Cranio-sacral therapy is firstly implausible, and secondly it lacks evidence of effectiveness (see for instance here, here, here and here). Yet, some researchers are nevertheless not deterred to test it in clinical trials. While this fact alone might be seen as embarrassing, the study below is a particular and personal embarrassment to me, in fact, I am shocked by it and write these lines with considerable regret.
Why? Bear with me, I will explain later.
The purpose of this trial was to evaluate the effectiveness of osteopathic manipulative treatment and osteopathy in the cranial field in temporomandibular disorders. Forty female subjects with temporomandibular disorders lasting at least three months were included. At enrollment, subjects were randomly assigned into two groups: (1) osteopathic manipulative treatment group (n=20) and (2) osteopathy in the cranial field [craniosacral therapy for you and me] group (n=20). Examinations were performed at baseline (E0) and at the end of the last treatment (E1), and consisted of subjective pain intensity with the Visual Analog Scale, Helkimo Index and SF-36 Health Survey. Subjects had five treatments, once a week. 36 subjects completed the study.
Patients in both groups showed significant reduction in Visual Analog Scale score (osteopathic manipulative treatment group: p = 0.001; osteopathy in the cranial field group: p< 0.001), Helkimo Index (osteopathic manipulative treatment group: p = 0.02; osteopathy in the cranial field group: p = 0.003) and a significant improvement in the SF-36 Health Survey – subscale “Bodily Pain” (osteopathic manipulative treatment group: p = 0.04; osteopathy in the cranial field group: p = 0.007) after five treatments (E1). All subjects (n = 36) also showed significant improvements in the above named parameters after five treatments (E1): Visual Analog Scale score (p< 0.001), Helkimo Index (p< 0.001), SF-36 Health Survey – subscale “Bodily Pain” (p = 0.001). The differences between the two groups were not statistically significant for any of the three endpoints.
The authors concluded that both therapeutic modalities had similar clinical results. The findings of this pilot trial support the use of osteopathic manipulative treatment and osteopathy in the cranial field as an effective treatment modality in patients with temporomandibular disorders. The positive results in both treatment groups should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field and support the importance of an interdisciplinary collaboration in patients with temporomandibular disorders. Implications for rehabilitation Temporomandibular disorders are the second most prevalent musculoskeletal condition with a negative impact on physical and psychological factors. There are a variety of options to treat temporomandibular disorders. This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life after osteopathic manipulative treatment and osteopathy in the cranial field. Our findings support the use of osteopathic manipulative treatment and osteopathy in the cranial field and should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field in patients with temporomandibular disorders. Rehabilitation experts should consider osteopathic manipulative treatment and osteopathy in the cranial field as a beneficial treatment option for temporomandibular disorders.
This study has so many flaws that I don’t know where to begin. Here are some of the more obvious ones:
- There is, as already mentioned, no rationale for this study. I can see no reason why craniosacral therapy should work for the condition. Without such a rationale, the study should never even have been conceived.
- Technically, this RCTs an equivalence study comparing one therapy against another. As such it needs to be much larger to generate a meaningful result and it also would require a different statistical approach.
- The authors mislabelled their trial a ‘pilot study’. However, a pilot study “is a preliminary small-scale study that researchers conduct in order to help them decide how best to conduct a large-scale research project. Using a pilot study, a researcher can identify or refine a research question, figure out what methods are best for pursuing it, and estimate how much time and resources will be necessary to complete the larger version, among other things.” It is not normally a study suited for evaluating the effectiveness of a therapy.
- Any trial that compares one therapy of unknown effectiveness to another of unknown effectiveness is a complete and utter nonsense. Equivalent studies can only ever make sense, if one of the two treatments is of proven effectiveness – think of it as a mathematical equation: one equation with two unknowns is unsolvable.
- Controlled studies such as RCTs are for comparing the outcomes of two or more groups, and only between-group differences are meaningful results of such trials.
- The ‘positive results’ which the authors mention in their conclusions are meaningless because they are based on such within-group changes and nobody can know what caused them: the natural history of the condition, regression towards the mean, placebo-effects, or other non-specific effects – take your pick.
- The conclusions are a bonanza of nonsensical platitudes and misleading claims which do not follow from the data.
As regular readers of this blog will doubtlessly have noticed, I have seen plenty of similarly flawed pseudo-research before – so, why does this paper upset me so much? The reason is personal, I am afraid: even though I do not know any of the authors in person, I know their institution more than well. The study comes from the Department of Physical Medicine and Rehabilitation, Medical University of Vienna, Austria. I was head of this department before I left in 1993 to take up the Exeter post. And I had hoped that, even after 25 years, a bit of the spirit, attitude, knowhow, critical thinking and scientific rigor – all of which I tried so hard to implant in my Viennese department at the time – would have survived.
Perhaps I was wrong.
Some of you will remember the saga of the British Chiropractic Association suing my friend and co-author Simon Singh (eventually losing the case, lots of money and all respect). One of the ‘hot potatoes’ in this case was the question whether chiropractic is effective for infant colic. This question is settled, I thought: IT HAS NOT BEEN SHOWN TO WORK BETTER THAN A PLACEBO.
Yet manipulators have not forgotten the defeat and are still plotting, it seems, to overturn it. Hence a new systematic review assessed the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants.
The authors reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). The inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. The authors included the following types of peer-reviewed studies in our search: RCTs, prospective cohort studies, observational studies, case–control studies, case series, questionnaire surveys and qualitative studies.
Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study. Only 5 studies were rated as high quality: four RCTs (low risk of bias) and a qualitative study.
The authors found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect).
Reduction in crying: RCTs mean difference.
The risk of reported adverse events was low (only 8 studies mentioned adverse effects at all, meaning that the rest were in breach of research and publication ethics): seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed.
The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.
For several reasons, I find this review, although technically sound, quite odd.
Why review uncontrolled data when RCTs are available?
How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?
How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?
Why do they not explain the implications of none of the RCTs being placebo-controlled?
How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?
How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?
Why do they not point out that this is unethical?
My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:
Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.
Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”
We probably all heard about the horrific stories related to Larry Nassar who, on January 24, 2018, was sentenced to 40 to 175 years in a Michigan state prison after pleading guilty to the sexual assault of numerous minors and US gymnasts. But few of us, I think, had any idea that these stories also relate to alternative medicine. This is an excerpt from an article in the LOS ANGELES TIMES.
… McKayla Maroney, the Olympic gold medalist who says she was paid $1.25 million by the United States Olympic Committee and USA Gymnastics to stop her from speaking out, put it flatly: “Dr. Nassar was not a doctor.”
No wonder the survivors chose to crush that word. “Doctor” was Nassar’s supreme and founding lie. It notarized him as a professional pledged to heal, and launched his 20-year child-molestation spree, gaining him a sturdy disguise, a complicity network, access to victims and a savage sense of entitlement.
What allowed Nasser to use the honorific? In 1993, he received a doctorate in osteopathic medicine from Michigan State University. MSU, of course, went on to protect and pay Nassar, the almighty and trusted doctor, as a faculty member for 20 years. Lou Anna Simon, MSU’s president, resigned this week amid charges that the university covered for Nassar and enabled him. USA Gymnastics, where Nassar also passed as a doctor, is similarly accused of giving safe harbor to a known criminal, while hushing and deceiving his victims. Under pressure, the group announced this week that the entire USAG board would resign.
Osteopathic medicine focuses on the joints, muscles and spine. Historically, though, osteopathy — its original name — was closely associated with a set of esoteric massage styles that some researchers now consider ineffective or worse. For its part, MSU’s College of Osteopathic Medicine still teaches these unusual manipulations — a special “benefit” unique to osteopathic medicine — describing them as a form of “hands-on diagnosis and treatment.”
Some historical context: Andrew Taylor Still, the founder of osteopathy, wrote of his medical discoveries in 1897: “I could twist a man one way and cure flux … shake a child and stop scarlet fever … cure whooping cough in three days by a wring of the child’s neck.”
Modern osteopathic medicine uses none of these techniques to treat infections — or anything else. But the specter of violence and child abuse that Still conjured in his early writings continues to haunt the fringes of osteopathic medicine. These practices include intravaginal manipulation. Fisting. This was the “medical procedure” Nassar performed on so many young girls.
According to his victims, Nassar’s attention wasn’t on their hamstrings or ACLs; instead, he focused on their anuses, breasts and vaginas. In January 2017, one victim spelled it out in her complaint: “Nassar digitally penetrated Plaintiff Jane A. Doe’s vagina multiple times without prior notice and without gloves or lubricant.” Other victims describe Nassar’s forcing his “dry fingers” into their anuses and vaginas. The violent fisting was excruciating. “I’d want to scream,” said Kassie Powell, an MSU pole vaulter. As Amy Labadie, a gymnast, put it: “My vagina was sore during my competition because of this man.”
Then came the gaslighting. When the girls blew the whistle, Nassar and his enablers tirelessly reasserted his privileges as a doctor. “We were manipulated into believing that Mr. Nassar was healing us as any normal doctor is supposed to do,” Capua testified. Just last year, the American Osteopathic Assn. released a statement to MLive.com, the Michigan news service, saying that intravaginal manipulations are indeed an approved, if rare, osteopathic treatment for pelvic pain…
END OF EXCERPT
I feel sick and am speechless.
But before my detractors point it out: yes, such monserous transgressions do occur in conventional healthcare too. And no, I am not implying that all osteopaths are criminal perverts.
This overview by researchers from that Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, UK, was aimed at summarising the current best evidence on treatment options for 5 common musculoskeletal pain presentations: back, neck, shoulder, knee and multi-site pain. Reviews and studies of treatments were considered of the following therapeutic options: self-management advice and education, exercise therapy, manual therapy, pharmacological interventions (oral and topical analgesics, local injections), aids and devices, other treatments (ultrasound, TENS, laser, acupuncture, ice / hot packs) and psychosocial interventions (such as cognitive-behavioural therapy and pain-coping skills).
Here are the findings for those treatments most relevant in alternative medicine (it is interesting that most alternative medicines were not even considered because of lack of evidence and that the team of researchers can hardly be accused of an anti-alternative medicine bias, since its senior author has a track record of publishing results favourable to alternative medicine):
Current evidence shows significant positive effects in favour of exercise on pain, function, quality of life and work related outcomes in the short and long-term for all the musculoskeletal pain presentations (compared to no exercise or other control) but the evidence regarding optimal content or delivery of exercise in each case is inconclusive.
The evidence from a good quality individual patient data meta-analysis suggests that acupuncture may be effective for short-term relief of back pain and knee pain with medium summary effect sizes respectively compared with usual care or no acupuncture. However, effects on function were reported to be minimal and not maintained at longer-term follow-up. Similarly for neck and shoulder pain, acupuncture was only found to be effective for short-term (immediately post-treatment and at short-term follow-up) symptom relief compared to placebo.
Current evidence regarding manual therapy is beset by heterogeneity. Due to paucity of high quality evidence, it is uncertain whether the efficacy of manual therapy might be different for different patient subgroups or influenced by the type and experience of professional delivering the therapy. On the whole, the available evidence suggests that manual therapy may offer some beneficial effects on pain and function, but it may not be superior to other non-pharmacological treatments (e.g. exercise) for patients with acute or chronic musculoskeletal pain.
Overall. the authors concluded that the best available evidence shows that patients with musculoskeletal pain problems in primary care can be managed effectively with non-pharmacological treatments such as self-management advice, exercise therapy, and psychosocial interventions. Pharmacological interventions such as corticosteroid injections (for knee and shoulder pain) were shown to be effective treatment options for the short-term relief of musculoskeletal pain and may be used in addition to non-pharmacological treatments. NSAIDs and opioids also offer short-term benefit for musculoskeletal pain, but the potential for adverse effects must be considered. Furthermore, the optimal treatment intensity, methods of application, amount of clinical contact, and type of provider or setting, are unclear for most treatment options.
These findings confirm what we have pointed out many times before on this blog. There is very little that alternative therapies have to offer for musculoskeletal pain. Whenever it is possible, I would recommend exercise therapy initiated by a physiotherapist; it is inexpensive, safe, and at least as effective as acupuncture or chiropractic or osteopathy.
Practitioners of alternative medicine will, of course, not like this solution.
Acupuncturists may not be that bothered by such evidence: their focus is not necessarily on musculoskeletal but on a range of other conditions (with usually little evidence, I hasten to add).
But for chiropractors and osteopaths, this is much more serious, in my view. Of course, some of them also claim to be able to treat a plethora of non-musculoskeletal conditions (but there the evidence is even worse than for musculoskeletal pain, and therefore this type of practice is clearly unethical). And those who see themselves as musculoskeletal specialists have to either accept the evidence that shows little benefit and considerable risk of spinal manipulation, or go in a state of denial.
In the former case, the logical conclusion is to look for another job.
In the latter case, the only conclusion is that their practice is not ethical.
This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:
The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.
Specifically, the Minister directed the Council to undertake:
1) A review of the status of the reserved act in other Canadian jurisdictions,
2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and
3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.
In addition, the Minister requested the Council to seek written input on the issue from:
- Manitoba Chiropractic Stroke Survivors
- Manitoba Chiropractic Association
- College of Physiotherapists of Manitoba
- Manitoba Naturopathic Association
- College of Physicians and Surgeons of Manitoba
- other relevant interested parties as determined by the Council
… The review indicated that further research is required to:
- strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
- establish safety and efficacy of CSM in infants and children
- assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.
… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.
Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:
- Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
- Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.
It was based on a design-based logistic regression analysis of the European Social Survey (ESS), Round 7. The researchers distinguished 4 modalities: manual therapies, alternative medicinal systems, traditional Asian medical systems and mind-body therapies.
In total, 25.9% of the general population had used at least one of these therapies during the last 12 months which was around one-third of the proportion of those who had visited a general practitioner (76.3%). Typically, only one treatment had been used, and it was used more often as complementary rather than alternative treatment. The usage varied greatly by country (see Table 1 below). Compared to those in good health, the use of CAM was two to fourfold greater among those with health problems. The health profiles of users of different CAM modalities varied. For example, back or neck pain was associated with all types of CAM, whereas depression was associated only with the use of mind-body therapies. Individuals with difficult to diagnose health conditions were more inclined to utilize CAM, and CAM use was more common among women and those with a higher education. Lower income was associated with the use of mind-body therapies, whereas the other three CAM modalities were associated with higher income.
The authors concluded that help-seeking differed according to the health problem, something that should be acknowledged by clinical professionals to ensure safe care. The findings also point towards possible socioeconomic inequalities in health service use.
As I said, this is one of the rare surveys that is worth studying in some detail. This is mainly because it is rigorous and its results are clearly presented. Much of what it reports has been known before (for instance, we showed that the use of CAM in the UK was 26% which ties in perfectly with the 21% figure considering that here only 4 CAMs were included), but it is undoubtedly valuable to see it confirmed based on sound methodology.
Apart of what the abstract tells us, there are some hidden gems from this paper:
- 8% of CAM users had used CAM exclusively (alternative use), without any visits to biomedical professionals in the last 12 months. This may look like a low figure, but I would argue that it is worryingly high considering that alternative usage of CAM has the potential to hasten patients’ deaths.
- The most frequently used CAM treatment was massage therapy, used by 11.9% of the population, followed by homeopathy (5.7%), osteopathy (5.2%), herbal treatments (4.6%), acupuncture (3.6%), chiropractic (2.3%), reflexology (1.7%) and spiritual healing (1.3%). Other modalities (Chinese medicine, acupressure and hypnotherapy) were used by around by 1% or less. The figure for homeopathy is MUCH smaller that the ones homeopaths want us to believe.
- About 9% of healthy survey-participants had used at least one of the CAM modalities during the last 12 months. One can assume that this usage was mostly for disease-prevention. But there is no good evidence for CAM to be effective for this purpose.
- The highest ORs for the use of Traditional Asian Medical Systems were found in Denmark, Switzerland and Israel, followed by Austria, Norway and Sweden. The highest OR for the use of Alternative Medical Systems was found in Lithuania, while manual therapies were most commonly used in Finland, Austria, Switzerland, Germany and Denmark. Moreover, Denmark, Ireland, Slovenia and Lithuania had the highest ORs for using mind-body therapies. France, Spain and Germany presented a common pattern, with relatively similar use of the different modalities. Poland and Hungary had low ORs for use of the different CAM modalities.
But by far the nicest gem, however, comes from my favourite source of misinformation on matters of health, WDDTY. They review the new survey and state this: The patients are turning to alternatives for a range of chronic conditions because they consider the conventional therapy to be inadequate, the researchers say. Needless to point out that this is not a theme that was addressed by the new survey, and therefore its authors also do not draw this conclusion.
The TIMES HIGHER EDUCATION (THE) reported yesterday that the British School of Osteopathy (BSO) has won university college title, meaning that it could be on the road towards full university status. University college title, awarded by the Privy Council on the advice of the Department for Education (DfE) and the Higher Education Funding Council for England, is usually seen as a step towards full university status. The London-based BSO already secured degree-awarding powers and access to Hefce public teaching and research funding in 2015. The BSO will be known, from September, as the University College of Osteopathy.
The THE quoted me saying “Osteopathy is based on implausible assumptions, and there is no good evidence for its effectiveness. Yet osteopaths regularly make all sorts of therapeutic claims. These facts make the BSO not a candidate for becoming a university; on the contrary, such a move would significantly downgrade the credibility of UK universities and make a mockery of academia and evidence-based healthcare.”
Charles Hunt, the BSO principal, responded: “We recognise that for some of the things that some osteopaths are doing, there is very limited evidence [to demonstrate their effectiveness], and we need to gain more for that. But within medicine, there’s a lot of things that also do not have evidence for them, but some medical practitioners are doing [them anyway].”
The BSO principal should offer a course on logical fallacies and enlist as the first student in it, I thought when reading his response.
Anyway, having stated that “osteopaths regularly make all sorts of therapeutic claims”, I better provide some evidence. Perhaps another occasion for a slide-show?
Here are a few images I found on Twitter that are relevant in this context.[please click to see them full size]
On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that
- mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
- serious adverse effects are being reported regularly;
- the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
- the consequences can be permanent neurological deficits and even deaths;
- under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
- there is no system to accurately monitor the risks;
- chiropractors are in denial of these problems.
Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.
The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57% of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.
Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.
But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the
- Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
- Department of Planning, Policy and Design, University of California, Irvine,
- VA Puget Sound Health Care System, Tacoma,
- New York Chiropractic College, Seneca Falls,
- Logan University College of Chiropractic, Chesterfield,
- University of Western States, Portland.
The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:
“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.
Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”
The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!
The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects. I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.
The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:
- The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
- For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.
Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:
- no harms associated with acupuncture,
- only trivial harm associated with spinal manipulations.
The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.
And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.
In the introduction, I stated that this small section of the guidelines is crucial.
The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.