’ acupuncturist would normally ask what is wrong with the patient; in the case of neck pain, he would probably ask several further questions about the history of the condition, when the pain occurs, what aggravates it etc. Then he might conduct a physical examination of his patient. Eventually, he would get out his needles and start the treatment.

A ‘traditional’ acupuncturist would ask similar questions, feel the pulse, look at the tongue and make a diagnosis in terms of yin and yang imbalance. Eventually, he too would get out his needles and start the treatment.

Is that holistic?

Certainly not! If we look at alternative practitioners in general, we cannot fail to notice that they tend to be the very opposite of holistic. They usually attribute a patients illness to one single cause such as yin/yang imbalance (acupuncture), subluxation (chiropractic), impediment of the life force (homeopathy), etc.

Holistic means that the patient is understood as a whole person. Our neck pain patient might have physical problems such as muscular tension; the acupuncturists might well have realised this and placed their needles accordingly. But neck pain, like most other symptoms, can have many other dimensions:

  • there could be stress;
  • there could be an ergonomically disadvantageous work place;
  • there could be a history of injury;
  • there could be a malformation of the spine;
  • there could be a tumour;
  • there could be an inflammation;
  • there could be many other specific diseases;
  • there could be relationship problems, et. etc.

Of course, the acupuncturists will claim that, during an acupuncture session, they will pick up on all of these. However, in my experience, this is little more than wishful thinking. And even if they did pick up other dimensions of the patient’s complaint, what can they do about it? They can (and often do) give rather amateur advice. This may be meant most kindly but it is rarely optimal.

And what about conventional practitioners, aren’t they even worse?

True, there often is far too much room for improvement. But at least the concept of multifactorial conditions and treatments is deeply ingrained in everyone who has been to medical school. We learn that symptoms/complaints/conditions/diseases are almost invariably multifactorial; they have many causes and contributing factors which can interact in complex ways. Therefore, responsible physicians always consider to treat patients in multifactorial ways; in the case of our neck pain patient:

  • the stress might need a relaxation programme,
  • the work place might need the input of an occupational therapist;
  • in case of an old injury, a physio might be needed;
  • specific conditions might need to be seen by a range of medical specialists;
  • muscular tension could be reduced by a massage therapist;
  • relationship problems might require the help of a psychologist; etc. etc.

I am NOT saying that all of this is necessary in each and every case. But I am saying that, in conventional medicine, both the awareness and the possibility for a professional multidisciplinary approach is well established. You don’t believe me? Ask a physiotherapist or an occupational therapist who refers more patients to them, an acupuncturist or a GP!

Alternative practitioners claim to be holistic and some might even be aware of the complexity of their patients’ symptoms. But, at best, they have an amateur approach to this complexity by dabbling themselves in issuing more or less suited advice. They are not adequately trained to do this job, and they refer very rarely.

My conclusion: professional multidiscipinarity is an approach deeply engrained in conventional medicine (we don’t often call it holism, perhaps because many doctors associate this term with charlatans), and it beats the mostly amateurish pseudo-holism of alternative practitioners any time.

The aim of this study was to evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain.

Patients with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology were randomised to receive 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. The NPQ score at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes) served as outcome measures. 517 patients were recruited. Their median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention.

The authors drew the following conclusions: acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.

Where to begin? There is much to be criticised about this study!

For starters, the conclusions are factually wrong. They should read “acupuncture sessions plus usual care and Alexander Technique lessons plus usual care both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.

On this blog, we have repeatedly discussed the ‘A+B versus B’ study design and the fact that it cannot provide information about cause and effect because it fails to control for placebo effects and the extra attention, time and empathy (for instance here and here). I suspect that this is the reason why it is so very popular in alternative medicine. It can make ineffective therapies appear to be effective.

Another point is a more clinical concern. Neck pain is not a disease, it is a symptom. In medicine we should, whenever possible, try to treat the cause of the underlying condition and not the symptom. Acupuncture is at best a symptomatic treatment. Usual care is often not very effective because we normally fail to see the cause of neck pain. In my view, alternative treatments should either be tested against placebo or sham interventions or against optimal care.

What is optimal care for nonspecific neck pain? As its causes are often unclear and usually multifactorial, the optimal treatment needs to be multifactorial (one could also call it holistic) as well. The causes often range from poor ergometric conditions at work to muscular tension, stress, psychological problems etc. Thus optimal care would be a team work tailor-made for each patient possibly including physiotherapists, pain specialists, clinical psychologists, orthopaedic surgeons etc.

My points here are:

  • neither acupuncture nor Alexander technique take account of this complexity,
  • they claim to be holistic but, in fact, this turns out to be merely a good sales-slogan,
  • usual care is usually no good,
  • if pragmatic trials using the ‘A+B versus B’ design make any sense at all, they should employ not usual care but optimal care for the control group.

In the end, we are left with a study that looks fairly rigorous at first sight, but that really tells us next to nothing (except that dedicating 600 minutes to patients in pain is not without effect). I am truly surprised that a top journal like the Annals of Internal Medicine decided to publish it.

Alternative medicine (AM) use has become popular among patients with cancer. I find this very easy to understand: faced with such a grave diagnosis, who would not be tempted to try everything that is being promoted as being helpful. And, by Jove, promoted it is! But does it do any good?

The evidence clearly shows that no form of AM is capable of changing the natural history of any form of cancer. This means the millions of websites that imply otherwise are criminally wrong and frightfully dangerous.

But some AMs might still be useful, namely for improving symptoms, well-being and quality of life (QOL) as supportive or palliative therapies. Unfortunately the evidence for this assumption is less sound than AM fans try to make us believe. Before this background, better research is needed and more trials would be welcome. A brand-new paper might tell us more.

The purposes of this study were to compare the QOL in CAM users and non-CAM users and to determine whether AM use influences QOL among breast cancer patients during chemotherapy.

A cross-sectional survey was conducted at two outpatient chemotherapy centers. A total of 546 patients completed the questionnaires on AM use. QOL was evaluated based on the European Organization for Research and Treatment of Cancer (EORTC) core quality of life (QLQ-C30) and breast cancer-specific quality of life (QLQ-BR23) questionnaires.

A total of 70.7% of patients were identified as AM users. There was no significant difference in global health status scores and in all 5 subscales of the QLQ C30 functional scales between AM users and non-AM users. On the QLQ-C30 symptom scales, AM users (44.96±3.89) had significantly (p = 0.01) higher mean scores for financial difficulties than non-AM users (36.29±4.81). On the QLQ-BR23 functional scales, AM users reported significantly higher mean scores for sexual enjoyment (6.01±12.84 vs. 4.64±12.76, p = 0.04) than non-AM users. On the QLQ-BR23 symptom scales, AM users reported higher systemic therapy side effects (41.34±2.01 vs. 37.22±2.48, p = 0.04) and breast symptoms (15.76±2.13 vs. 11.08±2.62, p = 0.02) than non-AM users. Multivariate logistic regression analysis indicated that the use of CAM modality was not significantly associated with higher global health status scores (p = 0.71).

The authors drew the following conclusions: While the findings indicated that there was no significant difference between users and non-users of AM in terms of QOL, AM may be used by health professionals as a surrogate to monitor patients with higher systemic therapy side effects and breast symptoms. Furthermore, given that AM users reported higher financial burdens (which may have contributed to increased distress), patients should be encouraged to discuss the potential benefits and/or disadvantages of using AM with their healthcare providers.

One needs to caution, of course, that this was not an RCT, and therefore cause and effect cannot be taken for granted. Nevertheless, I believe, that these findings should make us think critically about the wide-spread notion that the supportive and palliative use of AM leads to an improvement of QOL in cancer patients.

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