Efficacy of a standardized echinacea preparation (Echinilin™) for the treatment of the common cold:: a randomized, double-blind, placebo-controlled trial
Efficacy of a standardized echinacea preparation (Echinilin™) for the treatment of the common cold:: a randomized, double-blind, placebo-controlled trial
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DOI：
10.1111/j.1365-2710.2003.00542.x
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发表时间：
2004-02-01
影响因子：
2
通讯作者：
Basu, TK
中科院分区：
文献类型：
--
作者：
Goel, V;Lovlin, R;Basu, TK
背景：最近，紫锥菊重新成为消费者最常选择的治疗方法之一，他们希望它能减轻普通感冒的严重程度和持续时间。然而，到目前为止，这种应用的有限数量的临床试验的结果还不确定。这种不一致可能是研究人员使用标准化程度较低的紫锥菊产品的结果，这些产品可能缺乏发挥明确临床效果所需的足够数量的活性成分。因此，从新鲜收获的紫锥菊植物(可从加拿大温哥华BC的Echinlin自然因素营养产品公司购买)中分别制备了含有浓度分别为0.25、2.5和25 mg/mL的烷酰胺、菊花酸和多糖的配方。这项研究的目的是测试这种高度标准化的配方在减少自然获得的普通感冒症状严重程度和持续时间方面的有效性。方法：在一项随机、双盲、安慰剂对照试验中，282名年龄在18-65岁之间、前一年有两次或两次以上感冒病史但其他方面健康状况良好的受试者被招募。受试者随机接受紫锥菊或安慰剂治疗。他们被指示在与感冒有关的第一个症状出现时开始服用紫锥菊或安慰剂，第一天服用10剂，随后几天每天服用4剂，连续7天。每天记录症状的严重程度(10分制：0，最小；9，最大)和剂量。一名护士在感冒第3天和第8天的早上对受试者进行检查。结果：共有128名受试者患上普通感冒(59例紫锥菊，69例安慰剂)。在那些遵循所有研究方案的人中，紫锥菊组的每日总症状评分比安慰剂组低23.1%(P
Background: Recently, echinacea has regained popularity as one of the treatments chosen most commonly by consumers with the expectation that it will reduce the severity and duration of the common cold. However, the results from a limited number of clinical trials for this application have thus far been inconclusive. This incongruity may be the result of investigators utilizing poorly standardized echinacea products, likely devoid of sufficient quantities of active constituents necessary to exert a definitive clinical effect. Therefore, a formulation containing alkamides, cichoric acid, and polysaccharides at concentrations of 0.25, 2.5, and 25 mg/mL, respectively, was prepared from freshly harvested Echinacea purpurea plants (commercially available as Echinilin, Natural Factors Nutritional Products, Inc., Vancouver, BC, Canada). The objective of this study was to test the efficacy of this highly standardized formulation in reducing the severity and duration of symptoms of a naturally acquired common cold.Methods: In a randomized, double-blind, placebo-controlled trial, 282 subjects aged 18-65 years with a history of two or more colds in the previous year, but otherwise in good health, were recruited. The subjects were randomized to receive either echinacea or placebo. They were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for 7 days. Severity of symptoms (10-point scale: 0, minimum; 9, maximum) and dosing were recorded daily. A nurse examined the subjects on the mornings of days 3 and 8 of their cold.Results: A total of 128 subjects contracted a common cold (59 echinacea, 69 placebo). The total daily symptom scores were found to be 23.1% lower in the echinacea group than in placebo in those who followed all elements of the study protocol (P