Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change from baseline Menopause Rating Scale (MRS) total score at 3 months
研究概览
简要总结
This study determined the efficacy of non-hormonal therapy with citalopram compared to fluoxetine, for the treatment of menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome.
详细描述
Women's reproductive life goes through a senescence process called transition to menopause, which generates an imbalance in estrogenic hormonal regulation that is more evident between the fifth and sixth decades of life. This condition allows the passage from an active reproductive stage to an inactive one, which triggers an adaptative physiological response to the reduction of estrogens. However, the progressive depletion of estrogen levels causes clinical signs and symptoms in the central nervous system, metabolism, musculoskeletal apparatus, urogenital system, and skin. These symptoms lead to disability, work absenteeism, and health costs, affecting the quality of life of women in this stage. Vasomotor symptoms are the main clinical manifestation for which women seek treatment. Vasomotor syndrome (VMS) occurs in 75 to 80% of all women. The first-line management of menopausal symptoms is hormone replacement therapy (HRT). However, some patients present adverse effects or contraindications for using it.
The aim of this study was to determine the efficacy of the citalopram for treating menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome.
This study was a prospective randomized clinical trial, where 91 post-menopausal participants with severe baseline scores on the Menopause Rating Scale (MRS) were randomly selected and treated with citalopram (n=49) or fluoxetine (n=42). Changes from baseline MRS score at three and six months of treatment were evaluated.
Participants were randomly assigned to groups before each consult. Randomization was done using RAND and RANK functions from Excel-Word to generate unique random numbers for every participant´s ID. Fluoxetine is the Gold Standard treatment in Mexico, whereby it was used as the control medication. Loading doses of citalopram 20 mg orally or fluoxetine 20 mg orally were administrated.
Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. Some statical parameters, such as arithmetic median (µ), standard deviation (S.D.), and Hazard ratio, were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3. Tables and Forest plots were done in Excel-Word. Odds ratio (OR), Relative Risk (RR), and chi-squared were calculated with PAST 3.0 software. The assigned α value for this study was <0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who attended the climacteric consultation for the first time, without prior treatment of menopausal symptoms, and who met postmenopausal criteria.
- •Participants who met the criteria for vasomotor syndrome and score greater than 17 points in total MRS.
- •Participants without psychiatric pathology (psychiatric illnesses such as major depression, generalized anxiety disorder, among others).
- •Participants who agreed to participate and gave their written informed consent.
排除标准
- •Participants who had contraindications to receive serotonin reuptake inhibitors (SSRIs).
- •Participants who were receiving prior treatment for the postmenopausal or vasomotor syndrome.
- •Participants who did not agree to participate or sign the informed consent.
研究组 & 干预措施
Fluoxetine group
Participants received fluoxetine, 20 mg tablets, once a day for six months.
干预措施: Fluoxetine 20 MG (Drug)
Citalopram group
Participants received citalopram, 20 mg tablets, once a day for six months.
干预措施: Citalopram 20mg (Drug)
结局指标
主要结局
Change from baseline Menopause Rating Scale (MRS) total score at 3 months
时间窗: 3 months
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. It considers the score of the somatic, urogenital, and psychological domains. A score of 0-4 was considered minimal severity, 5-8 mild, 9-16 moderate, and greater than 17 severe.
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 3 months
时间窗: 3 months
It considers the score obtained from the somatic dimension, which includes hot flashes, heart problems, sleep problems, and muscle and joint pain. A score of 0-2 was considered minimal severity, 3-4 mild, 5-8 moderate, and greater than 9 severe.
Change from baseline Menopause Rating Scale (MRS) total score at 6 months
时间窗: 6 months
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. It considers the score of the somatic, urogenital, and psychological domains. A score of 0-4 was considered minimal severity, 5-8 mild, 9-16 moderate, and greater than 17 severe.
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 3 months
时间窗: 3 months
It considers the score obtained from the urogenital dimension, which includes sexual problems, bladder problems and vaginal dryness. A score of 0 was considered minimal severity, 1 mild, 2-3 moderate, and greater than 4 severe.
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 3 months
时间窗: 3 months
It considers the score obtained from the psychological dimension, which includes depression, irritability, anxiety and tiredness. A score of 0-1 was considered minimal severity, 2-3 mild, 4-6 moderate, and greater than 7 severe.
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 3 months
时间窗: 3 months
Item 1 considers the score obtained from hot flashes on the MRS scale. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 6 months
时间窗: 6 months
It considers the score obtained from the somatic dimension, which includes hot flashes, heart problems, sleep problems, and muscle and joint pain. A score of 0-2 was considered minimal severity, 3-4 mild, 5-8 moderate, and greater than 9 severe.
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 6 months
时间窗: 6 months
It considers the score obtained from the urogenital dimension, which includes sexual problems, bladder problems and vaginal dryness. A score of 0 was considered minimal severity, 1 mild, 2-3 moderate, and greater than 4 severe.
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 6 months
时间窗: 6 months
It considers the score obtained from the psychological dimension, which includes depression, irritability, anxiety and tiredness. A score of 0-1 was considered minimal severity, 2-3 mild, 4-6 moderate, and greater than 7 severe.
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 6 months
时间窗: 3 months
Item 1 considers the score obtained from hot flashes on the MRS scale. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
次要结局
- Change from the severity of individual Menopause Rating Scale (MRS) items at 6 months(6 months)