osteopathy
This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.
Nine trials with a total of 779 participants were included in the meta-analysis.
- low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
- moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
- low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).
The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.
Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):
- For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
- Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
- It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
- The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
- The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
- In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
- Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
- In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
- In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
- An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED
I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.
It follows that the main conclusion of the authors of the review should be modified:
There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.
Spinal manipulation is usually performed by a therapist (chiropractor, osteopath, physiotherpist, doctor, etc.). But many people do it themselves. Self-manipulation is by no means safer than the treatment by a therapist, it seems. We have previously seen cases where the results were dramatic:
- Spinal epidural haematoma after neck manipulation (edzardernst.com)
- A ‘Self-Chiropractic Spinal Manipulation’ that resulted in death (edzardernst.com)
Now, a further case has been reported. In this paper, American pathologists present a tragic case of fatal vertebral artery dissection that occurred as the result of self-manipulation of the cervical spine.
The decedent was a 40-year-old man with no significant past medical history. He was observed to “crack his neck” while at work. Soon after, he began experiencing neck pain, then developed stroke-like symptoms and became unresponsive. He was transported to a local medical center, where imaging showed bilateral vertebral artery dissection. His neurological status continued to decline, and brain death was pronounced several days later.
An autopsy examination showed evidence of cerebellar and brainstem infarcts, herniation, and diffuse hypoxic-ischemic injury. A posterior neck dissection was performed to expose the vertebral arteries, which showed grossly visible hemorrhage and dilation. There was no evidence of traumatic injury to the bone or soft tissue of the head or neck. Bilateral dissection tracts were readily appreciated on microscopic examination. Death was attributed to self-manipulation of the neck, which in turn led to bilateral vertebral artery dissection, cerebellar and brainstem infarcts, herniation, hypoxic-ischemic injury, and ultimately brain death.
It seems clear to me that only few and spectacular cases of this nature are being published. In other words, the under-reporting of adverse effects of self-manipulation must be close to 100%. It follows that the risk of sel-manipulation is impossible to quantify. I suspect it is substancial. In any case, the precautionary principle compells me to re-issue my warning:
do not allow anybody to manipulate your neck, not even yourself!
The aim of this study was to establish an international consensus regarding the use of spinal manipulation and mobilisation among infants, children, and adolescents among expert international physiotherapists. Twenty-six international expert physiotherapists in manual therapy and paediatrics voluntarily participated in a 3-Round Delphi survey to reach a consensus via direct electronic mail solicitation using Qualtrics®. Consensus was defined a-priori as ≥75% agreement on all items with the same ranking of agreement or disagreement. Round 1 identified impairments and conditions where spinal mobilisation and manipulation might be utilised. In Rounds 2 and 3, panelists agreed or disagreed using a 4-point Likert scale.
Eleven physiotherapists from seven countries representing five continents completed all three Delphi rounds. Consensus regarding spinal mobilisation or manipulation included:
● Manipulation is not recommended: (1) for infants across all conditions, impairments, and
spinal levels; and (2) for children and adolescents across most conditions and spinal levels.
● Manipulation may be recommended for adolescents to treat spinal region-specific joint
hypomobility (thoracic, lumbar), and pain (thoracic).
● Mobilisation may be recommended for children and adolescents with hypomobility, joint
pain, muscle/myofascial pain, or stiffness at all spinal levels.
The authors of this paper concluded that consensus revealed spinal manipulation should not be performed on infants regardless of condition, impairment, or spinal level. Additionally, the panel agreed that manipulation may be recommended only for adolescents to treat joint pain and joint hypomobility (limited to thoracic and/or lumbar levels). Spinal mobilisation may be recommended for joint hypomobility, joint pain, muscle/myofascial pain, and muscle/myofascial stiffness at all spinal levels among children and adolescents.
Various forms of spinal manipulations are the hallmark therapy of chiropractors. Almost 100% of their patients recieve these interventions. So, what will our friends, the chiros, say about the consensus? Might it be this:
- Physiotherapists are not the experts on spinal manipulation.
- Only chiropractors can do them properly.
- And when WE do them, they are very good*!
(* for our income)
These days, it has become a rare event – I am speaking of me publishing a paper in the peer-reviewed medical literature. But it has just happened: Spanish researchers and I published a meta-analysis on the effectiveness of craniosacral therapy. Here is its abstract:
The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models.
Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits.
We concluded that the qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.
So, CST is not really an effective option for any condition.
Not a big surprise! After all, the assumptions on which CST is based fly in the face of science.
Since CST is nonetheless being used by many healthcare professionals, it is, I feel, important to state and re-state that CST is an implausible intervention that is not supported by clinical evidence. Hopefully then, one day, these practitioners will remember that their ethical obligation is to treat their patients not according to their beliefs but according to the best available evidence. And, hopefully, our modest paper will have helped rendering healthcare a little less irrational and somewhat more effective.
As we have often discussed on this blog, chiropractic spinal manipulations can lead to several complications and can result in vascular injury, including traumatic dissection of the vertebral arteries with often dire consequences – see, for instance, here:
- Chiropractor caused a Vertebral Artery Dissection from a completely unnecessary neck adjustment
- Associations between cervical artery dissection and spinal manipulation
- Chiropractic spinal manipulation is a risk factor for cranio-cervical artery dissection
- Double-sided vertebral artery dissection in a 33-year-old man. The chiropractor is not guilty?
- Vertebral artery dissection in a pregnant woman after cervical spine manipulation
- Chiropractic manipulations are a risk factor for vertebral artery dissections
- Cervical artery dissection and stroke related to chiropractic manipulation
- Vertebral artery dissection after chiropractic manipulation: yet another case
- Pseudoaneurysm of Neck External Carotid Artery Related to Chiropractic Manipulation
- Cervical Arterial Dissections and Association With Cervical Manipulative Therapy
- Chiropractic adjustments are causing more and more strokes in younger adults
- Another case of stroke due to chiropractic
- More about the dangers of chiropractic
- The incidence of severe adverse events after chiropractic spinal manipulative therapy
- Catastrophic injuries after chiropractic treatment
- “As soon as the chiropractor manipulated my neck, everything went black”
This recent paper is a most unusual addition to the list. It is a case report of a 43-year-old woman who was admitted to the emergency department after performing a self-chiropractic spinal manipulation. She experienced headache and vomiting and was unresponsive with severe hypertension at the time of hospital admission. Clinical computerized tomography angiography showed narrowing of the right vertebral artery but was inconclusive for dissection or thrombosis.
The patient died a short while later. At autopsy, subacute dissection of the right vertebral artery was identified along with cerebral edema and herniation. A small peripheral pulmonary thromboembolism in the right lung was also seen. Neuropathology consultation confirmed the presence of diffuse cerebral edema and acute hypoxic-ischemic changes, with multifocal acute subarachnoid and intraparenchymal hemorrhage of the brain and spinal cord.
The authors concluded that this case presents a unique circumstance of a fatal vertebral artery dissection after self-chiropractic manipulation that, to the best of our knowledge, has not been previously described in the medical literature.
- an immediate osteopathic manipulative therapy (OMT) intervention group,
- a delayed OMT (waiting period) group.
The intervention consisted of three to four OMT sessions over 4–6 weeks, after which the participants switched (crossed-over) groups. The OMT techniques included a mandatory HVLA thrust technique to the lumbar spine region and any (or none) combination of the following four techniques: (i) soft tissue, (ii) muscle energy, (iii) myofascial, and (iv) articulatory. For patients who could not tolerate the HVLA treatment, a physician had to attempt this technique, minimally by attempting to place the patient in the position to perform this maneuver.
The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values.
- This study is far too small to allow conclusions about safety.
- The trial compared OMT with no therapy; it is likely that the observed outcomes have little to do with OMT but are due to a placebo response.
- The primary outcome measure showed no effect which essentially means that the study finding was that OMT is ineffective.
My conclusion:
a poor study conducted by wishful thinkers.
The aim of this study was to investigate whether there is a difference in outcome between participants with high compared to low pain self-efficacy (PSE) receiving manual therapy, acupuncture, and electrotherapy.
Participants were stratified into high or low baseline (i) PSE, (ii) shoulder pain and disability index (SPADI), and (iii) did or did not receive the treatment. Whether the effect of treatment differs for people with high compared to low PSE was assessed using the 95% confidence interval of the difference of difference (DoD) at a 5% significance level (p < 0.05).
Treatment was labelled using 3 categories, 2 of which were subcategories of the first
- “Any passive treatment” – any form of manual therapy and/or acupuncture and/or electrotherapy.
- “Any manual therapy” – shoulder or spine joint mobilisations, deep transverse frictions, capsular stretches, trigger point therapy, muscle facilitation, or other techniques listed by the treating physiotherapist.
- “Spinal/shoulder joint mobilisation” – for example, Maitland, Kaltenborn or Mulligan techniques.
To be categorised, treatment must have been delivered by the physiotherapist at least once and may have been delivered in conjunction with other treatments.
Six-month SPADI scores were consistently lower (less pain and disability) for those who did not receive passive treatments compared to those who did (statistically significant less pain and disability in 7 of 24 models). However, DoD was statistically insignificant.
The authors concluded that PSE did not moderate the relationship between treatment and outcome. However, participants who received passive treatment experienced equal or more pain and disability at 6 months compared to those who did not. Results are subject to confounding by indication but do indicate the need for further appropriately designed research.
This analysis suggests that manual therapy, electrotherapy, or acupuncture in addition to advice and exercise offered no improvement in pain or disability at six months, irrespective of PSE. Some patients who receive these treatments experienced more pain and disability at six months compared to those who do not.
I am not aware of compelling evidence that either of these treatments, all of which are often recommended, are effective for shoulder pain, and the results of this new study certainly do not suggest they are. However, as the design of the study was not primarily for this research question, these findings are, of course, merely tentative and need to be investigated further.
Craniosacral therapy (CST) is a widely taught component of osteopathic medical education. It is included in the standard curriculum of osteopathic medical schools, despite controversy surrounding its use. This paper seeks to systematically review randomized clinical trials (RCTs) assessing the clinical effectiveness of CST compared to standard care, sham treatment, or no treatment in adults and children.
A search of Embase, PubMed, and Scopus was conducted on 10/29/2023 with no restriction placed on the date of publication. Additionally, a Google Scholar search was conducted to capture grey literature. Backward citation searching was also implemented. All RCTs employing CST for any clinical outcome were included. Studies not available in English as well as any studies that did not report adequate data for inclusion in a meta-analysis were excluded. Multiple reviewers were used to assess for inclusions, disagreements were settled by consensus. PRISMA guidelines were followed in the reporting of this meta-analysis. Cochrane’s Risk of Bias 2 tool was used to assess for risk of bias. All data were extracted by multiple independent observers. Effect sizes were calculated using a Hedge’s G value (standardized mean difference) and aggregated using random effects models.
The primary study outcome was the effectiveness of CST for selected outcomes as applied to non-healthy adults or children and measured by standardized mean difference effect size. Twenty-four RCTs were included in the final meta-analysis with a total of 1,613 participants. When results were analyzed by primary outcome, no significant effects were found. When secondary outcomes were included, results showed that only Neonate health, structure (g = 0.66, 95% CI [0.30; 1.02], Prediction Interval [-0.73; 2.05]) and Pain, chronic somatic (g = 0.34, 95% CI [0.18; 0.50], Prediction Interval [-0.41; 1.09]) showed statistically significant effects. However, wide prediction intervals and high bias limit the real-world implications of this finding.
The authors concluded that CST did not demonstrate broad significance in this meta-analysis, suggesting limited usefulness in patient care for a wide range of indications.
To this, one should perhaps add that CST is one of those forms of so-called alternative medicine (SCAM) that is utterly implausible; there is not conceivable mechanism by which CST might work other than a placebo effects. Therefore, the finding that it is ineffective (positive effects on secondary outcomes are most likely due to residual bias and possibly fraud) is hardly surprising. The most sensible conclusion, in my view, is that CST too ridiculous to merit further research because that would, in effect, be an unethical waste of resources.
The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:
- education programs that support knowledge and self-care strategies;
- exercise programs;
- some physical therapies, such as spinal manipulative therapy (SMT) and massage;
- psychological therapies, such as cognitive behavioural therapy; and
- medicines, such as non-steroidal anti-inflammatory medicines.
The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:
- lumbar braces, belts and/or supports;
- some physical therapies, such as traction;
- and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.
As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:
Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.
The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.
The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.
Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.
The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.
The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.
The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.
___________________________
This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:
WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.
That explains a lot!
It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:
Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.
Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.
Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).
The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.
Why?
Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?
The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.
Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.
As promised, here is my translation of the article published yesterday in ‘Le Figaro’ arguing in favour of integrating so-called alternative medicine (SCAM) into the French healthcare system [the numbers in square brackets were inserted by me and refer to my comments listed at the bottom].
So-called unconventional healthcare practices (osteopathy, naturopathy, acupuncture, homeopathy and hypnosis, according to the Ministry of Health) are a cause for concern for the health authorities and Miviludes, which in June 2023 set up a committee to support the supervision of unconventional healthcare practices, with the task of informing consumers, patients and professionals about their benefits and risks, both in the community and in hospitals. At the time, various reports, surveys and press articles highlighted the risks associated with NHPs, without pointing to their potential benefits [1] in many indications, provided they are properly supervised. There was panic about the “booming” use of these practices, the “explosion” of aberrations, and the “boost effect” of the pandemic [2].
But what are the real figures? Apart from osteopathy, we lack reliable data in France to confirm a sharp increase in the use of these practices [3]. In Switzerland, where it has been decided to integrate them into university hospitals and to regulate the status of practitioners who are not health professionals, the use of NHPs has increased very slightly [4]. With regard to health-related sectarian aberrations, referrals to Miviludes have been stable since 2017 (around 1,000 per year), but it should be pointed out that they are a poor indicator of the “risk” associated with NHPs (unlike reports). The obvious contrast between the figures and the press reports raises questions [5]. Are we witnessing a drift in communication about the risks of ‘alternative’ therapies? [6] Is this distortion of reality [7] necessary in order to justify altering the informed information and freedom of therapeutic choice of patients, which are ethical and democratic imperatives [8]?
It is the inappropriate use of certain NHPs that constitutes a risk, more than the NHPs themselves! [9] Patients who hope to cure their cancer with acupuncture alone and refuse anti-cancer treatments are clearly using it in a dangerous alternative way [10]. However, acupuncture used to relieve nausea caused by chemotherapy, as a complement to the latter, is recommended by the French Association for Supportive Care [11]. The press is full of the dangers of alternative uses, but they are rare: less than 5% of patients treated for cancer according to a European study [12]. This is still too many. Supervision would reduce this risk even further [13].
Talking about risky use is therefore more relevant than listing “illusory therapies”, vaguely defined as “not scientifically validated” and which are by their very nature “risky” [14]. What’s more, it suggests that conventional treatments are always validated and risk-free [15]. But this is not true! In France, iatrogenic drug use is estimated to cause over 200,000 hospital admissions and 10,000 deaths a year [16]. Yes, some self-medication with phytotherapy or aromatherapy does carry risks… just like any self-medication with conventional medicines [17]. Yes, acupuncture can cause deep organ damage, but these accidents occur in fewer than 5 out of every 100,000 patients [18]. Yes, cervical manipulations by osteopaths can cause serious or even fatal injuries, but these exceptional situations are caused by practitioners who do not comply with the decree governing their practice.[19] Yes, patients can be swindled by charlatans, but there are also therapeutic and financial abuses in conventional medicine, such as those reported in dental and ophthalmology centres. [20]
Are patients really that naive? No. 56% are aware that “natural” remedies can have harmful side-effects, and 70% know that there is a risk of sectarian aberrations or of patients being taken in by a sect [21]. In view of the strong demand from patients, we believe that guaranteeing safe access to certain NHPs is an integral part of their supervision, based on regulation of the training and status of practitioners who are not health professionals, transparent communication, appropriate research, the development of hospital services and outpatient networks of so-called “integrative” medicine combining conventional practices and NHPs, structured care pathways with qualified professionals, precise indications and a safe context for treatment.[22] This pragmatic approach to reducing risky drug use [17] has demonstrated its effectiveness in addictionology [23]. It should inspire decision-makers in the use of NHPs”.
- Reports about things going wrong usually do not include benefits. For instance, for a report about rail strikes it would be silly to include a paragraph on the benefits of rail transport. Moreover, it is possible that the benefits were not well documented or even non-existent.
- No, there was no panic but some well-deserved criticism and concern.
- Would it not be the task of practitioners to provide reliable data of their growth or decline?
- The situation in Switzerland is often depicted by enthusiasts as speaking in favour of SCAM; however, the reality is very different.
- Even if reports were exaggerated, the fact is that the SCAM community does as good as nothing to prevent abuse.
- For decades, these therapies were depicted as gentle and harmless (medicines douces!). As they can cause harm, it is high time that there is a shift in reporting and consumers are informed responsibly.
- What seems a ‘distortion of reality’ to enthusiasts might merely be a shift to responsible reporting akin to that in conventional medicine where emerging risks are taken seriously.
- Are you saying that informing consumers about risks is not an ethical imperative? I’d argue it is an imperative that outweighs all others.
- What if both the inappropriate and the appropriate use involve risks?
- Sadly, there are practitioners who advocate this type of usage.
- The recommendation might be outdated; current evidence is far less certain that this treatment might be effective (“the certainty of evidence was generally low or very low“)
- The dangers depend on a range of factors, not least the nature of the therapy; in case of spinal manipulation, for instance, about 50% of all patients suffer adverse effects which can be severe, even fatal.
- Do you have any evidence showing that supervision would reduce this risk, or is this statement based on wishful thinking?
- As my previous comments demonstrate, this statement is erroneous.
- No, it does not.
- Even if this figure is correct, we need to look at the risk/benefit balance. How many lives were saved by conventional medicine?
- Again: please look at the risk/benefit balance.
- How can you be confident about these figures in the absence of any post-marketing surveillance system? The answer is, you cannot!
- No, they occur even with well-trained practitioners who comply with all the rules and regulations that exist – spoiler: there hardly are any rules and regulations!
- Correct! But this is a fallacious argument that has nothing to do with SCAM. Please read up about the ‘tu quoque’ and the strawman’ fallacies.
- If true, that is good news. Yet, it is impossible to deny that thousands of websites try to convince the consumer that SCAM is gentle and safe.
- Strong demand is not a substitute for reliable evidence. In any case, you stated above that demand is not increasing, didn’t you?
- Effectiveness in addictionology? Do you have any evidence for this or is that statement also based on wishful thinking?
My conclusion after analysing this article in detail is that it is poorly argued, based on misunderstandings, errors, and wishful thinking. It cannot possibly convince rational thinkers that SCAM should be integrated into conventional healthcare.
PS
The list of signatories can be found in the original paper.
