Safety and efficacy of an herbal formula, Gwakhyangjeonggi-san on atopic dermatitis with gastrointestinal symptoms

Abstract

Introduction: Gwakhyangjeonggi-san (GJS) is an herbal formula with anti-inflammatory and anti-allergic properties that is broadly used to treat a wide range of diseases including gastrointestinal disorders and allergic diseases. There have been several clinical studies conducted on its effects on atopic dermatitis (AD). So far, no randomized controlled trials have been conducted. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GJS for treating patients with AD that have gastrointestinal symptoms. Methods and analysis: A randomized, double-blind, placebo-controlled, parallel-group, clinical trial has been designed to investigate the clinical efficacy and safety of GJS on patients with AD that have gastrointestinal symptoms. A total of 58 participants with AD will be recruited and randomly allocated to the GJS or placebo group in a 1:1 ratio. The participants will be administered GJS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and after 4 and 8 weeks. The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks. The secondary outcomes will include the eczema area and severity index (EASI), dermatology life quality index (DLQI), EuroQoL 5 dimensions 5 levels (EQ-5D-5L), and immunological factors. The Korean Gastrointestinal Symptom Rating Scale (KGSRS), Nepean Dyspepsia Index will also be obtained for assessing the gastrointestinal status. Discussion: The findings of this study are expected to provide evidence on the safety and effectiveness of GJS and for treating patients with AD that have gastrointestinal symptoms. Additionally, the study will explore the mechanism of GJS action via gut microbiome. This study will provide new perspectives on approaching treatment for AD. Ethics and dissemination: The study protocol was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH2019-06-002-001). Trial registration number: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004299).

Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis

“…Furthermore, the SCORAD score range was set by referring to the existing herbal medicine clinical trial for patients with AD and digestive diseases. [7,8] Considering that this is a pilot study to confirm the exploratory effect and feasibility of BJT administration, we referred to a study that targeted SCORAD scores of 15 or more and less than 50 points [7] and another study that targeted SCORAD scores of between 25 or more and 50 or lower, [8] and predefined a wide range of SCORAD score between 15 or more and up to 50 as an inclusion criterion.…”

“…Herbal medicine contains multiple active components that act on multiple targets and therefore has the potential to overcome the limitations of conventional medication with a single active constituent [24] . Accordingly, studies of herbal medicine treatment targeting AD patients with digestive symptoms are being actively conducted [7,8] …”

“…[24] Accordingly, studies of herbal medicine treatment targeting AD patients with digestive symptoms are being actively conducted. [7,8] BJT is an herbal formula that has been approved by the Korean Ministry of Food and Drug Safety and is commercially marketed for the following symptoms: weak constitution, tiredness, weakness after illness, anorexia, and night sweating. In addition, according to a systematic review of the use of BJT for the treatment of AD, there were statistically significant improvements in the oozing and crust score and the total equivalent amount of topical agents when using BJT compared to placebo.…”

“…Furthermore, corticosteroids and calcineurin inhibitors are used to temporarily relieve itching in AD, although concerns persist about side effects, such as capillary dilatation, redness, and skin atrophy [5] . Therefore, interest in herbal medicines which are derived from natural products that are relatively safe and have multi-component, multi-target, and multi-pathway characteristics is increasing, and related research is being actively conducted [6–8] …”

“…[5] Therefore, interest in herbal medicines which are derived from natural products that are relatively safe and have multi-component, multi-target, and multi-pathway characteristics is increasing, and related research is being actively conducted. [6][7][8] Experimental studies have reported the effects of Bojungikgitang (BJT; Bu Zhong Yi Qi Tang in Chinese and Hochuekkito in Japanese) on digestive aspects, such as gastric protection and intestinal motility, [9][10][11] as well as on the alleviation of dermatitisrelated symptoms and reduction of blood immunoglobulin E (IgE) levels in an AD model. [12] A clinical study demonstrated that BJT administration for 6 months in AD patients with anorexia, low fever, excessive sweating, and palpitations significantly decreased the use of topical steroids and immunomodulators than in the placebo group.…”