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

alternative medicine

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.

Yesterday, I received a tweet from a guy called Bart Huisman (“teacher beekeeping, nature, biology, classical homeopathy, agriculture, health science, social science”). I don’t know him and cannot remember whether I had previous contact with him. His tweet read as follows:

“Why should anyone believe what Professor Edzard Ernst says, after he put his name to a BBC programme, he now describes as “deception”.”

This refers to a story that I had almost forgotten. It’s a nice one with a ‘happy ending’, so let me recount it here briefly.

In 2005, the BBC had hired me as an advisor for their 4-part TV series on alternative medicine.

The first part of the series was on acupuncture, and Prof Kathy Sykes presented the opening scene taking place in a Chinese operation theatre. In it a Chinese women was having open heart surgery with the aid of acupuncture. Kathy’s was visibly impressed and said on camera that the patient was having the surgery “with only needles to control the pain.”  However, the images clearly revealed that the patient was receiving all sorts of other treatments given through intra-venous lines. So, Prof Sykes was telling the UK public a bunch of porkies. This was bound to confuse many viewers.

One of them was Simon Singh. At the time, I did not know Simon (to be honest, I did not even know of him) and was surprised to receive a phone call from him. He politely asked me to confirm that I had been the adviser of the BBC on this production. I was happy to confirm this fact. Then he asked why I had missed such a grave error. I replied that I could not possibly have spotted it, because all I had been asked to do was to review and correct the text of the programme which the BBC had sent to me by email. Before it was broadcast, I had not seen a single passage of the film.

Correcting the text had already led to several problems (not so much regarding the acupuncture part but mostly the other sections), because the BBC was reluctant to change several of the mistakes I had identified. When I told them that, in this case, I would quit, they finally found a way to alter them. But the cooperation had been far from easy. I explained all this to Simon and eventually he asked me whether I would be willing to support the official complaint he was about to file with the BBC. I agreed. This is probably where I used the term ‘deception’ that Mr Huisman mentioned in his tweet.

So, Simon submitted his complaint and eventually won the case.

But this is not the happy ending I was referring to.

During the course of the complaint, Simon and I realised that we were thinking alike and were getting on well. A few months later, he suggested that the two of us write a book together about alternative medicine. At first, I was hesitant. Simon said, “let’s try just one chapter, and see how it works out.” So we did. It turned out to be fun and instructive for both of us. So we did the other chapters as well. The book was published in 2008 and is called TRICK OR TREATMENT. It was published in about 20 different languages and the German version became ‘science book of the year in 2011 (I think).

And that’s not the happy ending either (in fact, it caused a lot of hardship for Simon who was sued by the BCA; luckily, he won that case too).

The real happy ending is the fact that Simon and I became friends for life.

Thank you Bart Huisman for reminding me of this rather lovely story.

 

By guest blogger Loretta Marron

If scientists were fearful of a clinical trial’s producing negative results, would they even pursue it? A draft Chinese regulation issued in late May aims to criminalise individual scientists and organisations whom China claims damage the reputation of Traditional Chinese Medicine (TCM).

Beijing has a reputation for reprimanding those who decry TCM. Such criticism is blocked on Chinese Internet. Silencing doctors is becoming the norm.

In January 2018, former anaesthetist, Tan Qindong, was arrested and spent more than three months in detention after criticising a widely advertised, best-selling ‘medicinal’ TCM liquor. Claiming that it was a ‘poison’, he believed that he was protecting the elderly and vulnerable patients with high blood pressure. Police claimed that a post on social media damaged the reputation of the TCM ‘liquor’ and of the company making it. Shortly after release, he suffered post-traumatic stress and was hospitalised.

On 30 December 2019, Chinese ophthalmologist, the late Dr Li Wenliang, was one of the first to recognise the outbreak of COVD-19. He posted a private warning to a group of fellow doctors about a possible outbreak of an illness resembling severe acute respiratory syndrome (SARS). He encouraged them to protect themselves from infection. Days later, after his post when viral, he was summoned to the Public Security Bureau in Wuhan and forced to “admit to lying about the existence of a worrying new virus”. Li was accused of violating the provisions of the “People’s Republic of China Public Order Management and Punishment Law” for spreading “unlawful spreading of untruthful topics on the internet” and of disturbing the social order. He was made to sign a statement that he would “halt this unlawful behaviour”.

In April 2020, Chinese physician Yu Xiangdong, a senior medico who worked on the front line battling COVID-19, posted on Weibo, a Twitter-like site, a criticism of the use of antibiotics and TCM to treat COVID-19. He was demoted from his positions as assistant dean at the Central Hospital in the central city of Huangshi and director of quality management for the city’s Edong Healthcare Group. Well known for promoting modern medicine amongst the Chinese, Yu had almost a million followers on social media. All his postings vanished.

Beijing insists that TCM has been playing a crucial role in COVID-19 prevention, treatment and rehabilitation. Claims continue to be made for “effective TCM recipes”. However, no randomised clinical trial has been published in any reputable journal.

TCM needs proper scrutiny, but criticising it could land you years in prison. If the benefits of suggested herbal remedies are to be realised, good clinical studies must be encouraged. For TCM, this might never be permitted.

Don’t think for a moment that you are safe in Australia.

Article 8.25 of the Free Trade Agreement Between the Government of Australia and the Government of the People’s Republic of China reads:

Traditional Chinese Medicine Services (“TCM”)

  1. Within the relevant committees to be established in accordance with this Agreement, and subject to available resources, Australia and China shall cooperate on matters relating to trade in TCM services.
  2. Cooperation identified in paragraph 2 shall:

(a)    include exchanging information, where appropriate, and discussing policies, regulations and actions related to TCM services; and

(b)   encourage future collaboration between regulators, registration authorities and relevant professional bodies of the Parties to facilitate trade in TCM and complementary medicines, in a manner consistent with all relevant regulatory frameworks. Such collaboration, involving the competent authorities of both Parties – for Australia, notably the Department of Health, and for China the State Administration of Traditional Chinese Medicine – will foster concrete cooperation and exchanges relating to TCM.

‘HOMEOPATHY RESOURCE’ claim they are the online web site for accurate information on homeopathy, homeopaths and homeopathic organizations. On 18 June, they published an article entitled “Another Remarkable Demonstration of Homeopathy’s Effectiveness in Covid-19: ONLY 19 Deaths out of 35 million in Kerala, India”. Here it is in its full beauty:

The State of Kerela India has shown that homeopathy and grassroots health care works dramatically well in epidemic and pandemic situations.. The state, in spite of areas of great density, has reported only 19 deaths. This compares to the UK which has a population of 66 million people but a tragic 41,698 deaths.

The region’s Health Minister Shailaja Teacher has been called the “Coronavirus Slayer” after introducing homeopathy as a primary means of dealing with the epidemic. Kerala India has already come through two Nipah virus epidemics under her watch.

Tactics used by Shailaja included encouraging the use of homeopathy. In a recent media meeting, she talked about the need “to improve the immunity and resistance power of each individual not yet positive to Coronavirus, with the help of Homeopathic/ Ayurvedic medicines. That will help them resist the Coronavirus infection, help them to tide over the infection well, if at all they contract it…… everyone should take Homeopathic & Ayurvedic preventative treatments available.”

According to Dr E.S.Rajendran who practices in Kerala “The total number of people who received the homeopathic preventive medicine Ars alb 30 through Kerala government as on June 1st was 10 million. An equal number of people have also received the same through voluntary organisations. The remaining population is expected to receive the preventive medicine in another one month.” This distribution was carried out in each district with the help of resident associations and was achievable because there is a huge demand for homeopathy from the people.

_____________________________________

Do ‘HOMEOPATHY RESOURCE’ really think that this is ‘accurate information’?

Do they feel that it amounts to evidence that homeopathy prevents COVID-19 infections?

Do they believe that it is responsible to promote such a message?

If so, they are more deluded than their homeopathic remedies are diluted!

There is a plethora of factors that might have contributed to the low infection rate in Kerela. Here are some that spring into my mind (in descending order of probability):

  1. Social distancing measures might have been put in place at the right time.
  2. Hand-washing might have been better accepted than in the UK.
  3. Face-masks might have been more common.
  4. The government might have been less incompetent than the one in the UK.
  5. The pandemic might be arriving with some delay in Kerela (in the last 2 days the COVID cases have more than doubled in Kerela).
  6. The hot weather might have inhibited the spread of the infection.
  7. The Ayurvedic medicine mentioned by the health minister might have worked.
  8. There might be many more cases due to under-diagnosis and poor testing.
  9. The holy cows might have prevented infections.
  10. Homeopathy works dramatically well in epidemic and pandemic situations.

Call me a sceptic, but – whatever turns out to be true (and I sincerely hope that the case numbers stay low in Kerela) – I do not think that ‘HOMEOPATHY RESOURCE’ is providing accurate information with their recent post.

And call me a pessimist, but I fail to see any good evidence to assume that homeopathic remedies have any effect in treating or preventing viral infections. In fact,

HIGHLY DILUTE HOMEOPATHIC REMEDIES ARE PURE PLACEBOS! 

Siddha medicine is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. It is thought to be one of the oldest system of healthcare of India that developed during the Indus civilization, which flourished between 2500 and 1700 BCE.

It has been reported that the Indian ‘National Institute of Siddha’ (NIS) claim to have successfully treated 160 COVID-19 positive patients. Subsequently, they have requested the government to hand over all COVID-19 Care Centres in Chennai and let Siddha doctors treat all COVID-patients. They say they are confident of flattening the curve in Chennai and convert it into a safe zone in just matter of days.

The NIS claim to have three potent combinations of Siddha drugs. “Depending upon the availability and quantity required for treating Coronavirus positive patients, we have after thorough research, come out with three different effective combinations of the Siddha preparations,” Dr R Meenakumari, Director of NIS, said. The treatment low-cost compared to the prohibitive cost in corporate hospitals and all the Siddha medicines are locally available, she added. “We have requested the state government to hand over all the COVID-19 Care Centres to us and allow us to treat all the patients. Our Siddha drug combination is potent enough to convert a positive patient into Coronavirus negative in three days’ time,” she claimed.

Her confidence stems from the fact that the Siddha doctors here have “successfully” treated 160 patients besides
23 inmates of the Puzhal Central Prison. “Initially, we treated 85 patients with SRM Medical College and Hospital and another 75 at the Greater Chennai Corporation… They all recovered and tested negative after five days of successful treatment,” she claimed. “The combination that we have prepared will help to cure the infected patient within three days… Siddha medicine has huge potential to treat the patients and there are possibilities to use the medicine to save precious human lives”.

The combination drug in question seems to be similar to or identical with Kabasura KudineerAlso termed ‘Nilavembu Kudineer‘, this drug is a powder form of medicine mainly used in the treatment of respiratory problems such as fever, cold, severe phlegm and flu. This polyherbal Siddha medicine is also widely used as a prophylactic during times of viral epidemics. To get the proper benefits, it should be made into a decoction and then consumed. 
Kabasura Kudineer
is made up of 15 different ingredients:

  1. ginger,
  2. cloves,
  3. aakarkara,
  4. harad,
  5. oregano,
  6. giloy,
  7. chiretta,
  8. nagarmotha,
  9. kali mirch
  10. tragiainvolucrata,
  11. vajradanti,
  12. malabar nut,
  13. kuth,
  14. ajwain,
  15. leghupatha.

In 2009, it allegedly helped containing the spread of swine flu and, in 2012, the then Chief Minister Jayalalithaa had requested public to use Nilavembu Kudineer prepared by the Institute to prevent dengue.

Meanwhile, the ‘Central Council for Research in Siddha’ has sent a proposal to the state government to include the
traditional medicine in the treatment protocols at the state-run CCCs. “We have also urged the state government to include the Brahmananda Bhairava Mathirai a herbo-mineral preparation, which has already been approved by the AYUSH ministry to treat persons with COVID-19 related fever, at all the COVID-19 wards,” a senior doctor at the CCRS said.

Of course, we all wish that an effective treatment against COVID-19 will be found soon. However, what the NIS calls THOROUGH RESEARCH looks like a flimsy bit of pseudo-research. And their assertion that their herbal mixture turns positive into negative patients within three days is a claim that sounds far too good to be true.

I have no reason to doubt that the NIS is full of good intentions. But I am reminded of Bert Brecht’s bon mot: ‘the opposite of good is not evil, but good intentions’.

I recently came across a short article from 2009 in the BMJ reporting that: “The World Health Organization has said that homoeopathy should not be used to treat several serious diseases such as HIV, tuberculosis, and malaria...”

At the time most people (including myself) were rather pleased that the WHO took what was considered a clear stance, I remember. Reading the short paragraph again today, I must say I am underwhelmed. In fact, if I analyse it carefully, I have to admit that the statement is nonsense.

This would be inconsequential or trivial, were it not for the hundreds of similar statements warning people that HOMEOPATHY SHOULD NOT BE USED FOR SERIOUS CONDITIONS.

Have I confused you?

No, I am not claiming the homeopathy SHOULD be used for serious conditions! I am saying that the statement is misleading and can easily be misunderstood. Some people might interpret it as meaning that, alright homeopathy must not be used for serious diseases, but can be used for all other conditions. Come to think of it, the WHO has often been seen promoting so-called alternative medicine (SCAM), and therefore I cannot be sure that this is not the message they wanted to send out.

Highly diluted homeopathic remedies contain nothing; they are therefore biologically implausible. Crucially, the best evidence fails to show that they work beyond a placebo effect. Therefore, employing it for a serious condition might hasten the patient’s death. But using it for a less serious condition is surely not much better.

Imagine someone takes it for asthma, or psoriasis, or coronary heart disease, or rheumatoid arthritis, or flu, or food poisoning, or the common cold, etc, etc. If he uses it as a sole treatment, he will suffer needlessly. If he uses it as a complementary treatment (Hahnemann did expressly forbid such combinations), he might not be affected negatively except for the time and money invested. But his health would not benefit, and therefore the WHO (or anyone else for that matter) should not imply that this is fine.

It follows that the warning HOMEOPATHY SHOULD NOT BE USED FOR SERIOUS CONDITIONS is nonsense. The only sound advice is this:

HOMEOPATHY SHOULD NOT BE USED FOR ANY CONDITIONS.

 

This was essentially the question raised in a correspondence with a sceptic friend. His suspicion was that statistical methods might produce false-positive overall findings, if the research is done by enthusiasts of the so-called alternative medicine (SCAM) in question (or other areas of inquiry which I will omit because they are outside my area of expertise). Consciously or inadvertently, such researchers might introduce a pro-SCAM bias into their work. As the research is done mostly by such enthusiasts; the totality of the evidence would turn out to be heavily skewed in favour of the SCAM under investigation. The end-result would then be a false-positive overall impression about the SCAM which is less based on reality than on the wishful thinking of the investigators.

How can one deal with this problem?

How to minimise the risk of being overwhelmed by false-positive research?

Today, we have several mechanisms and initiatives that are at least partly aimed at achieving just this. For instance, there are guidelines on how to conduct the primary research so that bias is minimised. The CONSORT statements are an example. As many studies pre-date CONSORT, we need a different approach for reviews of clinical trials. The PRISMA guideline or the COCHRANE handbook are attempts to make sure systematic reviews are transparent and rigorous. These methods can work quite well in finding the truth, but one needs to be aware, of course, that some researchers do their very best to obscure it. I have also tried to go one step further and shown that the direction of the conclusion correlates with the rigour of the study (btw: this was the paper that prompted Prof Hahn’s criticism and slander of my work and person).

So, problem sorted?

Not quite!

The trouble is that over-enthusiastic researchers may not always adhere to these guidelines, they may pretend to adhere but cut corners, or they may be dishonest and cheat. And what makes this even more tricky is the possibility that they do all this inadvertently; their enthusiasm could get the better of them, and they are doing research not to TEST WHETHER a treatment works but to PROVE THAT it works.

In the realm of SCAM we have a lot of this – trust me, I have seen it often with my own eyes, regrettably sometimes even within my own team of co-workers. The reason for this is that SCAM is loaded with emotion and quasi-religious beliefs; and these provide a much stronger conflict of interest than money could ever do, in my experience.

And how might we tackle this thorny issue?

After thinking long and hard about it, I came up in 2012 with my TRUSTWORTHYNESS INDEX:

If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his TI would be 1.

Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.

An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.

Of course, this is all a bit simplistic, and, like all other citation metrics, my TI provides us not with any level of proof; it merely is a vague indicator that something might be amiss. And, as stressed already, the cut-off point for any scientist’s TI very much depends on the area of clinical research we are dealing with. The lower the plausibility and the higher the uncertainty associated with the efficacy of the experimental treatments, the lower the point where the TI might suggest  something  to be fishy.

Based on this concept, I later created the ALTERNATIVE MEDICINE HALL OF FAME. This is a list of researchers who manage to go through life researching their particular SCAM without ever publishing a negative conclusion about it. In terms of TI, these people have astronomically high values. The current list is not yet long, but it is growing:

John Weeks (editor of JCAM)

Deepak Chopra (US entrepreneur)

Cheryl Hawk (US chiropractor)

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

The logical consequence of a high TI would be that researchers of that nature are banned from obtaining research funds and publishing papers, because their contribution is merely to confuse us and make science less reliable.

I am sure there are other ways of addressing the problem of being mislead by false-positive research. If you can think of one, I’d be pleased to hear about it.

 

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