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).