‘Healing, hype or harm? A critical analysis of complementary or alternative medicine’ is the title of a book that I edited and that was published in 2008. Its publication date coincided with that of ‘Trick or Treatment?’ and therefore the former was almost completely over-shadowed by the latter. Consequently few people know about it. This is a shame, I think, and this post is dedicated to encouraging my readers to have a look at ‘Healing, hype or harm?’
One reviewer commented on Amazon about this book as follows: Vital and informative text that should be read by everyone alongside Ben Goldacre’s ‘Bad Science’ and Singh and Ernt’s ‘Trick or Treatment’. Everyone should be able to made informed choices about the treatments that are peddled to the desperate and gullible. As Tim Minchin famously said ‘What do you call Alternative Medicine that has been proved to work? . . . Medicine!’
This is high praise indeed! But I should not omit the fact that others have commented that they were appalled by our book and found it “disappointing and unsettling”. This does not surprise me in the least; after all, alternative medicine has always been a divisive subject.
The book was written by a total of 17 authors and covers many important aspects of alternative medicine. Some of its most famous contributors are Michael Baum, Gustav Born, David Colquhoun, James Randi and Nick Ross. Some of the most important subjects include:
As already mentioned, our book is already 6 years old; however, this does not mean that it is now out-dated. The subject areas were chosen such that it will be timely for a long time to come. Nor does this book reflect one single point of view; as it was written by over a dozen different experts with vastly different backgrounds, it offers an entire spectrum of views and attitudes. It is, in a word, a book that stimulates critical thinking and thoughtful analysis.
I sincerely think you should have a look at it… and, in case you think I am hoping to maximise my income by telling you all this: all the revenues from this book go to charity.
On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.
The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).
Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don't have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.
The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.
No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.
Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.
A recent article by Frank King (DC, ND) caught my eye. In it, he praises homeopathy in glowing terms. First I was not sure whether he is pulling my leg; then I decided he was entirely serious. Am I mistaken?
Here is the crucial passage for you to decide:
Even though the founder of homeopathy lived more than 200 years ago, he wrote about genetics. Samuel Hahnemann, MD, not only emphasized the importance of natural healing methods, he also recognized the influence of genetics in some types of illnesses.
Hahnemann used the term miasm to refer to the source of chronic diseases. He recognized several miasms, such as psora (meaning “itch”), syphilis, tuberculosis, gonorrhea, and cancer. In addition to recognizing and naming these miasms, he developed homeopathic remedies to address and correct them.
When your patient treatment protocols reach a plateau with chiropractic and nutritional support, consider turning to the constitutional homeopathic remedies, miasms, and detoxification formulas. Toxins inhibit the body’s ability to heal by interfering with the normal nerve pathways.
For example: Due to the steady growth in heavy-metal exposure modern civilization has experienced since the Industrial Revolution, mercury could be considered a modern miasm. Animal studies indicate that mercury’s negative effects can carry through to future generations, just as some of the other miasms do.
Mercurius is homeopathically prepared mercury to help address the symptoms of mercury toxicity, which can manifest as slow thought processes, chilliness, weak digestion, sore throat, and night sweats.
This is just one of the more than 1,300 Homeopathic Pharmacopoeia of the United States ingredients recognized by the FDA.
Homeopathy can be the perfect complement to chiropractic care. It can correct the energetics (including the genetics) of the deepest areas of the body, mind, and emotions, where the hands of the chiropractor can’t reach.
In case you don’t know much about homeopathy, it is true that Hahnemann believed in ‘miasms’, i.e. noxious vapours as the cause of a disposition to certain diseases. Even by Hahnemann’s standards, it turned out to be one of his more crazy ideas. To claim that, by believing in miasms, he foresaw the science of genetics is more than a little far-fetched.
In case you are not sure what toxins do in our body, rest assured that only chiropractors believe they inhibit the body’s ability to heal by interfering with the normal nerve pathways.
And in case you think you suffer from slow thought processes, chilliness, weak digestion, sore throat, and night sweats and thus feel like rushing to the next pharmacy to buy some Mercurius, don’t! This would not eliminate any mercury from your body, it would just eliminate cash from your pocket (in that sense, homeopathy might indeed occasionally reach where the hands of the chiropractor can’t reach).
One can say a lot about alternative medicine, I think, but nobody can deny that it regularly provides us with perfect (unintentional) comedy.
Chiropractors, like other alternative practitioners, use their own unique diagnostic tools for identifying the health problems of their patients. One such test is the Kemp’s test, a manual test used by most chiropractors to diagnose problems with lumbar facet joints. The chiropractor rotates the torso of the patient, while her pelvis is fixed; if manual counter-rotative resistance on one side of the pelvis by the chiropractor causes lumbar pain for the patient, it is interpreted as a sign of lumbar facet joint dysfunction which, in turn would be treated with spinal manipulation.
All diagnostic tests have to fulfil certain criteria in order to be useful. It is therefore interesting to ask whether the Kemp’s test meets these criteria. This is precisely the question addressed in a recent paper. Its objective was to evaluate the existing literature regarding the accuracy of the Kemp’s test in the diagnosis of facet joint pain compared to a reference standard.
All diagnostic accuracy studies comparing the Kemp’s test with an acceptable reference standard were located and included in the review. Subsequently, all studies were scored for quality and internal validity.
Five articles met the inclusion criteria. Only two studies had a low risk of bias, and three had a low concern regarding applicability. Pooling of data from studies using similar methods revealed that the test’s negative predictive value was the only diagnostic accuracy measure above 50% (56.8%, 59.9%).
The authors concluded that currently, the literature supporting the use of the Kemp’s test is limited and indicates that it has poor diagnostic accuracy. It is debatable whether clinicians should continue to use this test to diagnose facet joint pain.
The problem with chiropractic diagnostic methods is not confined to the Kemp’s test, but extends to most tests employed by chiropractors. Why should this matter?
If diagnostic methods are not reliable, they produce either false-positive or false-negative findings. When a false-negative diagnosis is made, the chiropractor might not treat a condition that needs attention. Much more common in chiropractic routine, I guess, are false-positive diagnoses. This means chiropractors frequently treat conditions which the patient does not have. This, in turn, is not just a waste of money and time but also, if the ensuing treatment is associated with risks, an unnecessary exposure of patients to getting harmed.
The authors of this review, chiropractors from Canada, should be praised for tackling this subject. However, their conclusion that “it is debatable whether clinicians should continue to use this test to diagnose facet joint pain” is in itself highly debatable: the use of nonsensical diagnostic tools can only result in nonsense and should therefore be disallowed.
DOCTOR Jeffrey Collins, a chiropractor from the Chicago area, just sent me an email which, I think, is remarkable and hilarious – so much so that I want to share it with my readers. Here it is in its full length and beauty:
If you really think you can resolve all back pain syndromes with a pill then you are dumber than you look. I’ve been a chiropractor for 37 years and the primary difference between seeing me vs. an orthopedic surgeon for back pain is simple. When you have ANY fixation in the facet joint, the motor untitled is compromised. These are the load bearing joints in the spine and only an idiot would not realize they are the primary source of pain. The idea of giving facet blocks under fluoroscopy is so dark ages. Maybe you could return to blood letting. The fact that you attack chiropractors as being dangerous when EVERY DAY medical doctors kill people but that’s OK in the name of science. Remember Vioxx? Oh yeah that drug killed over 80,000 patients that they could find. It was likely double that. Oddly I have treated over 10,000 in my career and nobody died. Not one. I guess I was just lucky. I went to Palmer in Iowa. The best chiropractors come out of there. I should qualify that. The ones that have a skill adjusting the spine.
I will leave you with this as a simple analogy most patients get. Anyone who has ever “cracked their knuckles” will tell you that they got immediate relief and joint function was restored instanter. That’s chiropractic in a nutshell. Not complicated and any chiropractor worth his salt can do that for 37 years without one adverse incident. A monkey could hand out pain pills and you know it. Only in America do you have to get a script to get to a drugstore so everybody gets a cut. What a joke. Somehow mitigating pain makes you feel better about yourselves when you are the real sham. Funny how chiropractors pay the LOWEST malpractice rates in the country. That must be luck as well. Where’s your science now? I would love to debate a guy like you face to face. If you ever come to Chicago email me and let’s meet. Then again guys like you never seem to like confrontation.
I’ve enjoyed this and glad I found your site. Nobody reads the crap that you write and I found this by mistake. Keep the public in the dark as long as you can. It’s only a matter of time before it’s proven DRUGS ARE WORTHLESS.
I am pleased that DOCTOR Collins had fun. Now let me try to have some merriment as well.
This comment is a classic in several ways, for instance, it
- starts with a frightfully primitive insult,
- boasts of the author’s authority (37 years of experience) without mentioning anything that remotely resembles real evidence,
- provides pseudoscientific explanations for quackery,
- returns to insults (only an idiot … return to blood letting),
- uses classical fallacies (…medical doctors kill people),
- returns to more boasting about authority (I went to Palmer in Iowa. The best chiropractors come out of there…),
- injects a little conspiracy theory (…everybody gets a cut),
- returns to insults (…you are the real sham… guys like you never seem to like confrontation.)
- and ends with an apocalyptic finish: It’s only a matter of time before it’s proven DRUGS ARE WORTHLESS.
I should not mock DOCTOR Collins, though; I should be thankful to him for at least two reasons. Firstly, he confirmed my theory that “Ad hominem attacks are signs of victories of reason over unreason“. Secondly, he made a major contribution to my enjoyment of this otherwise somewhat dreary bank holiday, and I hope the same goes for my readers.
An article with this title was published recently by a team from Israel; essentially, it reports two interesting case histories:
A 59-year-old male underwent a course of acupuncture for chronic low back pain, by a acupuncturist. During the therapy, the patient noted swelling at the point of puncture, but his therapist dismissed the claim. The region continued to swell, and three days later his family doctor diagnosed cellulitis and prescribed oral amoxicillin with clavulanic acid. The following day the patient’s condition worsened—he started to suffer from chills and more intense pain, so he went to the emergency room. At that stage, the patient had a fever of 37.9°C, a pulse of 119, and a blood pressure of 199/87. Edema was noted over the patient’s entire right flank (Figure 1A). Laboratory results were notable for a level of glucose of 298 mg/dL, sodium of 128 mmol/L, and white blood count (WBC) of 26,500 cells/μL with left shift. An emergency CT revealed an abscess of the abdominal wall involving the muscles, but no intra-abdominal pathology (Figure 1B).
Figure 1.The patient received broad-spectrum antibiotics and was taken to the operating room for debridement. Upon incision there was subcutaneous edema with no puss, gangrene of the entire external oblique muscle, and an abscess between the external and internal oblique muscles. The muscles were debrided back to healthy, bleeding tissue and the wound copiously irrigated with saline. The wound was left open, with gauze and iodine as a cover. Gram stains and cultures returned group B streptococcus (GBS) sensitive to penicillin, and antibiotic coverage was adjusted accordingly. The patient returned to the operating room for serial debridement until the wound developed healthy granulation tissue. The patient received four units of blood and required 13 days of hospitalization. To date, he suffers from a disfiguring wound of his abdominal wall.
Considering the fact that group B streptococci live primarily in the female vagina, and that the acupuncturist was a young female, it is possible to assume that the cause for this grave illness was due to improper hygiene while treating our patient with acupuncture. Although rare, this tragic consequence of acupuncture has been seen previously by other researchers.
A 27-year-old male with chronic cervical and back pain without any previous medical treatment or imaging was referred to a tertiary medical facility. To manage his pain, the patient used the services of a chiropractor who used cervical manipulation. Immediately after such a manipulation, the patient felt a severe cervical pain; 30 minutes after manipulation the patient started feeling paresthesia in his hands and legs. The patient was admitted to an emergency room with symptoms of progressive weakness in all four extremities and weakness. No additional symptoms were seen. Immediate MRI demonstrated an epidural hematoma at the C3-4 level (Figure 2).
The patient underwent immediate surgery to evacuate the hematoma via an anterior approach and C3-4 cage placement. The day after surgery the patient showed a remission of symptoms. At 6 months follow-up his remission was complete.
The literature includes several reports of SSPE immediately following a chiropractic manipulation that was considered the cause of this event. The authors of this case report concluded that chiropractic procedures can be dangerous when performed by practitioners who might be only partially trained, who might tend to perform an insufficient patient examination before the procedure, and thus endanger their patients.
On this blog, I have repeatedly warned that not all alternative treatments are free of risks. These two cases are impressive reminders of this undeniable fact.
I am sure that most proponents of alternative medicine will try to claim that
- such complications are true rarities,
- I am alarmist to keep alerting my readers to such events,
- conventional medicine is dimensions more harmful,
- the above cases are caused by poor practice.
However, I feel compelled to stress that there are no adequate post-marketing surveillance systems in alternative medicine and that the true frequencies of such events are therefore unknown. It seems therefore imperative (and not alarmist) to publicize such risks as widely as possible – in the hope that alternative practitioners, one day, might do the ethically and morally correct thing and implement proper surveillance of their practices.
The above title was used for a Statement for Healthcare Professionals From the American Heart Association/American Stroke Association
I have taken the liberty to quote its abstract in full:
Purpose—Cervical artery dissections (CDs) are among the most common causes of stroke in young and middle-aged adults. The aim of this scientific statement is to review the current state of evidence on the diagnosis and management of CDs and their statistical association with cervical manipulative therapy (CMT). In some forms of CMT, a high or low amplitude thrust is applied to the cervical spine by a healthcare professional.
Methods—Members of the writing group were appointed by the American Heart Association Stroke Council’s Scientific Statements Oversight Committee and the American Heart Association’s Manuscript Oversight Committee. Members were assigned topics relevant to their areas of expertise and reviewed appropriate literature, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge.
Results—Patients with CD may present with unilateral headaches, posterior cervical pain, or cerebral or retinal ischemia (transient ischemic or strokes) attributable mainly to artery–artery embolism, CD cranial nerve palsies, oculosympathetic palsy, or pulsatile tinnitus. Diagnosis of CD depends on a thorough history, physical examination, and targeted ancillary investigations. Although the role of trivial trauma is debatable, mechanical forces can lead to intimal injuries of the vertebral arteries and internal carotid arteries and result in CD. Disability levels vary among CD patients with many having good outcomes, but serious neurological sequelae can occur. No evidence-based guidelines are currently available to endorse best management strategies for CDs. Antiplatelet and anticoagulant treatments are both used for prevention of local thrombus and secondary embolism. Case-control and other articles have suggested an epidemiologic association between CD, particularly vertebral artery dissection, and CMT. It is unclear whether this is due to lack of recognition of preexisting CD in these patients or due to trauma caused by CMT. Ultrasonography, computed tomographic angiography, and magnetic resonance imaging with magnetic resonance angiography are useful in the diagnosis of CD. Follow-up neuroimaging is preferentially done with noninvasive modalities, but we suggest that no single test should be seen as the gold standard.
Conclusions—CD is an important cause of ischemic stroke in young and middle-aged patients. CD is most prevalent in the upper cervical spine and can involve the internal carotid artery or vertebral artery. Although current biomechanical evidence is insufficient to establish the claim that CMT causes CD, clinical reports suggest that mechanical forces play a role in a considerable number of CDs and most population controlled studies have found an association between CMT and VAD stroke in young patients. Although the incidence of CMT-associated CD in patients who have previously received CMT is not well established, and probably low, practitioners should strongly consider the possibility of CD as a presenting symptom, and patients should be informed of the statistical association between CD and CMT prior to undergoing manipulation of the cervical spine.
In my view, this is an important statement to which I have little to add – however, I hope that the readers of this post will have comments, criticisms, observations, opinions, etc.
Some chiropractors claim that their main intervention, spinal manipulation, works for nonspecific neck pain by improving inter-vertebral range of motion (IV-RoM). But IV-RoM is difficult to measure, and whether it is related to clinical outcomes seems uncertain. Researchers from the Institute of Musculoskeletal Research & Clinical Implementation and the Anglo-European College of Chiropractic have just published a study that might throw some light on this issue. According to its authors, it was aimed at answering the following research questions:
- Does cervical spine flexion and extension IV-RoM increase after a course of spinal manipulation?
- Is there a relationships between any IV-RoM increases and clinical outcomes?
- How does palpation compare with objective measurement in the detection of hypo-mobile segments?
Thirty patients with nonspecific neck pain and 30 healthy controls matched for age and gender received quantitative fluoroscopy (QF) screenings to measure flexion and extension IV-RoM (C1-C6) at baseline and 4-week follow-up. Patients received up to 12 neck manipulations and completed NRS, NDI and Euroqol 5D-5L at baseline, plus PGIC and satisfaction questionnaires at follow-up. IV-RoM accuracy, repeatability and hypo-mobility cut-offs were determined. Minimal detectable changes (MDC) over 4 weeks were calculated from controls. Patients and control IV-RoMs were compared at baseline as well as changes in patients over 4 weeks. Correlations between outcomes and the number of manipulations received and the agreement (Kappa) between palpated and QF-detected of hypo-mobile segments were calculated.
QF had high accuracy (worst RMS error 0.5σ) and repeatability (highest SEM 1.1σ, lowest ICC 0.9σ) for IV-RoM measurement. Hypo-mobility cut offs ranged from 0.8σ to 3.5σ. No outcome was significantly correlated with increased IV-RoM above MDC and there was no significant difference between the number of hypo-mobile segments in patients and controls at baseline or significant increases in IV-RoMs in patients. However, there was a modest and significant correlation between the number of manipulations received and the number of levels and directions whose IV-RoM increased beyond MDC (Rho=0.39, p=0.043). There was also no agreement between palpation and QF in identifying hypo-mobile segments (Kappa 0.04-0.06).
The authors concluded that this study found no differences in cervical sagittal IV-RoM between patients with non-specific neck pain and matched controls. There was a modest dose-response relationship between the number of manipulations given and number of levels increasing IV-RoM – providing evidence that neck manipulation has a mechanical effect at segmental levels. However, patient-reported outcomes were not related to this.
This conclusion seems a little odd to me. In my view the study suggests a clearly negative answer to all the three research questions formulated above. An interesting paragraph from the authors’ discussion section provides further insight: The lack of a relationship between symptomatic improvement and increased IV-RoM is also of interest. Clearly other mechanisms that improved the comfort and functional capacity of the patients in this study were in play, including spontaneous recovery. Other important biological factors may have included chemical factors in joint and muscle and activation patterns in the latter. However, this study seemed to rule out central pain hypersensitivity as a factor, as this was not detected at baseline in any of the patients. Psychological and social factors and their influence on functional behavior may also have had a role and may have been influenced by the interventions received.
So, spinal manipulation does not seem to work by improving IV-RoM. Could this be because spinal manipulation does not work at all?
What is the best treatment for the millions of people who suffer from chronic low back pain (CLBP)? If we are honest, no therapy has yet been proven to be overwhelmingly effective. Whenever something like that happens in medicine, we have a proliferation of interventions which all are promoted as effective but which, in fact, work just marginally. And sure enough, in the case of CLBP, we have a constantly growing list of treatments none of which is really convincing.
One of the latest additions to this list is PILATES.
Pilates? What is this ? One practitioner describes it as follows: In Pilates, we pay a lot of attention to how our body parts are lined up in relation to each other, which is our alignment. We usually think of our alignment as our posture, but good posture is a dynamic process, dependent on the body’s ability to align its parts to respond to varying demands effectively. When alignment is off, uneven stresses on the skeleton, especially the spine, are the result. Pilates exercises, done with attention to alignment, create uniform muscle use and development, allowing movement to flow through the body in a natural way.
For example, one of the most common postural imbalances that people have is the tendency to either tuck or tilt the pelvis. Both positions create weaknesses on one side of the body and overly tight areas on the other. They deny the spine the support of its natural curves and create a domino effect of aches and pains all the way up the spine and into the neck. Doing Pilates increases the awareness of the proper placement of the spine and pelvis, and creates the inner strength to support the natural curves of the spine. This is called having a neutral spine and it has been the key to better backs for many people.
Mumbo-jumbo? Perhaps; in any case, we need evidence! Is there any at all? Surprisingly, the answer is yes. Recently, someone even published a proper systematic review.
This systematic review was aimed at evaluating the effectiveness of Pilates exercise in people with chronic low back pain (CLBP).
A search for RCTs was undertaken in 10 electronic. Two independent reviewers did the selection of evidence and evaluated the quality of the primary studies. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs could be included.
The methodological quality of RCTs ranged from “poor” to “excellent”. A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.
The authors drew the following conclusions: Pilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.
So, Pilates can be added to the long list of treatments that work for CLBP, albeit not convincingly better than most other therapies on offer. Does that mean these options are all as good or as bad as the next? I don’t think so.
Let’s assume chiropractic/osteopathic manipulations, massage and various forms of exercise are all equally effective. How do we decide which is more commendable than the next? We clearly need to take other important factors into account:
- acceptability for patients
If we use these criteria, it becomes instantly clear that chiropractic and osteopathy are not favourites in this race for the most commendable CLBP-treatment. They are neither cheap nor free of risks. Massage is virtually risk-free but not cheap. This leaves us with various forms of exercise, including Pilates. But which exercise is better than the next? At present, we do not know, and therefore the last two factors are crucial: if people love doing Pilates and if they easily stick with it, then Pilates is fine.
I am sure chiropractors will (yet again) disagree with me but, to me, this logic could hardly be more straight forward.
There is some (albeit not compelling) evidence to suggest that chiropractic spinal manipulation might be effective for treating non-specific back pain. But what about specific back pain, such as the one caused by a herniated disc? Some experts believe that, in patients suffering from such a condition, manipulations are contra-indicated (because the latter can cause the former), while others think that manipulation might be an effective treatment option (although the evidence is far from compelling). Who is correct? The issue can only be resolved with data from well-designed clinical investigations. A new trial might therefore enlighten us.
The stated purposes of this study were:
- to evaluate patients with low-back pain (LBP) and leg pain due to magnetic resonance imaging-confirmed disc herniation treated with high-velocity, low-amplitude spinal manipulation in terms of their short-, medium-, and long-term outcomes of self-reported global impression of change and pain levels
- to determine if outcomes differ between acute and chronic patients using.
The researchers conducted a ‘prospective cohort outcomes study‘ with 148 patients with LBP, leg pain, and physical examination abnormalities with concordant lumbar disc herniations. Baseline numerical rating scale (NRS) data for LBP, leg pain, and the Oswestry questionnaire were obtained. The specific lumbar spinal manipulation was dependent upon whether the disc herniation was intraforaminal or paramedian as seen on the magnetic resonance images and was performed by a chiropractor. Outcomes included the patient’s global impression of change scale for overall improvement, the NRS for LBP, leg pain, and the Oswestry questionnaire at 2 weeks, 1, 3, and 6 months, and 1 year. The proportion of patients reporting “improvement” on the patient’s global impression of change scale was calculated for all patients and for acute vs chronic patients. Pre-treatment and post-treatment NRS scores were compared using the paired t test. Baseline and follow-up Oswestry scores were compared using the Wilcoxon test. Numerical rating scale and Oswestry scores for acute vs chronic patients were compared using the unpaired t test for NRS scores and the Mann-Whitney U test for Oswestry scores.
Significant improvements for all outcomes at all time points were reported. At 3 months, 91% of patients were “improved”, and 88% were “improved” after 1 year. Acute patients improved faster by 3 months than did chronic patients. 81.8% of chronic patients 89.2% felt “improved” at 1 year. No adverse events were reported.
The researchers concluded that a large percentage of acute and importantly chronic lumbar disc herniation patients treated with chiropractic spinal manipulation reported clinically relevant improvement.
Does this new study meaningfully contribute to our knowledge about the effectiveness of chiropractic manipulation for back pain caused by herniated discs? The short answer to this question is NO.
A longer answer might be that the report does tell us something relevant about the quality of this research project. We know from countless studies that ~50% of patients experience adverse effects after spinal manipulations by a chiropractor. This means that any report claiming that NO ADVERSE EFFECTS WERE REPORTED is puzzling to a degree that we have to seriously question its quality or even honesty. In this context, it is relevant to mention that a recent review of the evidence concluded that a cause-effect relationship exists between the manipulative treatment and the development of disc herniation.
The positive outcomes reported in this new study could, of course, be due to a range of factors which are unrelated to the manipulations administered by the chiropractors:
- natural history of disc herniation
- regression towards the mean
- other treatments employed by the patients
- social desirability
To be able to say with any degree of certainty that the manipulations had anything to do with the observed positive outcomes would require an entirely different study-design. Should we assume that this is not known in the world of chiropractic? Or should we consider that chiropractors shy away from rigorous research because they fear its results?
The term prospective cohort outcomes study, seems to be a chiropractic invention (cohort studies are by definition prospective, and observational studies are usually prospective). It seems that, behind this long and impressive word, one can easily hide the fact that this study design fails to make the slightest attempt of controlling for non-specific effects; the term sounds scientific – but when we analyse what it means, we discover that this methodology is little more than a self-serving consumer survey. Most scientists would call such an investigation quite simply an OBSERVATIONAL STUDY.
I think it is time that chiropractors start doing proper research which actually does answer some of the many open questions regarding spinal manipulation.