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

TCM

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Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

Kampo, the traditional Japanese herbal medicine, developed out of traditional Chinese herbal medicine after it was introduced into Japan in the 7th century. In the early 20th century, Kampo was further influenced by modern Western medicine and science. The Kampo system is a pragmatic and simplified version of Chinese herbal medicine. Kampo medicines are standardised and not normally individualised as in Chinese herbal medicine. They are based on the symptoms of the patient, interpreted in the tradition of Kampo. Kampo diagnostic criteria consider hypofunction and hyperfunction, heat and cold, superficies and interior, and yin and yang.

Today, Kampō is fully integrated into the Japanese national health care system, and numerous Kampo preparations are registered in Japan and reimbursable from public funds. In Japan, Kampo is thus not a so-called alternative medicine (SCAM), but outside this country it clearly is.

Standardised Kampo formulas contain mixtures of herbal ingredients. They are manufactured under proper quality control. The most commonly used plants include liquorice, ginger and Chinese peony root. Most Japanese doctors routinely prescribe Kampo medicines, and most patients combine Kampo with Western medicine. Since 2002, the teaching of Kampo has been included in Japanese curricula of medical and pharmacy education. The efficacy of Kampo medicines is often less solidly documented than one would hope or expect. There is a remarkable shortage of high-quality clinical trials.

As Kampo medicines contain pharmacologically active ingredients, they can also cause adverse effects and might interact with synthetic drugs. Yet, the risks of Kampo are currently woefully under-investigated. And this is why an analysis of adverse events associated with Kampo formulations that was just published is particularly important.

The researchers obtained reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analysed.

There were 4,232 reported adverse events associated with Kampo. They related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix.

The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba.

The authors concluded that Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.

While this paper presents invaluable data, its authors offer little by way of critical discussion. There is hardly any good evidence to show that any of the Kampo formulas are effective. Thus a discussion needs to be had about the question whether they generate more good than harm. The authors are completely silent on this important issue, and I suspect the reason might be that Kampo is a bit of a ‘holy cow’ in Japan that must not be questioned.

The numbers of adverse events are impressively high, but we do not know how they compare to adverse events in other areas of healthcare. For instance, it would be valuable to have comparative data indicating how many adverse events occurred with Kampo compared to synthetic drugs per 1 000 patients using them.

Thus we are left with the conclusion that, once proper post-marketing methods are employed to monitor SCAM, we are likely to realise that adverse events do occur more frequently than SCAM enthusiasts might have predicted. In my view, it is high time that we have effective adverse event monitoring in all areas of SCAM.

Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.

But is it effective?

The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.

Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).

The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.

I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:

  • Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
  • The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
  • There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
  • There seemed to be a sizable publication bias hidden in the data.
  • All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
  • Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.

I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.

Reiki is a form of energy healing popularised by the Japanese Mikao Usui (1865-1926). ‘Rei’ means universal spirit (sometimes thought of as a supreme being), and ‘ki’ is the assumed universal life energy. Reiki is broadly based on some of the obsolete concepts of Traditional Chinese Medicine. Reiki practitioners believe that they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

This study (entitled ‘ The Power of Reiki’) was conducted to pilot testing the feasibility and efficacy of Reiki to provide pain relief among pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods (“delta”) of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods: a decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained pediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is an unusual conclusion in that it is strictly speaking correct. What is wrong, however, that the abstract reports findings related to the alleged effectiveness of Reiki. A feasibility study is not designed for that purpose. I therefore suggest to ignore all allusions to therapeutic effects.

This, I think, begs the question as to why it is necessary or productive to study Reiki in clinical trials.

  • The treatment is not plausible.
  • There have been many trials already.
  • The ones that are sufficiently rigorous fail to show that it has any effects beyond placebo.
  • The medical literature is already highly polluted with Reiki studies reporting false-positive results.
  • This can only confuse researchers who attempt to conduct reviews on the subject.
  • Reiki studies discredit clinical research.
  • They are a waste of valuable resources.
  • Arguably, they are even unethical.

If you ask me, it is high time to stop researching such implausible nonsense.

 

The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).

The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.

The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.

I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:

In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.

Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?

But why do SCAM-fans not get it?

Why do we see trial after trial and review after review ignoring this simple and obvious fact?

I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!

But that’s cheating!

And isn’t cheating unethical?

My answer is YES!

(If you want to read a more detailed answer, please read our in-depth analysis here)

 

 

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:

Study No 1

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.

Study No 2

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.

Study No 3

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.

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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?

So-called alternative medicine (SCAM) for animals is popular. A recent survey suggested that 76% of US dog and cat owners use some form of SCAM. Another survey showed that about one quarter of all US veterinary medical schools run educational programs in SCAM. Amazon currently offers more that 4000 books on the subject.

The range of SCAMs advocated for use in animals is huge and similar to that promoted for use in humans; the most commonly employed practices seem to include acupuncture, chiropractic, energy healing, homeopathy (as discussed in the previous post) and dietary supplements. In this article, I will briefly discuss the remaining 4 categories.

ACUPUNCTURE

Acupuncture is the insertion of needles at acupuncture points on the skin for therapeutic purposes. Many acupuncturists claim that, because it is over 2 000 years old, acupuncture has ‘stood the test of time’ and its long history proves acupuncture’s efficacy and safety. However, a long history of usage proves very little and might even just demonstrate that acupuncture is based on the pre-scientific myths that dominated our ancient past.

There are many different forms of acupuncture. Acupuncture points can allegedly be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, bee-stings, injections, light, colour, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Traditional Chinese acupuncture is based on the Taoist philosophy of the balance between two life-forces, ‘yin and yang’. In contrast, medical acupuncturists tend to cite neurophysiological theories as to how acupuncture might work; even though some of these may appear plausible, they nevertheless are mere theories and constitute no proof for acupuncture’s validity.

The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition. According to ‘Western’ acupuncturists, acupuncture is effective mostly for chronic pain. Acupuncture has, for instance, been used to improve mobility in dogs with musculoskeletal pain, to relieve pain associated with cervical neurological disease in dogs, for respiratory resuscitation of new-born kittens, and for treatment of certain immune-mediated disorders in small animals.

While the use of acupuncture seems to gain popularity, the evidence fails to support this. Our systematic review of acupuncture (to the best of my knowledge the only one on the subject) in animals included 14 randomized controlled trials and 17 non-randomized controlled studies. The methodologic quality of these trials was variable but, on average, it was low. For cutaneous pain and diarrhoea, encouraging evidence emerged that might warrant further investigation. Single studies reported some positive inter-group differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. However, these trials require independent replication. We concluded that, overall, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

Serious complications of acupuncture are on record and have repeatedly been discussed on this blog: acupuncture needles can, for instance, injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 human fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg. Information on adverse effects of acupuncture in animals is currently not available.

Given that there is no good evidence that acupuncture works in animals, the risk/benefit balance of acupuncture cannot be positive.

CHIROPRACTIC

Chiropractic was created by D D Palmer (1845-1913), an American magnetic healer who, in 1895, manipulated the neck of a deaf janitor, allegedly curing his deafness. Chiropractic was initially promoted as a cure-all by Palmer who claimed that 95% of diseases were due to subluxations of spinal joints. Subluxations became the cornerstone of chiropractic ‘philosophy’, and chiropractors who adhere to Palmer’s gospel diagnose subluxation in nearly 100% of the population – even in individuals who are completely disease and symptom-free. Yet subluxations, as understood by chiropractors, do not exist.

There is no good evidence that chiropractic spinal manipulation might be effective for animals. A review of the evidence for different forms of manual therapies for managing acute or chronic pain syndromes in horses concluded that further research is needed to assess the efficacy of specific manual therapy techniques and their contribution to multimodal protocols for managing specific somatic pain conditions in horses. For other animal species or other health conditions, the evidence is even less convincing.

In humans, spinal manipulation is associated with serious complications (regularly discussed in previous posts), usually caused by neck manipulation damaging the vertebral artery resulting in a stroke and even death. Several hundred such cases have been documented in the medical literature – but, as there is no system in place to monitor such events, the true figure is almost certainly much larger. To the best of my knowledge, similar events have not been reported in animals.

Since there is no good evidence that chiropractic spinal manipulations work in animals, the risk/benefit balance of chiropractic fails to be positive.

ENERGY HEALING

Energy healing is an umbrella term for a range of paranormal healing practices, e. g. Reiki, Therapeutic Touch, Johrei healing, faith healing. Their common denominator is the belief in an ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today ‘energy’ healing systems are amongst the most popular alternative therapies in many countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be little more than a veneer of pseudo-science.

Considering its implausibility, energy healing has attracted a surprisingly high level of research activity in the form of clinical trials on human patients. Generally speaking, the methodologically best trials of energy healing fail to demonstrate that it generates effects beyond placebo. There are few studies of energy healing in animals, and those that are available are frequently less than rigorous (see for instance here and here). Overall, there is no good evidence to suggest that ‘energy’ healing is effective in animals.

Even though energy healing is per se harmless, it can do untold damage, not least because it can lead to neglect of effective treatments and it undermines rationality in our societies. Its risk/benefit balance therefore fails to be positive.

DIETARY SUPPLEMENTS

Dietary supplements for veterinary use form a category of remedies that, in most countries, is a regulatory grey area. Supplements can contain all sorts of ingredients, from minerals and vitamins to plants and synthetic substances. Therefore, generalisations across all types of supplements are impossible. The therapeutic claims that are being made for supplements are numerous and often unsubstantiated. Although they are usually promoted as natural and safe, dietary supplements do not have necessarily either of these qualities. For example, in the following situations, supplements can be harmful:

  1. Combining one supplement with another supplement or with prescribed medicines
  2. Substituting supplements for prescription medicines
  3. Overdosing some supplements, such as vitamin A, vitamin D, or iron

Examples of currently most popular supplements for use in animals include chondroitin, glucosamine, probiotics, vitamins, minerals, lutein, L-carnitine, taurine, amino acids, enzymes, St John’s wort, evening primrose oil, garlic and many other herbal remedies. For many supplements taken orally, the bioavailability might be low. There is a paucity of studies testing the efficacy of dietary supplements in animals. Three recent exceptions (all of which require independent replication) are:

Dietary supplements are promoted as being free of direct risks. On closer inspection, this notion turns out to be little more than an advertising slogan. As discussed repeatedly on this blog, some supplements contain toxic materials, contaminants or adulterants and thus have the potential to do harm. A report rightly concluded that many challenges stand in the way of determining whether or not animal dietary supplements are safe and at what dosage.  Supplements considered safe in humans and other cross-species are not always safe in horses, dogs, and cats.  An adverse event reporting system is badly needed.  And finally, regulations dealing with animal dietary supplements are in disarray.  Clear and precise regulations are needed to allow only safe dietary supplements on the market.

It is impossible to generalise about the risk/benefit balance of dietary supplements; however, caution is advisable.

CONCLUSION

SCAM for animals is an important subject, not least because of the current popularity of many treatments that fall under this umbrella. For most therapies, the evidence is woefully incomplete. This means that most SCAMs are unproven. Arguably, it is unethical to use unproven medicines in routine veterinary care.

 

 

 

PS

I was invited several months ago to write this article for VETERINARY RECORD. It was submitted to peer review and subsequently I withdrew my submission. The above post is a slightly revised version of the original (in which I used the term ‘alternative medicine’ rather than ‘SCAM’) which also included a section on homeopathy (see my previous post). The reason for the decision to withdraw this article was the following comment by the managing editor of VETERINARY RECORD:  A good number of vets use these therapies and a more balanced view that still sets out their efficacy (or otherwise) would be more useful for the readership.

Determined to cover as many so-called alternative medicines (SCAMs) as I possibly can, I was intrigued to see an article in the EVENING STANDARD about a SCAM I had not been familiar with: YANG SHENG.

Here is an excerpt of this article:

When people meet Katie Brindle, they usually ask whether she does acupuncture. “In fact, I specialise in yang sheng,” she says, a sigh in her voice. “It’s a massive aspect of Chinese medicine that no one knows anything about.” She’s on a mission to change that. Yang sheng is, in simplest terms, “prevention not cure” and Brindle puts it into practice with Hayo’u, her part-beauty brand, part-wellness programme, which draws on rituals in Far Eastern medicine. The “Reset” ritual, for example, is based on the Chinese martial art of qigong and involves shaking, drumming and twisting the body to wake up your circulation — Brindle says it stimulates digestion and boosts immunity. The “Body Restorer”, a gentle massage of the neck, chest and back, has a history of being used as a form of treatment for fever, muscle pain, inflammation and migraines. The principle underpinning all the practices is that small changes in your daily routine can help prevent your body from illness. Brindle wants it to be accessible: the website is free, and she is planning Facebook live-streams later in the year. There will also be a book in April, focusing on prevention rather than cure…

Frustrated about the overtly adversorial nature of this article, I did a few searches (not made easy by the fact that Yang and Sheng are common names of authors and yangsheng is the name of an acupuncture point) and found that Yang Sheng is said to be a health-promoting method in Traditional Chinese Medicine (TCM) that includes movement, mental exercise, and breathing technique. It is used mainly in China but has apparently it is currently enjoying an ever-widening acceptance in the Western world as well.

Is there any evidence for it?

Good question!

A paper from 1998 reported an observational study with 30 asthma patients, with varying degrees of illness severity. They were taught Qigong Yangsheng under medical supervision and asked to exercise independently, if possible, on a daily basis. They kept a diary of their symptoms for half a year including peak-flow measurements three times daily, use of medication, frequency and length of exercise as well as five asthma-relevant symptoms (sleeping through the night, coughing, expectoration, dyspnea, and general well-being). A decrease of at least 10 percent in peak-flow variability between the 1st and the 52nd week occurred more frequently in the group of the exercisers (n = 17) than in the group of non-exercisers (n = 13). When comparing the study year with the year before the study, there was improvement also in reduced hospitalization rate, less sickness leave, reduced antibiotic use and fewer emergency consultations resulting in reduced treatment costs. The authors concluded that Qigong Yangsheng is recommended for asthma patients with professional supervision. An improvement in airway capability and a decrease in illness severity can be achieved by regular self-conducted Qigong exercises.

The flaws of this study are obvious, and I don’t even bother to criticise it here.

Unfortunately, that was the only ‘study’ I found.

I also located many websites most of which are all but useless. Here is one that offers some explanations:

Yang sheng is a self-care approach. What makes this any different from all those other wellbeing manuals? The short answer is, that this is advice rooted in thousands of years of wisdom. Texts on how to preserve and extend life, health and wellbeing have been part of the Chinese tradition since the 4thcentury BC. They’ve had over 25 centuries to be refined and are time tested.

Yang sheng takes into account core theories like yin and yang, adhering to the laws of nature and harmonious free flow of Qi around the body (see below). As the active pursuit of the best possible functioning and balance of the whole self – body, mind and spirit. Yang Sheng takes into consideration your relationships to people and the environment.

In the West, we systematically neglect wellness and disease prevention. We take our good health for granted. We assume that we cannot avoid disease. And then when we are ill, we treat the symptoms of disease rather than finding the root cause.

Yang Sheng is about discovering energy imbalances long before they turn into overt disease. It works on the approach of eliminating small health niggles and balancing the body to stay healthy.

If this sounds like a conspiracy of BS to you, I would not blame you.

So, what can we conclude from this? I think, it is fair to say that:

  • Yang Sheng is being promoted as yet another TCM miracle.
  • It is based on all the obsolete nonsense that TCM has to offer.
  • Numerous therapeutic and preventative claims are being made for it.
  • None of them is supported by anything resembling good evidence.
  • Anyone with a serious condition who trusts Yang Sheng advocates puts her/his life in danger.
  • The EVENING STANDARD is not a source for reliable medical information.

I don’t expect many of my readers to be surprised, concerned or alarmed by any of this. In my view, however, this lack of alarm is exactly what is alarming! We have become so used to seeing bogus claims and dangerous BS in the realm of SCAM that abnormality has gradually turned into something close to normality.

I find the type of normality that incessantly misleads consumers and endangers patients quite simply unacceptable.

Acupuncture is all over the news today. The reason is a study just out in BMJ-Open.

The aim of this new RCT was to investigate the efficacy of a standardised brief acupuncture approach for women with moderate-tosevere menopausal symptoms. Nine Danish primary care practices recruited 70 women with moderate-to-severe menopausal symptoms. Nine general practitioners with accredited education in acupuncture administered the treatments.

The acupuncture style was western medical with a standardised approach in the pre-defined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group received no acupuncture but was offered treatment after 6 weeks. Outcomes were the differences between the two groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.

Thirty-six patients received the intervention, and 34 were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes, day-and-night sweats, general sweating, menopausal-specific sleeping problems, emotional symptoms, physical symptoms and skin and hair symptoms compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent three weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.

The authors concluded that the standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.

The only thing that I find amazing here is the fact the a reputable journal published such a flawed trial arriving at such misleading conclusions.

  • The authors call it a ‘pragmatic’ trial. Yet it excluded far too many patients to realistically qualify for this characterisation.
  • The trial had no adequate control group, i.e. one that can account for placebo effects. Thus the observed outcomes are entirely in keeping with the powerful placebo effect that acupuncture undeniably has.
  • The authors nevertheless conclude that ‘acupuncture treatment produced a fast and clinically relevant reduction’ of symptoms.
  • They also state that they used this design because no validated sham acupuncture method exists. This is demonstrably wrong.
  • In my view, such misleading statements might even amount to scientific misconduct.

So, what would be the result of a trial that is rigorous and does adequately control for placebo-effects? Luckily, we do not need to rely on speculation here; we have a study to demonstrate the result:

Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.

Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.

Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)

Setting: Community in Australia.

Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.

Interventions:10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.

Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.

Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.

Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

My conclusion from all this is simple: acupuncture trials generate positive findings, provided the researchers fail to test it rigorously.

An article referring to comments Prof David Colquhoun and I recently made in THE TIMES about acupuncture for children caught my attention. In it, Rebecca Avern, an acupuncturist specialising in paediatrics and heading the clinical programme at the College of Integrated Chinese Medicine, makes a several statements which deserve a comment. Here is her article in full, followed by my short comments.

START OF QUOTE

Just before Christmas an article appeared in the Times with the headline ‘Professors raise alarm over rise of acupuncture for children’. There has been little or nothing in the mainstream press relating to paediatric acupuncture. So, in a sense, and in the spirit of ‘all press is good press’, this felt like progress. The article quoted myself and Julian Scott, and mentioned several childhood conditions for which children seek treatment. It also mentioned some of the reasons that parents choose acupuncture for their children.

However, it included some negative quotes from our old friends Ernst and Colquhoun. The first was Ernst stating that he was ‘not aware of any sound evidence showing that acupuncture is effective for any childhood conditions’. Colquhoun went further to state that there simply is not ‘the slightest bit of evidence to suggest that acupuncture helps anything in children’. Whilst they may not be aware of it, good evidence does exist, albeit for a limited number of conditions. For example, a 2016 meta-analysis and systematic review of the use of acupuncture for post-operative nausea and vomiting (PONV) concluded that children who received acupuncture had a significantly lower risk of PONV than those in the control group or those who received conventional drug therapy.[i]

Ernst went on to mention the hypothetical risk of puncturing a child’s internal organs but he failed to provide evidence of any actual harm. A 2011 systematic review analysing decades of acupuncture in children aged 0 to 17 years prompted investigators to conclude that acupuncture can be characterised as ‘safe’ for children.[ii]

Ernst also mentioned what he perceived is a far greater risk. He expressed concern that children would miss out on ‘effective’ treatment because they are having acupuncture. In my experience running a paediatric acupuncture clinic in Oxford, this is not the case. Children almost invariably come already having received a diagnosis from either their GP or a paediatric specialist. They are seeking treatment, such as in the case of bedwetting or chronic fatigue syndrome, because orthodox medicine is unable to effectively treat or even manage their condition. Alternatively, their condition is being managed by medication which may be causing side effects.

When it comes to their children, even those parents who may have reservations about orthodox medicine, tend to ensure their child has received all the appropriate exploratory tests. I have yet to meet a parent who will not ensure that their child, who has a serious condition, has the necessary medication, which in some cases may save their lives, such as salbutamol (usually marketed as Ventolin) for asthma or an EpiPen for anaphylactic reactions. If a child comes to the clinic where this turns out not to be the case, thankfully all BAcC members have training in a level of conventional medical sciences which enables them to spot ‘red flags’. This means that they will inform the parent that their child needs orthodox treatment either instead of or alongside acupuncture.

The article ended with a final comment from Colquhoun who believes that ‘sticking pins in babies is a rather unpleasant form of health fraud’. It is hard not to take exception to the phrase ‘sticking pins in’, whereas what we actually do is gently and precisely insert fine, sterile acupuncture needles. The needles used to treat babies and children are usually approximately 0.16mm in breadth. The average number of needles used per treatment is between two and six, and the needles are not retained. A ‘treatment’ may include not only needling, but also diet and lifestyle advice, massage, moxa, and parental education. Most babies and children find an acupuncture treatment perfectly acceptable, as the video below illustrates.

The views of Colquhoun and Ernst also beg the question of how acupuncture compares in terms of safety and proven efficacy with orthodox medical treatments given to children. Many medications given to children are so called ‘off-label’ because it is challenging to get ethical approval for randomised controlled trials in children. This means that children are prescribed medicines that are not authorised in terms of age, weight, indications, or routes of administration. A 2015 study noted that prescribers and caregivers ‘must be aware of the risk of potential serious ADRs (adverse drug reactions)’ when prescribing off-label medicines to children.[iii]

There are several reasons for the rise in paediatric acupuncture to which the article referred. Most of the time, children get better when they have acupuncture. Secondly, parents see that the treatment is gentle and well tolerated by their children. Unburdened by chronic illness, a child can enjoy a carefree childhood, and they can regain a sense of themselves as healthy. A weight is lifted off the entire family when a child returns to health. It is my belief that parents, and children, vote with their feet and that, despite people such as Ernst and Colquhoun wishing it were otherwise, more and more children will receive the benefits of acupuncture.

[i] Shin HC et al, The effect of acupuncture on post-operative nausea and vomiting after pediatric tonsillectomy: A meta-analysis and systematic review. Accessed January 2019 from: https://www.ncbi.nlm.nih.gov/pubmed/26864736

[ii] Franklin R, Few Serious Adverse Events in Pediatric Needle Acupuncture. Accessed January 2019from: https://www.medscape.com/viewarticle/753934?src=trendmd_pilot

[iii] Aagaard L (2015) Off-Label and Unlicensed Prescribing of Medicines in Paediatric Populations: Occurrence and Safety Aspects. Basic and Clinical Pharmacology and Toxicology. Accessed January 2019 from: https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcpt.12445

END OF QUOTE

  1. GOOD EVIDENCE: The systematic review cited by Mrs Avern was based mostly on poor-quality trials. It even included cohort studies without a control group. To name it as an example of good evidence, merely discloses an ignorance about what good evidence means.
  2. SAFETY: The article Mrs Avern referred to is a systematic review of reports on adverse events (AEs) of acupuncture in children. A total of 279 AEs were found.  Of these, 25 were serious (12 cases of thumb deformity, 5 infections, and 1 case each of cardiac rupture, pneumothorax, nerve impairment, subarachnoid haemorrhage, intestinal obstruction, haemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. Considering that there is no reporting system of such AEs, this list of AEs is, I think, concerning and justifies my concerns over the safety of acupuncture in children. The risks are certainly not ‘hypothetical’, as Mrs Avern claimed, and to call it thus seems to be in conflict with the highest standard of professional care (see below). Because the acupuncture community has still not established an effective AE-surveillance system, nobody can tell whether such events are frequent or rare. We all hope they are infrequent, but hope is a poor substitute for evidence.
  3. COMPARISON TO OTHER TREATMENTS: Mrs Avern seems to think that acupuncture has a better risk/benefit profile than conventional medicine. Having failed to show that acupuncture is effective and having demonstrated that it causes severe adverse effects, this assumption seems nothing but wishful thinking on her part.
  4. EXPERIENCE: Mrs Avern finishes her article by telling us that ‘children get better when they have acupuncture’. She seems to be oblivious to the fact that sick children usually get better no matter what. Perhaps the kids she treats would have improved even faster without her needles?

In conclusion, I do not doubt the good intentions of Mrs Avern for one minute; I just wished she were able to develop a minimum of critical thinking capacity. More importantly, I am concerned about the BRITISH ACUPUNCTURE COUNCIL, the organisation that published Mrs Avern’s article. On their website, they state: The British Acupuncture Council is committed to ensuring all patients receive the highest standard of professional care during their acupuncture treatment. Our Code of Professional Conduct governs ethical and professional behaviour, while the Code of Safe Practice sets benchmark standards for best practice in acupuncture. All BAcC members are bound by these codes. Who are they trying to fool?, I ask myself.

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