Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2017

Open Access 01-12-2017 | Study protocol

Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial

Authors: Kwan-Il Kim, Hae Jeong Nam, Mia Kim, Junhee Lee, Kyuseok Kim

Published in: BMC Complementary Medicine and Therapies | Issue 1/2017

Login to get access

Abstract

Background

The incidence of preadolescent acne among women is increasing. Acne deteriorates the quality of life; conventional treatment options are limited and have not been effective against acne, particularly acne associated with menstruation. Despite evidence that acne associated with menstruation abnormalities naturally improves when menstruation recovers to normal, there have only been few studies on the effects of dysmenorrhea treatment on acne. Therefore- we designed this study to assess the effects of gyejibokryung-hwan (GBH) and dangguijagyag-san (DJS), which are widely used in dysmenorrhea treatment, on acne associated with menstruation cycle.

Methods

This is a protocol for a randomized, double-blind, parallel-group, placebo-controlled and multicenter trial. One hundred and sixteen participants with dysmenorrhea accompanied by acne vulgaris will be recruited at three centers and randomized into two groups, the herbal treatment group and placebo group. The participants will receive GBH or DJS based on pattern identification or placebo granules thrice daily for 8 weeks, with an 8-week follow up. The primary outcome will be the mean percentage change in the count of inflammatory acne lesions. The secondary outcomes would be based on dysmenorrhea numeric rating scale, verbal multidimensional scoring system for dysmenorrhea, acne numeric rating scale, investigator’s static global assessment scale of facial acne vulgaris, and safety testing. Adverse events will also be reported.

Discussion

The effects of GBH or DJS used in dysmenorrhea treatment on acne associated with the menstrual cycle will be evaluated. The findings of this trial will provide evidence regarding the effect of herbal medicine in improving acne vulgaris associated with menstruation in women.

Trial registration

Korean Clinical Trial Registry (http://​cris.​nih.​go.​kr; registration number: KCT0002259). Date of registration: March 10, 2017
Literature
1.
Zouboulis CC, Eady A, Philpott M, Goldsmith LA, Orfanos C, Cunliffe WC, et al. What is the pathogenesis of acne? Exp Dermatol. 2005;14(2):143–52.CrossRefPubMed
2.
Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, et al. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008;58(1):56–9.
3.
Poli F, Dreno B, Verschoore M. An epidemiological study of acne in female adults: results of a survey conducted in France. J Eur Acad Dermatol Venereol. 2001;15(6):541–5.CrossRefPubMed
4.
Yentzer BA, Hick J, Reese EL, Uhas A, Feldman SR, Balkrishnan R. Acne vulgaris in the United States: a descriptive epidemiology. Cutis. 2010;86(2):94–9.PubMed
5.
Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. The Br J Dermatol. 1997;136(1):66–70.CrossRefPubMed
6.
Preneau S, Dreno B. Female acne -a different subtype of teenager acne? J Eur Acad Dermatol Venereol. 2012;26(3):277–82.CrossRefPubMed
7.
Lucky AW. Quantitative documentation of a premenstrual flare of facial acne in adult women. Arch Dermatol. 2004;140(4):423–4.CrossRefPubMed
8.
Burton JL, Cartlidge M, Shuster S. Variations in sebum excretion during the menstrual cycle. Acta Derm Venereol. 1973;53(2):81–4.PubMed
9.
Williams M, Cunliffe WJ. Explanation for premenstrual acne. Lancet (London, England). 1973;2(7837):1055–7.CrossRef
10.
Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21(6):762–78.CrossRefPubMed
11.
Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, et al. Primary dysmenorrhea consensus guideline. J Obstet Gynaecl Can. 2005;27(12):1117–46.CrossRef
12.
Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014;89(5):341–6.PubMed
13.
Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104–13.CrossRefPubMed
14.
George R, Clarke S, Thiboutot D. Hormonal therapy for acne. Semin Cutan Med Surg. 2008;27(3):188–96.CrossRefPubMed
15.
Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, et al. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003;49(1 Suppl):S1–37.CrossRefPubMed
16.
Jung J, Lee JA, Ko MM, You S, Lee E, Choi J, et al. Gyejibongneyong-hwan, a herbal medicine for the treatment of dysmenorrhoea with uterine fibroids: a protocol for a randomized controlled trial. BMJ Open. 2016;6(11):e013440.CrossRefPubMedPubMedCentral
17.
Kotani N, Oyama T, Sakai I, Hashimoto H, Muraoka M, Ogawa Y, et al. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhea--a double-blind study. Am J Chin Med. 1997;25(2):205–12.CrossRefPubMed
18.
Lee HW, Jun JH, Kil KJ, Ko BS, Lee CH, Lee MS. Herbal medicine (Danggui Shaoyao San) for treating primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Maturitas. 2016;85:19–26.CrossRefPubMed
19.
Sun L, Liu L, Zong S, Wang Z, Zhou J, Xu Z, et al. Traditional Chinese medicine Guizhi Fuling capsule used for therapy of dysmenorrhea via attenuating uterus contraction. J Ethnopharmacol. 2016;191:273–9.CrossRefPubMed
20.
Yoshino T, Katayama K, Horiba Y, Munakata K, Yamaguchi R, Imoto S, et al. The Difference between the Two Representative Kampo Formulas for Treating Dysmenorrhea: An Observational Study. Evid Based Complement Alternat Med. 2016;2016:3159617.CrossRefPubMedPubMedCentral
21.
Rehman H, Begum W, Anjum F, Tabasum H, Zahid S. Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial. J Complement Integr Med. 2015;12(1):61–9.CrossRefPubMed
22.
Dreno B. Assessing quality of life in patients with acne vulgaris: implications for treatment. Am J Clin Dermatol. 2006;7(2):99–106.CrossRefPubMed
23.
Loney T, Standage M, Lewis S. Not just ‘skin deep’: psychosocial effects of dermatological-related social anxiety in a sample of acne patients. J Health Psychol. 2008;13(1):47–54.CrossRefPubMed
24.
Su P, Chen Wee Aw D, Lee SH, Han Sim Toh MP. Beliefs, perceptions and psychosocial impact of acne amongst Singaporean students in tertiary institutions. J Dtsch Dermatol Ges. 2015;13(3):227–33.PubMed
25.
Tanghetti EA, Kawata AK, Daniels SR, Yeomans K, Burk CT, Callender VD. Understanding the burden of adult female acne. J Clin Aesthet Dermatol. 2014;7(2):22–30.PubMedPubMedCentral
26.
Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration. J Clin Epidemiol. 2006;59(11):1134–49.CrossRefPubMed
Metadata
Title
Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial
Authors
Kwan-Il Kim
Hae Jeong Nam
Mia Kim
Junhee Lee
Kyuseok Kim
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2017
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-017-1813-1

Other articles of this Issue 1/2017

BMC Complementary Medicine and Therapies 1/2017 Go to the issue

Research article

Coarse needle surface potentiates analgesic effect elicited by acupuncture with twirling manipulation in rats with nociceptive pain

Research article

Phytomedical assessment of two Cymbopogon species found in Nkonkobe Municipality: toxicological effect on human Chang liver cell line

Research article

Urinary metabolomics study on the protective role of Orthosiphon stamineus in Streptozotocin induced diabetes mellitus in rats via 1H NMR spectroscopy

Research article

Antibacterial and antibiotic resistance modulatory activities of leaves and bark extracts of Recinodindron heudelotii (Euphorbiaceae) against multidrug-resistant Gram-negative bacteria

Research article

Bitterness and antibacterial activities of constituents from Evodia rutaecarpa

Research article

Evaluation of antioxidant, anti-inflammatory, analgesic and antipyretic activities of the stem bark of Sapindus mukorossi