A double-blind, placebo-controlled, double-centre study of the effects of an oral multivitamin-mineral combination on stress

Objectives. To assess the effects of a multivitamin-mineral combination (Be rocca Calmag) treatment on stress in a large sample of South Africans. Method. 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 patient s (150) from 1000 adults with predetermined high stress levels. Dropouts fr om the study were replaced. Study medication safety was evaluated by record ing adverse events. On day 1 (baseline) patients were subjected to an indiv idual in-depth assessment that included a biographical questionnaire, four psychological scales, and collateral information from close relatives. On d ay 30 tend of the study period) or at the latest 7 days after the last plan ned medication intake, the assessment was repeated for purposes of pre- and post-response comparison. Results. Thirty-three patients dropped out and were replaced, leaving 300 p atients who completed the study - 151 in group I (multivitamin-mineral comb ination), and 149 in group 2 (placebo). There were no statistically signifi cant 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 anal yses for age (18 - 44 and 45 - 65 years), gender and ethnicity showed no ge neral effect on the overall study outcome. Conclusions. The multivitamin-mineral combination tested is well tolerated and can be used as part of a treatment programme for stress-related symptom s at the recommended dose.