Abstract
BackgroundIn consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE), and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial.Methods/DesignA randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL), KRTE only group (KO), acupuncture only group (AO), and KRTE and acupuncture combined treatment group (KA). After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS) and investigator global assessment (IGA) from baseline to the end of the trial.Trial RegistrationThe trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0000071.
Highlights
In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested
Acne vulgaris is a common skin disease encountered in dermatology practice; it is caused by changes in pilosebaceous units [1,2]
Through the menstrual cycle, can be affected by the level of sex hormones, such as estrogen and androgen, relevant to increased sebum production, which play a central role in development of acne; we will restrict the participants to male patients with acne vulgaris [2,29]
Summary
Acne vulgaris is a common skin disease encountered in dermatology practice; it is caused by changes in pilosebaceous units [1,2]. Acne vulgaris is a chronic dermatosis of the pilosebaceous follicle with four fundamental etiopathogenic factors: sebaceous hyperproduction, follicular hyperkeratinization, Despite this treatment for care of acne vulgaris, a substantial number of acne patients widely seek to use traditional Chinese medicine (TCM) due to a lack of response to western medical treatment [10] and their concern regarding side effects, such as burning, erythema, desquamation, pigmentation, xerosis, and chapped lips, among others [11,12,13,14,15]. Despite common use of a combination of herbal medicine and acupuncture in clinical practice, these studies have rarely demonstrated an interaction between herbal medicine and acupuncture, and have rarely used a waiting list- or western medical treatment group as a control group Considering these methodological flaws, we will conduct a trial to assess the interaction effect and efficacy of Keigai-rengyo-to extract (KRTE) and acupuncture using the 2 × 2 factorial design and the feasibility of a large clinical trial. Through the menstrual cycle, can be affected by the level of sex hormones, such as estrogen and androgen, relevant to increased sebum production, which play a central role in development of acne; we will restrict the participants to male patients with acne vulgaris [2,29]
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