RESUMEN
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).
RESUMEN
OBJECTIVE: Asthma and allergic rhinitis are chronic inflammatory diseases of the conducting nasal airway. Traditional Chinese medicine has long been used for supplemental therapy of allergic diseases, especially asthma and allergic rhinitis. We previously reported the effects of a mixed herbal formula in patients with allergic rhinitis. However, the immune-modulatory mechanism underlying the effects of herbal medicine for the treatment of allergic diseases remains unclear. METHODS: We investigated the physiologic changes in dendritic cell (DC) and CD4(+) T cell activity in patients with asthma and allergic rhinitis who were treated with a mixed herbal formula composed of Xin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu- jun-zi-tang. Specifically, we set up in vitro autologous or heterologous co-culture experiments between DCs and CD4(+) T cells, and used flow cytometry and ELISA to analyze the expression of surface molecules on DCs and the release of cytokines by CD4(+) T cells. RESULTS: Expression of HLA-DR on DCs was suppressed following treatment with the mixed herbal formula. Surface expression of CD40, CD54 and CD86 on DCs was also attenuated after treatment. In autologous co-cultures, CD4(+) T cells increased their IL-10 production while decreasing TNF-α production. In heterologous co-cultures, IL-10 secretion by T cells was enhanced, while IL-12, IL-4, IL-5 and TNF-α secretion were reduced. CONCLUSION: Our mixed herbal formula attenuated the allergic reaction by modifying the physiologic function of the DC-CD4(+) T cell interaction. Further investigations are necessary to understand the mechanism of immune modification mediated by the mixed herbal formula.