The History of Homeprophylaxis and review of the evidence to support it’s efficacy. The Medical Research Council shows conventional vaccination is effective in 61%89% of cases.1 Whilst NHS guidelines state that side effects from immunisations are rare, concerned parents are starting to question the effectiveness and safety of the UK immunisation policy.2 Some professional homeopaths offer an alternative to conventional vaccination in the form of homeoprophylaxis, where homeopathic remedies are prescribed to prevent infectious diseases. This article aims to inform homeopaths by investigating the role that homeoprophylaxis has to offer in disease prevention. The origins of homeoprophylaxis can be traced back to Hahnemann’s time when it was first used as a preventive for scarlet fever. Genus epidemicus remedies were exclusively used until the invention of nosodes, which are now more commonly prescribed. It was during this period that homeopaths first became polarised about the use of homeoprophylaxis, and unfortunately this state still exists. There is no standard programme in terms of a potency and dosage strategy, which adds to the negative feelings surrounding this practice from some professional homeopaths. There are a number of studies that highlight the effectiveness of homeopathic remedies for disease prevention, which indicates that it may be a useful measure. Homeopaths may be unaware of this research and until this addressed, alongside the implementation of a standardised prescribing technique, it is doubtful whether all members of the homeopathic community will embrace it. Introduction According to the National Health Immunisation Schedule3 a four-year-old child will be exposed to 32 viruses through vaccination. Naturally a child’s immune system would be unlikely to encounter this many infections on the same day. There is growing concern regarding side effects that occur following vaccination which include 1 convulsions, neurological complications, arthritis, temporary coma, asthma and auto immune diseases.4 Lankinen et al.5 highlight an urgent need to improve vaccine safety systems, as only six people are employed in this field to monitor 17 countries. The lack of structure for reporting side effects following vaccination may mean that the adverse symptoms logged are only the tip of the iceberg. There is no doubt that vaccinations are increasing: by comparing the 1985 and 2010 UK immunisation schedule four new diseases (hib, meningitis, mumps and rubella) have been added, resulting in eight additional vaccinations.6 The World Health Organisation which is responsible for setting world wide vaccination policy, do not recommend immunising against mumps or rubella, yet in the UK this is standard procedure. These are mild infections that provide children with lifelong immunity when caught. Although it is outside the scope of this article to investigate the potential side effects and efficacy of vaccinations, it is an important discussion and helps to set the scene as to why patients may look to alternative approaches for disease prevention. This article will investigate the role of homeoprophylaxis in disease prevention, and explore whether it is a viable alternative to immunisation. It is important to understand the origins of this approach, and to be aware of where it fits with homeopathic philosophy. . Genus Epidemicus - Hahnemann According to Handley 7 Hahnemann had considered using vaccination for disease prevention as it appeared to mirror his philosophy of curing “like with like”. However he rejected it due its toxic nature and the risks involved of introducing disease into the human body. It was Hahnemann who first discovered that remedies could be used to prevent disease. During the 1801 epidemics of scarlet fever in Germany, Hahnemann treated victims of the disease with the remedy Belladonna achieving impressive results. Developing his thoughts in this area, led him to believe that a remedy capable of curing an infection so quickly, must be able to prevent it. Hahnemann was treating a family who had all contracted scarlet fever with the exception of the eldest daughter, who had been taking Belladonna to assist with joint problems. This uncovered the 2 prophylactic nature of Belladonna, and Hahnemann began prescribing this remedy as a preventative measure for scarlet fever. Hahnemann eventually declared that “this preventive remedy never failed”.8 Hufeland, a colleague of Hahnemann, also believed in the prophylactic power of Belladonna for scarlet fever. His in depth analysis of Belladonna led the Prussian government to make its use obligatory during a scarlet fever epidemic in 1838.9 This method of using homeoprophylaxis is known as genus epidemicus prescribing; a term first used by Hahnemann. Hahnemann believed that the remedy must be capable of curing the disease it was trying to prevent, in order for it to be effective as a prophylactic. He thought all disease epidemics had individualising aspects that needed to be taken into account when prescribing genus epidemicus. This was demonstrated when he prescribed both Belladonna and Aconite for two different epidemics of scarlet fever. Chase, another homeopath contemporary to Hahnemann, reported Belladonna was not useful in preventing scarlet fever.10 This confirms Hahnemann’s observation regarding the importance of studying individual epidemics. It could be considered that Belladonna did not act prophylactically for the epidemic Chase was treating because another remedy was indicated. Birch and Winston both support Hahnemann’s theory regarding the importance of individualisation during epidemics.11 Winston highlights a polio epidemic when Lathyrus Sativa was initially the indicated preventive remedy for the outbreak, which later changed to Gelsemium. Kent Kent agreed with Hahnemann and believed that remedies must be able to cure a disease in order to prevent it, although Kent also thought that a lesser degree of similitude was required for prevention than for cure. Kent only used homeoprophylaxis when diseases were a real threat and not routinely against every illness, believing that homeopathy was about individualisation and not generalisation.12 This statement challenges Hahnemann’s approach of prescribing the same remedy to multiple individuals. However the work of both Hahnemann and Boenninghausen proves this methodology works, as they were successful in preventing disease using genus epidemicus remedies. Grimmer’s findings also 3 showed that a single epidemic remedy gave the highest level of protection for disease prevention.13 Nosodes -Hering Hering potentised the saliva of a rabid dog and used Lyssinum as a cure and preventative for rabies.14 The invention of nosodes was a different rationale for disease prevention and may be one of the reasons why Hahnemann doubted the efficacy of Lyssinum, calling its success “delusional”. He believed that it was the rare occurrence of rabies in dogs that provided the protection not the nosode. Despite this criticism Hering continued his work, believing he had discovered a way of providing vaccinations that were not toxic. Kent strongly challenged Hering by criticising the use of nosodes in homeopathy, considering it “unsound practice”.15 It is a shame that a more detailed argument was not put forward by Kent as it is difficult to understand his reasoning. Perhaps Kent thought nosodes bore no relation to genus epidemicus remedies and therefore were not considered homeopathic. However if the symptom picture of Lyssinum is studied, the principle of genus epidemicus prescribing is still very much apparent. Hahnemann’s principle was that the remedy must be able to cure the disease it was trying to prevent. Many of the symptoms that came through in the proving of Lyssinum are identical to the disease rabies, illustrating that nosodes may have more similarity to genus epidemicus remedies than first thought. Some homeopaths advise caution when prescribing nosodes as they are potentially dangerous noxious materials.16 However this fear may be unfounded: mechanisms are in place to ensure that any harmful substances contained within the remedies are not activated. Although potentisation renders remedies chemically harmless, homeopaths who practice homeoprophylaxis always prescribe nosodes in potencies higher than 30c, ensuring that any original molecules are extinguished. It is believed that nosodes work by delivering an energetic form of the disease to the patient, which addresses their underlying susceptibility to that particular infection, providing protection without any of the toxic side effects that many believe are associated with vaccination. 4 Boenninghausen Boenninghausen was a student of Hahnemann and together they treated and prevented a major cholera epidemic using Camphor, Cuprum Metallicum and Veratrum Album. Although Boenninghausen acknowledged the prophylactic power of remedies, he believed that individual susceptibility was more likely to be the reason that patients did not contract cholera.17 Boenninghausen continued to add to Hering’s work on nosodes and discovered that the remedy Variolinum was similar to smallpox, and could be used as a good preventative against the disease. Burnett Burnett used Variolinum as a preventative for smallpox over a period of 9 years, and testified that he had not seen a single patient contract the disease. Despite this apparent success he remained cautious, and was always looking for further proof of the effectiveness of homeoprophylaxis. 18 Burnett continued to add to Hering’s work and discovered that Bacillinum could be used as a prophylactic remedy against tuberculosis. By studying the symptoms of the disease and comparing them to the remedy picture of Bacillinum, it highlights how similar they are.19 After reviewing the history of homeoprophylaxis, the author’s support of using nosodes for disease prevention has shifted to a more positive plane. Although Hahnemann never prescribed nosodes, it should be remembered they had not been fully developed during his life time. Now the remedy pictures of nosodes have been studied, a firm conclusion can be drawn that they do have a similar remedy picture of the disease they are trying to prevent, and therefore adhere to Hahnemann’s principle. Discussion Although it was Hahnemann who discovered that homeopathic remedies were not only capable of curing diseases, but could also be used to prevent them, he also supported and praised Jenner’s work on vaccination. In the Organon, he wrote that “smallpox had not spread with such widespread virulence since the use of Jenner’s 5 vaccination”.20 With these divided views it is difficult to report on Hahnemann’s informed opinion of vaccination as this practice was still very immature during his lifetime. He lacked sufficient experience to be able to formulate a judgment either for or against it. However Hahnemann did hold stringent views on the importance of a healthy diet and applying minimum intervention, so it is possible to speculate that he would not have become a keen advocate of vaccination. Different approaches to disease prevention There are currently three options available for preventing infectious diseases: vaccination, homeoprophylaxis or taking no measures. Kent reminds us that “prevention is better than cure”; therefore selecting an approach for disease prevention is important, whether it be via vaccination or homeoprophylaxis.21 In some cases the risk may be too great to take no precautions. For example, typhoid fever has a mortality rate of between 12 – 30% so preventative measures may be wise, if exposure to the disease should occur.22 Remedies can either be prescribed to prevent disease if exposure or epidemics are encountered, or routinely given when no contact has occurred as a preventative measure. This is one of the most significant discussions between homeopaths, and agreement cannot be reached on which approach affords the best protection. Prescribing when a patient had been exposed to a disease or during an epidemic was the method first demonstrated by Hahnemann. This technique was also favoured by Hering, Boenninghausen, Burnett and Kent, believing that not all individuals need protecting from all diseases. This fits in with the homeopathic philosophy of individual susceptibility, first discussed by Hahnemann. This method of prescribing also highlights issues that may arise if remedies are given when exposure has not taken place. For example, if a patient’s vital force is weak, or the patient is highly susceptible to that particular disease, then using a nosode when it is not indicated may leave a lasting effect on the vital force. 6 Discussion There is no standard homeopathic regime to offer patients when it comes to an alternative to conventional vaccination. Initially the author considered that routinely preventing against all infectious diseases was sensible, whether homeopathically or via vaccination, but after investigation this view has now changed. For milder childhood diseases such as measles, mumps and rubella, it may be preferable to be vaccinated by Mother Nature and catch the disease, which will provide lifelong immunity. Vaccinating against these diseases, whether conventionally or homeopathically, may result in individuals catching the disease at a later age when complications can be more serious. However prevention may be preferable to cure for more life-threatening diseases such as meningitis or typhoid. Prophylactic medication should be considered in these cases if exposure or an epidemic has occurred. Routinely using homeoprophylaxis may well be damaging to the long term health of the patient, as it may be unwise to use remedies when the patient’s susceptibility clearly does not indicate their use. However, Golden believes that an improvement in the general health of patients occurs as a result of routinely taking homeoprophylaxis. These factors should be considered when prescribing remedies when they are not indicated. Another issue that arises from routinely prescribing remedies is that it may contradict one of the main principles of homeopathy; minimum intervention at all times. A good example of this is in general practice when homeopathic remedies are not always prescribed if a patient is coping adequately with a disease process. With this in mind only diseases that are a real danger to the patient should be prescribed for and therefore prevented. The most sensible approach is to evaluate how virulent the disease is and assess how likely the individual is to contract it. For example, The National Health Immunisation Schedule advises vaccinating a two-month-old baby against tetanus. In order for tetanus to thrive it needs anaerobic conditions, so a sensible measure may be to wash deep penetrating cuts with 3% hydrogen peroxide, which encourages oxygen to the area. This solution appears a more sensible approach than vaccinating or taking a homeopathic prophylactic when there is very little 7 likelihood of contracting the disease. A two-month-old month old baby cannot move, will not be in contact with soil, and therefore not in danger from deep cuts to the skin. When considering whether disease prevention is necessary, another approach could be to research the statistics for the infection to evaluate how common it is. According to the Health Protection Agency in the three-year period 2005-2008 there were 17 instances of tetanus in the UK. This small number of tetanus infections indicates that disease prevention may be an unnecessary measure as tetanus is so rare. Eight of these cases had previously been vaccinated (47%), highlighting that disease prevention does not always work.23 Another example is polio; since 2002 The World Health Organisation has declared Europe a polio free zone, therefore taking preventative measures against this disease may no longer necessary. The vaccination or homeopathic prophylactic could be considered if travelling to an area outside of Europe when polio is present. If the actual risk of contracting every infectious disease was evaluated in this way beforehand, then patients may be able to avoid taking so many unnecessary precautions. What is the evidence base? The earliest recorded trials of homeoprophylaxis were in the 1800s; 2,027 patients were prescribed Belladonna as a prophylactic against scarlet fever resulting in a 96.1% efficacy rate.24 Dudgeon reported that Belladonna was 86% effective in preventing scarlet fever in a study involving 1,646 children. Although these studies involved a significant sample size, there are no figures available to compare infection rates in people who had not taken Belladonna.25 Eaton used Variolinum 30c as a preventative for smallpox on 2,806 patients, and proved an efficacy rate of 99.5%.26 Taylor-Smith and Edin used Lathyrus as a prophylactic against polio in 82 participants, and it proved to be 100% effective. In both studies significant numbers of patients had been exposed to the disease.27 8 Testing on Animals Day researched the effectiveness of kennel cough nosode in 214 dogs. Recent admissions were contracting the disease at a rate of 92% but after treatment using the nosode only 1.9% of dogs caught kennel cough. Day also compared the success of the nosode to conventional vaccination and concluded it was more effective.28 However a more recent study found the opposite. The nosode of francisella tularensis, which is a pathogen fatal to small mammals, was prescribed to a number of mice. The nosode proved 22% effective whilst protection from conventional vaccination offered 100% efficacy.29 A new study found that the nosode Coli 30c was six times more effective than a placebo in preventing escherichia coli diarrhoea in neonatal piglets. This is an extremely robust study which fits the parameters set by conventional medicine for clinical trials.30 Clinical Trials In 1987 Fox concluded that Pertussin 30c as a prophylactic for whooping cough was 82% effective.31 This figure compares favourably to conventional vaccination; The Medical Research Council found that the effectiveness of whooping cough immunisation ranged from 61% to 89%. Interestingly all of the large scale studies for homeoprophylaxis have been performed in developing countries such as Brazil and Cuba where finance may prohibit the use of expensive vaccines. Castro and Nogueira used Meningococcinum 10c nosode as a preventative against meningitis in 18,640 people in Brazil. The results showed there were lower recorded instances of meningitis in the homeoprophylaxis group 99.98%; compared to 99.50% in the placebo group. However this was not a robust study: the trail was designed around using 30c potency, but due an error at the pharmacy the remedy was dispensed as 10c.32 A recommendation was made to repeat the trial with 30c potency, which was taken up by Mroninski et al. who also concluded that the results were statistically significant. The trial showed an efficacy rate 99.99% for homeoprophylaxis compared to 99.94% in the placebo group. This was a large scale trial which involved 65,826 participants.33 9 Marino conducted the only study using genus epidemicus instead of nosodes. The remedy choice was made after full repertorisation of 20 people suffering with dengue fever. One dose of the remedy Eupatorium Perfolatum 30c was dispensed to 40% of the population (1,959 individuals), from five of the most affected neighbourhoods in Brazil. As a result incidents decreased by 81.5% in one neighbourhood, which was highly significant compared to other neighbourhoods who had not received the homeoprophylaxis. These impressive results led Marino to design another trial with a genus epidemicus combination remedy, Eupatorium Perfoliatum, Phosphorus and Crotalus Horridus. However there were serious flaws with the control and reporting mechanisms of this trial: 20,000 doses were administered but only 524 participants could be located for follow-up results, and 140 of them had contracted dengue fever. Due to the low numbers of participants available afterwards an efficacy rate of 73.4% was recorded.34 Golden is an ardent supporter of routinely prescribing remedies for disease prevention and has performed a 15-year study into homeoprophylaxis. The study involved 2,342 survey responses but only 1,159 separate children. Recorded results show an efficacy rate of 90.4% for homeoprophylaxis. However 285 of the children (24.59%) had been previously vaccinated before embarking on Golden’s programme. Therefore it remains unknown whether the vaccination or the homeopathic remedy was successful in preventing the disease in these children.35 The Finlay Institute in Cuba is a scientific organisation dedicated to vaccine research and production. With limited funds, they needed to control an outbreak of leptospirosis that had the potential to affect the whole population of Cuba; conventional vaccine was ruled out on cost. 2.2 million participants were given the nosode of leptospirosis, which covered around 95% of the population at risk. The infection rates reduced dramatically below previously recorded trends. This is an interesting study due to the large size of the sample group and the results obtained. It will be interesting to see how the homeopathic community reacts to this new research.36 10 Antibody Production Another divide within the homeopathic community is whether nosodes involve the production of antibodies to provide future immunity, and the evidence base is equally divided. When Smits tested the level of antibodies to diphtheria, polio and tetanus (DPT) in ten children before, and one month after giving homeopathic preparations of DTP 30c and 200c, he found no rise in antibody levels.37 Whilst Patterson and Boyd studied alterations of schick tests following administration of Alum Precipitated Toxoid (APT) 30c and Diphtherinum 200c. and concluded that there was a significant positive correlation between homeopathic remedies and antibody production. Although 60.6% of patients acquired antibodies after the homeopathic remedies, the sample size was small, and included only 44 participants. Further research needs to be undertaken before the association between remedies and antibody production can be fully understood. It would be interesting to compare the results of this trial with a similar trial testing antibody production after conventional DPT vaccine.38 Discussion If homeopathic remedies do not increase antibody levels, then the only way to measure the effectiveness of homeoprophylaxis is through clinical trials. However trying to prove the efficacy of homeoprophylaxis within the normal parameters that conventional medicine is tested is very difficult. Firstly, in order to perform a large scale study funding would be required. Most clinical trials are funded by pharmaceutical companies who stand to make considerable profits once the medication has been tested. There is very little cost involved making or selling homeopathic remedies, so there is no financial incentive for companies to prove their efficacy. Secondly, ethics committees may prevent such studies from being conducted as they may not allow children to be deprived of approved conventional vaccinations. With these factors in mind, consideration should be given to the most suitable method for testing whether homeoprophylaxis works. Instead of comparing the effectiveness of homeoprophylaxis to a placebo it is more important to see how it works in relation to vaccination. This is because the vast majority of the population decides to be 11 vaccinated rather than taking no precautions at all. A case in point is Fox, who showed Pertussin having an efficacy rate 82%. Based on this result Pertussin may appear a risky means of disease prevention, but when compared to the success rates of 61% - 89% for vaccination, it may become a more desirable option. The success of homeoprophylaxis for disease prevention cannot be disputed when analysing the results of trials performed in much earlier years. Efficacy rates are high; Bradford 96.1%, Dudgeon 86%, Eaton 99.5% and Taylor-Smith and Edin 100%. The robust methods now used to test medicine in clinical trials were not in place during this era, which may explain the high efficacy rates for homeoprophylaxis throughout this period. Proving the effectiveness of homeopathy for disease prevention today is difficult within the realms of double blind, randomised and placebo controlled trials that are designed to test conventional medicine. However one homeoprophylaxis trial does mange to fit into this difficult model, the latest piece of research by Camerlink et al. showing homeoprophylaxis to be 6 times more effective than a placebo in preventing diarrhoea in piglets. This is an impressive result given how difficult it is for homeopathy to conform to the parameters laid down for clinical trials The studies conducted for meningitis and leptospirosis show homeoprophylaxis as being an effective measure for disease prevention. Although the trials do not conform to the same standards applied to conventional medication they should not be discounted as these studies show that homeoprophylaxis was very effective. The National Health Service produces literature for patients stating that immunisations have eradicated infectious diseases, yet there is no reference to any clinical trials. This literature provides reassurance to patients that vaccinations work because the National Health Service is willing to stand by its claims. Unfortunately the same cannot be said for homeopathy. Patients want some form of guarantee that they will not contract an infectious disease after taking precautions, and the National Health Service appears to provide this. However, it is doubtful whether a local GP would be prepared to sign a disclaimer confirming the efficacy and safety of vaccinations if asked. 12 Homeopathy is currently experiencing unprecedented criticism, and it may be fear of further attacks that prevents homeopaths commenting on or prescribing homeoprophylaxis. The Faculty of Homeopathy advises that there is no reliable homeopathic substitute for vaccination, and relying on homeopathy may create a false sense of security since efficacy is not proven. The Society of Homeopaths direct members to neither recommend or advise against vaccinations. They prefer homeopaths to offer a balance of literature to the patient in order for them to make an informed choice. Golden publishes efficacy results and states that homeoprophylaxis is a viable alternative to vaccination. If homeoprophylaxis is ever to be taken seriously then homeopaths need to be more firm in their beliefs like Golden and The National Health Service. Conclusion Homeoprophylaxis has evolved from genus epidemicus remedies being prescribed only when exposure to the disease had occurred, into the indiscriminate use of nosodes when no threat has been encountered. If homeoprophylaxis is to be used in this way, then the only choice available is to prescribe nosodes. This is because the disease’s individual characteristics need to be studied to prescribe the genus epidemicus, and this can not be done in advance of the disease arriving. Nosodes are now more commonly used for disease prevention and although Kent labelled them as “isopathy”, they do follow Hahnemann’s philosophy of “like cures like”. The author believes that homeoprophylaxis should be used in the way Hahnemann intended; only when there is a real threat of infection. Greater education of patients regarding infectious diseases is needed in order to minimise the use of all medication, whether homeopathic or conventional. Patients frequently use methods of disease prevention when there is no real threat of infection. An example of this is most children in the UK are vaccinated against polio, when there is no real threat to health; Europe has been polio free since 2002. There are many different methodologies, potency and dosage choices that are practiced for homeoprophylaxis and there is no collective agreement amongst with regard to the best approach. Investigation showed that the trials performed in the earlier years illustrate much greater efficacy rates for homeoprophylaxis than the 13 recent trials analysed. Clinical trials had not been invented when the earlier studies were performed, and are now designed around testing conventional medication. The methodology of clinical trials makes it difficult to demonstrate the effectiveness of homeoprophylaxis, and could explain why the results are not as conclusive as they were in the past. It may be a more sensible approach to evaluate homeoprophylaxis effectiveness in practice as opposed to evaluating its efficacy in clinical trials designed for conventional medicine. It will be interesting to observe whether perception of homeoprophylaxis changes once the study, which showed the Leptosporosis nosode to be effective on 2.2 million participants is more widely published. Although Camerlink et al. showed homeoprophylaxis to be 6 times more effective than a placebo, it is more important to assess how homeoprophylaxis works in comparison to conventional vaccination. The importance of this was highlighted by comparing the 82% effectiveness of Pertussin to the 61%-89% success rates of conventional vaccinations. If taken with no comparisons then an 82% efficacy rate may be unacceptable, but once evaluated against vaccination it becomes more viable alternative for prevention against whooping cough. Until a true comparison of conventionally vaccinated and homeoprophylaxis patients is conducted, then the efficacy of homeopathic remedies for disease prevention cannot be confirmed or denied. However what cannot be ignored are the large scale studies that show a definite decline in disease after application of homeoprophylaxis. There also appears to be a general lack of education of patients surrounding infectious diseases. The first question that needs to be asked is whether protection is really necessary. If the patient had come into contact with an infectious disease, or was travelling to an area where there was a real threat of infection, then information regarding different methods of disease prevention should be discussed. This approach will result in improved education, and may mean that fewer vaccinations or homeopathic remedies are taken. The Society of Homeopaths advise members to offer a balance of literature regarding vaccinations in order for the public to make an informed decision. Patients may be unaware of the concerns regarding the safety and effectiveness of vaccinations, and 14 should be provided with enough information to be able to choose. Although there are a number of arguments that still have to be overcome before everyone will embrace homeoprophylaxis, professional homeopaths do have a responsibility to be aware of the studies highlighting the effectiveness of vaccinations and homeoprophylaxis, in order to conform to this directive. Ultimately any choice regarding disease prevention must rest with the patient, who has to live with any health consequences that may occur as a result of their decision. References 1 Medical Research Council. (1951) The Prevention of Whooping Cough by Vaccination. British Medical Journal. 1: p.1463-1471. 2 National Health Service Immunisation Information. 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