Efficacy and safety of (Physta) water extract plus multivitamins on quality of life, mood and stress: a randomized placebo-controlled and parallel study.

BACKGROUND

The use of alternative and complementary medicines to alleviate stress has increased to avoid the negative effects of pharmaceutical drugs.

OBJECTIVE

This study investigated the safety and efficacy of in combination with multivitamins (EL+MV) versus placebo on improving quality of life (QoL), mood and stress in moderately stressed healthy participants.

METHODS

This randomised, double-blind, placebo-controlled 24-week study enrolled 93 participants aged 25-65 years, with a body mass index of 18-30 kg/m, scoring ≤18 in tension and ≤14 in fatigue subscale of Profiles of Mood Scores (POMS) questionnaire and supplemented with EL+MV or placebo. The primary endpoints were QoL measured by 12-Item Short Form Health Survey (SF-12) questionnaire and mood measured by POMS. The secondary endpoint was stress measured by Multi-Modal Stress Questionnaire (MMSQ). The safety of the intervention product was measured by complete metabolic panel, lipid and renal analysis including several immune parameters.

RESULTS

While there were no significant between-group differences, within-group improvements were observed in the SF-12 QoL, POMS and MMSQ domains. In the SF-12 domain, improvements were seen in role limitation due to emotional health ( = 0.05), mental component domain ( < 0.001), emotional well-being ( < 0.001), social functioning ( = 0.002) as well as vitality ( = 0.001) at week 12. An increasing trend in POMS-vigour domain was also observed in the EL+MV group at week 12. A 15% decrease in physical stress domain ( < 0.05) compared with 0.7% in the placebo group was also observed in MMSQ. When the subjects were subgrouped according to age, 25-45 and 46-65 years of age, for primary outcomes, between-group significance was observed in the 25-45 year group in the social functioning domain of SF-12 ( = 0.021) and POMS-vigour ( = 0.036) in the 46-65 year group. No significant changes were observed in vital signs and complete metabolic panel. Regarding immune parameters, the lymphocytes increased significantly in the active group (≤0.05). In total, 13 adverse events were reported: six on placebo and seven on EL+MV.

CONCLUSION

EL+MV may support the QoL, mood, stress and immune parameters in healthy participants.

TRIAL REGISTRATION

This study has been registered at clinicaltrials.gov (NCT02865863).