Effect of Biodegradable Microneedle Acupuncture in Mild to Moderate Atopic Dermatitis: a single-blinded randomized controlled pilot trial.

IF 1.2 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Soo-Yeon Park, Ji-Hoon Song, Nguyen Cong Duc, Gihyun Lee
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Abstract

Objectives: The need for alternative therapies for atopic dermatitis (AD) has emerged due to the side effects of conventional therapies. Biodegradable microneedle acupuncture (BMA) is a novel medical device that overcame the shortcomings of traditional intradermal acupuncture (IDA), such as foreign body feeling and allergic dermatitis. This study aimed to evaluate the efficacy and safety of BMA for patients with Mild to Moderate AD compared with the IDA.

Methods: An assessor-blinded, parallel, non-superiority, randomized controlled pilot trial was conducted. Thirty adult participants were recruited from a single hospital and were equally divided into the experimental or control group. They were treated with BMA or IDA on both sides of LI11, ST36, and PC6 for four hours. Over four weeks, both interventions were performed eight times in total. The primary endpoint was the objective scoring AD (O-SCORAD) index. The secondary endpoints were visual analog scale (VAS) for itch and sleep disturbance, dermatology life quality index (DLQI), skin hydration, and transepidermal water loss (TEWL).

Results: Enrolled thirty participants completed the trial. After the trial, all endpoints remarkably improved compared with the baseline in both groups, except for the TEWL. Between the two interventions, there were no remarkable differences in the fourth week, except for the VAS score for itch and DLQI. No serious adverse events occurred during the study period.

Conclusion: Both BMA and IDA were effective in improving Mild to Moderate AD, and they were safe. BMA can be an alternative to conventional acupuncture for patients with sensitive skin, including metal allergies.

可生物降解微针治疗轻至中度特应性皮炎的疗效:一项单盲随机对照试验。
目的:由于常规治疗的副作用,特应性皮炎(AD)的替代疗法的需求已经出现。生物可降解微针(BMA)是一种新型的医疗器械,克服了传统皮内针刺(IDA)的异物感和过敏性皮炎等缺点。本研究旨在评价BMA与IDA对轻度至中度AD患者的疗效和安全性。方法:采用评估盲法、平行、非优势、随机对照试验。研究人员从一家医院招募了30名成年参与者,将他们平均分为实验组和对照组。分别在LI11、ST36和PC6两侧应用BMA或IDA治疗4小时。在四周的时间里,两种干预总共进行了八次。主要终点为客观评分AD (O-SCORAD)指数。次要终点是瘙痒和睡眠障碍的视觉模拟量表(VAS)、皮肤病生活质量指数(DLQI)、皮肤水化和经皮失水(TEWL)。结果:30名受试者完成了试验。试验结束后,除TEWL外,两组的所有终点均较基线显著改善。除了瘙痒和DLQI的VAS评分外,两种干预措施在第四周无显著差异。研究期间未发生严重不良事件。结论:BMA和IDA治疗轻中度AD均有效且安全。对于包括金属过敏在内的敏感皮肤患者,BMA可以替代传统针灸。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pharmacopuncture
Journal of Pharmacopuncture INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
2.10
自引率
7.10%
发文量
42
审稿时长
10 weeks
期刊介绍: The Journal of Pharmacopuncture covers a wide range of basic and clinical science research relevant to all aspects of the biotechnology of integrated approaches using both pharmacology and acupuncture therapeutics, including research involving pharmacology, acupuncture studies and pharmacopuncture studies. The subjects are mainly divided into three categories: pharmacology (applied phytomedicine, plant sciences, pharmacology, toxicology, medicinal plants, traditional medicines, herbal medicine, Sasang constitutional medicine, herbal formulae, foods, agricultural technologies, naturopathy, etc.), acupuncture (acupressure, electroacupuncture, laser acupuncture, moxibustion, cupping, etc.), and pharmacopuncture (aqua-acupuncture, meridian pharmacopuncture, eight-principles pharmacopuncture, animal-based pharmacopuncture, mountain ginseng pharmacopuncture, bee venom therapy, needle embedding therapy, implant therapy, etc.). Other categories include chuna treatment, veterinary acupuncture and related animal studies, alternative medicines for treating cancer and cancer-related symptoms, etc. Broader topical coverage on the effects of acupuncture, the medical plants used in traditional and alternative medicine, pharmacological action and other related modalities, such as anthroposophy, homeopathy, ayurveda, bioelectromagnetic therapy, chiropractic, neural therapy and meditation, can be considered to be within the journal’s scope if based on acupoints and meridians. Submissions of original articles, review articles, systematic reviews, case reports, brief reports, opinions, commentaries, medical lectures, letters to the editor, photo-essays, technical notes, and book reviews are encouraged. Providing free access to the full text of all current and archived articles on its website (www.journal.ac), also searchable through a Google Scholar search.
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