West C P, Hillier H
Department of Obstetrics and Gynaecology, University of Edinburgh, UK.
Hum Reprod. 1994 Jun;9(6):1058-63. doi: 10.1093/oxfordjournals.humrep.a138633.
The objective of this study was to determine the effectiveness of ovarian suppression by a GnRH agonist analogue in 32 women with prospectively confirmed severe premenstrual tension. The design was a randomized, double-blind study comparing goserelin 3.6 mg with placebo, both given as a monthly s.c. injection for 3 months. Self-assessment was by daily visual analogue scales (VAS) for anxiety and depression, daily quantitative symptom rating for breast discomfort, swelling, irritability, tension, depression and by monthly Hospital Anxiety and Depression (HAD) scales. Of the 16 women in each group, 15 completed active and 12 completed placebo therapy. Median symptom scores for whole cycles showed a significant reduction of breast discomfort and swelling during active treatment, with no significant improvement in psychological symptoms. Analysis by cycle phase showed that for individual subjects, pre-treatment differences in VAS scores for anxiety and depression were abolished in a significantly greater proportion of actively treated cycles. Within-group comparisons showed a marked placebo effect and, comparing the two groups, differences reached significance only during treatment cycle 1 and the first post-treatment cycle for anxiety with no significant differences for depression. It was concluded that while suppression of ovarian activity with a gonadotrophin-releasing hormone analogue dampens down cyclical mood swings, it has a more marked effect on the physical components of the premenstrual syndrome. Results reconfirm the positive role of placebo in the management of this condition.
本研究的目的是确定促性腺激素释放激素(GnRH)激动剂类似物对32名经前瞻性确诊为严重经前紧张症的女性进行卵巢抑制的有效性。研究设计为一项随机、双盲研究,比较戈舍瑞林3.6毫克与安慰剂,二者均每月皮下注射一次,共注射3个月。自我评估采用每日焦虑和抑郁视觉模拟量表(VAS)、每日乳房不适、肿胀、易怒、紧张、抑郁的定量症状评分以及每月医院焦虑和抑郁(HAD)量表。每组16名女性中,15名完成了活性药物治疗,12名完成了安慰剂治疗。整个周期的症状评分中位数显示,活性药物治疗期间乳房不适和肿胀显著减轻,心理症状无显著改善。按周期阶段分析表明,对于个体受试者,在接受活性药物治疗的周期中,焦虑和抑郁的VAS评分的治疗前差异在显著更多的周期中消失。组内比较显示出明显的安慰剂效应,两组比较时,差异仅在治疗周期1和治疗后第一个周期的焦虑方面达到显著水平,抑郁方面无显著差异。得出的结论是,虽然用促性腺激素释放激素类似物抑制卵巢活动可减轻周期性情绪波动,但对经前综合征的身体成分有更显著的影响。结果再次证实了安慰剂在这种疾病管理中的积极作用。