Evidence map›Paper›PMID 41122303›Full record

ArticleF1000Research2025

Effectiveness of Chinese herbal medicine on improving sleep and mental health in adults: Study protocol for a stepped-wedge cluster randomized trial.

Hiu To Tang, Hoi Ki Wong, Jingyuan Luo, Jialing Zhang, Qin Liu, Lixiang Zhai, Rachel Ngan Yin Chan, Yun Kwok Wing, Shirley Xin Li, Wing Fai Yeung and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in F1000Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

16 authors.

Hiu To TangVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.ORCID https://orcid.org/0009-0004-8519-172X
Hoi Ki WongVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Jingyuan LuoVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Jialing ZhangVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Qin LiuSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Lixiang ZhaiSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Rachel Ngan Yin ChanLi Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.
Yun Kwok WingLi Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.
Shirley Xin LiSleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong, Hong Kong SAR, China.
Wing Fai YeungSchool of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.
Albert YeungDepression Clinical and Research Program, Massachusetts General Hospital, Boston, USA.
Francesco RecchiaSchool of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
Chun Hoi CheungVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Junjun YangSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Danny J YuVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.ORCID https://orcid.org/0000-0002-1811-3682
Zhaoxiang BianVincent V.C. Woo Chinese Medicine Clinical Research Institute, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Depression, anxiety, and insomnia significantly impact global health and impose substantial health burdens worldwide. Conventional treatments including pharmacotherapy and psychotherapy face limitations in efficacy, side effects, and accessibility. Despite preliminary evidence suggesting the potential of Chinese herbal medicine (CHM) in managing these conditions, large-scale evaluations are lacking. This study aims to examine the effectiveness of CHM for the treatment of adults experiencing mild-to-moderate symptoms of depression, anxiety, and insomnia. Methods: This study will be a multicenter, pragmatic stepped-wedge cluster randomized trial. Districts will be randomized to receive the CHM intervention sequentially in four steps based on a computer-generated number, while control districts remain unexposed until their respective intervention phase. The intervention consists of a three-level stepped-care approach: Level 1 involves herbal tisane for mild symptoms, Level 2 offers standardized CHM for moderate symptoms or non-responders to Level 1, and Level 3 combines personalized CHM with psychotherapy for those not improved by Level 2. Symptom severity will be assessed using validated scales, Patient Health Questionnaire-9 for depression, Generalized Anxiety Disorder-7 for anxiety, and Insomnia Severity Index for insomnia, with primary outcomes measured at baseline, post-intervention, and follow-up. The study was approved by the Hong Kong Baptist University Research Ethics Committee (Approval No.: REC/22-23/0709). Discussion: This study will provide significant insights into the effectiveness of a stepped-care CHM intervention for alleviating depression, anxiety, and insomnia. The results could guide future decision-making regarding the integration of CHM into mainstream healthcare systems in Hong Kong and beyond. Trial registration: Chinese Clinical Trial Registry, ChiCTR2400083685, April 30, 2024, https://www.chictr.org.cn/hvshowprojectEN.html?id=251238&v=1.0.

Indexed as

Drugs, Chinese HerbalMental HealthSleepSleep Initiation and Maintenance DisordersAdultAnxietyDepressionFemaleHumansMalePragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeDrugs, Chinese HerbalanxietyChinese herbal medicinedepressioninsomniastepped-care modelstepped-wedge trial

Identifiers

PMID41122303
PMCPMC12536410

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.