An abstract from the recent ‘2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES’ caught my attention. It is not available on-line; therefore let me reproduce it here in full:
The role of placebo effects in mindfulness-based analgesia 1. Jonathan Davies. University of Sydney, Sydney, NSW, Australia. 2. Louise Sharpe. University of Sydney, Sydney, NSW, Australia. 3. Melissa Day. University of Queensland, Brisbane, QLD, Australia. 4. Ben Colagiuri. University of Sydney, Sydney, NSW, Australia.
Background: Mindfulness meditation can reduce pain both in experimental and clinical settings, though it is not known to what extent mindfulness-specific vs placebo-like expectancy effects account for these changes. This study aimed to: 1. establish whether placebo effects contribute to mindfulness-mediated analgesia; and 2. identify putative cognitive mechanisms responsible for placebo- vs mindfulness-mediated analgesia. Methods: We compared the effects of focussed-attention mindfulness training (6 x 20 min), sham mindfulness, and a no-treatment in a double-blind RCT for experimental heat pain. Sham mindfulness instructions lacked the ‘active ingredients’ of the real training but were matched on all other contextual factors. Results: Both real and sham mindfulness training led to greater pain tolerance relative to no treatment, but there was no difference between the real and sham training. This was accompanied by increased expectancy, beliefs, and pain-related cognitive processes in the two mindfulness groups relative to no treatment, but again there were no differences between real and sham training on these outcomes. There were no effects on pain intensity, pleasantness or threshold. Conclusion: These findings suggest that mindfulness training – at least those involving focused-attention – may lead to improved pain tolerance via the placebo effect rather than any specific mindfulness-related mechanisms. Potential mediators of these effects will be discussed.
I find this study remarkable in two ways:
- It shows that, with a bit of fantasy, ingenuity and will, one can design and use sham procedures even in clinical trials of mind/body therapies.
- Its results suggest that, if one does control for placebo effects, these treatments may not prove to be more than a placebo therapy.
What implications might this have for clinical practice?
Mindfulness is currently hugely popular. It would not be surprising, if the news that it might rely purely on placebo effects would calm down the enthusiasm about this treatment. Many might ask, does it matter? As long as patients benefit, the mechanism of action seems irrelevant. This, of course, is an interesting debate which we have had on this blog many times before.
What do you think?
It is hardly surprising that Gwyneth Paltrow’s obsession with so-called alternative medicine (SCAM) for the vagina is motivating women to try some of it. The consequences can be dramatic; not only for the wallet but also for the vagina!
Vaginal steaming made global headlines in 2015 after its promotion by celebrity Gwyneth Paltrow. One of many female genital modification practices currently on offer in Anglo-Western nations – practices both heavily promoted and critiqued – vaginal steaming is claimed to offer benefits for fertility and overall reproductive, sexual or even general health and wellbeing. We analysed a selection of online accounts of vaginal steaming to determine the sociocultural assumptions and logics within such discourse, including ideas about women, women’s bodies and women’s engagement with such ‘modificatory’ practices. Ninety items were carefully selected from the main types of website discussing vaginal steaming: news/magazines; health/lifestyle; spa/service providers; and personal blogs. Data were analysed using thematic analysis, within a constructionist framework that saw us focus on the constructions and rationalities that underpin the explicit content of the texts. Within an overarching theme of ‘the self-improving woman’ we identified four themes: (1) the naturally deteriorating, dirty female body; (2) contemporary life as harmful; (3) physical optimisation and the enhancement of health; and (4) vaginal steaming for life optimisation. Online accounts of vaginal steaming appear both to fit within historico-contemporary constructions of women’s bodies as deficient and disgusting, and contemporary neoliberal and healthist discourse around the constantly improving subject.
A recent case-report tells a cautionary tale. Here is its abstract:
Vaginal steaming has gained increased popularity as a method to achieve empowerment by providing vaginal tightening and to “freshen” the vagina.
A 62-year-old woman sustained second-degree burns following vaginal steaming in an attempt to reduce vaginal prolapse.
Clinicians need to be aware of alternative treatments available to women so that counselling may mitigate any potential harm.
As the full paper is not available to me, I had to rely on another report for further information.
The woman had been suffering from a prolapsed vagina and had been led to believe the vaginal steaming could help avoid surgery. Spas advertising “v-steaming” claim it has been used throughout history in countries in Asia and Africa. They claim the practice, which is sometimes called Yoni steaming, acts to “detox” the vagina, can ease period pains, help with fertility and much more. Experts, however, warn that it can be dangerous and point out that there is no good evidence for the health claims being made.
Dr Vanessa Mackay, a consultant and spokeswoman for the Royal College of Obstetricians and Gynaecologists, says it is a “myth” that the vagina requires extensive cleaning or treatment. She recommends using plain, unperformed soaps on the external vulva area only. “The vagina contains good bacteria, which are there to protect it,” she said in a statement. “Steaming the vagina could affect this healthy balance of bacteria and pH levels and cause irritation, infection (such as bacterial vaginosis or thrush) and inflammation. It could also burn the delicate skin around the vagina (the vulva).”
Dr Magali Robert, who authored the case-report, said the injured woman attempted to steam her vagina on the advice of a traditional Chinese doctor. The woman, who gave permission for her case to be shared, sat over the boiling water for 20 minutes on two consecutive days before presenting at an emergency department with injuries. She sustained second-degree burns and had to delay reconstructive surgery while she healed.
Dr Robert, who works in pelvic medicine and reconstructive surgery in Calgary, said word of unconventional therapies like steaming can spread through channels like the internet and word-of-mouth. “Health care providers need to be aware of alternative therapies so that they can help women make informed choices and avoid potential harm,” she says in the article.
Guest post by Toby Katz
Who am I?
I’m a final-year graduate medic (also hold an Economics degree) studying at St George’s University. I founded the Integrative Medicine Society at the university, with the aim of hosting talks on evidence-based CAM. My interest in evidence-based CAM arose as many of my family members have benefitted from different CAM interventions (mostly due to chronic MSk pain), where conventional interventions (physiotherapy and chronic pain teams) have failed to resolve their issues.
When it comes to the CAM debate, I see myself as a centrist. I am both a CAM apologist and sceptic and in recent years I have looked to educate myself around this subject. I have read Ernst’s Desktop Guide to CAM and Moral Maze books, spoken to Professor Colquhoun and most recently I undertook the Foundation Course in CAM run by the College of Medicine. My review of the course follows.
Overall, there’s a lot to learn from both sides of the debate and the debate continues due to systematic issues in the UK. Ad hominem attacks don’t help anyone, but conversation can. I hope I can converse with many of you in the future.
The Foundation Course
Two days of fast-paced talks on Integrative/Complementary and Alternative Medicine. The topics included: Resilience, nutritional therapy, medical acupuncture, MSk methods for non-osteopaths, homeopathy, herbs and spices, imagery and relaxation, cancer, hypnotherapy and social prescribing.
The speakers included: Professor David Peters, Dr Catherine Zollman (Medical Director for Penny Brohn), Heather Richards (Nutritional Therapist), Dr Elizabeth Thompson (GP and homeopath), Trevor Hoskisson (Hypnotherapist), Dr Mike Cummings (BMAS), Simon Mills (Medical Herbalist) – at least two of these are already in the infamous Alt Med Hall of Fame!
My initial feelings upon hearing the talks were that most of these individuals are inherently good people, who want the best outcomes for their patients. Their aim is to operate in the areas of medicine where conventional medicine doesn’t hold the answers – chronic pain, idiopathic headache, IBS etc. But there were also people who were advocating the use of unproven alternative therapies.
These were some of my thoughts I jotted down during the two days:
Professor Peters – Constantly speaking in generalisations. Uses historic references, romantic and philosophical language to entice listeners but generally has little point to what he says. Suffers from tangential thinking. Loses track of his own point. Very Freudian-like thinking (everyone has gone through childhood trauma according to him).
Dr Catherine Zollman – Brilliant. Absolutely brilliant. The doctor I resonate most closely with out of everyone speaking. Promoting the holistic management of a cancer diagnosis; integrating (not undermining) conventional medicine with complementary ways of dealing with the stress surrounding the diagnosis and much more. Works for a non-for-profit organisation. She has many years of oncology experience and strives to create a patient-centred approach to management.
Dr Mike Cummings – promoting medical acupuncture mainly for myofascial pain syndrome. I volunteered to receive acupuncture in my shoulder (have had post-op muscular pain since April). He dry-needled one of my trigger points and it helped, for a few days – this is better than anything a physio has done for me so far. I don’t know why dry-needling isn’t taught at medical school to help with myofascial pain syndrome.
Dr Elizabeth Thompson – Very respectable but I do feel the homeopathy ship has well and truly sailed. Provided ‘evidence’ on how ‘succussion’ changes the make-up of water molecules. Though Dr Thompson is medically trained, there are many non-medical homeopaths who promote things such as homeoprophylaxis and anti-vaccine views and I’m more worried about these such homeopaths. I do respect Dr Thompson and believe her when she says she has helped many patients. Whether this is due to placebo or the get-better-anyway effect I don’t know.
What they were promoting
On reflection, it’s clear that there was a real mix in promoting evidence-based therapies and eyebrow-raising alternatives – this is often difficult for those with an untrained eye to spot the difference. There was a general air of distrust with modern science and EBM floating around the room at all times. Sure, there are things wrong with it, but I think it’s done us pretty well over the last few decades!
I irritated a few speakers when I asked about the evidence behind their claims!
What to take away
There were many GPs present, who stated they’re often in a difficult position in the current system of healthcare we have in the UK. Around half of all consultations are MSk based, many of which are associated with chronic, muscular pain. The WHO analgesic pathway does little for these patients (unless you want to knock them for six with oxycodone) and physiotherapists struggle to make a real difference in a 30-minute appointment. The truth is, we are not providing GPs with the right toolkit to cope with these “difficult” patients.
– Get a copy of Ernst et al.’s Desktop Guide for CAM
– Release more formal guidelines using this book as a base for any positive evidence
– Engage in conversation with those from both sides. We have a lot to learn from one another
– SCRAP the forms of CAM that have no plausibility
Food for thought
– If a patient’s pain improves after a session of acupuncture and not from physiotherapy, does it fit with a utilitarian ethical model to deny this person access to acupuncture if EBM shows acupuncture has rates similar to placebo?
– Chronic myofascial pain syndrome. Can we manage it better in primary care? Why not teach dry needling to healthcare professionals? (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107879/ – Desai et al suggest it works)
– What is the alternative for no CAM for many patients who suffer? If patient’s choice is reduced, does that not reduce their autonomy?
If anyone wishes to contact me, you can at email@example.com
Fibromyalgia (FM) is one of the most frequent generalized pain disorders. It accounts for a sizable proportion of healthcare costs. Despite extensive research, the etiology (the ‘root cause’) of FM remains unknown – except, of course, to SCAM practitioners!
And almost every one of them claims to treat the ‘root cause’ of the condition. Which must mean that they are able to tackle its etiology, usually some disturbance of the ‘vital force’ or ‘energy’ flow. To patients, this sadly sounds impressive.
But what, if the etiology of FM is something entirely different?
New research shows that most (if not all) patients with FM belong to a distinct population that can be segregated from a control group by their glycated haemoglobin A1c (HbA1c) levels, a surrogate marker of insulin resistance (IR). This was demonstrated by analysing the data after introducing an age stratification correction into a linear regression model. This strategy showed highly significant differences between FM patients and control subjects (p < 0.0001 and p = 0.0002, for two separate control populations, respectively).
A subgroup of FM patients meeting criteria for pre-diabetes or diabetes (patients with HbA1c values of 5.7% or greater) who had undergone treatment with metformin showed dramatic improvements of their widespread myofascial pain. This was shown comparing pre and post-treatment numerical pain rating scale (NPRS). Response to metformin plus standard treatment (ST) was followed by complete resolution of the pain (report of 0 of 10 in the NPRS) in 8 of 16 patients who had been treated with metformin (50%), a degree of improvement never observed before in such a large proportion of FM patients subjected to any available treatment. In contrast, patients treated with ST alone improved, but complete resolution of pain was generally not observed. Interestingly, some patients responded only to metformin and not to ST with NSRIs or membrane stabilizing agents. Importantly, there was a long-term retention of the analgesic effect of metformin.
The authors concluded that these findings suggest a pathogenetic relationship between FM and IR, which may lead to a radical paradigm shift in the management of this disorder.
From my perspective, these findings also suggest that all the many SCAMs allegedly claiming to tackle the ‘root cause’ of FM have been barking up the wrong tree. In fact, all these claims of SCAM practitioners about treating the ‘root causes’ can easily be disclosed as a simple (and sadly effective) marketing gimmick. Six years ago, I even challenged the world of SCAM to name a single treatment that treats the ‘root cause’ of any disease. As yet, nobody has come forward with a convincing suggestion.
I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:
Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.
I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.
So, let’s try again.
Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.
Dr Geer published a short article explaining the nature of naprapathy:
Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.
What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:
1st study (2007)
Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.
At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.
This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.
2nd study (2010)
Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.
89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.
Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.
3rd study (2016)
Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.
At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.
The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.
I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:
Chronic Neck Pain
Hip Muscle Strain
Knee Ligament Injuries
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Spinal Stenosis
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Sports Injuries of the Knee
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Odd, I’d say! Did all this change my mind about naprapathy? Not really.
But nobody – except perhaps Dr Greer – can say I did not try.
And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.
My friend Roger, the homeopath, alerted me to the ‘Self-Controlled Energo Neuro Adaptive Regulation‘ (SCENAR). He uses it in his practice and explains:
The scenar uses biofeedback; by stimulating the nervous system, it is able to teach the body to heal itself. The device sends out a series of signals through the skin and measures the response. Each signal is only sent out when a change, in response to the previous signal, is recorded in the electrical properties of the skin. Visible responses include reddening of the skin, numbness, stickiness (the device will have the feeling of being magnetically dragged), a change in the numerical readout and an increase in the electronic clattering of the device.
The C-fibres, which comprise 85% of all nerves in the body, react most readily to the electro-stimulation and are responsible for the production of neuropeptides and other regulatory peptides. A TENS unit will only stimulate the A & B-fibres for temporary relief.
The body can get accustomed to a stable pathological state, which may have been caused by injury, disease or toxicity. The Scenar catalyses the process to produce regulatory peptides for the body to use where necessary, by stimulation of C-fibres . It is these neuropeptides that in turn reestablish the body’s natural physiological state and are responsible for the healing process. As these peptides last up to several hours, the healing process will continue long after the treatment is over. The large quantity of neuropeptides and C-fibres in the Central Nervous System can also result in the treatment on one area aiding with other general regulatory processes, like chemical imbalances, correcting sleeplessness, appetite and behavioral problems.
Sounds like science fiction?
Or perhaps more like BS?
But, as always, the proof of the pudding is in the eating. Roger explains:
What conditions can Scenar treat?
In the UK, the devices are licensed by the British Standards Institute for pain relief only. Likewise the FDA has approved the Scenar for pain relief. However, because of the nature of the device, viz., stimulating the nervous system, the Russian experience is that Scenar affects all the body systems in a curative manner.
The Russian experience suggests that it can be effective for a very broad range of diseases, including diseases of the digestive, cardio-vascular, respiratory, musculo-skeletal, urinary, reproductive and nervous systems. It is also useful for managing ENT diseases, eye diseases, skin conditions and dental problems. It has also been found beneficial in burns, fractures, insect bites, allergic reactions, diseases of the blood and disorders involving immune mechanisms; endocrine, nutritional and metabolic disorders; stress and mental depression, etc.
It is known to give real relief from many types of pain. It does so because it stimulates the body to heal the underlying disease causing the pain!
Another SCENAR therapist is much more specific. He tells us that SCENAR is effective for:
- Sports and other injuries
- Musculoskeletal problems
- Issues with circulation
- Respiratory diseases
- Digestive disorders
- Certain infections
- Immune dysfunctions
Perhaps I was a bit hasty; perhaps the SCENAR does work after all. It is certainly offered by many therapists like Roger. They cannot all be charlatans, or can they?
Time to do a proper Medline search and find out about the clinical trials that have been done with the SCENAR. Disappointingly, I only found three relevant papers; here they are:
A new technique of low-frequency modulated electric current therapy, SCENAR therapy, was used in treatment of 103 patients with duodenal ulcer (DU). The influence of SCENAR therapy on the main clinical and functional indices of a DU relapse was studied. It was shown that SCENAR therapy, which influences disturbed mechanisms of adaptive regulation and self-regulation, led to positive changes in most of the parameters under study. Addition of SCENAR therapy to the complex conventional pharmacotherapy fastened ulcer healing, increased the effectiveness of Helicobacter pylori eradication, and improved the condition of the gastroduodenal mucosa.
Administration of artrofoon in combination with SCENAR therapy to patients with localized suppurative peritonitis in the postoperative period considerably reduced plasma MDA level, stabilized ceruloplasmin activity, and increased catalase activity in erythrocytes compared to the corresponding parameters in patients receiving standard treatment in combination with SCENAR therapy.
The author recommends a self-control energoneuroadaptive regulator (SCENAR) as effective in the treatment of neurogenic dysfunction of the bladder in children with nocturnal enuresis. This regulator operates according to the principles of Chinese medicine and may be used in sanatoria and at home by the children’s parents specially trained by physiotherapist.
While the quantity of the ‘studies’ is lamentable, their quality seems quite simply unacceptable.
We are thus left with two possibilities: either the SCENAR is more or less what its proponents promise and the science has for some strange reason not caught up with this reality; or the reality is that SCENAR is a bogus treatment used by charlatans who exploit the gullible public.
I know which possibility I favour – how about you?
Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.
The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.
Sounds more than a little weird?
Yes, I agree.
Perhaps we need some real evidence.
The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).
Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.
The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:
- The theory on which PPT is based is not plausible (to put it mildly).
- It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
- The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
- The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
- Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
- The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.
So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.
Osteopathy is a tricky subject:
- Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
- Yet many osteopaths use them also for a myriad of non-spinal conditions.
- Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
- The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
- Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.
A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints. Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.
Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.
In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.
The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”
Some of the most obvious weaknesses of this review include the following:
- In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
- In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
- Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
- One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
- The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.
Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.
Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.
Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.
Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.
Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.
The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.
There are numerous problems with this study:
- The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
- A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
- For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
- If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
- The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
- The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
- Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.
My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.
Chiropractors believe that their spinal manipulations bring about a reduction in pain perception, and they often call this ‘manipulation-induced hypoalgesia’ (MIH). It is unknown, however, whether MIH following high-velocity low-amplitude spinal manipulative therapy is a specific and clinically relevant treatment effect.
This systematic review was an effort in finding out.
The authors investigated changes in quantitative sensory testing measures following high-velocity low-amplitude spinal manipulative therapy in musculoskeletal pain populations, in randomised controlled trials. Their objectives were to compare changes in quantitative sensory testing outcomes after spinal manipulative therapy vs. sham, control and active interventions, to estimate the magnitude of change over time, and to determine whether changes are systemic or not.
Fifteen studies were included. Thirteen measured pressure pain threshold, and 4 of these were sham-controlled. Change in pressure pain threshold after spinal manipulative therapy compared to sham revealed no significant difference. Pressure pain threshold increased significantly over time after spinal manipulative therapy (0.32 kg/cm2, CI 0.22–0.42), which occurred systemically. There were too few studies comparing to other interventions or for other types of quantitative sensory testing to make robust conclusions about these.
The authors concluded that they found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.
An odd conclusion, if there ever was one!
A more straight forward conclusion might be this:
MIH is yet another myth to add to the long list of bogus claims made by chiropractors.