Department of Internal Medicine, Clinical Hospital Dubrava, Zagreb, Croatia.
Phytother Res. 2010 Feb;24(2):175-81. doi: 10.1002/ptr.2877.
The study was designed to investigate efficacy and safety of Astragalus membranaceus (AM) in the treatment of patients with seasonal allergic rhinitis (SAR). AM is an active component in the herbal and mineral complex (HMC) registered in Croatia as a food supplement Lectranal. The study was designed as a 6-weeks, double-blind, placebo-controlled clinical trial and conducted in 48 adult patients with a moderate to severe SAR. The treatment efficacy was evaluated by the mean change in the symptom score (TSS), quality of life (QoL), specific serum IgE and IgG, nasal eosinophils, and physicians' and patients' global evaluation. Compared to placebo, HMC significantly decreased the intensity of rhinorrhea while for other primary efficacy variables the treatment groups did not differ. In contrast, investigators and patients equally judged the treatment with HMC as more efficacious. In addition, the analysis of changes from baseline inside the groups for TSS, QoL, and 4 main symptoms of SAR were strikingly in favor of the active treatment. In patients with SAR due to weed pollen allergy HMC significantly improved primary variables, reflective TSS and QoL. The study revealed a significant number of positive signals indicating the therapeutic effectiveness of the HMC in patients with SAR which should be further tested in larger, multicentre trials with more patients.
本研究旨在探讨黄芪（AM）治疗季节性过敏性鼻炎（SAR）患者的疗效和安全性。AM 是一种在克罗地亚注册为草药和矿物质复合物（HMC）的活性成分，作为食品补充剂 Lectranal。该研究设计为 6 周、双盲、安慰剂对照的临床试验，在 48 名中度至重度 SAR 成年患者中进行。通过症状评分（TSS）、生活质量（QoL）、特异性血清 IgE 和 IgG、鼻嗜酸性粒细胞以及医生和患者的整体评估来评估治疗效果。与安慰剂相比，HMC 可显著降低流涕的强度，而对于其他主要疗效变量，治疗组之间没有差异。相比之下，调查员和患者同样认为 HMC 治疗更有效。此外，对 TSS、QoL 和 SAR 的 4 个主要症状的基线内变化进行的分析明显有利于主动治疗。在杂草花粉过敏引起的 SAR 患者中，HMC 可显著改善主要变量，反映 TSS 和 QoL。该研究揭示了大量表明 HMC 对 SAR 患者治疗效果的积极信号，应该在更多患者的更大规模、多中心试验中进一步测试。
