A meta-analysis compared the effectiveness of spinal manipulation therapies (SMT), medical management, physical therapies, and exercise for acute and chronic low back pain. Studies were chosen based on inclusion in prior evidence syntheses. Effect sizes were converted to standardized mean effect sizes and probabilities of recovery. Nested model comparisons isolated non-specific from treatment effects. Aggregate data were tested for evidential support as compared to shams.
The results suggest that, of 84% acute pain variance, 81% was from non-specific factors and 3% from treatment. No treatment was better than sham. Most acute results were within 95% confidence bands of that predicted by natural history alone. For chronic pain, 66% out of 98% was non-specific, but treatments influenced 32% of outcomes. Chronic pain treatments also fitted within 95% confidence bands as predicted by natural history. The evidential support for treating chronic back pain as compared to sham groups was weak, but chronic pain appeared to respond to SMT, while whole systems of chiropractic management did not.
The authors of this intriguing paper conclude: Meta-analyses can extract comparative effectiveness information from existing literature. The relatively small portion of outcomes attributable to treatment explains why past research results fail to converge on stable estimates. The probability of treatment superiority between treatment arms was equivalent to that expected by random selection. Treatments serve to motivate, reassure, and calibrate patient expectations – features that might reduce medicalization and augment self-care. Exercise with authoritative support is an effective strategy for acute and chronic low back pain.
This essentially indicates that none of these treatments for low back pain are convincingly effective. In turn this means we might as well stop using them. Alternatively, we could opt for the therapy that carries the least risks and cost. As the authors point out, this treatment is exercise.
Visceral Manipulation (VM) was developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, VM is a miracle cure for just about every disease imaginable. On one of his many websites, Barral claims that: Comparative Studies found Visceral Manipulation Beneficial for Various Disorders
|Acute Disorders Whiplash Seatbelt Injuries Chest or Abdominal Sports Injuries
Digestive Disorders Bloating and Constipation Nausea and Acid Reflux GERD Swallowing Dysfunctions
Women’s and Men’s Health Issues Chronic Pelvic Pain Endometriosis Fibroids and Cysts Dysmenorrhea Bladder Incontinence Prostate Dysfunction Referred Testicular Pain Effects of Menopause
Emotional Issues Anxiety and Depression Post-Traumatic Stress Disorder
|Musculoskeletal Disorders Somatic-Visceral Interactions Chronic Spinal Dysfunction Headaches and Migraines Carpal Tunnel Syndrome Peripheral Joint Pain Sciatica
Pain Related to Post-operative Scar Tissue Post-infection Scar Tissue Autonomic Mechanisms
Pediatric Issues Constipation and Gastritis Persistent Vomiting Vesicoureteral Reflux Infant Colic
This sounds truly wonderful, and we want to learn more. The text goes on to explain that:
VM assists functional and structural imbalances throughout the body including musculoskeletal, vascular, nervous, urogenital, respiratory, digestive and lymphatic dysfunction. It evaluates and treats the dynamics of motion and suspension in relation to organs, membranes, fascia and ligaments. VM increases proprioceptive communication within the body, thereby revitalizing a person and relieving symptoms of pain, dysfunction, and poor posture.
Fascinating! Sceptics might think that such phraseology is a prime example of pseudo-scientific gobbledegook – but wait:
An integrative approach to evaluation and treatment of a patient requires assessment of the structural relationships between the viscera, and their fascial or ligamentous attachments to the musculoskeletal system. Strains in the connective tissue of the viscera can result from surgical scars, adhesions, illness, posture or injury. Tension patterns form through the fascial network deep within the body, creating a cascade of effects far from their sources for which the body will have to compensate. This creates fixed, abnormal points of tension that the body must move around, and this chronic irritation gives way to functional and structural problems.
Imagine an adhesion around the lungs. It would create a modified axis that demands abnormal accommodations from nearby body structures. For example, the adhesion could alter rib motion, which could then create imbalanced forces on the vertebral column and, with time, possibly develop a dysfunctional relationship with other structures. This scenario highlights just one of hundreds of possible ramifications of a small dysfunction – magnified by thousands of repetitions each day….the sinuvertebral nerves innervate the intervertebral disks and have direct connections with the sympathetic nervous system, which innervates the visceral organs. The sinuvertebral nerves and sympathetic nervous system are linked to the spinal cord, which has connections with the brain. In this way someone with chronic pain can have irritations and facilitated areas not only in the musculoskeletal system (including joints, muscles, fascia, and disks) but also the visceral organs and their connective tissues (including the liver, stomach, gallbladder, intestines and adrenal glands), the peripheral nervous system, the sympathetic nervous system and even the spinal cord and brain….
Visceral Manipulation is based on the specific placement of soft manual forces to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations can potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body….Visceral Manipulation works only to assist the forces already at work. Because of that, trained therapists can be sure of benefiting the body rather than adding further injury or disorganization.
By now, we are all wondering how Barral was able to dream up this truly fantastic panacea. Reading on, we learn that it was not ‘dreamt up’ at all – it was developed through painstaking research and rigorous science:
Jean-Pierre Barral first became interested in biomechanics while working as a registered physical therapist of the Lung Disease Hospital in Grenoble, France. That’s where he met Dr. Arnaud, a recognized specialist in lung diseases and a master of cadaver dissection. Working with Dr. Arnaud, Barral followed patterns of stress in the tissues of cadavers and studied biomechanics in living subjects. This introduced him to the visceral system, its potential to promote lines of tension within the body, and the notion that tissues have memory. All this was fundamental to his development of Visceral Manipulation. In 1974, Barral earned his diploma in osteopathic medicine from the European School of Osteopathy in Maidstone, England. Working primarily with articular and structural manipulation, he began forming the basis for Visceral Manipulation during an unusual session with a patient he’d been treating with spinal manipulations.
During the preliminary examination, Barral was surprised to find appreciable movement. The patient confirmed that he felt relief from his back pain after going to an “old man who pushed something in his abdomen.”
This incident piqued Barral’s interest in the relationship between the viscera and the spine. That’s when he began exploring stomach manipulations with several patients, with successful results gradually leading him to develop Visceral Manipulation. Between 1975 and 1982, Barral taught spinal biomechanics at England’s European School of Osteopathy. In collaboration with Dr. Jean-Paul Mathieu and Dr. Pierre Mercier, he published Articular Vertebrae Diagnosis.
With all this serious science, we are, of course, keen to learn about the studies of VM published in peer-reviewed journals. Amazingly, there seems to be an acute shortage of that sort of thing. You can buy many books by Barral, but to the best of my knowledge, there are no studies of VM by Barral or anyone else in medical journals. My own searches resulted in precisely zero papers, and Medline returns not a single article of Barral J-P on VM, osteopathy or manipulation.
This is odd, I must say!
Could all this important-sounding scientific (some might say pseudo-scientific) text be a complete fake? Where are the ‘COMPARATIVE STUDIES’ mentioned above? Could it be that VM is nothing more than a rip-off for gullible half-wits?
I really cannot imagine - after all, VM is even being taught at some universities! And one could never make all this up; that would be dishonest!!!
I hope my readers can point me to the proper science of VM and thus put my suspicions to rest.
If we ask how effective spinal manipulation is as a treatment of back pain, we get all sorts of answers. Therapists who earn their money with it – mostly chiropractors, osteopaths and physiotherapists - are obviously convinced that it is effective. But if we consult more objective sources, the picture changes dramatically. The current Cochrane review, for instance, arrives at this conclusion: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies.
Such reviews tend to pool all studies together regardless of the nature of the practitioner. But perhaps one type of clinician is better than the next? Certainly many chiropractors are on record claiming that they are the best at spinal manipulations. Yet it is conceivable that physiotherapists who do manipulations without being guided by the myth of ‘adjusting subluxations’ have an advantage over chiropractors. Three very recent systematic reviews might go some way to answer these questions.
The purpose of the first systematic review was to examine the effectiveness of spinal manipulations performed by physiotherapists for the treatment of patients with low back pain. The authors found 6 RCTs that met their inclusion criteria. The most commonly used outcomes were pain rating scales and disability indexes. Notable results included varying degrees of effect sizes favouring spinal manipulations and minimal adverse events resulting from this intervention. Additionally, the manipulation group in one study reported significantly less medication use, health care utilization, and lost work time. The authors concluded that there is evidence to support the use of spinal manipulation by physical therapists in clinical practice. Physical therapy spinal manipulation appears to be a safe intervention that improves clinical outcomes for patients with low back pain.
The second systematic Review was of osteopathic intervention for chronic, non-specific low back pain (CNSLBP). Only two trials met the authors’ inclusion criteria. They had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up. The authors drew the following conclusions: There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.
The third systematic review sought to determine the benefits of chiropractic treatment and care for back pain on well-being, and aimed to explore to what extent chiropractic treatment and care improve quality of life. The authors identified 6 studies (4 RCTs and two observational studies) of varying quality. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of other/extra treatments as a positive outcome; two studies reported a positive effect of chiropractic intervention on pain, and two studies reported a positive effect on disability. The authors concluded that it is difficult to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.
Yes, yes, yes, I know: the three reviews are not exactly comparable; so we cannot draw firm conclusions from comparing them. Five points seem to emerge nevertheless:
- The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
- There seem to be considerable differences according to the nature of the therapist.
- Physiotherapists seem to have relatively sound evidence to justify their manipulations.
- Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
- Considering that the vast majority of serious complications after spinal manipulation has occurred with chiropractors, it would seem that chiropractors are the profession with the worst track record regarding manipulation for back pain.
Did I previously imply that osteopaths are not very research-active? Shame on me!
Here are two brand-new studies by osteopaths and they both seem to show that their treatments work.
Well, perhaps we better have a closer look at them before we start praising osteopathic research efforts.
THE FIRST STUDY
Researchers from the ‘European Institute for Evidence Based Osteopathic Medicine’ in Chieti, Italy, investigated the effect of osteopathic manipulative therapy (OMT) on the length of hospital-stay (LOHS) in premature infants. They conducted an RCT on 110 preterm newborns admitted to a single specialised unit. Thus the subjects with a gestational age between 28 and 38 weeks were randomized to receive either just routine care, or routine care with OMT for the period of hospitalization. Endpoints were differences in LOHS and daily weight gain. The results showed a mean difference in LOHS between the OMT and the control group: -5.906 days (95% C.I. -7.944, -3.869; p<0.001). However, OMT was not associated with any change in daily weight gain.
The authors’ conclusion was bold: OMT may have an important role in the management of preterm infants hospitalization.
THE SECOND STUDY
The second investigation suggested similarly positive effects of OMT on LOHS in a different setting. Using a retrospective cohort study, US osteopaths wanted to determine whether there is a relationship between post-operative use of OMT and post-operative outcomes in gastrointestinal surgical patients, including time to flatus, clear liquid diet, and bowel movement [all indicators for the length of the post-operative ileus] as well as LOHS. They thus assessed the records of 55 patients who underwent a major gastrointestinal operation in a hospital that had been routinely offering OMT to its patients. The analyses showed that 17 patients had received post-operative OMT and 38 had not.The two groups were similar in terms of all variables the researchers managed to assess. The time to bowel movement and to clear liquid diet did not differ significantly between the groups. The mean time to flatus was 4.7 days in the non-OMT group and 3.1 days in the OMT group (P=.035). The mean post-operative hospital LOHS was also reduced significantly with OMT, from 11.5 days in the non-OMT group to 6.1 days in the OMT group (P=.006).
The authors concluded that OMT applied after a major gastrointestinal operation is associated with decreased time to flatus and decreased postoperative hospital LOHS.
WHAT SHOULD WE MAKE OF THESE RESULTS?
Some people may have assumed that OMT is for bad backs; these two studies imply, however, that it can do much more. If the findings are correct, they have considerable implications: shortening the time patients have to spend in hospital would not only decrease individual suffering, it would also save us all tons of money! But do these results hold water?
The devil’s advocate in me cannot help but being more than a little sceptical. I fail to see how OMT might shorten LOHS; it just does not seem plausible! Moreover, some of the results seem too good to be true. Could there be any alternative explanations for the observed findings?
The first study, I think, might merely demonstrate that more time spent handling premature babies provides a powerful developmental stimulus. Therefore the infants are quicker ready to leave hospital compared to those children who did not receive this additional boost. But the effect might not at all be related to OMT per se; if, for instance, the parents had handled their children for the same amount of time, the outcome would probably have been quite similar, possibly even better.
The second study is not an RCT and therefore it tells us little about cause and effect. We might speculate, for instance, that those patients who elected to have OMT were more active, had lived healthier lives, adhered more rigorously to a pre-operative diet, or differed in other variables from those patients who chose not to bother with OMT. Again, the observed difference in the duration of the post-operative ileus and consequently the LOHS would be entirely unrelated to OMT.
I suggest therefore to treat these two studies with more than just a pinch of salt. Before hospitals all over the world start employing osteopaths right, left and centre in order to shorten their average LOHS, we might be well advised to plan and conduct a trial that avoids the pitfalls of the research so far. I would bet a fiver that, once we do a proper independent replication, we will find that both investigations did, in fact, generate false positive results.
My conclusion from all this is simple: RESEARCH CAN SOMETIMES BE MISLEADING, AND POOR QUALITY RESEARCH IS ALMOST INVARIABLY MISLEADING.
On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.
Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.
The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.
The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.
The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.
This review is timely and sound. Yet several factors need consideration:
1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.
2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.
3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]
4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.
Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.
Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.
The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.
A recent post of mine seems to have stimulated a lively discussion about the question IS THERE ANY GOOD EVIDENCE AT ALL FOR OSTEOPATHIC TREATMENTS? By and large, osteopaths commented that they are well aware that their signature interventions for their most frequently treated condition (back pain) lack evidential support and that more research is needed. At the same time, many osteopaths seemed to see little wrong in making unsubstantiated therapeutic claims. I thought this was remarkable and feel encouraged to write another post about a similar topic.
Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:
STRUCTURAL PROBLEMS, such as those affecting the proper mobility and function of the body’s framework, can lead to a range of problems. These may include:
- Postural – such as scoliosis
- Respiratory – such as asthma
- Manifestations of brain injury – such as cerebral palsy and spasticity
- Developmental – with delayed physical or intellectual progress, perhaps triggering learning behaviour difficulties
- Infections – such as ear and throat infections or urinary disturbances, which may be recurrent.
OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth transition into normal, healthy adult life.
As children cannot give informed consent, this is even more tricky than treating adults with therapies of questionable value. It is therefore important, I think, to ask whether osteopathic treatments of children is based on evidence or just on wishful thinking or the need to maximise income. As it happens, my team just published an article about these issues in one of the highest-ranking paediatrics journal.
The objective of our systematic review was to critically evaluate the effectiveness of osteopathic manipulative treatment (OMT) as a treatment of paediatric conditions. Eleven databases were searched from their respective inceptions to November 2012. Only randomized clinical trials (RCTs) were included, if they tested OMT against any type of control intervention in paediatric patients. The quality of all included RCTs was assessed using the Cochrane criteria.
Seventeen trials met our inclusion criteria. Only 5 RCTs were of high methodological quality. Of those, 1 favoured OMT, whereas 4 revealed no effect compared with various control interventions. Replications by independent researchers were available for two conditions only, and both failed to confirm the findings of the previous studies. Seven RCTs suggested that OMT leads to a significantly greater reduction in the symptoms of asthma, congenital nasolacrimal duct obstruction, daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic, otitis media, or postural asymmetry compared with various control interventions. Seven RCTs indicated that OMT had no effect on the symptoms of asthma, cerebral palsy, idiopathic scoliosis, obstructive apnoea, otitis media, or temporo-mandibular disorders compared with various control interventions. Three RCTs did not report between-group comparisons. The majority of the included RCTs did not report the incidence rates of adverse-effects.
Our conclusion is likely to again dissatisfy many osteopaths: The evidence of the effectiveness of OMT for paediatric conditions remains unproven due to the paucity and low methodological quality of the primary studies.
So, what does this tell us? I am sure osteopaths will disagree, but I think it shows that for no paediatric condition do we have sufficient evidence to show that OMT is effective. The existing RCTs are mostly of low quality. There is a lack of independent replication of the few studies that suggested a positive outcome. And to make matters even worse, osteopaths seem to be violating the most basic rule of medical research by not reporting adverse-effects in their clinical trials.
I rest my case – at least for the moment.
According to the UK General Osteopathic Council, osteopathy is a system of diagnosis and treatment for a wide range of medical conditions. It works with the structure and function of the body, and is based on the principle that the well-being of an individual depends on the skeleton, muscles, ligaments and connective tissues functioning smoothly together.
To an osteopath, for your body to work well, its structure must also work well. So osteopaths work to restore your body to a state of balance, where possible without the use of drugs or surgery. Osteopaths use touch, physical manipulation, stretching and massage to increase the mobility of joints, to relieve muscle tension, to enhance the blood and nerve supply to tissues, and to help your body’s own healing mechanisms. They may also provide advice on posture and exercise to aid recovery, promote health and prevent symptoms recurring.
In case this sounds a bit vague to you, and in case you wonder what this “wide range of conditions” might be, rest assured, you are not alone. So let’s try to be a little more concrete and clear up some of the confusion around this profession. There are two very different types of osteopaths: US osteopaths are virtually identical with conventionally trained physicians; their qualification is equivalent to those of medical practitioners and they can, for instance, specialise to become GPs or neurologists or surgeons etc. Elsewhere, osteopaths are non-medically qualified alternative practitioners. In the UK, they are regulated by statute, in other counties not. And as to the “wide range of conditions”, I am not aware of any disease or symptom for which the evidence is convincing.
Osteopaths most commonly treat patients suffering from Chronic Non-Specific Low Back Pain (CNSLBP) using a set of non-drug interventions, particularly manual therapies such as spinal mobilisation and manipulation. The question is how well are these techniques supported by reliable evidence. To answer it, we must not cherry-pick our evidence but we need to consider the totality of the reliable studies; in other words, we need an up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for CNSLBP was recently published by Australian experts.
A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.
I guess, this comes as a bit of a surprise to many consumers who have been told over and over again by osteopaths and their supporters that the evidence is sound. Personally, I am not at all surprised because, two years ago, we published a similar review, albeit with a wider spectrum of conditions, namely any type of musculoskeletal pain. We managed to include a total of 16 RCTs. Five of them suggested that osteopathy leads to a significantly stronger reduction of musculoskeletal pain than a range of control interventions. However, 11 RCTs indicated that osteopathy, compared to controls, generates no change in musculoskeletal pain. At the time, we felt that these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.
This lack of convincing evidence is in sharp contrast to the image of osteopaths as back pain specialists. The UK General Osteopathic council, for instance, sates that Osteopaths’ patients include the young, older people, manual workers, office professionals, pregnant women, children and sports people. Patients seek treatment for a wide variety of conditions, including back pain…In addition, thousands of websites try to convince the consumer that osteopathy is a well-proven therapy for chronic low back pain – not to mention the many other conditions for which the evidence is even less sound.
As so often in alternative medicine, these claims seem to be based more on wishful thinking than on reliable evidence. And as so often, the victims of bogus claims are the consumers who are being misled into making wrong therapeutic decisions, wasting money, and delaying recovery from illness.
Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.
Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus inert interventions, sham SMT, other interventions, and for SMT as an adjunct to other forms of treatment.
The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.
The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”
In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”
This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.
Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.
Musculoskeletal and rheumatic conditions, often just called “arthritis” by lay people, bring more patients to alternative practitioners than any other type of disease. It is therefore particularly important to know whether alternative medicines (AMs) demonstrably generate more good than harm for such patients. Most alternative practitioners, of course, firmly believe in what they are doing. But what does the reliable evidence show?
To find out, ‘Arthritis Research UK’ has sponsored a massive project lasting several years to review the literature and critically evaluate the trial data. They convened a panel of experts (I was one of them) to evaluate all the clinical trials that are available in 4 specific clinical areas. The results for those forms of AM that are to be taken by mouth or applied topically have been published some time ago, now the report, especially written for lay people, on those treatments that are practitioner-based has been published. It covers the following 25 modalities:
Chiropractic (spinal manipulation)
Kinesiology (applied kinesiology)
Magnet therapy (static magnets)
Osteopathy (spinal manipulation)
Qigong (internal qigong)
Our findings are somewhat disappointing: only very few treatments were shown to be effective.
In the case of rheumatoid arthritis, 24 trials were included with a total of 1,500 patients. The totality of this evidence failed to provide convincing evidence that any form of AM is effective for this particular condition.
For osteoarthritis, 53 trials with a total of ~6,000 patients were available. They showed reasonably sound evidence only for two treatments: Tai chi and acupuncture.
Fifty trials were included with a total of ~3,000 patients suffering from fibromyalgia. The results provided weak evidence for Tai chi and relaxation-therapies, as well as more conclusive evidence for acupuncture and massage therapy.
Low back pain had attracted more research than any of the other diseases: 75 trials with ~11,600 patients. The evidence for Alexander Technique, osteopathy and relaxation therapies was promising by not ultimately convincing, and reasonably good evidence in support of yoga and acupuncture was also found.
The majority of the experts felt that the therapies in question did not frequently cause harm, but there were two important exceptions: osteopathy and chiropractic. For both, the report noted the existence of frequent yet mild, as well as serious but rare adverse effects.
As virtually all osteopaths and chiropractors earn their living by treating patients with musculoskeletal problems, the report comes as an embarrassment for these two professions. In particular, our conclusions about chiropractic were quite clear:
There are serious doubts as to whether chiropractic works for the conditions considered here: the trial evidence suggests that it’s not effective in the treatment of fibromyalgia and there’s only little evidence that it’s effective in osteoarthritis or chronic low back pain. There’s currently no evidence for rheumatoid arthritis.
Our point that chiropractic is not demonstrably effective for chronic back pain deserves some further comment, I think. It seems to be in contradiction to the guideline by NICE, as chiropractors will surely be quick to point out. How can this be?
One explanation is that, since the NICE-guidelines were drawn up, new evidence has emerged which was not positive. The recent Cochrane review, for instance, concludes that spinal manipulation “is no more effective for acute low-back pain than inert interventions, sham SMT or as adjunct therapy”
Another explanation could be that the experts on the panel writing the NICE-guideline were less than impartial towards chiropractic and thus arrived at false-positive or over-optimistic conclusions.
Chiropractors might say that my presence on the ‘Arthritis Research’-panel suggests that we were biased against chiropractic. If anything, the opposite is true: firstly, I am not even aware of having a bias against chiropractic, and no chiropractor has ever demonstrated otherwise; all I ever aim at( in my scientific publications) is to produce fair, unbiased but critical assessments of the existing evidence. Secondly, I was only one of a total of 9 panel members. As the following list shows, the panel included three experts in AM, and most sceptics would probably categorise two of them (Lewith and MacPherson) as being clearly pro-AM:
Professor Michael Doherty – professor of rheumatology, University of Nottingham
Professor Edzard Ernst – emeritus professor of complementary medicine, Peninsula Medical School
Margaret Fisken – patient representative, Aberdeenshire
Dr Gareth Jones (project lead) – senior lecturer in epidemiology, University of Aberdeen
Professor George Lewith – professor of health research, University of Southampton
Dr Hugh MacPherson – senior research fellow in health sciences, University of York
Professor Gary Macfarlane (chair of committee) – professor of epidemiology, University of Aberdeen
Professor Julius Sim – professor of health care research, Keele University
Jane Tadman – representative from Arthritis Research UK, Chesterfield
What can we conclude from all that? I think it is safe to say that the evidence for practitioner-based AMs as a treatment of the 4 named conditions is disappointing. In particular, chiropractic is not a demonstrably effective therapy for any of them. This, of course begs the question, for what condition is chiropractic proven to work! I am not aware of any, are you?
Daniels and Vogel recently published an article entitled “Consent in osteopathy: A cross sectional survey of patients’ information and process preferences” (INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE 2012, 15:3, p.92-102). It addresses an important yet woefully under-researched area.
I find most laudable that two osteopaths conduct research into medical ethics; but the questions still are, does the article tell us anything worth knowing and is it sufficiently rigorous and critical? As the journal does not seem to be available on Medline, I cannot provide a link. I therefore take the liberty of quoting the most important bits from directly the abstract here.
Objective: To explore and describe patients’ preferences of consent procedures in a sample of UK osteopathic patients.
Methods: A cross sectional survey using a new questionnaire was performed incorporating paper and web-based versions of the instruments. 500 copies were made available, (n = 200) to patients attending the British School of Osteopathy (BSO) clinic, and (n = 300) for patients attending 30 randomly sampled osteopaths in practice. Quantitative data were analysed descriptively to assess patient preferences; non-parametric analyses were performed to test for preference difference between patients using demographic characteristics.
Results: 124 completed questionnaires were returned from the BSO sample representing a 41% response rate. None were received from patients attending practices outside of the BSO clinic. The majority (98%) of patient respondents thought that having information about rare yet potentially severe risks of treatment was important. Patients’ preferred to have this information presented during the initial consultation (72%); communication method favoured was verbal (90%). 99% would like the opportunity to ask questions about risks, and all respondents (100%) consider being informed about their current diagnosis as important.
Conclusion: Patients endorse the importance of information exchange as part of the consent process. Verbal communication is very important and is the favoured method for both receiving information and giving consent. Further research is required to test the validity of these results in practice samples
The 0% response-rate in patients from non-BSO practices is, of course, remarkable and not without irony. In my view, it highlights better than anything else the fact that informed consent rarely appears on the osteopathic radar screen. In a way, this increases the praise we should give the two authors for tackling the issue.
The central question of the survey is whether patients want to know about the risks of osteopathy. This is more than a little bizarre: informed consent is not an option, it is a legal, moral and ethical obligation. It seems therefore odd to ask the question “do you want to learn about the risks which you are about to be exposed to?”
Even odder is, I think, the second question “when do you want to receive this information?” It goes without saying that informed consent has to happen before the intervention! This is what, common sense tells us, the law dictates and ethical codes prescribe.
There is general agreement amongst health care professionals and ethicist that verbal consent does suffice in most therapeutic situations, that patients must have the opportunity to ask questions, and that informed consent also extends to diagnostic issues. So, the questions referring to these issues are also a bit strange or naive, in my view.
The article might be revealing mostly by what it does not address rather than by what it tells us. It would be really valuable to know the percentage of osteopaths who abide by the legal, moral and ethical imperative of informed consent in their daily practice. To the best of my knowledge, this information is not available [if anyone has such information, please let me know and provide the reference]. Assuming that it is similar to the percentage of UK chiropractors who obtain informed consent, it might be seriously wanting: only 45% of them routinely obtain informed consent from their patients.
Another issue that, in my view, would be relevant to clarify is the nature of the information provided by osteopaths to patients, other than that of serious risks associated with spinal manipulation/mobilisation. Do they tell their patients about the evidence suggesting that osteopathy does (not) work for the condition at hand? Do they elaborate on non-osteopathic treatments for that disease? I fear that the answers to these questions might well be negative.
Imagine a patient being told that there is no good evidence for effectiveness of osteopathy, that the possibility of some harm exists, and that other interventions might actually do more good than harm than what the osteopath has to offer. How likely is it that this patient would agree to receiving osteopathic treatment?
For most alternative practitioners, including osteopaths, informed consent and most other important ethical issues have so far remained highly uncomfortable areas. This may have a good and simple reason: they have the potential to become real and serious threats to their current practice and business. I suspect this is why there is so very little awareness of and research into the ethics of alternative medicine: “best not to wake sleeping lions”, seems to be the general attitude.
The survey by Daniels and Vogel, even though it touches upon an important topic, avoids the truly pertinent questions. It therefore looks to me a bit like a fig leaf shamefully hiding an area of potential embarrassment.
And where do we go from here? I predict that the current strategy of alternative practitioners to ignore and violate medical ethics as much as possible will not be tolerated for much longer. Double standards in health care cannot and should not survive. The sooner we begin addressing some of these uncomfortable questions with rigorous research, the better – perhaps not for the practitioner but certainly for the patient.