Women
Conditions
Interventions
Study Group : 23 women with cervical columnar epithelium ectopy submitted to 10 sessions of systemic acupuncture, with 25x40mm needles in 12 points selected according to diagnosis of Traditional Chin
Other
E02.190.044
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: women in the menamma with ectopy of the cervical glandular epithelium on the cervical surface in the vaginal environment without any previous treatment
Exclusion criteria
Exclusion criteria: non-pregnant, non-lactating, nonimmunosuppressed of any kind
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desfecho primário esperado 1: Avaliar a acupuntura como tratamento para ectopia cervical uterina, em 51 mulheres saudáveis, randomizadas, através da análise do diferencial das porcentagens de áreas de ectopia nos grupos estudo (acupuntura) e controle (expectante). O método utilizado para observar a ação da acupuntura foi o cálculo do diferencial das porcentagens de áreas de ectopia (delta Pe) no início do tratamento e no seguimento em 3 meses, obtido pela medida, em imagem fotográfica colposcópica, das áreas de total do colo uterino, do orifício externo do colo uterino e da área de ectopia, utilizando o programa de computador AxioVision LE. O Teste t-Student para amostras independentes foi utilizado para o cálculo do delta Pe, utilizando o nível de significância alfa igual a 5%. A duração da execução do protocolo foi de 4,5 anos, no período de novembro de 2010 a dezembro de 2015.;Primary Outcomes found 1: There was a reduction in the percentage of ectopy area in the patients of the Study Group in relation to the control group at 3 months of follow-up, from November 2010 to December 2015, observed by the greater variation of the percentages of areas of ectopy. We obtained through the Student t-Test for independent samples p <0.001, in the comparison of the groups.;Expected primary outcome 2: Identify the most frequent syndromic diagnosis, according to Traditional Chinese Medicine (TCM) for ectopy of the uterine cervix. We analyzed in 51 healthy women from November 2010 to December 2015, randomized in Study group (acupuncture) and control group (expectant), all the symptoms, including the gynecological, systemic and emotional aspects referred in anamnesis. Each symptom according to the TCM corresponds to an energetic disorder, due to the specific imbalance of one of the fundamental substances (Yin, Yang, Qi and Xue) attributed to its corresponding Organs, in this way the syndrome can be constituted of numerous combinations. Thus, through the analysis o combinations | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome: Obtain the relationship between ectopy size and HPV DNA positivity in 51 healthy women from November 2010 to December 2015. In order to calculate the percentage of ectopy area, we used a colposcopic image of the areas of total uterine cervix, the external orifice of the uterine cervix and the ectopy area, using the AxioVision LE computer program. For the identification of HPV DNA, we collected samples from the uterine cervix in a liquid medium and used the COBAS4800 method, Roche® by the technique of amplification of the target DNA by means of Chain Polymerase Reaction (PCR). The Student's t-Test for independent samples was applied for the comparison between averages of ectopy percentages and HPV DNA positivity using the alpha significance level of 5%. ;Secondary outcome found: Comparison between averages of percentages of ectopy and HPV DNA positivity, in 51 healthy women from November 2010 to December 2015, revealed no statistical significance, using Student's t-Test for independent samples (p = 0.114). | — |
Countries
Brazil
Contacts
Public ContactJulisa;Silvana Maria Ribalta;Fernandes
Universidade Federal de São Paulo;Universidade Federal de São Paulo
Outcome results
None listed