Charlotte Leboeuf-Yde, DC,MPH,PhD, is professor in Clinical Biomechanics at the University of Southern Denmark and works at the French-European Institute of Chiropractic in Paris. She is a chiropractor with extensive research experience, for example, she was one of the first chiropractors to have studied adverse reactions of spinal manipulation.
Charlotte certainly knows a thing or two about adverse effects of spinal manipulation, and I have always found her work interesting. Therefore, I was delighted to find a recent blog post where she discussed the Cassidy study of 2008 and two opposed views on the validity of this much-discussed paper.
One team (Paulus &Thaler) argued, Charlotte explained, that the Cassidy case-control study is faulty, because vertebro-basilar stroke in general was not separated from stroke specifically caused by vertebral artery dissections, the presumed culprit in cervical spinal manipulation. According to Paulus & Thaler, this would potentially result in a dilution of ‘real’ manipulative-related strokes among all other causes of stroke that are much more common. They argue that the Cassidy-analyses therefore were polluted by this misclassification, whereas the other team (Murphy et al) vehemently disagrees.
The final word is clearly not yet pronounced on this issue, Charlotte concluded, and both teams agree that research has to address various methodological challenges to obtain a trustable answer. Nevertheless, without an international collaboration involving prospective cases this seems an almost impossible task, particularly in view of the rarity of the condition; problems in capturing all cases (going from the reversible to the permanent injuries); the likely large anatomical and physiological variations between individuals; and the daunting task of obtaining relevant and precise descriptions of treatments from a multitude of practitioners.
In the meantime, Charlotte concluded, “practitioners and patients have to make a decision, similarly to judging risk in other walks of life, such as, should I take the plane or stay at home?”
I have always thought highly of Charlotte’s work, however, her conclusion made me doubt whether my high opinion of her reasoning was justified.
Should I take the plane or stay at home?
This question is not remotely similar to the question “should I have chiropractic upper neck manipulation or not?”
Here are a the two main reasons why:
- Taking the plane of demonstrably effective in transporting you from A to B, while neck manipulation is not demonstrably effective for anything.
- If you want to go from A to B [assuming B is far way], you need to fly. If you have neck pain or other symptoms, you can employ plenty of therapies other than neck manipulations.
Charlotte Leboeuf-Yde, DC,MPH,PhD, may be a professor in Clinical Biomechanics etc., etc., however, logical and critical thinking do not seem to be her forte.
So, how should we deal with the risks of chiropractic neck manipulations? I think, we should deal with them as responsible healthcare professionals deal with any other suspected therapeutic risks: we must ask whether the known risks of the treatment outweigh the known benefits (as they do with spinal manipulation). If that is so, we have an ethical, legal and moral duty not to employ the therapy in question in routine care. At the same time, we must focus or research efforts on producing full clarity about the open questions. It’s called the precautionary principle!
Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”
This clearly begs the question IS IT EFFECTIVE?
This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.
The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”
In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.
Here are some of the most obvious reasons:
- there are far too few studies for a firm conclusion,
- the included RCTs lack scientific rigour,
- all trials originate from China where reliability seems to be a serious problem,
- traction is not a useful therapy for radiculopathy,
- the primary studies violate research ethics by not reporting adverse effects.
Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.
We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.
Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.
They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.
Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.
In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.
The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?
I think the answer is NO!
If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?
The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.
Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?
No, here is the answer directly from the ANF:
The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.
Yes, I was too.
The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!
But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:
An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.
The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.
Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.
… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.
Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.
I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.
Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.
The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.
So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.
END OF QUOTE
The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.
Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.
So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.
The risks of consulting a chiropractor have regularly been the subject of this blog (see for instance here, here and here). My critics believe that I am alarmist and have a bee in my bonnet. I think they are mistaken and believe it is important to warn the public of the serious complications that are being reported with depressing regularity, particularly in connection with neck manipulations.
It has been reported that the American model Katie May died earlier this year “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck” This is the conclusion drawn by the L.A. County Coroner.
According to Wikipedia, Katie tweeted on January 29, 2016, that she had “pinched a nerve in [her] neck on a photoshoot” and “got adjusted” at a chiropractor. She tweeted on January 31, 2016 that she was “going back to the chiropractor tomorrow.” On the evening of February 1, 2016, May “had begun feeling numbness in a hand and dizzy” and “called her parents to tell them she thought she was going to pass out.” At her family’s urging, May went to Cedars Sinai Hospital; she was found to be suffering a “massive stroke.” According to her father, she “was not conscious when we got to finally see her the next day. We never got to talk to her again.” Life support was withdrawn on February 4, 2016.
Katie’s death certificate states that she died when a blunt force injury tore her left vertebral artery, and cut off blood flow to her brain. It also says the injury was sustained during a “neck manipulation by chiropractor.” Her death is listed as accidental.
Katie’s family is said to be aware of the coroner’s findings. They would not comment on whether they or her estate would pursue legal action.
The coroner’s verdict ends the uncertainty about Katie’s tragic death which was well and wisely expressed elsewhere:
“…The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke four or five days later… Thus, it seems to be jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” … Her two chiropractic manipulations might well have either worsened an existing intimal tear or caused a new one that led to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.”
My conclusions are as before and I think they need to be put as bluntly as possible: avoid chiropractors – the possible risks outweigh the documented benefits – and if you simply cannot resist consulting one: DON’T LET HIM/HER TOUCH YOUR NECK!
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 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 encompasses many bizarre treatments, but one of the weirdest must be craniosacral therapy (CST). The assumptions underlying CTS are:
- light manual touch of the head moves the joints of the cranium;
- this movement stimulates the flow of the cerebrospinal fluid;
- the enhanced flow has profound and positive effects on human health.
None of these assumptions are supported by evidence. In fact, they are as implausible as assumptions in alternative medicine get.
CST was developed by the osteopath John Upledger, D.O. in the 1970s, as an offshoot osteopathy in the cranial field, or cranial osteopathy, which was developed in the 1930s by William Garner Sutherland. Apart from this confusing terminology, we are also confronted with a confusing array of therapeutic claims; CST seems to be recommended for most conditions.
And the evidence? As good as none!
This is why any new trial is worth a mention. A recent study tested CST in comparison to sham treatment in chronic non-specific neck pain patients. 54 blinded patients were randomized to either 8 weekly units of CST or light touch sham treatment. Outcomes were assessed before and after treatment (week 8) and a further 3 months later (week 20). The primary outcome was pain intensity on a visual analogue scale; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients’ global impression of improvement and safety.
In comparison to sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 as well as at week 20. Minimal clinically important differences in pain intensity at week 20 were reported by 78% of the CST patients, while 48% even had substantial clinical benefit. Significant differences at week 8 and 20 were also found for pain on movement, functional disability, physical quality of life and patients’ global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8; anxiety only at week 20. No serious adverse events were reported.
The authors from the Department of Internal and Integrative Medicine, University of Duisburg-Essen and the Institute of Integrative Medicine, University of Witten/Herdecke, Germany, concluded that CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and quality of life up to 3 months post intervention.
Oddly, this is not even close to the conclusion I am going to draw: inadequate control for placebo and other non-specific effects generated a false-positive result.
Who is correct?
I suggest we wait for an independent replication to decide.
Some people seem to believe that the field of alternative medicine resembles a quaint little cottage industry where money hardly matters. A new analysis shows how far from the truth this impression is.
In the 2007 US National Health Interview Survey, use of complementary health approaches, reasons for this use, and associated out of pocket (OOP) costs were captured in a nationally representative sample of 5,467 US adults. Ordinary least square regression models that controlled for co-morbid conditions were used to estimate aggregate and per person OOP costs associated with 14 painful health conditions.
The analyses suggest that individuals using complementary approaches spent a total of $14.9 billion OOP on these approaches to manage three painful conditions: arthritis, back pain and fibromyalgia. Around 7.5 billion of that total was spent on consulting practitioners such as chiropractors and acupuncturists. Total OOP expenditures seen in those using complementary approaches for their back pain ($8.7 billion) far outstripped that of any other condition, with the majority of these costs ($4.7 billion) resulting from visits to complementary providers. Annual condition-specific per-person OOP costs varied from a low of $568 for regular headaches, to a high of $895 for fibromyalgia. The total expenditure on complementary medicine was comparable to that on conventional care.
The authors concluded that adults in the United States spent $14.9 billion OOP on complementary health approaches (e.g., acupuncture, chiropractic, herbal medicines) to manage painful conditions including back pain ($8.7 billion). This back pain estimate is almost 1/3rd of total conventional healthcare expenditures for back pain ($30.4 billion) and 2/3rds higher than conventional OOP expenditures ($5.1 billion).
These are truly eye-watering sums. The obvious question is: IS THIS MONEY WELL-SPENT?
The short answer, I fear, is NO!
The alternative therapies in question are not based on compelling evidence in the management of these painful conditions. Some are clearly not better than placebo, and others are apparently supported by some research but its quality is hardly good enough to rely upon.
This level expenditure is both impressive and worrying. It highlights an enormous waste of resources, alerts us to an urgent need for truly rigorous research, and demonstrates how high the stakes really are.
Nonspecific neck pain is extremely common, often disabling, and very costly for us all. If we believe those who earn their money with them, effective treatments for the condition abound. One of these therapies is osteopathy. But does osteopathic manipulation/mobilisation really work?
The objective of a recent review (the link I originally put in here does not work, I will supply a new one as soon as the article becomes available on Medline) was to find out. Specifically, the authors wanted to assess the effectiveness of osteopathic manipulative treatment (OMT) in the management of chronic nonspecific neck pain regarding pain, functional status, and adverse events.
Electronic literature searches unrestricted by language were performed in March 2014. A manual search of reference lists and personal communication with experts identified additional studies. Only randomized clinical trials (RCTs) were included, and studies of specific neck pain or single treatment techniques were excluded. Primary outcomes were pain and functional status, and secondary outcome was adverse events.
Studies were independently reviewed using a standardized data extraction form. Mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated for primary outcomes. GRADE was used to assess quality of the evidence.
Of 299 identified articles, 18 were evaluated and 15 excluded. The three included RCTs had low risk of bias. The results show that moderate-quality evidence suggested OMT had a significant and clinically relevant effect on pain relief (MD: -13.04, 95% CI: -20.64 to -5.44) in chronic nonspecific neck pain, and moderate-quality evidence suggested a non-significant difference in favour of OMT for functional status (SMD: -0.38, 95% CI: -0.88 to -0.11). No serious adverse events were reported.
The authors concluded that, based on the three included studies, the review suggested clinically relevant effects of OMT for reducing pain in patients with chronic nonspecific neck pain. Given the small sample sizes, different comparison groups, and lack of long-term measurements in the few available studies, larger, high-quality randomized controlled trials with robust comparison groups are recommended.
Yet again I am taken aback by several things simultaneously:
- the extreme paucity of RCTs, particularly considering that neck pain is one of the main indication for osteopaths,
- the rather uncritical text by the authors,
- the nonsensical conclusions.
Let me offer my own conclusions which are, I hope, a little more realistic:
GIVEN THE PAUCITY OF THE RCTs AND THEIR SMALL SAMPLE SIZES, IT IS NOT POSSIBLE TO CLAIM THAT OMT FOR NONSPECIFIC NECK PAIN IS AN EVIDENCE-BASED APPROACH