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

alternative medicine

George Lakhovsky, a Russian-born scientist, believed to have found out that every cell of the human body has its own frequency. Healthy cells emit a frequency radiation, he claimed, and whenever a part of the body gets damaged, inflamed or ill, the resonance of those cells become less intense. When pathogens, bacteria, microbes take over, they disrupt the healthy cells with their harmful frequency, Lakhovsky thought.

Based on these notions, Lakhovsky constructed a device capable of generating a field of frequencies in a very broad spectrum. He argued that, if one would place a sick person or an affected body part in this frequency spectrum, those diseased cells would recognize their own frequency, tune in and would start resonating in their own, healthy frequency again. Thus the illness would disappear, Lakhovsky thought.

He felt it should be possible to halt and even cure degenerative diseases like cancer in this way. After a long time of experimenting unsuccessfully, he called Nicola Tesla for help. Tesla had the blueprints for the oscillator machine ready for use. Their multi-wave oscillator was said to activate healing processes and cured most cases of cancer, leukaemia, osteoporosis etc.

An important part of Lakhovsky’s work took place in 1920-1930. In France, Italy, England and Germany multiple of Lakhovsky’s machines were operating. But then they slowly started disappearing again. Many people said the reason for this was that the quick results provided by the machines made the hospitals unnecessary and no profits could be made by them.

The Second World War put an end to much of Lakhovsky’s work. While visiting the US, Lakhovsky was struck by a car and died under mysterious circumstances aged 72.

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Is this intriguing story the script of a bizarre film?

No, it is a true – well, partly true – story which I have taken from this article by a therapist who, like many others, uses Lakhovsky’s oscillator for treating patients (and sells potions, some of which cost well over Euro 1 000!). Another article by a practitioner offering this treatment claims that the oscillator is effective for the following indications:

  • vitalising cells,
  • activation of the body’s own healing powers,
  • anti-ageing,
  • wellness,
  • improving general well-being,
  • pain reduction,
  • detox,
  • rejuvenation of skin,
  • improvement of visual aspect of the skin.

The article further assures us that the treatment is totally free of side-effects and can be used as an adjunctive therapy for almost any disease.

Yet another website advertises the therapy as follows: Have you lost a loved one to cancer? Georges Lakhovsky had a 98% success rate in treating fatal cancers over an 11-year period. Today we celebrate a 50% five-year survival rate.

And this is what Wikipedia tells us about the Lakhovsky oscillator (depicted in the photo above, together with its inventor):  The main circuit basically consists of concentric rings forming electrical dipole antennas having capacitive gaps opposing each other by 180° (called Lakhovsky antennas). The circuit is fed with high voltage, high frequency, impulses from a generator, usually a Tesla coil. If set up correctly, the unit is supposed to create a broad band frequency spectrum of low amplitude, consisting of much more substantially lower and higher frequencies, from 1 Hz to 300 GHz, than those of the exciting generator, usually several 100 kHz to a few MHz from a Tesla transformer or several kilohertz from an induction coil. But the power of this broad band noise spectrum is very low. In order to create more harmonics and sub-harmonics, an additional spark gap on the secondary side has been found in some devices, being mounted directly on the antenna, or being mounted in parallel to the secondary coil…

In an attempt to find out whether the machine works, I have searched for published, peer-reviewed clinical evidence on the Lakhovsky oscillator. I was unable to find any. If any of my readers are aware of any evidence, please let me know.

Already in 2017, the Russian Academy of Sciences (RAS) had issued a statement saying that “The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available.”Now Russia’s ‘Commission against Pseudoscience’ called homeopathy a “pseudoscience” whose effectiveness hasn’t been proven, which is harmful to patients because they spend money and time on ineffective treatments.Since 1995, qualified doctors who are also trained in homeopathy have been licensed to practice homeopathic medicine in Russian hospitals and clinics, and their practice has been regulated. However, the Commission has now recommended that Russia’s Ministry of Health forbid doctors from prescribing homeopathic medicine and ban the homeopathic medicines themselves from state medical institutions. “Homeopathy is not harmless: patients spend a lot of money on drugs that don’t work and neglect means of treatment with proven effectiveness. This can lead to adverse outcomes, including death of the patient,” the Commission wrote.

In response to the recommendation, the health ministry announced the formation of a working group of medical experts to suggest proposals for further regulation of homeopathy. A spokesman said that medicines whose efficiency is not clinically proven should not be procured using public funds, nor prescribed to treat the sick.

Russia has proved a profitable market for foreign suppliers of homeopathic medicine such as French company Boiron, which opened its Russian subsidiary in 2005. “Today, the Russian market is our company’s fourth largest in terms of turnover, after France, the US and Italy. Russia has always been interesting for Boiron because of the large population, and a relatively high incidence of illness and lower level of medicine consumption in comparison with Europe,” general director of Boiron in Russia Irina Nikulina said.

According to figures from Russian pharmaceutical market analysts DSM Group, Boiron sold 35 percent of all the homeopathic medicine sold in Russia last year, or 2.88 billion rubles (USD 49.5 million) worth of medicine. Boiron produces Russia’s most popular homeopathic medicine, called Oscillococcinum, which is marketed to relieve flu symptoms and accounted for 18.98 percent of all homeopathic medicines sold in 2016.

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The many international initiatives aimed at minimising the harm done by homeopathy are slowly beginning to yield results. It took many years for politicians to realise that the supposedly harmless homeopathy is, in fact, not harmless at all. Homeopathy causes harm by:

  1. wasting people’s money,
  2. distracting patients from effective treatments,
  3. the ill-conceived advice homeopaths give to patients,
  4. making a mockery of evidence-based medicine,
  5. violating the principles of medical ethics,
  6. undermining rational thinking in society.

One therefore has to applaud Russia’s ‘Commission against Pseudoscience’, hope that the working group does produce robust advice, and support similar initiatives in other countries.

 

 

In 2015, the Hungarian Academy of Sciences stated that “Homeopathic remedies don’t meet the criteria of evidence based medicine”  and that homeopathic products should follow the same strict scientific standards as conventional drugs. In 2017, the Scientific Advisory Board of European Academies (EASAC) concluded that there is no substantial evidence that homeopathy works and may even be harmful to our health.

Now, Hungary is about to act. New regulation is tightening the marketing of homeopathic products in Hungary. From Wednesday this week, homeopathic remedies can only be distributed in Hungary without a therapeutic indication or claim. The reason for this move is that none of the products’ efficacy have been adequately confirmed by rigorous clinical trials.

In a statement, the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) said the changes are due to a law amendment that came into effect last year. The new regulation only allows homeopathic medicines with therapeutic indications authorized before Hungary’s accession to the EU (2004), to be marketed after July 1, 2020, if they have complied with the EU regulations on the marketing of these medicines.

Currently, Hungary has no homeopathic product with therapeutic efficacy proven in clinical trials. The product license of homeopathic products – in compliance with the legislation of the European Union – can be obtained by two different procedures in Hungary. The so-called simplified procedure can be used for “high-dilution products” marketed without a therapeutic indication, in which case the effectiveness of the product does not need to be certified.

The “normal” procedure is applicable to homeopathic medicinal products marketed for a therapeutic indication, in which case, just as any other medicinal products, therapeutic efficacy must be clinically proven. OGYÉI emphasized that from July 1st, the advertising of marketable homeopathic remedies may only contain the label text of the product, no additional information.

The move by the Hungarian authorities is, of course, most welcome. It brings Hungary finally in line with the rest of the EU. The many enthusiasts of homeopathy will no doubt suspect a worldwide conspiracy against homeopathy. If so, they merely disclose how far they have put their heads into the sand. Such measures are nothing but the long overdue actions towards abolishing double standards that have existed far too long and have helped nobody except the homeopathic industry.

Amongst all the many bizarre treatments so-called alternative medicine (SCAM) has to offer, distant healing is probably one of the least plausible. Essentially, it involves healers sending healing ‘energy’ to far remote patients. This energy is then supposed to stimulate the patients’ ability to heal themselves.

In my recent book, I summarise it as follows:

Distant healing is a form of ‘energy healing’ where the healer operates at a distance from the patient. This distance can be considerable; proponents of distant healing see no obstacle in healing even over very large distances.

      1. The term ‘energy’ must be put in inverted commas, because the underlying concepts have nothing in common with the energy defined in physics. Real energy is measurable and quantifiable.
      2. ‘Energy’ as used in alternative medicine describes a nebulous concept of a life-force that originates from the obsolete notions of vitalism. This type of ‘energy’ is neither measurable nor quantifiable.
      3. In distant healing, the healer, who often works for free, sends ‘healing energy’ across space in the belief that it is received by the patient and thus stimulates her self-healing potential. This process does not require the physical presence of the patient.
      4. Proponents of distant healing offer various modes of action for their treatment; some claim, for instance, that quantum physics provides a scientific explanation as to how it works.
      5. The assumptions that underpin distant healing are not biologically plausible.
      6. There has been some research testing whether distant healing is effective. Most of the studies available to date have serious methodological flaws. One review of 8 clinical trials showed that the majority of the rigorous trials do not to support the hypothesis that distant healing has specific therapeutic effects. The results of two studies furthermore suggest that distant healing can be associated with adverse effects.[1] And another review concluded that the evidence to date does not yet provide confidence in its clinical efficacy.[2]
      7. Reading the literature published by proponents of distant healing, one cannot help but being impressed by the amount of pseudo-scientific language that is being employed to mislead the reader.

[1] https://www.ncbi.nlm.nih.gov/pubmed/12778776

[2] https://www.ncbi.nlm.nih.gov/pubmed/26665044

Considering its implausibility, it hardly comes as a surprise that Prof Walach studied distant healing in some detail. In fact, he published three studies of it:

2001: Chronically ill patients treated by spiritual healing improve in quality of life: results of a randomized waiting-list controlled study. Wiesendanger H, Werthmüller L, Reuter K, Walach H.

Objective: Little is known about the effects of distant healing in chronically ill patients, the population most likely to see a healer in practice. This study investigated whether distant healing as found in normal practice with patients representative of those seeking treatment from healers changes patients’ quality of life substantially.

Method: Randomized, waiting-list controlled study of distant healing (anonymous, amulet, and allowing for personal contact) in chronically ill patients.

Outcome measure: Patient-reported quality of life as expressed by the sum of all MOS SF-36 health survey items.

Results: Sixty patients were treated by various methods of distant healing over 5 months; 59 patients were put on a waiting list (control). Quality of life improved significantly (p < 0.0005) in the treated group (10 points), while it remained stable in the control group. Positive expectation was significantly correlated with outcome.

Conclusion: Chronically ill patients who want to be treated by distant healing and know that they are treated improve in quality of life.

2002: Distant Healing and Diabetes Mellitus. A Pilot Study M Ebneter 1M BinderO KristofH WalachR Saller

Background: The Institut für Grenzgebiete der Psychologie und Psychohygiene, Freiburg (IGPP) in cooperation with the Abteilung Naturheilkunde, University Hospital, Zürich investigated whether Distant Healing has a beneficial effect on patients with diabetes mellitus regarding the state of the disease and quality of life.

Objective: The goal of the pilot study was to observe the progression of the disease with various medical and psychological measures and to explore which of them might be sensitive for measuring possible treatment effects.

Patients and methods: 14 diabetic patients were observed for a period of 16 weeks. Within this time they underwent a treatment of 4 consecutive weeks (weeks 9-12) by 5 experienced and trustworthy healers each. Patients were informed about the duration of the treatment but not about the time point of its beginning. Patients and healers never met and there was no contact between researchers and patients during the study period.

Results: With regard to medical parameters, reduction in fructosamine level was observed during the healing period, increasing fructosamine level after the end of the healing period. Sensitivity, measured only at the beginning and at the end of the study period, decreased significantly. The other parameters showed some significant changes but there was no correlation to the Distant Healing intervention. Regarding the psychological data, only improvements were observed.

Conclusions: The results indicate the possibility that a Distant Healing intervention could have certain effects on patients with diabetes mellitus.

2008: Effectiveness of Distant Healing for Patients With Chronic Fatigue Syndrome: A Randomised Controlled Partially Blinded Trial (EUHEALS) Harald Walach 1Holger BoschGeorge LewithJohannes NaumannBarbara SchwarzerSonja FalkNiko KohlsErlendur HaraldssonHarald WiesendangerAlain NordmannHelgi TomassonPhil PrescottHeiner C Bucher

Background: Distant healing, a form of spiritual healing, is widely used for many conditions but little is known about its effectiveness.

Methods: In order to evaluate distant healing in patients with a stable chronic condition, we randomised 409 patients with chronic fatigue syndrome (CFS) from 14 private practices for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred (waiting for 6 months) distant healing. Half the patients were blinded and half knew their treatment allocation. Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions. Change in Mental Health Component Summary (MHCS) score (SF-36) was the primary outcome and Physical Health Component Summary score (PHCS) the secondary outcome.

Results: This trial population had very low quality of life and symptom scores at entry. There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups. There was a non-significant outcome (p = 0.11) for healing with PHCS (1.11; 95% CI -0.255 to 2.473 at 6 months) and a significant effect (p = 0.027) for blinding; patients who were unblinded became worse during the trial (-1.544; 95% CI -2.913 to -0.176). We found no relevant interaction for blinding among treated patients in MHCS and PHCS. Expectation of treatment and duration of CFS added significantly to the model.

Conclusions: In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.

So, Walach first conducted an RCT and found that patients who were told that they received the healing experienced improvements. These improvements were therefore due to the expectations of these patients and had nothing to do with the distant healing per se. Next Walach conducted a study with diabetics and found that distant healing might have some significant effects. This study not only lacked a control group but its sample size was also tiny. Therefore, he called it a ‘pilot study’ and never followed it up with a proper trial with diabetic patients – all in the good old SCAM tradition of abusing the term. Finally, Walach conducted a multi-centre RCT with 409 CFS-patients and found that distant healing is ineffective. Subsequently, he seems to have stopped initiating further studies of distant healing.

The sequence of publications is remarkable on several levels. To me, it demonstrates the importance of running a proper trial at the outset of conducting research into a subject. This avoids wasting resources and betraying the trust of patients in clinical research. To a more hard-nosed sceptic, it would probably prove how utterly futile it usually is to conduct any studies of treatments that are too implausible for words.

But the story also reveals something more intriguing. I think it displays the mindset of a pseudoscientist in an exemplary fashion. Walach conducted three studies of distant healing. They were all very different in design, patient population, outcome, etc. But they all are entirely consistent with what both common sense and science would have told even the most open-minded scientist: distant healing is neither plausible nor effective beyond placebo. Yet Walach seems to refuse drawing such a conclusion. His last publication on the subject was a qualitative analysis of some of the data from his CFS-RCT. In it he states that our results support data that imply the existence of a psychophysical pathway in healing through spiritual rituals…

If your own studies fail to that a therapy works would you then use weasel-words to promote the idea that your results support data that imply the existence of a psychophysical pathway in healing through spiritual rituals? Or would you openly declare that the therapy in question is useless and therefore potentially dangerous?

Perhaps this is the difference between a scientist and a pseudoscientist?

When I previously wrote about Pranic Healing I boldly asked whether it is a hoax. This prompted several furious reactions of believers who thought my question was insulting. Meanwhile, I informed myself more thoroughly and am happy to confirm that Pranic Healing is not a hoax at all. In fact, it is much worse.

What, you forgot what Pranic Healing is?

How could you?

According to one website, Pranic Healing is a

no touch, non-invasive healing technique that was founded by Grand Master Choa Kok Sui. It is a synthesis of healing techniques from ancient China, Tibet and India in which Prana is used to heal a wide variety of illnesses. Pranic Healing is not only used to cure illness or physical ailments but also can be cure person of his psychological ailments. To be very simple in this computer age as the computer contains the hardware and the software. In human body hardware is our physical body and the software’s are the Human emotions which includes Anger, Grief, Anxiety, Stress , fatigue, our karmas, pride, fear, Phobias and many more.

These human viruses affect the physical body of a person. In Pranic healing Grand Master Choa kok Sui has taught to remove these negative emotions from our system in a very simple but powerful and effective way. Grand Master Choa Kok Sui did lot of research and experiment for treating different diseases and ailments and made is very simple so that anybody can learn it. Today Pranic healing is taught and practiced in more than 80 countries of the world and its books are available in more than 34 languages. Pranic Healing is not intended to replace orthodox western medicine, but rather to complement it. Countless people and their families have been treated and are enjoying a better quality of life through Pranic Healing.

‘Grand Master’ Choa was born August 15, 1952, in the Philippines. His parents were of Chinese descent and became successful business people. Choa was raised in this environment of business and absorbed its lessons only too well. Sadly, he seemed to have been immune to his own healing innovation, as he died young in 2007. But his Pranic Healing empire lives on and today it is a hugely profitable business.

Prana Crystals sell a wide range of products, for instance ‘healing wants’ which they advertise as follows:

Healing Wands made from various stones and crystals have been used round the globe Rare 496 grams Quartz crystal wand Imagefor healing purposes since ages. They help in cleansing of the entire body or aura or they can also be used to heal an affected part of the body or chakra. These wands can also be used for massaging purpose. They absorb the negative energy and release stress and pressure and help in transferring the positive energy of the stone. Healing Wands are available in variety of stones and crystals in different sizes. Each one of them have specific characteristics and uses. We have a variety of Wands available to meet your requirements.

My favourite wand is the one pictured on the right here. It is the Rolls Royce of all the wands on offer and therefore it can obviously not come cheap. But at US$ 1999 (yes, one thousand nine hundred and ninety-nine American dollars) it is still a bargain, because it rids you of all the diseases and negative energy that you can dream of.

During my recent crash course in Pranic Healing, I came across dozens of websites, hundreds of testimonials, uncounted comments and a plethora of curious things. Let me share just one of them with you:

Pranic Weight Loss Body Sculpting Face Lift is a fascinating area of the applications of the teachings of Master Choa Kok Sui for health and beauty. This workshop helps you look prettier and loose weight without surgery, exhausting exercises and medicine, just by using the knowledge of subtle energy.

Using specific combination of colour pranas and techniques, your skin can look 10 to 20 years younger. In fact the lines and wrinkles of the face are storage of negative and unpleasant feelings and experiences such as anger, fear and grief. When this emotional garbage is cleared and released, the face will look younger, brighter and revitalized.

Certain colour Pranas have the power to disintegrate and remove fat, wrinkles and lines from your system to create a healthier and better-looking body. In fact the lines and wrinkles of the face are storage of negative and unpleasant feelings and experiences such as anger, fear and grief. When this emotional garbage is cleared and released, the face will look younger, brighter and revitalized.

No, Pranic Healing is most certainly not  hoax, and I was wrong to imply it. My sincere apologies! It is pure and simple exploitation of  vulnerable people who have not had the opportunity to learn how to think critically.

 

When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.

This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.

In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:

Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

In their paper, the authors state this:

It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.

My comments to this are as follows:

  1. Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
  2. Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
  3. Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
  4. Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.

Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:

  • We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
  • Observational studies cannot easily determine cause and effect between the therapy and the outcome.
  • Observational studies cannot be a substitute for RCTs.
  • Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
  • Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
  • If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
  • SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.

In 2012, we evaluated the efficacy/effectiveness of lavender for the reduction of stress/anxiety.

Our systematic review included 15 RCTs. Two trials scored 4 points on the 5-point Jadad scale, the remaining 13 scored two or less. Results from seven trials appeared to favour lavender over controls for at least one relevant outcome. We concluded that methodological issues limit the extent to which any conclusions can be drawn regarding the efficacy/effectiveness of lavender. The best evidence suggests that oral lavender supplements may have some therapeutic effects. However, further independent replications are needed before firm conclusions can be drawn.

Since 2012, more evidence has emerged. The latest study on the subject aimed to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. It was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL).

For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001). See the source image

The authors of the new study concluded that that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

Hurray, this seems to be a decent trial with a positive result for SCAM!

And why not? It is not at all implausible that lavender has hypnotic effects. There are now quite a few reasonably sound trials that suggest it works. Moreover, it is safe and not very expensive (or even free, if you can grow it yourself).

I for one am more than happy to report a positive finding for a SCAM and merely regret that I cannot do so more often.

Pisa syndrome (PS) is a condition in which there is sustained involuntary flexion of the body and head to one side and slight rotation of the trunk so the person appears to lean like the Leaning Tower of Pisa. The PS can occur as a complication of Parkinson’s disease (PD). It can also be an adverse effect of some medications. It is characterized by a trunk lateral flexion higher than 10 degrees which is reversible when lying. The underlying pathophysiological mechanisms responsible for the development of PS are poorly understood. One pathophysiological hypothesis is that PS in PD is caused by an altered verticality perception, due to a somatosensory impairment.

The management of PS remains a challenge. Physiotherapy with early rehabilitation emphasising stretching exercises for the external oblique and paraspinal muscles is usually recommended. Therapy is also needed to improve static, dynamic posture and the control of pain symptoms. Osteopathic Manipulative Treatment (OMT) is also sometimes advocated for PS, but does it work?

The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry. In this single-blinded trial the investigators studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received OMT plus MIRT for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) was also performed.

At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT – 326.00±491.24 mm2, p = 0.01). The experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).

The authors concluded that among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.

The authors entitled their paper ‘Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: A Pilot Randomized Placebo-Controlled Trial’. As a pilot study, it should not test efficacy but explore the feasibility of a definitive trial. The fact the authors report outcome data, indicates to me that this is, in fact, not a pilot study, but a hopelessly underpowered clinical trial. This means that the findings could be due merely to chance alone. And this, in turn, means that the researchers owe it to their patients to conduct a properly powered RCT.

Michael Dixon LVOOBEMAFRCGP has been a regular feature of this blog (and elsewhere). He used to be a friend and colleague until … well, that’s a long story. Recently, I came across his (rather impressive) Wikipedia page. To my surprise, it mentions that Dixon

See the source image“has been criticised by professor of complementary medicine and alternative medicine campaigner Edzard Ernst for advocating the use of complementary medicine. Ernst said that the stance of the NHS Alliance on complementary medicine was “misleading to the degree of being irresponsible.”[31] Ernst had previously been sympathetic to building a bridge between complementary and mainstream medicine, co-writing an article with Michael Dixon in 1997 on the benefits of such an approach.[32] Ernst and Dixon write “missed diagnoses by complementary therapists giving patients long term treatments are often cited but in the experience of one of the authors (MD) are extremely rare. It can also cut both ways. A patient was recently referred back to her general practitioner by an osteopath, who was questioning, as it turned out quite correctly, whether her pain was caused by metastates. Good communication between general practitioner and complementary therapist can reduce conflicts and contradictions, which otherwise have the potential to put orthodox medicine and complementary therapy in an either/or situation.”

REFERENCES

31) February 2009, 24. “Academics and NHS Alliance clash over complementary medicine”. Pulse Today.

32) ^ Update – the journal of continuing education for General Practitioners, 7th May 1997

I have little recollection of the paper that I seem to have published with my then friend Michael, and it is not listed in Medline, nor can I find it in my (usually well-kept) files; the journal ‘Update’ does not exist anymore and was obviously not a journal good enough for keeping a copy. But I do not doubt that Wiki is correct.

In fact, it is true that, in 1997, I was still hopeful that bridges could be built between conventional medicine and so-called alternative medicine (SCAM). But I had always insisted that they must be bridges built on solid ground and with robust materials.

Put simply, my strategy was to test SCAM as rigorously as I could and to review the totality of the evidence for and against it. Subsequently, one could consider introducing those SCAMs into routine care that had passed the tests of science.

Dixon’s strategy differed significantly from mine. He had no real interest in science and wanted to use SCAM regardless of the evidence. Since the publication of our paper in 1997, he has pursued this aim tirelessly. On this blog, we find several examples of his activity.

And what happened to the bridges?

I’m glad you ask!

As it turns out, very few SCAMs have so far passed the test of science and hardly any SCAM has been demonstrated to generate more good than harm. The material to build bridges is therefore quite scarce, hardly enough for solid constructions. Dixon does still not seem to be worried about this indisputable fact. He thinks that INTEGRATED MEDICINE is sound enough for providing a way to the future. I disagree and still think it is ‘misleading to the degree of being irresponsible’.

Who is right?

Dixon or Ernst?

Opinions about this differ hugely.

Time will tell, I suppose.

The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.

The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”

No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.

The FDA issued the warning letters to Hevert Pharmaceuticals, LLCMediNatura, Inc.8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.

Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.

Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.

The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.

The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems

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Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:

  • “Arnica,”
  • “Calmvalera comp.,”
  • “Gelsemium comp.,”
  • “Hepar comp.,”
  • “Lymphaden comp.”

The FDA referred to the following injectable homeopathic products from 8046255 Canada:

  • “Articula,”
  • “Mesenchyme,”
  • “Connectissue,”
  • “MuSkel-Neural,”
  • “Ouch,”
  • “Ithurts,”
  • “Adipose,”
  • “Systemic Detox,”
  • “Hair,”
  • “Neuro 3,”
  • “Infla,”
  • “Collagen,”
  • “Prolo,”
  • “Lymph 1,”
  • “GI,”
  • “Neuro,”
  • “Arthros,”
  • “Male+,”
  • “Immunexx,”
  • “Relief+,”
  • “Intra-Cell,”
  • “Facial,”
  • “ANS/CNS”.

The FDA warning to World Health Advanced Technologies, Ltd referred to:

  • “Enercel AM,”
  • “Enercel Forte,”
  • “Enercel Max,”
  • “Enercel Mist-Nasal,”
  • “Enercel Mist Nebulizer,”
  • “Enercel PM,”
  • “Vanicel,”
  • “Enercel Plus,”
  • “Enercel Plus IM.”

The FDA warning referred to the following products by MediNatura, and the claims made for them include:

  • Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
  • Traumeel Injection Solution: … treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
  • Engystol Injection Solution:  support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
  • Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
  • Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
  • Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”

The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.

Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”

Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”

As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.

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