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 (Berocca 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 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.
RESULTS: 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.
CONCLUSIONS: 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.

RCT Entities:   Population Interventions Outcomes