Efficacy and safety of Jingqianshu granules in patients with premenstrual syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.

Introduction: 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.

Aim: This study aimed to evaluate the clinical efficacy and safety of JQS in women with PMS characterized by liver stagnation and qi stagnation.

Method: 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.

Results: 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.

Conclusion: 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.

Trial registration: This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).