Triticum vulgare para el tratamiento del síndrome genitourinario de la menopausia, Armenia, Colombia / Triticum vulgare for the treatment of genitourinary syndrome of menopause, Armenia, Colombia

OBJETIVO: Evaluar la eficacia y la seguridad de Triticum vulgare en el tratamiento del síndrome genitourinario de la menopausia (SGUM). MÉTODO: Estudio cuasiexperimental (antes-después, con grupo control) en mujeres posmenopáusicas (amenorrea ≥ 36 meses, hormona estimulante del folículo > 40 U/l y estradiol < 25 pg/ml), sexualmente activas, con un índice de maduración vaginal (IMV) < 50 y pH ≥ 5, citología cervical negativa (Papanicolaou) y diagnóstico de SGUM, atendidas en el programa de climaterio y menopausia de una clínica privada de mediana complejidad, en Armenia, Quindío (Colombia). Se seleccionaron 207 mujeres con edad promedio de 55,19 ± 7,28 años. Se realizó un muestreo consecutivo. Se asignaron dos grupos: A (n = 105), que recibió T. vulgare, y B (n = 102), que recibió placebo. Se hizo seguimiento al inicio (basal) y 4, 8 y 12 semanas después, utilizando el IMV y el Índice de Función Sexual Femenina (IFSF). Los síntomas del SGUM se evaluaron con una escala visual analógica (EVA). Se aplicó estadística descriptiva. RESULTADOS: La puntuación media del IMV fue mayor en las semanas 4, 8 y 12 en todas las mujeres del grupo A (p = 0,01). Se observó una diferencia significativa en el promedio final de la puntuación del IMV de T. vulgare frente al placebo (p < 0,05). Al final del estudio, el grupo A mostró una mejoría significativa en la puntuación promedio del IFSF, en comparación con el grupo B (p < 0,001). Las puntuaciones de la EVA presentaron una disminución progresiva a lo largo del estudio, pero fueron comparables entre los dos grupos (p = 0,813). CONCLUSIONES: T. vulgare es una efectiva, segura e innovadora alternativa, no hormonal, para el tratamiento del SGUM. No se registraron eventos adversos, por lo que se demostró su seguridad.

OBJECTIVE: To evaluate the efficacy and safety of Triticum vulgare in the treatment of genitourinary syndrome of menopause. METHOD: Quasi-experimental study (before-after, with control group) in postmenopausal women (amenorrhea ≥ 36 months, FSH > 40 U/L and estradiol < 25 pg/ml), sexually active, with a vaginal maturation index (VMI) < 50 and pH ≥ 5, negative cervical cytology (Papanicolaou) and with a diagnosis of genitourinary syndrome of menopause (SGUM); who were treated in the climacteric and menopause program of a private clinic of medium complexity, in Armenia, Quindío (Colombia). 207 participants were selected, with a mean age of 55.19 ± 7.28 years. A consecutive sampling was carried out. Two groups were assigned: A (n = 105) with T. vulgare and B (n = 102) with placebo. Follow-up was done at baseline (baseline), four, eight and twelve weeks later, using the VMI and the female sexual function index (IFSF). Symptoms of SGUM were evaluated using a visual analog scale (VAS). Descriptive statistics were applied. RESULTS: The mean score of the IMV was higher in weeks 4, 8 and 12 in all the participants of group A (p = 0.01). A significant difference was observed in the final mean MVI score of T. vulgare versus placebo (p < 0.05). At the end of the study, group A showed a significant improvement in the mean IFSF score, compared to placebo (p < 0.001). The VAS scores showed a progressive decrease throughout the study but were comparable between the two groups (p = 0.813). CONCLUSIONS: T. vulgare is an effective, safe and innovative non-hormonal alternative for the treatment of SGUM. No adverse events were recorded, guaranteeing their safety.

Hormone treatment as first line therapy is safe and relieves pelvic pain in women with bowel endometriosis / O tratamento hormonal como terapia de primeira linha é seguro e melhora a dor pélvica em mulheres com endometriose intestinal

ABSTRACT Objective: To evaluate clinical features and complications in patients with bowel endometriosis submitted to hormonal therapy. Methods: Retrospective study based on data extracted from medical records of 238 women with recto-sigmoid endometriosis treated between May 2010 and May 2016. Results: Over the course of follow-up, 143 (60.1%) women remained in medical treatment while 95 (39.9%) presented with worsening of pain symptoms or intestinal lesion growth (failure of medical treatment group), with surgical resection performed in 54 cases. Women in the Medical Treatment Group were older (40.5±5.1 years versus 37.3±5.8 years; p<0.0001) and had smaller recto sigmoid lesions (2.1±1.9 versus 3.1±2.2; p=0.008) compared to those who had failed to respond to medical treatment. Similar significant reduction in pain scores for dysmenorrhea, chronic pelvic pain, cyclic dyschezia and dysuria was observed in both groups; however greater reduction in pain scores for dyspareunia was noted in the Surgical Group. Subjective improvement in pain symptoms was also similar between groups (100% versus 98.2%; p=0.18). Major complications rates were higher in the Surgical Group (9.2% versus 0.6%; p=0.001). Conclusion: Patients with recto-sigmoid endometriosis who failed to respond to medical treatment were younger and had larger intestinal lesions. Hormonal therapy was equally efficient in improving pain symptoms other than dyspareunia compared to surgery, and was associated with lower complication rates in women with recto-sigmoid endometriosis. Medical treatment should be offered as a first-line therapy for patients with bowel endometriosis. Surgical treatment should be reserved for patients with pain symptoms unresponsive to hormonal therapy, lesion growth or suspected intestinal subocclusion.

RESUMO Objetivo: Avaliar características clínicas e complicações em pacientes com endometriose intestinal submetidos ao tratamento hormonal. Métodos: Dados de prontuários de 238 pacientes com endometriose de retossigmoide tratadas entre maio de 2010 e maio de 2016 foram coletados para este estudo retrospectivo. Resultados: Durante o período de acompanhamento, 143 (60,1%) mulheres mantiveram tratamento clínico, enquanto 95 (39,9%) tiveram piora dos sintomas de dor ou aumento da lesão intestinal (grupo falha de tratamento clínico), sendo 54 submetidas ao tratamento cirúrgico. As mulheres no Grupo Tratamento Clínico eram mais velhas (40,5±5,1 anos versus 37,3±5,8 anos; p<0,0001) e tinham lesões intestinais menores (2,1±1,9 versus 3,1±2,2; p=0,008) em comparação ao grupo falha de tratamento clínico. Redução significativa e semelhante do escore de dor na dismenorreia, dor pélvica crônica, disquezia cíclica e disúria cíclica foi observada nos Grupos Tratamento Clínico e Cirúrgico. Dispareunia, no entato, teve uma redução maior no Grupo Cirurgia. A redução subjetiva dos sintomas dolorosos também foi semelhante entre os Grupos Clínico e Cirúrgico (100% versus 98,2%; p=0,18). O Grupo Tratamento Cirúrgico foi relacionado a uma maior taxa de complicações graves (9,2% versus 0,6%; p=0,001) em comparação ao Grupo Tratamento Clínico. Conclusão: Falha no tratamento clínico em pacientes com endometriose de retossigmoide foi observada em mulheres mais jovens que tinham lesões intestinais maiores. O tratamento clínico hormonal foi igualmente eficaz na melhora dos sintomas de dor, exceto dispareunia, em comparação ao tratamento cirúrgico em mulheres com endometriose intestinal, mas com menor taxa de complicações. O tratamento clínico deve ser oferecido como primeira opção em pacientes com endometriose intestinal, enquanto o tratamento cirúrgico deve ser reservado para pacientes sem melhora nos sintomas de dor com tratamento hormonal, progressão das lesões ou suspeita de suboclusão intestinal.

An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis.

Vaginitis is among the most common conditions for which women seek medical care, with vaginal discharge accounting for approximately 10 million office visits each year. Since there are no published studies till date that evaluated the Clinical Effectiveness and Safety of Topical Cream of Formula A [Ofloxacin (0.75 % w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared to Formula B [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], and Formula D [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence we undertook this randomized controlled Post Marketing Multicentric trial. Materials and methods: Female subjects diagnosed with mild to moderate symptoms of Vaginitis were eligible and those fulfilling the subject selection criteria were randomized to receive either Formula A, Formula B, Formula C or Formula D for 14 days. The Primary efficacy measures were assessment of symptoms of Vaginitis i.e. vaginal pruritis, vaginal irritation, vaginal soreness or pain, dyspareunia, vaginal erosion and vaginal inflammation and Secondary efficacy measures were assessment of Physical characteristics of vaginal discharge, assessment of pH of vaginal discharge and Microbiological evaluation. Assessment of Safety was done by recording the occurrence of adverse drug reactions. Results: The clinical success rates were comparable and even far better in case of Formula A group (in vaginal pain, Dyspareunia and vaginal erosion it was 100 %, in case of vaginal inflammation it was 92.655 % while in case of vaginal irritation, it was 94.767 % and vaginal pruritus, it was 87.096 %). Adverse events were mild and self limiting while it was totally absent in case of Formula A group. Conclusion: Topical Cream of Formula A is safe and effective for the treatment of mild to moderate vaginitis.

Efectos del valerato de estradiol ciproterona sobre el síndrome climaterio y parámetros bioquímicos en mujeres chilenas / Effects of estradiol valerate and ciproterone acetate on climateric syndrome and biochemical parameters in Chilean women

La menopausia se asocia a un demostrado aumento del riesgo de enfermedad cardiovascular y de osteoporosis, lo que justifica el uso de terapia hormonal de reemplazo. Como ésta se plantea por tiempo prolongado, debe ser efectiva en prevenir las complicaciones y en suprimir el síndrome climatérico. Se estudió la eficacia de la asociación de valerato de estradiol (VE) y acetato de ciproterona (CPA) en la reducción de los síntomas asociados a menopausia. Se analizaron, prospectivamente, 342 mujeres durante 6 meses, consignando la intensidad de sus síntomas y los cambios en peso, presión arterial y parámetros bioquímicos. Las oleadas de calor, así como otros síntomas y signos, disminuyeron en intensidad. No hubo diferencia significativa en la evolución del peso ni de la presión arterial, aunque sí en algunos parámetros del perfil lipídico y hepático. Se concluye que la asociación VE y CPA reduce la intensidad de los síntomas climatéricos en el grupo estudiado