METHODOLOGICAL ISSUES IN STUDIES OF PREMENSTRUAL CHANGES

METHODOLOGICAL ISSUES IN STUDIES OF PREMENSTRUAL CHANGES
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DOI:
10.1016/0306-4530(85)90036-8
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发表时间:
1985-01-01
影响因子:
3.7
通讯作者:
ENDICOTT, J
ENDICOTT, J
中科院分区:
医学2区
文献类型:
--
作者:
HALBREICH, U;ENDICOTT, J

文献摘要

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在经前变化的研究中应考虑的主要方法学问题进行了讨论。它们包括:(1)选择反映经前变化(PMC)亚型多样性的明确定义的受试者组;(2)通过每日监测等级变化或在可能时通过客观程序确认回顾性报告;(3)需要考虑经前生物学变化的多样性,而不是比较平均水平,因为不同的病理生理学变化可能与不同的行为和情绪变化有关;(4)应用多变量、时间相关的方法来探索PMC的病理生理学;(5)需要在治疗试验的活性药物阶段之前排除安慰剂应答者,以及(6)此类试验需要是双盲、安慰剂对照的,并且如果可能,需要交叉设计。对这些问题的关注应该会增加研究结果的一致性,并最终更好地理解PMC的病理生理学,并找到合理有效的治疗方法。
The main methodological issues that should be considered in studies of premenstrual changes are discussed. They include: (1) the selection of well-defined groups of subjects who reflect the diversity of subtypes of premenstrual changes (PMC); (2) the confirmation of retrospective reports through daily monitoring of changes by ratings, or by objective procedures when possible; (3) the need to consider the diversity of premenstrual biological changes instead of comparing average levels, since there is a likelihood that different pathophysiological changes are connected with diverse behavioral and mood changes; (4) application of a multivariate, time-related approach to explore the pathophysiology of PMC; (5) the need to exclude placebo responders prior to the active drug phase in treatment trials and (6) the need for such trials to be double-blind, placebo-controlled and, if possible, of a cross-over design. Attention to such issues should lead to increased consistency of findings across studies and eventually to a better understanding of the pathophysiology of PMC and to a rational, effective treatment.