Zhou Zhenzhen, Li Weili, Liu Yanfeng, Si Fujian, Wang Dongmei, Sun Xu, Song Nan, Chen Wenjing, Du Huilan
Hebei University of Traditional Chinese Medicine, No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang, 050091, Hebei, China.
Anhui Provincial Hospital of Traditional Chinese Medicine, Hefei, 230000, China.
Int J Clin Pharm. 2025 Jun 28. doi: 10.1007/s11096-025-01949-5.
Premenstrual syndrome (PMS) is a common disorder characterized by recurring somatic, emotional, and behavioral symptoms during the luteal phase of the menstrual cycle. Core manifestations include irritability, anxiety, insomnia, mood swings, breast tenderness, and headache. In Traditional Chinese Medicine (TCM), PMS with liver and qi stagnation is considered a pattern resulting from internal organ imbalance. Jingqianshu granules (JQS), a Chinese patented medicine, are traditionally used to soothe the liver, relieve depression, regulate qi, and alleviate pain.
This study aimed to evaluate the clinical efficacy and safety of JQS in women with PMS characterized by liver stagnation and qi stagnation.
A total of 156 eligible participants were randomly assigned in a 2:1 ratio to receive JQS (n = 104) or placebo (n = 52) over three menstrual cycles, followed by a three-cycle post-treatment follow-up. The primary outcome was the change in the Daily Record of Severity of Problems (DRSP) scores. Secondary outcomes included TCM syndrome scores and improvements in individual symptoms. Safety was assessed by adverse event reporting and laboratory monitoring.
The full analysis set (FAS) included 155 participants, and the per-protocol set (PPS) included 137. After three treatment cycles, DRSP scores were significantly reduced in the JQS group compared to placebo (FAS: - 14.3 ± 8.85 vs. - 10.1 ± 7.61; PPS: - 14.5 ± 8.61 vs. - 10.2 ± 7.13; both P < 0.001) with a moderate effect size (Cohen's d = 0.51), indicating clinical relevance. TCM syndrome scores also showed greater improvement in the JQS group (FAS: 7.7 ± 3.11 vs. 9.0 ± 4.13; PPS: 7.7 ± 3.19 vs. 9.4 ± 4.23; P < 0.05). The JQS group exhibited significant improvements in individual DRSP symptoms including anxiety, fatigue, emotional instability, concentration difficulty, and breast tenderness (P < 0.05). Adverse events were mild and comparable between the groups (4.81% in JQS vs. 3.92% in placebo; P > 0.05), with no serious events reported.
Jingqianshu granules significantly alleviated PMS symptoms and demonstrated good tolerability, supporting their use as a safe and effective treatment option for women with liver and qi stagnation-type PMS.
This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).
经前期综合征（PMS）是一种常见疾病，其特征是在月经周期的黄体期反复出现躯体、情绪和行为症状。核心表现包括易怒、焦虑、失眠、情绪波动、乳房胀痛和头痛。在传统中医（TCM）中，肝郁气滞型经前期综合征被认为是由内脏失衡导致的一种证型。经前舒颗粒（JQS）是一种中成药，传统上用于疏肝、解郁、理气、止痛。
本研究旨在评估经前舒颗粒对肝郁气滞型经前期综合征女性的临床疗效和安全性。
总共156名符合条件的参与者按2:1的比例随机分组，在三个月经周期内接受经前舒颗粒（n = 104）或安慰剂（n = 52）治疗，随后进行三个周期的治疗后随访。主要结局是问题严重程度每日记录（DRSP）评分的变化。次要结局包括中医证候评分和个体症状的改善情况。通过不良事件报告和实验室监测评估安全性。
全分析集（FAS）包括155名参与者，符合方案集（PPS）包括137名。三个治疗周期后，与安慰剂组相比，经前舒颗粒组的DRSP评分显著降低（FAS：-14.3±8.85 vs. -10.1±7.61；PPS：-14.5±8.61 vs. -10.2±7.13；均P < 0.001），效应大小为中等（科恩d = 0.51），表明具有临床意义。中医证候评分在经前舒颗粒组也有更大改善（FAS：7.7±3.11 vs. 9.0±4.13；PPS：7.7±3.19 vs. 9.4±4.23；P < 0.05）。经前舒颗粒组在DRSP的个体症状包括焦虑、疲劳、情绪不稳定、注意力难以集中和乳房胀痛方面有显著改善（P < 0.05）。不良事件轻微，两组之间相当（经前舒颗粒组为4.81%，安慰剂组为3.92%；P > 0.05），未报告严重事件。
经前舒颗粒显著缓解经前期综合征症状，并显示出良好的耐受性，支持其作为肝郁气滞型经前期综合征女性的一种安全有效的治疗选择。
本试验在中国临床试验注册中心（ChiCTR2200058599）注册。
