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[植物提取物-维生素组合对流感样感染的减少作用:一项随机、双盲、安慰剂对照研究]

[Reduction of influenza-like infections by a phytoextract-vitamin-combination: a randomized, double-blind, placebo-controlled study].

作者信息

Rösler D, Fuchs N, Markolin G, Edler B, Kuklinski B, Kästenbauer T

机构信息

Institut für Nährstofftherapie Lungau, Unternberg/Osterreich.

出版信息

MMW Fortschr Med. 2012 Dec 17;154 Suppl 4:115-22.

Abstract

BACKGROUND

Recurrent infections are signs of a weakened immune system, and can be traced to a lack of vitamins and minerals. The objective of this study was to investigate the effect of a nutriological combination of vitamins, trace elements and phytochemicals on the incidence and duration of influenza-like infections.

METHODS

Healthy subjects at risk of increased infection exposure took part in a randomized, double-blind, placebo controlled study, each involving a supplementation period of 12 weeks. The occurrence and severity of influenza-like infections and resort to study medication was documented by diary entries. SF-36 questionnaires to measure the health-related quality of life were completed at the start and end of the study. At final examination compliance was examined with respect to returned study medication, diaries and a questionnaire administered to evaluate the effect, safety, and tolerability of the test substance.

RESULTS

Of 100 randomized participants, 80 (38 test treatment and 42 placebo) completed the study according to the protocol. In the test treatment group there were 60 influenza-like infections (1.6 infections/12 weeks), significantly fewer (p = 0.0003) compared with the placebo group with 113 episodes (2.7 infections/12 weeks). Further, the average number of days that the infection lasted was shorter in the test treatment group at 10.0 +/- 6.7 days, which was significantly shorter (p = 0.0003) than the placebo group at 28.5 +/- 13.6 days. The influenza-like symptom score and the mean duration of sick leave did not differ statistically between groups. Participants in the test treatment group assessed the global effectiveness of the test substance significantly better (p < 0.0001) than the participants of the placebo group. At the beginning of the study there was no difference between groups with respect to SF-36 results. However, at the completion of the study 6 of the 8 scales of SF-36 in the test treatment group were significantly better compared with the placebo group.

CONCLUSION

In summary, consumption of the complex nutriological test preparation was associated with a significant reduction in the incidence of influenza-like infections, as well as their duration, and it was associated with significantly improved vitality, social functioning, and psychological well-being.

摘要

背景

反复感染是免疫系统减弱的迹象,且可追溯至维生素和矿物质的缺乏。本研究的目的是调查维生素、微量元素和植物化学物质的营养组合对类流感感染的发生率和持续时间的影响。

方法

有感染风险增加的健康受试者参与了一项随机、双盲、安慰剂对照研究,每项研究都有一个为期12周的补充期。通过日记记录类流感感染的发生情况、严重程度以及使用研究药物的情况。在研究开始和结束时完成SF-36问卷以测量与健康相关的生活质量。在最终检查时,根据归还的研究药物、日记以及用于评估受试物质的效果、安全性和耐受性的问卷来检查依从性。

结果

100名随机参与者中,80名(38名试验治疗组和42名安慰剂组)按照方案完成了研究。试验治疗组有60例类流感感染(1.6次感染/12周),与安慰剂组的113例发作(2.7次感染/12周)相比显著更少(p = 0.0003)。此外,试验治疗组感染持续的平均天数为10.0±6.7天,明显短于安慰剂组的28.5±13.6天(p = 0.0003)。类流感症状评分和病假的平均持续时间在两组之间无统计学差异。试验治疗组的参与者对受试物质总体有效性的评价明显优于安慰剂组的参与者(p < 0.0001)。在研究开始时,两组在SF-36结果方面没有差异。然而,在研究结束时,试验治疗组SF-36的8个量表中有6个与安慰剂组相比明显更好。

结论

总之,食用复合营养测试制剂与类流感感染的发生率及其持续时间的显著降低相关,并且与活力、社会功能和心理健康的显著改善相关。

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