Budeiri D J, Li Wan Po A, Dornan J C
Pharmacoepidemiology Section, School of Pharmacy, Queen's University of Belfast.
Br J Obstet Gynaecol. 1994 Aug;101(8):689-95. doi: 10.1111/j.1471-0528.1994.tb13186.x.
To demonstrate similarities and differences between the various instruments used by clinical trialists for measurement of premenstrual syndrome to encourage development of consensus of measurement to aid future research.
Computer and manual searches of all trials of drugs used for premenstrual syndrome supplemented by retrieval of all questionnaires and scales cited. Letters were sent to the main manufacturers to identify trials not in the public domain.
Number of scales in current use for classifying premenstrual syndrome; the symptoms included within them; their organisation of symptoms into clusters; the numerical values used in the scaling; the most frequently used items; and the extent of overlap in the criteria used.
Three hundred and fifty clinical trials of 115 different drugs were identified. The most common symptoms or signs used in the scales were (frequency in square brackets) irritability [44], headache or migraine [40], depression [37], tearfulness [34], tension [31], anxiety [31], breast tenderness [31], mood swings or lability [30], back pain [30], weight gain [29], abdominal bloating [28], lack of concentration [28], food craving [28], and increased appetite [26]. Sixty-five different questionnaires or scales were used to classify premenstrual syndrome and for assessing entry eligibility and treatment outcomes; of these 65, 47 included sufficient details for a formal analysis and 18 scales grouped the symptoms or items into clusters or subgroups.
There is wide diversity in the scales used for assessing entry eligibility and treatment outcomes in premenstrual syndrome. This makes comparative evaluation of possible treatments extremely complex and difficult. It is recommended that authorities and organisations involved in conducting trials of treatments for premenstrual syndrome develop a consensus statement about the best instrument to be used. Regulatory authorities could perhaps provide guidance to which scales they would accept when clinical trials of drugs for premenstrual syndrome are submitted to them for assessment. This would ensure that industry-sponsored trials provide objective data. Consensus is required given the poor performance of most current treatments of premenstrual syndrome.
阐述临床试验人员用于测量经前综合征的各种工具之间的异同，以促进测量方法的共识形成，助力未来研究。
通过计算机和手工检索所有用于经前综合征的药物试验，并补充检索所引用的所有问卷和量表。向主要制造商发送信函，以识别未公开的试验。
当前用于分类经前综合征的量表数量；其中包含的症状；症状聚类情况；量表使用的数值；最常用的项目；以及所用标准的重叠程度。
共识别出115种不同药物的350项临床试验。量表中最常见的症状或体征（方括号内为出现频率）为：易怒[44]、头痛或偏头痛[40]、抑郁[37]、流泪[34]、紧张[31]、焦虑[31]、乳房胀痛[31]、情绪波动或不稳定[30]、背痛[30]、体重增加[29]、腹部胀满[28]、注意力不集中[28]、渴望食物[28]和食欲增加[26]。65种不同的问卷或量表用于经前综合征的分类以及评估入选资格和治疗结果；其中65种里，47种包含足够细节可进行正式分析，18种量表将症状或项目聚类或分组。
用于评估经前综合征入选资格和治疗结果的量表存在广泛差异。这使得对可能的治疗方法进行比较评估极其复杂和困难。建议参与经前综合征治疗试验的当局和组织就最佳使用工具制定一份共识声明。监管当局或许可以提供指导，说明在经前综合征药物临床试验提交评估时他们会接受哪些量表。这将确保行业资助的试验提供客观数据。鉴于目前大多数经前综合征治疗方法效果不佳，达成共识是必要的。
