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Abstract Objectives: In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM). Methods: A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness. Results: After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05). Conclusions: Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.
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OBJECTIVE:To compare therapeutic efficacy and safety of chlorquinaldol-promestriene and miconazole nitrate for simple vulvovaginal candidiasis (VCC).METHODS:In retrospective analysis,a total of 231 patients with simple VCC were divided into observation group (116 cases) and control group (115 cases).Observation group was given Chlorquinaldol-promestriene vaginal tablet (0.2 g) every night.Control group was given Miconazole nitrate suppositories (200 mg) every night.Both groups received a course of treatment,lasting for 7 d.Clinical efficacies of 2 groups were observed at the first and second recheck.The symptom relief time recurrence and ADR of effective patients were observed.RESULTS:There was no statistical significance in the total response rates of 2 groups at the first reexamination,as well as total response rates of 2 groups and symptom relief time of effective patients at the second reexamination(P＞0.05).At the second reexamination,reoccurrence rate of observation group was significantly lower than that of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups(P＞0.05).CONCLUSIONS:Chlorquinaldol-promestriene is similar to miconazole nitrate for VCC in therapeutic efficacy and safety,but chlorquinaldol-promestriene is better than miconazole nitrate in reducing recurrence rate.
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OBJECTIVE:To compare therapeutic efficacy and safety of chlorquinaldol-promestriene and miconazole nitrate for simple vulvovaginal candidiasis (VCC).METHODS:In retrospective analysis,a total of 231 patients with simple VCC were divided into observation group (116 cases) and control group (115 cases).Observation group was given Chlorquinaldol-promestriene vaginal tablet (0.2 g) every night.Control group was given Miconazole nitrate suppositories (200 mg) every night.Both groups received a course of treatment,lasting for 7 d.Clinical efficacies of 2 groups were observed at the first and second recheck.The symptom relief time recurrence and ADR of effective patients were observed.RESULTS:There was no statistical significance in the total response rates of 2 groups at the first reexamination,as well as total response rates of 2 groups and symptom relief time of effective patients at the second reexamination(P＞0.05).At the second reexamination,reoccurrence rate of observation group was significantly lower than that of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups(P＞0.05).CONCLUSIONS:Chlorquinaldol-promestriene is similar to miconazole nitrate for VCC in therapeutic efficacy and safety,but chlorquinaldol-promestriene is better than miconazole nitrate in reducing recurrence rate.
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OBJECTIVE:To investigate therapeutic efficacy and recurrence rate of vaginal administration of lactobacillus com-bined with chlorquinaldol-promestriene for senile patients with atrophic vaginitis. METHODS:150 senile patients with atrophic vag-initis were selected and divided into group A,B,C according to random number table,with 50 cases in each group. Group A was given Lactobacillus vaginal capsules,2 capsules,qd (at bedtime);group B given Chlorquinaldol-promestriene vaginal tablets,1 tablet,qd(at bedtime);group C given Chlorquinaldol-promestriene vaginal tablets,1 tablet,qd(at bedtime),and Lactobacillus vaginal capsules,2 capsules,qd,next morning,implanting into vagina. 3 groups received treatment for 18 d. Clinical efficacy, vaginal health score,vaginal symptom score and vaginal pH value were observed in 3 groups,and the occurrence of ADR and re-currence rate during follow-up period (12 months) were recorded. RESULTS:The total effective rate of group C was 94.00%, which was significantly higher than group A(72.00%)and B(74.00%),with statistical significance(P0.05). After treatment,vaginal health score of 3 groups were increased significantly,while vaginal symptom score and vaginal pH value were decreased significantly;and the improvement of above indexes in group C were significantly better than in group A and B,with statistical significance(P<0.05). No obvious ADR was found in 3 groups during treatment. The recurrence rate of group C during follow-up period(4.00%)was significantly lower than that of group A(18.00%)and group B(20.00%),with statistical significance(P<0.05). CONCLUSIONS:Vaginal administration of lactobacillus combined with chlorquinaldol-promestriene for se-nile patients with atrophic vaginitis can effectively relieve clinical symptoms and signs,improve vaginal cleanliness,regulate the lo-cal pH value and reduce the risk of recurrence,with good safety.
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Objetivo: Avaliar a eficácia, segurança e aceitabilidade de cremes vaginais contendo promestriene (Colpotrofine®, Laboratórios Teva do Brasil) ou estriol (Ovestrion®, MSD, Brasil), em mulheres no climatério e na menopausa. Método: Estudo prospectivo, randomizado, aberto, de grupos paralelos e controlado. Locais: Instituto de Ginecologia da Universidade Federal do Rio de Janeiro e Faculdade de Medicina da Valença. Material: 80 mulheres na menopausa ou climatério, para quem o tratamento com creme vaginal de estrogênio foi indicado. Intervenção(s): As pacientes aplicaram 1g do creme vaginal, respectivo, a cada noite por 20 dias e depois uma aplicação semanal durante seis meses consecutivos. As pacientes foram distribuídas aleatoriamente sucessivamente numa proporção de 1:1, de acordo com a sua ordem de chegada: as pacientes ímpares foram designadas para receber promestriene e as com números pares foram designadas para receber estriol. Principal medida de desfecho(s): A variável de resposta primária foi a maturação do epitélio vaginal, avaliada pela citologia vaginal e medida pelo índice de Frost. Ambos os tratamentos melhoraram significativamente o trofismo do epitélio vaginal. Resultado(s): Uma melhoria acentuada (94,1%) foi indicado para pacientes do grupo promestriene por três meses, culminando na melhoria de 100% em 6 meses (p <0,0001). Houve clara melhoria dos sintomas da menopausa para ambos os grupos, sendo os tratamentos seguros e bem tolerados. Pacientes do grupo promestriene foram significativamente (p <0,038) mais satisfeitas (100%) com seu tratamento em comparação ao grupo estriol (73,33%). Conclusão(s): Ambos os tratamentos reverteram a atrofia vaginal, levando a um epitélio vaginal saudável, com destaque estatisticamente significativo para o promestriene, o que condicionou a uma melhoria da qualidade de vida.