Evidence map›Paper›PMID 29196484›Full record

Trial reportBMJ open2017

Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial.

Joong Il Kim, Pumsoo Kim, Jin-Hyun Lee, Yoo-Jin Kim, Na-Rae Yang, Myong Ki Baeg, Ja Sung Choi, Hye-Jung Kim, Jayoung Kim, Yun-Young Sunwoo and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 41% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

13 authors at 4 institutions in 1 country.

Joong Il KimInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Pumsoo KimInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Jin-Hyun LeeDepartment of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
Yoo-Jin KimInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Na-Rae YangInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Myong Ki BaegInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Ja Sung ChoiInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Hye-Jung KimInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Jayoung KimInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Yun-Young SunwooInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Jung-Han LeeDepartment of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
Hyekyung HaK-herb Research Center, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Tae-Yong ParkInstitute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.
Catholic Kwandong University International St. Mary's Hospital · KRCatholic Kwandong University · KRWonkwang University · KRKorea Institute of Oriental Medicine · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIrritable bowel syndrome (IBS), known as a functional and organic gastrointestinal disorder, is a collection of symptoms that occur together and generally include pain or discomfort in the abdomen and changes in bowel movement patterns. Due to the limitations of conventional treatments, alternative IBS treatments are used by many patients worldwide. Samryungbaekchulsan (SRS), a herbal formula, has long been used for alleviating diarrhoea-predominant IBS (D-IBS) in traditional Korean medicine. Otilonium bromide (OB) is an antimuscarinic compound used to relieve spasmodic pain in the gut, especially in IBS. Although herbal formulae and Western drugs are commonly coadministered for various diseases in Korea, few clinical studies have been conducted regarding the synergic effects of these treatments for any disease, including D-IBS. METHODS AND ANALYSIS: This trial is a randomised, double-blinded, placebo-controlled, double-dummy, four-arm, parallel study. After a 2-week preparation period, 80 patients with D-IBS will be randomly assigned to one of four treatment groups consisting of SRS (water extract granules, 5 g/pack, three times a day) with OB (tablet form, one capsule three times a day) or their placebos, with treatment lasting for 8 weeks. Post-treatment follow-up will be conducted 4 weeks after the end of treatment. The primary outcome is the finding obtained using the Subject's Global Assessment of Relief method. The secondary outcomes are the severity of symptoms related to D-IBS, determined using a 10-point scale, and the change in symptoms. ETHICS AND DISSEMINATION: This trial has full ethical approval of the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS15MISV0033) and the Korean Ministry of Food and Drug Safety (30769). The results of the study will be disseminated through a peer-reviewed journal and/or conference presentations. TRIAL PROTOCOL VERSION: IS15MISV0033 version 4.0 (25 July 2016). TRIAL REGISTRATION NUMBER: KCT0001621 (approval date: 10 August 2015).

Indexed as

Abdominal PainClinical ProtocolsDefecationDiarrheaDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIrritable Bowel SyndromeMaleMuscarinic AntagonistsPlant ExtractsQuaternary Ammonium CompoundsRepublic of KoreaMuscarinic AntagonistsoctyloniumPlant ExtractsQuaternary Ammonium Compoundsclinical trial protocolirritable bowel syndromeotilonium bromiderandomized controlled studysamryungbaekchulsan

Identifiers

PMID29196484
PMCPMC5719308
OpenAlexW2775159216

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.