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一项补充人参提取物的多种维生素复合物的双盲研究。

Double-blind study of a multivitamin complex supplemented with ginseng extract.

作者信息

Caso Marasco A, Vargas Ruiz R, Salas Villagomez A, Begoña Infante C

机构信息

Universidad Nacional Autónoma (UNAM), Mexico.

出版信息

Drugs Exp Clin Res. 1996;22(6):323-9.

PMID:9034759
Abstract

To remedy the deterioration in quality of life in large cities, the addition of ginseng root extract to a multivitamin base appears to produce a promising dietary supplement. The aim of the present study was to compare the quality-of-life parameters in subjects receiving multivitamins plus ginseng with those found in subjects receiving multivitamins alone. The study was comparative, randomized and double-blind, and it involved 625 patients of both sexes divided into two groups taking one capsule per day for 12 weeks. Group A received vitamins, minerals, trace elements and ginseng extract G115 (Pharmaton Capsules) while group B received vitamins, minerals and trace elements (multivitamin capsules) only. The resulting quality-of-life was assessed by a standardized 11-item questionnaire, validated by the Medical School of the National Autonomous University of Mexico (UNAM). Of the 625 patients recruited, 124 were excluded from the study due to lack of compliance with the treatment, so that 338 patients in group A and 163 patients in group B completed the study. By the end of the study, the 4th of the monthly assessments showed that both the group-A and the group-B treatments had induced a significant increase in the quality-of-life index, the change being 11.9 points for Pharmaton Capsules in group A which was significantly superior to the 6.4 average increase with the group-B capsules containing multivitamins alone. Group A showed significant improvement in every one of the 11 questionnaire items, whereas group B did not show significant improvement in any of these items. Significant increases in body weight and in diastolic blood pressure were recorded in the group B treated with the multivitamin alone. Adverse effects of the capsules were minimal in both groups. This study has demonstrated that Pharmaton Capsules were more effective than the multivitamin capsules alone in improving the quality-of-life in a population subjected to the stress of high physical and mental activity.

摘要

为改善大城市居民生活质量的恶化状况,在多种维生素基础上添加人参根提取物似乎能制成一种很有前景的膳食补充剂。本研究的目的是比较服用多种维生素加人参的受试者与仅服用多种维生素的受试者的生活质量参数。该研究为对照、随机和双盲研究,涉及625名男女患者,分为两组,每天服用一粒胶囊,持续12周。A组服用维生素、矿物质、微量元素和人参提取物G115(百立乐胶囊),而B组仅服用维生素、矿物质和微量元素(多种维生素胶囊)。通过一份由墨西哥国立自治大学医学院(UNAM)验证的标准化11项问卷对所得生活质量进行评估。在招募的625名患者中,有124名因未遵守治疗方案而被排除在研究之外,因此A组有338名患者和B组有163名患者完成了研究。到研究结束时,每月的第四次评估显示,A组和B组的治疗均使生活质量指数显著提高,A组的百立乐胶囊提高了11.9分,显著优于B组仅含多种维生素的胶囊平均提高的6.4分。A组在11项问卷项目中的每一项都有显著改善,而B组在这些项目中均未显示出显著改善。仅服用多种维生素治疗的B组记录到体重和舒张压显著增加。两组胶囊的不良反应均最小。本研究表明,在改善承受高身心活动压力人群的生活质量方面,百立乐胶囊比单独的多种维生素胶囊更有效。

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