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HOMEONEWS
Edición N° 16
Año 2012
2012
Segundo Semestre
Director: Farm. Fernando Estevez Castillo
DISTRIBUCION GRATUITA
PARA PROFESIONALES DE LA SALUD
SALUD
Homeonews
Edición N° 16 – Año 2012
Edición n° 16
Año 2012
Registro de la Propiedad Intelectual n°: 505276
Director: Fernando Oscar Estevez Castillo
Propietario: Fernando Oscar Estevez Castillo
E.Mail: [email protected] ó
[email protected]
Director: Fernando Estevez Castillo
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INDICE
1- Editorial, pág. 5.
2- Fitoterapia:
Tres hierbas para el tratamiento de la agitación nerviosa en niños; pág. 6.
3- Alopatía:
Evaluación de la función sexual masculina en pacientes con síntomas del
tracto urinario inferior (LUTS) asociados con hiperplasia prostática benigna
(BPH) tratados con un medicamento fitoterápico (Permixon), Tamsulosina o
Finasteride, pág. 16.
El impacto de las benzodiacepinas sobre la aparición de la pneumonía y la
mortalidad por la misma: un estudio de caso y control anidado y análisis de
sobrevida en un cohorte de base poblacional, pág. 17.
4- Homeopatía:
Efecto de los medicamentos homeopáticos en el estudio polisomnográfico
del sueño en adultos jóvenes con antecedentes de insomnio relacionado al
consumo de café, pág. 18.
5- Nutrición:
Variación de los efectos de tres desayunos diferentes sobre la saciedad
subjetiva y la posterior ingesta de energía a través del almuerzo y cena,
pág. 33.
6- Notas de interés:
-Jornada Internacional de actualización en Medicina Complementaria –
Módulo I “Nuevas opciones terapéuticas en enfermedades crónicas, pág.
44.
-Conferencia-Debate: Plantas medicinales y alimenticias: ejemplo de
neodesarrollo agrícola-productivo con inclusión social, pág 45.
-III Jornadas de Farmacia del Sudoeste Bonaerense, pág 50.
-Jornada de Medicina Biológica e Integrativa, pág. 54.
7- Novedades:
-Programa radial: “Amigos de lo Natural”, pág. 56.
-Nuevos productos: AloeGel; pág. 57.
-Carrera de Farmacia: Cátedra “Homeopatía”; pág. 58.
.
8- Ateneos y Cursos:
Homeonews
-Ateneos del Departamento de Homeopatía de la Universidad Maimónides
pág. 58.
-Cursos de la Sociedad Latinoamericana de Fitomedicina, pág. 59.
9- Formulario de suscripción, pág. 60.
Foto de tapa: Valeriana officinalis L. (Valerianaceae).
Las opiniones vertidas en los artículos firmados son responsabilidad de sus autores.
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EDITORIAL
Estimados colegas del equipo de salud:
Llegamos al final de este año, y no quería perder oportunidad de
reencontrarme con Uds. a través de un nuevo número de Homeonews, muy
completo, con trabajos realmente interesantes, y el resumen de muchas
actividades realizadas durante el 2012. .
En las próximas páginas, podrán encontrar un trabajo de FITOTERAPIA sobre
el tratamiento de la agitación nerviosa en niños con una mezclas de tres
extractos de hierbas; en ALOPATÍA, los efectos de tres medicamentos
utilizados para el tratamiento de la hiperplasia prostática benigna, sobre
la función sexual masculina y la relación de las benzodiacepinas con la
aparción de pneumonía y la mortalidad por la misma. En el Capítulo de
HOMEOPATÍA, una investigación realizada en Estados Unidos, para medir el
efecto de algunos medicamentos homeopáticos en el estudio
polisomnográfico del sueño en adultos jóvenes con insomnio relacionado
al consumo de café. Pasando a NUTRICIÓN, el estudio de tres desayunos
diferentes y sus efectos sobre la saciedad y la posterior ingesta de
energía a través del almuerzo y cena. En NOTAS DE INTERES, los
pormenores y resúmenes de cuatro eventos muy interesantes: “Jornada
Internacional de actualización en Medicina Complementaria” (Venezuela),
Diálogos del saber: Plantas medicinales y alimenticias, ejemplo de
neodesarrollo agrícola-productivo con inclusión social (Buenos Aires); III
Jornadas de Farmacia del Sudoeste Bonaerense (Bahía Blanca) y la
Jornada de Medicina Biológica e Integrativa (Neuquén). Con respecto a
NOVEDADES, Laboratorios Dr. Madaus presentó un nuevo producto, llamado
AloeGel; se designó a un nuevo cuerpo docente para la Cátedra de
Homeopatía, de la carrera de Farmacia de la Universidad Maimónides; una
destacada y prestigiosa incorporación a la conducción del programa radial
“Amigos de lo Natural” y en ATENEOS Y CURSOS, distintas alternativas
para sumar conocimientos.
Seguramente este mes, con la suma de compromisos sociales y familiares,
además de los balances laborales del año que se va y los proyectos para el
que viene, no va a ser el mejor momento para la lectura completa o en parte de
Homeonews,
Homeonews, pero se acercan las vacaciones, y quizás podemos aprovechar
ese tiempo para intercalar con nuestros momentos de ocio y esparcimiento, tan
necesarios y merecidos.
Bueno llegó el momento de despedirme, deseándoles que pasen unas muy
Felices Fiestas y que el año próximo sea el que Todos deseamos y
soñamos!!!
Farm. Fernando Estévez Castillo
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FITOTERAPIA
TRES HIERBAS PARA EL TRATAMIENTO DE LA AGITACION NERVIOSA
EN NIÑOS
Trompetter I, Krick B, Weiss Ga
a
PASCOE pharmazeutische Präparate GmbH, Schiffenberger Weg 55, 35394, Giessen,
Germany
[Wien Med Wochenschr. 2012 Nov 22]
RESUMEN
Los problemas emocionales y conductuales en niños y adolescentes no son
excepcionales. Emotional and behavioral problems in children and adolescents
are no exception. Para poder ver si una combinación de extractos de plantas,
puede ayudar a niños que sufren agitación nerviosa por aproximadamente dos
años, debido a depresión, entre otras causas, se realizó un estudio
observacional prospectivo, multicéntrico (2008), en 115 niños, entre 6 y 12
años. Las evaluaciones de los padres, mostraron una clara mejoría en los niños
con problemas de atención, que mostraban aislamiento social y/o eran
ansiosos/depresivos. Basado en las evaluaciones de los médicos, al final de la
observación, el 81.6-93.9 % de los niños afectados, no tenían síntomas o solo
algunos leves, teniendo en cuenta nueve de los trece evaluados, tales como
depresión, ansiedad en la escuela, otras ansiedades, problemas para dormir y
diferentes problemas físicos. El éxito terapéutico no fue influenciado por
medicación adicional u otras terapias. El tratamiento fue bien tolerado. Los
extractos de plantas utilizados, se han obtenido a partir St. John's Wort,
valeriana raíz, y passiflora.
Palabras clave: Agitación nerviosa, ansiedad, depresión, extractos de plantas,
niños.
ARTICULO ORIGINAL
Introduction
Especially, young people need a strong mental well-being to cope with all the
intricacies of life. However, during the last 16 years, the number of children and
adolescents showing psychosomatic symptoms is consistently high. There
might be no epidemic [1], but the following numbers are alarming anyway. In
any given year, worldwide 20 % of young people experience a mental health
problem, most commonly depression or anxiety [2]. In Austria, pupils every day
or at least several times a week suffer from sleep disorders (17.2 %), headache
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(14.4 %), petulance (14.2 %), nervousness (11.7 %), and/or backache (11.7 %)
[3]. Similar numbers have been measured in other countries, e.g., in Canada,
21–27 % of grade 6 adolescents feel depressed at least once a week, 21 % of
children at 2–5 years of age suffer from high levels of emotional problems,
anxiety problems, lack of concentration, and/or hyperactivity [4, 5].These
numbers are similar in other countries. In Germany, every sixth child or
adolescent shows psychiatric disorders [6, 7].
There is a scientific consensus that these children (and their families) have to
be supported and treated with adequate therapies [7–9], at least because
children with anxieties and depressive episodes are at increased risk for severe
emotional problems in adolescence and adulthood [10]. The broad range of
interventions for anxieties, nervousness, and depression involve cognitive
behavioral therapy as well as mostly chemical antidepressants, anxiolytics, and
hypnotics [11–13]. Especially, treatment with traditional allopathic medication is
controversially discussed addressing efficacy and safety of psychotropic agents
in pediatrics. Due to the potential for side effects and addiction, prolonged
treatment with chemical drugs as it is recommended by the WHO is often
accompanied by simultaneous impairment of quality of life [7, 9, 12, 14, 15]. As
a result, there is a clear increasing demand for complementary and alternative
medicine [16] such as a unique combination of extracts from Hypericum
perforatum (St. John’s Wort), Passiflora incarnata (Passionflower), and
Valeriana officinalis (Valerian). Beyond traditional knowledge about the usage of
Hypericum in treatment of mood and sleep disorders, recent studies have
shown various effects on central neurotransmitter systems [17, 18] and the
ability to act similar to conventional antidepressive drugs [18–20]. The
experimentally verified synergistic effect of Passiflora on Hypericum enables
application of a small amount of Hypericum with a simultaneous high efficacy.
This reduces the probability of side effects [21] and leads to effects more
comparable to the impact of Fluoxetine than to the impact of St. John’s Wort
extract alone [22]. Passiflora is traditionally used in combination with other
herbs as a mild sedative [23, 24]. The third plant, Valerian, is traditionally used
in medical conditions of sleep disorders and nervous agitation [25]. The
combination of all the three medical plants act on gamma-amino butyric acid
(GABA) and serotonin (5-HT) receptors, which are recognized targets of
pharmacological antidepressant treatment [26].
The aim of this observational study was the evaluation of safety and
effectiveness of the treatment of nervous agitation due to affective disorders in
children between 6 and 12 years of age with a fixed herbal combination
containing St. John’s Wort, Valerian, and Passionflower.
Material and Methods
Study objectives
After more than 40 years of experience with these plant extracts, we
hypothesized that a combination of St. John’s Wort, Valerian, and
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Passionflower has positive impact on children with nervous agitation due to
affective disorders.
Study duration
The duration of the study was from March 2008 to November 2009.
Study design
This multicenter, prospective observational study was conducted by 17
physicians (15 pediatricians, 1 neurologist, and 1 general practitioner) in
Germany.
Concept and design of the study as well as its ethical validity and performance
are based on the actual recommendations of the Bu ndesinstitut für Arzneimittel
und Medizinprodukte (BfArM, German Federal Institute for Drugs and Medical
Devices) and referred to the Declaration of Helsinki and Good Clinical Practice.
The study was registered on Clinical Trials under the trial registration number
NCT 01125579. Furthermore, this study followed the actual strengthening the
reporting of observational studies in epidemiology (STROBE) guidelines for
items to be included in reports on observational studies [27].
Study setting
Before the start of this study, the physicians got a briefing on the observational
plan, the ethical and scientific basis of this multicenter, prospective
observational study with observational character, the allocation procedure, and
the therapy schedule in accordance with the study protocol. Data assessment
included a physician-completed questionnaire and a standardized parent-report
questionnaire (Child Behavior Checklist (CBCL/4-18)) on three occasions:
before the treatment (visit 1, baseline), after approximately 2 weeks of the
treatment (visit 2), and after approximately 4 weeks of the treatment (visit 3).
The time point of final documentation was set at the physicians’ own discretion.
The concomitant diseases were grouped according to the ICD-10 classification.
All medications apart from the study medication were classified according to
the—to that time current—“Rote Liste 2008”.
Study participants
The children were chosen by the responsible physician and enrolled after the
informed written consent, and a data privacy policy statement had been
obtained from their legal guardian. Information of possible unwanted side
effects and the possibility to cancel the participation at any time without any
negative impact on the treatment of the child were given to the legal guardian.
Inclusion criteria were defined as follows: 6–12 years of age, history of
nervousness and agitation (including agitated depression) due to affective
disorders, informed consent to participate in the prospective cohort study
obtained from the legal guardian. Exclusion criteria contained children younger
than 6 years or older than 12 years of age, hypersensitivity to any of the
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ingredients, history of skin hypersensitivity to light, receiving phototherapy, or
any photodiagnostic procedures.
Variables studied
Target parameters for effectiveness were the influence of child’s disease on
everyday life of the family, the course of common symptoms, and the change in
the parent’s questionnaire CBCL (Table 1).
Interventions
Doses and duration of the treatment with herbal medicine were at the respective
physician’s discretion. The combination of three special dry extracts from
Hypericum perforatum (St. John’s Wort herb), Valeriana officinalis (Valerian
root), and Passiflora incarnata (Passionflower herb; Table 2) has been
administrated as tablet via oral route. Study medication was prescribed by a
physician and bought by the patient’s legal guardian.
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Results
Participants
Altogether 31 physicians were invited to collect data and 17 physicians agreed
to participate in the study. They gathered correctly and completely filled-out
case report forms of 115 children. Therefore, the participant rate was 54.8 %.
Descriptive data
The patient group involved in this study consisted of 69 boys (60 %) and 45 girls
(39.1 %). No statement of sex was made for one child, which explains the
missing 0.9 %. In average, the children were 9.4 years old (± 1.6) with an
average weight about 35.4 kg (± 9.6). The inclusion diagnosis “nervous
agitation” was made on average about 2.3 years ago. So, in the huge majority
of the treated children (92.6 %), a subchronic or chronic pattern of symptoms
was already present. Period of the treatment enfolded 2 weeks (n = 14),
including visit 1 and visit 2 or about 4 weeks (n = 101) including all the three
visits (Table 1). The average daily dose was 2–3 tablets in accordance with the
recommend dose of 1–3 tablets per day.
During the observation period, 16 children (13.9 %) received additional
medications related to the inclusion diagnosis, mainly hypnotics/sedatives (64
%) and psychopharmaceuticals/ psychoanaleptics (12 %). Eightyfour
percentages of the respective drugs were used as long-term medication. Up to
three nonmedical therapies were reported for 61 children (53 %) such as
psychological/ psychotherapeutic care (46.6 %) and progressive relaxation
(19.2 %). Concomitant diseases were mentioned for 21 children (18.3 %),
mainly emotional and behavioral disorders (40.7 %) and diseases of the
respiratory system (18.5 %). For 14 children (12.2 %) concomitant medication
was reported, mainly broncholytics/antiasthmatics, antiallergics, and
dermatologics.
Impairment of ordinary family life
Behavioral disorders of children and their therapies always affect the everyday
family life. At the first visit, parents estimated the impact via a visual analogue
scale with 5.95 in the mean. After the treatment, this average value improved to
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3.86. Altogether, a clearly positive development was achieved in 86.7 % of
children.
Child behavior questionnaire
Evaluation of the CBCL displays a detailed picture of the parents’ assessment
from the beginning until the end of the observation time. In comparison to
children of the same age, most of the children (up to 87.0 %) were assessed as
“normal” concerning items of the competency scales at all visits. Some children
showed aspects of “borderline abnormal” (up to 11.3 %) or “abnormal” (up to
13.0 %) behavior.
Until the end of the observation most children kept their level. According to
which the competency scale is viewed two to five children aggravated in their
problems, while an improvement was achieved for nine to ten children.
Analysis of syndrome scale items also showed that most children behaved
“normal” (85.2–64.3 %, depending on the scale). The majority of children were
stabilized in a normal behavior under the treatment. Slight aggravation of single
participants was detectable in items of a schizoid/compulsive (four children) or
dissocial behavior (three children). The highest proportion of “borderline normal”
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or “abnormal”-behaving children were detectable in the two scales “attention
problems” (35.7 %) and “anxiety/depression” (29.6 %) (Fig. 1).
Figure 1 gives an overview of the number of affected children, and the
development they underwent during the therapy. A clear improvement was
reported by legal guardians, whose children had attention problems, showed
social withdrawal, and/or were anxious/depressive. Between 61.0 and 87.0 % of
the affected children developed positively. In the same range was the progress
of children with physical and/or social problems. Even children with a
schizoid/compulsive behavior improved in their development. A little lower was
the percentage of children with a clear progress when the participants showed
dissocial (47.1 %) and/or aggressive behavior (50 %) at the beginning of the
observation. Altogether, up to 69.6 % of children who were assessed as
“borderline abnormal” or “abnormal” reached a “normal” assessment at the end
of the observation period. The therapeutic success was not influenced by
concomitant medication or therapies due to inclusion diagnosis.
Assessment of common symptoms by the physician
The statements about the problems of children with nervous agitation given by
the CBCL were confirmed by physicians in aspects such as the high number of
children affected by attention problems, anxiety/depression, aggressiveness,
and/or physical problems. In addition to this, the results of the symptom query
presented more details in some aspects. The scale “anxiety/depression” is
divided into three symptoms, which showed that the amount of children
suffering from examination anxieties (59.1 %) or other anxiety disorders (42.6
%) was much higher than the number of depressive children (29.6 %) in this
study. Physical problems are also mentioned for lots of children such as
tiredness/fatigue (54.8 %), abdominal/stomach pain (39.1 %), and/or headache
(42.6 %). Problems to fall or stay asleep were mentioned in 53.9 and 33.9 % of
the children, respectively. After the treatment, 81.6–93.9 % of the affected
children had no or just mild symptoms concerning nine of thirteen evaluated
symptoms such as depression, school/examination anxieties, further anxieties,
sleeping problems, and different physical problems (Fig. 2). The percentage of
children suffering from symptoms such as uncoordinated hyperkinesia,
aggressiveness/irritability, lack of concentration, and learning disorders was
clearly reduced in the end, too. Between 50.8 and 73.0 % of children with these
problems had no or just mild symptoms in the end. In general, concomitant
therapies or medication due to inclusion diagnosis did not affect the efficacy. At
the end of the observation period, the number of children with just slight or no
problems tended to be higher in cases without concomitant medication in
learning problems/ partial performance problems and problems in falling asleep.
A tendency for a better result with concomitant medication was reported for
compulsive uncoordinated movements.
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Tolerability
A good tolerability was reported for 97.4 % of the children. In seven cases, the
tolerability was described as moderate or poor, because of paradox reactions
(restlessness, weepiness, increased irritability, or aggressiveness) or other
adverse events such as redness in cheekbone region (one case) or stomach
pain (one case). All events were considered to have a possible relation to the
study treatment. In 53 children (46.1 %), the therapy was continued after the
end of the prospective cohort study.
Discussion
Contrary to various other diseases, nervous agitation due to depressive
episodes is not measurable by definite laboratory findings. Each child shows an
individual set of few to various symptoms with further variations in intensity. This
is also reflected by the assessments of parents, other legal guardians, and
physicians taking part in the presented study. Typical symptoms of the
examined children were attention problems, anxieties, depression, and
psychosomatic problems. However, approximately 40–50 % of children with
these disorders do not have a response to medication or behavioral therapy
alone [28, 29], and a combination of both is more effective [30]. On the other
hand, psychotropic medications are used too early [7] and about 25 % of
depressive adolescents develop substance abuse [31]. So, parents prefer
nonmedical therapies as initial treatment because of the higher risk of side
effects in therapies with chemical medication [30]. For these families, the tested
herbal combination of St. John’s Wort, Valerian, and Passionflower offers a
good alternative and fulfills the requested aspects. A good tolerability is
represented by just a few mild and transient side-effects. The assessments of
parents and physicians displayed a good efficacy on a broad spectrum of
symptoms linked to inclusion diagnosis.
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Moreover, it is possible to adjust the treatment individually because the good
efficacy was independent from concomitant nonmedical and medical
therapies—with three exceptions. In situations of learning problems and
problems falling asleep, the treatment without concomitant drug therapy due to
inclusion diagnosis tended to be more successful. In comparison to that
treatment of uncoordinated hyperkinesia seemed to be more effective with
concomitant medication. Another advantage for use of the study medication in
initial therapies is the fast onset: 3 h after first intake [22]. The experiences
collected by long marketing history and supported by the recent results of the
presented study showed that the study medication is useful in situations of
psychological mood disorders and sleep disorders due to nervousness also in
children between 6 and 12 years of age.
Limitations
Due to the officially required design of a multicenter, prospective observational
study some limitations are given. Therefore, it is unavoidable that safety and
effectiveness are observed without a placebo group and randomization. Lack of
blinding, the subjectivity of assessments, and the potential impact of the
relationship between child, parents, and physician on the child’s development
may also be limitations. On the other hand, this type of study offered the
possibility to prove the medication’s tolerability and effectiveness in everyday
life beyond a strictly controlled environment of a clinical study.
Acknowledgments
We thank all physicians, parents, and children who participated in the study.
Conflict of interests
Financial support for the analysis was provided by PASCOE pharmazeutische
Präparate GmbH, Germany. The sponsor had influence on the conduct of the
analysis to the extent that management and evaluation of the data was
conducted in the Department of Clinical Research of PASCOE
pharmazeutische Präparate GmbH.
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28. James A, Soler A, Weatherall R. Cognitive behavioural therapy for anxiety disorders in children and
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ALOPATIA
EVALUACION DE LA FUNCION SEXUAL MASCULINA EN PACIENTES
CON SINTOMAS DEL TRACTO URINARIO INFERIOR (LUTS) ASOCIADOS
CON HIPERPLASIA PROSTATICA BENIGNA (BPH) TRATADOS CON UN
MEDICAMENTO FITOTERAPICO (PERMIXON), TAMSULOSINA O
FINASTERIDE
Zlotta ARa, Teillac Pb, Raynaud JPc, Schulman CCa.
a
Department of Urology, Erasme Hospital, University Clinics of Brussels, 808
route de
Lennik, B-1070 Brussels, Belgium
b
Department of Urology, St-Louis Hospital, Paris, France
c
University Pierre and Marie Curie, Paris, France
[European Urology 2005 Aug; 48(2):269-76]
RESUMEN
Objetivo: La función sexual es uno de los aspectos en el tratamiento de los
síntomas del tracto urinario inferior (LUTS) asociados con la hiperplasia
prostática benigna (BPH) que ha ganado cada vez más atención. Se
compararon la influencia en la sexualidad masculina del Permixon, un extracto
lipídico esteroideo de Serenoa repens, con Tamsulosina y Finasteride,
utilizando un cuestionario específico validado, explorando las funciones
sexuales de los pacientes.
Métodos: Fue creada una base de datos que comprende a pacientes de tres
estudios principales randomizados a doble ciego - Permixon vs. Finasteride,
Permixon vs. Tamsulosin and Permixon 160 mg vs. 320 mg, incluyendo un total
de 2511 pacientes. Trecientos cincuenta y cuatro fueron de Tamsulosina, 545
de Finasteride y 1612 de Permixon. LUTS fue evaluado utilizando el
cuestionario I-PSS. Se registraron las tasas de flujo máximo y el volumen
prostático. Se utilizó el cuestionario MSF-4, que incluye 4 temas que exploran
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el interés del paciente en el sexo, la calidad de la erección, el logro del
orgasmo y la eyaculación. Este cuestionario fue mostrado como altamente
reproducible y clínicamente válido a través de diferentes culturas. Los
coeficientes de correlación fueron dados para evaluar la relación lineal entre las
variables contínuas.
Resultados: A los 3 meses, no hubo diferencias estadísticamente significativas
entre los tres grupos de tratamiento, en términos de I-PSS o Qmax evoluciones
(todos valores de p > 0.05). A los 6 meses, cuando se los compara con los
datos previos al tratamiento, hubo un ligero incremento en los desórdenes
sexuales en los pacientes tratados con Tamsulosina (+0.3) y Finasteride (+0.8),
mientras se dio una ligera mejoría en la terapia con Permixon (-0.2). Los
efectos adversos más frecuentemente reportados, después de Tamsulosina o
Finasteride, fueron los desórdenes en la eyaculación (ambos +0.2 en el
específico cuestionario MSF-4 pregunta 4). No hubo correlación entre la
evolución de las puntuaciones en el MSF-4 y la evolución en el I-PSS ni en los
pacientes tratados con Permixon, Finasteride o Tamsulosina. Sin embargo,
hubo una ligera correlación entre la puntuación de MSF-4 al inicio del estudio y
el I-PSS en la línea de base (r2 = 0.032). Aunque hubo correlación entre el
MSF-4 y la edad, al inicio del estudio (r2 = 0.1452), no hubo correlación entre la
evolución en el MSF-4 durante el tratamiento y la edad de los pacientes.
Conclusión: El presente estudio demuestra que la terapia con Permixon no
tuvo impacto negativo sobre las funciones sexuales masculinas. Tanto el
Finasteride como la Tamsulosina, tuvieron un ligero impacto sobre dichas
funciones, especialmente en la eyaculación, aunque estos efectos fueron raros
y en línea con los reportes previos que existían sobre estas dos drogas.
EL IMPACTO DE LAS BENZODIACEPINAS SOBRE LA APARICION DE LA
PNEUMONIAY LA MORTALIDAD POR LA MISMA: UN ESTUDIO DE CASO
Y CONTROL ANIDADO Y ANALISIS DE SOBREVIDA EN UN COHORTE DE
BASE POBLACIONAL
Eneanya Obioara1, Richard Hubbard1, Robert D Sanders2,3, Puja R Myles1
1
Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK
Department of Leucocyte Biology and Anaesthetics, Intensive Care and Pain Medicine,
Imperial College London, London, UK
3
Wellcome Department of Imaging Neuroscience, University College London, London, UK
2
[Thorax doi:10.1136/thoraxjnl-2012-202374]
Resumen
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Objetivos: Las benzodiacepinas han sido asociadas con un incremento en la
incidencia de infecciones, y mortalidad por sepsis, en enfermos críticos. Aquí,
nosotros determinamos el efecto del uso de social de las benzodiacepinas en la
aparición y la mortalidad por pneumonía.
Métodos: A través de un estudio de caso y control anidado, utilizando 29.697
controles y 4964 casos de pneumonía adquirida en la comunidad (CAP) a partir
de la Red de Mejoramiento de la Salud, base de datos de Atención Primaria de
la Salud, en Reino Unido (2001–2002), investigaron la asociación entre las
benzodiacepinas y la aparición de pneumonía mediante regresión logística
condicional. El modelo de regresión de Cox, se utilizó para determinar el
impacto de las benzodiacepinas en la mortalidad de los 4964 casos de CAP.
Los resultados son presentados como OR ajustados, HR ajustados e intervalo
de confianza 95% (CI).
Resultados: La exposición a las benzodiacepinas fue asociada con un
incremento en el riesgo de pneumonía (OR 1.54, 95% CI 1.42 to 1.67).
Individualmente, el diazepam, lorazepam y temazepam, pero no el
clordiazepóxido, fueron asociados con un incremento en la incidencia de CAP.
Como una clase, las benzodiacepinas, se asociaron con un incremento de 30
días (HR 1.22 (95% CI 1.06 to 1.39)) y mortalidad a largo plazo (HR 1.32 (95%
CI 1.19 to 1.47)) en pacientes con un diagnóstico previo de CAP.
Individualmente, el diazepam, clordiazepóxido, lorazepam y temazepam,
afectaron la mortalidad a largo plazo, en estos pacientes.
Conclusiones: Las benzodiacepinas fueron asociadas con un incremento del
riesgo de contraer y de mortalidad por CAP. Estos datos sugieren una
necesidad de más investigaciones en el perfil de seguridad inmunitario de las
benzodiacepinas.
HOMEOPATIA
EFECTO DE LOS MEDICAMENTOS HOMEOPATICOS EN EL ESTUDIO
POLISOMNOGRAFICO DEL SUEÑO EN ADULTOS JOVENES CON
ANTECEDENTES DE INSOMNIO RELACIONADO AL CONSUMO DE CAFE
Iris R. Bell a,b,c,d, Amy Howerter a,e, Nicholas Jackson a,d, Mikel Aickin a, Carol M.
Baldwin f, Richard R. Bootzin c
a
Department of Family and Community Medicine, The University of Arizona College of Medicine, Tucson,
AZ, USA
b
Department of Psychiatry, The University of Arizona College of Medicine, Tucson, AZ, USA
c
Department of Psychology, The University of Arizona, Tucson, AZ, USA
d
Mel and Enid Zuckerman College of Public Health, The University of Arizona, Tucson, AZ, USA
e
Division of Family Studies and Human Development, The University of Arizona, Tucson, AZ, USA
f
College of Nursing and Health Innovation, Office of World Health Promotion & Disease Prevention,
Arizona State University, Tempe, AZ, USA
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[Sleep Medicine 2011 May;12(5):505-11]
RESUMEN
Antecedentes: La Homeopatía es una medicina alternativa ampliamente
distribuida en todo el mundo, basada en los informes subjetivos de los
pacientes, para el diagnóstico y tratamiento. La polisomnografía ofrece una
metodología moderna para la evaluación objetiva de los efectos de la ingesta
de los medicamentos homeopáticos que los médicos indican para mejorar la
calidad del sueño en sujetos sensibles. Estudios previos en animales han
demostrado algunos cambios en los sueños sin movimientos oculares rápidos,
con ciertos medicamentos homeopáticos.
Métodos: Participaron del estudio, de un mes de duración, adultos jóvenes de
ambos sexos (edades 18–31) con puntuaciones promedio superiores en
escalas estandarizadas de personalidad para hostilidad cínica o sensibilidad a
la ansiedad (pero no ambas) y una historia de insomnio inducido por el
consumo de café. Los registros polisomnográficos fueron obtenidos en sus
casas, en dos noches sucesivas por semana, para un total de 8 registros
(noches 1, 2, 8, 9, 15, 16, 22, 23).
Sujetos: (N = 54) recibieron glóbulos placebo en la noche 8 (ciego simple) y
glóbulos verum en la noche 22 (doble ciego) a la 30c de uno de los dos
medicamentos homeopáticos, Nux Vomica o Coffea Cruda. Los individuos
completaron el índice de calidad de sueño de Pittsburgh, previo al comienzo de
la polisomnografía y al final del estudio de cada semana, así como también la
escala del perfil del estado de ánimo antes de acostarse en las noches
correspondientes al estudio.
Resultados: los remedios Verum incrementan significativamente el tiempo total
de sueño y NREM (sueño sin movimientos oculares rápidos), así como también
los despertamientos y cambios de fases. Los cambios en la actigrafía y en la
escala de autoevaluación de los efectos, no fueron significativos.
Conclusiones: El estudio demostró la viabilidad del uso, en los hogares, de los
registros del sueño de todas las noches, para estudiar los efectos de los
medicamentos homeopáticos. Los resultados son simlares, aunque no
idénticos, a aquellos reportados en animales con los mismos remedios. Los
posibles mecanismos de acción, incluyen la interrupción inicial de la dinámica
del los patrones del sueño no linear, por parte de los medicamentos Verum.
Palabras clave: Medicina alternativa y complementaria, homeopatía,
polisomnografía, café, insomnio, adultos jóvenes, Coffea cruda, Nux vómica.
ARTICULO ORIGINAL
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Introduction
Previous studies in many different countries have shown that a substantial
proportion of the general population, especially individuals with chronic
illnesses, use various types of complementary and alternative medicine (CAM)
[1–4]. Among CAM users, insomnia and depression/anxiety are common
conditions for which they seek alternative therapies [4,5]. Homeopathy, a 200year-old whole system of CAM developed by a German physician, is one of the
mostly widely known [6] and controversial modalities [7–9] for which clinicians
and consumers worldwide chaim therapeutic benefit in sleep disturbances and
fatigue, as well as other medical and psychiatric conditions [10–14].
Homeopathic clinicians often rely on subjective changes in sleep quality and
increased mental/physical energy as early indications of the actions of
homeopathic medicines (termed ‘‘remedies”) [15]. But the relative lack of
objective measures to evaluate homeopathy in human subjects has thus far
hindered advances in both clinical care and research. Polysomnography (PSG),
which can distinguís divergent findings, if present, between subjective sleep
complaints and objective all-night sleep recording assessments in certain types
of insomnia [16–18], offers a potentially valuable tool for homeopathic
investigations.
Multiple studies on healthy animals have shown measurable effects on sleep of
three different homeopathic remedies at potencies prepared to a dilution past
Avogadro’s number (Histamine, Coffea Cruda, and Nux Vomica) compared with
placebo. Each remedy at a 30c potency altered sleep patterns notably with
differential effects on electroencephalographic delta frequency (0.5– 2.5 Hz)
power during sleep [19–22]. Other investigators have demonstrated effects of
Nux Vomica 30c on alcohol-induced sleep time in mice [23,24].
Clinically, homeopaths report that Coffea Cruda patients are mild and timid, but
also irritable and oversensitive to all types of sensory stimuli, especially noise,
as well as to positive emotions [25,26]. Nux Vomica as a homeopathic remedy
is used clinically to treat people with competitive, irritable and impatient Type Alike behavioral patterns and tendencies to abuse alcohol, caffeine, and other
substances. Both Coffea Cruda and Nux Vomica patients report insomnia in the
middle of the night as a symptom [27]. Taken together with the clinical reports,
the animal EEG sleep data provide a basis for selecting Coffea Cruda and Nux
Vomica as candidate homeopathic remedies to test in the first homeopathic
PSG research on human subjects.
The primary purpose of the present within-subjects feasibility study was to
examine the PSG effects of one dose of placebo versus either Coffea Cruda
30c or Nux Vomica 30c in relatively healthy young adult human subjects with a
past history of coffee-induced insomnia. Because of the importance of personcentered factors in clinical expectations of remedy effects [27,28], inclusion
criteria included individual difference traits of increased levels of either anxiety
sensitivity or of Type A cynical hostility. Based on the animal studies, the
remedy effects were hypothesized to include changes in both quantity and
quality (variability in sleep stage changes and in awakenings after sleep onset)
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21
of NREM sleep, especially slow wave sleep, after controlling for within-subject
baseline sleep patterns and placebo effects.
2. Methods
2.1. Subjects
Potential subjects were identified by screening young adult male and female
college students (age range 18–31) enrolled in the introductory psychology
class at the University of Arizona, for scores on the 16-item anxiety sensitivity
index (ASI) [29], the 27-item Cook–Medley Cynical Hostility Scale (CMHO) [30],
and one 5-point rating item on self-rated physical health [31]. All potential
subjects had to score P3 out of 5 on a rating of global health and give a history
of coffee-induced insomnia in the past. The anxiety sensitivity and hostility
classifications were used to select the study participants, such that individuals
were chosen to be high hostile (above CMHO mean, below ASI mean) or high
anxiety sensitive (below CMHO mean, above ASI mean). Above- and
belowmean cutoffs for inclusion in the high anxiety sensitivity subgroup were
P16.8 for males and P19.1 for females on the ASI and <11.0 on the CMHO; for
the high hostility subgroup <16.8 for males and <19.1 for females on the ASI
andP11.0 on the CMHO. These cutoffs were determined by the study
statistician using the mean scores computed from the first 1036 people
screened for the study and are comparable to means published with similarly
aged samples [32–35]. Subjects were dynamically assigned [36] to one of the
two remedies, Nux Vomica or Coffea Cruda, using their CMHO and ASI scores,
age, and sex as balancing factors. The study was reviewed and approved by
the University of Arizona Institutional Review Board. Research staff contacted
eligible individuals and obtained written informed consent for the 4-week homebased PSG study participation. Because of the belief by some homeopaths that
beverage coffee (but not caffeine) sometimos antidotes homeopathic remedies,
subjects had to be willing to eliminate drinking coffee for the full duration of the
study, although they were encouraged to change to and stabilize prior noncoffee caffeinated beverages to maintain their customary daily caffeine intake
without interruption, if necessary. Exclusion criteria were pregnancy or planning
to become pregnant, major psychiatric or serious chronic medical conditions,
chronic use of medications other than contraceptive drugs, and/or a history of
anaphylactic shock. Subjects were paid $300 for their month-long participation.
Table 1 summarizes descriptive characteristics of the study participants.
2.2. Procedures
Participants underwent a total of eight all-night PSG and actigraphic recordings
in their own homes, distributed as 4 weekly pairs of consecutive nights (Week 1
baseline; Week 2 single-blind placebo pellets on night 8; Week 3 repeat
baseline; Week 4 double- blind verum homeopathic remedy pellets on night 22).
Thus, PSGs were performed on nights 1–2, 8–9, 15–16, and 22–23 of study
participation. Subjects were instructed not to consume alcohol on the day of the
recordings and not to consume caffeinated beverages or tobacco for 6 h prior to
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each PSG, but were otherwise encouraged to maintain their own habitual
dietary and sleep–wake patterns in order to obtain naturalistic data.
The inclusion of baseline recordings on nights 1, 2, 15, and 16 enabled the
establishment of typical sleep characteristics as a control for detecting effects of
taking pellets on nights 8 and 22.
Although subjects took no pellets on nights 9 or 23, most homeopaths claim to
see evolving changes over time in patients for days to weeks and even months
after administration of even a single 30c potency dose to patients [37–41]. Basic
science and animal studies offer some empirical support for such an assertion
[21,42–44].
Therefore, with the clinical prediction of carryover effects from pellet night 22 to
no-pellet night 23, the placebo week with recordings on nights 8 and 9 were
similarly structured. Because of the claim of persistent effects of homeopathic
remedies for variable periods of days to weeks after the last dose [45], the
placebo condition was always placed prior to the 2-arm verum condition in time
rather than attempting a simultaneous placebo versus remedy or
counterbalanced crossover design (see also Walach’s entanglement
considerations for homeopathic study designs [46]).
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All subjects completed the Pittsburgh sleep quality index (PSQI) [47,48] five
times during the study, at baseline prior to the PSG sessions, and at the end of
each study week. Prior to lights out on PSG nights, subjects also completed a
profile of mood state (POMS) [49] scale. Bedtimes and sleep periods varied in
accord with each individual’s customary bedtime and waking time habits.
Nevertheless, subjects were asked to choose the specific consecutive two days
of the week when the weekly recordings occurred and to undergo the PSGs on
the same two days of the week for each of the 4 weeks. Subjects completed a
daily morning sleep quality rating over the 4 weeks of participation.
Indistinguishable placebo and verum remedy pellets (Coffea Cruda 30c, Nux
Vomica 30c) were purchased from Hahnemann Laboratories, Inc. (San Rafael,
CA), an FDA-regulated homeopathic pharmacy experienced in collaborating on
research study protocols. The #30 lactose–sucrose dry pellets were certified for
purity and lack of contaminants by an independent testing laboratory. All vials of
placebo and remedy were number-coded, labeled for blinding, and assigned
sequentially by subject number on the basis of a design adaptive allocation
procedure appropriate for small sample studies [50,51]. Consistent with clinical
practice, subjects were asked to dissolve three pellets from their assigned study
vials under the tongue on night 8 (placebo) and night 22 (verum). On verum
night 22, half of each personality type group received Coffea Cruda 30c and half
received Nux Vomica 30c.
2.3. Polysomnographic and actigraphic recordings
Ambulatory PSGs were performed using Cadwell Laboratories Inc. Easy
Ambulatory 2 system equipment (Kennewick, WA). Recordings include six
unipolar EEG channels (C3, C4, Cz, Pz, O1, and O2 referenced to contralateral
mastoids),
bilateral
electrooculograms
(EOG),
mental/submental
electromyogram, and a two-lead electrocardiogram (bilateral sub-clavicle
electrode placement). Electrode impedance levels were kept below 5 kO.
Equipment settings for data acquisition included an EEG sampling rate of 200
Hz, a low pass filter set at 35 Hz and a high pass filter set at 0.53 Hz. A 60 cycle
notch filter was used to eliminate ambient electrical noise.
Actigraphic data were collected using a Mini Mitter Inc., Actiwatch-64 (Bend,
OR) worn on the subjects’ left wrist. The Actiwatch was programmed to record
in 15-s epochs, with movement sampled at 32 Hz. The actigraphs were
analyzed using Actiware-Sleep version 3.4 software (Mini Mitter Inc.), with
wake-threshold sensitivity set to medium. Actigraph Bedtime and Uptime were
entered as the lights out and lights on time, respectively, as determined by the
PSG recording.
Technicians performed the hookups in the subjects’ homes prior to customary
bedtimes and departed until the next day when they picked up the equipment
for data downloading. Data were scored in 30-s epochs in accord with standard
Rechtschaffen–Kales criteria [52] by a sleep technician certified to 94% interrater reliability criteria by a registered PSG technician and blinded to the remedy
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received. Arousal scoring was performed in accordance with the American
Academy of Sleep Medicine guidelines [53]. Subjects initiated a marker for
lights out by a button press on the Cadwell Easy Ambulatory 2 unit. Nights on
which subjects had less than 4 h of scorable sleep were not used in the
analyses as previous sleep studies have done [54,55]. Setting a minimum
threshold for time in bed (TIB) is a common control in ambulatory sleep studies
[55] to prevent skewed values of variables dependent on TIB, such as sleep
efficiency which is computed as total sleep time (TST) divided by TIB.
2.4. Statistics
Based on the clinical literature and animal studies, primary outcome variables of
interest were total sleep time, slow wave sleep, stage changes, and awakenings
after sleep onset, as a function of verum remedy versus placebo across all
subjects. Given the exploratory and early research phase nature of the current
study on human subjects, however, PSG sleep onset and rapid eye movement
(REM) latencies, REM and other NREM stages, as well as actigraphic
measures of TST, sleep onset latency, sleep efficiency, and fragmentation
index, were examined secondarily for possible effects. The focus of the current
paper is the effects of remedies themselves. Subsequent papers will report on
the interactions between remedy effects and personality types for POMS and
individual night effects on spectral EEG.
To facilitate use of personality as a covariate in regression models, a net
personality score (CMASI) was computed as a unitary continuous variable,
using the values from the ASI and CMHO, where a higher value signified
greater hostility and less anxiety sensitivity. CMASI scores are a linear
combination of the CMHO and ASI which varied from 0 to 1, with large values
denoting high CMHO and low ASI and small values denoting low CMHO and
high ASI. Due to the design of the study, CMHO and ASI scores are inversely
related.
Using the sleep outcome variables listed above as dependent variables, we
tested whether the outcome variable for the verum week (nights 22, 23) differed
from means for the placebo week (nights 8, 9) after adjusting for the mean for
the four baseline nights (1, 2, 15, 16). Averaging all four baseline nights helped
lessen any confounds from first-night effects in the home setting on study night
1 by providing multiple assessments of the subjects’ usual sleep patterns
without study medications in both Weeks 1 and 3 of the protocol.
We utilized a random effect regression model for analysis, with person as the
random effect. The regression equations each controlled for sex, the CMASI net
personality score, the baseline value of the outcome variable, and total time in
bed. For example, we tested whether a subject’s Week 4 (verum) stage
changes differed from their Week 2 (placebo) stage changes, after adjusting for
their own baseline stage changes, sex, CMASI and total time in bed.
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Descriptive statistics, t-tests, and v2 analyses were used to assess
demographic variables. STATA 10.0 was used for all data reduction and
analyses.
3. Results
A total of 4279 people were screened for the study. Seventy people met all
eligibility criteria, volunteered and enrolled in the study. But 5 participants who
started the study were administratively withdrawn due to early protocol
violations making them ineligible for study participation (e.g., beginning
medication on the exclusion list, an undisclosed health problem on the
exclusion list). Three subjects opted out of the study (e.g., schedule conflicts,
catching the flu) prior to treatment allocation and 3 subjects were not within the
targeted age range for the present study, leaving a total of 59 participants who
received the homeopathic treatment and completed the study. Five subjects
from the remaining 59 enrolled participants did not meet the criterion for the
minimum 4 h of sleep per night and/or did not have enough data on their
baseline recordings for analysis. The results reported reflect the findings from
the remaining 54 participants (allocated to Coffea Cruda [n = 26] or Nux Vomica
[n = 28] on night 22).
In-home recordings pose unique challenges for data quality. Portions of
different nights and unavailability for some subjects on certain nights
contributed to difficulties obtaining complete data. Individual electrodes or,
rarely, the main battery pack cables detached during the sleep period on
various nights in different subjects, resulting in partial data loss. On average,
out of the 4 possible baseline nights (nights 1, 2, 15, 16) subjects contributed
2.96 ± 1.00 baseline nights. There were two possible nights of data on both
placebo and remedy weeks. Subjects on average contributed 1.39 ± 0.74 and
1.33 ± 0.67 days, respectively, on placebo and remedy week. Outcome data on
missing nights (due to the absence of data or failure to meet the sleep quality
standard) were imputed as follows: any values that had valid data on any
preceding or following night in the study design were determined by linear
interpolation. Then, any remaining missing values were filled in by carrying the
last value forward. The final sample of young adults (N = 54) in the current
report had a mean age of 20 SD 2 years (50% female). Table 1 shows that the
subsets of subjects who received Coffea Cruda (n = 26) versus Nux Vomica (n
= 28) did not differ in age, gender distribution, CMASI, PSQI, baseline PSG and
sleep diary parameters.
Table 2 gives the verum effects in comparison with placebo and significance
levels for the effects of the remedies together and separately. These effects are
reported using unstandardized coefficients with standard errors to interpret the
variables in their unit of measurement. When data from the two remedies were
combined, overall PSG for the remedy week showed significantly longer TST,
increased NREM sleep including more minutes in stage 2 and increased slow
wave sleep (SWS), with a trend toward increased minutes of stage 4 sleep (b =
5.8, P < 0.10) compared with placebo. Remedies also led to more sleep
disruptions after sleep onset, with significantly increased awakenings, number
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of stage changes, and more type 2 arousals compared to placebo. In the
remedy-specific within-subject analyses, Coffea Cruda and Nux Vomica
recipients both showed similar significant effects of increasing TST and NREM
on verum as compared with placebo nights. But only Nux Vomica effects were
significant for increases in type 2 arousals and on the Arousal Index on verum
versus placebo nights.
Differences between Nux Vomica and Coffea Cruda treatment groups for
remedy week nights 22 and 23 were compared. The only variable with a
significant difference was a lower arousal index for the Coffea Cruda recipients
(b = 1.24, 95% confidence interval 2.5 to 0.01, t = 2.1, P = 0.049). Nux
Vomica and Coffea Cruda recipients did not significantly differ on the remaining
variables listed in Table 2.
Within-subject analyses of the actigraphic measures, which depend on
indications of gross motor activity of the wrist rather than EEG, showed no
significant treatment effects on TST, sleep onset latency, sleep efficiency, or
fragmentation index. For the subjective measures, individuals receiving Coffea
Cruda showed a trend toward a decrease in POMS fatigue on the post-verum
night compared with the post-placebo night (Table 2). Overall, remedy (verum)
week was not different from placebo week on the subjective ratings of global
sleep quality on the weekly PSQI, after controlling for baseline values. On the
daily morning sleep diary ratings (3 possible categories: fatigued, somewhat
refreshed, refreshed), the only finding was a trend toward poorer subjective
sleep for Nux Vomica compared with placebo in a logistic regression, controlling
for personality and sex (OR 0.29, CI 0.08–1.11, P = 0.07).
4. Discussion
The current study demonstrates the feasibility of using in-home all-night sleep
recordings with ambulatory PSG equipment in young adults to assess the
effects of homeopathic remedies. Both remedies led to an increase in TST
reflected mainly in increased NREM sleep. The increased NREM time is similar
to observations from previous animal sleep studies with Coffea Cruda 30c [19–
21].
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In addition, consistent with the animal data showing increased variability of EEG
sleep after Nux Vomica 30c [56], the human subjects in the present study had a
significant increase in stage changes on remedy nights compared to those on
placebo nights. The Nux Vomica group also demonstrated a higher arousal
index than did the Coffea Cruda subjects. Despite an increase in sleep
disruption after sleep onset, manifested by more awakenings on remedy week
nights versus placebo nights, POMS fatigue ratings were lower for the remedy
nights. Notably, during open-ended exit interviews while still blinded, many
subjects reported their perceptions of greater sleep disruption following placebo,
compared to remedy nights. The POMS fatigue subscale findings are consistent
with the latter qualitative observations.
One possible interpretation of the data could be that the seeming changes in
sleep during the remedy week resulted from the passage of time and general
adaptation of subjects to the study protocol and equipment, rather than that of
remedy effects. The objective findings, however, are not fully consistent with a
time effect by itself. The regression analyses were controlled for PSG sleep
variable findings not only on nights 1–2, but also on nights 15–16. If subjects
were simply sleeping better as time passed in the study without a role for the
remedies themselves, then awakenings and other measures of transient sleep
disturbances during the night should have decreased by the remedy week
(study Week 4). Instead, even though TST increased, the number of
awakenings, sleep stage changes, and arousal index increased, especially with
Nux Vomica 30c.
Moreover, personality type interacted with the specific remedy received to
produce differential changes in the POMS; effects are reported elsewhere [57].
Thus, even if the passage of time contributes to some of the apparent
differences between theWeek2 placebo and Week 4 remedy findings, the data
suggest remedy effects beyond those from the simple passage of time.
Individual susceptibility to unique remedy-specific, as opposed to non-specific
placebo, symptoms in healthy human subjects appears characteristic of other
widely-used homeopathic remedies in 30c potency as well [58].
The use of objective markers of remedy effects such as PSG recordings offers
an innovative approach to advancing work in a controversial area such as
homeopathy, where most contested clinical studies rely on subjective
assessments alone. Waking EEG also has shown promise in documenting the
effects of individualized homeopathic remedies on patient populations [59,60].
In the present study, it is notable that the PSG but not the actigraphic measures
showed remedy effects above those attributable to placebo.
The ability of homeopathic remedies to cause subtle and unique subjective
symptoms that conventional standardized questionnaires can miss [58] and the
current observation of significant remedy effects on sleep EEG, but not
actigraphy, suggest caution in relying solely on actigraphy for future sleep
studies of homeopathic remedies. Because of the dependence on muscle
movement, actigraphy can underestimate sleep latency, waking periods, and
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28
total sleep time as compared with PSG recordings whenever subjects are
awake, but physically inactive [61].
The study design was deliberately structured with single-blind placebo
preceding allocation to one or the other of the two double-blind remedies in
order to address a different potential methodological and theoretical concern,
i.e., the reported risk of non-local or entanglement confounds of placebo and
remedy effects, when treatment arms are administered double-blind in a closed
system of a homeopathic study. Keeping the experimental system open with
single-blind placebo may have provided a strategy to reduce the risk of
entanglement between placebo and remedy effects [62–65].
The mixed directionality of the sleep changes on remedy nights, i.e., some
improvements and some disruptions in PSG variables, is consistent with the
clinical literature and practice theory [15,66,67]. That is, homeopaths claim
bidirectional and mixed direction effects for their remedies under several
common circumstances dependent on (a) initial state of the host; and/or (b)
differential direction of global versus local effects (improved global with
worsened local changes). Nonlinear, bidirectional effects of homeopathic
remedies, especially early in the course of the response, are consistent with
state dependency. That is, the same remedy at the same potency (e.g., 30c)
can cause a set of transient symptoms in a healthy person, but alleviate similar
symptoms in a sick person or animal [66]. Given previous data on evolving
nonlinear changes over time after administration of homeopathic remedies
[22,68], further examination of the dynamics of the physiological and self-report
measures over time will be essential [69]. The brief time period in which the
PSG recordings were obtained following remedy administration (2 nights) would
reflect only an initial, destabilized transitional phase in the dynamic response to
the remedies [70].
In summary, the current findings on human sleep are similar but not identical to
previously-reported, objectively-measurable effects of the same two
homeopathic remedies on animals. Future studies are needed to evaluate
longitudinal changes in EEG dynamics and to examine evolution of sleep
patterns over a much longer period of time after remedy administration in
persons with primary insomnia and in healthy individuals. Overall, the sleep
literature on various forms of alternative medicine, including homeopathy, is
very limited, requiring more rigor and more study [71–73]. Moreover, the
present findings do not address the question of whether or not either of the
homeopathic remedies tested here would be therapeutic for certain people with
insomnia. Rather, the data provide initial evidence for feasibility of the PSG
methodological approach and the ability of homeopathic remedies to alter
objective sleep in human subjects.
New basic science evidence begins to address some of the major concerns of
skeptics about the plausibility of biological activity in homeopathic remedies
[43,44,74–78]. Several different laboratories have reported measurable physicochemical changes in the solvent during the succussion (vigorous shaking)
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29
procedure in homeopathic remedy preparation, even when the dilution process
takes the original source material past Avogadro’s number of molecules.
Thus, the data open the door to reconsidering the biological as well as
psychological effects of adjunctive use of homeopathic remedies in human
subjects [79].
Acknowledgments
This study was supported by National Center for Complementary and
Alternative Medicine Grants R21 AT000388 and K24 AT000057 to IRB. The
authors would like to thank Keith Fridel, PhD RPSGT for training and
supervising the sleep scoring, and Elizabeth Acker, Michael Biuso, Erica Morey,
Molly Taylor, and Alivia Wieseler for their technical assistance in data collection
and quality assurance procedures. Dr. Bell serves as a consultant to Standard
Homeopathic Co./Hyland’s Inc., a homeopathic manufacturer whose products
were not used in the current study. Standard Homeopathic Co./Hyland’s Inc. did
not provide any funding for the current study.
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NUTRICION
VARIACION DE LOS EFECTOS DE TRES DESAYUNOS DIFERENTES
SOBRE LA SACIEDAD SUBJETIVA Y LA POSTERIOR INGESTA DE
ENERGIA A TRAVES DEL ALMUERZO Y LA CENA
Rosalind Fallaize, Louise Wilson, Juliet Gray, Linda M. Morgan, Bruce A.
Griffin.
Department of Nutrition and Metabolism, Faculty of Health and Medical Sciences, University of
Surrey, Guildford, Surrey GU2 7XH, UK
[Eur J Nutr. 2012 Sep 5]
RESUMEN
Objetivo: Determinar el impacto relativo de tres desayunos isocalóricos, de
composición variable, sobre la saciedad, el hambre y la posterior ingesta de
energía.
Métodos: En un diseño triple cruzado, 30 hombres sanos (edad de 21.7 ± 1.2
años; BMI, 23.1 ± 2.7 kg/m2) fueron randomizados a uno de tres desayunos de
ensayo, en 3 ocasiones diferentes, separadas por una semana. Los desayunos
consistieron en, huevos con tostadas, cereales (copos de maíz) con leche y
tostadas, o una medialuna y jugo de naranja. Se registraron, a intervalos de 30
minutos, la saciedad por calificación subjetiva, el hambre, la plenitud y el deseo
de comer, mediante escalas analógicas visuales electrónicas (VAS). La ingesta
de energía fue evaluada por el peso de la comida ingerida en el almuerzo y
cena, ad libitum.
Resultados: Los participantes mostraron un incremento de la saciedad, menos
hambre y un menor deseo de comer, después del desayuno que contenía
huevos con respecto al de cereales (p\0.02), y el basado en medialunas
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(p\0.0001). El desayuno con huevos, fue también acompañado por una baja
significativa de la ingesta de energía con respecto a los otros dos, en el
almuerzo y cena, respectivamente, 1,284 ± 464 (huevos) versus 1,442 ± 426
kcal (medialuna), p = 0.03, 1,407 ± 379 (cereales) en el almuerzo y 1,899 ±
729 (huevo) versus 2,214 ± 620 kcal (cereales), p = 0.02, 2,047 ± 712
(medialuna) en la cena. El desayuno con el mayor efecto sobre la saciedad y
sus consecuencias sobre la posterior ingesta de energía, fue el que tuvo el
mayor contenido de proteinas y el más bajo de carbohidratos con respecto a
los otros dos.
Conclusión: Estos hallazgos produjeron evidencia para sustentar la
importancia de la elección de los alimentos para el desayuno para incrementar
la saciedad por la mañana y reducir la ingesta de energía en el almuerzo.
Palabras clave: Saciedad – Proteína dietaria – Desayuno – Huevos
ARTICULO ORIGINAL
Introduction
The passive overconsumption of energy is recognised as a major causative
factor in the development of obesity [1].
This has fuelled interest in the identification of foods that can increase satiety as
a means of limiting energy intake and promoting weight loss. While there is an
evidence to suggest that foods can promote effects on satiety that are
independent of their macronutrient content or energy density, dietary protein
has been implicated as the macronutrient with the greatest impact in increasing
satiety, most notably when consumed at breakfast rather than later in the day
[2–7]. This finding has focused attention on foods that are high in protein and
commonly consumed at breakfast.
Intervention studies with eggs have provided some of the strongest evidence to
support a positive effect of dietary protein in increasing satiety and decreasing
subsequent energy intake [8–11]. However, of these two effects, data on
measures of satiety have always been weaker and less convincing, possibly
because of the subjective nature of the measurements, aspects of study design,
inappropriate choice of comparative foods or subjects and/or the timing of
meals. One study that compared the consumption of three iso-caloric lunches of
baked potato, eggs or a chicken sandwich showed significant effects on satiety,
but not on the subsequent intake of energy [8]. Two other studies that showed
significant effects on both satiety, subsequent energy intake and weight loss
compared eggs against a bagel [9, 10], a food that is less commonly consumed
at breakfast in Europe than in North America. The aim of the present study was
to determine the relative effects of three iso-caloric breakfasts on subjective
measures of satiety and subsequent energy intake at an ad libitum lunch and
evening meal in young, healthy men.
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Methods
Participants
Participants were recruited from the male student population at the University of
Surrey via e-mails, posters and personal communications. Previously published
[12] and unpublished studies using VAS scoring and ad libitum intake of food at
buffet meals have established that a minimum sample size of 30 participants is
required to achieve statistically significant differences between test meals. All
participants underwent an initial screening visit in the Clinical Investigation Unit
(CIU) at the University of Surrey prior to taking part in the study. Before this
visit, participants were sent a ‘Participant Information Sheet’, which explained all
aspects of the study. Height, weight and BMI were measured at this initial
screening visit. Participants completed a general health questionnaire, a Dutch
Eating Behaviour Questionnaire (DEBQ) [14] and ‘SCOFF’ questionnaire [15] to
assess their general health, tendency for restrained eating and eating disorders,
respectively. They were also given full instruction and a demonstration on how
to use the PRO-Diary VAS scoring watches. All participants had to be habitual
breakfast eaters and accustomed to eating three meals a day. They also had to
meet the entry criteria that included being a healthy male (as determined by
health questionnaire), aged between 18 and 35 years with a BMI C 18.5 B 30
kg/m2 and a weekly alcohol consumption of \28 units. Exclusion criteria
included smoking, a dislike, intolerance or allergy to the test foods (eggs, wheat
and dairy), any eating disorder or restrained eating behaviour, as determined by
the ‘SCOFF’ and DEBQs, and participation in any other research study within 1
month of this study. Those meeting the entry criteria were invited to take part
and asked to provide written and witnessed consent of participation.
Experimental protocol
The study had a randomised, three way, crossover design with three iso-caloric
breakfast options, to which participants were assigned in a randomised order,
as determined by block randomisation. This was achieved by placing a random
order of treatment options, for example, ABC or BCA, into identical sealed
envelopes. The envelopes were marked with sequential numbers and
distributed to the volunteers in the order of their arrival. This method ensured
allocation concealment and reduced selection bias. Participants were instructed
to maintain their normal lifestyles on the day before each study day, but to
refrain from alcohol, caffeine and physical exercise, other than walking, and to
record anything they ate or drank between 18:00 and 20:00 h. They were asked
to consume their evening meal no later than 20:00 h, and then fast for 12 h; that
is, they were allowed water, but no foodstuffs or energy-containing drinks until
breakfast the next morning. On each study day, participants arrived at the CIU
at 08:30 h. The first VAS score was completed immediately before breakfast at
08:45 h. All study meals were consumed within 30 min, in silence, in individually
isolated, curtained-off, booths. Each breakfast meal was served with water (180
ml). Post-breakfast VAS scores were completed at 09:30 h and at 30-min
intervals thereafter, until lunch at 12:30 h. During the morning, participants were
allowed free access to water and to engage in such activities as reading,
working on a PC or watching films, none of which contained any references to
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food or eating. Diet: Test breakfasts, buffet lunch and evening meal The three
test breakfasts were iso-caloric (*330 kcal/ 1,386 kJ), but differed in
macronutrient content (Table 1).
The egg breakfast consisted of two poached eggs on a slice of white toast and
water (180 ml), the cereal and toast breakfast, a bowl of cornflakes with semiskimmed milk, a slice of white toast and water (180 ml), and the croissant and
orange juice breakfast, a croissant with butter and jam and orange juice (180
ml). The two main outcome measures were subjective ratings of satiety, as
assessed throughout the day by the response to three questions using VAS,
and subsequent energy intake at lunch and evening meal as measured by
weighed food intakes. All meals were prepared fresh on the day of the study,
using products bought from local supermarkets. Lunch consisted of an ad
libitum intake of food from a buffet of cheese sandwiches, plain crisps and water
(180 ml). Participants were instructed to eat until ‘comfortably full’. Post-lunch
VAS scores commenced at 13:30 h and at 30-min intervals thereafter, until the
evening meal at 17:45 h. After lunch, participants were free to leave the CIU.
While the participants were instructed to avoid eating or drinking anything other
than water, to which they were given free access, they were asked to record in
a diary any food or drink that was consumed during the afternoon. Participants
returned at 17:30 h for the evening meal, which consisted of pasta with a
tomato-based sauce and cheese (Table 2) and water (180 ml). Participants
were once again instructed to eat until ‘comfortably full’. The end of the evening
meal marked the end of the study day.
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Subjective ratings of satiety
Ratings of satiety were determined using electronic VAS on a PRO-Diary watch
(Camtech, UK). Electronic instrumentation was used to increase reliability of
data capture and decrease investigator workload. Similar electronic systems
have been previously validated against traditional paper VAS scales [13]. The
PRO-Diary watches had the capacity for up to eight questions, but only three
questions were used to measure satiety in this study, the delivery order of which
was randomised during each study day. Each individual was allocated a PRODiary watch at the start of each study day, and VAS scores were measured at
8:45am immediately prior to breakfast, and then every 30 min from 09:30 to
17:30, with a 1-h break between 12:30 and 13:30 h.
Energy consumption by weighed food intake
Foods were weighed at both lunch and dinner on each study day. Both the
lunch and dinner meals were offered ad libitum. Each participant was presented
with a preweighed meal in a quantity far exceeding their usual portion size and
was asked to eat until they were ‘comfortably full’, after which the remains of the
meal were re-weighed to determine food intake.
Statistical analysis
Data from the PRO-Diary watches were downloaded at the end of each study
day via PRO-Diary software into an excel spreadsheet. Missing VAS scores (in
total less than 1 %) were interpolated to provide an average value. The area
under the curve (AUC) for the VAS score profile for each question was
calculated in the morning, before lunch (short-term inhibition of food intake), and
in the afternoon, between lunch and evening meal (long-term inhibition of food
intake), and for the whole day, using the trapezoidal rule [16]. VAS scores
(AUCs) and energy intake data were checked for normality using the Shapiro–
Wilk test. Variance between the three test breakfasts, for normally distributed
data, was determined by a one-way analysis of variance (ANOVA) and post hoc
Bonferroni test for pairwise differences. Asymmetric data were log transformed
and, if still asymmetric, examined by a Friedman’s ANOVA and post hoc
Wilcoxon signed rank test. Baseline VAS results, including product-liking scores
(palatability) for the three test breakfasts, were tested in the same way.
Differences were considered significant at p B 0.05, except for the post hoc
Wilcoxon signed ranks test, in which significance was set at p B 0.02 (i.e.
p\0.05/3). Differences in VAS scores over time were assessed by a general
linear model (VAS scores as the response variable, time and breakfast meal as
interactive terms in the model) and a post hoc Tukey–Kramer test for the
pairwise comparison of individual time points. All statistical analyses were
performed using SPSS software (version 18.0, SPSS Inc., Chicago, IL). The
mean score at each time point for each meal was calculated and represented
graphically. The energy and composition of the test meals (including lunch and
evening meal) were calculated using data from the food manufacturer,
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McCance and Widdowson’s Composition of Foods [17], and the UK Food
Standards Agency.
Food Portion Sizes [18]. The energy conversion factors used to determine the
percentage contribution of macronutrients were 3.75 kcal (15.75 kJ)/gram for
carbohydrate, 4 kcal (16.8 kJ)/gram for protein and 9 kcal (37.8 kJ)/gram for fat.
Ad libitum food intake at lunch was combined with that of the evening meal and
any other recorded intake to provide total energy intake for the day.
The study was granted a favourable ethical opinion from the University of
Surrey’s Advisory Committee on Ethics.
Results
Of the 33 male subjects screened, 31 met the inclusion criteria and were
randomised into the study. One participant was unable to attend study days,
leaving 30 participants to complete all three arms of the intervention study.
The characteristics of the 30 male participants including the mean ± SD age
and body mass index (range, median) were 21.7 ± 1.15 (19–24, 22) years and
23.1 ± 2.65 (18.5–29.7, 22.9) kg/m2, respectively.
Subjective measures of satiety, prospective consumption and hunger (VAS
scores) were variably distributed, even after log transformation, and were thus
subjected to parametric and nonparametric tests. Less than 15 VAS scores
were incomplete in a total of 1,530 responses (\1 %). Energy intake data were
normally distributed and analysed by parametric tests.
There was no significant difference in response to the questions: ‘How hungry
do you feel?’ (Q1), ‘How much do you think you could eat?’ (prospective
consumption) (Q2) or ‘How full do you feel?’ (Q3), at baseline. There was also
no significant difference in the product-liking and palatability between the egg-,
cereal- or croissantbased breakfasts as assessed by questionnaire (data not
shown). Following the test breakfasts, and prior to the ad libitum lunch,
participants were consistently the most full, had less desire to eat (prospective
consumption) and were less hungry after consumption of the egg breakfast
compared to the cereal- and croissant-based breakfasts (Fig. 1). There were
significant differences for all three questions between the egg- and croissantbased breakfasts from 30 to 150 min after the breakfast. This showed the
cereal- and the croissant-based breakfasts to be the second and third most
satiating meals, respectively. This pattern of differential responses was not
maintained in the afternoon after the ad libitum lunch and before the evening
meal, when there was no clear difference in satiety ratings between the
breakfast meals (Fig. 1). When VAS scores were analysed as AUCs, the results
were consistent in showing the same significant differences in satiety ratings
between the egg-, cereal- and croissant-based breakfasts before, but not after
lunch (Table 3). No food or drink, other than water, which was unrestricted and
unrecorded, was consumed before lunch and between the lunch and evening
meal.
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There was significant variation in the intake of energy at the ad libitum lunch
and evening meal after the three breakfast meals. The egg-based breakfast
was followed by a significantly lower intake of energy at lunch relative to the
croissant-based breakfast (p = 0.030). The egg-based breakfast was also
associated with a significantly lower intake of energy at the evening meal
relative to the cerealbased breakfast (p = 0.023) (Fig. 2). The combined energy
intakes for lunch and evening meal produced a significantly lower intake after
the egg-based breakfast relative to the cereal-based breakfast (p = 0.007).
There was no difference in energy intake between the cereal and croissantbased breakfast at either the lunch or evening meal.
Discussion
This study showed that an egg-based breakfast had a greater effect on
subjective feelings of satiety (increased fullness, hunger and decreased desire
to eat) and reduced the subsequent intake of energy, in comparison with two
other iso-caloric breakfasts.
Obese and overweight subjects have been previously shown to consume less
energy, protein, fat and carbohydrate at an ad libitum lunch and up to 36 h after
the isocaloric consumption of eggs versus a bagel breakfast [8–11]. Ratliff et al.
[11] found that the same type of subjects consumed less energy over 24 h in
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response to an egg breakfast compared to a bagel breakfast. While these
studies were formative in establishing the satiating properties of high-protein
foods such as eggs, both compared eggs against a bagel, a food that is less
commonly consumed at breakfast in Europe as compared to North America.
These studies also used food diaries to estimate energy intake after an ad
libitum lunch, a method prone to the underreporting of energy and fat intake,
and thus less reliable than weighing food intake directly [19, 20]. The three test
breakfast meals in the present study contained foods that are commonly
consumed at breakfast in Europe, extending the applicability and thus relevance
of the results. The study design was also extended to allow the direct
assessment of ad libitum intake of energy by weighed food intake at two
subsequent meals (lunch and evening meal).
A significantly reduced intake of energy at lunch was observed between the two
breakfasts with the greatest difference in satiety. This suggests that the ability of
the egg-based breakfast to reduce energy intake at lunch may have depended
upon the magnitude of the satiety response and duration over which this
response was maintained. Increased feelings of satiety have not always been
followed by a reduced intake of energy at the next meal [21, 22]. In studies that
have reported a reduced energy intake, this effect was apparent 3 h after an
egg-based breakfast [9, 11], but not after 4 h when eggs were consumed at
lunch rather than breakfast [8]. In accordance with the present findings, these
earlier studies showed that as the time period between the two meals
increased, the impact of the test meal in reducing subsequent energy intake
was decreased. Since in reality, the period of time between breakfast and lunch
may be greater than 4 h, this may limit the effects of breakfast on satiety, to
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reducing the urge to snack between meals, rather than reducing food
consumption at the lunch.
The egg-based breakfast contained a significantly higher proportion of energy
from protein than either the cereal or croissant (22 vs. 12 and 6 %,
respectively), and fat (57 vs. 27 and 50 %, respectively), and a lower proportion
of energy from carbohydrates (21 vs. 61 and 44 %, respectively).
While most studies have shown that protein is the most satiating of all the
macronutrients [2–5], particularly at breakfast [6], some others have not [23,
24]. High-protein foods have been repeatedly shown to have a greater effect on
satiety than foods high in fat or carbohydrate [25]. There is also evidence to
suggest that a minimum of 50 g of protein is required to elicit a measurable
effect on satiety [26]. However, if the protein content of the egg-based breakfast
contributed to the effect on satiety in the present study, this would provide
evidence to refute the existence of a critical threshold for protein intake, given
that this breakfast contained only 18 g of protein.
The rate of food consumption, and more specifically, slowing bite rate, has been
shown to reduce energy intake, possibly through increased satiety [27]. In the
present study, the participants were given 30 min to consume the breakfast
meals. However, the exact time and rate of consumption was not recorded and
could potentially have influenced subsequent satiety ratings. The unrestricted
intake of water between meals could also have influenced the outcome. There
was no difference in palatability between the three test breakfasts, as assessed
in the ‘product-liking’ questionnaire, thus removing the possibility of liking or
preference for foods, which has been previously shown to stimulate the drive to
eat more frequently [28]. However, there was still potential for confounding
influences produced by the orosensory stimulation of satiety. This could include
differences in the sensory quality of the foods, such as texture and temperature,
and differences in familiarity and expectancy of the meals in relation to the
habitual intake of the participants [29, 30]. In the last respect, many of the
participants overate at the ad libitum meals. The mean intake of energy at lunch
and dinner was 3,431 (±915) kcal (14,410 (±3,843) kJ (range, 1,313 kcal (5,515
kJ)–5,934 kcal (24,923 kJ)). This raises the possibility that the breakfast meals
provided less energy than the habitual breakfasts of the participants. Since
none of our participants were obese, and few could be classed as extremely
physically active, the energy consumed at lunch and dinner was in excess of
their nutritional requirements (energy requirements for males aged 19–50 years
= 2,550 kcal/day, COMA, 1991 [31]; or aged 18–50 years = 2,450 kcal, DoH
[18]). This might suggest that the normal mechanisms of satiety that control the
intake of food were overridden by environmental and psychological factors [32].
While the participants, who were all male university students, were instructed to
eat until ‘comfortably full’, younger males have been previously shown to
display an opportunistic response and overconsume in lunchtime appetite
studies [33]. It is conceivable that this finding invalidates the interdependency
between the two ad libitum meals, and any conclusions relating to the influence
of the breakfasts on energy intake at the evening meal.
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Conclusion
An egg-based breakfast was accompanied by unequivocally greater effects on
subjective measures of satiety and reduced subsequent energy intake relative
to two other breakfast meals. These findings provide evidence to highlight the
importance of food choice at breakfast to help in promoting morning satiety and
in reducing energy intake at lunch.
Acknowledgments This work was supported by a small undergraduate student
project grant from the University of Surrey. Foods for the breakfasts, lunches
and evening meals were purchased with the support from the British Egg
Industry Council.
Conflict of interest Juliet Gray and Bruce Griffin have acted as scientific
advisors to the British Egg Information Service. The study was originally
conceived and conducted at the University of Surrey as an independent
undergraduate research project. The authors did not receive any payment, or
external input into the study design, interpretation of results or conclusions, or
any financial support, other than that described above.
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6. Leidy HJ, Bossingham MJ, Mattes RD, Campbell WW (2009) Increased dietary protein consumed at
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9. Van der Wal JS, Marth JM, Khosla P, Jen KC, Dhurandhar NV (2005) Short term effect of eggs on
satiety in overweight and obese subjects. J Am Coll Nutr 24:510–515
10. Van der Wal JS, Gupta A, Khosla P, Dhurandhar NV (2008) Egg breakfast enhances weight loss. Int J
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11. Ratliff J, Leite JO, de Ogburn R, Puglisi MJ, VanHeest J, Fernandez ML (2010) Consuming eggs for
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14. van Strien T, Frijters JER, Bergers GPA, Defares PB (1986) The Dutch Eating Behaviour
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5:295–315
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29. Stubbs JR (1999) Peripheral signals affecting food intake. Nutrition 15:614–625
30. Yeomans MR, Chambers L (2011) Satiety-relevant sensory qualities enhance the satiating effects of
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31. Dietary reference values for food energy and nutrients for the United Kingdom. Report of the panel on
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NOTAS DE INTERES
JORNADA INTERNACIONAL DE ACTUALIZACION
EN MEDICINA COMPLEMENTARIA – MODULO I
“NUEVAS OPCIONES TERAPEUTICAS EN ENFERMEDADES CRONICAS”
MARACAIBO - VENEZUELA
El sábado 23 de junio del corriente año, tuvo lugar en el Auditorio del Hotel
Kristoff de la Ciudad de Maracaibo, Venezuela, la Jornada Internacional de
Actualización en Medicina Complementaria, Módulo I, cuyo título fue:
“Nuevas opciones terapéuticas en enfermedades crónicas”, auspiciada por
la Sociedad Latinoamericana de Fitomedicina.
Los disertantes invitados para el desarrollo del Módulo I, fueron, el Dr. Jorge
Alonso (Arg.) y el Farm. Fernando Estevez Castillo (Arg.).
Al finalizar la Jornada, los disertantes, Dr. Jorge Alonso y el Farm. Fernando Estevez
Castillo, junto a los organizadores del evento y funcionarios del Ministerio del Poder
Popular para la Salud y del Instituto Nacional de Higiene “Rafael Rangel”
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La actividad contó con la asistencia de un gran número de médicos, no solo del
lugar de la sede del evento, sino también de otros Estados del país, así como
también con la presencia de un grupo de funcionarios del Ministerio del Poder
Popular para la Salud (Productos Naturales) y del Instituto Nacional de
Higiene “Rafael Rangel”, quienes intercambiaron experiencias, opiniones y
comentarios, con los disertantes, reafirmando de esta manera, la importancia
de los Medicamentos Homeopáticos y Fitoterápicos para el abordaje de
enfermedades crónicas, así como también la necesidad de contar con
Legislaciones adecuadas para estos tipos de productos, profesionales
capacitados en la temática y laboratorios en condiciones óptimas para producir
los mismos.
Para el próximo año, se tiene proyectado el desarrollo del Módulo II, con otra
temática, y en otra Ciudad de Venezuela.
Conferencia – Debate
Plantas Medicinales y Alimenticias:
Ejemplo de neodesarrollo agrícola-productivo con inclusión social
Honorable Senado de la Nación – Buenos Aires
La Dirección General de Relaciones Institucionales del Honorable Senado
de la Nación, a través del programa de transdisciplinariedad "Diálogo de
Saberes", realizó el pasado 19 de Octubre, un encuentro cuyo título fue:
“Plantas Medicinales y Alimenticias: ejemplo de neodesarrollo agrícolaproductivo con inclusión social”.
Este Ciclo de Conferencias, tiene como propósito generar un ámbito propicio
para la difusión e intercambio de conocimientos y modos de pensar sobre
distintas cuestiones que plantea nuestra sociedad actual, vinculadas con
aspectos económicos, culturales, científicos y tecnológicos que estimamos de
particular interés por su incidencia en el progreso material y espiritual de la
humanidad.
En esta oportunidad, la actividad se desarrolló en el Salón Auditorio del Edificio
Alfredo Palacios del Honorable Senado de la Nación sito en la Ciudad
Autónoma de Buenos Aires, bajo la coordinación del Dr. Ricardo Machiavelli,
y su apertura estuvo a cargo de la Dra. Lía Mendez, Directora General de la
Dirección General de Relaciones Institucionales de la Presidencia del
Honorable Senado de la Nación.
Luego siguieron tres conferencias, que plantearon la temática propuesta
desde diferentes puntos de vista, y finalmente se permitieron las
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preguntas de los asistentes y el intercambio de opiniones y debate con
los disertantes.
CONFERENCIAS
1- “Aprovechamiento de los recursos vegetales del país para el
desarrollo de medicamentos fitoterápicos y nutracéuticos”, Dr. Cristian
Desmachelier (Presidente de Neotrópico Consultants. Asesor del Ministerio de
CyT de la Nación)
2- “Plantas medicinales: su inclusión en el Sistema Público de Salud de
Argentina y Latinoamérica”, Dr. Jorge Alonso (Presidente de la Sociedad
Latinoamericana de Fitomedicina)
3- “Chía (Salvia hispánica): ejemplo de desarrollo de neocultivos en Argentina”,
Farm. Fernando O. Estevez Castillo (Director del Curso de Posgrado de
Farmacia Homeopática, FFyB – UBA, Director Científico de Laboratorios Dr.
Madaus & Farmacia+Natural)
RESUMENES
“Aprovechamiento de los recursos vegetales del país para el
desarrollo de medicamentos fitoterápicos y nutracéuticos”
Dr. Cristian Desmachelier
De acuerdo a las cifras que maneja actualmente el Ministerio de Salud de la Nación, las
provincias correspondientes al noreste argentino, son las más afectadas por la falta de
medicamentos para su atención primaria de la salud, existiendo focos epidémicos y sectores
altamente vulnerables que debido a su precariedad económica, no cuenta con un acceso
legítimo a sus necesidades primordiales.
Por otra parte, se ha comprobado un déficit en la llegada de medicamentos básicos a través del
plan de emergencia medicamentosa conocido como “Plan Remediar”, el cual incluso carece de
algunos fármacos que resulten eficaces para las necesidades epidemiológicas de la región.
Ante esta delicada situación, las posibilidades de poder adquirir un medicamento en farmacias
por parte de estos sectores vulnerables se hace difícil dada la precariedad económica en la
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que están sumergidos, ya sea por falta de trabajo o sueldos que apenas alcanzan a cubrir
necesidades básicas.
A ello se suma la pérdida de identidad cultural, el desarraigo y la falta de educación de estos
sectores, en donde las nuevas generaciones prácticamente desconocen sus raíces y los
saberes ancestrales delegados por sus antecesores. Precisamente una parte importante del
acervo cultural está dado por las plantas medicinales, cuyo correcto manejo y uso ha sido un
bastión generacional que como huella digital, ha permitido una identidad propia para estas
culturas. Poder devolver parte de este conocimiento a la comunidad, y darle un justo
reconocimiento como patrimonio cultural de la región, son una de las premisas que basan esta
propuesta, además de incorporar a la propia comunidad como nueva mano de obra
aprovechando los conocimientos de domesticación que tienen sobre diferentes especies de la
región, pasibles de ser incorporadas en los proyectos sanitarios que den respuesta a las
necesidades epidemiológicas locales, con costos mucho menores a los que normalmente el
Estado está acostumbrado a gastar.
Antecedentes: Los países de Latinoamérica cuentan con la mayor biodiversidad vegetal de
todo el mundo, lo cual se erige en un patrimonio único e irreemplazable, y que puede ser el
punto de partida de nuevos polos de desarrollos productivos regionales. Esta situación ha sido
contemplada por varios países de la región, que sin dudar, han incorporado las plantas
medicinales en los sistemas de salud, con óptimos resultados según surgen de las propias
auditorías efectuadas por la propia Organización Mundial de la Salud. Precisamente este
máximo organismo de referencia sanitaria mundial, es el que propicia e insta a los diferentes
gobiernos, a que apliquen en sus políticas sanitarias, la incorporación de plantas medicinales.
A raíz de ello, el gobierno de Brasil por medio de un decreto del año 2006 firmado por el
presidente Lula da Silva, ha incorporado de manera obligatoria a las plantas medicinales en el
SUS (Sistema Único de Salud). De manera similar, México ha incorporado la medicina
indigenista en los propios hospitales de varios Estados de ese país, a efectos de atender las
necesidades culturales que a diario reclamaban las diferentes comunidades indígenas. Chile,
Bolivia y Perú cuentan con Departamentos de Medicina Tradicional en sus propios Ministerios
de Salud, lo cual es una muestra de la importancia que para esos países representa la
temática.
“Plantas medicinales: su inclusión en el Sistema Público de Salud de
Argentina y Latinoamérica”
Dr. Jorge Alonso
Desde tiempos inmemoriables, el hombre ha hecho uso de las plantas con diferentes fines, ya
sea para alimentarse, vestirse, curarse o construir su propia vivienda. De hecho, las plantas
medicinales han constituido la herramienta por excelencia del arte de curar a través de miles de
años. Sin embargo, con la llegada de la síntesis química, se propone un nuevo estereotipo de
abordaje terapéutico en los últimos 70 años, sostenido por la posibilidad de patentamiento de
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las nuevas moléculas que se sinteticen. Este modelo hegemónico ha permitido sin lugar a
dudas desarrollar una industria farmacéutica floreciente, con hallazgos novedosos e
importantes para la salud, prevaleciendo la seguridad, eficacia y calidad de cada producto por
encima de todas las cosas, pero que debido a sus altos costos, ha hecho perder la
ACCESIBILIDAD de este recurso a vastos sectores de la población mundial.
En la reunión de Alma-Ata realizada por la OMS a mediados de la década del ’70, se propone a
los diferentes gobiernos, revalidar y reconsiderar las prácticas terapéuticas tradicionales de
cada país, para así poder satisfacer la demanda de medicamentos que por razones
económicas, muchos países se veían privados en su acceso. Es así que comienza a
revalidarse la Medicina Tradicional China, la Homeopatía, la Fitoterapia y la Medicina
Ayurvédica, como las disciplinas más importantes del ámbito alternativo de la salud. Su
incorporación en la enseñanza oficial universitaria, también constituyó un importante hito para
su jerarquización académica, y su puesta en práctica en los sistemas de atención primaria de la
salud.
En los diferentes países de América se han llevado a cabo diferentes tareas para revalidar
estos conocimientos ancestrales y ponerlos en la práctica en los servicios de salud. En cuanto
al panorama de la República Argentina, a mediados de la década del ‘90 el país contaba con
un sistema de cobertura sanitaria bastante aceptable, en donde los remedios sintéticos
llegaban a muy bajos costos a los sectores carenciados, no planteándose en ningún momento
otro tipo de abordaje de los problemas sanitarios, que no sea el oficial. Sin embargo, la política
neoliberal imperante a fines de esa década, produjo un desempleo creciente, el cierre de
muchas fábricas nacionales y el comienzo de una desvalorización de los ingresos salariales.
Esto produjo que en el año 2001 el sistema colapsara totalmente, produciéndose una
devaluación muy importante de la moneda, sumado a la retención de los ahorros de los
ciudadanos, lo cual derivó en 40% de desocupación y en un 55% de indigentes, sin acceso a
medicamentos básicos y a los sistemas de salud primarios. Fue por ello menester realizar
acciones conjuntas entre los diferentes sectores de la comunidad, a fin de crear un marco
propicio que pueda asegurar la correcta provisión de medicamentos a la población. En ese
sentido, la Asociación Argentina de Fitomedicina elevó a las autoridades de la Cooperación
Italiana (COE) y Región Lombardía, una propuesta que contempló la fabricación de
fitomedicamentos con altos estándares de calidad, a ser elaborados por laboratorios
provinciales (aprobados por ANMAT = Administración Nacional de Medicamentos, Alimentos y
Tecnología Médica) a partir de materias primas provenientes de cultivos realizados en áreas
cedidas por diferentes intendencias provinciales, y en la cual trabajarían sectores de la
población desocupados o jefes de familia con recursos económicos restringidos.
En los controles de calidad actuaron Universidades provinciales, y en la correcta identificación
botánica, así como en la selección de terrenos, tanto botánicos como ingenieros agrónomos
calificados, lo cual nos da una idea de la interacción entre las distintas disciplinas que
conforman la Fitomedicina. Se efectuaron estudios epidemiológicos en las regiones
seleccionadas, a efectos de conocer índices de prevalencia de enfermedades y el grado de
conocimiento de las personas sobre el empleo de plantas medicinales. Este tipo de modelo se
ha planteado como un proyecto perfectamente autosustentable, en la medida que todos los
actores interactúen entre sí.
Asimismo, fueron llevadas a cabo actividades docentes hacia la población como hacia el
cuerpo profesional de APS. Por otra parte, fue elaborado un libro sobre Plantas Autóctonas de
Argentina y APS, de distribución gratuita a Universidades y Centros de APS de Argentina. Las
plantas medicinales seleccionadas que constituyeron fitomedicamentos fueron:
-
Ambay (Cecropia pachystachia)
Congorosa (Maytenus ilicifolia)
Caléndula (Calendula officinalis)
Carqueja (Baccharis trimera)
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En cuanto a la revaloración de otras especies, se rescató un cultivo ancestral propio de los
países andinos, que es el Amaranto (Amaranthus mantegazzianus), con un contenido en
nutrientes muy importante, pudiendo satisfacer carencias alimenticias entre niños de escasos
recursos y desnutridos. Sobre las plantas que comenzaron a cultivarse en el proyecto
(Caléndula y Amaranto), se han realizado manuales de cultivo que se constituyen en un
documento y una herramienta indispensables para lograr estos objetivos, de los cuales no
habían antecedentes en el país. De las otras especies autorizadas, se están elaborando
nuevos manuales.
Un hecho importante del proyecto fue el de revalorizar el conocimiento ancestral de las culturas
originarias de nuestro país, lo cual pudo cristalizarse en diciembre del 2005 en un encuentro
llevado a cabo en Posadas (Misiones) denominado “Encuentro de Culturas para la Salud”, y
que conglutinó exposiciones orales sobre temas de salud de los integrantes de las culturas
Mapuche, Toba y Guaraní, entre otras. El evento fue inaugurado musicalmente por el coro de
indígenas Tobas y contó con la participación de autoridades de salud provinciales.
Es importante señalar que los fitomedicamentos elaborados en el proyecto son distribuidos
gratuitamente en los Centros de Atención Primaria de la Salud seleccionados a tal fin, y que
todas estas acciones son reconocidas y propuestas por la propia Organización Mundial de la
1-2
Salud en sus programas de Atención Primaria de la Salud . Gracias al aporte económico del
Gobierno Italiano se pudo cristalizar este proyecto, denominado “Cultivando la Salud”, el cual
pretende generar polos productivos provinciales aprovechando los propios recursos florísticos
regionales, y que a futuro permitan propiciar modelos de gestión autosustentables, con la
significativa reducción en los gastos en salud (compra de medicamentos costosos, menores
efectos iatrogénicos, etc ).
Como corolario de este proyecto, el 10 de agosto de 2006 se llevó a cabo la Jornada Nacional
de Medicamentos Fitoterápicos en el propio auditorio del Senado de la Nación, y el cual
contó con más de 300 inscriptos entre investigadores universitarios, cámaras de laboratorios
nacionales y extranjeros, diputados, senadores, la OPS/OMS, profesionales de la salud, un
representante de la Embajada de Italia y autoridades sanitarias no solo de Argentina, sino
también de países vecinos: Uruguay, Chile, Brasil y Perú. Esta Jornada contó, a su vez, con la
participación de disertantes de EE.UU y Guatemala. La Jornada fue una muestra del gran
interés que despertó el proyecto “Cultivando la Salud”, como modelo para ser ejecutado en
todo el país. Actualmente estamos planificando junto a los presidentes de las Comisiones de
Salud de las Cámaras de Senadores y Diputados, las tareas organizativas para llevar adelante
un proyecto similar a nivel de la Nación.
“Chía (Salvia hispánica): ejemplo de desarrollo de neocultivos en
Argentina”
Farm. Fernando O. Estevez Castillo
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Hay evidencia científica que muestra que la semilla de chía (Salvia hispánica L.) comenzó a
usarse en la alimentación humana unos 3500 años antes de Cristo y se convirtió en un cultivo
básico en el Centro de México entre 1500 y 900 años A.C.
La conquista española reprimió a los nativos, suprimiendo sus tradiciones y destruyendo la
mayoría de la producción agrícola intensiva y el sistema de comercialización existente. Muchos
cultivos que mantuvieron una posición preponderante en las dietas de la América precolombina, entre ellos la chía, fueron destruidos por los españoles debido a la estrecha
asociación con la religión y fueron reemplazados por otras especies extranjeras (trigo, cebada,
zanahorias, etc.) que tenían una gran demanda entre los conquistadores.
La chía sobrevivió sólo en pequeños parches en áreas montañosas escarpadas del sur de
México y Guatemala hasta que un programa de investigación y desarrollo se inició en 1991, a
partir de un grupo de productores, entidades comerciales y personal técnico y científico de
Argentina, Bolivia, Colombia, Perú y los Estados Unidos, seleccionando nuevas áreas de
producción y prácticas de desarrollo, con el fin de poner a la chía en el mercado como un
nuevo producto.
Esta semilla ofrece el mayor contenido de ácidos grasos omega-3 disponible en el reino vegetal
(tiene el mayor porcentaje conocido de ácido alfa-linolénico); contiene más proteínas, lípidos,
energía y fibra (pero menos carbohidratos) que el arroz, la cebada, la avena, el trigo o el maíz;
es una excelente fuente de calcio, fósforo, magnesio, potasio, hierro, zinc y cobre; es pobre en
sodio (78 veces menos que el salmón, 237 veces menos que el atún) y a diferencia de otras
fuentes de ácidos grasos omega-3, no tiene "sabor a pescado".
La ciencia actual explica por qué las antiguas civilizaciones consideraban a la chía un
componente básico de su dieta. La composición química de misma y su valor nutricional, le
confiere un gran potencial para usarla dentro de los mercados alimenticios e industriales. Así,
la información tecnológica ha dado una excelente oportunidad para crear una industria
agrícola, totalmente capaz de ofrecer al mundo un “cultivo nuevo y antiguo a la vez”.
III JORNADAS DE FARMACIA DEL SUDOESTE BONAERENSE
Del 9 al 10 de Noviembre pasado, tuvo lugar en el Salón de Actos del
Rectorado de la Universidad Nacional del Sur, sito en la Ciudad de Bahía
Blanca, las III Jornadas de Farmacia del Sudoeste Bonaerense, organizadas
por el Departamento de Biología, Bioquímica y Farmacia de la mencionada
Casa de Estudios.
Estas Jornadas fueron declaradas de interés municipal, fueron gratuitas y
contaron con el auspicio del citado Departamento, la Secretaría General de
Ciencia y Tecnología de la UNS, el Colegio de Farmacéuticos de la Provincia
de Buenos Aires y el Ente Coordinador de Unidades Académicas de Farmacia
y Bioquímica (ECUAFyB), y cuyo objetivo fundamental es promover la
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integración profesional y el conocimiento científico en las diferentes áreas de
las Ciencias Farmacéuticas.
Se desarrollaron de 9 a 19 hs, con la disertación de especialistas locales y
nacionales, y fueron dirigidas a Farmacéuticos y alumnos de quinto año de la
carrera de Farmacia.
El Farm. Fernando Estevez Castillo durante sus dos disertaciones.
Las actividades se desarrollaron a través de Conferencias plenarias a cargo de
especialistas en cada materia, quienes expusieron los siguientes temas:
-“Presentación líneas de investigación del área farmacéutica de la Universidad
Nacional del Sur”, Dra. Noelia Gonzalez Vidal y Dra. Verónica Ramirez Rigo
(UNS)
-“Homeopatía: de la receta al medicamento”, Farm. Fernando Estevez
Castillo (Fac. de Farmacia y Bioquímica, UBA)
-“Avances en nanotecnologia farmacéutica”, Dr. Carlos Bregni (Fac. de
Farmacia y Bioquímica, UBA)
-“Relevancia de las evaluaciones económicas den el sector salud en contextos
inflacionarios”, Dra. Nebel Moscoso (UNS)
-“Farmacoterapia oncológica”, Dr. Eduardo Lagomarsino (Fac. de Farmacia y
Bioquímica, UBA)
-“El antiinflamatorio natural: Árnica montana”, Farm. Fernando Estevez
Castillo (Laboratorios Dr. Madaus)
-“Medicamentos producidos en el Laboratorio de Hemoderivados de la
Universidad Nacional de Córdoba”, Dra. Cecilia Sobrero (Laboratorio de
Hemoderivados, UNC)
-“PVC de calidad médica en soluciones parenterales y biomédicos”, Farm.
Marcelo Atempiz (Laboratorios Rivero)
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-“Sentirnos bien, vernos bien. La importancia de la hidratación cutánea”, Esp.
en Producción de Cosméticos Andrea Spagnuoli (Fac. de Farmacia y
Bioquímica, UBA - ANMAT)
-“Normalización en el área farmacéutica”, Farm. Mariana Funes (IRAM).
-“Ejercicio Profesional Farmacéutico: Herramientas Institucionales”, Farm.
Isabel Reinoso y Farm. Nicolás Troffe (Colegio de Farmacéuticos de la Prov.
de Bs. As.)
Todas las actividades se caracterizaron por la presencia de gran cantidad de
asistentes, tanto de alumnos de la carrera de Farmacia como Farmacéuticos,
quienes además pudieron participar a través de preguntas a los
Conferencistas.
Organizadores de las Jornadas
Por último quisiera felicitar a los organizadores, a través de la D
Drraa.. N
Nooeelliiaa
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o
n
z
á
l
e
z
V
i
d
a
l
González Vidal, por el éxito alcanzado en estas III Jornadas, y por seguir
siendo excelentes anfitriones, además de progresar año tras año, en la
organización de esta actividad, como por ejemplo, con la incorporación
de un importante número de posters, con trabajos de investigación de la
Universidad Nacional del Sur.
RESUMENES DE ALGUNAS CONFERENCIAS
El antiinflamatorio natural: Arnica montana
Arnica montana es una planta de la familia de las Asteraceae, originaria del centro y sur de
Europa, que crece principalmente en las praderas de las montañas (entre los 700 y 2500
msnm). Su recolección silvestre intensiva, la ha puesto en peligro de extinción en varios países,
por lo cual fue incluida en los listados de la Convención de Washington (1981)sobre la
protección de especies y la Unión Europea ha establecido medidas de control para la
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conservación de la misma. Se cultiva en Alemania, España, Hungría y Reino Unido, aunque
buena parte de la materia prima sigue proviniendo de la recolección silvestre en España y
Rumania.
Contrariamente a lo esperado, el Árnica era desconocido para los médicos greco-romanos y
tampoco se mencionó en los textos de la Alta Edad Media. Fue introducida en 1533, por el
editor de la obra Physica de Santa Hildegarda de Bingen, para referirse a una planta con
propiedades medicinales, mágicas y fabulosas. La especie Árnica montana L., fue descripta
por Linneo en 1753, alcanzando gran éxito en el siglo XVIII, para el tratamiento de golpes e
inflamaciones y se popularizó a lo largo de los siglos XIX y XX.
La parte utilizada de la planta, varía de acuerdo al tipo de medicamento elaborado; los
capítulos florales para los fitomedicamentos, y la planta entera, incluyendo la raíz, para los
homeopáticos. Actualmente el Árnica es utilizada en formas farmacéuticas de uso externo,
excepto en el caso de los medicamentos homeopáticos (uso interno), para reducir el dolor e
inflamación resultante de lesiones, accidentes y/o traumas quirúrgicos, incluyendo hematomas,
esguinces, torceduras, contusiones y edemas por fracturas, así como también como adyuvante
en tratamientos de enfermedades crónicas, tales como: artritis, artrosis, gota y otras
enfermedades inflamatorias de articulaciones y músculos. Los principales compuestos activos
que contiene la planta, son lactonas sesquiterpénicas (ésteres de helenalina y 11,13–
dihidrohelenalina), que inhiben la activación del factor de transcripción NF-κB (factor de
transcripción nuclear kappa B), interfiriendo de esta manera con la regulación de los genes que
codifican muchos mediadores inflamatorios. Entre otros componentes, los polisacáridos,
estimulan la fagocitosis y reducen las hematomas.
Existen un número importante de investigaciones con Árnica montana (in vivo e in vitro) que
confirman la eficacia de las preparaciones que la contienen, como antiinflamatorio. Como
medicamento fitoterápico, el Arnica montana, se presenta en formas de uso externo, tales
como, tinturas, geles, cremas y pomadas. El uso interno, solo es permitido en las formas
homeopáticas (glóbulos, gotas, tabletas), donde la dilución respectiva de la tintura madre inicial,
elimina su acción tóxica por esta vía, ya que las lactonas sesquiterpénicas pueden causar
irritación de la mucosa gástrica, náuseas, vómitos y diarreas.
HOMEOPATIA: “De la receta al medicamento”
La HOMEOPATIA es un sistema terapéutico, creado por un médico alemán, el Dr. CHRISTIAN
FEDERICO SAMUEL HAHNEMANN (1755-1843), y que se caracteriza por aplicar la Ley de los
Similares y utilizar los medicamentos en dosis infinitesimales para lograr la curación de los
pacientes.
En nuestro país y en el mundo podemos destacar tres Escuelas Médicas Homeopáticas: 1)
UNICISTA: es la Escuela Hahnemanniana Clásica u Ortodoxa, que sigue los lineamientos
dados por el Creador de éste Sistema Terapéutico, y que utiliza un solo medicamento, en alta
potencia (en dinamización muy alta) para cada paciente, de acuerdo a su totalidad sintomática,
para lograr la curación. Ej.: el médico, luego de la consulta le prescribe Lycopodium 1000C 1
Papel. 2) PLURALISTA: siguen los mismos lineamientos que la escuela anterior, pero utilizan
más de un medicamento, en alta potencia, para cada paciente, pero administrándolos en forma
única y alternada, debido a que su concepción es que con un solo medicamento no pueden
cubrir la totalidad sintomática del individuo. Ej.: el médico, luego de la consulta le prescribe: 1º
día: Lycopodium 1000C 1 Papel, 2º día Sulphur 1000C 1 Papel, 3º día Nux vómica 1000C 1
Papel y al 4º día vuelve al primer medicamento, y así sucesivamente. 3) COMPLEJISTA: tienen
un enfoque diferente al de las dos Escuelas anteriores, ya que no tienen en cuenta la totalidad
sintomática, sino los síntomas de la enfermedad local, utilizando un medicamento compuesto
por más de una droga, en bajas potencias (en dinamizaciones bajas). Ej.: Chelidonium 3X,
Taraxacum 3X, Cynara 4X Gotas.
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Todas los medicamentos homeopáticos, independientemente la orientación del médico
prescriptor, se preparan de acuerdo a lo especificado en las principales Farmacopeas
Homeopáticas, teniendo en cuenta las monografías de las materias primas (drogas y
vehículos), los métodos de preparación de los productos intermedios (tinturas madre,
soluciones madre y dinamizaciones) y de las distintas formas farmacéuticas, aplicando como
condición indispensable, las Buenas Prácticas de Manufactura de Medicamentos
Homeopáticos.
En Argentina, existe Legislación a nivel Nacional y también en algunas Provincias, que regulan
la elaboración del Medicamento Homeopático en la oficina de Farmacia, como medicamento
magistral, con excepción de La Rioja, donde también existe la posibilidad de elaboración
industrial, aunque todavía sin reglamentar. Con respecto a la Formación del profesional
Farmacéutico, existen algunas Facultades que han incorporado la Materia Homeopatía, como
optativa u obligatoria, durante el grado, así como Cursos de Posgrado para los egresados.
La aplicación de la atención farmacéutica en la Farmacia Homeopática requiere una
capacitación específica en esta materia (ver párrafo anterior), para poder asesorar a los
pacientes, con respecto a la posología, formas de administración, interacciones,
contraindicaciones y conservación de este tipo de medicamento.
Para poder comprender correctamente los distintos pasos que se siguen en una Farmacia
Homeopática, desde la Receta al Medicamento, trabajaremos durante esta Conferencia, sobre
recetas médicas reales, contemplando y explicando cada una de las diferentes etapas que
comprenden la interpretación de la receta, la elaboración y dispensación del medicamento
homeopático.
JORNADA DE MEDICINA BIOLOGICA E INTEGRATIVA
Neuquén 2012
El sábado 17 de Noviembre, se realizó en la Ciudad de Neuquén, una Jornada
de Medicina Biológica e Integrativa, organizada por la Farmacia
Farmacéuticos Asociados de dicha ciudad y por Farmacia+Natural de
Buenos Aires, y auspiciada por Powerfarm® y Laboratorios Dr. Madaus.
La actividad se desarrolló en el Auditorio del Consejo Provincial de Educación,
y tuvo como disertantes a la Dra. Ana María Soerensen1 y al Farm. Fernando
O. Estevez Castillo.
La apertura de la Jornada estuvo a cargo del Farm. Federico Arrigoni,
Director Técnico de Farmacia Farmacéuticos Asociados, empresa con
destacada trayectoria en la Ciudad de Neuquén, y organizadora de otros
eventos relacionados con la Medicina Natural, tales como la I Jornada de
Homeopatía del Comahue, realizada en el año 2007, cuyo principal disertante
fue el prestigioso y recordado Dr. Ricardo Alvarez.
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Los temas abordados por la Dra. Ana María Soerensen fueron: Actualización
en Medicina Naturista, Medicina Biológica o Integrativa. Modelo de paciente,
diagnóstico y tratamiento. Educación para la salud. Concepto de sistema en
biología. Terapia complementaria por sistemas. Semiología de la mano.
Oculoanálisis. Alcances y limitaciones. Reflexoterapias. Orofaringe: lengua
hepática, saburral, en constipación y diarrea, reumática, en terreno
cancerígeno, en parasitosis, etc. Diagnóstico y tratamiento.
La Dra. Ana María Soerensen durante la parte práctica (izq.) y su disertación (der.)
A la presentación teórica de los temas, la Dra. Ana María Soerensen le sumó
también la parte práctica, lo cual facilitó el entendimiento y despertó gran
interés en todos los presentes.
Por su parte, el Farm. Fernando O. Estevez Castillo, desarrolló el siguiente
temario: Escuelas Homeopáticas (Unicista, Pluralista y Complejista).
Similitudes y diferencias. Características del medicamento. Su aplicación en el
sistema de Salud Público y Privado. Evaluación de resultados. Compendio de
orientación terapéutica basado en la tradición popular homeopática CentroEuropea. Antecedentes y evolución en Argentina. Investigaciones nacionales e
internacionales.
De izq. a der: Farm. Fernando Estevez Castillo, Dra. Ana M.
Soerensen, y organizadores de la Jornada: Farm. Federico
Arrigoni, Farm. Patricia Hirsch y Farm. Pedro Alfieri
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Por último, todos los asistentes recibieron en un CD, el material de la Jornada,
y el cierre estuvo a cargo del Farm. Federico Arrigoni, quien se comprometió
a realizar el próximo año, otras actividades de similares características, para
fomentar estas disciplinas no convencionales, colaborando de esta manera con
la formación de los profesionales de la salud que las practican.
1
Médica egresada de la Facultad de Medicina de la Universidad de Buenos Aires. Master en
Psiconeuroinmunoendocrinología-Univ. Favaloro. Posgrados en formación intensiva en Cardiología. Docente de Cursos
de Medicina Naturista, Oculoanálisis, Terapia Biológica y Quiropraxia, en Argentina y el exterior. Docente de la
Diplomatura anual en Medicinas no convencionales y Terapias Complementarias, Módulos sobre Medicina Naturista y
Homotoxicología (Universidad de Belgrano). Docente del Curso intensivo en Medicina Integrativa, Asociación Médica
Argentina. Co-Autora de los libros, Rumbo a la salud y Vivir en plenitud y autora de numerosos trabajos presentados en
Congresos Nacionales e Internacionales
NOVEDADES
PROGRAMA RADIAL
“AMIGOS DE LO NATURAL”
Alimentación – Salud – Ecología – Hábitos saludables
FM 94.7 (RADIO PALERMO)
TODOS LOS MIERCOLES DE 15 A 16 HS
CONDUCEN
DR. JORGE ALONSO
FARM. FERNANDO ESTEVEZ CASTILLO
PRODUCCION
También podés escucharlo a través de la web:
www.radiopalermo.com.ar
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NUEVOS PRODUCTOS
ALOEGEL
Laboratorios Dr. Madaus & Co., ha presentado un nuevo producto llamado
ALOEGEL, de uso externo, de alto poder descongestivo a base de Aloe vera,
rico en cualidades emolientes, hidratantes y antisépticas, procurando alivio en
el caso de irritaciones cutáneas.
Presentación:
Gel uso externo por 75 gramos.
Para más información:
Av. Luis María Campos 585 – Buenos Aires – Argentina (C1426BOD)
Tel.: (54) (11) 4771-1734 / 4772-2428
Fax: (54) (11) 4775-4380
e.mail: [email protected]
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CARRERA DE FARMACIA : CATEDRA “HOMEOPATIA”
En Argentina existen hasta el momento, solo tres Facultades de Farmacia que
dictan una materia relacionada a la Homeopatía, dentro del Plan de Estudios
de la carrera de Farmacia. Dos de ellas, la tienen como materia optativa o
electiva: la Facultad de Bioquímica, Química y Farmacia de la Universidad
Nacional de Tucumán (“Introducción a la Farmacia Homeopática”); y la
Facultad de Bioquímica, Quimica y Farmacia de la Universidad Nacional de
San Luis (“Homeopatía”).
La Facultad de Ciencias de la Salud de la Universidad Maimónides, es la
única en el país, que dicta de forma obligatoria, la materia ”Homeopatía”,
a los alumnos del cuarto año de la carrera de Farmacia.
A partir de Julio del presente año, fue designado como Profesor Titular de la
Cátedra de “Homeopatía”, el Farm. Fernando Oscar Estevez Castillo,
acompañado por la Farm. Miriam Bruno como Profesora Adjunta, ambos
profesionales con una dilatada trayectoria en la práctica y enseñanza de la
Farmacotecnia Homeopática, quienes brindarán una información teórica
completa y actualizada, con trabajos prácticos incluidos, para lograr que el
alumno pueda interpretar, elaborar y dispensar medicamentos
homeopáticos.
ATENEOS Y CURSOS
ATENEOS
Ateneos del Departamento de Homeopatía
Universidad Maimónides. Hidalgo 775, Buenos Aires. Aula 307.
Entrada libre para Médicos y Estudiantes de Medicina.
Para más información:
Departamento de Homeopatía - Universidad Maimónides
Hidalgo 775, Buenos Aires - Argentina
Tel. (54-11) 4905-1142
[email protected]
www.homeos.org ; www.maimonides.edu
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CURSOS
Sociedad Latinoamericana de Fitomedicina
Cursos a distancia para profesionales de la Salud
Curso de Fitomedicina:
Son 40 módulos en formato PDF totalmente ilustrados. Se entregan de a 4
módulos por semana. Se abordan las principales patologías humanas de
acuerdo a los diferentes sistemas o aparatos. Se incluyen formulaciones para
todos los casos con aval de las principales farmacopeas de todo el mundo. El
examen consiste en un multiple choice de 30 preguntas o el cursista puede
optar por la redacción de una monografía con tema a determinar
oportunamente.
Curso de Fitodermatología y Fitoestética:
Se trata de 16 módulos en formato PDF totalmente ilustrados. Se abordan las
principales patologías dermatológicas (acné, psoriasis, vitiligo, alopecía,
celulitis, rosácea, legislación, etc). Se incluyen formulaciones para todos los
casos con aval de las principales farmacopeas de todo el mundo. El examen
consiste en un multiple choice de 30 preguntas o el cursista puede optar por la
redacción de una monografía con tema a determinar oportunamente.
Curso de Alimentos Funcionales y Nutracéuticos:
Este curso consta de 30 módulos en formato PDF totalmente ilustrados, donde
el alumno podrá tener acceso a toda una gama de información moderna
relacionada con la actividad científicamente demostrada por aquellos principios
activos comprendidos en nuestros alimentos y en productos nutracéuticos. El
rol preventivo que cumplen en muchas enfermedades, así como el
mejoramiento de procesos crónicos tras su consumo, hace de esta temática
una materia obligada para todo profesional de la salud. El examen consiste en
un multiple choice de 30 preguntas o la redacción de una monografía.
Curso de Medicina Indigenista Americana:
Se trata de un curso en formato PDF totalmente ilustrado, distribuido en 20
módulos, a enviarse cada fin de semana. El curso se acompaña de trabajos
científicos referidos a tópicos tratados en el temario. Se verán la organización
política y social, los aspectos religiosos y las cosmovisiones sobre salud y
enfermedad de las principales etnias y civilizaciones americanas: Sioux,
Apaches, Mayas, Aztecas, Caribes, Kunas, Jíbaros, Guaraníes, Incas,
Aymarás, Mapuches, Onas, y muchos más. La evaluación consistirá en una
monografía o realizar un multiple choice.
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