Halbreich U, Endicott J
Psychoneuroendocrinology. 1985;10(1):15-32. doi: 10.1016/0306-4530(85)90036-8.
The main methodological issues that should be considered in studies of premenstrual changes are discussed. They include: the selection of well-defined groups of subjects who reflect the diversity of subtypes of premenstrual changes (PMC); the confirmation of retrospective reports through daily monitoring of changes by ratings, or by objective procedures when possible; 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; application of a multivariate, time-related approach to explore the pathophysiology of PMC; the need to exclude placebo responders prior to the active drug phase in treatment trials and 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.
本文讨论了在经前变化研究中应考虑的主要方法学问题。这些问题包括：选择能反映经前变化（PMC）亚型多样性的明确界定的受试者群体；通过每日评分监测变化或在可能的情况下通过客观程序来证实回顾性报告；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变化可能与不同的行为和情绪变化相关；应用多变量、与时间相关的方法来探索PMC的病理生理学；在治疗试验的活性药物阶段之前需要排除安慰剂反应者，并且此类试验需要采用双盲、安慰剂对照设计，如有可能采用交叉设计。关注这些问题应能提高各项研究结果的一致性，并最终更好地理解PMC的病理生理学，从而实现合理、有效的治疗。
