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A homoeopathic drug proving of Carcharhinus leucas 30CH and a subsequent comparison with that of Galeocerdo cuvier hepar 30CHNaidoo, Nalini January 2018 (has links)
Submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homoeopathy, Durban University of Technology, Durban, South Africa, 2018. / Introduction
The aim of this study was to conduct a homoeopathic proving of Carcharhinus leucas in the thirtieth centesimal potency (30CH) and to subsequently establish and describe the symptomatology in standard materia medica format and then compare this symptomatology to Galeocerdo cuvier hepar 30CH.
Methodology
The homoeopathic proving of Carcharhinus leucas 30CH was conducted at the Durban University of Technology and was accomplished by means of a randomised, double blind, placebo controlled trial.
Carcharhinus leucas 30CH was manufactured by the researchers according to Method 6, Method 8a and 10 of the German Homoeopathic Pharmacopoeia (Benyunes, 2005: 36-39).
The homoeopathic proving was conducted in the form of a double blind placebo controlled study of Carcharhinus leucas 30CH with a total of 30 healthy provers. The prover sample was divided into two groups by a process of randomisation. Twenty four provers (80%) comprised the verum group and the remaining 6 provers (20%) comprised the placebo group. The identity of the proving substance and the potency used was not disclosed to provers. Provers documented their physical, mental and emotional status for one week preceding the administration of the proving remedy. A comprehensive physical examination and case history of every prover was taken before and after the proving period. Provers were instructed to ingest one powder three times a day for two days but were told to discontinue the powders once symptoms arose. The duration of the proving spanned 6 weeks and throughout the proving process, researchers were in constant communication with all the participants. Upon completion of the proving process, journals were collected and
the information therein was translated into materia medica and repertory format. This was done in order to acquire the remedy picture of Carcharhinus leucas 30CH. Thereafter, the symptomatology of Carcharhinus leucas 30CH was compared to the symptomatology of Galeocerdo cuvier hepar 30CH.
Results
The proving of Carcharhinus leucas 30CH produced a total of 590 already existing rubrics and 43 new rubrics. The majority of these rubrics were located in the MIND (127), GENERALS (64), HEAD (55), EXTREMITIES (50), and EYE (34). In regard to
the mind, prominent features were apparent such as anger, anxiety, cheerfulness, an aversion or amelioration within company, difficulty concentrating or increased focus, varying delusions and fears and irritability. Pertaining to the head, headaches were evident with varying concomitants and modalities, with headaches predominantly affecting the forehead and sides. Sensations included dryness, heat, heaviness, perspiration and shaking. The extremities displayed symptoms primarily in the forearms, legs and thighs and sensations included paralysis, shaking, swelling and weakness. In regard to the eye, eye pain with multiple modalities were apparent, with symptoms related to the canthi and eyelids. Sensations included heat, heaviness, inflammation, itching and photophobia as well as a visible discolouration of the eye.
Analysis of the results presented an understanding of the similarities and differences between Carcharhinus leucas 30CH and Galeocerdo cuvier hepar 30CH.
Conclusion
As hypothesised, it was evident that administering Carcharhinus leucas 30CH to healthy individuals did yield observable symptomatology. Additionally, it was apparent that various correlations between Carcharhinus leucas 30CH and Galeocerdo cuvier hepar 30CH existed / M
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Reação histológica de exposições pulpares em dentes de ratos à aplicação do laser de baixa intensidade somente ou em associação ao capeamento com hidróxido de cálcioCrisci, Fernando Simões [UNESP] 12 March 2002 (has links) (PDF)
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crisci_fs_me_arafo.pdf: 2027540 bytes, checksum: 4b3628dd1cdd46049844ef97ba6d858a (MD5) / O presente estudo avaliou a reação histológica do efeito do laser de baixa intensidade diodo semicondutor de arseneto de gálio e alumínio (GaA1As, com comprimento de onda de 785 nm, infravermelho, com potência de emissão de 50 mW, densidade de energia de 3 J/cm2, em emissão contínua, por meio de ponta especial de fibra óptica, por um período de 2 segundos) em exposições pulpares induzidas em dentes de ratos. Foram utilizados 60 ratos, dos quais cada animal ofereceu dois dentes (totalizando 120), que foram distribuídos em 5 grupos experimentais: grupo I (controle), exposição capeada com hidróxido de cálcio; grupo II, laser imediato + hidróxido de cálcio; grupo III, laser imediato + hidróxido de cálcio + laser após 24 horas; grupo IV, laser imediato + hidróxido de cálcio + laser após 24 e 48 horas; e grupo V, somente a aplicação do laser. Decorridos os períodos experimentais de sete e 30 dias, os animais foram mortos, as peças removidas e preparadas para análise histológica. De acordo com a proposta e as condições específicas deste trabalho, os resultados nos permitem concluir que as associações laser imediato + hidróxido de cálcio e laser imediato + hidróxido de cálcio + laser 24 horas, foram os grupos que apresentaram os melhores resultados tanto aos sete dias (efeito antiinflamatório), quanto aos trinta dias (efeito no reparo tecidual). / The present study evaluated the histological reaction of the low poweer laser effect, diode laser semiconductor of gallium aluminum arsenide (GaA1As, with wavelenght of 785 nm, infra-red, potency of emission of 50 mW, energy density of 3 J/cm2, with continuous emission, through special tip of optic fiber, for a period of two seconds) in exposed pulp induced in teeth of mice. Sixty mice were used, of which each animal offered two teeth (totaling 120), that were distributed in 5 experimental groups: group I(control group) exposed capping with calcium hydroxide; group II, immediate laser + calcium hydroxide; group III, immediate laser + calcium hydroxide + laser after 24 hours; group IV, immediate laser + calcium hydroxide + laser after 24 and 48 hours; and group V, only laser application. After the experimental periods of seven and thirty days, the animals were killed, the pieces were removed and prepared for histological analysis. In agreement with the proposal and the specific conditions of this study, the results allow us conclude that the associations of immediate laser + calcium hydroxide and immediate laser + calcium hydroxide + laser after 24 hours, were the groups that presented the best results in the periods of seven days (anti-inflammatory effect), and thirty days (effect in the tissue repair).
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The effectiveness of homoeopathic simillimum in the treatment of job burnout in the human service fieldVaithilingam, Heshma January 2005 (has links)
Thesis(M.Tech.: Homoeopathy)-Dept of Homoeopathy, Durban Institute of Technology, 2005
xxiii, 96 leaves / The purpose of this double blind placebo controlled study was to evaluate the efficacy of homoeopathic simillimum in the treatment of job burnout in the human services field. / M
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A Homoeopathic C4 trituration proving of Withania somnifera with a subsequent comparison to the conventional 30CH proving of Withania somniferaPillay, Nickita Nikki January 2017 (has links)
Submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homoeopathy, Durban University of Technology, Durban, South Africa, 2017. / The C4 trituration method is a unique method for homoeopathically proving a substance and determining its therapeutic properties. The process requires the use of a mortar and pestle and involves many rounds of grinding (triturating) the raw substance. During the trituration process symptoms are experienced by the triturator.
Withania somnifera, commonly known as Ashwagandha in Ayurvedic medicine is highly regarded for its clinical efficacy as an adaptogenic herb. Due to the herb’s therapeutic properties and extensive use in Ayurvedic medicine a comprehensive homoeopathic drug proving was conducted at The Durban University of Technology by Laidlaw in 2015.
Aim
The aim of this study was to conduct a homoeopathic C4 trituration proving of Withania somnifera with a subsequent comparison to the conventional 30CH proving of Withania somnifera which was conducted by Laidlaw in 2015.
The study was of a qualitative and exploratory nature hence employed a qualitative methodology with purposive sampling. Participants were required to triturate up to the fourth potency [C4] and all the symptoms experienced were recorded in the journals provided.
The study incorporated thematic analyses of data. The data was transliterated by the researcher, thereafter those symptoms were classified systematically and converted into rubrics using Schroyens (2012) repertory. Recorded symptoms were collated to create a C4 trituration representation. Subsequently the symptoms obtained from the C4 trituration proving of Withania somnifera was comparatively analysed against the symptoms of the conventional 30CH proving of Withania somnifera, which was conducted by Laidlaw (2015).
Method
This research study followed a qualitative methodology which comprised a single blind study, and a proving sample. This was a qualitative study; the requirement for sample size is usually up to 10 participants until saturation of data, but this study utilised 18 participants to ensure the generation of rich data. Participants triturated 91: 100 lactose to the fourth potency [C4] using a mortar and pestle. All symptoms experienced were recorded in journals. The analysis of the data followed a qualitative phenomenological methodology.
Results
The C4 trituration proving yielded 145 rubrics. Two of these rubrics were newly formulated. The majority of the rubrics were produced in the MIND and HEAD section. There were 100 Grade 1 rubrics, 44 Grade 2 rubrics and 1 Grade 3 rubrics.
Conlcusion
The C4 trituration produced a symptom picture of Withania somnifera, which was comparable to the 30CH conventional proving. The C4 trituration proving produced observable changes in the triturators’ state of health but predominantly MIND symptoms were evoked. The symptom picture created with the C4 trituration had many similarities to the 30CH conventional proving. The polarity of symptoms that existed in Withania somnifera was observed in both provings and included symptoms such as: anxiety vs tranquillity, increased concentration vs decrease in concentration.
Differences between the C4 trituration proving and the 30CH conventional proving were found in the description of physical symptoms such as headaches, in the types of delusions that occurred in each proving, and in some mental symptoms such as anger, sadness, clarity, and introspection. / M
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Comparative nuclear magnetic resonance study of Natrum muriaticum LM1 produced in-house and obtained from commercial sources respectivelyMiller, Garth Meredith January 2017 (has links)
Submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homoeopathy, Durban University of Technology, Durban, South Africa, 2017. / Introduction
Hahnemann was adamant that his methodology for LM1 prescription be reproduced exactly, in order to develop the latent medicinal properties of the crude substance reliably (Barthel 1991). Yet quality assurance practices during manufacturing are currently aligned to Good Manufacturing Process, in adherence to Pharmacopeia which permit substantial deviation from the strict quantities and practices (Kayne 2006) prescribed in Hahnemann’s 6th edition Organon (Hahnemann and O'Reilly 2001). Often the equipment, methods and practices favour expedience or utilise new technologies, under an assumption that the remedy produced is unaffected, since the mechanisms underlying the action of homoeopathic remedies are not understood or determined (Barthel 1991).
Aim
The primary purpose of this study was to compare and evaluate the nuclear magnetic resonance (NMR) spectra of Natrum muriaticum LM1, produced using strict adherence to original Hahnemannian methodology, to samples sourced from a representative variety of sources available to local homoeopathic practitioners, in the medicinal prescription form patients may receive.
Additionally, the researcher set out to confirm that these Natrum muriaticum LM1 samples could be shown to produce distinct NMR spectra when compared to a Lactose LM1 control.
The final objective was to ascertain whether two samples produced with the same strict adherence to Hahnemannian methodology, from same source materials would yield similar NMR Spectra, distinct from a Lactose LM1 control sample.
Methodology
The researcher produced an in-house Natrum muriaticum LM1 (0/1) sample in accordance with aphorism 272 of the 6th edition Organon (Hahnemann and O'Reilly 2001). Similarly, a second sample was produced by the DUT Homoeopharmaceutics Senior Lecturer, within the same ambient conditions and protocol. A third sample was produced by a local make-to-order (MTO) company, using the same sodium chloride crude substance sample utilised in the production of the first two samples. These three samples emulate the make-to-order (MTO) options available to homoeopathic practitioners.
A fourth sample was obtained ex-stock from highly regarded local supplier (Homoeopathix Trading Company (South Africa)), while the fifth and sixth samples were procured ex-stock from highly regarded suppliers abroad, Helios (United Kingdom) and Roy & Co. (India) respectively. These samples represented the make-to-stock (MTS) sourcing options available to homoeopathic community.
The researcher transported the samples to Chemistry Department of the University of Stellenbosch Chemistry Department in Cape Town. Any external influences such as vibration, changes in temperature, electromagnetic disturbances, heat or strong light were avoided or minimised as far as was practical.
The six LM1 potency samples were prepared immediately prior to NMR analysis from their respective source materials to a 20% alcohol concentration, as could be done in practice for the patient prescription where the alcohol content would serve as a preservative.
Four controls comprised the seventh, eighth, ninth and tenth samples, for comparative analysis and to confirm sample homogeneity.
. Lactose (LM1)
. Source lactose in solution
. Water used in preparation of NMR samples
. Ethanol solvent
The ten samples were assigned a random reference number by Dr Jaco Brand (Nuclear Magnetic Resonance Unit Manager), to remove bias during NMR analysis. Five samples were drawn from each of the ten randomised samples and labelled, while deuterated dimethyl sulfoxide-d6 (DSMO) contained within a separate capillary tube served as an external lock and reference solvent.
The researcher then carried out the analysis under qualified supervision to ensure best-practice was applied throughout. The resulting data (FID) was processed to derive the chemical shift and relative integration values, which were captured into a Microsoft® Excel 2010 spreadsheet to calculate the relative integration values of each sample run. Statistical analysis was performed in GNU PSPP version 085, the data was analysed using descriptive statistics and the non-parametric tests, Kruskal-Wallis and Mann-Whitney U-test (due to small data size and nature of distribution) at a statistical significance interval of α = 0.05.
Results
Natrum muriaticum LM1 samples sourced from a variety of make-to-order (MTO) and make-to-stock manufacturing environments produced almost universally distinct NMR spectra profiles in terms of chemical shifts and relative integration values of the CH2, CH3 and H2O signals, at an alcohol concentration of 20%, when compared to a Lactose LM1 control sample.
When the NMR spectra of make-to-order (MTO) and make-to-stock (MTS) remedies were analysed and compared to each other in terms of chemical shifts and relative integration values of the CH2, CH3 and H2O signals, they were for the most part statistically distinct, but some anomalous results emerged.
There was no statically significant difference in NMR spectra in terms of chemical shift, between the two samples produced in the same environment using the methodology to closely aligned to Organon (Hahnemann and O'Reilly 2001), yet in terms of relative integration values, they were statistically distinct.
Conclusion
The low alcohol percentage associated with the medicinal dosage of LM1 prepared for analysis failed to produce an OH peak on NMR spectra. In addition, it is not possible to identify the variables or indeed account for the nature of NMR spectra that are produced after sample analysis.
This study concludes that while NMR was able to discern physico-chemical distinction between LM1 potency Natrum muriaticum remedies to control conclusively, this does not translate to practical application of NMR for quality control or remedy comparison for LM potencies at alcohol content levels, associated with medicinal prescription. / M
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The relative efficacy of Advanced Brain Food and a homeopathic complex (Quietude) in the management of Attention Deficit Hyperactivity Disorder (ADHD) in males between the ages of 8 and 13 yearsLottering, John-John Brian January 2006 (has links)
Dissertation submitted in partial compliance with the requirements of the Master's Degree in Technology: Homoeopathy, Durban Institute of Technology, 2006. / The aim of the study was to evaluate the efficacy of a Nutritional Supplement (Advanced Brain Food®) and a homoeopathic complex (Quietude®) in the management of Attention Deficit Hyperactivity Disorder (ADHD). ADHD is primarily a childhood disorder affecting ten to twenty percent of school going children. The three main presenting features of ADHD are inattention, impulsivity, and hyperactivity. This triad often results in numerous adjustment difficulties for the child in the social and academic sectors (NIH Consensus Statement, 1998). / M
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Reação histológica de exposições pulpares em dentes de ratos à aplicação do laser de baixa intensidade somente ou em associação ao capeamento com hidróxido de cálcio /Crisci, Fernando Simões. January 2002 (has links)
Resumo: O presente estudo avaliou a reação histológica do efeito do laser de baixa intensidade diodo semicondutor de arseneto de gálio e alumínio (GaA1As, com comprimento de onda de 785 nm, infravermelho, com potência de emissão de 50 mW, densidade de energia de 3 J/cm2, em emissão contínua, por meio de ponta especial de fibra óptica, por um período de 2 segundos) em exposições pulpares induzidas em dentes de ratos. Foram utilizados 60 ratos, dos quais cada animal ofereceu dois dentes (totalizando 120), que foram distribuídos em 5 grupos experimentais: grupo I (controle), exposição capeada com hidróxido de cálcio; grupo II, laser imediato + hidróxido de cálcio; grupo III, laser imediato + hidróxido de cálcio + laser após 24 horas; grupo IV, laser imediato + hidróxido de cálcio + laser após 24 e 48 horas; e grupo V, somente a aplicação do laser. Decorridos os períodos experimentais de sete e 30 dias, os animais foram mortos, as peças removidas e preparadas para análise histológica. De acordo com a proposta e as condições específicas deste trabalho, os resultados nos permitem concluir que as associações laser imediato + hidróxido de cálcio e laser imediato + hidróxido de cálcio + laser 24 horas, foram os grupos que apresentaram os melhores resultados tanto aos sete dias (efeito antiinflamatório), quanto aos trinta dias (efeito no reparo tecidual). / Abstract: The present study evaluated the histological reaction of the low poweer laser effect, diode laser semiconductor of gallium aluminum arsenide (GaA1As, with wavelenght of 785 nm, infra-red, potency of emission of 50 mW, energy density of 3 J/cm2, with continuous emission, through special tip of optic fiber, for a period of two seconds) in exposed pulp induced in teeth of mice. Sixty mice were used, of which each animal offered two teeth (totaling 120), that were distributed in 5 experimental groups: group I(control group) exposed capping with calcium hydroxide; group II, immediate laser + calcium hydroxide; group III, immediate laser + calcium hydroxide + laser after 24 hours; group IV, immediate laser + calcium hydroxide + laser after 24 and 48 hours; and group V, only laser application. After the experimental periods of seven and thirty days, the animals were killed, the pieces were removed and prepared for histological analysis. In agreement with the proposal and the specific conditions of this study, the results allow us conclude that the associations of immediate laser + calcium hydroxide and immediate laser + calcium hydroxide + laser after 24 hours, were the groups that presented the best results in the periods of seven days (anti-inflammatory effect), and thirty days (effect in the tissue repair). / Orientador: Fábio Luiz Camargo Villela Berbert / Coorientador: Lizeti Toledo de Oliveira Ramalho / Banca: Renato de Toledo Leonardo / Banca: Jesus Djalma Pécora / Mestre
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The relative efficacy of Advanced Brain Food and a homeopathic complex (Quietude) in the management of Attention Deficit Hyperactivity Disorder (ADHD) in males between the ages of 8 and 13 yearsLottering, John-John Brian January 2006 (has links)
Thesis (M.Tech.: Homoeopathy)-Dept. of Homoeopathy, Durban Institute of Technology, 2006
xxv, 261 leaves / The aim of the study was to evaluate the efficacy of a Nutritional Supplement (Advanced Brain Food®) and a homoeopathic complex (Quietude®) in the management of Attention Deficit Hyperactivity Disorder (ADHD). ADHD is primarily a childhood disorder affecting ten to twenty percent of school going children. The three main presenting features of ADHD are inattention, impulsivity, and hyperactivity. This triad often results in numerous adjustment difficulties for the child in the social and academic sectors (NIH Consensus Statement, 1998).
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As personagens femininas leitoras nos contos machadianosSanfelice, Simone Antonia 29 August 2014 (has links)
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Previous issue date: 2014-08-29 / This research aims to investigate the presence of female reader characters within Machado de Assis tales narrative discourse, subject of very few critical studies. The corpus selected took into consideration the books read by the female reader characters and the interference of these readings in the narrative context. Through a detailed analysis based on 2008 Nova Aguilar Complete Works, we came to a selection of five tales, situated strategically on different phases of the author´s literary production: "O anjo das donzelas , Miss Dollar , D. Benedita , Capítulo dos chapéus and Missa do galo . We inquired in what way these female characters read and the extent in which the readings interfered their worldview. The hypothesis pointed different perspectives taken by the narrator in his ambivalent attitude of critical confirmation and denial, through irony, of the female reader characters pattern of reading. The theoretical references in this study were Wolfgang Iser and Wayne Booth, linked to the interaction between text and reader and to the discursive strategies of the author and the narrator in the story. The conclusion is that by means of gaps, potencies of denial and reversals in the narrative discourse, one can assure the way Machado de Assis projects to the actual reader, other interpretative possibilities. This contributes not only to a new female reader education, with critical capacity, but also to a woman with greater thinking and action autonomy, by the turn of the XIX to XX century, in Brazil / Esta pesquisa se propõe a investigar a presença das personagens leitoras no discurso narrativo dos contos machadianos, temática com poucos estudos críticos a respeito. O corpus selecionado levou em consideração tanto os livros lidos pelas personagens leitoras quanto a interferência dessas leituras no contexto da narrativa. Por meio de um minucioso levantamento feito a partir da edição de 2008, da Obra completa da Nova Aguilar, chegamos à seleção de cinco contos, estrategicamente situados em fases distintas da produção do autor: "O anjo das donzelas , Miss Dollar , D. Benedita , Capítulo dos chapéus e Missa do galo . Perguntávamos de que maneira essas personagens femininas liam e em que medida essas leituras interferiam na sua visão de mundo. A hipótese apontava para as diferentes perspectivas assumidas pelo narrador na sua atitude ambivalente de confirmação e de negação crítica, por meio da ironia, do padrão de leitura das personagens-leitoras. Os referenciais teóricos deste estudo foram os de Wolfgang Iser e os de Wayne Booth, vinculados à interação entre texto e leitor e às estratégias discursivas do autor e do narrador no relato. A conclusão foi a de que por meio dos vazios, das potências de negação e das inversões, presentes em menor ou maior grau no discurso narrativo, constata-se o modo como Machado de Assis projeta, para o leitor real, outras possibilidades interpretativas e, desta forma, contribui para a formação não só de uma nova leitora, com capacidade crítica, mas também de uma mulher com maior autonomia de pensamento e ação, na passagem do século XIX ao XX, no Brasil
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Eficácia e tolerabilidade da homeopatia e da fluoxetina no tratamento da depressão / Efficacy and tolerability of homeopathy or fluoxetine in the treatment of depressionAdler, Ubiratan Cardinalli [UNIFESP] 29 July 2009 (has links) (PDF)
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Publico-158.pdf: 944844 bytes, checksum: 11e50030a0a0e68e8344f966c5ddbd87 (MD5) / A busca por tratamentos “naturais” ou em conformidade com crenças e valores próprios, bem como experiências nas quais o tratamento com antidepressivos causou efeitos adversos desagradáveis ou pareceu ineficaz são razões apontadas por pacientes com depressão para o uso de alternativas ao tratamento convencional. O tratamento homeopático é uma dessas alternativas, apesar da falta de estudos clínicos que indiquem a eficácia de qualquer método de homeopatia no tratamento da depressão. Apesar de ter sido reconhecida como especialidade médica desde 1980, o ensino da homeopatia no Brasil era realizado à parte das escolas de medicina até 2003, quando a Faculdade de Medicina de Jundiaí (FMJ – Jundiaí, São Paulo) iniciou uma especialização em homeopatia segundo o método mais aperfeiçoado de Hahnemann. Os alunos são treinados em ambulatórios integrados ao sistema único de saúde de Jundiaí. Um desses ambulatórios é voltado ao tratamento homeopático da depressão, objeto dos dois artigos do presente estudo. O primeiro artigo relata o tratamento de uma série de 15 casos de depressão tratados durante 7 a 14 semanas com o método mais aperfeiçoado de Hahnemann. O escore de depressão, avaliado pela escala de depressão de Montgomery e Åsberg (MADRS) diminuiu da média basal de 24,87 (± 5,81) para 9,73 (± 8,16; p< 0,0001) na segunda avaliação e apenas um paciente não apresentou resposta e remissão do episódio depressivo. Estes resultados ressaltaram a necessidade de um estudo randomizado e controlado para avaliação do tratamento homeopático da depressão. O segundo artigo teve como objetivo investigar a não-inferioridade e tolerabilidade dos medicamentos homeopáticos na dinamização cinqüenta-milesimal (LM) em relação à fluoxetina, em um estudo prospectivo, randomizado, duplo-cego e double-dummy, uma vez que um estudo controlado com placebo não foi autorizado pela Comissão Nacional de Ética em Pesquisa. Noventa e um pacientes com depressão moderada a grave foram aleatoriamente alocados para receber, durante oito semanas, uma potência LM de um medicamento individualizado em solução alcoólica (1 gota três vezes por semana) e cápsulas de placebo, ou 20 mg de fluoxetina por dia e gotas de álcool a 30 por cento. Aqueles que não responderam após 4 semanas de tratamento receberam, de maneira cega, 40 mg de fluoxetina/dia ou uma medicação homeopática diferente e respectivos placebos. As medidas de eficácia foram a evolução do escore médio MADRS e as taxas de resposta e remissão na 4ª e 8ª semanas de tratamento. Uma margem de 1,45 foi especificada para a análise de não-inferioridade com base em dados da literatura. A tolerabilidade foi avaliada por meio da escala de avaliação de efeitos adversos da Sociedade Escandinávia de Psicofarmacologia. Os resultados mostraram que não houve diferença significativa entre os dois grupos em relação à evolução dos escores médios de depressão na 4ª (p=0.654) e 8ª (p=0.965) semanas de tratamento. Também não houve uma diferença significativa nas taxas de resposta ou remissão nos dois grupos. A análise de não-inferioridade mostrou que as potências LM não foram inferiores à fluoxetina, uma vez que os limites superiores dos intervalos de confiança foram inferiores à margem de não-inferioridade: as diferenças médias (homeopatia – fluoxetina) foram -3,04 (95 por cento IC = -6,95; 0,86) e -2,4 (95 por cento IC = -6,05; 0,77) na 4a e 8a semanas, respectivamente. Tolerabilidade: não houve diferenças significativas entre as taxas de efeitos colaterais entre os dois grupos, apesar dos pacientes tratados com fluoxetina terem apresentado uma maior porcentagem de efeitos adversos perturbadores e uma maior tendência a serem excluídos por efeitos adversos. Conclusões: este estudo exemplifica a possibilidade de se realizarem estudos randomizados e controlados no tratamento homeopático da depressão e indica a não-inferioridade em relação à fluoxetina no tratamento da fase aguda da depressão moderada a grave. / Background: Homeopathy is a Complementary and Integrative Medicine used in depression. Aims: this study investigated the non-inferiority and tolerability of individualized homeopathic medicines (Q-potencies) in acute depression, using fluoxetine as active control. Methods: Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg/day (up to 40 mg/day) in a prospective, randomized, double-blind double-dummy 8 week, single-center trial. Primary efficacy measure was the analysis of the mean change in the MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Results: Mean MADRS scores differences were not significant at the 4th (p=0.654) and 8th weeks (p=0.965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy – fluoxetine) were -3.04 (95% CI = -6.95; 0.86) and -2.4 (95% CI = -6.05; 0.77) at weeks 4th and 8th, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported adverse side effects and a there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. Conclusions: This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression. / TEDE / BV UNIFESP: Teses e dissertações
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