MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

This is the title of a lecture I was asked to give yesterday to an audience of palliative cancer care professionals. During the last days, I have therefore thought about the Anderson-tale quite a bit. For those who don’t know the story (is there such a person?), it is a tale about two con-men who promise the emperor new clothes which, they claim, are invisible to anyone who is incompetent or stupid. When the Emperor parades before his subjects in his new clothes, no one dares to say that he is, in fact, naked. Finally, a child cries out, “But he isn’t wearing anything at all!”

The story is obviously a metaphor for a scenario where something is generally accepted as being good simply because nobody has the courage or insight to oppose popular opinion – nobody except a naïve child, that is. It is a fitting tale for alternative medicine and a superb one to depict my own personal history.

It got more fascinating the more I thought about it. As a metaphor for alternative medicine it offers at least four different perspectives:

  • The quacks seem to get away with even the most obvious lies.
  • The VIP is too gullible and vain to realise that he is being done.
  • The sycophants are happy to play along because they hope to benefit from not speaking the truth.
  • The child has not yet learnt how to ‘play along’ and therefore speaks the truth without a second thought.

The parallels to the current boom in alternative medicine are, I think, so striking that I do hardly need to explain them. The parallels to my own past, however, might require some explanation.

During the last 25 years, I have met more quacks making false claims than I care to remember. Some virtually sold the emperor clothes that were non-existent. One even offered him a report that suggested that the UK’s ailing healthcare system could be saved by maximizing the use of bogus therapies, such as homeopathy, for serious illnesses – more about that in a minute.

I even once had the honour to meet the emperor, our Queen – and it is not she who I here refer to. She was not at all gullible. The emperor I mean is actually our future emperor, the Queen’s son. He has provided us with ample evidence to doubt his intelligence, and it is he who has fallen for the con-men I refer to.

The sycophants are those ‘experts’ who Charles tends to assemble around him. They do know better, I think, but they do not tell him the truth because they know that people like Charles cannot tolerate any facts that fail to confirm his views. So they duly applaud even the silliest of notions hoping to keep their place in the entourage.

And the naïve child? Yes, of course, that’s me. When I arrived in Exeter 23 years ago, I did think that I was appointed to employ science as a tool to find the truth. Once I had done the research, I shouted: “But he isn’t wearing anything at all!” – metaphorically speaking, of course.

And that was something neither the emperor nor the sycophants could tolerate. When I said what had to be said about the ‘Smallwood Report’, the combined effort of the emperor and his sycophants put an end to my activities in Exeter.

Yes, in relation to alternative medicine, the story of THE EMPEROR’S NEW CLOTHES could be most interesting!

But did the palliative care experts invite me to tell it?

The more I thought about it, the more I doubted this.

Eventually, I arrived at the conclusion they wanted to hear about the evidence for or against alternative treatments for cancer. A pity really, because arguably the other aspect are much more entertaining.

 

 

Yes, I have a new book out. It is on homeopathy, and the publisher thought it important enough to issue a press-release. I thought you might be interested in reading it – if nothing else, it could be a welcome distraction from the catastrophic new from America. Here it is:

As a junior doctor, Edzard Ernst worked in a homeopathic hospital, practised homeopathy, and was impressed with its results. As his career progressed and he became a research scientist, he investigated the reasons for this efficacy and began to publish the evidence. This new book Homeopathy – The Undiluted Facts presents what he has learned to a lay audience. As an authoritative guide, it is complemented by an 80-page lexicon on the subject, covering definitions, key ingredients and protagonists in its history from founder Samuel Hahnemann to supporter Prince Charles.

Edzard Ernst says: “Homeopathy has been with us for more than 200 years and today millions of patients and consumers swear use its remedies on a daily basis. While some people seem to believe in it with a quasi-religious fervor, others loath it with a similarly deeply-felt passion. In this climate, it is far from easy for consumers to find simple, factual and reliable material on this subject. My book aims to fill this gap.”

There are many misconceptions and myths surrounding homeopathy which Ernst is able to dispel. In the final chapter, he covers both spurious arguments made by proponents of homeopathy and spurious arguments made by its opponents.

For example, in countering the notion that patients who use homeopathy must be stupid, he points out that many patients consult homeopaths because they have needs which are not met by conventional medicine. During a consultation with a homeopath, patients often experience more sympathy, empathy, and compassion. To dismiss this as stupidity would mean missing a chance to learn a lesson.

Ernst encourages both skepticism and openness to new ideas. He says: “This book is based on the all-important principle that good medicine must demonstrably generate more good than harm. Where this is not the case, I will say so without attempting to hide the truth.”

I have been alerted to the fact that my former medical school in Munich at one of Germany’s highest-ranked universities is currently running an elective course in homeopathy. For those who do not read German (the original announcement [apparently posted all over Munich university hospitals] is copied below), it teaches the use of homeopathy in/for:

  • INTERNAL MEDICINE
  • NEONATOLOGY
  • SINUSITIS
  • RECURRENT OTITIS MEDIA
  • INSOMNIA
  • PALLIATION OF RESPIRATORY PROBLEMS
  • PROSTATE CANCER
  • POST-TRAUMATIC SYNDROMES
  • BIPOLAR DISEASE
  • MULTIMORBID PATIENTS WITH UVEITIS
  • COUGH
  • DISEASES OF THE FEMALE BREAST
  • SUPPORTIVE CANCER CARE
  • PAEDIATRIC ASTHMA

The course is being organised by Dr. med. Sigrid Kruse, von Haunersches Kinderspital des Klinikums der Universität München in co-operation with the ‘Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte’. The lecturers of this course seem to be mostly homeopaths from practices in and around Munich.

This article provides further explanations:

The project „Homeopathy in pediatrics“ was established in the Dr. von Hauner’s Children’s Hospital University of Munich in 1995 to integrate homeopathy into a university hospital. Selected children (outpatients and in the wards) are treated conventionally and homeopathically. The Karl and Veronica Carstens-Foundation initially financed the project over six years. An association of parents, whose children were treated for cancer, funded the project for one year. Since 2002, for the first time in Germany, the National Health Insurance is providing the financial background for two consultants for Homeopathy at this University hospital.

Who are we?

Dr. Mira Dorcsi-Ulrich, who initiated the project and carries out the supervision. She is a pediatrician in her own practice with 23 years of experience.

Dr. Sigrid Kruse has managed to integrate homeopathy into the clinic, starting at first in 1995 as a resident for pediatrics. Now she fulfills the requests of doctors and parents in the wards demanding concomitant homeopathic treatment.

Dr. Christian Lucae mainly treats the outpatients while focussing on his research project with children showing attention-deficit-hyperactivity-syndrome (ADHS).

Concomitant homeopathic therapy was successful in the following cases: intracerebral bleeding 3rd degree in premature babies, drug withdrawal in neonates addicted mothers, epilepsy, handicapped children, ADHS, migraine, tic, recurrent infections, asthma and atopic eczema, complications in wound healing and other problems. Homeopathic treatment of children parallel to conventional methods is particularly well accepted in the treatment of cancer. The side effects of oncological treatment like vomiting and stomatitis can be relieved, aggressions and anxiety intercepted and life quality improved.

END OF QUOTE

Which journal with a modicum of self-respect or rigor allows a homeopath to publish anything like the last paragraph without providing a jot of evidence? The answer is the ‘ALLGEMEINE HOMOEOPATHISCHE ZEITUNG’ – no further explanation needed, I think.

Courses like the one above, run at university level, make me first a little speechless and then more than a little angry. Medical schools should have other roles than teaching impressionable students things that fly in the face of science and evidence. They should guide them to become responsible doctors not misguide them to turn into irresponsible quacks. The fact that this comes from the medical school where I,  many years ago, studied, graduated, worked and made both my MD and PhD theses renders the whole thing painfully sad for me personally.

But let’s not get depressed… ‘always look on the bright side of life’!!!

Luckily, there are glimpses of a bright side here. For instance, the fact that doctor Quak is one of the lecturers of this course (see below) is not without jollity, I must admit. Also amusing – at least to me – is be the vision of Dr. med. Mira Dorcsi-Ulrich (see below) standing in front of her students explaining the findings of one of the few RCT of individualised homeopathy for paediatric asthma. This study from my team found no evidence that “adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.”

——————————————————————————————————————————————

Here is the German original announcement of the course:

RINGVORLESUNG IM WINTERSEMESTER 2016/2017
HOMÖOPATHIE VON DER THEORIE ZUR PRAXIS MIT PRAXISBEISPIELEN UND PATIENTENVORSTELLUNGEN

1. 20.10.2016 … IN DER INNEREN MEDIZIN: MÖGLICHKEITEN UND GRENZEN Dr. med. Ulf Riker
2. 27.10.2016 … IN DER NEONATOLOGIE: IKTERUS, ASPHYXIE UND UNRUHE Dr. med. Monika Grasser
3. 03.11.2016 … BEI PATIENTEN MIT SINUSITIS Dr. med. Michael Schreiner
4. 10.11.2016 … BEI KINDERN MIT REZIDIVIERENDER OTITIS MEDIA Dr. med. Christian Lucae
5. 17.11.2016 … BEI SCHLAFSTÖRUNGEN Dr. med. Brigitte Seul
6. 24.11.2016 … BEI PALLIATIV-PATIENTEN MIT RESPIRATORISCHEN PROBLEMEN Herbert Michalczyk
7. 01.12.2016 … IN DER BEGLEITUNG VON PATIENTEN MIT EINEM PROSTATA-CARCINOM Uwe Kraemer-Hoenes
8. 08.12.2016 … BEI POSTTRAUMATISCHER BELASTUNGS-STÖRUNG Dr. med. Ingrid Pfanzelt
9. 15.12.2016 … BEI EINER PATIENTIN MIT BIPOLARER AFFEKTIVER STÖRUNG Dr. med. Stephan Gerke
10. 12.01.2017 … BEI EINEM MULTIMORBIDEN PATIENTEN MIT UVEITIS Dr. med. Thomas Quak
11. 19.01.2017 … BEI PATIENTEN MIT HUSTEN Dr. med. Renate Grötsch
12. 26.01.2017 … BEI ERKRANKUNGEN DER WEIBLICHEN BRUST Dr. med. Ute Bullemer
13. 02.02.2017 … IN DER BEGLEITUNG VON KREBSPATIENTEN MIT Q-POTENZEN Miclós Takács
15. 09.02.2017… BEI KINDERN MIT ASTHMA BRONCHIALE Dr. med. Mira Dorcsi-Ulrich
Organisation: Dr. med. Sigrid Kruse, Dr. von Haunersches Kinderspital des Klinikums der Universität München
E-Mail: sigrid.kruse@med.uni-muenchen.de in Zusammenarbeit mit dem Landesverband Bayern des Deutschen Zentralvereins homöopathischer Ärzte,

This press-release just came to my attention:

Today, with the stroke of his pen, Governor Tom Wolf adds Pennsylvania to the list of states that acknowledge the value of alternative healthcare from a qualified professional. Pennsylvania becomes the 21st U.S. jurisdiction to regulate naturopathic medicine. The new law HB516 regulates naturopathic doctors; ensuring patients can trust that their wellness professional holds a graduate degree from an accredited naturopathic medical school.

Heidi Weinhold, N.D. and Legislative Chair of the Pennsylvania Association of Naturopathic Physicians (PANP), says, “This is a historic day for naturopathic medicine. The governor’s approval will throw open the doors for more Pennsylvania students to choose this academic course of study. Then, they can return home from a four-year graduate program to set up a practice as a naturopathic doctor.”

The PANP members worked for the last 16 years with the state legislature to advance the much-needed recognition of this growing medical field. Their goal was to increase the credibility and minimize the confusion between professionals with an advance degree and the self-study practitioner. “Naturopathic professionals also seek to better coordinate and collaborate with medical professionals across the spectrum. We believe in integrative care, and this law gives us the stature we need to work N,” explains Dr. Weinhold.

Under the new law, the terms Naturopathic Doctor and ND will be reserved exclusively for those who have attended four-year, post-graduate level programs at institutions recognized by the United States Department of Education. “This protects the scope-of-work and title for graduates from an accredited N.D. program,” offers Dr. JoAnn Yanez, executive director of the Association of Accredited Naturopathic Colleges.

Naturopathic Doctors are currently practicing at Cancer Treatment Centers of America in Philadelphia, as well as the University of Pittsburgh Medical Centers, where they work side by side with medical doctors in an integrative setting. More patients could be served in this manner once naturopathic doctors are registered in this state. Both Penn State Hershey Medical Center and West Penn Allegheny General Hospital have indicated that they would hire Naturopathic Doctors if they were registered in the state.

“The PANP will be working over the next year on implementation of the legislation in order that NDs can begin to register with the Board of Medicine. A number of Representatives and Senators have encouraged us to come back to the legislature next session in order to expand the scope of this bill. We are very encouraged about the future of naturopathic medicine in Pennsylvania,” says Dr. Marie Winters, manager of the Naturopathic Medicine Department of the Cancer Treatment Centers of America and president of PANP.

The law will go into effect January 1, 2018.

Pennsylvania joins these other jurisdictions which regulate naturopathic medicine: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Kansas, Maine, Maryland, Minnesota, Montana, New Hampshire, North Dakota, Oregon, Rhode Island, Utah, Vermont, Washington, Puerto Rico and U.S. Virgin Islands, and these provinces in Canada: Alberta, British Columbia, Manitoba, Ontario, Saskatchewan.

END OF QUOTE

Here are a few comments and issues that I find remarkable about this announcement:

  • Naturopaths are called ‘naturopathic doctors’, yet in the same sentence it is pointed out that they are ‘wellness professionals’. I am not sure what the latter, woolly term is supposed to mean – perhaps that naturopathy cannot effectively treat diseases?
  • The document speaks of ‘accredited naturopathic medical schools’. Has anyone checked the utter nonsense that is being taught there? The answer is yes, Britt Marie Hermes has, and her verdict is truly depressing and devastating.
  • Naturopaths instantly interpret the new regulation as a ‘governor’s approval’ and ‘recognition’. It shows why alternative practitioners want to be regulated: they foremost crave the APPROVAL and the RECOGNITION they clearly do not deserve.
  • Naturopaths believe in ‘integrative care’ – of course they do, because this is nothing but a ploy for smuggling quackery into evidence-based medicine (EBM).
  • Naturopaths want to be ‘peer-to-peer with other disciplines’ – but they are unable to show that their interventions generate more good than harm. This effectively is an attempt to place quackery on the same level as EBM.
  • Naturopaths already treat cancer patients in the state! Really? Do they use Laetrile, or homeopathy?
  • Naturopaths are portrayed as being a benefit to public health. Has anyone considered that the opposite might be the case? See for instance here and here.

Athletes tend to adopt a healthy life-style, and today this seems to include the regular intake of a range of dietary supplements. Supplements specifically marketed for sports-people promote good health and performance, we are constantly told – but is this true?

A 2010 review found that “there is good evidence that caffeine can improve single-sprint performance, while caffeine, creatine and sodium bicarbonate ingestion have all been demonstrated to improve multiple-sprint performance. The evidence is not so strong for the performance-enhancing benefits of β-alanine or colostrum. Current evidence does not support the ingestion of ribose, branched-chain amino acids or β-hydroxy-β-methylbutyrate, especially in well trained athletes.”

However, a 2011 paper was considerably more cautious: “For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, β-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk.”

The purpose of this new article was to collect the most recent data regarding the safety of well-known or emerging dietary supplements used by athletes.

The review suggests that about 90% of sports supplements contain estrogenic endocrine disruptors, and about 25% of them having a higher estrogenic activity than acceptable. About 50% of the supplements are contaminated by melamine, a source of non-protein nitrogen. Additional data accumulate toward the safety of nitrate ingestion. In the last 2 years, the safety of emerging supplements such as higenamine, potentially interesting to lose weight, creatine nitrate and guanidinoacetic acid has been evaluated but still needs further investigation.

The authors of this article claim that “the consumption of over-the-counter supplements is very popular in athletes. Although most supplements may be considered as safe when taking at the recommended doses, athletes should be aware of the potential risks linked to the consumption of supplements. In addition to the risks linked to overdosage and cross-effects when combining different supplements at the same time, inadvertent or deliberate contamination with stimulants, estrogenic compounds, diuretics or anabolic agents may occur.”

Despite these cautions, the market for supplements is growing and the myth that supplements are good for health continues. The truth is, however, more complex and far less encouraging:

  • It is impossible to generalise across the entire range of highly diverse supplements.
  • Some have positive effects.
  • The vast majority do nothing at all.
  • Most are quite harmless.
  • Some can have serious adverse effects.
  • All of them cause harm to your bank account.

During the last two decades, I have had ample occasion to study the pseudo-arguments of charlatans when trying to defend the indefensible. Here I will try to disclose some of them in the hope that this might help others to identify charlatans more easily and to react accordingly.

Let’s say someone publishes a document showing evidence that homeopathy is a useless therapy. Naturally, this will annoy the many believers in homeopathy, and they will counter by attempting to make a range of points:

  1. THEY WILL STATE THAT THERE IS EVIDENCE TO THE CONTRARY. For instance, proponents of homeopathy can produce studies that seem to ‘prove’ homeopathy’s efficacy. The facts that these are flawed or irreproducible, and that the totality of the evidence is not positive does hardly ever bother them. Charlatans are born cherry-pickers.
  2. THEY WILL SUGGEST THAT THE EXISTING EVIDENCE HAS BEEN MIS-QUOTED. Often they will cite out of context from original studies one or two sentences which seem to indicate that they are correct. Any reminders that these quotes are meaningless fall on deaf ears.
  3. THEY WILL SAY THAT THE PUBLISHED EVIDENCE WAS MISINTERPRETED. Often the evidence is complex and can therefore be open to interpretation. Charlatans use this fact and spin the evidence such that it suits their needs. Charlatans are spin-doctors.
  4. THEY WILL SAY THAT SCIENTIFIC EVIDENCE IS OVER-RULED BY CENTURIES OF EXPERIENCE. The notion that millions of satisfied customers cannot be wrong is used frequently to distract from negative evidence. The fact that such experience can be due to a host of non-specific effects, the natural history of the condition or regression to the mean will not convince the charlatan.
  5. THEY WILL SUGGEST THAT THE AUTHOR IS PAID BY BIG PHARMA TO TRASH HOMEOPATHY. Whenever seemingly reasonable arguments have been exhausted, overtly irrational notions or blatant lies will come into play. The allegation that anyone criticising homeopathy is corrupt is one of the most popular such notion. The truth does not have a high value in charlatanry.
  6. THEY WILL SAY THAT THE CRITIC HAS NO TRAINING IN HOMEOPATHY AND IS THUS NOT COMPETENT. Equally popular is the claim that only trained and experienced homeopaths are able to judge over homeopathy. This pseudo-argument is most handy: experienced homeopaths are invariably believers, and the notion essentially claims that only those who believe in it can judge homeopathy. In other words, criticism of homeopathy is by definition invalid.
  7. THEY WILL SAY THAT THE CRITIC HAS PREVIOUSLY BEEN CRITICISED FOR HIS POOR RESEARCH. Similarly, homeopaths might claim that the critic is someone who is being criticised for being a very bad scientist; therefore, it would be a mistake to trust anything he or she says. Ad hominem is the name of the game!
  8. THEY WILL TRY TO RIDICULE THE CRITIC. Readers of this blog will have noticed how some commentators belittle their opponents by giving them laughable nicknames thus undermining their authority. The obvious aim is to make them look less than credible. Charlatans are like little children.
  9. THEY WILL CLAIM THAT IN OTHER AREAS OF HEALTHCARE THE EVIDENCE IS ALSO NOT CONVINCING. The ‘tu quoque’ fallacy is popular for distracting from the embarrassingly negative evidence in quackery – never mind that problems in the aviation industry are no argument for using flying carpets.
  10. THEY WILL POINT OUT HOW SAFE HOMEOPATHY IS COMPARED TO OTHER DRUGS. This is another form of the ‘tu quoque’ fallacy; it works very well for distracting from the problems with homeopathy and regularly convinces lay people.
  11. THEY WILL SAY THAT MEDICAL RESEARCH IS GENERALLY SO FLAWED THAT IT CANNOT BE TRUSTED. The fact that some medical research is less than rigorous is used here to claim that evidence in general is unreliable. The best solution is therefore to go by experience – a big step into the dark ages, but charlatans don’t seem to mind.
  12. THEY WILL REVERSE THE BURDEN OF PROOF. Homeopathy (or any other alternative therapy) may not have been proven to be effective, they claim, but it has not been proven to be ineffective. Therefore, they say, we must give it the benefit of the doubt. The facts that a) science cannot prove a negative and that b) we therefore should use those treatments that are supported by positive evidence is being ignored by charlatans.

These 12 pseudo-arguments are in my experience the most common defences of charlatanry. I am sure there are others – and I would be delighted if you did elaborate on them in the comments section below. Thanks!

This website tells us that ‘Stopain Migraine’ is the first topical product to effectively relieve migraine pain. It is a safe alternative to other migraine relief products that begins to work as soon as it’s applied. And the press release informs us that Troy Healthcare extended its Stopain line with a Stopain Migraine offering – a topical pain relieving gel that is massaged onto the back of the neck and behind each ear.

“Many of the women we shopped with told us they like that Stopain Migraine lacks systemic side effects and can be used in conjunction with other products – whether that’s natural remedies like peppermint essential oil, Epsom salts and ginger tea, or even prescription drugs or other over-the-counter products,” stated Anthony Cicini, VP Troy Healthcare.

Stopain Migraine begins to work as soon as it’s applied, can be reapplied after 30 minutes, and can be used up to four times daily, the company noted. It’s unique in that it can be used alone, or in addition to other ingestible migraine products to relieve migraine pain.

The homeopathic blend of ingredients follow the guidelines of The Homeopathic Pharmacopoeia of the United State and is recommended by both by primary care physicians and OBGYNs, the company stated.

In addition to providing effective relief quickly, Stopain Migraine offers peace of mind for migraine sufferers, knowing the product is free from aspirin, acetaminophen and caffeine, has no known drug interactions and contains no dyes or preservatives.

Consumers can now find Stopain Migraine nationwide for the suggested retail price of $11.99

END OF PRESS RELEASE

Any evidence, you’d probably ask. A quick Medline search located this abstract:

OBJECTIVE:

To determine whether topical menthol 6% gel will relieve a migraine attack.

MATERIALS AND METHODS:

A single-center, open-label pilot trial of 25 patients with at least 1 year of diagnosed episodic migraine and <15 headache days per month. Patients treated one migraine attack with STOPAIN topical menthol 6% gel to skull base within 2 h of headache onset. Headache pain severity was assessed prior to and after gel application.

RESULTS:

Thirty-two patients enrolled and 25 completed the study. Prior to treatment, 7 patients had mild pain, 13 moderate pain, and 5 severe pain. Two hours following gel application, 7 (28%) patients had no pain, 7 (28%) mild pain, 6 (25%) moderate pain, and 5 (20%) severe pain. The majority of patients had similar pain intensity (8; 32%) or improvement (13; 52%). At 24-h, only two non-rescued patients still had mild headache. Of the 25 completers, 2 patients took rescue medication prior to the 2-h period, and an additional 10 patients rescued between 2 and 24 h.

CONCLUSION:

Study results showed a significant improvement in headache intensity by 2 h after gel application. This pilot study shows STOPAIN gel may be effective in treating an acute migraine attack.

A pilot study! I thought pilots were for testing feasibility, not effectiveness!

No control group! The observed effect is therefore not attributable to ‘Stopain’ at all!

But there is more! Iranian researchers published this RCT:

OBJECTIVE:

To investigate the efficacy and safety of the cutaneous application of menthol 10% solution for the abortive treatment of migraine.

BACKGROUND:

Peppermint and its active ingredient menthol have long been used for the treatment of various pain conditions including headache.

METHODS:

This is a randomised, triple-blind, placebo-controlled, crossed-over study conducted in the neurology Clinic of Nemazee Hospital, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran, from March 2007 to March 2008. The patients were recruited via local newspaper advertisements. Eligible patients were categorised into two groups and a 10% ethanol solution of menthol (as drug) and 0.5% ethanol solution of menthol (as placebo) were applied to the forehead and temporal area in a crossover design. Pain free, pain relief, sustained pain free and sustained pain relief end-points were measured by questionnaires using a visual analogue scale.

RESULTS:

The intent-to-treat population consisted of 35 patients (80% women, 20% men, mean age: 29.6 +/- 6.2) with 118 migraine attacks. In the intent-to-treat population, the menthol solution was statistically superior to the placebo on 2-h pain free (p = 0.001), 2-h pain relief (p = 0.000), sustained pain free and sustained pain relief end-points (p = 0.008). The menthol solution was also more efficacious in the alleviation of nausea and/or vomiting and phonophobia and/or photophobia (p = 0.02). In the per-protocol population, there was significantly higher number of patients who experienced at least one pain free/pain relief after the application of menthol rather than the placebo (p = 0.002). No significant difference was seen between the adverse effects of the drug and the placebo groups (p = 0.13).

CONCLUSION:

Menthol solution can be an efficacious, safe and tolerable therapeutic option for the abortive treatment of migraine.

Yes, you are quite right; this must be a different product. It contains just menthol and at a higher concentration than ‘Stopain’.

So what does ‘Stopain’ actually contain?  I must say that 6% menthol does not sound very homeopathic to me! The website of Troy Healthcare tells us that it has a total of 4 ingredients:

Mentholum 1X HPUS – 50.00%
Belladonna 3X HPUS – 1.33%
Iris Versicolor 6X HPUS – 1.33%
Sanguinaria Canadensis 6X HPUS – 1.33%

And what do the three homeopathically diluted ingredients do?

Is the term ‘homeopathic’ used here merely to attract a certain type of customer?

And why do they claim that ‘Stopain’ is effective when there is no evidence?

Or perhaps there is evidence and they haven’t published it?

And why do they claim that ‘Stopain’ is the first topical product?

Wasn’t a German topical menthol product marketed years ago?

Search me! I am not sure I know all the answers.

I hope someone from Troy Healthcare reads this and cares to explain.

Chiropractors have been shown to over-use X-rays (a worry about which I cautioned almost 20 years ago) and to refer for lumbar radiography inconsistent with the current clinical guidelines for low back pain. It is unknown whether this is due to lack of adherence with, or a lack of awareness of relevant guidelines. The aim of this study was to clarify this issue; more specifically, the authors wanted to determine Australian chiropractors’ awareness of, and reported adherence to, radiographic guidelines for low back pain.

An online survey was distributed to Australian chiropractors from July to September, 2014. Survey questions assessed demographic, chiropractic practice and radiographic usage characteristics, awareness of radiographic guidelines for low back pain and the level of agreement with current guidelines. Results were analysed with descriptive statistics and logistic regression analysis.

A total of 480 surveys were completed online. Only 49.6 % of the responders reported awareness of radiographic guidelines for low back pain. Chiropractors reported a likelihood of referring for radiographs for low back pain: in new patients (47.6 %); to confirm biomechanical pathologies (69.0 %); to perform biomechanical analysis (37.5 %); or to screen for contraindications (39.4 %). Chiropractors agreed that radiographs for low back pain could be useful for: acute low back pain (54.0 %); screening for contraindications (55.8 %); or to confirm diagnosis and direct treatment (61.3 %). Poorer adherence to current guidelines was seen, if the chiropractor referred to in-house radiographic facilities, practiced a technique other than diversified technique or was unaware or unsure of current radiographic guidelines for low back pain.

The authors of this paper concluded that only 50 % of Australian chiropractors report awareness of current radiographic guidelines for low back pain. A poorer awareness of guidelines is associated with an increase in the reported likelihood of use, and the perceived usefulness of radiographs for low back pain, in clinical situations that fall outside of current guidelines. Therefore, education strategies may help to increase guideline knowledge and compliance.

I am tempted to rephrase the last sentence: EDUCATION STRATEGIES MAY HELP TO INCREASE THE KNOWLEDGE THAT RESPONSIBLE HEALTHCARE PROFESSIONALS SHOULD WORK PRIMARILY FOR THE BENEFIT OF THEIR PATIENTS RATHER THAN FOR THE BENEFIT OF THEIR BANK ACCOUNTS.

In my view, this investigation confirms that:

  • chiropractors still grossly over-use X-rays (it probably is fair to assume that the responders of this survey were relatively guideline-conform compared to non-responders; if that were true, the true figures of X-ray overuse would be even higher)
  • they use X-rays for spurious reasons;
  • they are ill-informed about the existing evidence;
  • they have not abandoned the myth of ‘subluxation’, i. e. ‘biomechanical pathologies’.

Of course, the data are from Australia, and chiros elsewhere might claim that they are more guideline-conform than their Australian colleagues. But, in their discussion section, the authors of the present paper point out that “three previous studies have quantitatively assessed the adherence of registered chiropractors to radiographic guidelines for the management of low back pain (LBP). Two surveys performed in Canada with 26 and 32 responses respectively found that 63 and 59 % would use radiography for acute LBP without indicators of potential pathology and 68 and 66 % thought that radiography was useful in the evaluation of acute LBP.”

Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.

This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!

The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.

The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.

Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”

I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.

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I found this on Twitter; fascinating isn’t it?

So much so, that I decided to run a quick ‘reality check’: are any of these claims based on anything resembling sound evidence?

Here we go:

IT HELPS BRING ABOUT RECOVERY

This is the sort of woolly language that quacks of any type seem to adore. Recovery of what? Perhaps recovery from delusion? No evidence for that, I am sure.

IT CAN REDUCE YOUR BLOOD PRESSURE

Yes, there are some studies on this topic. There is even a systematic review of the relevant trials; it was published by chiros in a chiro journal and it nevertheless concluded that there is currently a lack of low bias evidence to support the use of Spinal Manipulative Therapy as a therapy for the treatment of hypertension. Future investigations may clarify if SMT is effective for treating hypertension, either by itself or as an adjunctive therapy, and by which physiologic mechanism this occurs.

IT IMPROVES THE NERVOUS SYSTEM

Another woolly claim, if there ever was one. What does it mean? Nothing! Consequently, there also is no evidence to back it up.

BETTER POSTURE AND FLEXIBILITY

Chiros will probably claim that the exercises they sometimes recommend might lead to improvements in posture and flexibility of the musculoskeletal system. Even though there is not much good evidence for this, it might still be true. But chiropractic manipulations are unlikely to achieve these aims.

STRONG IMMUNE SYSTEM

There are some studies to imply that spinal manipulations stimulate the immune system. This is what I wrote about them previously: If we look at the actual research that might support such strange claims, we find that that it is scarce, flimsy and unconvincing. To the best of my knowledge, nobody has yet shown that people who receive regular chiropractic care are protected from conditions mediated via the immune system. Unless such a phenomenon can be demonstrated beyond reasonable doubt, we should be highly sceptical of the claim that chiropractic care stimulates the immune system and thus generates better health. In my view, regular chiropractic adjustments stimulate only one thing: the cash flow of the therapist.

LESS NEED FOR MEDICATIONS

This is one of the favourite claims of chiros. It is  supported by evidence showing that patients who see a chiropractor use less drugs than those who don’t. But that is due to chiros traditionally being anti-drug; they thus advise their patients not to take any drugs. Very different from claiming their patients need less medications, I’d say. In fact, it seems to me like saying people who regularly go to church pray more than those who don’t.

Why is any of this important?

Some might think that all of this is trivial, irrelevant and boring. I beg to differ.

It matters, I think, because such promotion and bogus claims are what consumers are constantly exposed to. Eventually, many will believe this nonsense, even if it is overtly wrong or stupid. What is being trumpeted loudly a thousand times might eventually be believed.

In other words, such advertisements are relevant because they shape the minds of the public. As responsible healthcare professionals, we ought to be aware of these campaigns and do what we can to correct the false impressions they generate.

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