The Efficacy and Safety of a Fixed Combination of Chinese Herbal Medicine in Chronic Urticaria: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Abstract

Background: Chronic urticaria is a bothersome skin disease, and Chinese herbal medicine (CHM) is commonly used as adjuvant therapy. This study aimed to evaluate the effectiveness and safety of the mixture of two CHM formula, Xiao-Feng-San (XFS) and Qing-Shang-Fang-Feng-Tang (QSFFT), in treating urticaria through a randomized, double-blind, placebo-controlled clinical trial.Methods: 78 participants entered the screening phase between November 2012 and August 2015. Participants were randomly and equally allocated in either CHM group (2 gm XFS and 2 gm QSFFT four times a day and 5 mg levocetirizine once daily for 28 days followed by 5 mg levocetirizine once daily alone for 28 days) or control group (placebo and 5 mg levocetirizine daily followed by 5 mg levocetirizine once daily for 28 days alone). Symptom improvement was set as the primary outcome, and the influence on sleep quality and changes in serum markers were used as secondary outcomes. Per protocol design was applied to the final analysis.Results: A total of 56 participants entered the final analysis stage. Participants in the CHM group had more prominent symptom relief on day 56 (the weekly urticaria activity score, UAS7, as 9.9 ± 9.2 vs. 15.6 ± 10.8, p = 0.038). In the CHM group, participants' symptom severity reduced progressively (trend analysis, p < 0.001) while the decreasing trend was less favored in the control group (trend analysis, p = 0.056). The life quality improved gradually in both groups, while the differences between CHM and control groups were statistically insignificant. For urticaria-related cytokines, interferon-γ seemed to decrease positively in the CHM group (about 30.8% reduction from baseline, trend analysis p = 0.013). For safety issue, the CHM prescription was well-tolerated with no noticeable long-term side effects when compared to the control group. At 6-month follow-up of symptom changes after the end of the trial, the CHM group participants reported positive results in no recurrence or ≥50% improvement (36.3% in CHM group vs. 20% in Control group, p = 0.103).Conclusions: The combination of XFS and QSFFT tended to be feasible and tolerable adjuvant therapy for urticaria in addition to standard therapy. However, larger study population with longer follow-up duration may be still needed.Trial registration: NCT01715740 (ClinicalTrials.gov).

Natural history, prognostic factors and patient perceived response to treatment in chronic spontaneous urticaria

“…Unfortunately, for patients that trial alternative medicine, their reported response rates are even lower with only 20-29% of patients reporting benefit in our study. This would be consistent with the inconclusive studies in acupuncture and traditional Chinese medicine [19][20][21][22][23]. Although, 21% of our patients reported visiting a naturopath, we could not find any studies in the literature that have studied the use of and effectiveness of naturopathic therapies in the treatment of CSU.…”

“…There has been some studies that looked at acupuncture for global symptom improvement when used in conjunction with pharmacologic therapy however a recently published meta-analysis showed there is overall a low level of evidence for its use [19]. There has also been a few randomized trials that have looked at the use of traditional Chinese medicine as an adjunct to traditional pharmacologic therapy in CSU with varying results [20][21][22][23]. However, to our knowledge, there has not been any studies that have evaluated patient uptake of these alternative medicine practices and their perceived benefit.…”

Cimifugin ameliorates imiquimod-induced psoriasis by inhibiting oxidative stress and inflammation via NF-κB/MAPK pathway

“…The dry root of Saposhikovia divaricata, also called 'Fang-Feng' , is a traditional Chinese herb that has anti-inflammatory and anti-allergic properties and is widely used as a drug in rheumatism, urticaria, and skin pruritus [9,10]. It is found that chromones are the major active ingredients in 'Fang-Feng' , consisting of Prim-oglucosylcimifugin and cimifugin [11][12][13].…”

Quantitative Analysis of 18 Marker Components in the Traditional Korean Medicine, Cheongsangbangpung-Tang, Using High-Performance Liquid Chromatography Combined with Photodiode Array Detector

“…Recently, Yang et al [8] conducted and reported a pilot study on the effectiveness and safety of chronic urticarial in combination with Xiao-Feng-San and Qing-Shang-Fang-Feng-Tang.…”

“…In this study, a simultaneous quantitative analysis method was developed using 18 selected marker analytes for the quality evaluation of CSBPT based on HPLC separation combined with photodiode array detection (PDA). The selected components were prim-O-glucosylcimifugin (3) and 5-O-methylvisammioside (9) from Saposhnikoviae Radix, oxypeucedanin hydrate (13) from Angelicae Dahuricae, arctigenin (11) and arctiin (16) from Forsythiae Fructus, baicalin (12), wogonoside (14), and baicalein (15) from Scutellariae Radix, ferulic acid (7) from Cnidii Rhizoma, pulegone (18) from Schizomepetae Spica, geniposide (1) from Gardeniae Fructus, coptisine chloride (2) and berberine chloride (4) from Coptidis Rhizoma, narirutin (8) and hesperidin (10) from Aurantii Fructus Immaturus, and liquiritin apioside (5), liquiritin (6), and glycyrrhizin (17) from Glycyrrhizae Radix et Rhizoma.…”