Introduction. Modern world presents us a wide variety of sources of stress: conflicts, unpleasant news, infectious diseases, and many other events test our psyche for strength every day. The term “stress” refers to processes involving perception, appraisal, and response to noxious events or stimuli. Stress experiences can be emotionally (e.g., interpersonal conflict, loss of loved ones, unemployment) or physiologically (e.g., food deprivation, illness, drug withdrawal states) challenging. In addition, regular and binge use of addictive substances may serve as pharmacological stressors. Acute stress activates adaptive responses, but prolonged stress leads to “wear-and-tear” (allostatic load) of the regulatory systems, resulting in biological alterations that weaken stress-related adaptive processes and increase disease susceptibility. Faced with exhaustion, people habitually resort to stimulants - caffeine in coffee or green tea, energy drinks, alcohol, and medications - for example, nootrops or antidepressants. However temporary stimulation effect, side effects of drugs, deterioration in the quality of life dictate the need for other approaches to solving the problem. The need for a balanced approach to soft, restorative therapy is the main idea that the herbal combination which includes Griffonia simplicifolia, Crocus sativus, Citrus sinensis, Withania somnifera, Melissa oficinalis, Asparagus officinalis may be used. These plants have a long history of use as an adaptogens in the ayurvedic system of complementary medicine, and are used to counteract the negative effects of stress. Modern researches have begun to identify a number of active components that may have useful therapeutic applications - a range of bioactive constituents, including withanolides, glycowithanolides, sitoindosides, withaferin A, and other therapeutically active phytochemicals [1, 2]. Other studies have identified anticancer, antidepressant, anxiolytic, cardioprotective, antioxidant, thyroid modulating, immunomodulating, antibacterial, neuroprotective, antifungal, anti-inflammatory, and hematopoietic activities [1, 2, 3]. The primary aim of the stage of studies was to evaluate the mood, exhaustion, stress resistance, and sleep quality of herbal combination and safety of influence in the long term including. We hypothesized that, compared with previous state, the Herbal containing treatments would reduce negative mood responses to multi-tasking is safety and harmless.
Materials and methods. A total of 23 female and 16 male undergraduate volunteers (mean age 37.2 years, age range 18–73) took part in the study, which was approved by the RCLIN Ethics Committee and was carried out in accordance with the Declaration of Helsinki (1989). Prior to participation, each volunteer signed an informed consent form and completed a medical health questionnaire. All participants reported that they were in good health, and were taking no illicit social drugs. Additionally, they were free of any ‘over-the-counter’ or prescribed medications, with the exception, for some female volunteers, of the contraceptive pill. Symptoms of chronic stress were assessed by using Symptom Check List-90-Revised (SCL-90-R) Questionnaire. Severity of anxiety and its type were determined on the anxiety scale (Spielberger С.D.). Asthenia Rating Scale (Subjective Asthenia Rating MFI-20)
(E.M.Smets et al) was used to determine the presence, severity and type of asthenic syndrome. Sleep quality assessment was also conducted. Patients were questioned before, 2 and 4 weeks after taking the herbal composition in a standard dose twice a day. Data on safety and adverse effects of the herbal combination were collected at the second week, at end of 4 weeks and 4 and 12 weeks after finishing. Safety was assessed by studying a complete blood count, cytolysis markers, glomerular filtration level, 12-leads’ rest electrocardiogram taking.
Results and discussions. Self-reported questionnaires were used. The SCL-90-R instrument is used to measure psychological stress. This 90-item scale determines general stress experienced in the previous week, with higher scores representing higher stress and allows distinguishing different subtypes such as Somatization, Obsessive—Compulsive, Interpersonal Sensitivity, Depression, Anxiety, requirement of health services. Subjective Asthenia Rating MFI-20 evaluates physical and mental asthenic symptoms, social anxiety, and correlates with possible values ranging from 0 to 100. Perceived stress was used as a continuous variable in the present analysis to determine any effect of treatment. Baseline scores were compared with scores at the second week and posttreatment ones at end of 4 weeks.
All data were expressed as means with standard deviation. Categorical data and discrete data were expressed as numbers with percentages. Changes in the scores from baseline were calculated and expressed as mean change and percent change from baseline. Differences at the level of P < .05 were regarded as statistically significant.
A total of 39 adults (16 men and 23 women) between the ages of 18 and 73 years were enrolled in the present study. All subjects in the trial had chronic stress symptoms. The majority were troubled with difficulties in concentration (66%) and insomnia (74%). About 59% of the subjects had problems with anxiety and 64% with mental fatigue. Other major symptoms included physical exhaustion, restlessness, and headaches.
The primary outcome of the study was obtained from the SCL-90-R score. The male and female groups were similar with respect to baseline SCL-90-R scores (P = .83). At both subsequent time points, however, the mean SCL-90-R score of both groups decreased significantly. This was a superior response. A reduction in MFI-20 scores was observed at the end of second and fourth weeks for male and female groups. However, the female group experienced a significantly greater degree of reduction than the men group at the end of the second week (34%, P = .0035) and the fourth week (50% reduction at 4 weeks, P < .0001).
Thus, mildly challenging stimuli limited in duration can be “good stress” or “eustress” and may increase motivation to achieve goal-direct outcomes and homeostasis – this can result in a sense of mastery and accomplishment, and can be perceived as positive and exciting. However, the more prolonged and more intense the stressful situation, the lower the sense of mastery and adaptability and thus the greater the stress response and risk for persistent homeostatic dysregulation. The perception and appraisal of stress relies on specific aspects of the presenting external or internal stimuli and may be moderated or mediated by personality traits, emotional state, and physiological responses that together contribute to the experience of distress. [4, 8] Obviously, the precursor of serotonin 5-hydroxytryptophan or 5-HTP added to herbal combination can restore the level of serotonin and improve the emotional state [3, 9]. This combination also contains a patented formula of citrus extract - Serenzo ™ - for which the clinical studies have shown an anxiolytic effect due to a double mechanism of action: reducing stress-associated inflammation due to inhibition of ICAM1 activity and reducing the severity of stress-associated symptoms, such as manifestation of aggression and mood variability, restoration of gastrointestinal tract function, improving sleep quality [4, 5, 9]. Another important source of stress at the molecular level is protein glycation - the process of the interaction of dietary (derived from food) carbohydrates with collagen from tissues such as blood vessels and skin, leading to the formation of strong cross-links - the so-called glycated proteins. This process helps increase the stiffness of collagen, which as a result leads to disorders of the cardiovascular system and the appearance of such unpleasant external signs of aging, such as wrinkles. The composition of the drug contains Sensoril ™ patented extract of Ashwagandha (Withania somnifera),) and Bluenesse® - Melissa oficinalis extract, a rich source of rosmarinic acid. Both components are known for their anti-glycation abilities [2, 5, 8].
The quality and quantity of hours of night sleep were evaluated by the subjective scale of the patient. No significant differences between the male and female groups were observed at baseline or second week score. However, at the end of the fourth week, most patients with insomnia noted a significant improvement in sleep quality (55% for female group, P < .0001 and 64% for male group P < .0001), a decreasing of “problem” nights (44%, P < .0020) and an increasing of average duration of sleep for 1.3 hours. What is especially important, most of these patients noted a reduction in appetite by the second week, and this is great result for patients whose health status and goal – to control body weight - namely overweight and a BMI above 25 kg / m2.
Sleep deprivation is a common chronic stressor that may contribute to increased risk for obesity and metabolic diseases, including abdominal obesity, insulin resistance, hypertension, atherosclerosis that may predispose individuals to cardiovascular disease and type II diabetes. [8] Cross-sectional analyses have found a significant association between short sleep duration and increased prevalence of obesity or higher BMI in both adult and child samples. Two recent meta-analyses have found that short sleep duration (<5h per night for adults, <10h per night for children) significantly predicted obesity. Moreover, BMI was 0.35 kg/m2 lower for every additional hour of sleep [8]. Of course, the short duration of the study did not allow us to assess the effect on the metabolic syndrome, body weight, etc., but this may be a task for further promising study. Herbal combitation also contains the proprietary formula enzyme-treated asparagus extract (ETAS ™) [6]. For this form of extract, nootropic effects and increased stress tolerance and sleep quality are also shown in tests on healthy volunteers [6, 7]. As a mechanism of action, stimulation of the production of heat shock protein HSP7025 has been established.
Data on adverse events were collected and analyzed, considering all 39 subjects. Only 3 subjects (8%) out of 39 reported effects such as giddiness, heaviness of head, nausea, and hyperacidity. The severity of these adverse events was mild and temporary. The treatment was tolerable to most of the subjects. As for safety there were no deviations in a complete blood count, cytolysis markers, glomerular filtration level, 12-leads’ rest electrocardiogram, including QTc duration
Conclusions. The results of this observations suggest that herbal combination reduces psychological and physiological markers of stress, improves mental well-being. We conclude that herbal combination can be useful for health management in patients experiencing chronic stress. However, further studies are required to bolster the potential of herbal combination to prevent mental, metabolic, stress-associated symptoms caused by long-term chronic stress.
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