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Clinical research protocol to evaluate the effectiveness and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic - Virtual Health Library (VHL) Regional Portal

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  • School of Medicine University of Sao Paulo

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Abstract: In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic.
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CLINICAL RESEARCH PROTOCOL TO EVALUATE THE
EFFECTIVENESS AND SAFETY OF INDIVIDUALIZED
HOMEOPATHIC MEDICINE IN THE TREATMENT AND
PREVENTION OF THE COVID-19 EPIDEMIC
Researcher in charge: Prof. Dr. Marcus Zulian Teixeira
Scientific Coordinator of the Scientific Department of Homeopathy at
São Paulo Medical Association (Associação Paulista de Medicina)
SUPPORT:
São Paulo Homeopathic Association (APH)
Brazilian Homeopathic Medical Association (AMHB)
March 2020
Copyright © 2020 Marcus Zulian Teixeira (editor)
All rights reserved. No part of this work may be reproduced, by any means,
without the express permission of the editor.
English translation of the original Portuguese edition by Prof. Dr. Michael Frass.
ISBN: 978-65-86826-00-5.
Brazilian Book Chamber (CBL)
Indexing Data (Portuguese and English edition): VHL Regional Portal.
DOI: 10.13140/RG.2.2.27581.61925/1
Prof. Dr. Marcus Zulian Teixeira
Rua Teodoro Sampaio, 352/128 - CEP: 05406-000 - São Paulo/SP Brazil -
http://www.homeozulian.med.br
Lattes Curriculum - National Council for Scientific and Technological
Development (CNPQ)
ORCID
Publons - ResearcherID
ResearchGate
Virtual Health Library (VHL - Brazil)
Clinical research protocol to evaluate the effectiveness and safety of
individualized homeopathic medicine in the treatment and prevention of
the COVID-19 epidemic.
Abstract
In addition to the recognized application in chronic diseases, individualized
homeopathy can also act in a resolutive or complementary way in acute cases,
including epidemic diseases. However, to achieve this intent, it presents a
specific semiologic and therapeutic methodology that must be followed and
respected, with the risk of not presenting the desired efficacy and safety. In the
case of epidemic diseases, which due to the virulence of their agents causes a
common symptomatological picture in most susceptible individuals, the
individualized homeopathic medicine (homeopathic medicine of the epidemic
genius) should present similarity with the set of characteristic symptoms and
signs of the patients affected in the different stages of each epidemic outbreak.
Studies show the efficacy and safety of this prophylactic and/or therapeutic
practice in several epidemics of the past. Therefore, after the survey of possible
homeopathic drugs individualized from the epidemic genius of each epidemic,
its prophylactic and/or large-scale therapeutic application should be supported
by previous clinical trials that demonstrate its efficacy and safety, in line with the
ethical and bioethical aspects of research involving human beings. Fulfilling
these premises of good clinical practice, we developed the current protocol with
the objective of investigating, in a randomized, double-blind and placebo-
controlled clinical trial, the effectiveness and safety of possible individualized
homeopathic drugs of epidemic genius of COVID-19, in adjuvant and
complementary treatment of patients affected by the disease. If effectiveness
and safety are confirmed, and only in this condition, the medicine may be used
in a generalized and collective manner in the treatment and prevention of the
current epidemic.
Keywords: Homeopathy; Epidemics; Epidemic genius; Ethics in research;
Randomised controlled clinical trial; COVID-19.
SUMMARY
I. INTRODUCTION 1
II. LITERATURE REVISION
II.1. COVID-19 epidemic 4
II.2. Homeopathy
II.2.1. Introduction 6
II.2.2. Epistemological premises of the homeopathic model
II.2.2.1. Principle of therapeutic similarity 7
II.2.2.2. Homeopathic pathogenetic trial or experiment 9
II.2.2.3. Dynamized or potentized medicine (ultra-high dilutions) 10
II.2.2.4. Individualized medicine (therapeutic individualization) 12
II.2.3. Guidelines for homeopathic treatment in epidemic diseases
II.2.3.1. Samuel Hahnemann 14
II.2.3.2. James Tyler Kent 18
II.2.4. Evidence of the effectiveness of homeopathy in epidemic diseases 19
II.3. Study of the epidemic genius of the current COVID-19 pandemic 24
II.3.1. Homeopathic medicines of the epidemic genius for prevention or the
treatment of mild to moderate disease (COVID-19) 29
II.3.2. Homeopathic medicines of the epidemic genius for the treatment of
severe disease (COVID-19) 31
II.3.3. Homeopathic medicines of the epidemic genius for the treatment of
critical states (COVID-19) 32
II.4. Ethical and bioethical aspects of research in human beings 34
III. STUDY JUSTIFICATION 37
IV. STUDY OBJECTIVE 38
V. PATIENTS AND METHOD 39
V.1. Sample calculation 39
V.2. Inclusion and exclusion criteria 39
V.3. Study dynamics 39
V.3.1. Randomized, double-blind, placebo-controlled clinical trial 40
V.3.2. Preparation and delivery of medicine 41
V.3.3. Statistical analysis 41
V.3.4. Work plan 42
V.3.5. Budget 42
V.3.6. Work team 42
VI. REFERENCES 43
VII. ANNEXES
VII.1. Annex 1 - Informed Consent Form 52
VII.2. Annex 2 - Adverse Events Form 55
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
I. INTRODUCTION
Coronavirus is a family of viruses that can cause damage to animals and
humans. In humans, it can result in respiratory infections ranging from a cold to
severe acute respiratory syndromes. The new coronavirus (SARS-Cov-2 or
2019-nCoV) produces the disease classified as COVID-19, which started in the
city of Wuhan (China) in December 2019.
In the clinical management of cases of human infection by SARS-CoV-2, there
are still no effective therapeutic measures, and many details remain to be
clarified. However, it is known that the virus has high transmissibility and can
cause acute respiratory syndrome ranging from asymptomatic or mild cases
(around 80%) to very severe cases with respiratory failure (around 5% to 10%).
Its lethality varies, mainly, according to the age group and associated
comorbidities.
As there is currently no vaccine for COVID-19 prophylaxis, the best form of
prevention is to avoid exposure to coronavirus through hygienic-prophylactic
measures (constant hand washing, avoiding contact with infected people and
agglomerations, among others).
In view of this lack of specific treatment and / or vaccine that can be used to
control and / or prevent the current epidemic, respectively, the search for other
therapeutic and preventive approaches is necessary, in order to minimize the
harmful consequences of this pandemic outbreak that plagues humanity.
Therefore, homeopathy can be a complementary and adjuvant alternative to
existing hygienic-prophylactic measures and to the existing therapeutic arsenal,
and can be used as a measure to promote the health of the population,
provided that the safety and effectiveness of its proposals are scientifically
validated.
Medical specialty recognized by the Federal Council of Medicine (CFM) of
Brasil since 1980, homeopathy is taught to doctors in the form of post-
graduation lato sensu and, since 2004, medical residency. With established
scientific assumptions (principle of therapeutic similarity, homeopathic
pathogenetic experimentation and use of individualized and potentized
medicines) and broad and secular application, it presents a growing body of
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
evidence in the field of basic and clinical research (Teixeira, 2011a, 2018, 2019;
Cremesp, 2017a, 2017b, 2017c).
Using an integrative approach in the diagnosis and treatment of organic
disorders (mental, general and private), homeopathy can act preventively in
most of the acute or chronic diseases, ahead of the process of their installation.
To accomplish this goal, the homeopathic medicine must stimulate a systemic
and homeostatic reaction of the organism against the various susceptibilities
that predisposes to illness, being essential to select an individualized medicine
according to the totality of signs and symptoms characteristic of each sick
individual.
In addition to its recognized application in chronic diseases, individualized
homeopathy can also act in a resolutive or complementary manner in acute
cases, including epidemic diseases. However, to achieve this goal, it presents a
specific semiological and therapeutic methodology that must be followed and
respected, with the risk of not presenting the desired efficacy and safety.
In the case of epidemic diseases, which, due to the virulence of their agents,
causes a common symptom picture in most susceptible individuals, the
individualized homeopathic medicine (homeopathic medicine of the epidemic
genius) must show similarity with the set of signs and symptoms of patients
affected at different stages. or phases of each epidemic outbreak. Studies show
the effectiveness and safety of this prophylactic and / or therapeutic practice in
several past epidemics (Teixeira 2009a, 2010a, 2013a, 2014, 2015a, 2015b).
Therefore, after surveying the possible individualized homeopathic medicines of
the epidemic genius of each epidemic, their prophylactic and / or therapeutic
application on a large scale must be supported by previous clinical trials that
demonstrate their efficacy and safety (Dantas et al., 2008), in line with the
ethical and bioethical aspects of research involving human beings (Brasil,
2012).
Fulfilling these premises of good clinical practice, the current protocol aims to
investigate, in a randomized, double-blind, placebo-controlled clinical trial, the
gold standard of clinical epidemiology (Oliveira et al., 2015), the efficacy and
safety of possible individualized homeopathic medicines of the epidemic genius
of COVID-19, indicated for adjuvant and complementary treatment of patients
affected by the disease.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
If the hypothesis is confirmed, and only in this condition, the medicine can be
used in a generalized and collective way in the treatment and prevention of the
current epidemic (Brasil, 2012).
On the other hand, in order for us to execute this and other research protocols,
necessary for the scientific basis of the assumptions and proposals for
homeopathic treatment, an impartial posture on the part of doctors, researchers
and teachers is necessary, allowing rational and scientific space to propose,
discuss and apply its projects in research institutions and health services.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
II. LITERATURE REVISION
II.1. COVID-19 epidemic
Coronaviruses cause respiratory and intestinal infections in humans and
animals; being that the majority of coronavirus infections in humans are caused
by species of low pathogenicity, leading to the development of mild respiratory
symptoms; however, they can eventually cause serious infections in high-risk
groups, the elderly and children.
Prior to 2019, two highly pathogenic and animal-derived coronavirus species
(SARS-CoV and MERS-CoV) were responsible for outbreaks of severe acute
respiratory syndromes. In the current human infection with the new coronavirus
(SARS-Cov-2 or 2019-nCoV), the clinical spectrum is not completely described,
as well as its pattern of infectivity, transmissibility, morbidity and mortality, is not
known. There is still no vaccine or specific drugs available and, currently, the
treatment is basic and non-specific support (Brazil, 2020).
Analogously to what has been happening in dozens of other countries, in
several continents, the sustained spread from person to person (community) is
occurring in Brazil, transmitted through respiratory droplets of infected people,
similar to the way influenza and other respiratory pathogens spread.
Analogously to the SARS-CoV and MERS-CoV outbreaks of the past, health
professionals have represented a significant portion of the number of cases
infected by SARS-Cov-2, acting as possible vectors in the spread and
amplification of this epidemic.
The average incubation period for SARS-Cov-2 infection is 5-6 days, with an
interval that can reach up to 14 days. In turn, the average transmission period
for infected patients is seven days after the onset of symptoms; however,
infected and asymptomatic individuals can also transmit the virus (Brasil, 2020).
The clinical spectrum of coronavirus infection is very broad, ranging from a
simple cold to severe and fatal pneumonia. As we will see below, knowledge of
the signs and symptoms of each epidemic is indispensable for choosing the
respective individualized homeopathic medicine of the epidemic genius.
In general, the clinical signs and symptoms referred are mainly respiratory
(fever, cough and difficulty breathing). The evaluation of dozens of patients with
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
pneumonia and laboratory diagnosis of SARS-Cov-2 infection admitted to the
Wuhan Jin Yin-tan Hospital (Wuhan, China) points to a higher rate of
hospitalization in male patients over 50 years. The main symptoms observed
were fever, cough, shortness of breath, muscle pain, mental confusion,
headache, sore throat, rhinorrhea, chest pain, diarrhea, nausea and vomiting.
Imaging tests showed that most patients had bilateral pneumonia (Chen et al.,
2020).
According to a report by the joint WHO-China mission on COVID-19 (WHO,
2020) released in February/2020, based on tens of thousands of cases with
laboratory confirmation, typical signs and symptoms included fever, dry cough,
fatigue, production phlegm, shortness of breath, sore throat, headache,
myalgia, arthralgia, chills, nausea, vomiting, nasal congestion, diarrhea,
hemoptysis and conjunctival congestion.
That report showed that the majority of people infected with the SARS-Cov-2
virus developed mild illness and recovered. Around 80% of infected patients
had mild to moderate disease, including cases with and without pneumonia,
13.8% had severe disease and 6.1% reached critical and fatal states. Among
the individuals most at risk of developing severe cases were the elderly (over 60
years old) and those with chronic diseases, such as hypertension, diabetes,
cardiovascular diseases, chronic respiratory diseases and cancer. (WHO, 2020)
In this retrospective study, the gross mortality rate (CFR) was 3.8%, varying
with the location and intensity of transmission (ie 5.8% in Wuhan vs. 0.7% in
other areas in China) . The CFR was higher in the early stages of the outbreak,
halving after one month of the disease. (WHO, 2020)
As prevention and control measures, in view of the absence of a vaccine or
other treatment, the Ministry of Health (Brasil, 2020) recommends daily
preventive actions that can assist in the prophylaxis of the spread of respiratory
viruses in general, such as: frequent hygiene of hands with soap and water or
alcoholic preparation; avoid touching eyes, nose and mouth without proper
hand hygiene; avoid close contact with sick people; cover your mouth and nose
when coughing or sneezing; stay at home and avoid contact with people when
you are sick; clean and disinfect frequently touched objects and surfaces,
among others.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
It is worth mentioning that the economic and social impacts caused by COVID-
19 will be of great magnitude and directly proportional to the duration of the
epidemic, given that social isolation is the only preventive measure to control
the spread of the virus. Therefore, proposals that have the potential to assist in
the prophylaxis and / or treatment of SARS-Cov-2 infection should be tried, as
long as they are easy to implement and do not cause risks to the population.
Homeopathy fits this profile.
II.2. Homeopathy
II.2.1. Introduction
Homeopathy is a therapeutic model employed worldwide and that has
awakened in recent decades, along with other approaches to integrative
medicine, the growing interest of users, medical students and physicians
(Teixeira et al., 2004, 2005; Teixeira and Lin, 2013), in order to be a safe and
efficient medical practice, proposing to understand and treat the disease-patient
binomial according to a vitalistic, globalizing and humanistic anthropological
approach (Teixeira, 2009b, 2017a), valuing the various aspects of sick
individuality.
Founded by the German physician Samuel Hahnemann in 1796, homeopathy is
a medical specialty recognized by the Federal Council of Medicine (CFM) of
Brazil since 1980 (Resolution CFM Nº 1000/1980), with the title of specialist
conferred by the Brazilian Medical Association (AMB) since 1990 (Resolution
CFM Nº 2.068/2013). (Teixeira, 2019)
Developing its activities in parallel to conventional and hegemonic medicine, it
disseminates its theoretical, practical and scientific rationality in lato sensu
postgraduate courses, taught by training entities linked to the Brazilian
Homeopathic Medical Association (AMHB). In 2004, after Resolution CFM
1634/2002, was offered in the medical residency program of the Federal
University of the State of Rio de Janeiro (UNIRIO - University Hospital Gaffrée e
Guinle). Currently, two more medical residency programs offer homeopathy as
a service training option (Regional Public Hospital of Betim, Minas Gerais, since
2014; Federal University of Mato Grosso do Sul, since 2015). (Teixeira, 2019)
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
Although it has existed for more than two centuries as a therapeutic option in
several countries, homeopathy remains marginalized in the face of modern
scientific rationality, because it is based on unorthodox concepts that challenge
the dominant biomedical thought.
The homeopathic treatment model employs the principle of cure by similarity,
administering infinitesimal doses of single and individualized medications that,
having been previously tried in healthy individuals, caused symptoms similar to
those of sick individuals. To become a homeopathic medicine, the substance
must undergo pathogenetic experimentation protocols in humans and have its
primary effects described in Homeopathic Materia Medica. (Teixeira, 2011a,
2013e, 2019)
In short, homeopathic scientific rationality is based on four pillars or
epistemological premises: (1) principle of therapeutic similarity, (2) homeopathic
pathogenetic trial or experimentation, (3) dynamized or potentized medicine
(ultra-high dilutions) and (4) individualised medicine according to symptomatic
totality (therapeutic individualization).
II.2.2. Epistemological premises of the homeopathic model
II.2.2.1. Principle of therapeutic similarity
Based on the study of the pharmacological properties of dozens of drugs of his
time, in which he observed a secondary reaction (indirect effect) of the
organism after the primary action (direct effect) of several classes of drugs,
Hahnemann reported an aphorism for the action of drugs in the human
constitution.
Every agent that acts upon the vitality, every medicine, deranges more or less the
vital force, and causes a certain alteration in the health of the individual for a longer
or a shorter period. This is termed primary action. […]. To its action our vital force
endeavors to oppose its own energy. This resistant action is a property, is indeed an
automatic action of our life-preserving power, which goes by the name of secondary
action or counteraction. (Hahnemann, 1995, § 63)
Illustrating this phenomenon or natural law, Hahnemann describes the primary
action of the drugs of his time, promoting changes in the various physiological
systems, and the consequent secondary action of the organism (vital reaction
or life-preserving power), which manifests itself in order to neutralize the
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
primary disorders promoted by drugs, seeking to return to homeostatic balance
prior to drug intervention.
[...] Excessive vivacity follows the use of strong coffee (primary action), but
sluggishness and drowsiness remain for a long time afterwards (reaction, secondary
action), if this be not always again removed for a short time by imbibing fresh
supplies of coffee (palliative). After the profound stupefied sleep caused by opium
(primary action), the following night will be all the more sleepless (reaction,
secondary action). After the constipation produced by opium (primary action),
diarrhea ensues (secondary action); and after purgation with medicines that irritate
the bowels, constipation of several days duration ensues (secondary action). And in
like manner it always happens, after the primary action of a medicine that produces
in large doses a great change in the health of a healthy person, that its exact
opposite, when, as has been observed, there is actually such a thing, is produced in
the secondary action by our vital force. (Hahnemann, 1995, § 65).
By administering to sick individuals the simple substances that have aroused
similar symptoms in healthy experimenters (similia similibus curentur), the
principle of therapeutic similarity aims to stimulate a reaction of the body against
their own disorders or diseases, inducing a curative homeostatic response.
Cited since Hippocrates, the principle of similarity (vital or homeostatic reaction)
finds its scientific basis in the rebound effect of modern drugs (paradoxical
reaction of the organism), being described after discontinuation or change in
doses of numerous classes of medicines that act palliatively (contrary or
antagonistic) to the symptoms of diseases, aggravating the initially suppressed
symptoms. The rebound effect is confirmed in hundreds of clinical and
experimental pharmacology studies (Teixeira, 1998, 1999, 2006, 2007a, 2007b,
2009c, 2010b, 2011b, 2012a, 2012b, 2013b, 2013c, 2016).
Despite the idiosyncratic character of this rebound phenomenon, which
manifests itself in a small proportion of individuals, scientific evidence warns of
the occurrence of severe and fatal iatrogenic events due to this paradoxical
reaction of great intensity, after the administration of modern drugs: anti-
inflammatory drugs (selective and non-selective of cyclooxygenases) causing
thrombotic events (AMI and stroke), secondarily to the primary antithrombotic
action; long-term bronchodilators causing irreversible bronchospasms;
antidepressants serotonin reuptake inhibitors exacerbating depression and
suicidal ideations; immunobiological drugs triggering severe forms of multiple
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
sclerosis and psoriasis; among other classes of drugs (Teixeira, 2006, 2007a,
2007b, 2009c, 2010b, 2011b, 2012a, 2012b, 2013b, 2013c, 2016).
When used according to the principle of therapeutic similarity, the great
magnitude of this rebound effect can also awaken proportional curative
responses. Therefore, since 2003, we have been proposing a systematization
for the use of the curative rebound effect of 1,250 modern drugs, administered
to sick individuals, at infinitesimal doses (dynamized, potentized or ultradiluted
medicine), the same drugs that cause similar adverse events, in order to
stimulate a homeostatic or paradoxical reaction of the body against its own
disorders (Teixeira, 2003, 2005, 2010c, 2011c, 2011d, 2013d).
In a postdoctoral project completed in 2017, we evidenced the efficacy and
safety of this proposal in the use of potentized estrogen (17-beta estradiol) in
homeopathic treatment of chronic pelvic pain in patients with endometriosis
refractory to conventional hormone treatments, through a randomized, double-
blind and placebo-controlled clinical trial (Teixeira, 2017b; Teixeira et al., 2016,
2017a, 2017b). This was made possible by the fact that endometriosis is an
estrogen-dependent syndrome and 17-beta estradiol presents as pathogenetic
effects (adverse events) a set of signs and symptoms very similar to
endometriosis syndrome (anxiety, depression, insomnia, migraine, abdominal
pain, dysmenorrhoea, dyspareunia and endometrial hyperplasia, among others)
(The United States Pharmacopeial Convention, 2004).
II.2.2.2. Homeopathic pathogenetic trial or experimentation
To acquire knowledge of the healing properties of substances that allow the
application of the principle of therapeutic similarity, homeopathy uses
homeopathic pathogenetic trial or experimentation as a model of
pharmacological clinical research (similar to preclinical phase 1 trial), valuing all
classes of symptomatic manifestations (mental, general and paticular) aroused
by medicines in humans, called by modern pharmacology as adverse or side
effects of drugs.
The whole pathogenetic effect of the several medicines must be known; that is to
say, all the morbid symptoms and alterations in the health that each of them is
specially capable of developing in the healthy individual must first have been
observed as far as possible, before we can hope to be able to find among them, and
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
to select, suitable homoeopathic remedies for most of the natural disease.
(Hahnemann, 1995, § 106)
Following the premises stipulated by Hahnemann (Hahnemann, 1995, § 105-
145), around 3,000 substances were experimented with following several
experimental protocols (Teixeira, 2013e), with the aim of getting to know and
catalog the pathogenetic power of the medicines, in order, when called on to
cure, to be able to select from among them one, from the list of whose
symptoms an artificial disease may be constructed, as similar as possible to the
totality of the principal symptoms of the natural disease sought to be cured.
All signs and symptoms observed in the various pathogenetic trials of
homeopathic drugs were compiled for Homeopathic Materia Medica, following
an anatomical-functional systematization.
In clinical practice, the homeopathic physician also uses the Repertory of
Homeopathic Symptoms, in which all homeopathic medicines that aroused the
same symptom in trials are grouped in the same rubric, facilitating the
selection of the homeopathic drug that encompasses the characteristic totality
of signs and symptoms of the individual.
II.2.2.3. Dynamized or potentized medicine (ultra-high dilutions)
Contrary to the biochemical and dose-dependent pharmacological model, the
biomedical reasoning is surprising to the fact that ultradiluted substances
(dynamized or potentized) at concentrations lower than the Avogadro constant
(6.02 x 1023 mol-1) may arouse some response in biological systems or living
beings, which is the main target of criticism of the homeopathic model.
With the initial objective of avoiding the poisonings and symptomatic
aggravations that the principle of therapeutic similarity could cause in patients,
Hahnemann proposed a pharmacotechnique for the preparation of homeopathic
drugs (dynamization or potentization), in which the substances are diluted and
agitated successively in order to reduce the primary pathogenetic effect. A
posteriori, he observed that these infinitesimal and imponderable preparations
mobilized biological activity in spheres of individuality not affected by weight
doses, such as psychoemotional dynamics (Hahnemann, 1995, § 269).
In a simplified way, the pharmacotechnical method of dynamization or
potentization described in the Brazilian Homeopathic Pharmacopoeia (2011),
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
consists of centesimal and successive dilutions of the matrix substance,
accompanied by 100 vigorous agitations (succussions) per passage (centesimal
hahnemannian or cH).
Above the 12th potency or dynamization, these ultra-high dilutions present
concentrations lower than the Avogadro constant (6.02 x 1023 mol-1), in which
there is no grass molecule of the substance of origin in the final solution,
making them free of toxicity and/or adverse events (Dantas, 2017; Dantas and
Rampes, 2000), as demonstrated by bisecular homeopathic treatment with toxic
substances of high pathogenetic power (Arsenicum album, Atropa belladonna,
Cuprum metallicum, Lachesis muta, Phosphorus and Rhus toxicodendron,
among others).
In the classic homeopathic treatment, these ultra-high dilutions are administered
in potencies 12cH, 30cH, 200cH and 1000cH, among others, in single monthly
doses or repeated daily, according to the clinical indication (chronic or acute
diseases, respectively).
The ability of this drug information (contained in the infinitesimal doses of
ultradiluted substances) to promote changes in physiological systems,
analogous to weight doses, has been studied in scientific studies employing
physicochemical or biological models of research.
Some hypotheses based on experimental physicochemical models seek a
scientific explanation for the phenomenon of transmission of information of the
primary effects of substances in homeopathic ultra-dilutions. Among them, we
mention the researches that study the electromagnetic changes of water
according to quantum electrodynamics, in which the aqueous solution would not
represent an inert cluster of molecules but rather a dynamic medium, capable of
selecting and catalyzing molecular reactions according to the various
electromagnetic fields of the solute dissolved inside it. Through mathematical
and experimental models, they infer that the electromagnetic field of a solute
can generate certain domains of stable coherence in the solvent (with specific
structures and vibrations), producing clusters of water molecules (with specific
sizes, shapes and properties), such as an electromagnetic signature of the
solute in water (water memory). Thus, the organization of water would be a
coherent process, reproducible and associated with long-range electromagnetic
interactions and very low intensity, transmitting the electromagnetic information
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
of the solute initially diluted and agitated by the process of dynamization
(Homeopathy, 2007).
In biological models of research, numerous experimental studies in the various
areas of scientific knowledge and research models (in vitro, plants and
animals), support the assumption that infinitesimal doses can awaken biological
phenomena similar to those obtained with weighted doses of the same
substances, validating the use of ultra-high diluted drugs by homeopathic
therapy (Homeopathy, 2009, 2010).
II.2.2.4. Individualized medicine (therapeutic individualization)
According to Hahnemann, the doctor who is called a legitimate artist of healing
should be able to recognize what should be cured in each case individually and
understand the curative element of medicines, adapting them in quality and
quantity to the needs of the sick, according to the principle of therapeutic
similarity.
Understanding the process of illness as a weakening of the physiological
mechanisms of adaptation and compensation, Hahnemann correlated any
physiological imbalance with the corresponding symptomatic manifestations
presented by the individual, using the set of signs and symptoms (symptomatic
totality) as the main reference for diagnosing affection of the vital force
(individual predisposition, morbid susceptibility or homeostatic imbalance) and
to prescribe the homeopathic medicine more similar to the sick individuality.
[...] the totality of these its symptoms, of this outwardly reflected picture of the
internal essence of the disease, that is, of the affection of the vital force, must be the
principal, or the sole means, whereby the disease can make known what remedy it
requires - the only thing that can determine the choice of the most appropriate
remedy - and thus, in a word, the totality of the symptoms must be the principal,
indeed the only thing the physician has to take note of in every case of disease and
to remove by means of his art, in order that it shall be cured and transformed into
health. (Hahnemann, 1995, § 7)
In the set of manifest signs and symptoms, homeopathic semiology selects the
more striking, singular, uncommon and peculiar in each case, disregarding the
common, general and undefined symptoms due to the inherent absence of
individualizing power (idiosyncratic) in them.
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In this search for a homoeopathic specific remedy, that is to say, in this comparison
of the collective symptoms of the natural disease with the list of symptoms of known
medicines, in order to find among these an artificial morbific agent corresponding by
similarity to the disease to be cured, the more striking, singular, uncommon and
peculiar (characteristic) signs and symptoms of the case of disease are chiefly and
most solely to be kept in view; for it is more particularly these that very similar ones
in the list of symptoms of the selected medicine must correspond to, in order to
constitute it the most suitable for effecting the cure. The more general and undefined
symptoms: loss of appetite, headache, debility, restless sleep, discomfort, and so
forth, demand but little attention when of that vague and indefinite character, if they
cannot be more accurately described, as symptoms of such a general nature are.
(Hahnemann, 1995, § 153)
Associating drug individualization with the prescription of a single, simple
medicine at one time, it is strongly opposed to the simultaneous use of more
than one homeopathic drug (mixture of medicines or homeopathic complexes),
because homeopathic pathogenetic experimentation, a reference for the correct
and safe therapeutic prescription, was performed with simple and unique
substances.
In no case under treatment is it necessary and therefore not permissible to
administer to a patient more than one single, simple medicinal substance at one
time. It is inconceivable how the slightest doubt could exist as to whether it was
more consistent with nature and more rational to prescribe a single, simple medicine
at one time in a disease or a mixture of several differently acting drugs. It is
absolutely not allowed in homoeopathy, the one true, simple and natural art of
healing, to give the patient at one time two different medicinal substances.
(Hahnemann, 1995, § 273)
Therefore, adequate homeopathic treatment should prioritize the
individualization of the single medicine according to the most peculiar and
characteristic signs and symptoms of each patient, in its various constitutional
aspects (mental, general and particular), allowing, for the same disease, each
individual can receive different unique medications, according to their own
susceptibilities (physical, psychic, emotional, food and climatic , among others).
Several randomized clinical trials (RCT) that disrespected this drug
individualization, administering the same medicine to several individuals with
the same disease (exemplified in the indiscriminate use of Arnica montana for
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inflammatory processes in general; Ernst and Pittler, 1998), showed no
significant results compared to placebo, because they hurt the scientific
rationality of the homeopathic model. The same occurred with meta-analyses
and systematic reviews that grouped RCTs with non-individualized homeopathic
medicines (Shang et al., 2005; Mathie et al., 2017; Homeopathy Research
Institute), unlike those who valued individualizing therapy (Mathie et al., 2014;
Vithoulkas, 2017).
It is noteworthy that this process of drug individualization requires a regular and
variable follow-up period, in which the responses to the various drug
hypotheses (individualized single medicines) are evaluated successively,
adjusting the medications, doses and homeopathic potencies to the various
susceptibilities of each patient. (Teixeira, 2009d)
In addition to these brief citations used to exemplify the scientific basis of each
homeopathic epistemological premise, homeopathic assumptions are based on
hundreds of studies in several contemporary lines of research (Teixeira, 2011a,
2018, 2019; Cremesp, 2017a, 2017b, 2017c), contrary to prejudice propagated
indistinctly that there is no scientific evidence in homeopathy.
For the finding of our statement, we indicate the reading of the Special Dossier:
Scientific Evidence for Homeopathy, prepared by the Technical Chamber of
Homeopathy of Regional Council of Medicine of the State of São Paulo
(Cremesp) in 2017.
II.2.3. Guidelines for homeopathic treatment in epidemic diseases
II.2.3.1. Samuel Hahnemann
In a similar way to acute and chronic diseases, Hahnemann provides
individualizing semiological and therapeutic guidelines in the approach of
epidemic diseases (Teixeira 2009a, 2010a, 2013a, 2014, 2015a, 2015b).
Just as each patient presents a set of characteristic signs and symptoms that
differs from other individuals affected by the same acute or chronic disease,
each epidemic disease respects a phenomenon of a unique character,
differing vastly from all previous epidemics is a phenomenon with its own
characteristics. With this warning, Hahnemann criticizes the application of
the knowledge obtained in previous epidemics in new outbreaks of the same
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homeopathic medicine in the treatment and prevention of the covid-19 epidemic
disease, without conducting a meticulous examination of the pure picture of
the current disease.
In investigating the totality of the symptoms of epidemic and sporadic diseases it
is quite immaterial whether or not something similar has ever appeared in the
world before under the same or any other name. The novelty or peculiarity of a
disease of that kind makes no difference either in the mode of examining or of
treating it, as the physician must any way regard to pure picture of every
prevailing disease as if it were something new and unknown, and investigate it
thoroughly for itself, if he desire to practice medicine in a real and radical manner,
never substituting conjecture for actual observation, never taking for granted that
the case of disease before him is already wholly or partially known, but always
carefully examining it in all its phases; and this mode of procedure is all the more
requisite in such cases, as a careful examination will show that every prevailing
disease is in many respects a phenomenon of a unique character, differing vastly
from all previous epidemics [...]. (Hahnemann, 1995, § 100)
As the image of the pathological picture of collective diseases appears only
after the observation of a number of patients considered, Hahnemann
suggests the observation of several cases to form the complete picture of
the disease, based on the characteristic set of its symptoms and signs,
according to homeopathic semiology.
It may easily happen that in the first case of an epidemic disease that presents
itself to the physicians notice he does not at once obtain a knowledge of its
complete picture, as it is only by a close observation of several cases of every
such collective disease that he can become conversant with the totality of its
signs and symptoms. The carefully observing physician can, however, from the
examination of even the first and second patients, often arrive so nearly at a
knowledge of the true state as to have in his mind a characteristic portrait of it,
and even to succeed in finding a suitable, homoeopathically adapted remedy for
it. (Hahnemann, 1995, § 101)
In the search for the essence or genius of the epidemic (epidemic genius),
which will make it possible by similarity to identify among the various
substances tested the most appropriate medicine, the characteristic picture of
the epidemic will be formed by the totality of the most characteristic signs and
symptoms. This individualized medicine can be applied therapeutically to
patients affected by the same outbreak of the disease.
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In the course of writing down the symptoms of several cases of this kind the sketch
of the disease picture becomes ever more and more complete, not more spun out
and verbose, but more significant (more characteristic), and including more of the
peculiarities of this collective disease; on the one hand, the general symptoms (e.g.,
loss of appetite, sleeplessness, etc.) become precisely defined as to their
peculiarities; and on the other, the more marked and special symptoms which are
peculiar to but few diseases and of rarer occurrence, at least in the same
combination, become prominent and constitute what is characteristic of this malady.
All those affected with the disease prevailing at a given time have certainly
contracted it from one and the same source and hence are suffering from the same
disease; but the whole extent of such an epidemic disease and the totality of its
symptoms (the knowledge whereof, which is essential for enabling us to choose the
most suitable homoeopathic remedy for this array of symptoms, is obtained by a
complete survey of the morbid picture) cannot be learned from one single patient,
but is only to be perfectly deduced (abstracted) and ascertained from the sufferings
of several patients of different constitutions. (Hahnemann, 1995, § 102)
Discussing the nature and treatment of intermittent fever epidemics,
Hahnemann reiterates the need to individualize the specific homeopathic
remedy for the treatment of the epidemic manifestation, according to the
characteristic set of symptoms common to all patients. Maintaining its reasoning
coherence, he emphasizes the epistemological premise of using simple and
unique substances, avoiding complex means, in the individualization of the
homeopathic medicine.
Epidemics of intermittent fever, in situations where none are endemic, are of the
nature of chronic diseases, composed of single acute paroxysms; each single
epidemic is of a peculiar, uniform character common to all the individuals attacked,
and when this character is found in the totality of the symptoms common to all, it
guides us to the discovery of the homeopathic (specific) remedy suitable for all the
cases, which is almost universally serviceable in those patients who enjoyed
tolerable health before the occurrence of the epidemic, that is to say, who were not
chronic sufferers from developed psora. (Hahnemann, 1995, § 241)
In addition to indicating the homeopathic medicine as a therapeutic measure in
the manifest cases of the epidemic disease, Hahnemann also describes the use
of individualized homeopathy as a prophylactic practice.
A striking fact in corroboration of this is, that whilst previously to the year 1801,
when the smooth scarlatina of Sydenham still occasionally prevailed epidemically
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homeopathic medicine in the treatment and prevention of the covid-19 epidemic
among children, it attacked without exception all children who had escaped it in a
former epidemic; in a similar epidemic which I witnessed in Konigslutter, on the
contrary, all the children who took in time a very small dose of belladonna remained
unaffected by this highly infectious infantile disease. If medicines can protect from a
disease that is raging around, they must possess a vastly superior power of
affecting our vital force. (Hahnemann, 1995, footnote to § 33)
Subsequently to the year 1801 a kind of purpura miliaris (roodvonk), which came
from the West, was by physicians confounded with the scarlet fever, notwithstanding
that they exhibited totally different symptoms, that the latter found its prophylatic and
curative remedy in belladonna, the former in aconite, and that the former was
generally merely sporadic, while the latter was invariable epidemic. Of late years it
seems as if the two occasionally joined to form an eruptive fever of a peculiar kind,
for which neither the one nor the other remedy, alone, will be found to be exactly
homoeopathic. (Hahnemann, 1995, footnote to § 73)
Despite recognizing the benefits of the antiviral vaccine, introduced by his
contemporary Edward Jenner in 1796 (following observation and detailed
description of a series of 27 immunized cases), Hahnemann criticizes the
indiscriminate use of ultra-dilutions of disease by-products or the pathogen
(nosodes or biotherapics) as a prophylactic method or isopathic treatment
(principle of identity; aequalia aequalibus curentur), without the pathogenetic
experimentation of the by-product in healthy people and the application of
individualizing similarity.
A third mode of employing medicines in diseases has been attempted to be created
by means of Isopathy, as it is called - that is to say, a method of curing a given
disease by the same contagious principle that produces it. But even granting this
could be done, yet, after all, seeing that the virus is given to the patient highly
potentized, and consequently, in an altered condition, the cure is effected only by
opposing a simillimum to a simillimum. To attempt to cure by means of the very
same morbific potency (per Idem) contradicts all normal human understanding and
hence all experience. Those who first brought Isopathy to notice, probably thought
of the benefit which mankind received from cowpox vaccination by which the
vaccinated individual is protected against future cowpox infection and as it were
cured in advance. But both, cowpox and smallpox are only similar, in no way the
same disease. In many respects they differ, namely in the more rapid course and
mildness of cowpox and especially in this, that is never contagious to man by more
nearness. Universal vaccination put an end to all epidemics of that deadly fearful
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smallpox to such an extent that the present generation does no longer possess a
clear conception of the former frightful smallpox plague. Moreover, in this way,
undoubtedly, certain diseases peculiar to animals may give us remedies and thus
happily enlarge our stock of homoeopathic remedies. But to use a human morbific
matter (a Psorin taken from the itch in man) as a remedy for the same itch or for
evils arisen therefrom is - ? Nothing can result from this but trouble and aggravation
of the disease. (Hahnemann, 1995, footnote to § 56)
Remember that to be considered a homeopathic medicine and to be able to be
used therapeutically and/or prophylactically in a safe and effective way
according to the principle of similarity, any substance (simple or complex),
regardless of its origin, needs to be subjected to experimentation in human
individuals, so that its pathogenic symptoms are known and described. In this
way, any animal by-product (nosodes or biotherapics) can be used
homeopathically, as long as it is subjected to previous pathogenetic
experimentation and is prescribed according to the similarity of characteristic
signs and symptoms with the sick individuality.
Therefore, it is worth mentioning that the isopathic medicine or isotherapeutic
treatment (used according to the principle of identity and disregarding previous
pathogenetic experimentation, similar to modern oral immunotherapy) does not
match the homeopathic episteme and cannot be considered homeopathic.
(Teixeira, 2014, 2015a, 2015b)
II.2.3.2. James Tyler Kent
In his work Lectures on homeopathic philosophy, Lesson III, Kent (1998)
describes a semiological protocol for diagnosing the group of medicines of the
epidemic genius, based on the hahnemannian premises mentioned above.
He suggests the careful observation of 20 patients affected by the disease in
question, recording all the symptoms present in a schematic way (repertorial
classification), which when considered collectively ill present an image, as if a
single man had expressed all the symptoms. Putting in front of each symptom
the number of patients who manifested it, the homeopathic doctor will discover
the essential traits of the epidemic (nature of the disease) through the
common symptomatic totality (pathognomonic signs and symptoms) and
characteristic (peculiar signs and symptoms). Using a repertory of symptoms,
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he will select six or seven drugs that cover the symptomatic totality of that
epidemic (group of individualized homeopathic medicines of epidemic genius),
fixing the individual pictures of each drug in the study of homeopathic materia
medica.
Then proceeding from general to particular, for there is no other way to
proceed in homeopathy, the homeopathic physician will adapt the
characteristics of each patient to the particularities of each selected drug
(therapeutic individualization), because even in individuals of the same family
will be observed a small difference in each case. If none of the selected
medications are useful, the doctor should return to his or her original anamnesis
to see which of the other medicines is appropriate. Kent points out that the
application of epidemic genius in the selection of homeopathic medicines is
hard work, but brings spectacular results.
[...] Every remedy has in itself a certain state of peculiarities that identifies it as an
individual remedy, and the patient has also a certain state of peculiarities that
identifies him as an individual patient, and so the remedy is fitted to the patient. No
remedy must be given because it is in the list, for the list has only been made as a
means of facilitating the study of that epidemic. Things can only be made easy by an
immense amount of hard work, and if you do the drudgery in the beginning of an
epidemic, the prescribing for your cases will be rapid, and you will find your
remedies abort cases of sickness, make malignant cases simple, so simplify scarlet
fever that classification would be impossible, stop the course of typhoids in a week,
and cure remittent fevers in a day. (Kent, 1998, Lição III)
II.2.4. Evidence of the effectiveness of homeopathy in epidemic diseases
Several initiatives employing homeopathic medicines in the treatment and
prophylaxis of epidemic diseases are described in the literature, most of them
as reports of cured or immunized cases in which medicines of the epidemic
genius were used (Shepherd, 1996; Hoover, 2001; Shalts, 2005; Bradford,
2007).
In the shorter writing Some types of continuous and remitting fevers, published
in 1798 in Hufelands Journal der practischen Arzneykunde, Hahnemann
(2006a) describes the use of Ignatia amara in the treatment of a continuous and
sporadic fever that affected children in January 1797, which had the following
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characteristic symptoms: instead of skin heat, continued chills and great laxity;
forehead covered with cold sweat; memory weakness; excessively short and
spasmodic breathing. After two months, another fever of the same character,
but with different characteristic symptoms (immobility of the pupil, pressure pain
around the navel, stupor, decreased strength, relief from sweating, etc.),
returned to affect children, finding its curative medicine. In the following month,
he describes the use of Camphora in an influenza epidemic aggravated by the
use of Opium, in order to present a distinct set of peculiar symptoms. With
these examples, Hahnemann emphasizes the importance of individualizing the
medicine according to the characteristic symptoms of each epidemic (or stage)
of a similar character.
In another shorter writing entitled Cure and prevention of scarlet fever,
Hahnemann (2006b) describes the use of Atropa belladonna in the prophylaxis
and treatment of the initial phase of the scarlet fever epidemic that occurred in
the vicinity of Helmstädt to Königslutter in 1799, a medicine chosen according to
the epidemic genius of the initial phase of the disease: a medicine that is
capable of quickly blocking a disease in its beginnings should also be your best
preventive. He also describes the use of Opium and Ipeca in the treatment of
two morbid conditions of the fully developed disease, administering these drugs
in isolation or alternating, according to the assessment of each patient and the
set of signs and symptoms of each episode: From me, when called upon for
cases of fully developed disease (where it was not a matter of prevention or
preventing its onset), I realized that I had to combat two different states of the
body that sometimes quickly alternated, each of which was composed of a
convolute of symptoms. He also mentions the use of Matricaria chamomilla for
the skin disorder called insane skin and for the characteristic suffocating
cough that could come on the disease.
It is worth mentioning that Hahnemann, in the treatment of any epidemic
disease, prescribed the different medicines individually and at different
times (different stages of the disease), without ever mixing the drugs in
the same prescription (homeopathic complexes).
Other doctors described the high levels of protection that belladonna gave
children exposed to the same type of scarlet fever epidemic in the 1820s:
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Dudgeon (2002) reports that ten allopaths (Bloch, Cramer, Gelnecki, Wolf,
Ibrelisle, Velsen, Berndt, Schenk, Behr and Zeuch) used belladonna
prophylactically in 1646 children, observing the manifestation of symptoms in
only 123 cases (7.5%), a high degree of protection in an epidemic that affected
90% of those exposed at the time.
A review of these results of the prophylactic use of belladonna in scarlet fever,
published in the Hufelands Journal in 1826 (Hufeland, 1826), made the
Prussian government mandatory to use it during the 1838 epidemic (Dunham,
1994). These data show the use of belladonna as a specific prophylactic of
scarlet fever by allopathic doctors of the time.
In the shorter writing Cure and prevention of Asian cholera, Hahnemann
(2006c) describes the use of Camphora, Cuprum metallicum and Veratrum
album as homeopathic medicines to the epidemic genius of the successive
stages of the disease (prescribed individually, according to the similarity with
the symptoms each stage of the disease), to prevent and treat Asian cholera
during the 1831 epidemic in Germany. Preferably, he used Cuprum as a
prophylactic against cholera, Camphora for the treatment of the initial phase of
the disease, and Cuprum or Veratrum in the later phase (alone or alternately, as
the symptoms indicated). In his historical review, Shalts (2005) states that
during this epidemic (1831-1832) the mortality rates of European homeopathic
hospitals were 7-10%, while with conventional treatments they reached 40-80%.
Studying in a systematic way the symptoms that affected patients during the
cholera epidemic of 1849 in Europe, Von Böeninghausen (2005), in August of
the same year, proposed the administration of Camphora by non-doctors as an
individualized medicine of the epidemic genius for the treatment of patients
affected by the disease: Only the use of this remedy can and should be
entrusted to the hands of a non-physician. During this epidemic, according to
Shepherd (1996) and Hoover (2001), the mortality rate of patients undergoing
homeopathic treatment was 5-16%, while those receiving conventional
treatments showed 54-90%. Homeopathy was also used in the cholera
epidemic of 1854 in London (Leary, 1994, 1997), significantly reducing
mortality.
In the Lectures on homeopathic philosophy, Lesson XI, Kent (1998) describes
the treatment of some cases of the same epidemic of childhood diarrhea with
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the 30th potency of the medicine Podophyllum peltatum, which had in its
pathogenesis symptoms similar to those observed in sick patients (epidemic
genius), reporting that the cures were almost instantaneous, it seemed as if
there were no more stools after the first dose of the drug, although not always
using a single dose.
Meta-analysis of three randomized homeopathic clinical trials (Jacobs et al.,
2003) showed that individualized homeopathic treatment was significantly more
effective than placebo in childhood diarrhea epidemics. However, another
randomized clinical trial conducted by the same authors (Jacobs et al., 2006)
showed that non-individualized homeopathic treatment (complex or mixture of
five homeopathic medicines commonly indicated in the treatment of childhood
diarrhea), which disregarded the individualizing guidelines for the homeopathic
medicine of the epidemic genius, did not present a significant response to the
placebo.
In the shorter writing Treatment of typhus or hospital fever that currently
predominates, Hahnemann (2006d) describes the use of Bryonia alba,
Hyosciamus niger and Rhus toxicodendron as homeopathic medicines to the
typhus epidemic genius (prescribed in a single or alternate way, according to
similarity of symptoms between the patient and each stage of the disease), in
the treatment of the epidemic that affected Germany in 1813: Of the 183
patients I treated with this condition in Leipizig, I did not lose one, which caused
a great sensation among the members of the Russian Government that then
occupied Dresden, but no news was given by the medical authorities.
(Hahnemann, 1994).
A severe diphtheria epidemic has also been effectively treated by individualized
homeopathy: in the three-year (1862-4) historical records of the disease in
Broome County (New York, USA), there are reports of an 84% mortality rate
with conventional treatments and a rate of only 16% with homeopathic
treatment (Shalts, 2005).
In 1918, at the beginning of the Spanish flu pandemic that infected 20% of the
world population and killed around 30 million people, homeopathic doctors met
at the British Homeopathic Society (London) to discuss the probable drugs of
the epidemic genius, through the report of a series of cases and their
characteristic symptoms. The discussions and the results of this meeting were
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homeopathic medicine in the treatment and prevention of the covid-19 epidemic
published in a scientific periodical (British Homoeopathic Society, 1918), guiding
the individualized treatment of epidemic outbreaks in different regions and
countries.
Several homeopathic medicines were used to treat this epidemic outbreak
(Arsenicum album, Bryonia alba, Baptisia tinctoria, Eupatorium perfoliatum and
Gelsemium sempervirens, among others), according to the epidemic genius
observed in the different stages of the disease, times and regions (Hoover,
2001; Shalts , 2005; Baker, 1920). In estimates published in the Journal of the
American Institute of Homeopathy (Dewey, 1921), McCann referred that 26,000
cases of flu treated homeopathically in Ohio had a 1% mortality rate, contrasting
with the rate of 28% in 24,000 cases allopathically treated. In Philadelphia,
Pearson reported similar rates in 26,795 cases of flu treated homeopathically.
Recent reviews analyzed the results at the time and described the benefits of
homeopathic treatment in this influenza (Spanish flu) pandemic that devastated
humanity in the early 20th century (1918-1920). (The Canadian Academy of
Homeopathy, 2013; Jahn, 2014)
Systematic review of three placebo-controlled clinical trials (n = 2265) that used
the biotherapic Oscillococcinum (prepared with autolysate from the heart and
liver of an infected wild duck, a vector of the avian influenza virus) as a
specific preventive of influenza syndromes (ignoring the individualizing
guidelines cited above), there was no significant effect of this nosode on
placebo. (Vichers and Smith, 2006)
During a conjunctivitis epidemic in Pittsburgh (USA), a placebo-controlled
clinical trial was conducted to evaluate the effectiveness of Euphrasia officinalis
30cH (chosen according to the epidemic genius of previous years epidemics) in
preventing the disease, neglecting the entire symptomatic characteristic of the
current epidemic. The treatment group consisted of 658 students, who received
the homeopathic medicine for three consecutive days; the control group was
composed of 648 students, who received placebo in the same dosage. There
was no statistically significant difference in the incidence and severity of the
disease between the groups. (Mokkapatti, 1992)
In another epidemic of keratoconjunctivitis that occurred in Cuba, 108 patients
were randomly assigned for homeopathic (n = 58) and allopathic (n = 50)
treatment, using Pulsatilla nigricans 6cH as an individualized homeopathic
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homeopathic medicine in the treatment and prevention of the covid-19 epidemic
medicine of the epidemic genius of that epidemic. Homeopathic treatment was
significantly more effective than allopathic treatment in improving symptoms in
less than 72 hours. (Varela et al., 1995)
In Brazil, Marino (2006, 2008) evaluated the action of the individualized
homeopathic medicine Eupatorium perfoliatum in the prophylaxis of dengue
during the 2001 epidemic in São José do Rio Preto (SP), showing that the
homeopathic intervention showed a significant decrease in the incidence of the
disease before the control group.
II.3. Study of the epidemic genius of the current COVID-19
pandemic
Following the assumptions stipulated by Hahnemann and Kent, previously
described, using the reports and studies that described the signs and symptoms
common to several patients affected by COVID-19 in other countries, we can
raise some possible individualized homeopathic medicines for the epidemic
genius of the current pandemic, in its different stages.
Retrospective observational study with 99 cases infected with SARS-Cov-2 and
admitted to the Wuhan Jin Yin-tan Hospital (Wuhan, China) showed that the set
of signs and symptoms presented were: fever (83%), cough (82%), dyspnea
(31%), muscle pain (11%), mental confusion (9%), headache (8%), sore throat
(5%), rhinorrhea (4%), chest pain (2%), diarrhea (2%) and nausea and vomiting
(1%). According to imaging studies, 75% had bilateral pneumonia, 14% had
multiple spots and ground-glass opacity (interstitial thickening or partial alveolar
collapse) and 1% evolved with pneumothorax. 17% of patients developed acute
respiratory distress syndrome (ARDS) and, among them, 11% worsened in a
short period of time, dying from multiple organ failure: acute renal failure (ARF,
3%), acute respiratory failure (8%) and septic shock (4%). Elderly and comorbid
patients progressed more easily to severe and fatal respiratory diseases. (Chen
et al., 2020)
According to a report from the joint WHO-China mission, based on 55924 cases
infected with SARS-Cov-2, typical signs and symptoms included: fever (87.9%),
dry cough (67.7%), fatigue (38, 1%), phlegm production (33.4%), dyspnea
(18.6%), sore throat (13.9%), headache (13.6%), myalgia or arthralgia (14.8%),
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chills (11.4%), nausea or vomiting (5.0%), nasal congestion (4.8%), diarrhea
(3.7%), hemoptysis (0.9%) and conjunctival congestion (0.8%). In general, the
clinical picture started with fever and mild respiratory symptoms (dry cough), 5-
6 days after infection. 13.8% of patients had severe pneumonia, with dyspnea,
respiratory rate ≥30 / minute, blood oxygen saturation ≤93%, PaO2/FiO2 ratio <
300 and / or pulmonary infiltrates > 50% of the pulmonary field, in 24 to 48
hours. 6.1% of the patients had critical conditions, with respiratory failure, septic
shock and/or multiple organ dysfunction. Individuals with a higher risk of serious
illness were elderly and with chronic diseases. (WHO, 2020)
Retrospective observational study of 52 seriously ill adult patients with SARS-
CoV-2 pneumonia, admitted to the ICU of the Wuhan Jin Yin-tan Hospital
(Wuhan, China) between December 2019 and January 2020, showed that the
set of signs and symptoms presented were: fever (98%), cough (77%), dyspnea
(63.5%), myalgia or arthralgia (11.5%), malaise (35%), rhinorrhea (6%), and
chest pain (2%). The mean age of the patients was 59.7 years (with more
severe conditions progressing with age) and 40% had associated chronic
diseases. The majority of patients had insufficiency in any organ: ARDS (67%),
acute renal failure (29%), heart failure (23%), liver failure (29%) and
pneumothorax (2%). 71% of patients required mechanical ventilation
(respiratory failure). Patients who died were older. (Yang et al., 2020)
Retrospective observational study of 81 patients admitted with COVID-19
pneumonia between December 2019 and January 2020 described the
radiological findings (chest CT). The most common initial symptoms were fever
(73%) and dry cough (59%). Other non-specific symptoms included dizziness
(2%), diarrhea (4%), vomiting (5%), headache (6%) and generalized weakness
(9%). In pulmonary images, 79% had bilateral pulmonary involvement, 54% with
peripheral distribution and 44% with diffuse distribution, involving mainly the
right lower lobes (27%). The predominant pattern of abnormalities observed
was ground-glass opacity (65%), ill-defined margins (81%), smooth or irregular
interlobular septal thickening (35%), air bronchogram (47%) and adjacent
pleura thickening (32%). COVID-19 pneumonia manifested itself with
radiological abnormalities even in asymptomatic patients (preclinical phase),
with rapid evolution from opaque unilateral ground glass to diffuse bilateral,
transforming into consolidations over three weeks. (Shi et al., 2020)
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
Using the data from these studies and following Kents guidelines (Lesson III,
1998), initially, we must register the symptoms present in a schematic way
(repertory classification), placing in front of each symptom the number of
patients (%) who manifested it, discovering the essential features of the
epidemic through the common symptomatic totality (pathognomonic signs and
symptoms) and characteristic (peculiar signs and symptoms). (Table 1)
Table 1. Total signs and symptoms of COVID-19
Total signs and
symptoms
Chen et al.,
2020 (n=99)
WHO, 2020
(n=55924)
Yang et al.,
2020 (n=52)
Shi et al., 2020
(n=81)
Fever
83%
87.9%
98%
73%
Chills
11.4%
Dry cough
82%
67.7%
77%
59%
Dyspnea
31%
18.6%
63.5%
unreported
Fatigue / Weakness
38.1%
9%
Malaise
35%
Dizziness
2%
Phlegm production
33.4%
Myalgia or arthralgia
11%
14.8%
11.5%
Mental confusion
9%
Headache
8%
13.6%
6%
Sore throat
5%
13.9%
Rhinorrhea
4%
6%
Nasal congestion
4.8%
Hemoptysis
0.9%
Conjunctival congestion
0.8%
Chest pain
2%
2%
Diarrhea
2%
3.7%
4%
Nausea and vomiting
1%
5.0%
5%
Respiratory failure
(acute) / ARDS
acute (8%) /
17% (ARDS)
acute (6.1%)
71% /
67% (SDRA)
unreported
Pneumonia
(higher risk in the
elderly and patients with
chronic diseases)
unreported
severe
(13.8%)
severe (100%)
severe (100%)
bilateral
(75%)
unreported
bilateral (79%)
peripheral (54%)
diffuse (44%)
right lower lobe
(27%)
Ground-glass opacity
14%
65%
Poorly defined margins
81%
Septal thickening
35%
Pleural thickening
32%
Air bronchogram
47%
Pneumothorax
1%
2%
Multiple organ failure /
sepsis
ARF (3%) /
septic shock
(4%)
6.1%
ARF (29%),
IC (23%),
IH (29%)
unreported
Note: not reported refers to the unquestionable existence of the sign/symptom, although it has
not been quantified and computed.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
Despite the absence of scientific studies to substantiate the occurrence of
anosmia in this epidemic, doctors from several countries (China, South Korea,
Italy, England, Germany, France, the United States and Iran, among others)
have reported loss of smell (and the consequent loss of taste) in a large
percentage of patients affected by COVID-19, suggesting that the presence of
sudden anosmia (associated or not with respiratory symptoms) may indicate
SARS-Cov-2 infection, as has been observed in other viruses (Suzuki et al.,
2007).
Another epidemiological data related to climatic factors, an aspect highly valued
by individualizing homeopathy as a general symptom (climatic susceptibility), it
is worth mentioning that this pandemic, as well as other epidemics caused by
respiratory viruses (influenza serotypes), is spreading in the spring seasons
(Northern Hemisphere) and autumn (Southern Hemisphere), in which cold and
dry weather predominates.
With the description of this set of signs and symptoms, observed in hundreds to
thousands of patients, we must select the most frequent and peculiar ones, in
order to have the epidemic genius of COVID-19. Then, it is necessary to
transform the common language of these signs and symptoms into a
repertory language (repertoire classification of signs and symptoms,
according to the repertoire homeopathic rubrics described in the Homeopathic
Symptom Repertory) (Ribeiro Filho, 1998) (Tables 2 and 3).
We will add to this set of repertoire homeopathic rubrics the one that groups the
homeopathic medicines that have shown clinical efficacy in other respiratory
virus epidemics (influenza) in the past, as described in the aforementioned
history (II.4. Evidence of the effectiveness of homeopathy in epidemic
diseases).
Table 2. Overall symptomatic totality of COVID-19
Signs and symptoms in common
language
Signs and symptoms in repertory language
(repertoire homeopathic rubrics)
Fever + dry cough (onset of the
picture in general)
COUGH - DRY - Fever, during
Dyspnea
RESPIRATION - DIFFICULT
Myalgia + Arthralgia
GENERALITIES PAIN - Muscles, of
GENERALITIES PAIN - Joints, of
Respiratory failure (acute) / Acute
respiratory distress syndrome (ARDS)
RESPIRATION IMPEDED, obstructed
RESPIRATION ANXIOUS
Pneumonia: in the elderly, bilateral,
CHEST INFLAMMATION, Lungs
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
peripheral (pleuropneumonia), diffuse
and in the right lower lobe
Radiological changes: ground-glass
opacity (interstitial thickening or
alveolar collapse); septal and pleural
thickening (infiltration or fibrosis)
CHEST INFLAMMATION, Lungs, old people
CHEST INFLAMMATION, Lungs, right
CHEST INFLAMMATION, Lungs, right, lower lobe
CHEST INFLAMMATION, Lungs, pleura-
pneumonia
CHEST INFLAMMATION, Pleura
Multiple organ failure / sepsis
KIDNEYS SUPPRESSION of urine (anuria)
GENERALITIES SEPTICEMIA, blood poisoning
Anosmia
NOSE AND SMELL SMELL, wanting, lost
Cold and dry weather worsens
(autumn and spring seasons)
GENERALITIES SEASONS, autumn, inn, agg.
GENERALITIES SEASONS, spring, in, agg.
GENERALITIES WEATHER, cold dry weather, agg.
Homeopathic medicines used in
influenza epidemics in the past
GENERALITIES - INFLUENZA
Table 3. General symptomatic totality of COVID-19 in repertory language
Then (Kent, Lesson III, 1998), using a repertoire of symptoms, the
homeopathic doctor will select six or seven drugs that cover the entire
symptomatic of that epidemic (group of individualized drugs of the epidemic
genius of COVID-19), fixing the tables of each medicine in the study of
Homeopathic Materia Medica.
Performing the repertorization of the overall symptomatic totality of COVID-19
(Table 4), there are several possibilities for individualized homeopathic
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
medicines of the epidemic genius to be used in this epidemic, such as: Bryonia
Alba, Phosphorus, Rhus toxicodendron and Arsenicum album, among others.
Table 4. Repertorization of the overall symptomatic totality of COVID-19
Then (Kent, Lição III, 1998), proceeding from the general to the particular, as
there is no other way to proceed in homeopathy, we can adapt the
characteristics of each patient to the particularities of each selected drug
(therapeutic individualization), because even in individuals of the same family,
a small difference in each case will be observed.
Therefore, we must also select particular signs and symptoms at each stage of
the disease and, subsequently, repertorize and select individualized drugs to
administer to the respective patients.
Most people infected with the COVID-19 virus have a mild illness and are
recovering. Approximately 80% of laboratory confirmed patients had mild to
moderate disease, which includes cases with and without pneumonia; 13.8% have
severe disease (dyspnea, respiratory rate 30/minute, blood oxygen saturation
93%, PaO2/FiO2 ratio < 300, and/or pulmonary infiltrate > 50% of the pulmonary
field in 24-48 hours); and 6.1% are critical (respiratory failure, septic shock and/or
multiple organ dysfunction/failure). (WHO, 2020, p. 12)
II.3.1. Homeopathic medicines of the epidemic genius for the prevention
or treatment of mild to moderate disease (COVID-19)
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
For these stages of the disease, we will use the signs and symptoms of mild to
moderate involvement (WHO, 2020), including pneumonia without major
complications. (Tables 5 to 7)
Table 5. Symptomatic totality for prevention or mild to moderate disease
Signs and symptoms in common
language
Signs and symptoms in repertory language
(repertoire homeopathic rubrics)
Fever + dry cough (onset of the
picture in general)
COUGH - DRY - Fever, during
Dyspnea
RESPIRATION - DIFFICULT
Myalgia + Arthralgia
GENERALITIES PAIN - Muscles, of
GENERALITIES PAIN - Joints, of
Pneumonia in the elderly
CHEST INFLAMMATION, Lungs
CHEST INFLAMMATION, Lungs, old people
Anosmia
NOSE AND SMELL SMELL, wanting, lost
Cold and dry weather worsens
GENERALITIES WEATHER, cold dry weather, agg.
Homeopathic medicines used in
influenza epidemics in the past
GENERALITIES - INFLUENZA
Table 6. Symptomatic totality for prevention or mild to moderate disease
Table 7. Repertorization of symptomatic totality for prevention or mild
to moderate disease
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
As in the repertorization of the overall symptomatic totality of COVID-19, there
are several possibilities of homeopathic medicines of the epidemic genius to be
used in prevention or in the mild to moderate disease, such as: Bryonia Alba,
Rhus toxicodendron, Arsenicum album and Phosphorus, among others.
II.3.2 Homeopathic medicines of the epidemic genius for the treatment of
severe disease (COVID-19)
For this stage of the disease, we will use the signs and symptoms of severe
involvement (Chen et al., 2020). (Tables 8 to 10)
Table 8. Symptomatic totality for severe disease
Signs and symptoms in common
language
Signs and symptoms in repertory language
(repertoire homeopathic rubrics)
Fever + dry cough (onset of the
picture in general)
COUGH - DRY - Fever, during
Dyspnea
RESPIRATION - DIFFICULT
Myalgia
GENERALITIES PAIN - Muscles, of
Respiratory failure (acute) / Acute
respiratory distress syndrome (ARDS)
RESPIRATION IMPEDED, obstructed
RESPIRATION ANXIOUS
Pneumonia: in the elderly and bilateral
CHEST INFLAMMATION, Lungs
CHEST INFLAMMATION, Lungs, old people
Cold and dry weather worsens
GENERALITIES WEATHER, cold dry weather, agg
Table 9. Symptomatic totality for severe disease
Tabela 10. Repertorization of the symptomatic totality to the severe disease
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
As in previous repertorizations, we could assume several possibilities for
individualized homeopathic medicines of the epidemic genius to be used in the
serious situation of COVID-19, such as: Bryonia alba, Arsenicum album, Nux
vomica and Phosphorus, among others.
II.3.3 Homeopathic medicines of the epidemic genius for the treatment of
critical states (COVID-19)
For critically ill patients, we will use the signs and symptoms of the very serious
involvement of COVID-19 (Yang et al., 2020; Shi et al., 2020). (Tables 11 to 13)
Table 11. Symptomatic totality for the critical state
Signs and symptoms in common
language
Signs and symptoms in repertory language
(repertoire homeopathic rubrics)
Respiratory failure (acute) / Acute
respiratory distress syndrome (ARDS)
RESPIRATION IMPEDED, obstructed
RESPIRATION ANXIOUS
Pneumonia: in the elderly, bilateral,
peripheral (pleuropneumonia), diffuse
and in the right lower lobe
Radiological changes: ground-glass
opacity (interstitial thickening or
alveolar collapse); septal and pleural
thickening (infiltration or fibrosis)
CHEST INFLAMMATION, Lungs
CHEST INFLAMMATION, Lungs, old people
CHEST INFLAMMATION, Lungs, right
CHEST INFLAMMATION, Lungs, right, lower lobe
CHEST INFLAMMATION, Lungs, pleura-
pneumonia
CHEST INFLAMMATION, Pleura
Multiple organ failure / sepsis
KIDNEYS SUPPRESSION of urine (anuria)
GENERALITIES SEPTICEMIA, blood poisoning
Table 12. Symptomatic totality for the critical state
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
Table 13. Repertorization of the symptomatic totality to the critical state
In turn, for the critical states of COVID-19, the repertorization of the respective
signs and symptoms suggests other possibilities of individualized homeopathic
medicines of the epidemic genius, such as: Phosphorus, Bryonia alba,
Mercurius solubilis and Arsenicum album, among others.
To those who question the possibility of using individualized homeopathy in
critically ill patients, some studies have been carried out in the area (Intensive
Care Unit or Intensive Therapy Unit), showing the benefits of complementary
and adjuvant therapy for homeopathic treatment in these cases. (Oberbaum et
al., 2005; Teixeira et al., 2008; Frass et al., 2011; Frass et al., 2015)
As mentioned in the teachings of Hahnemann and Kent, the different
individualized homeopathic medicines of the epidemic genius, selected for the
different stages of COVID-19, must be individualized according to the
particularities of each patient, because no remedy must be given because it is
in the list, for the list has only been made as a means of facilitating the study of
that epidemic (Kent, 1998, Lesson III). Hard work of the homeopathic doctor
before his patients, to whom he dedicates his individual care and takes
responsibility for his actions.
However, if you want to indicate a homeopathic medicine of the epidemic
genius to treat or prevent an epidemic disease in a given population or
community, without individual monitoring and prescription, it is essential
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
to submit it to a properly designed clinical research protocol in order to
that its effectiveness and safety can be assessed.
Only then, in line with the bioethical principles of beneficence and non-
maleficence, could it be suggested for large-scale use. As Hippocrates said,
primum non nocere.
II.4. Ethical and bioethical aspects of research in human beings
Any research project involving human beings, such as the administration of a
supposed homeopathic medicine of the epidemic genius to a population or
community, without previous scientific proof of its efficacy and safety, must
comply with Resolution No. 466 of December 12, 2012, Ministry of Health/
National Health Council (Brazil, 2012), which incorporates, from the
perspective of the individual and collectivities, bioethical references, such as
autonomy, non-maleficence, beneficence, justice and equity, among others, and
aims to guarantee the rights and duties that concern research participants, the
scientific community and the State.
Among the ethical aspects of research involving human beings, several
fundamentals must be observed, such as: respect for the research participant,
balance between risks and benefits, guarantee that predictable damages will be
avoided and social relevance of the research.
On the other hand, the research must observe numerous requirements, among
which: be adequate to the scientific principles that justify it and with concrete
possibilities to respond to uncertainties; be based on scientific facts, previous
experimentation and/or assumptions appropriate to the specific area of
research; be carried out only when the knowledge to be obtained cannot be
obtained by other means; always seek that the expected benefits prevail over
the foreseeable risks and/or discomforts; obtaining free and informed consent
from the research participant and/or his legal representative; to assure research
participants the conditions for follow-up, treatment, comprehensive assistance
and guidance, as necessary; among others.
All research involving human subjects must be submitted to the appreciation of
Research Ethics Committees (CEP) or the National Research Ethics Committee
(CONEP), which, when analyzing and deciding to approve it, becomes co-
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
responsible for ensuring the protection of participants. The ethical review of
research projects involving human beings must be associated with their
scientific analysis, which must be correctly based on the text.
The researchers responsibility is non-delegable and indeclinable and includes
ethical and legal aspects, and the researcher is responsible for: submitting the
protocol duly instructed to CEP or CONEP, awaiting the decision for ethical
approval, before starting the research; prepare the Informed Consent Form
(ICF); develop the project as outlined; preparing and presenting the partial and
final reports; among other duties and responsibilities.
Among countless other ethical and bioethical aspects of research involving
human beings, we have brought some basic premises to exemplify the serious
shortcomings committed by those who intend to distribute homeopathic
medicines indiscriminately to an entire community without observing the ethical
and bioethical principles, fundamental for that the safety of the participants and
the effectiveness of the measure are guaranteed.
For the administration of a specific homeopathic medicine of the epidemic
genius to a population, or any other therapeutic proposal without scientific proof,
it is necessary to carry out previously controlled clinical trials, in accordance
with the steps mentioned in that Resolution.
This protocol is intended to exemplify the indispensable aspects for the
elaboration of a clinical research project, as well as the dynamics necessary to
execute a protocol according to ethical and scientific guidelines, clarifying
homeopathic colleagues as to the premises that must be followed in clinical
research involving human beings.
On the other hand, we are submitting this protocol to researchers and health
managers, requesting an opportunity to propose, discuss and apply this
proposal in the research institutions and health services that work and/or
administer it, in order to research and select medicines homeopathic drugs of
the epidemic genius of COVID-19 appropriate for the various stages of the
disease, as well as, in a second moment, to be able to apply it in a preventive
and community way.
In addition to previous expectations, the disclosure of this protocol in an online
and freely accessible form (indexed in the VHL Regional Portal) also aims to
raise awareness and invite other researchers, homeopaths or not, to apply the
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
method proposed in their work or research units, allowing the increase in the
sample of patients (greater accuracy of the results) and the elaboration of a
multicenter research project on the use of homeopathy in epidemic diseases.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
III. STUDY JUSTIFICATION
In view of the absence of preventive and/or curative therapies for the current
SARS-Cov-2 outbreak that plagues humanity, of the hundreds of thousands of
infected individuals worldwide, of millions of infect individuals by COVID-19,
among which hundreds of thousands died, and since Brazil is the actual
epicenter of this pandemic, with an exponential increase in patients and deaths,
it is essential to search for other therapeutic and/or prophylactic approaches
that can act in an adjuvant and complementary way to the measures hygienic
and isolation standards, with homeopathy being a low cost and safe alternative.
Just as it has acted in the prevention and treatment of several epidemics in the
past, the individualized homeopathic medicine for the epidemic genius of
COVID-19 could be adopted in all segments of health services and society, as
long as it proves to be effective and safe.
After the in-depth study and the survey of some drug hypotheses that can act
therapeutically and preventively in the current epidemic, we are proposing to
conduct a double-blind, placebo-controlled study to test the efficacy and safety
of the homeopathic medicine(s) X, Y and/or Z (one must choose which or which
drugs to be tested) in the adjuvant and complementary treatment of the various
stages of COVID-19.
If the hypothesis is confirmed in the treatment of the initial stages of the disease
(mild to moderate disease), the drug may also be used on a large scale in the
prevention of the current epidemic, as Hahnemann observed in the use of
Atropa belladonna in the treatment and prevention of scarlet fever: a medicine
that is capable of quickly blocking a disease in its beginnings should also be
your best preventive (Cure and prevention of scarlet fever, Hahnemann,
2006b).
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
IV. STUDY OBJECTIVE
The objective of this study will be to evaluate the effectiveness of the
homeopathic medicine(s) X, Y and/or Z (one must choose which or which
medicines to be tested) in dynamizations/potencies 30, 200 and 1000cH as
treatment adjuvant and complementary in the various stages of COVID-19,
through a randomized, double-blind and placebo-controlled clinical trial.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
V. PATIENTS AND METHOD
With this project, we propose to conduct a randomized, double-blind and
placebo-controlled short-term clinical trial (2-3 months) administering the
homeopathic medicine(s) X, Y and/or Z (one must choose which or which
medicines to be tested) (dynamizations/potencies 30, 200 and 1000cH) or
placebo to patients with COVID-19 at different stages of the disease,
concomitant with conventional support and treatment measures.
This study will be carried out with patients admitted to ward/infirmary or ICUs of
___ (Institution where the study will be carried out).
The ethical, practical and biosafety principles stipulated by the Ministry of
Health and the institutions Human Research Ethics Committees will be
respected, as well as the technical protocols of the hospital and the doctors
involved. The study will be initiated only after approval by the Institutions
Research Ethics Committee.
V.1. Sample calculation
For each stage of COVID-19 (mild to moderate disease, severe disease and
critical state), 50 patients (25 in each group: active and placebo) with manifest
disease and diagnosed by quantitative examination of the load will be studied
viral (RT-qPCR), followed up on ___ and/or ___ (ward and/or ICU of the
referred Institution). All patients and/or their companions/guardians will be
previously informed about the study and will sign the Informed Consent Form
(Annex 1) before entering the protocol.
V.2. Inclusion and exclusion criteria
Inclusion criteria will be considered: ___ (if any, include according to the
population chosen to participate in the project)
Exclusion criteria will be considered: ___ (if any, include according to the
population chosen to participate in the project)
V.3. Study dynamics
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
To participate in the project, the medical records of patients monitored at the
___ and/or ___ (ward and/or ICU of the referred Institution) will be evaluated in
order to confirm the general inclusion/exclusion criteria. If so, patients and/or
their companions/legal guardians will sign the Informed Consent Form (ICF)
(Annex 1).
V.3.1. Randomized, double-blind and placebo-controlled clinical trial
Once the inclusion/exclusion criteria are fulfilled and the ICF is signed, patients
and/or their companions/legal guardians will be referred to the performing
researcher to be informed about the dynamics of the proposed homeopathic
treatment and will receive the active homeopathic medicine(s) (X, Y and/or Z at
dynamization 30CH) or placebo, according to a randomization scale previously
stipulated according to the number of the patient entering the protocol (01, 02,
03, etc.) or bed number of ward room/ICU, each with its specific bottle,
previously randomized and blinded to the drug in use (active or placebo), so
that the researcher and patients are unaware of the allocated group.
Every patient will remain in the same allocated group (active or placebo) until
the end of their hospital treatment and the administration of the medicine(s)
(active or placebo) to patients will be performed by the team of nursing in the
prescribed dosage.
The drug(s) (active or placebo) will be administered initially in the dosage of 3
drops, 4 times a day (can be individualized, increased or decreased, according
to the stage of the disease and the evolution of the framework). Any change in
dosage must be included in the patients medical record, in order to enable
future analysis of the evolution of the groups (active and placebo).
In the case of randomization by bed number of ward room/ICU, with patient
discharge, the new patient will remain in the same group (active or placebo)
as the bed room initially randomized, facilitating the work of distribution and
medicine administration by the nursing team.
Patients will be evaluated daily (or several times a day) by the performing
researcher(s), during the hospitalization/treatment period. Each day, the effects
of the drug (active or placebo) on the general evolution of the clinical picture
will be assessed by reading the medical record, talking to the medical team
and/or individual anamnesis, allowing for an adjustment in dosage (doses and
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
potencies of the homeopathic medicine) depending on the clinical response: in
case of constant and progressive response, the 30cH potency will be
maintained; in case of absence or insufficient response, the potency will be
increased to 200cH and 1000cH, successively.
This potencies individualization becomes necessary to obtain progressive
gains in the homeopathic therapeutic response, due to the tolerance to the
same potency observed after a period of use (analogous to oral
immunotherapy).
As a mandatory premise for assessing the security of the proposal, possible
adverse events will be assessed periodically, being reported on the Adverse
Events Form (Annex 2).
Patients and their companions legal guardians will have easy access to the
researcher (phones and whatsapp), so that possible changes in the clinical
condition are communicated and the inherent measures (adjustment in dosage)
are quickly instituted.
At the end of the hospital treatment period, patient data will be computed and
stored, so that the evolution of the groups can be analyzed statistically.
V.3.2. Preparation and delivery of medicine
Will the preparation and supply of the active drugs (X, Y and/or Z in the
dynamizations 30, 200 and 1000cH) and placebo for the study period be
carried out by the ___ Laboratory or Pharmacy (responsible pharmacist and
contact).
The medicine will be made available in liquid form, in a 20% hydroalcoholic
solution, packaged in 60ml bottles with droppers and dispensed according to
the Brazilian Homeopathic Pharmacopoeia (Farmacopéia Homeopática
Brasileira, 2011). The vials with a volume of 60 ml will be sufficient for the
proposed dosage for each patient for a period of 2 months (3 drops, 4 times a
day, which corresponds to 720 drops), being replaced when they are finished.
V.3.3. Statistical analysis
The different variables of the clinical evolution of COVID-19 will be analyzed
statistically (global analysis between active and placebo groups), to verify the
possible existence of a significant clinical response to interventions.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
Quantitative variables will be described according to groups using summary
measures and compared between groups using comparative tests, t-Student
tests or Mann-Whitney tests according to the probability distribution of the
variables.
V.3.4. Work plan
This project has a perspective of duration of n (weeks or months) divided as
follows: n1 (days or weeks) for the selection of patients, n2 (weeks or months)
for the clinical trial and n3 (weeks or months) months for analysis and
publication of the results, according to the work plan below. (Table 14)
Table14. Work plan with project phases and procedures
Project phases
Responsible
Procedures
Selection of patients
Institution
professional
Anamnesis and/or reading of the medical record to
confirm the inclusion/exclusion criteria and signing the
Informed Consent Form.
Start of treatment
Performing
researcher(s)
Clarification on the dynamics of treatment and start of
the dispensing of active and placebo medicines
according to the randomization scale.
Throughout the
treatment period
Performing
researcher(s)
Daily assessment of patients in order to adjust the
dosage in accordance with the evolution of the clinical
picture.
End of treatment
period
Performing
researcher(s)
Patient data will be computed and stored.
Analysis and
publication of results
Performing
researcher(s)
Data tabulation, statistical analysis, writing and
publication of results.
V.3.5. Budget
The estimated budget for carrying out this project is based on the cost of
medicines, being estimated at $$ (value of costs).
V.3.6. Work team
1. Researcher in charge: Prof. Dr.Marcus Zulian Teixeira
2. Performing researcher:
3.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
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Teixeira MZ. Similitude in modern pharmacology. Br Homeopath J 1999; 88(3):
112-20.
Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative
rebound effect. Med Hypotheses 2003 ;60(2): 276-83.
Teixeira MZ. Paradoxical strategy for treating chronic diseases: a therapeutic
model used in homeopathy for more than two centuries. Homeopathy 2005;
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Teixeira MZ. Evidence of the principle of similitude in modern fatal iatrogenic
events. Homeopathy 2006; 95(4): 229-36.
Teixeira MZ. NSAIDs, Myocardial infarction, rebound effect and similitude.
Homeopathy 2007a; 96(1): 67-8.
Teixeira MZ. Bronchodilators, fatal asthma, rebound effect and similitude.
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Clinical research protocol to evaluate the effectiveness and safety of individualized
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Clinical research protocol to evaluate the effectiveness and safety of individualized
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
VII. ANNEXES
VII.1. Annex 1 Informed Consent Form (ICF)
Informed Consent Form (ICF)
Research data
Research title: Clinical research protocol to evaluate the effectiveness and safety of
individualized homeopathic medicine in the treatment and prevention of the covid-19
epidemic
Researcher in charge: Prof. Dr. Marcus Zulian Teixeira
Department/ Institution:
Identification data of the participant or legal guardian
1. Name:
Identity document No.: Sex: M□ F□
Date of birth:
Address:
2. Legal guardian:
Nature (degree of kinship, guardian, curator, etc.):
Identity document No.: Sex: M□ F□
Date of birth:
Address:
Introduction: You are being invited as a volunteer to participate in this clinical research
because you have coronavirus disease (COVID-19), are experiencing symptoms of the
disease and are receiving conventional treatment. This is a study on the efficacy and
safety of homeopathic treatment in patients with COVID-19, associated with
conventional treatment (complementary homeopathic treatment). The aim of this study
will be to evaluate the efficacy of the homeopathic medicine X, Y and/or Z, compared to
the use of placebo in the complementary treatment of COVID-19. For this, all
participants will receive ‘active’ homeopathic medicine (X, Y and/or Z) or ‘inactive’ or
‘placebo’ medicine (inert substance with no pharmacological effect) during the period of
n2 weeks (randomized, double-blind and placebo-controlled clinical trial). All patients
will be randomly distributed in these two groups (‘active’ medicine or ‘placebo’
medicine) and, like the homeopathic doctor, you won't know which group is allocated
(double-blind).
Procedures: Patients under conventional treatment and at all stages of the disease will
be included in this study.
If you agree to participate, you will be referred to the homeopathic doctor to start
treatment during your stay at this hospital, with daily evaluations of the homeopathic
doctor in conjunction with the other teams.
The medicines will be given at a dose of 3 drops, in the mouth, 4 times a day (every 6
hours). These doses may be increased or decreased according to the evaluation of the
homeopathic doctor, seeking a progressive improvement of his condition.
Discomforts and risks: All types of clinical research may involve some risk, and not all
are predictable. You may experience some discomfort during treatment due to the
occurrence of adverse reactions. Although homeopathic treatment does not usually
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
present serious adverse effects, it is important that any bothersome event that may
occur during the study is promptly reported to the homeopathic doctor.
Benefits: No direct benefits are guaranteed to participants. This is an experimental
study testing the hypothesis that homeopathic treatment can help in the improvement
of patients with COVID-19. Only at the end of the study can we conclude about the
presence of some benefit. Its participation may contribute to the development of a
therapeutic alternative to the current epidemic caused by coronavirus.
Alternative therapies: There are several conventional medications to treat disorders
caused by the disease and you do not need to participate in this study for your problem
to be treated with the therapies already approved. If you decide not to participate in the
study, you will receive treatment deemed appropriate for your condition.
Guaranteed access: At any stage of the study, you will have access to the
professionals responsible for the research to clarify any doubts. The main investigator
is the Dr. ___ which can be found in this ward (or CTI) or by phone/ whatsapp ___. If
you have any consideration or questions about research ethics, please contact the
Research Ethics Committee (CEP) (address and contacts).
Participation and closure: You are free to refuse to participate or withdraw your consent
and discontinue treatment at any time. Participation is voluntary and refusal to
participate will not incur any penalty or loss of benefits. Refusal or interruption shall in
no way prejudice the benefit of receiving any treatment, now or in the future, at this
Institution.
Secrecy and confidentiality: Your doctors will treat your identity with professional
standards of secrecy. Your chart will remain confidential. The information obtained will
be analyzed together with other patients, and the identification of any patient is not
disclosed. The researcher undertakes to use the data and the material collected only
for this research. A copy of this informed consent will be archived in your medical
records and one will be provided to you.
Update on results: During the course of the study, you will be informed about the partial
results of the research. If these new findings make it necessary to reassess your
individual situation or interrupt your participation in the study, the homeopathic doctor
will inform you. There may be circumstances in which you will be removed from the
study. These include marked worsening of your condition, not adherence to the
medication under study, if the researcher considers that it is in your best interest or if
the study is interrupted. You may be removed without the need for your consent. In
case of personal damage, directly caused by the procedures or treatments proposed in
this study (proven causal link), the participant will be entitled to medical treatment at
the Institution.
Expenses and compensation: There are no personal expenses for the participant at
any stage of the study. There is also no financial compensation related to your
participation.
Patient statement: I believe I have been sufficiently enlightened about the information I
have read or that has been read to me, describing the study Clinical research
protocol to evaluate the effectiveness and safety of individualized homeopathic
medicine in the treatment and prevention of the covid-19 epidemic. I discussed
with Dr. ___ about my decision to participate in this study. It was clear to me what are
the purposes of the study, the procedures to be performed, their discomforts and risks,
the guarantees of confidentiality and permanent clarification. It was also clear that my
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
participation is free of charge and that I am guaranteed access to conventional
treatment. I voluntarily agree to participate in this study and may withdraw my consent
at any time, before or during it, without penalty, injury or loss of any benefit I may have
acquired, including my care at this Hospital.
________________________________________
Signature of patient or legal representative Date: _____ / _____/ _____
________________________________________
Witness signature Date: _____ / _____/ _____
(Only for the project manager)
I declare that I have obtained in an appropriate and voluntary manner the Informed
Consent Form of this patient or legal representative for participation in this study.
________________________________________
Signature of the responsible for the study Date: _____ / _____/ _____
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Clinical research protocol to evaluate the effectiveness and safety of individualized
homeopathic medicine in the treatment and prevention of the covid-19 epidemic
VII.2. Annex 2 - Adverse Events Form
Patient: Identification:
Adverse Events Form
(include all adverse events that the patient has had since the previous visit, whether or
not it is related to the drug)
Adverse
Event
Start/
Finish
Event Type
(C) Constant
(I) Intermittent
(A) After
dosing
Severity
1. Mild
2. Moderate
3. Severe
4. Potentially
fatal
Relationship
0. Unrelated
1. Possible
2. Likely
3. Related
Investigator's
Action
0. None
1. Change in dose
2. Medication withdrawal
3. Introduction of new
medication
4. Discontinuation of the
study
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In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic.
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The article discussed the immanent problems of meta-analyses selecting a number of independent trials in homeopathy, within which, the purpose was to examine the effectiveness of homeopathic treatment. Our focus lied in clarifying that the complex effects of homeopathic treatment known from history and day-to-day practice have not been respected so far. The examination of most of the homeopathic trials showed that studies rarely account for homeopathic principles, in order to assess the effectiveness of the treatment. The main flaw was that trials reflect the point of view that the treatment with a specific remedy could be administered in a particular disease. However, homeopathy aims to treat the whole person, rather than the diseases and each case has to be treated individually with an individualized remedy. Furthermore, the commonly known events during the course of homeopathic treatment, such as “initial aggravation” and “symptom-shift” were not considered in almost all the studies. Thus, only few trials were eligible for meta-analyses, if at all. These and other factors were discussed and certain homeopathic principles were suggested to be respected in further trials. It is expected, that a better understanding of homeopathic principles would provide guidelines for homeopathic research, which are more acceptable to both homeopathy and conventional medicine.
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BackgroundA rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment. Methods Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised ‘reliable evidence’ if its risk of bias was low or it was unclear in one specified domain of assessment. ‘Effect size’ was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy. ResultsForty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as ‘high risk of bias’ and 23 as ‘uncertain risk of bias’; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was –0.33 (95% confidence interval (CI) –0.44, –0.21), which was attenuated to –0.16 (95% CI –0.31, –0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: –0.18 (95% CI –0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence. Conclusions The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.
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This is a unique work, which documents how homeopathy can achieve predictably successful results in emergencies such as anaphylactic shock, acute abdomen, acute asthma, myocardial infarction of the inferior wall, and oedema of the glottis. The book contains 145 well-documented case histories, similar to those written by the old American homeopathic clinicians. In each case it is clearly demonstrated how to quickly find the best remedy using straightforward Kentian repertorisation. The results are impressive. The authors show that conventional treatment and homeopathy can perfectly complement each other. This work offers also a lot of general information on homeopathy like potentisation, source materials used in homeopathic remedies and methods of administration. It also comprises a stringently edited materia medica of the most important 70 remedies for ICU and emergency situations. Both editors have extensive experience in emergency medicine and homeopathy. Michael Frass is former head of the intensive internal medicine unit at the Medical University of Vienna and Martin Bünder also has long-standing service in rescue and emergency medicine. Available at: http://www.narayana-verlag.com/homeopathy/pdf/Homeopathy-in-Intensive-Care-and-Emergency-Medicine-Michael-Frass-Martin-Buendner.14188_1.pdf
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Em virtude da valorização dos aspectos técnico-científicos no modelo biomédico, aspectos subjetivos da individualidade foram desprezados, tornando a medicina moderna desumanizada e reducionista na abordagem do processo de adoecimento humano. Com o intuito de resgatar a relação médico-paciente e a atenção integral ao indivíduo enfermo, com nítidos reflexos na qualidade e eficácia dos serviços prestados, a preocupação com a humanização da saúde passou a ser uma prioridade dos sistemas públicos, com a implantação de iniciativas nos diversos níveis de atenção. Desta forma, propostas humanísticas estão sendo incorporadas à formação médica nos cursos de graduação em Medicina e na rede de Atenção Básica em Saúde, visando contemplar, entre outros aspectos, "a compreensão dos determinantes sociais, culturais, comportamentais, psicológicos, ecológicos, éticos e legais, nos níveis individual e coletivo do processo saúde-doença". Neste contexto, o modelo homeopático, por aplicar em sua prática clínica diária uma abordagem semiológico-terapêutica individualizante e humanística na compreensão do processo saúde-doença e no tratamento das enfermidades, valorizando os determinantes éticos, filosóficos, antropológicos, psicológicos e socioambientais, poderia contribuir de forma adjuvante e complementar a humanização da formação médica, desde que seus preceitos sejam incorporados de forma regular e gradativa ao processo ensino-aprendizagem das instituições públicas e acadêmicas.
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Article
Background: An ongoing outbreak of pneumonia associated with the severe acute respiratory coronavirus 2 (SARS-CoV-2) started in December, 2019, in Wuhan, China. Information about critically ill patients with SARS-CoV-2 infection is scarce. We aimed to describe the clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia. Methods: In this single-centered, retrospective, observational study, we enrolled 52 critically ill adult patients with SARS-CoV-2 pneumonia who were admitted to the intensive care unit (ICU) of Wuhan Jin Yin-tan hospital (Wuhan, China) between late December, 2019, and Jan 26, 2020. Demographic data, symptoms, laboratory values, comorbidities, treatments, and clinical outcomes were all collected. Data were compared between survivors and non-survivors. The primary outcome was 28-day mortality, as of Feb 9, 2020. Secondary outcomes included incidence of SARS-CoV-2-related acute respiratory distress syndrome (ARDS) and the proportion of patients requiring mechanical ventilation. Findings: Of 710 patients with SARS-CoV-2 pneumonia, 52 critically ill adult patients were included. The mean age of the 52 patients was 59·7 (SD 13·3) years, 35 (67%) were men, 21 (40%) had chronic illness, 51 (98%) had fever. 32 (61·5%) patients had died at 28 days, and the median duration from admission to the intensive care unit (ICU) to death was 7 (IQR 3-11) days for non-survivors. Compared with survivors, non-survivors were older (64·6 years [11·2] vs 51·9 years [12·9]), more likely to develop ARDS (26 [81%] patients vs 9 [45%] patients), and more likely to receive mechanical ventilation (30 [94%] patients vs 7 [35%] patients), either invasively or non-invasively. Most patients had organ function damage, including 35 (67%) with ARDS, 15 (29%) with acute kidney injury, 12 (23%) with cardiac injury, 15 (29%) with liver dysfunction, and one (2%) with pneumothorax. 37 (71%) patients required mechanical ventilation. Hospital-acquired infection occurred in seven (13·5%) patients. Interpretation: The mortality of critically ill patients with SARS-CoV-2 pneumonia is considerable. The survival time of the non-survivors is likely to be within 1-2 weeks after ICU admission. Older patients (>65 years) with comorbidities and ARDS are at increased risk of death. The severity of SARS-CoV-2 pneumonia poses great strain on critical care resources in hospitals, especially if they are not adequately staffed or resourced. Funding: None.
Article
Background: In December, 2019, a pneumonia associated with the 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China. We aimed to further clarify the epidemiological and clinical characteristics of 2019-nCoV pneumonia. Methods: In this retrospective, single-centre study, we included all confirmed cases of 2019-nCoV in Wuhan Jinyintan Hospital from Jan 1 to Jan 20, 2020. Cases were confirmed by real-time RT-PCR and were analysed for epidemiological, demographic, clinical, and radiological features and laboratory data. Outcomes were followed up until Jan 25, 2020. Findings: Of the 99 patients with 2019-nCoV pneumonia, 49 (49%) had a history of exposure to the Huanan seafood market. The average age of the patients was 55·5 years (SD 13·1), including 67 men and 32 women. 2019-nCoV was detected in all patients by real-time RT-PCR. 50 (51%) patients had chronic diseases. Patients had clinical manifestations of fever (82 [83%] patients), cough (81 [82%] patients), shortness of breath (31 [31%] patients), muscle ache (11 [11%] patients), confusion (nine [9%] patients), headache (eight [8%] patients), sore throat (five [5%] patients), rhinorrhoea (four [4%] patients), chest pain (two [2%] patients), diarrhoea (two [2%] patients), and nausea and vomiting (one [1%] patient). According to imaging examination, 74 (75%) patients showed bilateral pneumonia, 14 (14%) patients showed multiple mottling and ground-glass opacity, and one (1%) patient had pneumothorax. 17 (17%) patients developed acute respiratory distress syndrome and, among them, 11 (11%) patients worsened in a short period of time and died of multiple organ failure. Interpretation: The 2019-nCoV infection was of clustering onset, is more likely to affect older males with comorbidities, and can result in severe and even fatal respiratory diseases such as acute respiratory distress syndrome. In general, characteristics of patients who died were in line with the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia. Further investigation is needed to explore the applicability of the MuLBSTA score in predicting the risk of mortality in 2019-nCoV infection. Funding: National Key R&D Program of China.
Article
Objective: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebo-controlled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50) decreased by 12.82 (P < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28; P < 0.001), non-cyclic pelvic pain (2.71; P = 0.009), and cyclic bowel pain (3.40; P < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: NCT02427386.
Article
Background: Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis. Methods/design: The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program 'New Homeopathic Medicines: use of modern drugs according to the principle of similitude' (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention. Discussion: The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016. Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02427386.