Raj Rajnish, Sharma Namita, Garg Rohit, Goyal Ekram
Department of Psychiatry, Government Medical College, Rajindra Hospital, Patiala, Punjab, India.
Ind Psychiatry J. 2021 Oct;30(Suppl 1):S140-S148. doi: 10.4103/0972-6748.328805. Epub 2021 Oct 22.
A high prevalence of psychiatric disorders, particularly depressive and anxiety disorders among women is observed through the postmenopausal stage.
The aim of this study is to compare the safety and efficacy of tibolone (TIB) and escitalopram (ESCIT) in postmenopausal women (PMW).
It was an interventional, open-label, hospital-based, follow-up study conducted on 60 PMW with the diagnosis of depression as per the Diagnostic and Statistical Manual of Mental Disorder-5 criteria. Patients were divided into two groups of 30 each, i.e. Group I (TIB-2.5 mg/day) and Group II (ESCIT-10-20 mg/day). The primary outcome was assessed for change in climacteric symptom scores on Greene's Climacteric Scale (GCS), severity of depression and anxiety on Hamilton Rating Scale for Depression (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A), and sexual functioning on Arizona Sexual Experience Scale (ASEX). The secondary outcome of well-being was assessed on World Health Organization Quality of life (QOL)-BREF. All the observations were carried out from baseline and at 2, 4, 8, and 12 weeks.
Both the groups showed significant improvement in climacteric and depressive symptoms. However, at the 8 and 12 weeks, mean ± standard deviation scores were significantly lower in Group I (GCS score - 24.80 ± 4.92, 20.30 ± 3.56; HAM-D score - 16.57 ± 5.83, 10.2 ± 5.67) compared to Group II (GCS score - 27.27 ± 5.83 and 23.33 ± 5.70, HAM-D score - 19.97 ± 7.98 and 16.17 ± 10.11). No significant difference between the groups was seen for anxiety on HAM-A scores. Only in Group I, there was significant improvement in ASEX scores. QoL in Group I had shown significant improvement in physical and psychological domain compared to Group II at different time interval, i.e. 4 and 8 week onward. In Group I, Alternative Dispute Resolution was reported to be 23.3%, whereas it was 56.7% in Group II. However, none were serious to warrant discontinuation.
TIB was better than ESCIT in improving depression, climacteric symptoms, and physical and psychological domain of QoL with an additional benefit of restoring sexual functioning.
在绝经后阶段，观察到精神障碍，尤其是女性中的抑郁和焦虑障碍患病率较高。
本研究的目的是比较替勃龙（TIB）和艾司西酞普兰（ESCIT）在绝经后女性（PMW）中的安全性和有效性。
这是一项基于医院的干预性、开放标签随访研究，对60名根据《精神疾病诊断与统计手册》第5版标准诊断为抑郁症的PMW进行。患者分为两组，每组30人，即第一组（TIB-2.5毫克/天）和第二组（ESCIT-10-20毫克/天）。主要结局指标评估了格林更年期量表（GCS）上更年期症状评分的变化、汉密尔顿抑郁量表（HAM-D）和汉密尔顿焦虑量表（HAM-A）上抑郁和焦虑的严重程度，以及亚利桑那性体验量表（ASEX）上的性功能。通过世界卫生组织生活质量简表（QOL-BREF）评估幸福感这一次要结局指标。所有观察均在基线以及第2、4、8和12周进行。
两组在更年期和抑郁症状方面均有显著改善。然而，在第8周和第12周时，与第二组（GCS评分 - 27.27±5.83和第23.33±5.70，HAM-D评分 - 19.97±7.98和16.17±10.11）相比，第一组（GCS评分 - 24.80±4.92，20.30±3.56；HAM-D评分 - 16.57±5.83，10.2±5.67）的平均±标准差得分显著更低。两组在HAM-A评分上的焦虑方面未见显著差异。仅在第一组中，ASEX评分有显著改善。在不同时间间隔，即第4周和第8周及之后，与第二组相比，第一组在身体和心理领域的生活质量有显著改善。在第一组中，报告的替代争议解决率为23.3%，而在第二组中为56.7%。然而，均无严重到需要停药的情况。
在改善抑郁、更年期症状以及生活质量的身体和心理领域方面，替勃龙优于艾司西酞普兰，且还有恢复性功能的额外益处。
