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Laser-Acupuncture to Control Blood Glucose in Type II Diabetes: A

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Laser-Acupuncture to Control Blood Glucose in Type II Diabetes: A ORIGINALES Laser-acupuncture to control blood glucose in Type II Diabetes: a randomized clinical trial Laser-acupuntura no controle da glicemia na Diabetes tipo II: ensaio clínico randomizado Acupuntura-láser para controlar la glucosa en sangre en la diabetes tipo II: un ensayo clínico aleatorizado Claudia Dayube Pereira1 Neide Aparecida Titonelli Alvim2 Raphael Dias de Mello Pereira3 Leila Brito Bergold4 Saint Clair dos Santos Gomes Junior5 Vanessa Damasceno Bastos6 1 PhD. Technician in Public Health from the Fernandes Figueira National Institute for Child, Female and Adolescent Health. Osvaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. [email protected] 2 PhD. Head Professor at the Department of Fundamental Nursing of the Anna Nery Nursing School/Federal University of Rio de Janeiro (DEF/EEAN/UFRJ). Rio de Janeiro, RJ, Brazil. 3 PhD. Adjunct Professor I at the Nursing Graduate Course of the University of Vassouras. Vassouras, RJ, Brazil. 4 PhD. Professor at the Nursing and Obstetrics Course of the UFRJ Campus/Macaé. Macaé, RJ, Brazil. 5 PhD. Biomedical Engineering Program PEB/Coppe of the Federal University of Rio de Janeiro. Clinical Research Unit of the Fernandes Figueira Institute/Fiocruz. Rio de Janeiro, RJ, Brazil. 6 Doctoral student. Subistitute Professor at the Public Health Department of the Anna Nery Nursing School/Federal University of Rio de Janeiro (EEAN/UFRJ). Rio de Janeiro, RJ, Brazil. https://doi.org/10.6018/eglobal.443241 Received: 8/09/2020 Accepted: 10/01/2021 ABSTRACT: Objective: To evaluate the effectiveness of laser-acupuncture applied to nursing care for people with type II diabetes mellitus. Methods: Randomized, triple-blinded clinical trial, with 42 type II diabetic participants, both genders, aged between 30 and 75 years, using oral hypoglycemic agents and difficulties in maintaining postprandial glycaemia ≤ 180mg/dl. Participants were randomly assigned to two different groups and submitted to standard laser-acupuncture, experimental arm, or simulated, control arm. Descriptive and association analyses between variables were used, with a significance level of 5% (p <0,05). To compare blood glucose results, Student’s t test was used for paired samples and Anova for repeated measurements. Results: A significant decrease in capillary glycaemia was observed in the participants in the experimental arm, a phenomenon not verified in those in the control arm. Conclusions: the plausibility Enfermería Global Nº 62 Abril 2021 Página 518 of using the technique as a technology for nursing care for people with type II diabetes mellitus is inferred. Brazilian Registry of Clinical Trials. UTN: U1111-1181-1675. Clinical Trials NCT02605889. Key words: Nursing Care; Diabetes Mellitus, Type 2; Complementary Therapies; Acupuncture Therapy. RESUMO: Objetivo: Avaliar a eficácia da laser-acupuntura aplicada ao cuidado de enfermagem à pessoas com diabetes mellitus tipo II. Métodos: Ensaio clínico randomizado, triplo cego, com 42 participantes diabéticos do tipo II, ambos os sexos, idades entre 30 a 75 anos, em uso de hipoglicemiantes orais e dificuldades para manter a glicemia pós prandial ≤ 180mg/dl. Os participantes foram distribuídos aleatoriamente em dois grupos distintos e submetidos a laser-acupuntura padrão, braço experimental, ou simulada, braço controle. Empregaram-se análises descritivas e de associação entre variáveis, com nível de significância de 5% (p<0,05). Para comparação entre os resultados da glicemia empregou-se teste t de Student para amostras pareadas e Anova para medidas repetidas. Resultados: Observou-se diminuição significativa na glicemia capilar dos participantes do braço experimental, fenômeno não verificado naqueles do braço controle. Conclusões: Infere-se a plausibilidade da utilização da técnica como tecnologia para o cuidado de enfermagem às pessoas com diabetes mellitus do tipo II. Registro Brasileiro de Ensaios Clínicos. UTN: U1111-1181-1675. Clinical Trials NCT02605889. Palavras-chave: Cuidados de Enfermagem; Diabetes Mellitus Tipo 2; Terapias Complementares; Terapia por Acupuntura. RESUMEN: Objetivo: Evaluar la efectividad de la acupuntura-laser aplicada al cuidado de enfermería de personas con diabetes mellitus tipo II. Métodos: Ensayo clínico aleatorizado, triple ciego, con 42 participantes diabéticos tipo II, ambos sexos, con edades comprendidas entre 30 y 75 años, con hipoglucemiantes orales y dificultades para mantener la glucemia posprandial ≤ 180mg/ dl. Los participantes fueron asignados aleatoriamente a dos grupos diferentes y sometidos a láser-acupuntura estándar, brazo experimental o brazo de control simulado. Se utilizaron análisis descriptivos y de asociación entre variables, con un nivel de significancia del 5% (p <0,05). Para comparar los resultados de glucosa en sangre, se utilizó la prueba t de Student para muestras pareadas y Anova para mediciones repetidas. Resultados: Se observó una disminución significativa de la glucemia capilar en los participantes del brazo experimental, fenómeno no verificado en los del brazo control. Conclusiones: Se infiere la plausibilidad de utilizar la técnica como tecnología para el cuidado de enfermería de personas con diabetes mellitus tipo II. Registro Brasileño de Ensayos Clínicos. UTN: U1111-1181-1675. Ensayos clínicos NCT02605889. Palabras clave: Cuidados de Enfermería; Diabetes Mellitus Tipo 2; Terapias Complementarias; Terapia por Acupuntura. INTRODUCTION Type II diabetes mellitus (DM-II) is a chronic noncommunicable disease (CNCD) characterized by persistent hyperglycemia due to insulin resistance or by decreased secretion(1). It is not a single disease, but a heterogeneous group of metabolic disorders that presents hyperglycemia in common, resulting from defects in the action and/or secretion of insulin(2). In 2005, 240 million people in the world had DM, representing an increase of 105 million over 20 years(3). By 2030, the disease shall reach 366 million people, and two- thirds will live in developing countries(3,4). Página 519 Enfermería Global Nº 62 Abril 2021 In the search for the control and prevention of CNCD, Brazil has been working with technical and strategic alliances with different bodies, such as the Ministry of Health (MH) and its health care institutions, Scientific Societies, Universities and Non- Governmental Organizations (NGOs) in partnership with the Southern Common Market (MERCOSUR), in addition to interinstitutional partnerships with the Pan- American Health Organization (PAHO), the World Health Organization (WHO) and the Joint Network of Actions for the Reduction and Management of Noncommunicable Diseases (CARMEN Network)(5). The persistence of high circulating glucose levels in the bloodstream causes micro and macro vascular lesions that over the years of exposure can lead to retinopathies, chronic kidney disease and skin lesions, amputation of the lower limbs or part of them. These complications compromise quality of life and generate early work disabilities, leading to increased costs to the Unified Health System (UHS) and the social security system(6,7). The treatment of the disease aims to avoid changes in blood glucose rates and considers a combination of pharmacological methods, changes in eating and behavioral habits(1,2). Acupuncture (AP) and other techniques of Traditional Chinese Medicine (TCM) have also been used as a therapeutic proposal for DM. Used for thousands of years for the treatment of this disease and other associated conditions, AP has been recommended by the WHO since 2002, as complementary treatment to the health of people with DM, with an indication of a reduction of up to 20% of blood glucose levels by endocrine stimulation, besides contributing to the control of stress, obesity, hyperphagia, hyperlipidemia, inflammation, altered activity of the sympathetic nervous system and insulin signaling defects, favoring immunity, and (8) the protection of organs targeted by the effects of hyperglycemia . The AP is a technique of the TCM, practiced for millennia aiming to promote the harmonization of energies for health production/preservation, through the stimulation of specific points of the body called acupoints(9,10). Among its application techniques is Laser acupuncture (LA), which does not use needles in its approach, as occurs in the traditional method of AP, using low intensity laser directly on the skin in the acupoints(9,10). LA has significant efficacy when compared to other AP methods and has the main advantages of being a rapid treatment, considering the length of stay of the patient in therapy, and a very low risk of local infection, considering that it is not an invasive procedure(11). The AP is able to integrate the context of nursing care into the quality of innovative technology, expanding the possibilities of the professional’s therapeutic action(9). However, there is a lack of studies with experimental designs demonstrating the scientific evidence of the efficacy of AP to DM-II and pointing out its limits and possibilities as care technology, providing care safety(12). Página 520 Enfermería Global Nº 62 Abril 2021 Thus, the objective of this research was to evaluate the efficacy of laser-acupuncture applied to nursing care for people with type II diabetes mellitus. MATERIAL AND METHOD Randomized, multicenter, triple-blind, two-arm clinical trial with random allocation rate of fifty percent per arm. The study was developed in three research centers in two states of the Southeastern Brazilian region: in the service laboratory of the Integrated Research-Assistance
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