Evidence map›Paper›PMID 31126315›Full record

ArticleTrials2019

Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial.

Tao Yin, Zhaoxuan He, Peihong Ma, Likai Hou, Li Chen, Kunnan Xie, Zilei Tian, Fumin Wang, Jing Xiong, Yi Yang and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
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

4 citing papers in PubMed, 30 citations in OpenAlex.

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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

12 authors at 1 institution in 1 country.

Tao YinAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Zhaoxuan HeAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Peihong MaAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Likai HouAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Li ChenAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Kunnan XieAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Zilei TianAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Fumin WangAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Jing XiongAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.
Yi YangAcupuncture-Brain Research Center, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Ruirui SunAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. cspsrr@126.com.
Fang ZengAcupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. zeng_fang@126.com.
Chengdu University of Traditional Chinese Medicine · CN

Funding

National Natural Science Foundation of Outstanding Youth Fund in China NO.81622052Ten Thousand Talent Program (CN) W02020595
6 · The paper itself

Abstract

backgroundAcupuncture is effective in functional constipation (FC) treatment, but the central mechanism has not been well investigated. This trial will combine functional magnetic resonance imaging (fMRI) and positron emission tomography-computed tomography (PET-CT) to investigate the potential central mechanism of acupuncture treatment for FC.

methodsThis is a multimodal neuroimaging randomized controlled trial. In total, 140 FC patients will be randomly allocated into four groups: the verum acupuncture group; the sham acupuncture group; the PEG 4000 group; and the waiting-list group. This trial will include a two-week baseline period and a two-week treatment period. Patients will receive 10 sessions of acupuncture, sham acupuncture, PEG 4000, or no intervention during the treatment period. The stool diary, Cleveland Constipation Score (CCS), Patient Assessment of Constipation Symptom (PAC-SYM), and Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) will be used to assess the clinical efficacy of different interventions. The MRI and PET-CT scans will be performed to detect cerebral functional changes in 15 patients in each group at baseline and at the end of treatment/waiting. Multimodal imaging data will be associated with clinical data to investigate possible correlation between brain activity changes elicited by different interventions and symptoms improvement. DISCUSSION: We hypothesize that acupuncture can treat FC through normalizing the pathological alteration of the cerebral activity. The results of this trial will allow us to re-testify the therapeutic effects of acupuncture treating for FC and to investigate the potential central mechanism of acupuncture treatment for FC from direct (cerebral glucose metabolism) and indirect (contrast of oxyhemoglobin and deoxyhemoglobin) approaches.

trial registrationChinese Clinical Trial Registry, ChiCTR1800016658 . Registered on 14 June 2018.

Indexed as

Randomized Controlled Trials as TopicAcupuncture TherapyBrainConstipationHumansMagnetic Resonance ImagingMultimodal ImagingPositron Emission Tomography Computed TomographyQuality ControlQuality of LifeAcupunctureCentral mechanismClinical trialFunctional constipationFunctional magnetic resonance imagingMultimodal neuroimagingPositron emission tomography-computed tomographyProtocol

Identifiers

PMID31126315
PMCPMC6534837
OpenAlexW2947234898

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.