Effects of the single supplementation and multiple doses of Passiflora incarnata L. on human anxiety: A Clinical Trial, Double-blind, Placebo-controlled, Randomized

Abstract

Object: This study aimed to investigate the effects of Passiflora incarnata L. on anxiety in humans. Method:The individuals were randomly assigned to one of the following groups: Placebo or experimental, n =30, single dose, as well as Placebo or Experimental, n =15, multiple dose. The experimental human anxiety was induced by simulated public speaking test in the following phases: Basal (B), stressful (A), speech 1 (S1), speech 2 (S2) and Final (F). We evaluated the Systolic Blood Pressure (SBP), and Diastolic (DBP), Heart Rate (HR), Electrical Conductance of Skin and extremities temperature (ET) and filled The state-trait anxiety inventory (STAI S e T).Results: During the single dose, the HR was reduced at the end of the speech (86±2.0 to 74±3.0 bpm) the experimental group compared to the placebo group (p<0.05); the STAI-S did not change. In the delineation of multiple doses, SBP was reduced, in mmHg, in the experimental group compared to the placebo group during all phases. Experimental: 106±1.0 (B), 111±1.0 (A), 121±2.0 (S1), 115±3 (S2), 104±2.0 (F) IntroductionAnxiety disorders reach over 25% prevalence, including the fear of public speaking [1]. Anxiety comprises emotional and behavioral factors through fear manifestation, insecurity, apprehensive anticipation, catastrophic thinking, increase in wakefulness or alert period and physiological, as activation of the hypothalamic-pituitary-adrenal (HPA) axis, leading neurovegetative symptoms such as insomnia, tachycardia, pallor, increased perspiration, muscle tension, trembling, dizziness, intestinal disorders, among others [2].The impact of anxiety on the individuals's health covers changes in blood pressure, heart rate and an increased risk of cardiovascular diseases such as coronary heart disease (risk tripled) and cerebrovascular [3].Therefore, researchers have invested in as natural forms taken to treat or ameliorate the symptoms of anxiety, such as the use of herbs. Plants that are most studied with anxiolytic potential are Kawa, the St. John's Wort and Passiflora spp. [4][5][6][7]. The Passiflora extract has been used in many researches, presenting in their chemical constitution polyphenols, polyunsaturated fatty acids, fiber and other substances, such as passiflorin, one indole alkaloid, being the last one associated with anxiolytic effects [3].The effects of Passiflora incarnata L on anxiety was previously assessed in animals [8,4] and in humans [9-10] with satisfactory results [7]. Epidemiological studies have shown that the fear of public speaking is one of the biggest phobias that affect people, being highly prevalent among students [11].The study proposal was to evaluate symptoms of anxiety of public speaking, under a single dose and multiple doses through the simulated public speaking (SPS) test through the intervention with the encapsulated dry extract of the whole plant Passiflora incarnata L. Materials and MethodsSubjects A study population consisted of university students, adults, healthy, between 24 and 31 years, of both sexes, wer...