Yonkers K A, Pearlstein T, Rosenheck R A
Yale School of Medicine, Department of Psychiatry and School of Public Health, New Haven, CT 06510, USA.
Arch Womens Ment Health. 2003 Nov;6(4):287-92. doi: 10.1007/s00737-003-0026-4.
As with a number of emotional disorders, premenstrual complaints lie on a continuum dictated by severity, number and type of symptoms experienced. Women with premenstrual dysphoric disorder (PMDD) generally constitute the most symptomatic subgroup among those experiencing premenstrual symptoms. Included in the Diagnostic and Statistical Manual IV (DSM-IV) criteria for PMDD is a requirement for a minimum of 5 symptoms and for confirmation of these symptoms over two months by concurrent symptom ratings. These requirements likely influence critical patient characteristics rendering trial participants and typical patients seeking treatment, very different.
Women were recruited from 6 primary care obstetric-gynecological practices for participation in an open trial assessing the effectiveness of a serotonin reuptake inhibitor as a treatment for subsyndromal (3-4 symptoms) and syndromal (>4 symptoms) PMDD. Women were screened with the Brief Patient Health Questionnaire and Last Menstrual Period Module. Eligible women were invited to chart symptoms daily for one cycle using the Daily Record of Severity of Problems. Current comorbidity was allowed if women experienced a cyclic change in mood and behavioral symptoms.
47% of 904 women screened in practice settings (n=426) endorsed current PMS symptoms. Of this group, 174 (41%) were not interested in receiving treatment through a research study, 152 (36%) were not eligible to receive treatment (symptoms not severe enough, subsequently declined premenstrual symptom worsening, were already taking a psychotropic or wanted to conceive), 10% were lost to follow-up or had incomplete questionnaires, and 41 (10%) agreed to chart. Of women who charted, 9 (22%) verified symptoms. 93 women (22% of the 426) had comorbid MDD, 23 (5.4%) had minor depressive disorder and 61 (14%) had panic disorder. 24% of women with possible PMDD endorsed suicidal thoughts at any level (several days, more than half the days or every day); 20% endorsed these thoughts for several days. These results are used as a springboard to discuss how treatment results from efficacy trials may differ from treatment results that include women seeking treatment in usual care settings.
These preliminary findings show that many women in primary care ob-gyn settings endorse serious premenstrual symptoms and have concurrent psychiatric conditions. Despite this, interest in study participation was low. This occurred even though the current study employed procedures that were much less rigorous than those used in the typical efficacy study. More work is needed to explore how the selectivity of patients included in clinical trials may bias estimates of how effective many agents will be in actual clinical practice.
与许多情绪障碍一样，经前不适症状存在一个由所经历症状的严重程度、数量和类型所决定的连续谱。经前烦躁障碍（PMDD）女性通常是经前症状女性中症状最明显的亚组。《精神疾病诊断与统计手册》第四版（DSM-IV）中PMDD的诊断标准包括至少5种症状，以及通过同期症状评分在两个月内确认这些症状。这些要求可能会影响关键的患者特征，使得试验参与者与寻求治疗的典型患者有很大不同。
从6家初级保健妇产科诊所招募女性参与一项开放试验，评估一种5-羟色胺再摄取抑制剂治疗亚综合征（3 - 4种症状）和综合征（>4种症状）PMDD的有效性。使用简短患者健康问卷和末次月经周期模块对女性进行筛查。符合条件的女性被邀请使用问题严重程度每日记录，连续一个周期每天记录症状。如果女性的情绪和行为症状有周期性变化，则允许存在当前合并症。
在实际诊所环境中筛查的904名女性（n = 426）中，47%认可当前存在经前综合征症状。在这组女性中，174名（41%）对通过研究接受治疗不感兴趣，152名（36%）不符合接受治疗的条件（症状不够严重、随后经前症状恶化情况下降、已经在服用精神药物或想要怀孕），10%失访或问卷不完整，41名（10%）同意记录症状。在记录症状的女性中，9名（22%）症状得到证实。93名女性（426名中的22%）患有合并性重度抑郁症，23名（5.4%）患有轻度抑郁症，61名（14%）患有惊恐障碍。24%可能患有PMDD的女性在任何程度上（几天、超过一半天数或每天）认可有自杀念头；20%认可这些念头持续了几天。这些结果被用作一个跳板，来讨论疗效试验的治疗结果与包括在常规护理环境中寻求治疗的女性的治疗结果可能有何不同。
这些初步发现表明，许多初级保健妇产科环境中的女性认可严重的经前症状且存在并发的精神疾病。尽管如此，参与研究的兴趣较低。即使当前研究采用的程序比典型疗效研究使用的程序宽松得多，这种情况仍然发生。需要开展更多工作来探索临床试验中纳入患者的选择性如何可能使对许多药物在实际临床实践中有效性的估计产生偏差。
