title: Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a study protocol for a randomized controlled pilot trial.
abstract: BACKGROUND
  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. 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
  A 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.
  
  
  BACKGROUND
  The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0000071.
authors.affiliation: Department of Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Kyu Seok
authors.initials: KS
authors.lastname: Kim
authors.forename: Yoon-Bum
authors.initials: YB
authors.lastname: Kim
mesh_terms: D000152:Acne Vulgaris / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D015670:Acupuncture Therapy / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D003131:Combined Modality Therapy; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D010865:Pilot Projects; D056910:Republic of Korea; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004365:Drugs, Chinese Herbal; C109859:keigai-rengyo-to