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.
The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.
The aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?
A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.
Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.
The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.
This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.
It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.
Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.
In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”
END OF QUOTE
As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:
- We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
- None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
- It seems more than questionable whether the benefits of SMT outweigh its risks.
Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.
The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.
A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.
The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!
The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”
To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:
- It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
- The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
- These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.
I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”
In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.
So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”
Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!
Perhaps you can agree with this statement then:
As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).
We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.
Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.
They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.
Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.
In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.
The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?
I think the answer is NO!
If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?
Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.
This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.
A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.
The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.
The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.
In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…
Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”
This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.
Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.
We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.
We must insist that regulators protect us from such quackery and prevent the serious harm it can do.
Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.
This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.
There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).
The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.
The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:
- better education of general practitioners,
- tightening of healthcare budgets,
- recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
- the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
- the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
- a more general realisation that these therapies can cause very serious harm,
- a mixture of the above factors.
Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.
Recently, the UK Advertising Standards Authority (ASA) together with the UK General Osteopathic Council (GOsC) have sent new guidance to over 4,800 UK osteopaths on the GOsC register. The guidance covers marketing claims for pregnant women, children and babies. It also provides examples of what kind of claims can, and can’t, be made for these patient groups.
Regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions only if they hold convincing evidence. Claims for treating conditions specific to pregnant women, children and babies are not supported by the evidence available to date.
The new ASA guidance is intended to help osteopaths talk about the healthcare they provide in a way that complies with the Advertising Codes and to protect consumers from being misled. It provides some basic principles and many examples of claims that are, and aren’t, acceptable. The ASA hopes it will provide greater clarity to osteopaths on how to advertise osteopathic care for pregnant women, children and babies responsibly.
Specifically, the guidance points out that “osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies, provided they are qualified to do so. Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.”
Examples of claims previously made by UK osteopaths which are “unlikely to be acceptable” include:
- Osteopaths often work with lactation consultations where babies are having difficulty feeding.
- Osteopaths are qualified to advise and treat patients across the full breadth of primary care practice.
- Osteopaths often work with crying, unsettled babies.
- Birth is a stressful process for babies.
- Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help.
- If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help.
- Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains.
- Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull.
- Midwives often recommend an osteopathic check-up for babies after birth.
- Osteopathy can help with breast soreness or mastitis after birth.
- If your baby is having difficulty breastfeeding, osteopathy might be able to help.
- Many pregnant women experience pain in the pelvic girdle area. Osteopaths offer safe, gentle manipulation and stretches.
- Many pregnant women find osteopathy relieves common symptoms such as nausea and heartburn.
- Use of osteopathy can limit perineum or pelvic floor trauma.
- If your baby suffers from constipation then osteopathy could help.
- Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health.
- In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established.
- Cranial osteopathy releases stresses and strains in the skull and throughout the body.
- Osteopaths can feel involuntary motion and mechanisms within the body.
- Cranial osteopathy aims to reduce restrictions in movement.
Elsewhere in the ASA announcement, we find the statement that “The effectiveness of osteopathy for treating some conditions is underpinned by robust evidence”. The two examples provided are rheumatic pain and joint pain. I have to say I was mystified by this. I am not aware of robust evidence for these two indications. Perhaps someone could help me out here and provide some references?
The only condition for which there is enough encouraging evidence is, as far, as I know low back pain – and even here I would not call the evidence ‘robust’. Am I mistaken? If you think so, please supply the evidence with links to the references.
But, in general, the new guidance is certainly a step in the right direction. Now we have to wait and see whether osteopaths change their advertising and behaviour accordingly and what happens to those who don’t.
WATCH THIS SPACE
Some osteopaths – similar to their chiropractic, naturopathic, homeopathic, etc. colleagues – claim they can treat almost any condition under the sun. Even gynaecological ones? Sure! But is the claim true? Let’s find out.
The aim of this recent review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.
In total, 24 studies were included. They addressed the following conditions: back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT was considered to be effective for pregnancy related back pain. For all other gynaecological and obstetrical conditions the evidence was considered to be uncertain. Only three studies mentioned adverse events after OMT.
The authors concluded that, although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.
Given the fact that the lead authors of this review come from the “Accademia Italiana Osteopatia Tradizionale, Pescara, Italy, we can probably answer the question in the title of this blog with a straight NO. I see no reason why OMT should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion. Sadly, this is unlikely to stop osteopaths to claim otherwise and continue to prey on the desperate and the gullible.
One might thus say that this review is totally unremarkable – but I would beg to differ: it highlights yet again one very important finding, namely the fact that trials of alternative therapies far too often fail to report adverse effects. I have stated this often already, but I will say it again: THIS OMISSION IS A VIOLATION OF RESEARCH ETHICS WHICH GIVES US A FALSE POSITIVE OVERALL PICTURE OF THE RISKS ASSOCIATED WITH ALTERNATIVE MEDICINE.
Would you like to see a much broader range of approaches such as nutrition, mindfulness, complementary therapies and connecting people to green spaces become part of mainstream healthcare?
Well, let me tell you about this exciting new venture anyway!
It is being promoted by Dr Dixon’s ‘College of Medicine’ and claims to be “the only accredited Integrative Medicine diploma currently available in the UK… [It] will provide you with an accredited qualification as an integrative medicine practitioner. The Diploma is certified by Crossfields Institute and supported by the College of Medicine and is the only one currently available in the UK. IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients. The model embraces conventional approaches as well as other modalities centred on lifestyle and mind-body techniques like mindfulness and nutrition.”
Dr Dixon? Yes, this Dr Michael Dixon.
College of Medicine? Yes, this College of Medicine.
Crossfields Institute? Yes this Crossfields Institute which promotes the Steiner/’Waldorf quackery and has Simon Fielding as the chair of trustees.
Simon Fielding? Yes, the Simon Fielding who “devoted much of his professional life to securing the recognition of osteopathy as an independent primary contact healthcare profession and this culminated in the passing of the Osteopaths Act in 1993. He was appointed by ministers as the first chair of the General Osteopathic Council responsible for bringing the Osteopaths Act into force… He is currently vice-chair of the board of trustees of The College of Medicine… In addition Simon has… served as a long term trustee on the boards of The Prince of Wales’s Foundation for Integrated Health… and was the founder chair of the Council for Anthroposophical Health and Social Care.”
You must admit, this IS exciting!
Now you want to know what modules are within the Diploma? Here they are:
- The Modern Context of IM: Philosophy, History and Changing Times in Medicine
- IM Approaches and Management of Conditions (part 1)
- Holistic Assessment: The Therapeutic Relationship, Motivational Interviewing & Clinical Decision Making in Integrative Medicine
- Critical Appraisal of Medicine and IM Research
- Holistic assessment: Social prescribing, a Community Approach in Integrative Medicine
- Managing a Dynamic IM Practice and Developing Leadership Skills
- IM Approaches and Management of Conditions (part 2)
- Independent Study on Innovation in Integrative Medicine
Sounds terrific, and it reminds me a lot of another course Michael Dixon tried to set up 13 years ago in Exeter. As it concerned me intimately, I wrote about this extraordinary experience in my memoir; here is a short excerpt:
…in July 2003… I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:
“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: ‘The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies’.”
When I stumbled on this announcement I was taken aback. Is Tooke envisaging a course for me to run? Has he forgotten to tell me about it? When I inquired, Tooke informed me that the medical school planned to offer a postgraduate “Pathway in Integrated Health” which had been initiated by Dr Michael Dixon, a general practitioner who had at that stage become one of the UK’s most outspoken proponents of spiritual healing and other dubious forms of alternative medicine, and for this reason was apparently very well regarded by Prince Charles.
A few days after I received this amazing news, Dr Dixon arrived at my office and explained with visible embarrassment that Prince Charles had expressed his desire to establish such a course in Exeter. His Royal Highness had already facilitated its funding which, in fact, came from Nelson’s, the manufacturer of homoeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit I had struggled – and even paid – to be separated from almost a decade ago because of its overtly anti-scientific agenda. The whole thing had been in the planning for several months. I was, it seemed, the last to know – but now that I had learnt about it, Dixon and Tooke urged me to contribute to this course by giving a few lectures.
I could no more comply with this request than fly. Apart from anything else, I was opposed in principle to the concept of “integration.” As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerous idea of equivalence – i.e., the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.
To add insult to injury, the course was to be sponsored by a major manufacturer of homoeopathic remedies. In all conscience, this seemed to me to be the last straw. Study after study carried out by my unit had found homoeopathy to be not only conceptually absurd but also therapeutically worthless. If we did not take a stand on this issue, we might just as well all give up and go home…
END OF QUOTE FROM MY MEMOIR
Dixon’s Exeter course was not a brilliant success; I think it folded soon after it was started. Well, better luck up the road in Bristol, Michael – I am sure there must be a market for quackery somewhere!
The queue outside my ‘ALT MED HALL OF FAME’ was getting restless because I did not admit any new members for some time. So, I better get cracking!
You remember, of course, who has been honoured so far; the list of members (main research interest, country) is as follows:
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
Today, we are going to have a look at Prof David Peters. This is what our friends from the ‘COLLEGE OF MEDICINE’ say about him:
“David Peters MB, ChB, DRCOG, DMSMed MFHom FLCOM trained as a GP, a musculoskeletal physician and also as a homeopathic and osteopathic practitioner. For fifteen years he directed the complementary therapies development programme at Marylebone Health Centre. Professor Peters is one of the founding faculty of the University of Westminster’s School of Life Sciences, where he is Clinical Director. Professor Peters is a member of the Council and former chair of the British Holistic Medical Association and Editor of its Journal of Holistic Healthcare. He has co-authored or edited six books about integrated healthcare. His research interests include the role of non-pharmaceutical treatments in mainstream medicine, wellbeing in long-term conditions and the development of integrated practitioners.”
I did my usual Medline search but found only 16 Medline-listed articles authored by David Peters. This is amazing because he has been involved in UK alt med much longer than I have. Even more amazing is that none of these papers seem to refer to clinical trials. Perhaps he is not convinced of this type of research?
In order to evaluate his output, I took the sentence that came nearest to a conclusion from the most recent 10 articles. Below you find first the titles of each paper (with the link to it), second the list of its authors and third the sentence that formulated a conclusion (in bold).
Cheshire A, Polley M, Peters D, Ridge D.
BMC Complement Altern Med. 2013 Nov 1;13:300. doi: 10.1186/1472-6882-13-300.
The BBPS provided a MSK pain management service that many patients found effective and valuable. Combining self-management with acupuncture was found to be particularly effective, although further consideration is required regarding how best to engage patients in self-management.
Cheshire A, Polley M, Peters D, Ridge D.
BMC Fam Pract. 2011 Jun 13;12:49. doi: 10.1186/1471-2296-12-49.
Provision of acupuncture and osteopathy for MSK pain is achievable in General Practice. A GP surgery can quickly adapt to incorporate complementary therapy provided key principles are followed.
Unwin J, Peters D.
Acupunct Med. 2009 Mar;27(1):21-5. doi: 10.1136/aim.2008.000083.
The Gateway Clinic has become an increasingly popular referral resource. The influences that drive referral to the clinic are multiple and follow “tacit guidelines”. GPs select patients on the basis of their individual clinical experience, informed by positive patient feedback and often only after more conventional medical treatment options have been exhausted.
Lewith GT, Breen A, Filshie J, Fisher P, McIntyre M, Mathie RT, Peters D.
Clin Med (Lond). 2003 May-Jun;3(3):235-40. Review.
This paper describes the current status and evidence base for acupuncture, homeopathy, herbal and manipulative medicine, as well as the regulatory framework within which these therapies are provided. It also explores the present role of the Royal College of Physicians’ Subcommittee on Complementary and Alternative Medicine (CAM) in relation to these developments. A number of CAM professions have encouraged the Royal College of Physicians Subcommittee to act as a reference point for their discussions with the conventional medical profession and the subcomittee believes that they are able to fulfil this function.
Peters D, Pinto GJ, Harris G.
Br Homeopath J. 2000 Jul;89 Suppl 1:S14-9
It is possible to introduce rigour and reflectiveness when providing a homeopathic service in general practice by assessing the needs of patient and practitioners, agreeing intake guidelines, developing referral processes, implementing audit cycles. Clear lines of communication can be established and a patient-centred outcome measure can be introduced into the treatment cycle.
I could not find any further articles that I could classify as providing data; so I stopped well short of the envisaged 10 papers. I have to admit, I was hesitant: does David deserve to be in the ALT MED HALL OF FAME? In the end, I gave him the benefit of the doubt. Why? Mainly because I am impressed with his scope of practice. Here is what he himself wrote about this aspect:
“I use a range of approaches: osteopathy and medical acupuncture, as well as nutrition and mind-body medicine – meditation, relaxation techniques, breath-work, self-hypnosis, biofeedback, and simple yoga-based exercises. Sometimes herbal medicines, complex homeopathy, nutritional supplements, trigger-point or joint injections can be a valuable too. Somatic Experiencing is a gentle form of body-centred psychotherapy for problems that have come on after traumatic incidents. When I want to assess the impact of stress on the body I use a painless approach involving computer-based heart rate variability testing and breath analysis; sometimes salivary cortisol profiling too. Where required I can prescribe conventional medicine and were they are needed I might suggest scans, X-rays or blood tests.”
Peter is perhaps not the most industrious researcher when it comes to publishing papers, but he fulfils the criterion of not ever publishing anything negative that might rock the boat or distract from the true value of alternative medicine.
LONG LIVE THE POSITIVE RESULT!