The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial.

The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial.
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DOI:
10.1186/1745-6215-15-261
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发表时间:
2014-07-02
期刊:
影响因子:
2.5
通讯作者:
Chien WT
Chien WT
中科院分区:
医学4区
文献类型:
--
作者:
Chan RY;Chien WT

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过敏性鼻炎是一种慢性疾病,影响全球10%至40%的人口。治疗过敏性鼻炎的中草药在中国古代已有数千年的历史,最近引起了全球研究人员的广泛关注。本研究评估了两种中药方剂[治疗过敏性鼻炎糖浆(CS)和玉屏风散(YS)]在3个月的随访中治疗本科护理学生过敏性鼻炎的效果,并与安慰剂对照组进行了比较。本研究采用双盲、随机对照、重复测量、三平行组设计,从香港一所大学随机招募249名受试者。基线测量后,参与者被随机分配到CS、YS或安慰剂组(每组83人)。主要结局,包括症状严重程度、生活质量和体质,在基线、立即、4周干预后1个月和3个月用自我管理的问卷进行测量。240名受试者完成了试验,其中9人(3.6%)退出。广义估计方程检验和两两对比检验的结果表明,接受CS的参与者症状明显减轻(CS与安慰剂的平均差值= 26.13-34.55,P <0.0005),生活质量显著改善(CS与安慰剂的平均差值= 12.81-16.76,P <0.001),气虚、阳虚和遗传特殊体质(CS与安慰剂的平均差值= 7.05-8.12,7.56-8.92,P <0.001)。4.48 ~ 8.10, P = 0.01 ~ < 0.0005, 0.001 ~ 0.004, 0.01 ~ < 0.0005)。与安慰剂组相比,接受YS治疗的参与者在症状严重程度、生活质量和一些身体结构方面也有了显著的改善。然而,在3个月内,其效果在强度(即较小的效应量)、症状种类、身体构成和可持续性方面较小。中药复方CS对阳虚或气虚体质的年轻成人(护生)变应性鼻炎能有效减轻症状,提高生活质量。建议对中国和/或亚洲变应性鼻炎患者进行进一步的对照试验,从社会人口统计学、种族和疾病特征方面进行研究,并进行长期随访。该试验已在ClinicalTrials.gov注册,ID: NCT02027194(2014年1月3日)。
Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently raised much attention among researchers globally. This study evaluates the effects of two Chinese herbal formulae [Cure-allergic-rhinitis Syrup (CS) and Yu-ping-feng San (YS)] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up, when compared to a placebo control group. A double-blind, randomised controlled trial with repeated-measures, three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong. After baseline measurements, participants were randomly assigned to CS, YS, or placebo groups (n = 83 per group). The main outcomes, including symptom severity, quality of life, and body constitution, were measured with self-administered questionnaires at baseline and immediately, 1 and 3 months after the 4-week interventions. 240 participants completed the trial, with 9 (3.6%) drop-outs. The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms (mean difference of CS vs. placebo = 26.13–34.55, P <0.0005) and improvements in quality of life (mean difference of CS vs. placebo = 12.81–16.76, P <0.001), and body constitution in ‘Qi-deficiency’, ‘Yang-deficiency’, and ‘Inherited Special’ (mean difference of CS vs. placebo = 7.05–8.12, 7.56–8.92, and 4.48–8.10, P = 0.01– < 0.0005, 0.001–0.004, and 0.01– < 0.0005, accordingly, at three post-tests). The participants who received YS also indicated significant greater improvements in symptom severity, quality of life, and a few patterns of body constitution when compared to the placebo group. However, its effects were lesser in strength (i.e., smaller effect sizes), varieties of symptoms, and body constitution and sustainability over the 3 months. The herbal formula CS was found effective to reduce symptoms and enhance quality of life in young adults (nursing students) with allergic rhinitis in ‘Yang- and/or Qi-deficiency’ body constitution. Further controlled trials of its effects in Chinese and/or Asians with allergic rhinitis in terms of socio-demographic, ethnic and illness characteristics and a longer-term follow-up are recommended. The trial has registered at ClinicalTrials.gov with an ID: NCT02027194 (3 January 2014).
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