背景:过敏性鼻炎(AR)或以打喷嚏为特征的季节性过敏,鼻塞,鼻痒,还有鼻腔分泌物,由对环境过敏原的免疫反应引发。目前的客户还监测循证天然药物/补充剂领域的个人改进。
方法:随机,双盲,安慰剂对照研究是对65名年龄在18至60岁之间的参与者进行的,这些参与者有2个或更多的过敏症状,如打喷嚏,鼻漏,鼻塞,和鼻腔瘙痒的累积时间超过每天1小时。研究参与者接受了NSO(250毫克)胶囊和2.5毫克胡椒碱(BioPerine)作为生物利用度增强剂或安慰剂,一天两次,食物后15天。通过从基线到第15天每天的总鼻部症状评分和AR症状持续时间的平均变化来评估主要目标。次要终点是总眼部症状评分的变化,AR症状频率和严重程度,血清免疫球蛋白E水平,和患者全球印象变化量表。在整个研究中监测不良事件。
结果:纳入了65例患者,所有患者都完成了研究,在NSO中N=33,在安慰剂中N=32。与安慰剂组相比,NSO组的鼻部症状总评分和眼部症状总评分显著降低,强调NSO在缓解AR症状方面的潜力。两组患者每天的AR症状发作次数和24小时内症状出现频率均在15天内显著减少,但NSO的改善程度显著高于安慰剂组.与安慰剂相比,NSO的患者总体变化印象的改善也明显更好。NSO中血清免疫球蛋白E水平降低,但与安慰剂没有显着差异。未观察到生命体征的临床显着变化,肝肾功能,血脂谱,血液学,空腹血糖,或研究结束时的尿液分析。
结论:研究结果表明,250mgNSO和2.5mg胡椒碱是治疗AR症状的有效且耐受性良好的补充剂。
BACKGROUND: Allergic rhinitis (AR) or seasonal allergy characterized by sneezing, nasal congestion, nasal itching, and nasal discharge, triggered by immune reactions to environmental allergens. Present day customers also monitor the personal improvements in the area of Evidence-Based natural medicines/supplements.
METHODS: A randomized, double-blind, placebo-controlled study was conducted on 65 participants aged 18 to 60 years having 2 or more allergic symptoms like sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day. The study participants received a capsule of NSO (250 mg) with 2.5 mg piperine (BioPerine) as a bioavailability enhancer or a placebo, twice a day, after food for 15 days. The primary objectives were evaluated by mean change in Total Nasal Symptom Score and the duration of AR symptoms per day from baseline to Day 15. Secondary endpoints were changes in Total Ocular Symptoms Score, AR symptom frequency and severity, serum Immunoglobulin E levels, and Patient Global Impression of Change scale. Adverse events were monitored throughout the study.
RESULTS: Sixty-five patients were enrolled and all of them completed the study, N = 33 in NSO and N = 32 in placebo. A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo, highlighting the potential of NSO in alleviating AR symptoms. The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo. Improvement in Patient Global Impression of Change was also significantly better in NSO compared to the placebo. Serum Immunoglobulin E levels decreased in NSO but were not significantly different from placebo. No clinically significant changes were observed in vital signs, liver and renal function, lipid profile, hematology, fasting blood sugar, or urine analysis at the end of the study.
CONCLUSIONS: The result of the study demonstrates that NSO 250 mg with 2.5 mg piperine is an effective and well-tolerated supplement for the management of AR symptoms.