O Transtorno Depressivo Maior (TDM) está entre as síndromes psiquiátricas que mais atingem a população em geral. A prevalência da depressão durante a vida é de 7 a 12% para homens e 20 a 25% para mulheres, independente de raça, educação, estado civil ou renda. Entre os idosos a prevalência é de aproximadamente 5%. Além do tratamento medicamentoso, as psicoterapias têm um papel importante durante a fase aguda e na fase de remissão. A Arteterapia é uma abordagem terapêutica primordialmente não verbal, e tem sido utilizada em diversos contextos, mas há carência de estudos quantitativos que comprovem sua eficácia. O objetivo deste trabalho foi avaliar a eficácia da Arteterapia para uma população de mulheres idosas com diagnóstico de TDM, segundo o DSM - 5 = Manual de Diagnóstico e Estatística dos Transtornos Mentais - 5º versão, medicadas. Participaram do estudo 66 idosas com diagnóstico de TDM em tratamento medicamentoso, sem mudança medicamentosa durante o estudo e intactas no ponto de vista da cognição. Essas idosas foram alocadas aleatoriamente em dois grupos: 33 constituíram o Grupo Experimental (GE), que constou de 20 oficinas de Arteterapia com duração de noventa minutos, semanalmente, e 33 participaram do Grupo Controle (GC) o qual não recebeu nenhuma intervenção. Ambos os grupos foram avaliados com as mesmas escalas no início e após 20 semanas. Foram utilizadas as seguintes escalas para avaliar aspectos cognitivos - Mini exame do Estado Mental (MEEM), o Teste do Desenho do Relógio (TDR), o teste de Fluência Verbal - categoria animal (FV), e o teste Trilhas A. Para a avaliação Visuoconstrutiva foi utilizada a Figura complexa de Rey - cópia e evocação. Para avaliar aspectos psiquiátricos foram utilizadas a Geriatric Depression Scale (GDS), a Escala de Beck para Depressão (BDI) e a Escala de Beck para Ansiedade (BAI). Para avaliar qualidade de vida - Functional Assessment Staging Test (FAST). No final do estudo 31 idosas completaram todas as oficinas do GE e 25 idosas do GC retornaram para as avaliações finais, apesar de todas terem sido contatadas. O GC diminuiu na GDS 0,6 ± 2,3 pontos, enquanto o GE diminuiu 3,2 ± 3,4 pontos, e esta diferença entre os grupos foi significante (p = 0,007). Na escala BDI, o GC diminuiu 1,6 ± 4,9 pontos e o GE diminuiu 8,6 ± 12,8 pontos (p = 0,025). Na escala BAI, o GC diminuiu 2,9 ± 1,4 pontos e o GE diminuiu 8,9 ± 14,5 pontos (p = 0,032). Não foram encontradas diferenças nas demais escalas. Assim, houve diferença entre os grupos Controle e Experimental após as 20 semanas nos aspectos psiquiátricos de depressão e ansiedade. Não foram observadas mudanças na cognição. Desta forma, intervenções como a deste estudo parecem auxiliar no tratamento de sintomas depressivos e ansiosos de idosas com TDM / Major Depressive Disorder (MDD) is, among the psychiatric syndromes, that most affect the general population. The prevalence of depression during life is 7 to 12% for men and 20 to 25% for women, regardless of race, education, marital status or income. Among the elderly, the prevalence is approximately 5%. In addition to drug treatment, psychotherapies have an important role during the acute phase and in the remission phase. Art Therapy is a therapeutic approach primarily nonverbal, and has been used in several contexts, but there is a lack of quantitative studies that prove its efficacy. The objective of this study was to evaluate the efficacy of Art therapy for a population of elderly women diagnosed with MDD, according to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM - 5). A total of 66 elderly women with a diagnosis of MDD were enrolled in the drug treatment, without drug change during the study and intact from the point of view of cognition. These elderly women were randomly allocated into two groups: 33 were the Experimental Group (EG), which consisted of 20 Art therapy workshops lasting 90 minutes, weekly, and 33 participated in the Control Group (CG), which received no intervention. Both groups were evaluated with the same scales at baseline and after 20 weeks. The following scales were used to evaluate cognitive aspects - Mini Mental State Examination (MMSE), Clock Drawing Test, Verbal Fluency Test - Animal Category (VF), and Trail A. To evaluate psychiatric aspects, the Geriatric Depression Scale (GDS), the Beck Depression Scale (BDI) and the Beck Anxiety Scale (BAI) were used. For the Visuoconstructive evaluation, Rey\'s Complex Figure and Delayed Recall was used. And to evaluate quality of life - Functional Assessment Staging Test (FAST). At the end of the study, 31 elderly women completed all EG workshops and 25 elderly women of CG returned to the final evaluations, although all were contacted. The CG decreased in the GDS 0.6 ± 2.3 points, while the EG decreased by 3.2 ± 3.4 points, and this difference between the groups was significant (p = 0.007). On the BDI scale, the CG decreased by 1.6 ± 4.9 points and the EG decreased by 8.6 ± 12.8 points (p = 0.025). On the BAI scale, the CG decreased by 2.9 ± 1.4 points and the EG decreased by 8.9 ± 14.5 points (p = 0.032). No differences were found in the other scales. Thus, there was difference between the Control and Experimental groups after the 20 weeks in the psychiatric depression and anxiety aspects. No changes in cognition were observed. Thus, interventions such as this study seem to aid in the treatment of depressive and anxious symptoms of elderly patients with TDM

O Transtorno Depressivo Maior (TDM) está entre as síndromes psiquiátricas que mais atingem a população em geral. A prevalência da depressão durante a vida é de 7 a 12% para homens e 20 a 25% para mulheres, independente de raça, educação, estado civil ou renda. Entre os idosos a prevalência é de aproximadamente 5%. Além do tratamento medicamentoso, as psicoterapias têm um papel importante durante a fase aguda e na fase de remissão. A Arteterapia é uma abordagem terapêutica primordialmente não verbal, e tem sido utilizada em diversos contextos, mas há carência de estudos quantitativos que comprovem sua eficácia. O objetivo deste trabalho foi avaliar a eficácia da Arteterapia para uma população de mulheres idosas com diagnóstico de TDM, segundo o DSM - 5 = Manual de Diagnóstico e Estatística dos Transtornos Mentais - 5º versão, medicadas. Participaram do estudo 66 idosas com diagnóstico de TDM em tratamento medicamentoso, sem mudança medicamentosa durante o estudo e intactas no ponto de vista da cognição. Essas idosas foram alocadas aleatoriamente em dois grupos: 33 constituíram o Grupo Experimental (GE), que constou de 20 oficinas de Arteterapia com duração de noventa minutos, semanalmente, e 33 participaram do Grupo Controle (GC) o qual não recebeu nenhuma intervenção. Ambos os grupos foram avaliados com as mesmas escalas no início e após 20 semanas. Foram utilizadas as seguintes escalas para avaliar aspectos cognitivos - Mini exame do Estado Mental (MEEM), o Teste do Desenho do Relógio (TDR), o teste de Fluência Verbal - categoria animal (FV), e o teste Trilhas A. Para a avaliação Visuoconstrutiva foi utilizada a Figura complexa de Rey - cópia e evocação. Para avaliar aspectos psiquiátricos foram utilizadas a Geriatric Depression Scale (GDS), a Escala de Beck para Depressão (BDI) e a Escala de Beck para Ansiedade (BAI). Para avaliar qualidade de vida - Functional Assessment Staging Test (FAST). No final do estudo 31 idosas completaram todas as oficinas do GE e 25 idosas do GC retornaram para as avaliações finais, apesar de todas terem sido contatadas. O GC diminuiu na GDS 0,6 ± 2,3 pontos, enquanto o GE diminuiu 3,2 ± 3,4 pontos, e esta diferença entre os grupos foi significante (p = 0,007). Na escala BDI, o GC diminuiu 1,6 ± 4,9 pontos e o GE diminuiu 8,6 ± 12,8 pontos (p = 0,025). Na escala BAI, o GC diminuiu 2,9 ± 1,4 pontos e o GE diminuiu 8,9 ± 14,5 pontos (p = 0,032). Não foram encontradas diferenças nas demais escalas. Assim, houve diferença entre os grupos Controle e Experimental após as 20 semanas nos aspectos psiquiátricos de depressão e ansiedade. Não foram observadas mudanças na cognição. Desta forma, intervenções como a deste estudo parecem auxiliar no tratamento de sintomas depressivos e ansiosos de idosas com TDM / Major Depressive Disorder (MDD) is, among the psychiatric syndromes, that most affect the general population. The prevalence of depression during life is 7 to 12% for men and 20 to 25% for women, regardless of race, education, marital status or income. Among the elderly, the prevalence is approximately 5%. In addition to drug treatment, psychotherapies have an important role during the acute phase and in the remission phase. Art Therapy is a therapeutic approach primarily nonverbal, and has been used in several contexts, but there is a lack of quantitative studies that prove its efficacy. The objective of this study was to evaluate the efficacy of Art therapy for a population of elderly women diagnosed with MDD, according to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM - 5). A total of 66 elderly women with a diagnosis of MDD were enrolled in the drug treatment, without drug change during the study and intact from the point of view of cognition. These elderly women were randomly allocated into two groups: 33 were the Experimental Group (EG), which consisted of 20 Art therapy workshops lasting 90 minutes, weekly, and 33 participated in the Control Group (CG), which received no intervention. Both groups were evaluated with the same scales at baseline and after 20 weeks. The following scales were used to evaluate cognitive aspects - Mini Mental State Examination (MMSE), Clock Drawing Test, Verbal Fluency Test - Animal Category (VF), and Trail A. To evaluate psychiatric aspects, the Geriatric Depression Scale (GDS), the Beck Depression Scale (BDI) and the Beck Anxiety Scale (BAI) were used. For the Visuoconstructive evaluation, Rey\'s Complex Figure and Delayed Recall was used. And to evaluate quality of life - Functional Assessment Staging Test (FAST). At the end of the study, 31 elderly women completed all EG workshops and 25 elderly women of CG returned to the final evaluations, although all were contacted. The CG decreased in the GDS 0.6 ± 2.3 points, while the EG decreased by 3.2 ± 3.4 points, and this difference between the groups was significant (p = 0.007). On the BDI scale, the CG decreased by 1.6 ± 4.9 points and the EG decreased by 8.6 ± 12.8 points (p = 0.025). On the BAI scale, the CG decreased by 2.9 ± 1.4 points and the EG decreased by 8.9 ± 14.5 points (p = 0.032). No differences were found in the other scales. Thus, there was difference between the Control and Experimental groups after the 20 weeks in the psychiatric depression and anxiety aspects. No changes in cognition were observed. Thus, interventions such as this study seem to aid in the treatment of depressive and anxious symptoms of elderly patients with TDM

The present day world has been experiencing rapid technological advancement on the one hand and increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, taking an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialled before its launch to ensure safety and efficacy. Of late, India has emerged as one of the preferred destinations to carry out clinical studies due to numerous advantages, primarily its diverse human gene pool and cost-competitiveness. However, there is very little understanding on the landscape of medical devices clinically trialled in India. It is to throw light on this critical issue with respect to the selection of participants in the clinical trial process, selection of locations and determination of trial duration that the present study has been carried out. In addition, the role of patents associated with the introduction of new medical devices in relation to the key challenges is examined. Furthermore, we studied the characteristics of clinical trials by industry and non-industry sponsors and between cardiovascular and other disease related trials. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008-2014. At the outset, the pattern of trials related to the most prominent diseases such as cardiology and cardiovascular diseases and those which are invasive and non-invasive are examined. Our findings indicate that almost 50% of the trials are related to diseases of cardiology, cardiovascular diseases and those which are invasive in nature. For studying the patenting aspect, we proposed a conceptual grouping of sponsors as Incumbent, Potential Entrant and Supporter, based on their patent holdings in the domestic market and in PCT (Patent Cooperation Treaty) filings. Patents owned by Primary Sponsor (PS) showed significant variations in their clinical trial characteristics particularly the invasiveness of device, disease type, locations and participants. Three quantitative models are developed to identify the factors that influence the selection of number of participants, locations and time taken to execute medical device clinical trials using multivariate statistical techniques. The results of the three conceptual models on number of participants, locations and trial duration showed invasiveness of device and disease type playing significant roles in all the three models. The number of PCTs owned by PS was found to be influential in selecting the number of locations and participants but not the patents owned in IPO (Indian Patent Office). We also observed significant differences between industry and non-industry sponsors in terms of their clinical trial characteristics. The findings of the study formed the basis to understand the medical device clinical trial landscape and other pertinent issues in the Indian context, which enabled us to derive appropriate inferences and policy implications.

La vancomycine est l'un des antibiotiques les plus prescrits, principalement utilisé pour les infections suspectées et confirmées à Staphylococcus aureus résistant à la méthicilline (SARM). Les infections par des souches de SARM font peser une charge importante sur le système de santé, à laquelle s'ajoute l'incertitude qui demeure quant à la posologie optimale de la vancomycine. Les récentes lignes directrices révisées sur le suivi thérapeutique de la vancomycine, publiées en 2020, avalisent principalement l'estimation directe de l'aire sous la courbe de concentration en fonction du temps (AUC) par l'utilisation d'équations bayésiennes ou pharmacocinétiques (PK) de premier ordre pour le suivi thérapeutique. Pour mieux informer la posologie de la vancomycine, nous avons d'abord mis à jour une revue précédente des analyses pharmacocinétiques de population (PopPK) de la vancomycine publiées chez les adultes et les enfants. Pour ce faire, nous avons déterminé les caractéristiques des modèles pharmacocinétiques rapportés et identifié les diverses sources potentielles de variabilité observées dans différentes sous-populations particulières. Motivés par la controverse existante autour des nouvelles directives de surveillance thérapeutique de la vancomycine et par l'absence d'une étude approfondie des méthodes recommandées, nous avons recueilli des données hospitalières et construit un cadre de modélisation qui nous a permis d'évaluer les recommandations des directives sur les méthodes de surveillance, tout en considérant une variété de scénarios et d'hypothèses cliniques réalistes. Notre analyse a confirmé que la surveillance bayésienne est la méthode la plus rapide et la plus fiable, à condition qu'elle soit correctement mise en œuvre, la plus importante condition pour cela étant l'utilisation de modèles bayésiens a priori appropriés. De plus, nous avons montré que le suivi bayésien ne nécessite pas nécessairement des niveaux de concentration de types creux ou pic et peut en fait être réalisé en utilisant un niveau aléatoire. Aussi, nous avons démontré que l'utilisation correcte des équations pharmacocinétiques de premier ordre exigerait au moins deux mesures de concentration à l'état d'équilibre. L’utilisation de la méthode creux-seulement de la vancomycine à l'état d'équilibre peut être tout aussi efficace dans certaines situations que nous avons explorées ici. En considérant la larges étendue et la grande variabilité des populations traitées à la vancomycine en termes d'âge, de gravité de l'infection et de scénarios cliniques, cette thèse adopte un regard objectif pour évaluer quantitativement le gain potentiel de chaque méthode de surveillance de la vancomycine, en explorant leur adéquation en termes d'effort nécessaire, de disponibilité des ressources et de gain potentiel. Compte tenu des lignes directrices sur la vancomycine récemment publiées et de la controverse qui persiste, nous pensons que cette thèse a permis de démêler la variété et la complexité de l'utilisation de la vancomycine et a apporté un éclairage supplémentaire plus objectifvement informé vers un suivi thérapeutique optimal de la vancomycine. / Vancomycin is among the most prescribed antibiotics, mainly used for suspected and confirmed methicillin-resistant Staphylococcus aureus (MRSA) infections. Infections by MRSA strains carry a substantial burden on the health care system, supplemented by the uncertainty that remains regarding vancomycin optimal dosing. The recent revised vancomycin therapeutic monitoring guidelines published in 2020, endorsed primarily the direct estimation of area under the concentration-time curve (AUC) through the use of Bayesian or first-order pharmacokinetic (PK) equations monitoring. To better inform vancomycin dosing, we first updated a previous review of published vancomycin population pharmacokinetic (PopPK) analysis in both adults and children. This was accomplished by determining the characteristics of the reported pharmacokinetic models and identifying the potential various sources of variability observed in different special subpopulations. Motivated by the existing controversy around the new vancomycin therapeutic monitoring guidelines and the lack of a thorough investigation of the recommended methods, we collected hospital data and built a modeling framework that allowed us to assess the guideline recommendations of monitoring methods while considering a variety of realistic clinical scenarios and assumptions. Our analysis affirmed that Bayesian monitoring is the fastest and most reliable method, conditional on its proper implementation, the most important being the use of proper Bayesian priors. Moreover, we showed that Bayesian monitoring does not necessarily require trough or peak concentration levels and can in fact be performed using a random level. Proper use of first-order PK equations required at least two steady-state concentration measurements. Alternatively, simpler trough-only vancomycin monitoring near steady-state can be as effective in certain cases that we explored here. By considering the wide ranges and the high variability in populations treated with vancomycin in terms of age, the severity of infection, and clinical scenarios, this thesis takes an objective look to quantitatively assess the potential gain of each vancomycin drug monitoring method, by investigating their suitability in terms of the effort needed, the availability of resources and the resulting gain. Considering the recently released vancomycin guidelines and the ensuing controversies between well-established clinical teams, we believe that this dissertation helped untangle the variety and complexity of vancomycin use and brought additional insights towards a more objective and optimal vancomycin therapeutic monitoring.

Introdução: Este estudo foi realizado com o intuito de avaliar efeitos da acupuntura sobre os pacientes com asma leve e moderada persistentes com o uso de beta-2 agonista ou corticoide inalatório. Métodos e casuística: Trata-se de um estudo prospectivo, duplo-cego, randomizado e cruzado com dois braços. Os 74 pacientes com diagnóstico de asma leve/moderada, de acordo com a classificação de GINA 2002/2003, foram divididos em dois grupos, sendo 31 do Grupo I, e 43 do Grupo II inicialmente. Foram realizadas consultas médicas e exames que incluíram espirometria, citologia de escarro induzido, NO expirado, preenchimento de escala de sintoma, questionários de qualidade de vida de asma e de SF 36, e realização de peak-flow, dependendo da Fase do protocolo. A Fase I constituiu-se dos exames pré-intervenção. Na Fase II, foram realizadas 10 sessões de Acupuntura Real no Grupo I e 10 sessões de Acupuntura Sham no Grupo II, na Fase III, houve 4 semana de washout, na Fase IV, houve a troca de técnicas de acupuntura, sendo uma sessão por semana e, na Fase V, realização dos exames. Resultados: Não há diferença nos critérios de avaliação no pré-tratamento entre dois grupos, com exceção de maior celularidade inflamatória no Grupo II. No entanto, houve uma redução significativa de eosinófilos (p = 0,035) e neutrófilos (p = 0,047), e aumento de macrófagos (p = 0,001), melhora da medida de volume do peak-flow (p = 0,01) na fase IV do Grupo II. No Grupo I, na avaliação de escala de sintomas diária, havia menor uso de medicação de resgate (p = 0,043) na Fase II, e, depois de receber a Acupuntura Sham na Fase IV, havia menos tosse (p = 0,007), menos chiado (p = 0,037), menos dispneia (p < 0,001) e menor uso de medicação de resgate (p < 0,001). No Grupo II, após receber o tratamento com a Acupuntura Sham na Fase II, houve diminuição de tosse (p = 0,037), de chiado (p = 0,013) e de dispneia (p = 0,014), e, na Fase IV, havia menos tosse (p = 0,040), sibilos (p = 0,012), dispneia (p < 0,001) e menos despertares noturnos (p = 0,009). Nos questionários de qualidade de vida de asma e de SF 36, foram encontrados alguns aspectos de melhora significantes na Acupuntura Sham dos dois grupos em relação à Fase I, mas os resultados da Acupuntura Real tiveram maiores índices de melhora em relação aos resultados da Acupuntura Sham nos dois grupos. Mas não há diferença significativa entre os dois na qualidade de vida de SF 36. Entretanto, não houve alteração de avaliação de espirometria e de óxido nítrico expirado. Conclusão: Este estudo demonstrou que o uso de Acupuntura Real num grupo de pacientes com a celularidade mais inflamatória teve melhor resultados de sintomas diários, tais como dispneia e despertar noturno, de medida de volume de peak-flow matutina, e de avaliação de qualidade de vida em asma e SF36, além da diminuição quantitativa de neutrófilos e de eosinófilos, com aumento de macrófagos, que justificam os efeitos anti-inflamatórios e imunitários. A acupuntura é uma terapia segura, não havendo nenhum efeito colateral observado neste projeto que possa interferir com a vida cotidiana e pode ser de grande auxílio no alívio de sintomas, com melhora de qualidade de vida e, possivelmente, pode ter uma ação na modulação do processo inflamatório de vias aéreas / Introduction: This survey has been conducted in order to evaluate the effects of acupuncture in patients with persistent mild and moderate asthma (according to GINA criteria 2003), using beta agonist and/or inhaled glucocorticoid. Methods and patients: This is a prospective, double blinded, randomized and cross-over study with two branches: 74 patients diagnosed with mild and moderate asthma were divided into two groups: Group I with 31, initiating with real acupuncture and Group II, starting with sham acupuncture. Medical interview and laboratory tests including spirometry, induced sputum citology, exhaled NO measurement, quality of life questionnaire (SF-36 and QQL), besides, daily symptom scores and measurement of peak-flow were performed, in the beginning of the study, and in the end of each phase of treatment. Phase I: laboratory tests and other qualitative measurements. There were 10 real acupuncture weekly sessions to Group I and 10 sham acupuncture sessions to Group II in Phase II. On the other hand, in the Phase IV, there was an exchange between Group I and Group II, which was receiving real acupuncture started to receive sham, and vice-versa, the number of sessions remained the same (10 weekly sessions). Phase III, during the interval between Phase II and Phase IV, there was an interval of 4 weeks of washout. Phase V: laboratory tests and other qualitative measurements. Results: There was no difference beween both the groups in all criteria of evaluation pré treatment, with only na exception: in the Group II there was large inflammatory cell counts. However, there was a significant reduction in eosinophils (p = 0.035) and neutrophils (p = 0.047), and increase of macrophages (p = 0.001), improved peak-flow measurement in the morning (p = 0.01) in Group II (started with sham) in Phase IV. In Daily Symptons Score, there was a significant reduction in use of rescue medication (p = 0.043) in Group I (real acupuncture) in Phase II and after received sham acupuncture (Phase IV), there were less cough (p = 0.007), less wheezing (p = 0.037), less dyspnea (p < 0.001) e less use of rescue medication (p < 0.001). In Group II, after received sham (Phase II), there were less cough (p = 0.037), less wheezing (p = 0.013) and less dyspnea (p = 0.014). In Phase IV, less cough (p = 0.040), wheezing (p = 0.012), dyspnea (p < 0.001) and less nocturnal awakening (p = 0.009). In the questionnaires of quality of life SF-36 and QQL, several domains were found to be improved after received sham acupuncture in both groups, comparing phase II against phase I, but the results found after received real acupuncture were better than sham in both groups. Although there was no statistic difference between both groups. However, there was no difference in exhaled NO and spirometry measurement. Conclusion: This survey demonstrated that the use of real acupuncture in a group of patients with large inflammatory cells counts could have contributed to reduce symptoms, improve quality of life, improved peak-flow measurement in the morning and reduced inflammatory cells count in induced sputum, therefore, acupuncture is a safe healing techniques, presented no adverse effects observed in this study, and could of great help in treatment of patients with mild and moderate asthma

Introdução: Este estudo foi realizado com o intuito de avaliar efeitos da acupuntura sobre os pacientes com asma leve e moderada persistentes com o uso de beta-2 agonista ou corticoide inalatório. Métodos e casuística: Trata-se de um estudo prospectivo, duplo-cego, randomizado e cruzado com dois braços. Os 74 pacientes com diagnóstico de asma leve/moderada, de acordo com a classificação de GINA 2002/2003, foram divididos em dois grupos, sendo 31 do Grupo I, e 43 do Grupo II inicialmente. Foram realizadas consultas médicas e exames que incluíram espirometria, citologia de escarro induzido, NO expirado, preenchimento de escala de sintoma, questionários de qualidade de vida de asma e de SF 36, e realização de peak-flow, dependendo da Fase do protocolo. A Fase I constituiu-se dos exames pré-intervenção. Na Fase II, foram realizadas 10 sessões de Acupuntura Real no Grupo I e 10 sessões de Acupuntura Sham no Grupo II, na Fase III, houve 4 semana de washout, na Fase IV, houve a troca de técnicas de acupuntura, sendo uma sessão por semana e, na Fase V, realização dos exames. Resultados: Não há diferença nos critérios de avaliação no pré-tratamento entre dois grupos, com exceção de maior celularidade inflamatória no Grupo II. No entanto, houve uma redução significativa de eosinófilos (p = 0,035) e neutrófilos (p = 0,047), e aumento de macrófagos (p = 0,001), melhora da medida de volume do peak-flow (p = 0,01) na fase IV do Grupo II. No Grupo I, na avaliação de escala de sintomas diária, havia menor uso de medicação de resgate (p = 0,043) na Fase II, e, depois de receber a Acupuntura Sham na Fase IV, havia menos tosse (p = 0,007), menos chiado (p = 0,037), menos dispneia (p < 0,001) e menor uso de medicação de resgate (p < 0,001). No Grupo II, após receber o tratamento com a Acupuntura Sham na Fase II, houve diminuição de tosse (p = 0,037), de chiado (p = 0,013) e de dispneia (p = 0,014), e, na Fase IV, havia menos tosse (p = 0,040), sibilos (p = 0,012), dispneia (p < 0,001) e menos despertares noturnos (p = 0,009). Nos questionários de qualidade de vida de asma e de SF 36, foram encontrados alguns aspectos de melhora significantes na Acupuntura Sham dos dois grupos em relação à Fase I, mas os resultados da Acupuntura Real tiveram maiores índices de melhora em relação aos resultados da Acupuntura Sham nos dois grupos. Mas não há diferença significativa entre os dois na qualidade de vida de SF 36. Entretanto, não houve alteração de avaliação de espirometria e de óxido nítrico expirado. Conclusão: Este estudo demonstrou que o uso de Acupuntura Real num grupo de pacientes com a celularidade mais inflamatória teve melhor resultados de sintomas diários, tais como dispneia e despertar noturno, de medida de volume de peak-flow matutina, e de avaliação de qualidade de vida em asma e SF36, além da diminuição quantitativa de neutrófilos e de eosinófilos, com aumento de macrófagos, que justificam os efeitos anti-inflamatórios e imunitários. A acupuntura é uma terapia segura, não havendo nenhum efeito colateral observado neste projeto que possa interferir com a vida cotidiana e pode ser de grande auxílio no alívio de sintomas, com melhora de qualidade de vida e, possivelmente, pode ter uma ação na modulação do processo inflamatório de vias aéreas / Introduction: This survey has been conducted in order to evaluate the effects of acupuncture in patients with persistent mild and moderate asthma (according to GINA criteria 2003), using beta agonist and/or inhaled glucocorticoid. Methods and patients: This is a prospective, double blinded, randomized and cross-over study with two branches: 74 patients diagnosed with mild and moderate asthma were divided into two groups: Group I with 31, initiating with real acupuncture and Group II, starting with sham acupuncture. Medical interview and laboratory tests including spirometry, induced sputum citology, exhaled NO measurement, quality of life questionnaire (SF-36 and QQL), besides, daily symptom scores and measurement of peak-flow were performed, in the beginning of the study, and in the end of each phase of treatment. Phase I: laboratory tests and other qualitative measurements. There were 10 real acupuncture weekly sessions to Group I and 10 sham acupuncture sessions to Group II in Phase II. On the other hand, in the Phase IV, there was an exchange between Group I and Group II, which was receiving real acupuncture started to receive sham, and vice-versa, the number of sessions remained the same (10 weekly sessions). Phase III, during the interval between Phase II and Phase IV, there was an interval of 4 weeks of washout. Phase V: laboratory tests and other qualitative measurements. Results: There was no difference beween both the groups in all criteria of evaluation pré treatment, with only na exception: in the Group II there was large inflammatory cell counts. However, there was a significant reduction in eosinophils (p = 0.035) and neutrophils (p = 0.047), and increase of macrophages (p = 0.001), improved peak-flow measurement in the morning (p = 0.01) in Group II (started with sham) in Phase IV. In Daily Symptons Score, there was a significant reduction in use of rescue medication (p = 0.043) in Group I (real acupuncture) in Phase II and after received sham acupuncture (Phase IV), there were less cough (p = 0.007), less wheezing (p = 0.037), less dyspnea (p < 0.001) e less use of rescue medication (p < 0.001). In Group II, after received sham (Phase II), there were less cough (p = 0.037), less wheezing (p = 0.013) and less dyspnea (p = 0.014). In Phase IV, less cough (p = 0.040), wheezing (p = 0.012), dyspnea (p < 0.001) and less nocturnal awakening (p = 0.009). In the questionnaires of quality of life SF-36 and QQL, several domains were found to be improved after received sham acupuncture in both groups, comparing phase II against phase I, but the results found after received real acupuncture were better than sham in both groups. Although there was no statistic difference between both groups. However, there was no difference in exhaled NO and spirometry measurement. Conclusion: This survey demonstrated that the use of real acupuncture in a group of patients with large inflammatory cells counts could have contributed to reduce symptoms, improve quality of life, improved peak-flow measurement in the morning and reduced inflammatory cells count in induced sputum, therefore, acupuncture is a safe healing techniques, presented no adverse effects observed in this study, and could of great help in treatment of patients with mild and moderate asthma