治疗痛经的草药对伴发寻常痤疮的影响：一项随机对照试验的研究方案
Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial.
作者信息
Kim Kwan-Il, Nam Hae Jeong, Kim Mia, Lee Junhee, Kim Kyuseok
机构信息
Department of Clinical Korean Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
出版信息
BMC Complement Altern Med. 2017 Jun 17;17(1):318. doi: 10.1186/s12906-017-1813-1.
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.
背景
青春期前女性痤疮的发病率正在上升。痤疮会降低生活质量；传统治疗方法有限，且对痤疮尤其是与月经相关的痤疮效果不佳。尽管有证据表明，月经异常相关的痤疮在月经恢复正常后会自然改善，但关于痛经治疗对痤疮影响的研究却很少。因此，我们设计了本研究，以评估广泛用于治疗痛经的桂皮茯苓丸（GBH）和当归芍药散（DJS）对与月经周期相关的痤疮的影响。
方法
这是一项随机、双盲、平行组、安慰剂对照的多中心试验方案。将在三个中心招募116名伴有寻常痤疮的痛经患者，并随机分为两组，即草药治疗组和安慰剂组。参与者将根据辨证接受GBH或DJS，或安慰剂颗粒，每日三次，持续8周，并进行8周的随访。主要结局将是炎性痤疮皮损计数的平均百分比变化。次要结局将基于痛经数字评定量表、痛经言语多维评分系统、痤疮数字评定量表、研究者对面部寻常痤疮的静态整体评估量表以及安全性检测。不良事件也将被报告。
讨论
将评估用于治疗痛经的GBH或DJS对与月经周期相关的痤疮的影响。本试验的结果将为草药改善女性月经相关寻常痤疮的效果提供证据。
试验注册
韩国临床试验注册中心（http://cris.nih.go.kr；注册号：KCT0002259）。注册日期：2017年3月10日。
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