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

vaccination

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As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:

In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Of course, not all SCAM professions focus on children. The following, however, treat children regularly:

  • acupuncturists
  • anthroposophical doctors
  • chiropractors
  • craniosacral therapists
  • energy healers
  • herbalists
  • homeopaths
  • naturopaths
  • osteopaths

I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.

A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.

Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.

Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.

As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:

  1. direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
  2. direct harm through the use of bogus diagnostic techniques;
  3. direct harm by using materials from endangered species;
  4. indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
  5. neglect due to using SCAM instead of an effective therapy for a serious condition;
  6. harm due to medicalising trivial states of reduced well-being;
  7. financial harm due to the costs of SCAM;
  8. harm through making a mockery of evidence-based medicine;
  9. harm caused by undermining rational thinking in the society at large;
  10. harm caused by inhibiting medical progress and research.

In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.

The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.

A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.

The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.

The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.

A survey with a response rate of 10%?

An investigation published 9 years after it has been conducted?

Who at the AECC is responsible for controlling the quality of the research output?

Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?

But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.

I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.

This clearly begs the question: is it not time to stop these charlatans?

What do you think?

The ‘International Federation of Anthroposophic Medical Associations’ have just published a ‘Statement on Vaccination‘. Here it is in its full beauty:

Vaccines, together with health education, hygiene and adequate nutrition, are essential tools for preventing infectious diseases. Vaccines have saved countless lives over the last century; for example, they allowed the eradication of small pox and are currently allowing the world to approach the elimination of polio.

Anthroposophic Medicine fully appreciates the contribution of vaccines to global health and firmly supports vaccination as an important measure to prevent life threatening diseases. Anthroposophic Medicine is not anti-vaccine and does not support anti-vaccine movements.

Physicians with training in Anthroposophic Medicine are expected to act in accordance with national legislation and to carefully advise patients (or their caregivers) to help them understand the relevant scientific information and national vaccination recommendations. In countries where vaccination is not mandatory and informed consent is needed, this may include coming to agreement with the patient (or the caregivers) about an individualized vaccination schedule, for example by adapting the timing of vaccination during infancy.

Taking into account ongoing research, local infectious disease patterns and socioeconomic risk factors, individual anthroposophic physicians are at times involved in the scientific discussion about specific vaccines and appropriate vaccine schedules. Anthroposophic Medicine is pro-science and continued scientific debate is more important than ever in today’s polarized vaccine environment.

Already in 2010, The European Council for Steiner Waldorf Education published a press release, implying a similar stance:

We wish to state unequivocally that opposition to immunization per se, or resistance to national strategies for childhood immunization in general, forms no part of our specific educational objectives. We believe that a matter such as whether or not to innoculate a child against communicable disease should be a matter of parental choice. Consequently, we believe that families provide the proper context for such decisions to be made on the basis of medical, social and ethical considerations, and upon the perceived balance of risks. Insofar as schools have any role to play in these matters, we believe it is in making available a range of balanced information both from the appropriate national agencies and qualified health professionals with expertise in the filed. Schools themselves are not, nor should they attempt to become, determiners of decisions regarding these matters.

Such statements sound about right. Why then am I not convinced?

Perhaps because there are hundreds of anthroposophic texts that seem to contradict this pro-vaccination stance (not least those from Rudolf Steiner himself). Today, anthroposophy enthusiasts are frequently rampant anti-vax; look at this quote, for instance:

… anthroposophic and con­ventional medicine have dramati­cally different viewpoints as to what causes common childhood illnesses. Conventional medicine views child­hood illnesses for which vaccines have been developed as a physical disease, inherently bad, to be pre­vented. Their main goal, therefore, is protection against contracting the disease making one free of illness. In contrast, these childhood illnesses are viewed by anthroposophic medi­cine as a necessary instrument in dealing with karma and, as discussed by Husemann, and Wolff, 6 the incar­nation of the child. During childhood illnesses, anthroposophic medical practitioners administer medical remedies to assist the child in deal­ing with the illness not only as a dis­ease affecting their physical body in the physical plane, but also for soul ­spiritual development, thereby pro­moting healing. In contrast, allopathic medicaments are aimed at suppression of symptoms and not necessarily the promotion of healing.

In Manifestations of Karma, Rudolf Steiner states that humans may be able to influence their karma and remove the manifestation of cer­tain conditions, i.e., disease, but they may not be liberated from the karmic effect which attempted to produce them. Says Steiner, “…if the karmic reparation is escaped in one direc­tion, it will have to be sought in another … the souls in question would then be forced to seek another way for karmic compensation either in this or in another incarnation.” 7

In his lecture, Karma of Higher Beings 8, Steiner poses the question, “If someone seeks an opportunity of being infected in an epidemic, this is the result of the necessary reaction against an earlier karmic cause. Have we the right now to take hy­gienic or other measures?” The an­swer to this question must be decided by each person and may vary. For example, some may accept the risk of disease but not of vaccine side effects, while others may accept the risk associated with vaccination but not with the disease.

Anthroposophic medicine teaches that to prevent a disease in the physical body only postpones what will then be produced in an­other incarnation. Thus, when health measures are undertaken to eliminate the susceptibility to a disease, only the external nature of the illness is eliminated. To deal with the karmic activity from within, Anthroposphy states that spiritual education is re­quired. This does not mean that one should automatically be opposed to vaccination. Steiner indicates that “Vaccination will not be harmful if, subsequent to vaccination, a person receives a spiritual education.”

Or consider this little statistic from the US:

Waldorf schools are the leading Nonmedical Exemption [of vaccinations] schools in various states, such as:

  • Waldorf School of Mendocino County (California) – 79.1%
  • Tucson Waldorf Schools (Arizona) – 69.6%
  • Cedar Springs Waldorf School (California) – 64.7%
  • Waldorf School of San Diego (California) – 63.6%
  • Orchard Valley Waldorf School (Vermont) – 59.4%
  • Whidbey Island Waldorf School (Washington) – 54.9%
  • Lake Champlain Waldorf School (Vermont) – 49.6%
  • Austin Waldorf School (Texas) – 48%

Or what about this quote?

Q: I am a mother who does not immunize my children.  I feel as though I have to keep this a secret.  I recently had to take my son to the ER for a tetanus shot when he got a fish hook in his foot, and I was so worried about the doctor asking if his shots were current.  His grandmother also does not understand.  What do you suggest?

A: You didn’t give your reasons for not vaccinating your children.  Perhaps you feel intuitively that vaccinations just aren’t good for children in the long run, but you can’t explain why.  If that’s the case, I think your intuition is correct, but in today’s contentious world it is best to understand the reasons for our decisions and actions.

There are many good reasons today for not vaccinating children in the United States  I recommend you consult the book, The Vaccination Dilemma edited by Christine Murphy, published by SteinerBooks.

So, where is the evidence that anthroposophy-enthusiasts discourage vaccinations?

It turns out, there is plenty of it! In 2011, I summarised some of it in a review concluding that numerous reports from different countries about measles outbreaks centered around Steiner schools seem nevertheless to imply that a problem does exist. In the interest of public health, we should address it.

All this begs a few questions:

  • Are anthroposophy-enthusiasts and their professional organisations generally for or against vaccinations?
  • Are the statements above honest or mere distractions from the truth?
  • Why are these professional organisations not going after their members who fail to conform with their published stance on vaccination?

I suspect I know the answers.

What do you think?

There is much propaganda for homeopathic vaccinations or homeoprophylaxis (as homeopaths like to call it, in order to give it a veneer of respectability), and on this blog we have discussed it repeatedly. The concept is unproven and dangerous. Yet it is being promoted relentlessly. Currently, I get > 12 million websites when I google ‘homeopathic vaccination’, and there are hundreds of dangerously misleading books and newspaper articles on the subject.

One study that I therefore always wanted to conduct was a trial comparing homeopathic ‘vaccines’ to placebo in terms of immunological response in human volunteers. Somehow, I never managed to get it going. Thus, I was delighted when, a few weeks ago, I received an article for peer-review (I hope I am allowed to disclose this fact here); it was almost exactly the trial I had dreamt of doing one day: the first ever study to test whether there is an antibody response to homeopathic vaccines. Now I am even more delighted to see that it has been published.

Its aim was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. The authors hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.

A placebo-controlled, double-blind RCT was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.

None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.

The authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

I think this is in every respect an excellent trial. It should once and for all get rid of what is arguably the homeopathy-cult’s most dangerous idea, namely that highly diluted homeopathic remedies can protect humans against infectious diseases. On this blog, I once called it ‘a danger for both the public and the individual who might believe in it … promoting HP is unethical, irresponsible and possibly even criminal.’

I said it ‘should’ get rid of this nonsense, but will it?

As homeopaths have, for now 200 years, showed themselves utterly impervious to evidence, I for one am not holding my breath. Yet, thanks to this excellent study, we can, when confronted with the notion of homeopathic vaccinations, henceforth point out that it is not just totally implausible but that, in addition, it has also been experimentally shown to be false.

My thanks to the Canadian investigators!

Oscillococcinum is by now well-known to readers of this blog, I am sure (see for instance here, here and here). It seems an important topic, not least because the infamous duck-placebo is the world’s best-selling homeopathic remedy. Just how popular it is was recently shown in a survey by the formidable ‘Office for Science and Society’ of the McGill University in Canada.

The researchers surveyed the five biggest pharmacy chains in Quebec: Jean-Coutu, Familiprix, Uniprix, Proxim, and Pharmaprix. For each chain, a sample of 30 pharmacies was chosen by a random number generator.

The calls started with the following script: “I would like to know if you carry a certain homeopathic remedy. It’s called Oscillococcinum, it’s a homeopathic remedy against the flu made by Boiron.” If they did not have it, the investigator asked if this was something they normally carried. He spoke to either a floor clerk or a member of the pharmacy staff behind the counter, depending on who knew the answer.

Out of the 150 pharmacies on the island of Montreal that were called for this investigation, 66% of them reported carrying Oscillococcinum (30% did not, while 4% could not be reached, often because the listed pharmacy had closed). Some chains were more likely to sell the product, with Jean-Coutu and Pharmaprix being the most likely (80% of their stores had it) and Proxim being the least likely (50% of their stores carried it).

The McGill researcher stated that the fact that two-thirds of Montreal-based pharmacies will sell us a pseudo-treatment for the flu that targets adults, children and infants alike is hard to square with the Quebec Order of Pharmacists’ mission statement. They describe said mission as “ensuring the protection of the public”, but how is the public protected when pharmacies are selling them placebo pills? The harm is partly financial: 30 doses of these worthless globules retail for CAD 36. It is also in the false sense of security parents will gain and the delay in proper treatment if needed. And, ultimately, it is in the legitimization of a pseudoscience the founding principle of which is that the more you add water to something (like alcohol), the more powerful it becomes.

I can only full-heartedly agree. One might even add a few more things, for instance that there are other dangers as well:

  1. If pharmacists put commercial gain before medical ethics, we might find it hard to trust this profession.
  2. If people take Oscillococcinum and their condition subsequently disappears (because of the self-limiting nature of the disease), they might believe that homeopathy is effective and consequently use it for much more serious conditions – with grave consequences, I hasten to add.
  3. If consumers thus start trusting homeopaths, they might also fall for some of their abominable health advice, e. g. that about not vaccinating their children.
  4. If a sufficiently large percentage of people believe in the magic of shaken water, our rationality will be undermined and we will encounter phenomena like Brexit or fascists as presidents (sorry, I has to get that off my chest).

Naturopathy is an eclectic system of health care that uses elements of alternative and conventional medicine to support and enhance self-healing processes. Naturopaths employ treatments based on therapeutic options that are thought of as natural, e. g. naturally occurring substances such as herbs, as well as water, exercise, diet, fresh air, pressure, heat and cold – but occasionally also acupuncture, homeopathy and manual therapies.

Naturopathy is steeped in the obsolete concept of vitalism which is the belief that living organisms are fundamentally different from non-living entities because they contain some non-physical element or are governed by different principles than are inanimate things. Naturopaths claim that they are guided by a unique set of principles that recognize the body’s innate healing capacity, emphasize disease prevention, and encourage individual responsibility to obtain optimal health. They also state that naturopathic physicians (NDs) are trained as primary care physicians in 4-year, accredited doctoral-level naturopathic medical schools.

However, applied to English-speaking countries (in Germany, a doctor of naturopathy is a physician who has a conventional medical degree), such opinions seem little more than wishful thinking. It has been reported that New Brunswick judge ruled this week that Canadian naturopaths — pseudoscience purveyors who promote a variety of “alternative medicines” like homeopathy, herbs, detoxes, and acupuncture — cannot legally call themselves “medically trained.”

The lawsuit was filed because actual physicians were frustrated that fake doctors were using terms like “medical practitioner” and saying they worked at a “family practice.” This conveyed the false idea that naturopaths were qualified at the same level as real doctors.

The argument from naturopaths was that they weren’t misleading anyone. “There’s not even the slightest hint of evidence that anyone has been misled — or worse, harmed,” [attorney Nathalie Godbout] said. “This mythical patient that has to be protected by naturopathic doctors — I haven’t met them yet.”

However, Justice Hugh McLellan wasn’t buying it. He said the justification for naturopaths using terms such as “doctor” and “family physician” are based on the assumption that “people are attuned to the meaning of words like “naturopathy.” Many patients might read a website or a Facebook ad out of context, he said, and fail to pick up on the difference between “a doctor listing his or her qualifications as ‘Dr. So-and-So, B.Sc., MD,’ as opposed to the listing that might include ‘B.Sc., ND [naturopathic practitioner].’”

“I see a risk here,” McLellan said, “that the words … could, in fact, imply or be designed to lead the public to believe these various naturopaths are entitled to practise medicine.”

Britt Marie Hermes, a former naturopath who now warns people about the shortcomings of the profession, said she was thrilled with the judge’s ruling: “This is a very encouraging step in the right direction toward ensuring public safety. Naturopaths are not doctors. The onus should not be on patients to vet the credentials and competency of someone holding themselves out to be a medically trained physician. Now, patients will have an easier time separating truly medically qualified physicians from naturopathic practitioners. Bravo New Brunswick!”

In view of the many horror-stories that emerge about naturopathy, I am inclined to agree with Britt:

In the context of healthcare the title ‘doctor’ or ‘physician’ must be reserved to those who have a conventional medical degree. Anything else means misleading the public to an unacceptable degree, in my view.

 

Some homeopaths claim that there is anecdotal support for the use of the homeopathic medicine Arsenicum album in preventing post-vaccination fever. As far as I know, the claim has not been tested in clinical trials. This study was aimed at evaluating the efficacy of this approach in preventing febrile episodes following vaccination.

In the community medicine out-patient of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, a double-blind, randomized, placebo-controlled trial was conducted on 120 children. All of them presented for the 2nd and 3rd dose of DPT-HepB-Polio vaccination and reported febrile episodes following the 1st dose. They were treated with Arsenicum album 30cH 6 doses or placebo (indistinguishable from verum), thrice daily for two subsequent days. Parents were advised to report any event of febrile attacks within 48h of vaccination.

The groups were comparable at baseline. Children reporting fever after the 2nd dose was 29.8% and 30.4% respectively for the homeopathy group and control group respectively [Relative Risk (RR)=1.008] with no significant difference (P=0.951) between groups. After the 3rd dose, children reporting fever were 31.5% and 28.3% respectively for the homeopathy group and control group respectively (RR=0.956) with no significant difference (P=0.719) between groups.

The authors concluded that empirically selected Arsenicum album 30cH could not produce differentiable effect from placebo in preventing febrile episodes following DPT-HepB-Polio vaccination.

I can hear it now, the chorus of homeopaths:

  • this is part of a conspiracy against homeopathy,
  • the authors of this study display an anti-homeopathy bias,
  • this study did not closely follow the principles of homeopathy,
  • it lacked the input by experience homeopaths,
  • no homeopath worth his money would use Arsenicum album 30cH for this purpose,
  • no homeopath in his right mind would employ 6 doses thrice daily for two subsequent days,
  • etc., etc.

Well guys, I have to disappoint you: the authors of this paper have the following affiliations:

  • Dept. of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
  • Dept. of Community Medicine, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
  • Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
  • National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India
  • Central Council of Homoeopathy, Vill, Champsara

So, perhaps it’s true: highly diluted homeopathic remedies are pure placebos.

 

On this blog, I have ad nauseam discussed the fact that many SCAM-practitioners are advising their patients against vaccinations, e. g.:

The reason why I mention this subject yet again is the alarming news reported in numerous places (for instance in this article) that measles outbreaks are now being reported from most parts of the world.

The number of cases in Europe is at a record high of more than 41,000, the World Health Organization (WHO) warned. Halfway through the year, 2018 is already the worst year on record for measles in Europe in a decade. So far, at least 37 patients have died of the infection in 2018.

“Following the decade’s lowest number of cases in 2016, we are seeing a dramatic increase in infections and extended outbreaks,” Dr. Zsuzsanna Jakab, WHO Regional Director for Europe, said in a statement. “Seven countries in the region have seen over 1,000 infections in children and adults this year (France, Georgia, Greece, Italy, the Russian Federation, Serbia and Ukraine).”

In the U.S., where measles were thought to be eradicated, the Centers for Disease Control and Prevention has reported 107 measles cases as of the middle of July this year. “This partial setback demonstrates that every person who is not immune remains vulnerable no matter where they live, and every country must keep pushing to increase coverage and close immunity gaps,” WHO’s Dr. Nedret Emiroglu said.  95 percent of the population must have received at least two doses of measles vaccine to achive herd immunity and prevent outbreaks. Some parts of Europe have reached that target, while others are even below 70 percent.

And why are many parts below the 95% threshold?

Ask your local SCAM-provider, I suggest.

 

In one of his many comments, our friend Iqbal just linked to an article that unquestionably is interesting. Here is its abstract (the link also provides the full paper):

Objective: The objective was to assess the usefulness of homoeopathic genus epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic outbreak in the state of Kerala, India.

Materials and Methods: A cluster- randomised, double- blind, placebo -controlled trial was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in August-September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo = 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82 clusters; placebo = 76 clusters) . Healthy participants (absence of fever and arthralgia) were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly follow-up was done for 35 days. Infection rate in the study groups was analysed and compared by use of cluster analysis.

Results: The findings showed that 2525 out of 19750 persons of Bryonia alba 30 C group suffered from chikungunya, compared to 2919 out of 18479 in placebo group. Cluster analysis showed significant difference between the two groups [rate ratio = 0.76 (95% CI 0.14 – 5.57), P value = 0.03]. The result reflects a 19.76% relative risk reduction by Bryonia alba 30C as compared to placebo.

Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in decreasing the incidence of chikungunya in Kerala. The efficacy of genus epidemicus needs to be replicated in different epidemic settings.

________________________________________________________________________________

I have often said the notion that homeopathy might prevent epidemics is purely based on observational data. Here I stand corrected. This is an RCT! What is more, it suggests that homeopathy might be effective. As this is an important claim, let me quickly post just 10 comments on this study. I will try to make this short (I only looked at it briefly), hoping that others complete my criticism where I missed important issues:

  1. The paper was published in THE INDIAN JOURNAL OF RESEARCH IN HOMEOPATHY. This is not a publication that could be called a top journal. If this study really shows something as revolutionarily new as its conclusions imply, one must wonder why it was published in an obscure and inaccessible journal.
  2. Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.
  3. The abstract states that the trial was aimed at assessing the usefulness of Bryonia C30, while the paper itself states that it assessed its efficacy. The two are not the same, I think.
  4. The trial was conducted in 2007 and published only 7 years later; why the delay?
  5. The criteria for the main outcome measure were less than clear and had plenty of room for interpretation (“Any participant who suffered from fever and arthralgia (characteristic symptoms of chikungunya) during the follow-up period was considered as a case of chikungunya”).
  6. I fail to follow the logic of the sample size calculation provided by the authors and therefore believe that the trial was woefully underpowered.
  7. As a cluster RCT, its unit of assessment is the cluster. Yet the significant results seem to have been obtained by using single patients as the unit of assessment (“At the end of follow-ups it was observed that 12.78% (2525 out of 19750) healthy individuals, administered with Bryonia alba 30 C, were presented diagnosed as probable case of chikungunya, whereas it was 15.79% (2919 out of 18749) in the placebo group”).
  8. The p-value was set at 0.05. As we have often explained, this is far too low considering that the verum was a C30 dilution with zero prior probability.
  9. Nine clusters were not included in the analysis because of ‘non-compliance’. I doubt whether this was the correct way of dealing with this issue and think that an intention to treat analysis would have been better.
  10. This RCT was published 4 years ago. If true, its findings are nothing short of a sensation. Therefore, one would have expected that, by now, we would see several independent replications. The fact that this is not the case might mean that such RCTs were done but failed to confirm the findings above.

As I said, I would welcome others to have a look and tell us what they think about this potentially important study.

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