Evidence map›Paper›PMID 40580262›Full record

Trial reportInternational journal of clinical pharmacy2025

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

Zhenzhen Zhou, Weili Li, Yanfeng Liu, Fujian Si, Dongmei Wang, Xu Sun, Nan Song, Wenjing Chen, Huilan Du

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Zhenzhen ZhouHebei University of Traditional Chinese Medicine, No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang, 050091, Hebei, China.
Weili LiAnhui Provincial Hospital of Traditional Chinese Medicine, Hefei, 230000, China.
Yanfeng LiuDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.
Fujian SiFeicheng Hospital of Shandong Yiyang Health Group, Shandong, 271600, China.
Dongmei WangShandong Provincial Hospital of Traditional Chinese Medicine, Jinan, 250011, China.
Xu SunQinhuangdao Shanhaiguan Pharmaceutical Co., Ltd., Qinhuangdao, 066200, China.
Nan SongQinhuangdao Shanhaiguan Pharmaceutical Co., Ltd., Qinhuangdao, 066200, China.
Wenjing ChenAnhui Provincial Hospital of Traditional Chinese Medicine, Hefei, 230000, China.
Huilan DuHebei University of Traditional Chinese Medicine, No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang, 050091, Hebei, China. duhuilan@hebcm.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPremenstrual 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.

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

methodA 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.

resultsThe 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.

conclusionJingqianshu 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 registrationThis trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).

Indexed as

Drugs, Chinese HerbalPremenstrual SyndromeAdultDouble-Blind MethodFemaleHumansTreatment OutcomeYoung AdultDrugs, Chinese HerbalChinese patent medicineJingqianshu granulesLiver stagnation and qi stagnation syndromePremenstrual syndromeRandomized controlled trialTraditional Chinese Medicine (TCM)

Identifiers

PMID40580262

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.