MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk/benefit

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Probiotics (live microorganisms for oral consumption) are undoubtedly popular, not least they are being cleverly promoted as a quasi panacea. But are they as safe as their manufacturers try to convince us? A synthesis and critical evaluation of the reports and series of cases on the infectious complications related to the ingestion of probiotics was aimed at finding out.

The authors extensive literature searches located 60 case reports and 7 case series including a total of 93 patients. Fungemia was the most common infectious complications with 35 (37.6%) cases. The genus Saccharomyces was the most frequent with 47 (50.6%) cases, followed by Lactobacillus, Bifidobacterium, Bacillus, Pedioccocus and Escherichia with 26 (27.9%), 12 (12.8%), 5 (5.4%), 2 (2.2%) and 1 (1.1%) case, respectively. Adults over 60 years of age, Clostridium difficile colitis, antibiotic use and Saccharomyces infections were associated with overall mortality. HIV infections, immunosuppressive drugs, solid organ transplantation, deep intravenous lines, enteral or parenteral nutrition were not associated with death.

The authors concluded that the use of probiotics cannot be considered risk-free and should be carefully evaluated for some patient groups.

Other authors have previously warned that individuals under neonatal stages and/or those with some clinical conditions including malignancies, leaky gut, diabetes mellitus, and post-organ transplant convalescence likely fail to reap the benefits of probiotics. Further exacerbating the conditions, some probiotic strains might take advantage of the weak immunity in these vulnerable groups and turn into opportunistic pathogens engendering life-threatening pneumonia, endocarditis, and sepsis. Moreover, the unregulated and rampant use of probiotics potentially carry the risk of plasmid-mediated antibiotic resistance transfer to the gut infectious pathogens. 

And yet another review had concluded that the adverse effects of probiotics were sepsis, fungemia and GI ischemia. Generally, critically ill patients in intensive care units, critically sick infants, postoperative and hospitalized patients and patients with immune-compromised complexity were the most at-risk populations. While the overwhelming existing evidence suggests that probiotics are safe, complete consideration of risk-benefit ratio before prescribing is recommended.

Proponents of probiotics will say that these risks are rare and confined to small groups of particularly vulnerable patients. This may well be so, but in view of the often uncertain benefits of probiotics, the incessant hype and aggressive marketing, I find it nevertheless important to keep these risks in mind.

As with any therapy, the question must be, does this treatment really generate more good than harm?

The over-use of X-ray diagnostics by chiropractors has long been a concern (see for instance here,and here). As there is a paucity of reliable research on this issue, this new review is more than welcome.

It aimed to summarise the current evidence for the use of spinal X-ray in chiropractic practice, with consideration of the related risks and benefits. The authors, chiropractors from Australia and Canada who did a remarkable job in avoiding the term SUBLUXATION throughout the paper, showed that the proportion of patients receiving X-ray as a result of chiropractic consultation ranges from 8 to 84%. I find this range quite staggering and in need of an explanation.

The authors also stated that current evidence supports the use of spinal X-rays only in the diagnosis of trauma and spondyloarthropathy, and in the assessment of progressive spinal structural deformities such as adolescent idiopathic scoliosis. MRI is indicated to diagnose serious pathology such as cancer or infection, and to assess the need for surgical management in radiculopathy and spinal stenosis. Strong evidence demonstrates risks of imaging such as excessive radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased costs. In most cases the potential benefits from routine imaging, including spinal X-rays, do not outweigh the potential harms. The authors state that the use of spinal X-rays should not be routinely performed in chiropractic practice, and should be guided by clinical guidelines and clinician judgement.

The problem, however, is that many chiropractors do not abide by those guidelines. The most recent data I am aware of suggests that  only about half of them are even aware of radiographic guidelines for low back pain. The reasons given for obtaining spinal X-rays by chiropractors are varied and many are not supported by evidence of benefit. These include diagnosis of pathology or trauma; determination of treatment options; detection of contraindications to care; spinal biomechanical analysis; patient reassurance; and medicolegal reasons.

One may well ask why chiropractors over-use X-rays. The authors of the new paper provide the following explanations:

  • lack of education,
  • ownership of X-ray facilities,
  • and preferred chiropractic technique modalities (i. e. treatment techniques which advocate the use of routine spinal X-rays to perform biomechanical analysis, direct appropriate treatment, and perform patient reassessment).

Crucially, the authors state that, based on the evidence, the use of X-ray imaging to diagnose benign spinal findings will not improve patient outcomes or safety. For care of non-specific back or neck pain, studies show no difference in treatment outcome when routine spinal X-rays have been used, compared to management without X-rays.

A common reason suggested by chiropractors for spinal X-ray imaging is to screen for anomalies or serious pathology that may contraindicate treatment that were otherwise unsuspected by the clinical presentation. While some cases of serious pathology, such as cancer and infection, may not initially present with definitive symptoms, X-ray assessment at this early stage of the disease process is also likely to be negative, and is not recommended as a screening tool.

The authors concluded that the use of spinal X-rays in chiropractic has been controversial, with benefits for the use of routine spinal X-rays being proposed by some elements of the profession. However, evidence of these postulated benefits is limited or non-existent. There is strong evidence to demonstrate potential harms associated with spinal X-rays including increased ionising radiation exposure, over-diagnosis, subsequent low-value investigation and treatment procedures, and increased unnecessary costs. Therefore, in the vast majority of cases who present to chiropractors, the potential benefit from spinal X-rays does not outweigh the potential harms. Spinal X-rays should not be performed as a routine part of chiropractic practice, and the decision to perform diagnostic imaging should be informed by evidence based clinical practice guidelines and clinician judgement.

So, if you consult a chiropractor – and I don’t quite see why you should – my advice would be not to agree to an X-ray.

The DAILY MAIL is by no means my favourite paper (see, for instance, here, here and here). This week, the Mail published another article which, I thought, is worth mentioning. The Mail apparently asked several UK doctors which dietary supplements they use for their own health (no mention of the number they had to approach to find any fitting into this category). The results remind me of a statement by the Permanent Secretary, Sir Humphrey Appleby in the famous TV series YES MINISTER: “if nobody knows anything then nobody can accuse anybody else of knowing nothing, and so the one thing we do know is that nobody knows anything, and that’s better than us knowing nothing”.

Below, I present the relevant quotes by the doctors who volunteered to be interviewed and add the most up-to date evidence on each subject.

Professor Christopher Eden, 57, is a consultant urological surgeon at the Royal Surrey County Hospital in Guildford.

“I take a 1g supplement of vitamin C daily. (The recommended daily amount, or RDA, is 40mg, which is equivalent to a large orange.) This amount of vitamin C makes the urine mildly acidic and increases the levels of an antimicrobial protein called siderocalin, found naturally in urine, which makes the environment less favourable to bad bacteria and reduces the risk of infection.”

Ascorbic acid (vitamin C) cannot be recommended for the prevention of urinary tract infections.

Louise Newson, 48, is a GP and menopause specialist based in Stratford-upon-Avon.

“Women going through the menopause or perimenopause may get bowel symptoms such as bloating which are due to hormone imbalances affecting the balance of gut bacteria. Probiotic (good bacteria) supplements correct this imbalance and are also linked to levels of the brain chemical serotonin, which can improve mood. This is important during the menopause. I make sure I take a probiotic daily, specifically one with a high bacteria count including Lactobacillus acidophilus. I look for one that has to be kept in the fridge, as this is a sign of a quality product.”

For … probiotics, prebiotics, acupuncture, homeopathy and DHEA-S, randomized, placebo-controlled trials are scarce and the evidence is unconvincing.

Professor Tony Kochhar, 45, is a consultant orthopaedic surgeon at London Bridge Hospital.

“Having taken statins for a couple of years, I developed tendonitis, inflammation in the foot, which caused pain around the outside of it. My GP told me to stop taking the statins, which helped, and I now control my condition with diet. I also take a supplement of collagen (a natural protein found in the tendons) to build up tendon structure and reduce pain. I take two 1,200mg collagen supplements daily and it has really helped. Within two weeks of starting them, my pain had gone.”

it is not possible to draw any definitive raccomendations on the use of nutraceutical supplementation in tendinopathies.

Dr Anne Rigg, 51, is a consultant oncologist at London Bridge Hospital.

“One theory is that vitamin D may help control normal breast cell growth and may even stop breast cancer cells from growing. The body creates vitamin D from sunlight on the skin when we are outdoors, but because of the British weather and the rightful use of sunscreen, it’s easy to become deficient. I take the recommended daily dose of 10mcg. [Fatty fish such as salmon and mackerel are good sources, too, but you’d have to eat them in large amounts to get the recommended daily dosage.] It’s vital not to overdose, as it can increase the risk of kidney stones: the vitamin helps absorb calcium from the diet, which can build up into stones.”

Supplementation with vitamin D did not result in a lower incidence of invasive cancer…

Dr Rob Hogan, 62, is an optometrist at iCare Consulting.

“I’m aware, too, of the increased risk of age-related macular degeneration (AMD), a leading cause of sight loss in people over 60. This is where the small central portion of the retina (the macula) at the back of the eye deteriorates. So I take MacuShield, a supplement which, studies have found, can help improve vision and keep the back of the eye healthy. It contains a mixture of natural compounds — lutein, zeaxanthin and meso-zeaxanthin — which are antioxidants that have been found in studies to improve vision and eye health. I take one a day, usually with a meal.”

In early AMD, macular pigment can be augmented with a variety of supplements, although the inclusion of MZ may confer benefits in terms of panprofile augmentation and in terms of contrast sensitivity enhancement.

Dr Milad Shadrooh, 37, is a dentist in Basingstoke, Hampshire.

“I take a varied supplement daily to maintain good health and, specifically, healthy teeth. It contains calcium (an adult’s RDA is 700mg, which is equivalent to three 200ml cups of milk) as most people, including me, don’t get enough in their diet.”

calciumsupplements that are used to prevent or treat osteoporosis appear to have beneficial effects on tooth retention as well.

Dr Joanna Gach, 49, is a consultant dermatologist at University Hospitals Coventry and Warwickshire NHS Trust.

“Every so often, I take a multivitamin capsule containing zinc, selenium and biotin. These are all helpful for sorting out my brittle nails and maintaining healthy hair.”

 no evidence supports the use of vitamin supplementation with vitamin E, vitamin C (ascorbic acid), vitamin A, retinoids, retinol, retinal, silicon, zinc, iron, copper, selenium, or vitamin B12 (Cyanocobalamin) for improving the nail health of well-nourished patients or improving the appearance of nails affected by pathologic disease.

Luke Cascarini, 47, is a consultant maxillofacial surgeon at Guy’s and St Thomas’ Hospital in London.

“I take a daily vitamin drink containing a high-dose vitamin B complex, which is necessary for good oral health.”

The published research reveals only a possible relationship between vitamins and minerals and periodontal disease. Vitamin E, zinc, lycopene and vitamin B complex may have useful adjunct benefits. However, there is inadequate evidence to link the nutritional status of the host to periodontal inflammation. More randomized controlled trials are needed to explore this association.

Dr Jenni Byrom, 44, is a consultant gynaecologist at Birmingham’s Women’s and Children’s Hospital.

“I take evening primrose oil for premenstrual symptoms such as breast pain. I take 1g of evening primrose oil daily and have found it really makes a difference.”

Evening primrose oil has not been shown to improve breast pain, and has had its licence withdrawn for this indication in the UK owing to lack of efficacy (it is still available to purchase without prescription).

Dr Sarah Myhill, 60, is a GP based in Wales.

“I take 10g of vitamin C dissolved in a glass of water every day before I start my shift — and I never get colds. I believe that high doses of vitamin C can kill bad microbes on contact — or, at least, help reduce the severity of infections such as colds and sore throats.”

 vitamin C has minimal or no impact on the duration of common cold or in the number of days at home or out of work.

Jonathan Dearing, 49, is a consultant orthopaedic surgeon specialising in sports injuries at BMI Carrick Glen Hospital in Ayrshire.

“I carry a vitamin D oral spray and use it after exercise, as it helps improve muscle recovery by regulating various processes that help them repair and grow.”

… supraphysiological dosages of vitamin D3 have potential ergogenic effects on the human metabolic system and lead to multiple physiological enhancements. These dosages could increase aerobic capacity, muscle growth, force and power production, and a decreased recovery time from exercise. These dosages could also improve bone density. However, both deficiency (12.5 to 50 nmol/L) and high levels of vitamin D (>125 nmol/L) can have negative side effects, with the potential for an increased mortality. Thus, maintenance of optimal serum levels between 75 to 100 nmol/L and ensuring adequate amounts of other essential nutrients including vitamin K are consumed, is key to health and performance. Coaches, medical practitioners, and athletic personnel should recommend their patients and athletes to have their plasma 25(OH)D measured, in order to determine if supplementation is needed. Based on the research presented on recovery, force and power production, 4000-5000 IU/day of vitamin D3 in conjunction with a mixture of 50 mcg/day to 1000 mcg/day of vitamin K1 and K2 seems to be a safe dose and has the potential to aid athletic performance. Lastly, no study in the athletic population has increased serum 25(OH)D levels past 100 nmol/L, (the optimal range for skeletal muscle function) using doses of 1000 to 5000 IU/day. Thus, future studies should test the physiological effects of higher dosages (5000 IU to 10,000 IU/day or more) of vitamin D3 in combination with varying dosages of vitamin K1 and vitamin K2 in the athletic population to determine optimal dosages needed to maximize performance.

Dr Glyn Thomas, 46, is a cardiologist and cardiac electrophysiologist at the Bristol Heart Institute.

“I take a magnesium supplement as it can help address an extra heartbeat — something I suffered with for 20 years.”

Whether magnesium supplementation could have a role in the prevention of AF in the community has not been tested.

_____________________________________________________

Firstly, let me congratulate those colleagues who actually might have got it right:

  1. Dr Hogan
  2. Dr Shadrooh
  3. Mr Cascarini
  4. Mr Dearing

I say ‘MIGHT HAVE GOT IT RIGHT’ because, even in their cases, the evidence is far from strong and certainly not convincing.

Secondly, let me commiserate those who spend their money on unproven supplements. I find it sad that this group amounts to two thirds of all the ‘experts’ asked.

Thirdly, let me remind THE DAILY MAIL of what I posted recently:  journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health. Surely, the Mail did us no favour in publishing this article. It will undoubtedly motivate lots of gullible consumers to buy useless or even harmful supplements.

And lastly, let me remind all healthcare professionals that promoting unproven treatments to the unsuspecting public is not ethical.

 

“Physiotherapy generally offers a highly science based approach to clinical practice.” This was a recent comment by someone (I presume a physiotherapist) on this blog. It got me thinking – is it true or false? I am in no position to review the entire field of physiotherapy in a blog post. What I will do instead, is list a few alternative therapies often used by physiotherapists.

  1. Acupuncture: many physiotherapists seem to love acupuncture. In the UK, for example, they have their own organisations. The AACP is the largest professional body for acupuncture in the UK with a membership of around 6000 chartered physiotherapists, practising medical acupuncture. They state that there is an increasing number of research publications in the UK and worldwide proving the treatment effectiveness of acupuncture when compared to (chemical) medication for example.
  2. Applied kinesiology: some physiotherapists offer applied kinesiology. This clinic, for instance, states that applied Kinesiology combines a system of muscle tests with acupuncture, reflex points emotion and nutrition to find any imbalances present in the whole person.
  3. Bowen technique: many physiotherapists use the Bowen technique. This practice advertises it as follows. If you’re looking for a way to treat tightness in your upper back, neck or shoulders or are suffering from respiratory pain or headaches, The Bowen Technique could be the answer you’re searching for. Achieving all these things as well as being a great way to treat sports injuries and enhance sporting performance, this therapy also promotes emotional wellbeing. A non-invasive therapy, it is equally suited for the treatment of acute (short-term) and chronic (long-term) conditions.
  4. Craniosacral therapy: some physios also employ craniosacral therapy. Here is an example. Craniosacral therapy as experienced by thousands of babies and people all around the country, has a proven track record at easing and relieving what makes babies upset. If your baby suffers from:
    • Colic
    • Wind
    • Digestive issues
    • Reflux
    • Unsettledness
    • Sleep problems
    • Ongoing crying
    • Difficulty with breast feeding/latch/suck
    • Other problems

    then call…

  5. Cupping: One physio writes this about cupping. It was good to see the public (Western cultures) exposed more to cupping therapy practice thanks to the recent Olympics in Rio 2016. Last Olympics in London 2012,  the Chinese and Japanese Athletes, amongst neighbouring nations, were readily seen to use and advocate the practice, along with the approval no doubt of their large team of Medical and Physiotherapy related support staff. This time however it has bridged to divide to Western World Athletes, such as Michael Phelps (he of 23 Olympic Golds fame). This advocacy of the practice and again the presumed support from his Medical and Sports science entourage with team USA, is a good barometer of the progress and acceptance within Western Medicine, for Cupping Therapy.
  6. Massage therapy: in many countries, massage and related techniques therapy always have been an integral part of physiotherapy.
  7. Feldenkrais method: The same applies to The Feldenkrais Method® is based on principles of physics, biomechanics, neuroscience, and the study of human motor development. Feldenkrais recognized the capability of the human brain to learn and relearn at any age – neuroplasticity. The method utilizes slow, gentle movements, and awareness of subtle differences to optimize learning, improve movement, and make changes in the brain.
  8. Kinesiology tape: If you have suffered an injury or illness that causes a problem with your functional mobility or normal activity, you may benefit from the skilled services of a physical therapist to help you return to your previous level of mobility.  Your physical therapist may use various exercises and modalities to help treat your specific problem.
  9. Reflexology: Here is what the UK Chartered Society of Physiotherapists writes about reflexology: Developed centuries ago in countries such as China, Egypt and India, reflexology is often referred to as a ‘gentle’ and ‘holistic’ therapy that benefits both mind and body. It centres on the feet because these are said by practitioners to be a mirror, or topographical map, for the rest of the body. Manipulation of certain pressure, or reflex, points is claimed to have an effect on corresponding zones in the body. The impact, say reflexologists, extends throughout – to bones, muscles, organs, glands, circulatory and neural pathways. The head and hands can also be massaged in some cases. The treatment is perhaps best known for use in connection with relaxation and relief from stress, anxiety, pain, sleep disorders, headaches, migraine, menstrual and digestive problems. But advocates say it can be used to great effect far more widely, often in conjunction with other treatments…
  10. Spinal manipulation: Physiotherapists learn spinal manipulation as part of continuing education courses in Canada. The Orthopaedic Division of the Canadian Physiotherapy Association is responsible for the standards of education and supervises exams required to meet the standards of the International Federation of Manipulative Physiotherapists (IFOMPT). In many other countries, the situation is similar.

These 10 therapies have all been discussed on this blog before. They lack

  • plausibility or
  • proof of efficacy or
  • proof of safety or
  • all of the above

In other words, they are NOT highly science-based.

QED

If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.

The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.

As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for  over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.

The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.

I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:

  • for what conditions, if any, they have been proven to be efficacious,
  • what adverse effects each active ingredient can cause,
  • with what other drugs they might interact,
  • how reliable the quality control for these injections is.

I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.

The Royal College of Chiropractors (RCC), a Company Limited by guarantee, was given a royal charter in 2013. It has following objectives:

  • to promote the art, science and practice of chiropractic;
  • to improve and maintain standards in the practice of chiropractic for the benefit of the public;
  • to promote awareness and understanding of chiropractic amongst medical practitioners and other healthcare professionals and the public;
  • to educate and train practitioners in the art, science and practice of chiropractic;
  • to advance the study of and research in chiropractic.

In a previous post, I pointed out that the RCC may not currently have the expertise and know-how to meet all these aims. To support the RCC in their praiseworthy endeavours, I therefore offered to give one or more evidence-based lectures on these subjects free of charge.

And what was the reaction?

Nothing!

This might be disappointing, but it is not really surprising. Following the loss of almost all chiropractic credibility after the BCA/Simon Singh libel case, the RCC must now be busy focussing on re-inventing the chiropractic profession. A recent article published by RCC seems to confirm this suspicion. It starts by defining chiropractic:

“Chiropractic, as practised in the UK, is not a treatment but a statutorily-regulated healthcare profession.”

Obviously, this definition reflects the wish of this profession to re-invent themselves. D. D. Palmer, who invented chiropractic 120 years ago, would probably not agree with this definition. He wrote in 1897 “CHIROPRACTIC IS A SCIENCE OF HEALING WITHOUT DRUGS”. This is woolly to the extreme, but it makes one thing fairly clear: chiropractic is a therapy and not a profession.

So, why do chiropractors wish to alter this dictum by their founding father? The answer is, I think, clear from the rest of the above RCC-quote: “Chiropractors offer a wide range of interventions including, but not limited to, manual therapy (soft-tissue techniques, mobilisation and spinal manipulation), exercise rehabilitation and self-management advice, and utilise psychologically-informed programmes of care. Chiropractic, like other healthcare professions, is informed by the evidence base and develops accordingly.”

Many chiropractors have finally understood that spinal manipulation, the undisputed hallmark intervention of chiropractors, is not quite what Palmer made it out to be. Thus, they try their utmost to style themselves as back specialists who use all sorts of (mostly physiotherapeutic) therapies in addition to spinal manipulation. This strategy has obvious advantages: as soon as someone points out that spinal manipulations might not do more good than harm, they can claim that manipulations are by no means their only tool. This clever trick renders them immune to such criticism, they hope.

The RCC-document has another section that I find revealing, as it harps back to what we just discussed. It is entitled ‘The evidence base for musculoskeletal care‘. Let me quote it in its entirety:

The evidence base for the care chiropractors provide (Clar et al, 2014) is common to that for physiotherapists and osteopaths in respect of musculoskeletal (MSK) conditions. Thus, like physiotherapists and osteopaths, chiropractors provide care for a wide range of MSK problems, and may advertise that they do so [as determined by the UK Advertising Standards Authority (ASA)].

Chiropractors are most closely associated with management of low back pain, and the NICE Low Back Pain and Sciatica Guideline ‘NG59’ provides clear recommendations for managing low back pain with or without sciatica, which always includes exercise and may include manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage) as part of a treatment package, with or without psychological therapy. Note that NG59 does not specify chiropractic care, physiotherapy care nor osteopathy care for the non-invasive management of low back pain, but explains that: ‘mobilisation and soft tissue techniques are performed by a wide variety of practitioners; whereas spinal manipulation is usually performed by chiropractors or osteopaths, and by doctors or physiotherapists who have undergone additional training in manipulation’ (See NICE NG59, p806).

The Manipulative Association of Chartered Physiotherapists (MACP), recently renamed the Musculoskeletal Association of Chartered Physiotherapists, is recognised as the UK’s specialist manipulative therapy group by the International Federation of Orthopaedic Manipulative Physical Therapists, and has approximately 1100 members. The UK statutory Osteopathic Register lists approximately 5300 osteopaths. Thus, collectively, there are approximately twice as many osteopaths and manipulating physiotherapists as there are chiropractors currently practising spinal manipulation in the UK.

END OF QUOTE

To me this sounds almost as though the RCC is saying something like this:

  1. We are very much like physiotherapists and therefore all the positive evidence for physiotherapy is really also our evidence. So, critics of chiropractic’s lack of sound evidence-base, get lost!
  2. The new NICE guidelines were a real blow to us, but we now try to spin them such that consumers don’t realise that chiropractic is no longer recommended as a first-line therapy.
  3. In any case, other professions also occasionally use those questionable spinal manipulations (and they are even more numerous). So, any criticism  of spinal manipulation  should not be directed at us but at physios and osteopaths.
  4. We know, of course, that chiropractors treat lots of non-spinal conditions (asthma, bed-wetting, infant colic etc.). Yet we try our very best to hide this fact and pretend that we are all focussed on back pain. This avoids admitting that, for all such conditions, the evidence suggests our manipulations to be worst than useless.

Personally, I find the RCC-strategy very understandable; after all, the RCC has to try to save the bacon for UK chiropractors. Yet, it is nevertheless an attempt at misleading the public about what is really going on. And even, if someone is sufficiently naïve to swallow this spin, one question emerges loud and clear: if chiropractic is just a limited version of physiotherapy, why don’t we simply use physiotherapists for back problems and forget about chiropractors?

(In case the RCC change their mind and want to listen to me elaborating on these themes, my offer for a free lecture still stands!)

Most people probably think of acupuncture as being used mainly as a therapy for pain control. But acupuncture is currently being promoted (and has traditionally been used) for all sorts of conditions. One of them is stroke. It is said to speed up recovery and even improve survival rates after such an event. There are plenty of studies on this subject, but their results are far from uniform. What is needed in this situation, is a rigorous summary of the evidence.

The authors of this Cochrane review wanted to assess whether acupuncture could reduce the proportion of people suffering death or dependency after acute ischaemic or haemorrhagic stroke. They included all randomized clinical trials (RCTs) of acupuncture started within 30 days after stroke onset. Acupuncture had to be compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischaemic or haemorrhagic stroke, or both. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

The investigators included 33 RCTs with 3946 participants. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only 6 trials (668 participants) comparing acupuncture with sham acupuncture.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain and were not confirmed by trials comparing acupuncture with sham acupuncture. In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain. These findings were not confirmed in trials comparing acupuncture with sham acupuncture.Trials comparing acupuncture with any control showed little or no difference in death or institutional care or death at the end of follow-up.The incidence of adverse events (eg, pain, dizziness, faint) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these patients (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain.

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

This Cochrane review seems to be thorough, but it is badly written (Cochrane reviewers: please don’t let this become the norm!). It contains some interesting facts. The majority of the studies came from China. This review confirmed the often very poor methodological quality of acupuncture trials which I have frequently mentioned before.

In particular, the RCTs originating from China were amongst those that most overtly lacked rigor, also a fact that has been discussed regularly on this blog.

For me, by far the most important finding of this review is that studies which at least partly control for placebo effects fail to show positive results. Depending on where you stand in the never-ending debate about acupuncture, this could lead to two dramatically different conclusions:

  1. If you are a believer in or earn your living from acupuncture, you might say that these results suggest that the trials were in some way insufficient and therefore they produced false-negative results.
  2. If you are a more reasonable observer, you might feel that these results show that acupuncture (for acute stroke) is a placebo therapy.

Regardless to which camp you belong, one thing seems to be certain: acupuncture for stroke (and other indications) is not supported by sound evidence. And that means, I think, that it is not responsible to use it in routine care.

Having yesterday been to a ‘Skeptics in the Pub’ event on MEDITATION in Cambridge (my home town since last year) I had to think about the subject quite a bit. As I have hardly covered this topic on my blog, I am today trying to briefly summarise my view on it.

The first thing that strikes me when looking at the evidence on meditation is that it is highly confusing. There seem to be:

  • a lack of clear definitions,
  • hundreds of studies, most of which are of poor or even very poor quality,
  • lots of people with ’emotional baggage’,
  • plenty of strange links to cults and religions,
  • dozens of different meditation methods and regimen,
  • unbelievable claims by enthusiasts,
  • lots of weirdly enthusiastic followers.

What was confirmed yesterday is the fact that, once we look at the reliable medical evidence, we are bound to find that the health claims of various meditation techniques are hugely exaggerated. There is almost no strong evidence to suggest that meditation does affect any condition. The small effects that do emerge from some meta-analyses could easily be due to residual bias and confounding; it is not possible to rigorously control for placebo effects in clinical trials of meditation.

Another thing that came out clearly yesterday is the fact that meditation might not be as risk-free as it is usually presented. Several cases of psychoses after meditation are on record; some of these are both severe and log-lasting. How often do they happen? Nobody knows! Like with most alternative therapies, there is no reporting system in place that could possibly give us anything like a reliable answer.

For me, however, the biggest danger with (certain forms of) meditation is not the risk of psychosis. It is the risk of getting sucked into a cult that then takes over the victim and more or less destroys his or her personality. I have seen this several times, and it is a truly frightening phenomenon.

In our now 10-year-old book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE, we included a chapter on meditation. It concluded that “meditation appears to be safe for most people and those with sufficient motivation to practise regularly will probably find a relaxing experience. Evidence for effectiveness in any indication is week.” Even today, this is not far off the mark, I think. If I had to re-write it now, I would perhaps mention the potential for harm and also add that, as a therapy, the risk/benefit balance of meditation fails to be convincingly positive. 

PS

I highly recommend ‘Skeptics in the Pub’ events to anyone who likes stimulating talks and critical thinking.

Currently, there are measles outbreaks almost everywhere. I have often pointed out that SCAM does not seem to be entirely innocent in this development. Now another study examined the relationship between SCAM-use and vaccination scepticism. Specifically, the researchers wanted to know whether a person’s more general health-related worldview might explain this relationship.

A cross-sectional online survey of adult Australians (N = 2697) included demographic, SCAM, and vaccination measures, as well as the holistic and magical health belief scales (HHB, MHB). HHB emphasises links between mind and body health, and the impact of general ‘wellness’ on specific ailments or resistance to disease, whilst MHB specifically taps ontological confusions and cognitive errors about health. SCAM and anti-vaccination were found to be linked primarily at the attitudinal level (r = -0.437). The researchers did not find evidence that this was due to SCAM practitioners influencing their clients. Applying a path-analytic approach, they found that individuals’ health worldview (HHB and MHB) accounted for a significant proportion (43.1%) of the covariance between SCAM and vaccination attitudes. MHB was by far the strongest predictor of both SCAM and vaccination attitudes in regressions including demographic predictors.

The researchers concluded that vaccination scepticism reflects part of a broader health worldview that discounts scientific knowledge in favour of magical or superstitious thinking. Therefore, persuasive messages reflecting this worldview may be more effective than fact-based campaigns in influencing vaccine sceptics.

Parents opposing vaccination of their kids are often fiercely determined. Numerous cases continue to make their way through the courts where parents oppose the vaccination of their children, often inspired by the views of both registered and unregistered health practitioners, including homeopaths and chiropractors. A recent article catalogued decisions by the courts in Australia, New Zealand, the UK and Canada. Most of them ruled in favour of vaccination and dismissed the arguments of those opposed to vaccination as unscientific. The author, an Australian barrister and Professor of Forensic Medicine, concluded that Australia should give serious consideration to emulating the model existing in multiple countries, including the United States, and should create a no-fault vaccination injury compensation scheme.

Such programs are based on the assumption that it is fair and reasonable that a community protected by a vaccination program accepts responsibility for and provides compensation in those rare instances where individuals are injured by it. To Me, this seems a prudent and ethical concept that should be considered everywhere.

I have often pointed out that, in contrast to ‘rational phytotherapy’, traditional herbalism of various types (e. g. Western, Chinese, Kampo, etc.) – characterised by the prescription of an individualised mixture of herbs by a herbalist – is likely to do more harm than good. This recent paper provides new and interesting information about the phenomenon.

Specifically, it explores the prevalence with which Australian Western herbalists treat menstrual problems and their related treatment, experiences, perceptions, and inter-referral practices with other health practitioners. Members of the Practitioner Research and Collaboration Initiative practice-based research network identifying as Western Herbalists (WHs) completed a specifically developed, online questionnaire.

Western Herbalists regularly treat menstrual problems, perceiving high, though differential, levels of effectiveness. For menstrual problems, WHs predominantly prescribe individualised formulas including core herbs, such as Vitex agnus-castus (VAC), and problem-specific herbs. Estimated clients’ weekly cost (median = $25.00) and treatment duration (median = 4-6 months) covering this Western herbal medicine treatment appears relatively low. Urban-based women are more likely than those rurally based to have used conventional treatment for their menstrual problems before consulting WHs. Only 19% of WHs indicated direct contact by conventional medical practitioners regarding treatment of clients’ menstrual problems despite 42% indicating clients’ conventional practitioners recommended consultation with WH.

The authors concluded that Western herbal medicine may be a substantially prevalent, cost-effective treatment option amongst women with menstrual problems. A detailed examination of the behaviour of women with menstrual problems who seek and use Western herbal medicine warrants attention to ensure this healthcare option is safe, effective, and appropriately co-ordinated within women’s wider healthcare use.

Apart from the fact, that I don’t see how the researchers could possibly draw conclusions about the cost-effectiveness of Western herbalism, I feel that this survey requires further comments.

There is no reason to assume that individualised herbalism is effective and plenty of reason to fear that it might cause harm (the larger the amount of herbal ingredients in one prescription, the higher the chances for toxicity and interactions). The only systematic review on the subject concluded that there is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication.

Moreover, VAC (the ‘core herb’ for menstrual problems) is hardly a herb that is solidly supported by evidence either. A systematic review concluded that, although meta-analysis shows a large pooled effect of VAC in placebo-controlled trials, the high risk of bias, high heterogeneity, and risk of publication bias of the included studies preclude a definitive conclusion. The pooled treatment effects should be viewed as merely explorative and, at best, overestimating the real treatment effect of VAC for premenstrual syndrome symptoms. There is a clear need for high-quality trials of appropriate size examining the effect of standardized extracts of VAC in comparison to placebo, selective serotonin reuptake inhibitors, and oral contraceptives to establish relative efficacy.

And finally, VAC is by no means free of adverse effects; our review concluded that frequent adverse events include nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or lactation. Theoretically, VAC might also interfere with dopaminergic antagonists.

So, to me, this survey suggests that the practice of Western herbalists is:

  1. not evidence-based;
  2. potentially harmful;
  3. and costly.

In a nutshell: IT IS BEST AVOIDED.

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