Evidence map›Paper›PMID 27884853›Full record

Trial reportBMJ open2016

Gyejibongneyong-hwan, a herbal medicine for the treatment of dysmenorrhoea with uterine fibroids: a protocol for a randomised controlled trial.

Jeeyoun Jung, Ju Ah Lee, Mi Mi Ko, Sooseong You, Eunhee Lee, Jiae Choi, Byoung-Kab Kang, Myeong Soo Lee

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. The Multiple Pharmacologic Functions and Mechanisms of Action of Guizhi Fuling Formulation.Evidence-based complementary and alternative medicine : eCAM · 2022
    Review
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

8 authors.

Jeeyoun JungKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Ju Ah LeeKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Mi Mi KoKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Sooseong YouKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Eunhee LeeDepartment of Obstetrics & Gynecology, College of Korean Medicine, Woo-Suk University, Jeonju, Korea.
Jiae ChoiClinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Byoung-Kab KangKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Myeong Soo LeeClinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.ORCID 0000-0003-0987-9093

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGyejibongneyong-hwan (GBH), or the Guizhi Fuling Formula in Chinese, is widely used to treat uterine fibroids in East Asian countries including Korea, China and Japan. This study will assess the efficacy and safety of the GBH formula for the treatment of dysmenorrhoea. METHODS AND ANALYSIS: This study will be a randomised double-blind controlled trial with two parallel arms: the GBH group and the placebo group. This trial will recruit 38 women between 18 and 45 years of age with secondary dysmenorrhoea with uterine fibroids. The investigational drugs, either GBH or placebo, will be administered to the participants three times per day for two menstrual periods (8 weeks). The participants will be followed up for three menstrual cycles after administration of the drugs. The primary outcome will be the Numeric Rating Scale score of average menstrual pain. All analyses will be performed with SAS (V.9.1.3; SAS Institute, Cary, North Carolina, USA) by a statistician blinded to the allocation of the groups. Statistical analysis will be undertaken on the intent-to-treat (ITT) basis with a 95% CI using the last observation carried forward for missing values. The ITT analysis will include all randomised patients. ETHICS AND DISSEMINATION: This research protocol has been reviewed and approved by the institutional review boards of the trial centre (number WSOH IRB 1606-03). Written informed consent will be obtained from all study participants prior to enrolment in the study. The results will be published in a peer-reviewed journal and will be disseminated electronically and in print. TRIAL REGISTRATION NUMBER: KCT0001967.

Indexed as

AdolescentAdultDouble-Blind MethodDrugs, Chinese HerbalDysmenorrheaFemaleHumansLeiomyomaMenstruationMiddle AgedNorth CarolinaPhytotherapyPlant ExtractsResearch DesignTreatment OutcomeYoung AdultDrugs, Chinese Herbalguizhi-fulinggyeongshingangjeehwanPlant ExtractsCOMPLEMENTARY MEDICINEGyejibongneyong-hwan, Guizhi Fuling, uterine fibroids, clinical trial, protocolGYNAECOLOGY

Identifiers

PMID27884853
PMCPMC5168531

What OpenQuestion holds

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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.