Schlebusch L, Bosch B A, Polglase G, Kleinschmidt I, Pillay B J, Cassimjee M H
Department of Medically Applied Psychology, Nelson R Mandela School of Medicine, University of Natal, Durban.
S Afr Med J. 2000 Dec;90(12):1216-23.
To assess the effects of a multivitamin-mineral combination (Berocca Calmag) treatment on stress in a large sample of South Africans.
This was a multiple-dose, double-blind, placebo-controlled, double-centre study. Patients were drawn from two centres with high stress levels (Durban and Johannesburg), each study recruiting the same number of patients (150) from 1,000 adults with predetermined high stress levels. Dropouts from the study were replaced. Study medication safety was evaluated by recording adverse events. On day 1 (baseline) patients were subjected to an individual in-depth assessment that included a biographical questionnaire, four psychological scales, and collateral information from close relatives. On day 30 (end of the study period) or at the latest 7 days after the last planned medication intake, the assessment was repeated for purposes of pre- and post-response comparison.
Thirty-three patients dropped out and were replaced, leaving 300 patients who completed the study--151 in group 1 (multivitamin-mineral combination), and 149 in group 2 (placebo). There were no statistically significant differences between the two groups regarding demographics and baseline stress scores at study entry. Both groups improved between baseline and the end of treatment as assessed. The degree of improvement was statistically significant and greatest in group 1 for all psychometric instruments, with this beneficial effect increasing over the course of the day. Subgroup analyses for age (18-44 and 45-65 years), gender and ethnicity showed no general effect on the overall study outcome.
The multivitamin-mineral combination tested is well tolerated and can be used as part of a treatment programme for stress-related symptoms at the recommended dose.
评估多种维生素 - 矿物质组合（倍乐信加镁）治疗对大量南非人应激反应的影响。
这是一项多剂量、双盲、安慰剂对照、双中心研究。患者来自两个压力水平较高的中心（德班和约翰内斯堡），每项研究从1000名预先确定为高压力水平的成年人中招募相同数量的患者（150名）。研究中的退出者会被替换。通过记录不良事件来评估研究药物的安全性。在第1天（基线），患者接受了一次深入的个人评估，包括一份传记问卷、四个心理量表以及来自近亲的旁证信息。在第30天（研究期结束）或最后一次计划服药后最晚7天，为了进行反应前后的比较，重复进行评估。
33名患者退出并被替换，剩下300名完成研究的患者——第1组（多种维生素 - 矿物质组合）有151名，第2组（安慰剂）有149名。两组在研究开始时的人口统计学特征和基线应激评分方面没有统计学上的显著差异。如评估所示，两组在基线和治疗结束之间均有改善。所有心理测量工具在第1组中的改善程度具有统计学意义且最大，这种有益效果在一天中逐渐增强。按年龄（18 - 44岁和45 - 65岁）、性别和种族进行的亚组分析显示，对总体研究结果没有普遍影响。
所测试的多种维生素 - 矿物质组合耐受性良好，可作为应激相关症状治疗方案的一部分，以推荐剂量使用。
