Evidence map›Paper›PMID 41107798›Full record

Trial reportBMC complementary medicine and therapies2025

Efficacy and safety of Shugan Jieyu capsules in combination with zolpidem for insomnia disorder with depressive symptoms: a double-blind randomized controlled trial.

Qianqian Xin, Dhirendra Paudel, Jiehan Zhang, Huafeng Wei, Yihong Cheng, Yan Xu, Ruichen Fang, Jinnong Jiang, Yuling Wang, Bin Zhang

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05764798 (Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05764798 phase1unknown statusnot on this map

Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms: A Randomized Double Blind Controlled Study

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2022 to 2024Enrolled60ConditionsInsomniaArmsExperimental group: Shugan Jieyu Capsule combined with zolpidem, Control group: Placebo combined with zolpidem
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
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

10 authors.

Qianqian Xin *Department of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Dhirendra Paudel *Department of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Jiehan Zhang *Shanxi Datong University School of Medicine, Datong, Shanxi, 037009, China.
Huafeng WeiDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Yihong ChengDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Yan XuDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Ruichen FangDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Jinnong JiangDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Yuling WangDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China.
Bin ZhangDepartment of Psychiatry, Sleep Medicine Center, Nanfang Hospital, Southern Medical University, No 1838, Guangzhou Northern Road, Guangzhou, Guangdong, 510515, China. zhang73bin@hotmail.com.

Funding

National Key R&D Program of China 2021YFC2501500
6 · The paper itself

Abstract

objectiveInsomnia disorder with depressive symptoms (IDDS) represents a significant clinical phenotype, with a bidirectional relationship where insomnia both contributes to and results from depression. This study aimed to assess the efficacy and safety of combining zolpidem with Shugan Jieyu in treating IDDS.

methodsIn a double-blind, randomized trial, 60 IDDS patients were assigned to zolpidem plus Shugan Jieyu (ZS) or zolpidem plus placebo (ZP) for 8 weeks, with 59 completing the study. Assessments included the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), polysomnography (PSG), and sleep diary. Mixed-model repeated-measures (MMRM) analysis was performed to assess the least squares means difference (LSMD) among the groups after 4 and 8 weeks of treatment. Subgroup analysis was performed on patients with sleep fragmentation (WASO ≥ 30 min).

resultsBoth groups showed significant improvements in ISI, PSQI, ESS, GAD-7, and PHQ-9, with no between-group differences. For the primary outcome (ISI), the between-group difference at week 8 was - 1.68 points (95% CI: -4.49 to 1.14; p = 0.238), corresponding to a small effect size (Cohen's d = 0.42). ZS significantly reduced WASO and increased TST at 8 weeks, whereas ZP showed no significant changes in these measures within the group. ZS reduced subjective sleep latency (sSL) significantly more than ZP at weeks 4 (LSMD - 12.21 min, 95% CI -22.54 to -1.87; p = 0.021; d = 0.23) and 8 (LSMD - 12.17 min, 95% CI -21.99 to -2.35; p = 0.016; d = 0.25). In the sleep fragmentation subgroup, ZS improved sSL and subjective sleep efficiency (sSE). Both treatments were well-tolerated.

conclusionCompared with taking zolpidem alone, the combination of zolpidem with Shugan Jieyu did not significantly improve insomnia, but showed preliminary non-objective signals in improving patients' perception of falling asleep, particularly in patients with sleep fragmentation.

trial registrationThe study is registered in the ClinicalTrials.gov (NCT05764798). Date registered: 30 November 2022.

Indexed as

DepressionDrugs, Chinese HerbalSleep Initiation and Maintenance DisordersZolpidemAdultDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypnotics and SedativesMaleMiddle AgedDrugs, Chinese HerbalHypnotics and SedativesZolpidemComplementary therapiesDepressionInsomniaPolysomnographySleep disorders

Identifiers

PMID41107798
PMCPMC12535106

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Registered trials

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.