Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.
What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.
But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago – except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.
A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]
Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:
- We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
- We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
- We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
- We need to reconsider our position.
- We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
- We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
- We still believe in science (or at least want people to believe that we do) – but we need a different type of science.
- We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
- We have determined that reductionist research methods disturb our subtle treatments.
- We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.
What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.
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.
“If ever there was a permanent cure for migraine, homeopathic medicines are the only one that can do this miracle. It may sound like an overstatement and quite quackerish, but it’s true. Long term treatment with homeopathy has an excellent cure for migraine headaches.” Statements like this can be found by the thousands on the internet, not just in relation to migraine but also about osteoarthritis. Both migraine and osteoarthritis are important domains for homeopathy, and most homeopaths would not doubt for a second that they can treat these conditions effectively. This is why it is so important to highlight the few sources which are not misleading consumers into making the wrong therapeutic decisions.
‘Healthcare Improvement Scotland’ (HCIS) have just published advice for patients suffering from migraine and osteoarthritis (the full document with all the evidence can be found here). I think it is worth having a close look and I therefore cite it in full:
Homeopathic remedies are prepared by repeated dilution and vigorous shaking of substances in water. Remedies are prepared from substances that in healthy people cause the signs and symptoms of the condition being treated. The more dilute the remedy is the more potent it becomes so that the most potent remedies are unlikely to contain any of the original substance.
People in Scotland have access to homeopathy through some GPs or a referral to homeopaths in the private sector, regional NHS clinics or the Centre for Integrative Care (CIC) (formerly Glasgow Homeopathic Hospital). Not all NHSScotland health boards provide funding for homeopathy; investment varies widely among those that do, and individual boards have begun to review funding for homeopathy services.
- Evidence of clinical effectiveness was reviewed from systematic reviews of four placebo controlled randomised trials of homeopathy for migraine published between 1991 and 1997; and systematic reviews of four active treatment controlled randomised trials of homeopathy for osteoarthritis published between 1983 and 2000. The quality of the evidence was low to moderate.
- Homeopathy for migraine has not been compared with active treatment in randomised controlled trials (RCTs). Of four RCTs comparing homeopathy with placebo, only one found homeopathy to be superior.
- Three RCTs in osteoarthritis comparing homeopathy with medicines for pain relief found either no difference between the interventions, or that analgesic treatment had a better effect than homeopathy. A further RCT comparing intra-articular injection of a homeopathic remedy with hyaluronic acid injections showed similar pain reduction in both groups.
- Published systematic reviews of homeopathy for migraine and osteoarthritis contain insufficient information to inform conclusions about safety.
- No evidence on the cost effectiveness of homeopathy for migraine was identified; and the evidence from a single cost-minimisation analysis of one homeopathic preparation for osteoarthritis is not generalisable to the UK.
- Homeopathy for migraine has not been compared with standard care in RCTs and no evidence of cost effectiveness has been identified..
- There is insufficient evidence to determine whether or not homeopathic treatment for osteoarthritis is clinically effective compared with standard care, and no relevant evidence of cost effectiveness has been identified.
- The evidence does not support treating migraine or osteoarthritis with homeopathy.
Before the fans of homeopathy start shouting “THIS IS ALL RUBBISH AND DISREGARDS IMPORTANT EVIDENCE!!!”, I should mention that the top experts in homeopathy were asked to contribute their evidence and were unable to find any convincing data that would have changed this negative verdict. And it is important to point out that HCIS is a respected, independent organisation that issues statements based on thorough, unbiased reviews of the evidence.
As I reported a while ago, the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ has assessed the effectiveness of homeopathy. The evaluation looks like the most comprehensive and most independent in the history of homeopathy. Its draft report concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
So, the HCIS is in excellent company and I have no doubt whatsoever that this new statement is correct – but I also have little doubt that homeopaths will dispute it.
Some time ago, the NYT carried an article entitled HOW YOGA CAN WRECK YOUR BODY. While this might be just a trifle alarmist, it seems clear that injuries can occur and do occur more and more – not least because yoga has become so very popular. It seems relevant therefore to ask what the risks truly are. A recent article might be useful in this respect.
The aim of this study was to examine whether a national sample of yoga practitioners would report discontinued use of yoga due to injury from the practice, assess what injuries resulted in discontinued use, determine what injuries were most common and identify injuries requiring medical attention. The authors used a secondary data analysis of a nationally representative sample of 23,393 adults from the United States.
The results indicate that less than 1% of individuals who had ever practiced yoga (n = 2230) reported an injury from yoga that led to discontinued use. Of those reporting injury, less than one-third (n = 4) reported seeking medical attention. The most commonly reported side-effect of yoga was back pain. Approximately, half of those reporting back pain sought medical attention.
The authors concluded that injury due to yoga is an infrequent barrier to continued practice and severe injury due to yoga is rare.
So, yoga is fairly safe but, in rare cases, injuries can occur. If you are interested in preventing such harm, there are some precautions you can take to make sure you do not sustain injuries.
And one last thing: in my experience, many yoga make quite absurd claims – so, if it sounds to be too good to be true, it probably is.
One alternative therapy that I have so far almost entirely neglected is Ayurveda. It is said to be one of the fastest growing system within this sector. Ayurvedic healing includes herbs, nutrition, panchakarma cleansing, acupressure massage, Yoga, Sanskrit, and Jyotish (Vedic astrology). The website of the ‘Choppra Center’ explains: Recognizing that human beings are part of nature, Ayurveda describes three fundamental energies that govern our inner and outer environments: movement, transformation, and structure. Known in Sanskrit as Vata (Wind), Pitta (Fire), and Kapha (Earth), these primary forces are responsible for the characteristics of our mind and body. Each of us has a unique proportion of these three forces that shapes our nature. If Vata is dominant in our system, we tend to be thin, light, enthusiastic, energetic, and changeable. If Pitta predominates in our nature, we tend to be intense, intelligent, and goal-oriented and we have a strong appetite for life. When Kapha prevails, we tend to be easy-going, methodical, and nurturing. Although each of us has all three forces, most people have one or two elements that predominate.
However, the evidence for its effectiveness is not overwhelming. In 2007, we published a systematic review of Ayurvedic treatments for rheumatoid arthritis (RA). Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. Of 3 placebo-controlled RCTs, one high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. We concluded that there is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.
Because of this paucity of reliable evidence, any new assessments are welcome.
The aim of this article was to review and meta-analyze the effectiveness and safety of different Ayurvedic interventions in patients with osteoarthritis (OA). 138 electronic databases were searched through August 2013. Randomized controlled trials, randomized crossover studies, cluster-randomized trials, and non-randomized controlled clinical trials were eligible. Adults with pre-diagnosed OA were included as participants.
Interventions were included as Ayurvedic, if they were explicitly labeled as such. The main outcome measures were pain, physical function, and global improvement. Risk of bias was assessed using the Cochrane risk of bias tool.
19 randomized and 14 non-randomized controlled trials on 12 different drugs and 3 non-pharmaceutical interventions with a total of 2,952 patients were included. For the compound preparation, Rumalaya, large and apparently unbiased effects beyond placebo were found for pain (standardized mean difference [SMD] -3.73; 95 % confidence interval [CI] -4.97, -2.50; P < 0.01) and global improvement (risk ratio 12.20; 95 % CI 5.83, 25.54; P < 0.01).
There was also some evidence that effects of the herbal compound preparation Shunti-Guduchi are comparable to those of glucosamine for pain (SMD 0.08; 95 % CI -0.20, 0.36; P = 0.56) and function (SMD 0.15; 95 % CI -0.12, 0.36; P = 0.41).
Based on single trials, positive effects were found for the compound preparations RA-11, Reosto, and Siriraj Wattana. For Boswellia serrata, Lepidium Sativum, a Boswellia serrata containing multicomponent formulation and the compounds Nirgundi Taila, Panchatikta Ghrita Guggulu, and Rhumayog, and for non-pharmacological interventions like Ayurvedic massage, steam therapy, and enema, no evidence for significant effects against potential methodological bias was found.
No severe adverse events were observed in any of the trials.
The authors concluded that the drugs Rumalaya and Shunti-Guduchi seem to be safe and effective drugs for treatment of OA-patients, based on these data. However, several limitations relate to clinical research on Ayurveda. Well-planned, well-conducted and well-published trials are warranted to improve the evidence for Ayurvedic interventions.
I am, of course, pleased that other too have noticed the paucity of good evidence and recommend more and better research into this area. There are, however, several things that worry me about this systematic review:
- How can there be a total absence of adverse effects? Even placebos would generate some.
- The conclusion that Rumalaya and Shunti-Guduchi are safe does not seem justified on the basis of just a few trials.
- My own review found quite encouraging effects for Boswellia serrate.
- 138 electronic databases? I did not even know that so many existed!
- I am also concerned by the way the treatments found to be ‘safe and effective’ are being promoted on the internet:
Rumalaya is a phytopharmaceutical formulation that relieves joint and bone ache associated with various orthopedic ailments. Its natural ingredients possess potent anti-inflammatory properties that alleviate pain. As an immunomodulator, Rumalaya modulates both the humoral and cell-mediated immune response to aches and pain. The medicine has strong anti-arthritic properties that work to combat arthritis.
- Rheumatic arthritis
- Rheumatoid arthritis
- Cervical and lumbar spondylosis
- Frozen shoulder
- Traumatic inflammatory conditions like fibrositis, bursitis, synovitis, capsulitis, tenosynovitis, myositis and sciatica.
I fail to see good evidence to support most of these claims.
Lastly, I find that the authors fail to warn the public in sufficiently strong terms of some of the drawbacks of Ayurvedic medicines. Many of them seem not to be safe. One of several problems is that they have been shown to be often contaminated/adulterated with toxic substances such as heavy metals.
My conclusion about the value of Ayurvedic medicines is therefore not so optimistic: EFFICACY IS USUALLY MORE THAN DOUBTFUL, WHILE RISKS ARE WELL-DOCUMENTED.
Have you noticed?
Homeopaths, acupuncturists, herbalists, reflexologists, aroma therapists, colonic irrigationists, naturopaths, TCM-practitioners, etc. – they always smile!
I think I might know the answer. Here is my theory:
Alternative practitioners have in common with conventional clinicians that they treat patients – lots of patients, day in day out. This wears them down, of course. And sometimes, conventional clinicians find it hard to smile. Come to think of it, alternative practitioners seem to have it much better. Let me explain.
Whenever a practitioner (of any type) treats a patient, one of three outcomes is bound to happen:
- the patient gets better,
- the patients roughly remains how she was and experiences no improvement,
- the patient gets worse.
In scenario one, everybody is happy. Both alternative and conventional practitioners will claim with a big smile that their treatment was the cause of the improvement. There is a difference though: the conventional practitioner who adheres to the principles of evidence-based medicine will know that the assumption is likely to be true, while the alternative practitioner is probably just guessing. In any case, as long as the patient gets better, all is well.
In scenario two, most conventional clinicians will get somewhat concerned and find little reason to smile. Not so the alternative practitioner! He will have one of several explanations why his therapy has not produced the expected result all of which allow him to carry on smiling smugly. He might, for instance, explain to his patient:
- You have to give it more time; another 10-20 treatment sessions and you will be as right as rain (unfortunately, further sessions will come at a price).
- This must be because of all those nasty chemical drugs that you took for so long – they block up your system, you know; we will have to do some serious detox to get rid of all this poison (of course, at a cost).
- You must realize that, had we not started my treatment when we did, you would be much worse by now, perhaps even dead.
In scenario three, any conventional clinician would have stopped smiling and begun to ask serious, self-critical questions about his diagnosis and treatment. Not so the alternative practitioner. He will point out with a big smile that the deterioration of the symptoms only appears to be a bad sign. In reality it is a very encouraging signal indicating that the optimal treatment for the patient’s condition has finally been found and is beginning to work. The acute worsening of the complaints is merely an ‘aggravation’ or’ healing crisis’. Such a course of events had to be expected when true healing of the root cause of the condition is to be achieved. The thing to do now is to continue with several more treatments (at a cost, of course) until deep healing from within sets in.
Many of us want the cake and eat it – but alternative practitioners, it seems to me, have actually achieved this goal. No wonder they smile!
In the US, the scope of practice of health care professionals is a matter for each state to decide. Only the one of doctors is regulated nationwide. Other health care professions’ scope of practice can vary considerably within the US. This means that a chiropractor in one state of the US might be allowed to do more (or less) than in the next state. But what exactly are US chiropractors legally allowed to do?
A recent paper was aimed at answering this very question. Its authors assessed the current status of chiropractic practice laws in the US.
A cross-sectional survey of licensure officials from the Federation of Chiropractic Licensing Boards e-mail list was conducted in 2011 requesting information about chiropractic practice laws and 97 diagnostic, evaluation, and management procedures. To evaluate content validity, the survey was distributed in draft form at the fall 2010 Federation of Chiropractic Licensing Boards regional meeting to regulatory board members and feedback was requested. Comments were reviewed and incorporated into the final survey.
Partial or complete responses were received from 96% (n = 51) of the jurisdictions. The states with the highest number of services that could be performed were Missouri (n = 92), New Mexico (n = 91), Kansas (n = 89), Utah (n = 89), Oklahoma (n = 88), Illinois (n = 87), and Alabama (n = 86). The states with the highest number of services that cannot be performed are New Hampshire (n = 49), Hawaii (n = 47), Michigan (n = 42), New Jersey (n = 39), Mississippi (n = 39), and Texas (n = 30).
The authors conclude that the scope of chiropractic practice in the United States has a high degree of variability. Scope of practice is dynamic, and gray areas are subject to interpretation by ever-changing board members. Although statutes may not address specific procedures, upon challenge, there may be a possibility of sanctions depending on interpretation.
For me, the most surprising aspect of this article was to realise how many ‘non-chiropractic’ activities chiropractors are legally permitted in some US states. Here are some of the items that amazed me most:
- birth certificates
- death certificates
- premarital certificates
- recto-vaginal exam
- i.v. injections
- prostatic exam
- genital exam
- ear irrigation
- colonic irrigation
- oral and i.v. chelation therapy
- hyperbaric chamber
I have to admit that I did not even know what a PREMARITAL CERTIFICATE’ is; so I looked it up. The first one I found on the internet was entitled “PURITY COVENANT” and committed the couple “to abstain from fornication and remain sincere to the Lord Jesus Christ and to each other”
I have to further admit that many other of the items on this list leave me equally speechless. For example, how can chiropractors with their training focussed on the musculoskeletal system responsibly complete a death certificate? Why are they allowed in some states to examine the genitalia of their patients?
I suspect the perceived need of chiropractors to do all these things must be closely related to their long-standing ambition to become primary care physicians. Just to be clear: a primary care physician is a physician who provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. I have always been more than just a bit perplexed how chiropractors, who state that they are musculoskeletal specialists, might even consider being competent primary care providers.
But regardless of common sense, they do! The US ‘Council of Chiropractic Education’ accreditation process, for instance, requires schools to educate and train students to become a “competent doctor of chiropractic who will provide quality patient care and serve as a primary care physician” and the chiro-literature is awash with statements such as this one: “The primary care chiropractic physician is a viable and important part of the primary health care delivery system, with many chiropractic physicians currently prepared to participate effectively and competently in primary care.” Moreover, the phenomenon is by no means limited to the US: “chiropractors in the UK view their role as one of a primary contact healthcare practitioner and that this view is held irrespective of the country in which they were educated or the length of time in practice.”
As far as I am concerned, chiropractors might view their role as whatever they want. The fact is that, even if they add many more items to the list of their ‘services’, they are very far from being competent primary care physicians. Being able to provide the first contact as well as continuous care of medical conditions, not limited by cause, organ system, or diagnosis is not a matter of wishful thinking.
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.
Many posts on this blog have highlighted the fact that homeopathic remedies, when tested in rigorous RCTs, are demonstrably nothing more than pure placebos. Homeopaths, of course, negate this fact but here is a surprising bit of new evidence that further confirms it – and it comes from the highest authority in homeopathy: from Samuel Hahnemann himself!
A well known psychic has been in contact with the great doctor who consequently has dictated a letter to her. Here it is (it came in German, but I took the liberty of translating it into English):
TO ALL HOMEOPATHS OF THE WORLD
I have been watching what you have been doing with my noble healing art for some time now, and I cannot hold back any longer. Enough is enough. You are all fools, bloody fools!
Sceptics and scientists and anyone else who can read the research that has been done with those ‘randomised trials’ that the allopaths are currently so fond of should know that homeopathic medicines, as you monumental idiots employ them, are ineffective. The results of these studies are perfectly true. Instead of asking yourself what you are doing wrong and how you are disobeying my most explicit orders, you insist on doubting that these modern methods generate the truth. How incredibly stupid you are!
I have provided you with a detailed set of instructions – but does any of you pseudo-homeopaths follow them? No, no, no! You are all traitors and ignorant dilettantes. Read my Organon and follow what I wrote; there is no need to re-invent the rules.
Let me remind you what I said in the Organon; I made it perfectly clear that a person receiving homeopathy must have:
- no coffee
- no spices
- no carbonated drinks
- no use of perfumes
- no smoked meat
- no cheese
- no duck
- no shellfish
- no large amounts of animal fat
- no sausages
- no spicy sauces
- no pastries or cakes
- no radishes
- no celery
- no onions or garlic
- no parsley
- no pepper
- no mustard
- no vanilla
- no bitter almonds
- no cloves
- no cinnamon
- no fennel
- no anise
- no green tea
- no spiced chocolate
- no liquors
- no herbal teas
- no tooth powder
- no excessive labour
- no mental exercise
That is simple enough, isn’t it? Or are you too moronic to follow even the simplest of instructions? As you constantly ignore my orders, how do you think my medicines can work?
Those who insist that the current evidence for homeopathy is negative are entirely correct. It is negative because you have been witless and incompetent! I have said it before and I say it again: HE WHO DOES NOT WALK ON EXACTLY THE SAME LINE WITH ME, WHO DIVERGES, IF IT BE BUT THE BREADTH OF A STRAW, TO THE RIGHT OR TO THE LEFT, IS AN APOSTATE AND A TRAITOR, AND WITH HIM I WILL HAVE NOTHING TO SAY.
Now, instead of finding excuses, go home and contemplate what I am telling you. Then do the right thing, conduct a randomised trial testing my proper method, and you will see.
I am very annoyed with all of you! And I am fast running out of patience.
Do as I say or become an allopath.
At this point, I should admit that the letter was, of course, not written by the inventor of homeopathy but by me, Edzard Ernst. Yet it could have been written by him; historians invariably describe him as intolerant, cantankerous and inflexible. Crucially, the dietary instructions outlined in the letter are those of Hahnemann as outlined in the ‘Organon’, his ‘opus maximus’. If he could send a letter via a psychic, Hahnemann would certainly complain about his followers disobeying his orders and he most likely would do it in a most disgruntled tone (the sentence in capital letters is actually a quote from Hahnemann).
This post is a bit of innocent fun, sure. But it also has some relevance to today’s homeopathy, I hope: modern homeopaths make a big thing out of following Hahnemann’s gospel to the letter. But, if we look carefully, we find that they only follow some of it, while ignoring entire sections of what their ‘über-guru’ told them. They argue that these bits are useless or erroneous or implausible and they want to be seen to be scientific and evidence-based. The obvious truth, however, is that everything Hahnemann has ever written about homeopathy is useless, erroneous and implausible and nothing of it is scientific or evidence-based. Homeopaths should draw the only possible conclusion and ignore the lot!
My 2008 evaluation of chiropractic concluded that the concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt. It also pointed out that the advice of chiropractors often is dangerous and not in the best interest of the patient: many chiropractors have a very disturbed attitude towards immunisation: anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit.
In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
D. D. Palmer’s son, B. J. Palmer (after literally walking [actually it was driving] over his father’s body) provided a much more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)
Such sentiments and opinions are still prevalent in the chiropractic profession – but today they are expressed in a far less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.
Not all chiropractors share such opinions. The chiropractic profession is currently divided over the issue of immunisation. Some chiropractors now realise that immunisations have been one of the most successful interventions ever for public health. Many others, however, do still vehemently adhere to the gospel of the Palmers. Statements like the following abound:
Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….
Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?
Yes, I do agree: the position of far too many chiropractors is ‘crystal clear’ – unfortunately it is also dangerously wrong.