Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Nov 24;6(11):e013440.
doi: 10.1136/bmjopen-2016-013440.

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

Jeeyoun Jung  1 , Ju Ah Lee  1 , Mi Mi Ko  1 , Sooseong You  1 , Eunhee Lee  2 , Jiae Choi  3 , Byoung-Kab Kang  1 , Myeong Soo Lee  3
Affiliations
Randomized Controlled Trial

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

Jeeyoun Jung et al. BMJ Open. .

Abstract

Introduction: Gyejibongneyong-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.

Keywords: COMPLEMENTARY MEDICINE; GYNAECOLOGY; Gyejibongneyong-hwan, Guizhi Fuling, uterine fibroids, clinical trial, protocol.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Flow chart of the study. GBH, Gyejibongneyong-hwan.
See this image and copyright information in PMC

References

    1. Chen NN, Han M, Yang H et al. . Chinese herbal medicine Guizhi Fuling formula for treatment of uterine fibroids: a systematic review of randomised clinical trials. BMC Complement Altern Med 2014;14:2 10.1186/1472-6882-14-2 - DOI - PMC - PubMed
    1. Liu JP, Yang H, Xia Y et al. . Herbal preparations for uterine fibroids. Cochrane Database Of Syst Rev 2013;(4):Cd005292 10.1002/14651858.CD005292.pub3 - DOI - PMC - PubMed
    1. Chen XX, Lin WL, Yeung WF et al. . Quality and safety control of Tumor-Shrinking Decoction (TSD), a Chinese herbal preparation for the treatment of uterine fibroids. Biotechnol Appl Biochem 2016. 10.1002/bab.1460 10.1002/bab.1460 - DOI - DOI - PubMed
    1. Akase T, Akase T, Onodera S et al. . A comparative study of the usefulness of toki-shakuyaku-san and an oral iron preparation in the treatment of hypochromic anemia in cases of uterine myoma. Yakugaku Zasshi 2003;123:817–24. 10.1248/yakushi.123.817 - DOI - PubMed
    1. Li D, Zhang Y, Han H et al. . Effect of lichong decoction on expression of IGF-I and proliferating cell nuclear antigen mRNA in rat model of uterine leiomyoma. J Tradit Chin Med 2012;32:636–40. - PubMed

Publication types

Associated data

LinkOut - more resources