This is a qualitative–quantitative study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus terrestris extract (1 tablet thrice daily for 90 days). Safety monitoring included vital signs, physical examination, laboratory tests, and occurrence of adverse events. Efficacy analysis included results of the Female Sexual Function Index (FSFI), dehydroepiandrosterone (DHEA) levels together with total and free testosterone, and the patient and physician assessments. There was a statistically significant improvement in total FSFI scores (P < 0.0001) post-treatment, with improvement among 106 (88.33%) subjects. There was a statistically significant (P < 0.0001) increase in the level of DHEA, while the levels of both serum testosterone (P = 0.284) and free testosterone decreased (P < 0.0001). Most adverse events recorded were related to the gastrointestinal tract. Physical examination showed no significant changes post-treatment. Based on the results, it is concluded that the T. terrestris extract is safe and effective in the treatment of female sexual dysfunction.
Introdução: Os dispositivos intrauterinos (DIU) são colocados na cavidade uterina para impedir a fecundação. Três tipos principais estão disponíveis: cobre, prata e o levonorgestrel. O DIU é um dos contraceptivos reversíveis mais eficazes. Apesar de diversas vantagens, é utilizado por 15% das mulheres em idade reprodutiva. A escolha do contraceptivo é pautada pela preferência da paciente ea orientação profissional. É necessário ampliar a percepção quanto a possíveis barreiras no uso: ignorância, atitudes pessoais negativas, histórico médico, experiência contraceptiva e percepção do risco de gravidez. Objetivo: Primário: avaliar a amostra demográfica de usuárias do DIU. Secundário: compreender os fatores relacionadas à aceitação ou rejeição do DIU. Métodos: Foi feita uma pesquisa quantitativa com a ciência e a aprovação no Comitê de Ética em Pesquisa. Incluíram-se mulheres com mais de 18 anos que utilizaram algum contraceptivo. Os dados foram coletados virtualmente (Google Docs). Resultados: Foram obtidas mil respostas, sendo 422 (42%) de usuárias de DIU e 578 (57%) de outros. As primeiras tinham idades entre 18 e 57 anos. A faixa dos 20 aos 40 correspondeu ao maior grupo, com 371 respostas (87%). Essas mulheres relataram que conheceram o DIU (189, ou 44%) pela internet e pelo ginecologista (149, ou 35%). O mais utilizado foi o de cobre (210, ou 49%). Os efeitos colaterais mais citados foram aumento do fluxo, sangramentos irregulares e dismenorreia. Não tiveram alteração 89 (21%). Sobre a intensidade desses efeitos, 166 (33%) responderam que foram pouco incômodos. Sobre a satisfação, 165 (39%) estão muito satisfeitas. Para outros métodos, as idades estavam entre18 e 69 anos. A faixa dos 18 aos 38 teve 493 respostas (85%). Das participantes, 397 (68%) relataram estar em uso de algum método, 576 (99%) já ouviram falar do DIU e 404 (69%) disseram que já consideraram usá-lo. Afirmaram não utilizar o DIU por medo de dismenorreia 216 (37%) e por medo da dor para a inserção 200 (34%). Conclusão: Após a realização deste trabalho, ficou clara a importância dos fatores socioculturais. Nas usuárias de DIU, podemos notar a maior parte dos dispositivos com formulação de cobre, o que pode ser atribuído ao menor custo, disponibilidade no Sistema Único de Saúde e durabilidade. A maioria conheceu o método pela internet ou pelo ginecologista. A taxa de continuação foi alta. Quanto aos efeitos colaterais, o aumento de volume da menstruação, a irregularidade e a dismenorreia são os mais citados. Esses têm menor grau de incomodo, o que não impede o uso e garantem alto grau de satisfação. As que não utilizam o DIU têm como métodos mais usados o anticoncepcional oral e o preservativo. Os motivos que as fizeram não utilizar o DIU são medo dos efeitos colaterais, medo de engravidar e dor na colocação. Questões com conceitos errôneos, patologias, religião e custo foram determinantes. Diante desses dados, é possível concluir que fatores como escolaridade, poder aquisitivo e acesso à informação são determinantes na escolha.
Background. Phlebotonics have beneficial effects on some symptoms related to chronic venous disease (CVD) of the lower limbs. The most commonly used one is diosmin, available in a pure semisynthetic form or as a micronized purified flavonoid fraction. Patients and Methods. The primary objective of this single-blind, randomized, parallel-group, prospective study was to assess the clinical noninferiority of nonmicronized diosmin 600 mg once daily (D-group) compared to micronized diosmin 900 mg plus hesperidin 100 mg once daily (D/H-group) over a 6-month treatment period. Adult patients with a symptomatic CVD of the lower limbs (C0-C3 grade; 20-60 mm on a 100 mm visual analog scale (VAS)) were included. The primary endpoint was the change (from baseline to last postbaseline value) of the intensity of the lower-limb symptoms on VAS. Results. 114 patients (mean age, 44.4 years; women, 90.4%) were randomized in the per-protocol analysis (D-group, n=57; D/H-group, n=57). Symptoms significantly improved in both groups with adjusted mean VAS changes of -24.9 mm (p<0.0001) in the D-group and -22.8 mm (p<0.0001) in the D/H-group, corresponding to approximately 50% reduction in basal symptom intensity. The difference between groups was -2.1 mm with an upper limit of one-sided 90% confidence interval equal to 1.0 mm for a noninferiority margin set at 20 mm (noninferiority demonstrated). Intent-to-treat analysis confirmed per-protocol analysis. Difficulty in swallowing the tablets (VAS) was significantly lower in the D-group compared to the D/H-group (9.4 mm and 54.7 mm at 6 months, respectively; p<0.0001). The overall safety of both study drugs was good. Conclusion. Nonmicronized diosmin 600 mg was proven to have a noninferior efficacy compared to micronized diosmin 900 mg plus hesperidin 100 mg, associated with greater ease in swallowing the tablet.
Purpose Urinary antiseptics including methenamine and methylene blue are used in the symptomatic treatment of urinary tract infections (UTIs). Patients and Methods This was a prospective, double-blind, randomized, double-dummy safety and efficacy study of 2 urinary antiseptic combinations in the symptomatic treatment of recurrent cystitis: methenamine 120mg + methylene blue 20mg (Group A) versus acriflavine 15mg + methenamine 250mg + methylene blue 20mg + Atropa belladonna L. 15mg (Group B). All subjects underwent pretreatment urine culture and antibiotic sensitivity tests prior to 3-day oral treatment with study drug, followed by 3 days of antibiotic therapy (based on urine culture) + study drug treatment. Efficacy was evaluated using the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA). The primary endpoint was the percentage of patients presenting improvement in cystitis manifestations on the UTISA domain “Urination Regularity” at Visit 2. The primary safety variable was the incidence of treatment-related adverse events. Results A total of 144 subjects were randomized per group and 272 completed the study. Primary endpoint analysis demonstrates homogeneity between treatment groups, with 69.4% and 72.2% subjects, respectively, showing improvement in the score of the urinary regularity UTISA domain after 3 days of treatment ( p = 0.87). At Visit 2, incidence of treatment-related adverse events was higher in Group B (Group A: n= 11, Group B: n= 31, p = 0.0057). Conclusion Both treatments were effective in reducing UTI symptoms assessed by UTISA questionnaire after 3 days of treatment. The two regimens were comparable in incidence of adverse events, but the combination of methenamine + methylene blue resulted in fewer treatment-related adverse effects.
In order to evaluate the safety and efficacy of Borago officinalis (900 mg borage oil capsules) in the treatment of patients presenting with cyclic mastalgia, 91 subjects were included in the study. Efficacy assessments were performed based on data obtained prior to the start of treatment (Pretreatment), and after each menstrual cycle (Assessment 2-following 45 days of treatment; and Assessment 3-at the end of the 90-day treatment period). Primary efficacy measures considered the results of the Mastalgia Questionnaire, including a 100 mm visual analog pain scale assessing mean, most intense mastalgia severity, and impact on work, sleep, and sexual activity. Safety and tolerability measures included any changes in vital signs and physical exam in relation to pretreatment, any changes in clinical laboratory exams in relation to pretreatment, and the occurrence of adverse events after the first dose of study medication. The VAS scores of the mean mastalgia and most severe mastalgia both showed statistically significant (p < 0.0001) reductions from Pretreatment to Assessment 3. Mean mastalgia scores improved among 92.3% of the treated patients, while most severe mastalgia scores improved among 93.4% of patients. There were sta-* Corresponding author. C. R. B. Gama et al. 364tistically significant improvements in the assessments of mastalgia impact on work (χ 2 = 28.24; gl = 4; p < 0.0001), sleep (χ 2 = 14.29; gl = 4; p = 0.0006), and sexual activity (χ 2 = 16.11; gl = 4; p = 0.0029) during the treatment period. The results of this study indicate a significant improvement in the mastalgia of the treated patients together with an improvement in the quality of life parameters evaluated. In terms of safety, the tolerability of the treatment was good, with the presence of some adverse events, all of which had been previously described with use of the Borago officinalis extract. No serious side effects were reported, and the events that did occur were transitory. Based on the results of this study, we concluded that the Borago officinalis extract was safe and effective in the treatment of cyclic mastalgia among the treated patients.
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