Safety and efficacy of Galgeun-tang-ga-cheongung-sinyi, a herbal formula, for the treatment of chronic rhinosinusitis

Abstract

Introduction:A herbal formula, Galgeun-tang-ga-cheongung-sinyi (GGTCS), is traditionally used for the treatment of rhinosinusitis in East Asian countries. However, there is a dearth of clinical evidence supporting the effects of this medication. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GGTCS for the treatment of chronic rhinosinusitis (CRS).Methods and analysis:To investigate the clinical efficacy and safety of GGTCS for the treatment of CRS, a randomized, double-blind, placebo-controlled, parallel group, clinical trial has been designed. A total of 58 participants with CRS will be recruited and randomly allocated to a GGTCS or placebo group in a 1:1 ratio. The participants will be administered GGTCS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and at 1, 2, 4, and 8 weeks after random allocation. The primary outcome measure will be the mean change in the Sino-Nasal Outcome Test-22 score from baseline to 8 weeks. The secondary outcomes will include the Total Nasal Symptom Score, EuroQoL 5 Dimensions 5 Levels score, Nasal Endoscopy Index, Lund-Mackay score, and total serum immunoglobulin E level.Discussion:The key elements for conducting a high-quality randomized clinical trial have been addressed in this protocol. In summary, the findings of this study are expected to provide a base for large-scale randomized controlled trials to confirm the safety and efficacy of GGTCS for the treatment of CRS and may consequently serve to improve future treatment strategies for this condition.Trial registration: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0002835).

Chinese herbal medicine for the treatment of chronic rhinosinusitis: protocol for a systematic review and meta-analysis

“…Hormones, sterols and other drugs are commonly used in the treatment of CRS, which are criticized for their obvious side effects [14]. In order to optimize the current treatment plan and means, we need to nd more effective treatment drugs or alternative complementary therapy.In a systematic review of four randomized controlled trials, no serious reactions occurred during the treatment of CRS with herbal medicine, but further certi cation is needed due to the quality and quantity limitations of inclusion [15].Traditional Chinese medicine has obvious effect on cytokines, especially in improving in ammatory response, enhancing immune function, promoting cilia activation and regulating tissue remodeling, which can reduce congestion and edema of nasal mucosa, promote the transmission of mucosal cilia, and restore the physiological function of nasal mucosa [16].It has been studied that BiYuanshu Oral Liquid can reduce the content of COX-2 and MMP-2 in the nasal mucosa, inhibit the chronic in ammatory response of CRS, and thus have repair function and anti-in ammatory effect on the local nasal mucosa [17].It also has a certain role in reducing postoperative mucosal edema and promoting the recovery of postoperative mucosal in ammation [18].…”

Herbal medicine for the treatment of chronic rhinosinusitis: A systematic review and meta-analysis

“…According to reports, the prevalence of CRS in the general population is about 5–12% ( Fokkens et al, 2020 ). CRS is associated with severe morbidity and poor health-related quality of life, and diagnosis places an enormous burden on healthcare services ( Mahboubi, 2018 ; Son et al, 2018 ; Dietz de Loos et al, 2019 ). In the United States, the total direct costs associated with CRS range from $10 to $13 billion per year, and the total indirect costs due to reduced labor productivity are estimated to exceed $20 billion per year ( Rudmik, 2017 ).…”

“…Given that it is recommended to include databases of traditional medicine when searching for studies of EATM modalities, such as HM or acupuncture, a systematic review on this topic needs to be further strengthened ( Wang et al, 2019 ). Furthermore, many randomized controlled trials (RCTs) have since been published on the effects of various HM treatments ( Son et al, 2018 ). Previous reviews have insufficiently addressed clinical heterogeneity in patients with CRS.…”

Clinical Evaluation of Acetaminophen–Galgeuntang Interaction Based on Population Approaches

“…As a result of its anti-inflammatory, anti-pyretic, analgesic [2], antioxidant [3], and anti-influenza virus [4] activities, GGT has been used to treat the common cold. In addition, GGT has been reported to modulate atopic dermatitis [5] and chronic rhinosinusitis [6]. GGT is frequently co-administered with Tylenol (acetaminophen) to treat the common cold in East Asia.…”