homeopathy
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, LLC; MediNatura, 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.
‘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.
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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):
- Social distancing measures might have been put in place at the right time.
- Hand-washing might have been better accepted than in the UK.
- Face-masks might have been more common.
- The government might have been less incompetent than the one in the UK.
- The pandemic might be arriving with some delay in Kerela (in the last 2 days the COVID cases have more than doubled in Kerela).
- The hot weather might have inhibited the spread of the infection.
- The Ayurvedic medicine mentioned by the health minister might have worked.
- There might be many more cases due to under-diagnosis and poor testing.
- The holy cows might have prevented infections.
- 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!
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.
Am I the only one who is tired of hearing that, in India, homeopathy is doing wonders for the current pandemic? All of the reports that I have seen are based on little more than hearsay, anecdotes or pseudo-science. If anyone really wanted to find out whether homeopathy works, they would need more than that; in fact, they would need to conduct a clinical trial.
But wait!
As it happens, there are already ~500 clinical trials of homeopathy. Many show positive effects, but the reliable ones usually don’t. Crucially, the totality of the evidence fails to be positive. So, running further studies is hardly a promising exercise. In fact, considering how utterly implausible homeopathy is, it even seems like an unethical waste of resources.
But many homeopaths disagree, particularly those in India. And it has been reported that several trials have been given the go-ahead in India and are now up and running. This regrettable fact is being heavily exploited for swaying public opinion in favour of homeopathy. The way I see it, the situation is roughly this:
- a few trials of homeopathy are being set up;
- they are designed by enthusiasts of homeopathy who lack research expertise;
- therefore their methodology is weak and biased towards generating a false-positive result;
- while this is going on, the homeopathic propaganda machine is running overtime;
- when the results will finally emerge, they will get published in a 3rd rate journal;
- homeopaths worldwide will celebrate them as a triumph for homeopathy;
- critical thinkers will be dismayed at their quality and will declare that the conclusions drawn by over-enthusiastic homeopaths are not valid;
- in the end, we will be exactly where we were before: quasi-religious believers in homeopathy will feel vexed because their findings are not accepted in science, and everyone else will be baffled by the waste of time, opportunity and resources as well as by the tenacity of homeopaths to make fools of themselves.
But criticising is easy; doing it properly is often more difficult.
So, how should it be done?
The way I see it, one should do the following:
- carefully consider the implausibility of homeopathy;
- thoroughly study the existing evidence on homeopathy;
- abandon all plans to study homeopathy in the light of the above.
But this hardly is inconceivable considering the current situation in India. If further studies of homeopathy are unavoidable, the following procedure might therefore be reasonable:
- assemble a team of experts including trial methodologists, statisticians, epidemiologists and homeopaths;
- ask them to design a rigorous protocol of one or two studies that would provide a definitive answer to the research question posed;
- make sure that, once everyone is happy with the protocol, all parties commit to abiding by the findings that will emerge from these trials;
- conduct the studies under adequately strict supervision;
- evaluate the results according to the protocol;
- publish them in a top journal;
- do the usual press-releases, interviews etc.
In India, it seems that the last point in this agenda came far too early. This is because, in this and several other countries, homeopathy has become more a belief system than a medicine. And because it is about belief, the believers will avert any truly meaningful and rigorous test of homeopathy’s efficacy.
Well, they did not directly admit that homeopathic remedies have no effects, of course. But, on 5/6/2020, they tweeted this :
DHU Arzneimittel
@dhu_de Jun 5
#Homöopathie Wissen
‘Pille’ und #Globuli – geht das? Ja, das geht, #Schwangerschaftsverhütung mit der #Pille und homöopathische Arzneimittel beeinflussen sich nicht gegenseitig.
Let me translate the text of this tweet for you:
The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.
Let me translate the text of this tweet for you:
The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.
And in what way is this an admission that homeopathic remedies have no effect?
Let me explain:
To issue such a categorical assurance, any responsible pharmaceutical company must have sound evidence. If not they would be open to expensive legal action, compensation, etc., in case a woman believed them and did get pregnant while taking both the contraceptive pill and a homeopathic remedy. Claiming that no interactions exist without evidence would be unwise, illegal and unethical. That means, there must be a published trial plus several independent replications demonstrating the absence of interactions between the contraceptive pill and homeopathic remedies.
German homeopathic manufacturers are, of course, responsible; I would never dare to doubt it! Ergo, such trials must be available, I thought. Therefore, I quickly conducted a few literature searches in an attempt to locate them.
Here are my findings:
No study on interactions of homeopathics with contraceptives.
No study on interactions of homeopathics with any drug.
(Should anyone have different information, please contact me without delay)
As I said, I do not doubt for a second that the largest German manufacturer, the ‘Deutsche Homöopathische Union’ (DHU), is a highly responsible company. So, how can they responsibly assure the public that there are no contraceptive/homeopathy interactions? How can they be so sure? Why are they not afraid of legal consequences?
There is really only one plausible explanation: they know very well that homeopathic remedies have no actions, and what has no actions cannot possibly cause any interactions!
Am I right, my dear friends at the DHU?
Please do respond if you have a minute!
Homeopathy has had its fair share of declarations, and now there is another one. I find this new one important because it is from German medical students and might thus indicate where German homeopathy is heading.
The ‘Bundesvertretung der Medizinstudenten in Deutschland’ – the German Medical Students’ Association – has recently looked into the evidence for and against homeopathy and came up with this poignant declaration:
Here is my translation for those who cannot read German; I have added a few footnotes to explain the German context:
- Homeopathy does not work beyond placebo [1].
- The legal health insurances should not reimburse homeopathy [2].
- The law stating that homeopathy can only be sold in pharmacies should be abolished [3].
- Medicines should only be licenced, if there is a valid proof of efficacy [4].
- In public debates, it must be made clear that homeopathy is not part of naturopathy [5].
- The medical degree in homeopathy must be scrapped [6].
- The teaching of homeopathy must be evidence-based and context-related [7].
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- This seems to refer to the wording a German manufacturer of homeopathic preparations tried to suppress.
- At the moment most German health insurances do pay for homeopathy.
- In Germany, pharmacies have a monopoly on homeopathic remedies.
- Since many years, there has been a special regulation in Germany whereby homeopathics could get a licence without proof of efficacy.
- German homeopaths tend to be keen on muddying the water by claiming homeopathy is part of naturopathy.
- All German students are being taught (and examined on) some rudimentary knowledge of homeopathy.
The new declaration is ‘spot on’. I congratulate the students for their courage and wisdom to publish it. They are the future of German medicine, a future where homeopathy’s place is exclusively in the history books as a bizarre episode of anti-science.
SIMILE is the newsletter of ‘The Faculty of Homeopathy’ which is the professional organisation of doctor homeopaths in the UK. Readers of this blog might know about SIMILE because I once published a post about it. Two years ago, the late Dr Peter Fisher (then the Queen’s homeopath) used SIMILE to re-publish a serious lie about me:
A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.
Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.
At the time, I complained and SIMILE (not Fisher) apologised unreservedly.
The current (May 2020) issue of SIMILE carries the following article. I find it quite humorous and therefore take the liberty of copying it here for you:
Every year in Austria a sceptic group called the Society for the Scientific Investigation of Parasciences (GWUP) announces the winner of the Golden Board in Front of the Head Award for what they deem as “unscientific nonsense”. Their award frequently goes to a representative of Austria’s homeopathy community.
However, it now appears Austrian homeopaths have turned the tables on their antagonists by bestowing the 2019 Award for pseudoscience to the GWUP.
But what seems on the surface to be a light hearted tit-for-tat gesture is in truth an attempt to raise questions about who these sceptic groups represent and their real aims.
The Austrian Society of Medical Homeopathy and the Veterinary Society for Homeopathy justify the award on the grounds that the GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors. They say that under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo.
The homeopaths accuse the sceptic group of fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine, which are successfully used by a large number of people around the world. Their aim, claim the homeopaths, is to position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine”.
As we can see, SIMILE learnt an important lesson: they now tell lies in a way that does no loner put them in the firing line. Instead they report then as said by someone else:
- GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors = lie No 1
- under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo = lie No 2
- fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine = lie No 3
- position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine” = lie No 4
Congratulation guys!
You have managed to find a way which enables you to promote untruth and shelter yourselves from considering criticism. You have, in other words, continued the age-old homeopathic tradition of effectively avoiding critical thinking.
THE HINDU reported on 22 May the following amazing story:
A corporator from Borivali, Riddhi Khursange, has distributed 10,000 bottles of Arsenicum Album 30, the homoeopathy medicine that was recommended by Ministry of AYUSH as a prophylactic for COVID-19. Another corporator from Ghatkopar, Pravin Chheda, has bought 25,000 bottles and has distributed over 7,100 in the past four days…
“The AYUSH Ministry must have based their claims on the benefits of the medication. The municipal corporation has also approved it for distribution,” said Mr. Chheda, who aims to distribute one lakh vials. He said all his family members have taken the three-day dose.
While the recommendation from AYUSH was issued on March 6, the Brihanmumbai Municipal Corporation (BMC) on May 8 issued a circular that 20 lakh people, including those in quarantine centres, will get the medicine.
Some experts, however, do not agree with such random, mass distribution. Also known as Ars Alb, the medication was termed as genus epidemicus (homoeopathy medicine indicated for an epidemic) during the H1N1 outbreak of 2008-2009. “Back then, Ars Alb proved extremely beneficial. But the current claim of AYUSH Ministry has not been backed by the process of genus epidemicus,” said Dr Bahubali Shah, former president of the Maharashtra Council of Homoeopathy.
“Another major problem is this general mass distribution of the medicine without an attempt to collect data on efficacy. There has to be a proper distribution protocol and a protocol for analysis. Right now, corporators, NGOs, the BMC and everyone who can get their hands on the medication are distributing it without any record-keeping,” he said.
Well-known chest physician, Dr. Zarir Udwadia, who is part of the State’s COVID-19 task force, said any alternative treatment still has to undergo a trial. “In my opinion, it should not be added on ad hoc,” said Dr. Udwadia.
The State government has set up a new committee to exclusively look at AYUSH remedies. Dr. T.P. Lahane, who is a part of the committee, said a meeting was planned on Thursday evening to discuss various options.
Meanwhile, a trial on 44 COVID-19 patients in Agra has shown that a homoeopathy medicine called Bryonia Alba was more beneficial than Ars Alb. “We have submitted our findings to Central Council of Homoeopathy and are now enrolling more patients for a bigger trial,” said Dr. Pradeep Gupta, principal of the Naiminath Homeopathy College and Hospital, who is conducting the trial.
He said 22 patients were given a placebo while 22 others were given homoeopathy medicines, Bryonia Alba, Ars Alb and Gelsemium. “19 patients who had fever, cough and weakness, responded to Bryonia within the first three days, two patients who had respiratory distress were first given Ars Alb, which relieved the breathing discomfort, but they had to be put on Bryonia Alba to relieve their fever and cough. Only one patient who came in with drowsiness was first given Gelsemium, but later put on Bryonia Alba for other symptoms,” said Dr. Gupta.
For patients in Agra, Bryonia Alba seems to be the genus epidemicus, he said. Dr. Gupta has now written to the Maharashtra government to conduct a similar trial on patients here.
Are they serious?
To me this sounds as though some amateurs are playing doctor and scientist.
I am sure we will have some homeopathy fans pointing out that India is doing very well in the pandemic and that this must be due to the widespread use of homeopathy. To this I answer that firstly India is sadly no longer doing all that well, and secondly that proof of efficacy requires more than speculation. They will reply that homeopathy has proven itself in many previous epidemics. And I will counter that this is just wishful thinking.
So, will the current pandemic finally provide the proof that homeopathy works?
No!
And the Indian homeopaths seem to be doing their utmost to obscure the picture in their hope that, in the end, they can nevertheless claim victory out of a shameful defeat.
The aim of this systematic review was to assess the efficacy of homeopathic remedies (HRs) in the treatment of mental disorders.
Italian psychiatrists performed a Medline/Embase search for studies written in English and published from any date to October 23, 2018. All randomized controlled trials enrolling patients with any psychiatric disorder and comparing HR with placebo, no treatment, or other psychotropic drugs were included.
A total of 212 studies were screened, 9 met all selection criteria and reported data on major depressive disorder (MDD) (n = 4), generalized anxiety disorder (n = 1), attention-deficit/hyperactivity disorder (n = 2), and premenstrual syndrome/dysphoric disorder (n = 2). Eight of 9 randomized controlled trials showed high risk of bias. Homeopathy showed greater efficacy in MDD compared with fluoxetine, and in premenstrual syndrome/dysphoric disorder compared with placebo, whereas no difference emerged between homeopathy and placebo in MDD and attention deficit/hyperactivity disorder.
The authors concluded that the available data on homeopathy in psychiatric disorders are insufficient to support their use in clinical practice.
In their discussion section, they also add an interesting note of caution: Ethical considerations should therefore prevent clinicians from recommending HRs, which have a cost either for patients or for health care systems, until when a sufficient amount of solid evidence becomes available. In addition, systematic reviews of randomized trials, if unavailable, are advisable for all medical conditions for which homeopathy is currently prescribed.
This is a rigorous, transparent and clear review which generates no surprises. Few critical thinkers would have expected a positive result. It also teaches us, I think, a valuable lesson about the difference between a rigorous and a flimsy review, between independent and biased research. In 2011, evidently pro-homeopathy authors published a paper of the latter kind. Here is its abstract:
Objective: To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.
Data sources: Eligible studies were identified using the following databases from database inception to April 2010: PubMed, CINAHL, PsycINFO, Hom-Inform, Cochrane CENTRAL, National Center for Complementary and Alternative Medicine grantee publications database, and ClinicalTrials.gov. Gray literature was also searched using Google, Google Scholar, the European Committee for Homeopathy, inquiries with homeopathic experts and manufacturers, and the bibliographic lists of included published studies and reviews. Search terms were as follows: (homeopath* or homoeopath*) and (placebo or sham) and (anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress* or dysthym* or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance). Searches included only English-language literature that reported randomized controlled trials in humans.
Study selection: Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network (SIGN) 50 guidelines. Overall assessments were made using the Grading of Recommendations Assessment, Development and Evaluation procedure. Identified studies were grouped into anxiety or stress, sleep or circadian rhythm complaints, premenstrual problems, attention-deficit/hyperactivity disorder, mild traumatic brain injury, and functional somatic syndromes.
Results: Twenty-five eligible studies were identified from an initial pool of 1,431. Study quality according to SIGN 50 criteria varied, with 6 assessed as good, 9 as fair, and 10 as poor. Outcome was unrelated to SIGN quality. Effect size could be calculated in 16 studies, and number needed to treat, in 10 studies. Efficacy was found for the functional somatic syndromes group (fibromyalgia and chronic fatigue syndrome), but not for anxiety or stress. For other disorders, homeopathy produced mixed effects. No placebo-controlled studies of depression were identified. Meaningful safety data were lacking in the reports, but the superficial findings suggested good tolerability of homeopathy. A funnel plot in 13 studies did not support publication bias (χ(2)(1) = 1.923, P = .166).
Conclusions: The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.
The two conclusions speak for themselves, I think. They should remind us that, although systematic reviews are in principle the most reliable source of evidence, it is still necessary to check the quality of the work and the independence of the worker.
Just when I thought I had seem all of the corona-idiocy, I found this paper by Dr Kajal Jain MD Homoeopathy (Materia Medica ) Medical Officer under Uttar Pradesh Public Service Commission. It promotes specific nosodes and other homeopathics against the current pandemic. In my view, it discloses a new dimension of the delusion which seems to have engulfed so many homeopaths. Allow me to copy a short passage from it:
TUBERCULINUM
A glycerine extract of a pure cultivation of tubercle bacilli (human).
As per Lectures on Homoeopathic Materia Medica by Dr Kent (page 1000) the Tuberculin nosode can prevent TB infection in those having predisposition to miasma. “If Tuberculinum bovinum be given in 10m, 50m, and CM potencies, two doses of each at long intervals, all children and young people who have inherited tuberculosis may be immuned from their inheritance and their resiliency will be restored
Burnett treated 54 cases of different types of TB Tuberculinum(Tub)/Bacillinum(Bac) 3
As stated in an article published in economic times ,countries without universal policies of BCG vaccination, such as Italy, the Netherlands, and the United States, have been more severely affected compared to countries with universal and long-standing BCG policies,” noted the researchers led by Gonzalo Otazu, assistant professor of biomedical sciences at NYIT.
The study noted that Australian researchers have recently announced plans to fast track large-scale testing to see if the BCG vaccination can protect health workers from the coronavirus.
The team compared various nations’ BCG vaccination policies with their COVID-19 morbidity and mortality and found a “significant positive correlation” between the year when universal BCG vaccination policies were adopted and the country’s mortality rate.
Iran, for instance, which has a current universal BCG vaccination policy that only started in 1984, has an elevated mortality rate with 19.7 deaths per million inhabitants, they said.
In contrast, Japan, which started its universal BCG policy in 1947, has approximately 100 times fewer deaths per million people, with 0.28 deaths, according to the study.
Brazil, which started universal vaccination in 1920 has an even lower mortality rate of 0.0573 deaths per million inhabitants, the scientists noted.
The researchers noted that among the 180 countries with BCG data available today, 157 countries currently recommend universal BCG vaccination.
The remaining 23 countries have either stopped BCG vaccination due to a reduction in TB incidence or have traditionally favoured selective vaccination of “at-risk” groups, they said.4
Thus we can see that Tuberculinium is reputed since a long timeas homoeoprophylactic in place of BCG. So Tuberculinum in high potency can act as an effective and dependable prophylactic in corona Virus .
PNEUMOCOCCINUM-
Pneumococcinum is reputed to prevent pneumonia. 5
In end stages OF CORONA VIRUS when we encounter symptoms like high fever ,pneumonia,pleurisy , -Pneumococcinum can be considered due to it being most similar to exisiting disease condition. Historically Pneumococcinum along with Influenzinum has been seen in eliciting drastic immunological responses in disease conditions following flu since it creates picture of pneumonia..
INFLUENZINUM and Oscillococcinum
Influenzinum is reputed to prevent flu and flu line symptoms 5
Oscilllococcinum –prepared from liver of wild duck has been observed to reduce course of illness due to influenza this it can be included as one of the probable medicnes in treatment of corona virus in earlier stages 6
A study conducted by Colombo GL1, Di Matteo S2 et al suggests that the treatment with Oscillococcinum could be helpful in preventing RTIs and improving the health status of patients who suffer from respiratory diseases7
Comparison of Allopathic vaccines and Nosodes
Allopathic vaccines are isopathic in nature, cude in nature unlike nosodes which are dynamic in nature with deeper penetrative abilities ..Nosodes when administered mimic the sickness and by natures law of cure prevent and treat illness.Nosodes being the same as original disease are more similar to the disease condition and are deeper in action since they are potentised
Thus realising effectiveness of nosodes in prevention and treatment of epidemics Nosodes are suggested as one of the probable approaches for COVID 19
This paper is so full of utter nonsense that I am unable to point it all out in a short blog-post. I trust you can easily identify it yourself. Let me therefore just focus on one specific point.
I did highlight reference 6 in the text for a special reason. Here is the reference provided by Dr Jain:
6. Vickers AJ, Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane Database Syst Rev 2000;(2):CD001957
It does not take much research to find out what is wrong with it. It refers to a Cochrane review which, of course, seems most laudable. To be precise, it refers to the 2000 version of this review which concluded that Oscillococcinum probably reduces the duration of illness in patients presenting with influenza symptoms. Though promising, the data are not strong enough to make a general recommendation to use Oscillococcinum for first-line treatment of influenza and influenza-like syndrome. Further research is warranted but required sample sizes are large. Current evidence does not support a preventative effect of homeopathy in influenza and influenza-like syndromes.
This review is today obsolete, as it has meanwhile up-dated no less than 4 (!) times.
The latest version of this review is from 2015 (authored by well-known proponents of homeopathy) and concluded as follows: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum® could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum®.
It is virtually impossible to not realise all this when accessing the reviews via Medline. And that leads me to fear that the author of the above paper, Dr Kajal Jain MD Homoeopathy (Materia Medica ) Medical Officer under Uttar Pradesh Public Service Commission, is not just deluded, but fraudulent.
