一种汉方药，加味逍遥散（kamishoyosan），改善经前综合征患者的月经相关症状：一项探索性开放标签随机对照试验。
完整摘要 · 中文译文
经前综合征（PMS）是一种心理或躯体症状。我们开展了一项开放标签、随机、探索性试验，旨在评估加味逍遥散（KSS）治疗PMS的疗效和安全性。KSS在三个月经周期内口服给药。主要终点为经前期月经困扰问卷（MDQ）总分的变化。次要终点包括MDQ总分及各分量表评分、每日症状问卷、工作生产力与活动受损（WPAI）问卷、总体印象、睡眠状态和心率。共纳入50例患者。主要终点即经前期MDQ总分在KSS治疗后显著改善。此外，KSS降低了月经周期期间的MDQ评分。在MDQ各分量表中，KSS降低了经前期疼痛、注意力、行为改变和负性情绪的评分。此外，情感高涨在月经周期期间减轻。每日症状问卷的结果表明，KSS治疗缓解了易激惹、易怒、焦虑、情绪不稳定、腹胀、畏寒和肩颈僵硬。WPAI活动受损评分在KSS组较低，总体印象倾向于KSS治疗。与KSS相关的唯一不良事件为1例头痛。这些探索性发现提示，KSS可能改善PMS中与月经相关的症状。
完整摘要 · 英文原文
Premenstrual syndrome (PMS) is a psychological or physical symptom. We conducted an open-label, randomized, exploratory trial with the aim of evaluating the efficacy and safety of kamishoyosan (KSS) for PMS. KSS was administered orally during three menstrual cycles. The primary endpoint was the change in the premenstrual Menstrual Distress Questionnaire (MDQ) total score. The secondary endpoints included MDQ total and subscale scores, a daily symptom questionnaire, the Work Productivity and Activity Impairment (WPAI) Questionnaire, overall impressions, sleep status, and heart rate. A total of 50 patients were enrolled. The primary endpoint, the premenstrual MDQ total score, was significantly ameliorated after KSS treatment. Furthermore, KSS reduced MDQ scores during the menstrual cycle. Among the MDQ subscales, KSS decreased score of pain, concentration, behavioral change, and negative feelings during the premenstrual cycle. In addition, hyperthymia reduced during the menstrual cycle. The results of the daily symptom questionnaire indicated that KSS treatment alleviated irritability, easy anger, anxiety, emotional instability, abdominal distension, coldness, and stiff shoulders.The WPAI activity impairment score was lower in the KSS group, and overall impression favoured in KSS treatment.. The only adverse event related to KSS was headache in one case. These exploratory findings suggest that KSS may improve menstrual-related symptoms in PMS.