Emberlin J C, Lewis R A
National Pollen and Aerobiology Research Unit, Institute of Health, University of Worcester, Worcester, WR2 6AJ, UK.
Curr Med Res Opin. 2006 Feb;22(2):275-85. doi: 10.1185/030079906X80440.
An inert cellulose powder has been on sale in the UK since 1994 as a remedy for hay fever but no scientific trials have been conducted previously. It is applied to the inside of the nose where it forms a gelatinous coating. The principal aim was to determine if there is a significant difference in the amount and type of rescue medication required for adult hay fever sufferers to control their symptoms while using either the inert cellulose powder or a placebo. The second objective was to see whether the cellulose powder resulted in an improvement in symptom control.
A double blind, placebo controlled study was conducted of 97 adult hay fever sufferers, over the grass pollen season of 2004. Participants (selectively recruited to be living within the catchment area of a 50-km radius from Worcester, UK) were assigned randomly to two groups (A, Active and B, Placebo) matched by age by decades and gender. Of those completing the trial, group A had 19 males and 28 females and group B had 21 males and 29 females. There were no significant differences between the groups in age distributions, severity of symptoms over the last 2 years or in medication taken. They completed daily symptom diary score cards and were allowed to take any medications they wished in addition to the inert cellulose powder or placebo because medication use was taken as an outcome measure. Results were analysed in relation to pollen counts.
Significant differences were found in the amounts of rescue medication taken by the active and placebo groups (p < 0.05). More people in the placebo group took rescue treatments than those in the active group. No significant differences were found (p < 0.01) between the active and placebo groups in Likert scores for any of the rhinitis nasal symptoms or in the total Likert symptom daily scores. No adverse events were reported during the study.
The amount of rescue medication taken by the placebo group was significantly more than that taken by the active group both overall, considering all types of medication, and also in the individual cases of antihistamines, nasal sprays and eye drops. These results provide evidence that the inert cellulose powder reduces the need to take rescue medication for the symptoms of hay fever.
自1994年以来,一种惰性纤维素粉末在英国作为治疗花粉热的药物出售,但此前尚未进行过科学试验。它被应用于鼻腔内部,在那里形成一层凝胶状涂层。主要目的是确定成年花粉热患者在使用惰性纤维素粉末或安慰剂时,控制症状所需的急救药物的数量和类型是否存在显著差异。第二个目的是观察纤维素粉末是否能改善症状控制情况。
在2004年的草花粉季节,对97名成年花粉热患者进行了一项双盲、安慰剂对照研究。参与者(通过选择性招募,居住在英国伍斯特半径50公里范围内的集水区)按年龄每十年和性别随机分为两组(A组,活性组;B组,安慰剂组)。在完成试验的人中,A组有19名男性和28名女性,B组有21名男性和29名女性。两组在年龄分布、过去两年症状的严重程度或所服用药物方面没有显著差异。他们填写每日症状日记评分卡,除了惰性纤维素粉末或安慰剂外,还可以服用任何他们希望服用的药物,因为药物使用情况被作为一项结果指标。结果根据花粉计数进行分析。
活性组和安慰剂组服用的急救药物数量存在显著差异(p<0.05)。安慰剂组中服用急救治疗的人数比活性组多。活性组和安慰剂组在任何鼻炎鼻腔症状的李克特评分或每日李克特症状总分方面均未发现显著差异(p<0.01)。研究期间未报告不良事件。
无论是考虑所有类型的药物,还是在抗组胺药、鼻喷雾剂和眼药水的个别案例中,安慰剂组服用的急救药物数量均显著多于活性组。这些结果提供了证据,表明惰性纤维素粉末可减少因花粉热症状而服用急救药物的需求。