A randomized, double-blind, placebo-controlled study of ten-cha (Rubus suavissimus) on house dust mite allergic rhinitis

A randomized, double-blind, placebo-controlled study of ten-cha (Rubus suavissimus) on house dust mite allergic rhinitis
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十茶(Rubus suavissimus)治疗屋尘螨过敏性鼻炎的随机、双盲、安慰剂对照研究

DOI:
10.1016/j.anl.2010.11.017
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发表时间:
2011
期刊:
影响因子:
1.7
通讯作者:
et al
et al
中科院分区:
医学3区
文献类型:
--
作者:
Yonekura S;Okamoto Y;Yamasaki K;Horiguchi S;Hanazawa T;Matsune S;Kurono Y;Yamada T;et al

文献摘要

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目的Ten-Cha自理是日本治疗变应性鼻炎最常见的补充替代药物,但缺乏实际疗效的证据。本研究于2009年7月至12月在千叶大学、鹿儿岛大学、福井大学、冈山大学和日本医科大学5所医院的耳鼻咽喉科进行,旨在探讨藤茶对屋尘螨变应性鼻炎的疗效。采用随机、双盲、集中登记和分配的研究。受试者每天摄入400毫克的Ten-Cha提取物或安慰剂(每天3粒),作为食物干预。受试者的数量是在预期效果与肥大细胞稳定药物相同的情况下选择的。以鼻过敏日记为基础的症状评分和生活质量评分用于评估。结果十茶组和安慰剂组分别为47和42例。在整个干预期间,十茶组对打喷嚏、流鼻涕、鼻塞和症状积分的改善率均大于安慰剂组,且十茶组的效果随时间的推移而增加。然而,两组之间的差异并不显著。结论Ten-Cha对变应性鼻炎有一定的治疗作用,但Ten-Cha的作用有限,与安慰剂无明显差异。这些结果表明,在本研究中使用的剂量下,Ten-Cha并没有表现出与肥大细胞稳定药物相同的效果。
OBJECTIVESelf-care with Ten-Cha is the most common complementary alternative medicine for allergic rhinitis in Japan, but evidence for an actual therapeutic effect is lacking. The purpose of the study was to investigate the effect of Ten-Cha (Rubus suavissimus) on house dust mite allergic rhinitis.METHODSThe study was performed in the otolaryngology departments of 5 facilities (Chiba University, Kagoshima University, Fukui University, Okayama University, and Nippon Medical School) from July to December 2009. A randomized double-blind study was performed with central enrollment and allocation. The subjects ingested 400mg of Ten-Cha extract or placebo (3 capsules/day) daily for 4 weeks as a food intervention. The number of subjects was chosen with anticipation of an effect equivalent to that of mast cell-stabilizing drugs. A nasal allergy diary-based symptom score and a QOL score were used for evaluation.RESULTSThe Ten-Cha and placebo groups included 47 and 42 subjects, respectively. The improvement rates for sneeze, nasal discharge, nasal obstruction, and symptom scores were greater in the Ten-Cha group than in the placebo group throughout the intervention period, and the effect tended to increase with time in the Ten-Cha group. However, the differences between the groups were not significant. QOL was not significantly improved in either group.CONCLUSIONIngestion of Ten-Cha had an effect on allergic rhinitis, but the effect of Ten-Cha was limited and did not differ significantly from placebo. These results suggest that Ten-Cha does not exhibit an effect equivalent to mast cell-stabilizing drugs at the dose used in this study.