MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

alternative medicine

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Who could resist reading an article entitled “Is Dead Vagina Syndrome Real? Plus, 4 Ways To Boost Your Libido“?

Well I couldn’t, particularly as it came from a site promisingly called ‘ALTERNATIVE DAILY’!

And I did not regret it. Here are some excerpts:

…“Dead vagina syndrome” or DVS is used to describe a woman’s over-sensitized vagina. Some people believe that regularly using a strong vibrator can cause a woman to lose feeling in her private parts. What’s worse, it’s thought that this desensitization of the nether regions makes it almost impossible for a woman to get aroused with an actual human partner. Thus, DVS is born. The theory behind the condition suggests that using a strong vibrator regularly will ultimately damage sensitive nerves around the clitoris and in the vagina…”

[Luckily, there is help – help from all natural, herbal remedies, no less. The article recommends the following cures]

Saffron

Saffron, a culinary delicacy, has a powerful libido-boosting effect. In fact, research suggests that saffron has been used traditionally as an aphrodisiac. And a little goes a long way. All you need is one or two strands to do the trick.

Maca root

Used for centuries in Asian countries, maca root has traditionally been used for male sexuality. But a study from the Department of Psychiatry, Massachusetts General Hospital has found that it may also be helpful for women in need of a sexual boost.

Nutmeg

In animal studies, nutmeg has been found to increase sexual activity in male rats. Interestingly, nutmeg has also been used traditionally as an aphrodisiac by African women and is still used today by women of all cultures. So, what’s good for men is obviously good for women too…

END OF QUOTE

Before you get all excited and start planting your own physic garden or hurry to the next health food shop, let me tell you this: I have looked into the evidence, and to call it flimsy would be the understatement of the year. There is no good reason to believe that these herbal remedies (or any other alternative therapy) can help women increase their libido.

Thankfully, the article ends on a truthful and reassuringly positive note: “most experts agree that DVS is not a real medical concern for women.”

… nor for men, I hasten to add.

 

A comprehensive review of the evidence relating to acupuncture entitled “The Acupuncture Evidence Project: A Comparative Literature Review” has just been published. The document aims to provide “an updated review of the literature with greater rigour than was possible in the past.” That sounds great! Let’s see just how rigorous the assessment is.

The review was conducted by John McDonald who no stranger to this blog; we have mentioned him here, for instance. To call him an unbiased, experienced, or expert researcher would, in my view, be more than a little optimistic.

The review was financed by the ‘Australian Acupuncture and Chinese Medicine Association Ltd.’ – call me a pessimist, but I do wonder whether this bodes well for the objectivity of the findings.

The research seems to have been assisted by a range of experts: Professor Caroline Smith, National Institute of Complementary Medicine, Western Sydney University, provided advice regarding evidence levels for assisted reproduction trials; Associate Professor Zhen Zheng, RMIT University identified the evidence levels for postoperative nausea and vomiting and post-operative pain; Dr Suzanne Cochrane, Western Sydney University; Associate Professor Chris Zaslawski, University of Technology Sydney; and Associate Professor Zhen Zheng, RMIT University provided prepublication commentary and advice. I fail to see anyone in this list who is an expert in EBM or who is even mildly critical of acupuncture and the many claims that are being made for it.

The review has not been published in a journal. This means, it has not been peer-reviewed. As we will see shortly, there is reason to doubt that it could pass the peer-review process of any serious journal.

There is an intriguing declaration of conflicts of interest: “Dr John McDonald was a co-author of three of the research papers referenced in this review. Professor Caroline Smith was a co-author of six of the research papers referenced in this review, and Associate Professor Zhen Zheng was co-author of one of the research papers in this review. There were no other conflicts of interest.” Did they all forget to mention that they earn their livelihoods through acupuncture? Or is that not a conflict?

I do love the disclaimer: “The authors and the Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) give no warranty that the information contained in this publication and within any online updates available on the AACMA website are correct or complete.” I think they have a point here.

But let’s not be petty, let’s look at the actual review and how well it was done!

Systematic reviews must first formulate a precise research question, then disclose the exact methodology, reveal the results and finally discuss them critically. I am afraid, I miss almost all of these essential elements in the document in question.

The methods section includes statements which puzzle me (my comments are in bold):

  • A total of 136 systematic reviews, including 27 Cochrane systematic reviews were included in this review, along with three network meta-analyses, nine reviews of reviews and 20 other reviews. Does that indicate that non-systematic reviews were included too? Yes, it does – but only, if they reported a positive result, I presume.
  • Some of the included systematic reviews included studies which were not randomised controlled trials. In this case, they should have not been included at all, in my view.
  • … evidence from individual randomised controlled trials has been included occasionally where new high quality randomised trials may have changed the conclusions from the most recent systematic review. ‘Occasionally’ is the antithesis of systematic. This discloses the present review as being non-systematic and therefore worthless.
  • Some systematic reviews have not reported an assessment of quality of evidence of included trials, and due to time constraints, this review has not attempted to make such an assessment. Say no more!

It is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.

So, what might we conclude from all this?

I don’t know about you, but for me this new review is nothing but an orgy in deceit and wishful thinking!

Sorry, but something I stated in my last post was not entirely correct!

I wrote that “I could not find a single study on Schuessler Salts“.

Yet, I do know of a ‘study’ of Schuessler Salts after all; I hesitate to write about it because it is an exceedingly ugly story that goes back to the ‘Third Reich’, and some people do not seem to appreciate me reporting about my research on this period.

The truth, however, is that I already did mention the Schuessler salts before on this blog: “…in 1941 a research unit was established in ‘block 5’ [of the Dachau Concetration Camp] which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.”

Wikipedia provides further details: [Im Dritten Reich] konnten erstmals mit staatlicher Billigung und Förderung Untersuchungen durchgeführt werden, in denen die behauptete Wirksamkeit „biochemischer“ Arzneimittel überprüft wurde. Solche Versuche fanden auch in den Konzentrationslagern Dachau und Auschwitz statt, unter Leitung des Reichsarztes SS Ernst-Robert Grawitz. Dabei wurden unter anderem künstlich herbeigeführte Fälle von Blutvergiftung und Malaria weitgehend erfolglos behandelt. Für die Häftlinge nahmen diese Experimente in den meisten Fällen einen tödlichen Ausgang.

My translation: During the Third Reich, it became possible for the first time possible to conduct with governmental support investigations into the alleged effectiveness of ‘biochemical’ Schuessler Salts. Such tests were carried out in the concentration camps of Dachau and Auschwitz under the leadership of Reichsarzt SS Ernst-Robert Grawitz. They involved infecting prisoners with sepsis and malaria and treating them – largely without success. Most of the prisoners used for these experiments died.

I also found several further sources on the Internet. They confirm what was stated above and also mention the treatment of TB with Schuessler Salts. Furthermore, they state that the victims were mostly Polish priests:

The last source claims that at least 28 prisoners died as a result of these unspeakably cruel experiments.

The most detailed account (and even there, it is just 2 or 3 pages) about these experiments that I could find is in the superb and extremely well-researched book ‘AUSCHWITZ, DIE NS MEDIZIN UND IHRE OPFER’ by Ernst Klee. In it (p 146), Klee cites Grawitz’s correspondence with Himmler where Grawitz discloses that, prior to the Dachau ‘Schuessler experiments’, there were also some in Auschwitz where all three victims had died. Apparently Grawitz tried to persuade Himmler to stop these futile and (even for his standards) exceedingly cruel tests; the prisoners suffered unimaginable pain before their deaths. However, Himmler reprimanded him sharply and instructed him to continue. Dr Kiesswetter was subsequently recruited to the team because he was considered to be an expert on the clinical use of Schuessler Salts.

[Another book entitled Der Deutsche Zentralverein homöopathischer Ärzte im Nationalsozialismus‘ also mentions these experiments. Its author claims that Weyherns was not a doctor but a Heilpraktiker (all other sources agree that he was a medic). In general, the book seems to down-play this deplorable story and reads like an attempt to white-wash German homeopathy during the Third Reich] .

Klee concludes his chapter by reporting the post-war fate of all the doctors involved in the ‘Schuessler experiments’:

Dr Waldemar Wolter was sentenced to death and executed.

Dr Hermann Pape disappeared.

Dr Rudolf Kiesswetter disappeared.

Dr Babor fled to Addis Abeba.

Dr Laue died.

Dr Heinrich Schuetz managed to become a successful consultant in Essen. Only in 1972, he was charged and tried by a German court to 10 years of jail. Several of his colleagues, however, certify that he was too ill to be imprisoned, and Schuetz thus escaped his sentence.

Why do I dwell on this most unpleasant subject?

Surely, this has nothing to do with today’s use of Schuessler Salts!

Do I do it to “smear homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis“, as Peter Fisher once so stupidly put it?

No!

I have other, more important reasons:

  • I do not think that the evidence regarding Schuessler Salts is complete without these details.
  • I believe that these are important historical facts.
  • I feel that the history of alternative medicine during the Third Reich is under-researched and almost unknown (contrary to that of conventional medicine for which a very large body of published evidence is now available).
  • I feel it should be known and ought to be much better documented than it is today.
  • I fear that we live in times where the memory of such atrocities might serve as a preventative for a resurgence of fascism in all its forms.

When I started this blog, I promised to discuss all major alternative modalities. This is a big task, and I am not nearly there yet. For instance, I have so far written hardly anything about ‘Schuessler Salts’, a derivative of homeopathy that is hugely popular in Germany and is slowly spreading also to other countries. According to ‘Homeopathy Plus’, Schuessler’s Tissue Salts are ‘a medicine chest for the whole family’. Specifically, his is what they say:

… Tissue Salts were first developed by the German doctor, Wilhelm Schuessler, who said ill-health was caused by an imbalance in the bodies twelve vital cell salts. Schuessler believed that these imbalances could be corrected by easily absorbed and homeopathically-prepared, micro-doses of each salt.

Schuessler’s Tissue Salts (also known as biochemic or cell salts) are potentised micro-doses of the 12 essential minerals your body needs to repair and maintain itself.  They are prepared in homeopathic 6X potencies that are gentle enough to be used by the youngest to the eldest member of your family. They can even be used with pets.

Schuessler introduced his homeopathically-Wilhelm Schüßlerprepared Tissue Salts more than 100 years ago but today, they have spread to most parts of the world where families and individuals rely on them as simple home treatments for a wide range of problems.

Tissue Salts, as either individual remedies or in combination, are an ideal addition to the home medicine cabinet for simple health complaints. They are:

  • Gentle
  • Absorbed rapidly
  • Natural
  • Pleasant tasting
  • Lactose free
  • Convenient to carry
  • Non-toxic and non-addictive
  • Safe to use with prescription medicines
  • Suitable for broad, general health complaints (unlike standard homeopathy that requires more precise symptom matching).

END OF QUOTE

Other websites offer much more concrete recommendations for the 12 specific remedies; for instance this one:

1.  KALI  PHOS (Kali Phosphoricum; Potassium Phosphate)
a. mental/emotional symptoms predominate
b. Feel as if “I’m too tired to rest.”
c. Anxiety, brain fatigue, irritability, temper-tantrums, sleeplessness, dizziness,
nervous asthma
d. easily bleeding gums

2.  KALI MUR (Kali Muriaticum; Potassium Chloride)
a. white mucus, swollen glands
b. white or gray coated tongue, glandular swellings, discharge of white, thick
mucus from nose or eyes
c. indigestion from rich food

3.  KALI SULPH (Kali Sulphuricum; Potassium Sulphate)
a. yellow mucus, later stages of illness, congestion and cough worse in evening
b. dandruff, yellow coated tongue, yellow crusts on eyelids
c. gas, poor digestion

4.  CALC PHOS (Calcarea Phosphorica; Calcium Phosphate)
a. teething remedy
b. upset stomach, post-nasal drip, chronic cold feet, poor dentition

5.  CALC SULPH (Calcarea Sulphurica; Calcium Sulphate)
a. sores that heal poorly, herpes blisters
b. pain in forehead, vertigo, pimples on the face

6.  CALC FLUOR (Calcarea Fluorica; Calcium Fluoride)
a. poor tooth enamel, cracks in palms of hands, lips
b. hemorrhoids

7.  NAT MUR (Natrum Muriate; Sodium Chloride)
a.  dryness of body openings, clear thin mucus
b. effects of excess overheating; itching of hair at nape of neck
c. early stage of common colds with clear, running discharge
d. insect bites (applied locally)

8.  NAT SULPH (Natrum Sulphuricum; Sodium Sulphate)
a. rarely needed
b. green stools and other excess bile symptoms
c. Sensitive scalp, greenish-gray or greenish-brown coating on tongue, influenza

9.  NAT PHOS (Natrum Phosphoricum; Sodium Phosphate)
a. simple morning sickness; acid rising in throat
b. Headache on crown of head, eyelids glued together in morning,
c. grinding of teeth in sleep; pain and sour risings from stomach after eating

10. MAG PHOS (Magnesia Phosphorica; Magnesium Phosphate)
a. Muscle spasms, cramps and menstrual cramps, if always better with heat
b. hiccups; trembling of hands
c. teeth sensitive to cold

11. FERRUM PHOS ( Ferrum Phosphate; Ferrum Phosphate)
a. first stages of inflammation, redness, swelling, early fever
b. congestive headache, earache, sore throat
c. loss of voice from overuse

12. SILICEA (Silica)
a. white pus forming conditions, boils (“homeopathic lancet”), stony-hard glands
b. Sty in eye area, tonsillitis, brittle nails

END OF QUOTE

All these promotional websites are guilty of two remarkable omissions:

  1. these remedies are biologically implausible,
  2. there is not a jot of evidence to suggest they are more than pure placebos.

Even if the ingredients named on the bottles were effective, the salts are far too dilute (6X signifies a dilution of 1: 1000000) to have any meaningful health effects. Unsurprisingly, there is no evidence whatsoever that these remedies work. I could not find a single study on Schuessler Salts – but if anyone knows of one, I would be ready to change my view. However, I did find this quote from the ‘Government Gazette of Western Australia’ 1946:

THE following report is issued under section 210 of the Health Act, 1911-1944:- It is claimed that the above “remedy” [Dr. Schuessler’s Cell Salts, Kali Phos. 3X] is “indicated in loss of mental power, brain fog, paralysis of any part, nervous headaches, neuralgic pains, general disability and exhaustion and sleeplessness from nervous disorders.” The “remedy” has been analysed and been found to contain potassium dihydrogen phosphate and lactose. The actual quantity of potassium dihydrogen phosphate in the “adult dose” is so minute that over 9,000 tablets would be necessary to give the minimum medicinal dose of this drug. Lactose is a sugar which is of no value in the treatment of any of the above-mentioned maladies. Dr. Schuessler’s Cell Salts can therefore have no curative value. They will bring about no improvement in any of the illnesses for which they are said to be indicated. Any expenditure on the purchase of these salts will be money wasted.

— C. E. COOK, Commissioner of Public Health
END OF QUOTE
The conclusion is depressingly simple: Schuessler Salts may be popular, but they are both implausible and unproven; hence they do not belong in anyone’s medicine chest.

A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.

A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.

The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.

And why would this be puzzling?

There are several minor oddities here, I think:

  • The first sentence of the conclusion is not based on the data presented.
  • The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
  • The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.

But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.

How can an acupuncture-trial be double-blind?

The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!

As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.

Park Sham Device Set

Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.

Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.

It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.

Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

The fact that many dentists practice dubious alternative therapies receives relatively little attention. In 2016, for instance, Medline listed just 31 papers on the subject of ‘complementary alternative medicine, dentistry’, while there were more than 1800 on ‘complementary alternative medicine’. Similarly, I have discussed this topic just once before on this blog. Clearly, the practice of alternative medicine by dentists begs many questions – perhaps a new paper can answer some of them?

The aims of this study were to “analyse whether dentists offer or recommend complementary and alternative medicine (CAM) remedies in their clinical routine, and how effective these are rated by proponents and opponents. A second aim of this study was to give a profile of the dentists endorsing CAM.

A prospective, explorative, anonymised cross-sectional survey was spread among practicing dentists in Germany via congresses, dental periodicals and online (n=250, 55% male, 45% female; mean age 49.1±11.4years).

Of a set of 31 predefined CAM modalities, the dentists integrated plant extracts from Arnica montana (64%), chamomile (64%), clove (63%), Salvia officinalis (54%), relaxation therapies (62%), homeopathy (57%), osteopathic medicine (50%) and dietetics (50%). The effectiveness of specific treatments was rated significantly higher by CAM proponents than opponents. However, also CAM opponents classified some CAM remedies as highly effective, namely ear acupuncture, osteopathic medicine and clove.

With respect to the characteristic of the proponents, the majority of CAM-endorsing dentists were women. The mean age (50.4±0.9 vs 47.0±0.9years) and number of years of professional experience (24.2±1.0 vs 20.0±1.0years) were significantly higher for CAM proponents than the means for opponents. CAM proponents worked significantly less and their perceived workload was significantly lower. Their self-efficacy expectation (SEE) and work engagement (Utrecht work engagement, UWE) were significantly higher compared to dentists who abandoned these treatment options. The logistic regression model showed an increased association from CAM proponents with the UWES subscale dedication, with years of experience, and that men are less likely to be CAM proponents than women.

The authors concluded that various CAM treatments are recommended by German dentists and requested by their patients, but the scientific evidence for these treatments are often low or at least unclear. CAM proponents are often female, have higher SE and work engagement.

GIVE ME A BREAK!!!

These conclusion are mostly not based on the data provided.

The researchers seemed to insist on addressing utterly trivial questions.

They failed to engage in even a minimum amount of critical thinking.

If, for instance, dentists are convinced that ear-acupuncture is effective, they are in urgent need of some rigorous education in EBM, I would argue. And if they use a lot of unproven therapies, researchers should ask whether this phenomenon is not to a large extend motivated by their ambition to improve their income.

Holistic dentistry, as it is ironically often called (there is nothing ‘holistic’ about ripping off patients), is largely a con, and dentists who engage in such practices are mostly charlatans … but why does hardly anyone say so?

 

 

Malaria is an infection caused by protozoa usually transmitted via mosquito bites. Malaria is an important disease for homeopaths because of Hahnemann’s quinine experiment: it made him postulate his ‘like cures like’ theory. Today, many experts assume that Hahnemann misinterpreted the results of this experience. Yet most homeopaths are still convinced that potentised cinchona bark is an effective prophylaxis against malaria. Some homeopathic pharmacies still offer homeopathic immunisations against the infection. In several cases, this has caused people who believed to be protected fall ill with the infection.

Perhaps because of this long tradition, homeopaths seem to have difficulties giving up the idea that they hold the key to effective malaria prevention. An article published in THE INDIAN EXPRESS entitled ‘Research suggests hope for homoeopathic vaccine to treat malaria’ reminds us of this bizarre phenomenon:

…In a laboratory test set-up, an ultra-dilute homoeopathic preparation was prepared by extracting samples from Plasmodium falciparum, the parasite that causes malaria. The homoeopathic preparation was used in-vitro to check if it had anti-malarial activity… “Homoeopathy has been criticised for lack of scientific evidence. This lab-model test established that a medicine developed from an organism that causes malaria can be used to treat the infection,” said Dr Rajesh Shah, principal investigator in the research.

Following the tests, Shah is approaching the government in order to conduct a full-fledged clinical trial for the homoeopathic medicine. “We found that the homoeopathic medicine exhibited 65 per cent inhibition against malaria while chloroquine treatment has 54 per cent efficacy,” Shah claimed. The research was published in the International Journal of Medical and Health Research in July. It observed that the homoeopathic solution inhibited enzyme called hemozoin is known to have an anti-malarial effect…

END OF QUOTE

I thought this story was both remarkable and odd. So I looked up the original paper. Here is the abstract:

The inventor has developed malaria nosode and has subjected it for evaluation of antimalarial activity in vitro assay along with few other homeopathy preparations. The potential antimalarial activity of the Malaria nosode, Malaria officinalis and China officinalis was evaluated by β-Hematin Formation Assay. The hemozoin content was determined by measuring the absorbance at 400 nm. The results were recorded as % inhibition of heme crystallization compared to negative control (DMSO) Malaria nosode, Malaria officinalis and China officinalis exhibited inhibition of hemozoin and the inhibition was greater than the positive control Chloroquine diphosphate used in the study. The study has shown anti-disease activity of an ultra-dilute (potentized) homeopathic preparation. The Malaria nosode prepared by potentizing Plasmodium falciparum organisms has demonstrated antimalarial activity, which supports the basic principle behind homeopathy, the law of similar.

Now I am just as puzzled!

Why would any responsible scientist advocate running a ‘full-fledged clinical trial’ on the basis of such flimsy and implausible findings?

Would that not be highly unethical?

Would one not do further in-vitro tests?

Then perhaps some animal studies?

Followed by first studies in humans?

Followed perhaps by a small pilot study?

And, if all these have generated positive results, eventually a proper clinical trial?

The answers to all these questions is YES.

But not in homeopathy, it seems!

There has been a flurry of legal actions against manufacturers of homeopathic products (mostly) in the US. Many of these cases seem to settle out of court which means that we hardly hear about them. Of those that go to court, most are being won by the plaintiffs, but unfortunately some are also lost.

The recent case of Allen v. Hyland’s, Inc. is such an incidence. The US lawyer Robert G Knaier has analysed this case in detail and recently published a paper about it. The article is fascinating and well worth reading in full.

Here I take the liberty to show you a (shorted) section of Knaier’s paper where he asks what went wrong:

… How did a jury decide that Hyland’s did not misrepresent the efficacy of its products? Surely, the court’s instruction that Hyland’s would be liable only if the plaintiffs proved homeopathy “cannot work” contributed to the result. So long as defense experts were able to propose ways that homeopathy might work, the jury was left with the difficult decision—for laypersons, in any event—of rejecting that testimony.

But should the jury ever have been put in the position of having to make that choice? Should the defense experts ever have been allowed to testify? Had the court in Allen granted the plaintiffs’ motions to exclude those experts, the case likely would have ended with a settlement. Without the ability to put on evidence supporting its products, Hyland’s may very well have recognized that it had no realistic chance of prevailing at trial. But the court denied those motions.

In this respect, the court erred. There can be little doubt that expert testimony in support of the efficacy of homeopathy fails tests of admissibility. Consider the Federal Rules of Evidence and the factors that courts should evaluate under Daubert and its progeny. Is testimony that homeopathy is effective “the product of reliable principles and methods”?

In other words, does it have a “reliable foundation”? Is “the reasoning or methodology underlying [it] . . . scientifically valid”?  As explained above, homeopathy’s core principles—provings, like cures like, and the law of minimum dose—are based on little more than Samuel Hahnemann’s late eighteenth-century speculations. They were not developed through, nor have they been validated by, controlled scientific studies… the principles and efficacy of homeopathy have been “tested” and “subjected to peer review and publication” — but they have consistently failed those tests and the scrutiny of that review process… Indeed, the FDA has stated that it simply is “not aware of scientific evidence to support homeopathy as effective.”

Thus, homeopathy’s “rate of error” is known, and far from gaining “general acceptance” in the scientific and medical community, it has gained near-universal condemnation. The defense of homeopathy, in some respects, presents a classic example of “unjustifiably extrapolat[ing] from an accepted premise to an unfounded conclusion.”  Advocates extrapolate from the efficacy of vaccines that similia similibus currentur has a sound scientific basis, and from the concept of hormesis that providing ultralow doses is well-founded methodology. But as one contemporary skeptic has explained, unlike homeopathic remedies, vaccines actually “contain measurable numbers of antigen molecules,” and “act by well-understood scientific mechanisms”; and hormesis, even in the limited circumstances in which it appears to operate, “describes a response to a low dose, not to no dose.”  As Martin Gardner noted many decades ago, the defense of homeopathy thus begins with plausible-sounding principles, and then “exaggerate[s] them to the point of absurdity.”  In other words, it impermissibly extrapolates to “unfounded conclusion[s].”

Finally, the defense of homeopathy glaringly fails to “account for obvious alternative explanations.” Do people who take homeopathic remedies sometimes feel better? Of course they do. But studies of homeopathy have overwhelmingly concluded that the reason for this is not that homeopathy is actually efficacious, but rather because it is “the ideal placebo.” It is cheap. It has no side effects (unless, as discussed below, it is adulterated). And practitioners spend substantial time with their “patients,” thus encouraging psychosomatic effects.

In the end, advocates of homeopathy may have little to stand on other than that many people—including some “experts” who would gladly be paid to testify—inexplicably seem to believe that it works. But this will not do. That homeopathy has many believers does not validate it as a scientifically sound “field of expertise,” or color it, against nearly 200 years of evidence to the contrary, as one “known to reach reliable results for the type of opinion the expert would give.”  As our Supreme Court perhaps most saliently observed, “general acceptance” of a principle cannot “help show that an expert’s testimony is reliable where the discipline itself lacks reliability.” As the Court explained, general acceptance of “principles of astrology or necromancy,” for example, would not transform those subjects into appropriately reliable subjects of expert testimony.  The Court could easily have added homeopathy to that list.

Thus, in allowing the jury to receive testimony about the principles of homeopathy—not as a matter of historic curiosity, but as a matter of scientific validity—the Allen court arguably abdicated its gatekeeping responsibility to screen out unreliable expert testimony. By permitting “experts” to testify in favor of a field the bases of which defy basic principles of biology, chemistry, and physics — indeed, in some respects “basic logical principles” — the “integrity and fairness of the trial process” was compromised.

END OF QUOTE

I fully agree with Knaier. Allowing the ‘flat earth society’ to present to a court their views about the shape of our planet, while instructing the jury that they must accept them as ‘evidence’ (unless the plaintiff can prove it to be untrue) cannot be the right way forward. In fact, it is a method of preventing progress. Following this logic, I cannot imagine the proponents of any absurdity – however ridiculous – to not be victorious in court.

Knaier’s ultimate conclusion is, I think correct: “Trial courts have robust power and clear responsibility to preclude litigants from introducing irrelevant and unreliable evidence in support of purportedly scientific claims… To the extent that courts continue abdicating their evidentiary gatekeeping role in this way, they may contribute to a waste of time and resources, financial harm to consumers, and risks to public health. But to the extent that litigants and courts strengthen their spines in this regard, take seriously the dangers of unfounded expert testimony, and make genuine efforts to seek and grant its exclusion, they might contribute to the health and well-being of both the courts and those who turn to them for help.”

Several national organisations of sceptics give annual awards to people and institutions who do outstanding work and those who do the opposite. Later this week, I will travel to Vienna, for instance, to give away one of this year’s ‘GOLDENES BRETT’, a negative prize for the most outrageous BS of 2017. Such things are good fun but also important tools in fighting nonsense. I probably will report about it when I am back.

Earlier this year, the UK sceptics awarded Gwyneth Paltrow with the well-earned RUSTY RAZOR. The ‘Bent Spoon’ is a similar type of prize. It has just been awarded by the Australian Skeptics to the proponent of the most preposterous piece of pseudoscientific or paranormal piffle of the year. Past winners have included Pete ’Paleo’ Evans, the CSIRO’s head Larry Marshall, the ABC, the Pharmacy Guild of Australia, the University of Wollongong, and a psychic dentist.

This year’s nominations are listed here. The winner of the 2017 Bent Spoon is the National Institute of Complementary Medicine at the University of Western Sydney. “When they were nominated last year they said they’d have a closer look at their site,” said Eran Segev, president of Australian Skeptics Inc. “But they’re still promoting unproven treatments and now also involved in a project to establish a clinic for Traditional Chinese Medicine on the campus of the University of Western Sydney. The 2017 winner’s involvement is described as ‘clinical trials’, but the University acknowledges that the TCM clinic may be opened to the public – a highly dubious pseudomedicine given the imprimatur of university ‘research’. “

On this blog, we have discussed several of the NICM’s papers. An interesting article about the NICM can also be found here. To give you an additional flavour of their research, here are the conclusions of just 5 of their recent articles:

CONCLUSION: In our study of acupuncture for menopausal hot flashes, higher expectancy after the first treatment did not predict better treatment outcomes. Future research may focus on other determinants of outcomes in acupuncture such as therapist attention. The relationship between smoking and hot flashes is poorly understood and needs further exploration.

Conclusion: There is a clear need to understand breast cancer survivors’ needs for physical and psychological support as they aim to regain control over their life through their experience of illness. More studies are needed to measure and evaluate these outcomes and to help identify breast cancer survivors’ healthcare seeking behaviours, during and after the acute treatment stage that addresses their physical, emotional, and spiritual needs. These results aim to inform future research design and evaluate and develop support services that are patient-centred and focus on whole health outcomes, shared decision-making, and quality of life.

CONCLUSION: These results are important for healthcare providers as they work with patients to identify life experiences, including ‘loss/potential loss’ and ‘the need for preservation’, that have personal significance. Some patients may realize that ‘enough is enough’; something needs to change. These intrinsic motivating factors may also be the impetus for eventual recovery for some individuals.

CONCLUSIONS: 16 weeks of Bikram yoga significantly improved perceived stress, general self-efficacy and HRQoL in sedentary, stressed adults. Future research should consider ways to optimise adherence, and should investigate effects of Bikram yoga intervention in other populations at risk for stress-related illness.

CONCLUSIONS: These findings suggest that long-term acupuncture treatment has targeted regulatory effects on multiple brain regions in rats with Alzheimer’s disease.

The ‘Bent Spoon’ was awarded mostly, I think, because of the persistently misleading claims made on the websites of the NICM. Go and have a look – I am sure you will agree: they are highly deserving winners.

In my opinion, these awards deserve our support. They are an effective means of fighting charlatans and promoting progress. They should be publicised much more widely.

 

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