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Objectives: The objectives of this study were to evaluate the efficacy and interaction of Keigai-rengyo-to extract (KRTE) and acupuncture in male patients with acne and the feasibility of a large clinical trial., Design: A randomized, assessor single-blinded, 2×2 factorial trial was conducted. The trial is registered with the Clinical Research Information Service, Republic of Korea: KCT0000071., Subjects: Forty-four (44) participants with acne vulgaris were 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)., Intervention: After randomization, patients in the AO and KA groups underwent eight sessions of acupuncture treatment, twice per week. Patients in the KO and KA groups were prescribed KRTE 3 times daily, 7.4 g each dose, after meals, for 4 weeks., Outcome Measures: The following outcome measurements were used in examination of subjects: mean percentage change and the count change of inflammatory and noninflammatory acne lesions, Skindex 29, investigator global assessment from baseline to end of trial, and proportion of dropouts and compliance with KRTE., Results: A significant interaction of KRTE and acupuncture was evident according to mean percent change of inflammatory acne lesions, but not of noninflammatory acne lesions from baseline to the end of the study. Statistically significant differences were observed in the primary effect on mean percent change of noninflammatory acne lesions, not by acupuncture, but by KRTE. Adjusted Skindex 29 score changes indicated no statistically significant reduction within groups and between groups. The improvement rate in patients with KRTE and acupuncture treatment was not significant, compared to patients with no KRTE and acupuncture treatment. The proportion of dropouts was 22.7% and rate of compliance with KRTE was 92.3%., Conclusions: For treatment of acne vulgaris, use of KRTE combined with acupuncture is recommended for inflammatory lesions and KRTE only is recommended for noninflammatory lesions. Further large-scale trials assuming a higher dropout rate and aimed at confirming the ability of KRTE and acupuncture to improve inflammatory and noninflammatory lesions in patients with acne are needed.

Endoscopic biliary stent insertion has been widely used for the treatment of benign biliary stricture (BBS). Thus, the development of stent materials in the perspectives of structure, mechanical properties, and biocompatibility has been also studied. However, conventional metal and plastic stents have several disadvantages, such as repeated procedures to remove or exchange them, dislodgment, restenosis, biocompatibility, and poor mechanical properties. Sustainable effectiveness, attenuation and prevention of fibrosis, and biocompatibility are key factors for the clinical application of stents to BBS treatment. In addition, loading drugs could show synergistic effects with stents' own performance. We developed a dexamethasone-eluting biodegradable stent (DBS) consisting of a sheath/core structure with outstanding mechanical properties and sustained release of dexamethasone, which maintained its functions in a BBS duct over 12 weeks in a swine model. The insertion of our DBS not only expanded BBS areas but also healed secondary ulcers as a result of the attenuation of fibrosis. After 16 weeks from the insertion, BBS areas were totally improved, and the DBS was degraded and thoroughly disappeared without re-intervention for stent removal. Our DBS would be an effective clinical tool for non-vascular diseases. This study describes the insertion of a drug-eluting biodegradable stent (DBS) into the bile duct. The sheath/core structure of DBS confers substantial durability and a sustained drug release profile. Drug released from the DBS exhibited anti-fibrotic effects without inflammatory responses in both in vitro and in vivo experiments. The DBS maintained its function over 12 weeks after insertion into the common bile duct, expanding benign biliary stricture (BBS) and reducing inflammation to heal secondary ulcers in a swine BBS model. After 16 weeks from the DBS insertion, the DBS thoroughly disappeared without re-intervention for stent removal, resulting in totally improved BBS areas. Our findings not only spotlight the understanding of the sheath/core structure of the biodegradable stent, but also pave the way for the further application for non-vascular diseases. [Display omitted] [ABSTRACT FROM AUTHOR]