Odesa National Medical University, Odesa, Ukraine
DOI 10.32782/2226-2008-2026-2-6
Objective of the study was to evaluate the effectiveness of a standardized Passiflora incarnata extract in reducing elevated anxiety levels in children with obesity.
Materials and Methods. A prospective, single-center, controlled study with parallel groups was conducted. A total of 56 adolescents aged 12–17 years with obesity and elevated anxiety were enrolled and allocated into the main group (n = 28) and the control group (n = 28) without randomization. Patients in the main group received a standardized Passiflora incarnata extract as part of combination therapy for 30 days. Anxiety levels were assessed using the Spielberger–Khanin scale, with separate evaluation of state and trait anxiety. Treatment effectiveness was analyzed using ROC analysis with determination of the area under the curve (AUC) and 95% confidence intervals.
Results. In the main group, a statistically significant reduction in state anxiety was observed after treatment (AUC = 0.858; 95% CI 0.739–0.937), indicating high discriminative ability of the model and a pronounced therapeutic effect. In the control group, the corresponding value was significantly lower (AUC = 0.581; 95% CI 0.442–0.712), which does not support clinically significant improvement. The effect on trait anxiety was less pronounced (AUC = 0.721; 95% CI 0.585–0.832 vs 0.523; 95% CI 0.385–0.658), consistent with its more stable nature and lower sensitivity to short-term interventions. The use of the extract was associated with reduced emotional tension, improved sleep, and was not associated with clinically significant adverse effects.
Conclusions. The standardized Passiflora incarnata extract provides a clinically significant reduction in state anxiety, demonstrates a favorable safety profile, and may be considered a reasonable adjuvant component of comprehensive therapy for psychological and emotional disorders in children with obesity.
Keywords: mental health, children, anxiety, obesity, phytotherapy.
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