Evidence map›Paper›PMID 37147763›Full record

ArticleJournal of traditional Chinese medicine = Chung i tsa chih ying wen pan2023

Therapy of replenishing and regulating for manic episode in bipolar disorder: study protocol for a prospective, double-blind, randomized controlled trial.

Yang Yang, Yuan Haining, Jia Hongxiao, Ning Yanzhe, Wang Di, Zhang Lei, Yan Kaijuan, Guo Yumeng, Wang Fei, Sun Weishuang and 1 more

Open access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

11 authors at 1 institution in 1 country.

Yang YangBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Yuan HainingBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Jia HongxiaoBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.
Ning YanzheBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.
Wang DiBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Zhang LeiBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Yan KaijuanBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Guo YumengBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Wang FeiBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Sun WeishuangBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Chen PeiBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders and National Center for Mental Disorders, Department of integrated traditional Chinese and Western medicine, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Beijing Advanced Sciences and Innovation Center · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bipolar disorder (BD) is a chronic and recurrent disorder characterized by biphasic mood episodes of mania or hypomania and depression. It affects more than 1% of the global population and is a leading cause of disability in young people. Currently available treatments for BD are still fairly limited in terms of efficacy, with high rates of non-adherence, non-response, and undesirable side effects. Traditional Chinese medicine (TCM) has a long history and rich experience in stabilizing mania and improving quality of life. Aiming at rebalancing and in BD, therapy of replenishing and regulating (RYRY therapy) has been in clinical use for years in China. The present prospective, double-blind, randomized controlled trial is designed to investigate the efficacy and safety of RYRY therapy for bipolar mania and its possible mechanism from the point of regulating gut microbiota and anti-inflammation. A total of 60 eligible participants will be recruited from Beijing Anding Hospital. They will be randomized to either the study group or the control group in a ratio of 1∶1. Participants allocated to the study group will receive RYRY granule, while placebo granule will be applied in the control group. Participants in both groups will be prescribed conventional therapy for manic episode in BD. Four scheduled visits will be conducted over 4 weeks. Outcome measurements include Young Mania Rating Scale, TCM Symptom Pattern Rating Scale, Treatment Emergent Symptom Scale, levels of C-reactive protein, interleukin-6 and tumor necrosis factor-α and the gut microbial community profile of stool samples. Safety outcomes and adverse events will also be recorded. In this study, we set a number of scientific and objective assessments to evaluate the efficacy of RYRY therapy and study into its possible mechanism, hopefully offering clinicians an alternative approach to BD.

Indexed as

Bipolar DisorderAdolescentDouble-Blind MethodHumansManiaProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment Outcomebipolar disorderclinical protocolgastrointestinal microbiomeinflammationreplenishing and regulating

Identifiers

PMID37147763
PMCPMC10133961
OpenAlexW4372337462

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.