The drug St. John’s wort (St. Johns’wort, hypericin) was presented in the form of capsules containing from 225 to 237.5 mg of dry extract of Hypericum perforatum (St. John’s wort). In this study, the drug turineurin was studied .. The active substance of the drug – hypericin has an antidepressant and some anxiolytic action. It is assumed that the mechanism of action of hypericin is largely similar to the mechanism of action of antidepressants of the class of non-selective MAO inhibitors. However, recent studies have shown that hypericin may have activity against the serotonergic system (inhibition of serotonin reuptake), and also has a tropism for GABA and benzodiazepine receptors [1]. The main indication for prescribing the drug is depression. Comparative studies have shown that its effectiveness in moderate to mild depression is similar to that of amitriptyline [2].
Study design and scope The study
was simple, non-comparable, open-source. Its duration for each patient was 28 days. During the study, each patient was examined 5 times: when included in the study, after 7.14, 21, 28 days. A total of 30 patients were included in the clinical picture of which there were signs of depression or anxiety, which were not symptoms of severe mental illness, such as schizophrenia or severe affective disorder. Most of the patients were consulted by a psychiatrist in the direction of a general practitioner, then they were observed on an outpatient basis.
Inclusion / exclusion criteria
According to the protocol, the study included patients with the following disorders (according to ICD-10):
– somatoform disorders – F45;
– depressive episode of mild severity – F32;
– other anxiety disorders – F41;
– reaction to severe stress and adaptation disorders – F43;
– other neurotic disorders – F48.
The following patients were excluded from the study:
– with acute and severe chronic somatic diseases in the stage of decompensation;
– with severe mental illness;
– abusers of psychoactive substances, in particular alcohol;
– those who did not give their consent to participate in the study and / or are unable to give a report on their condition.
Table 1. Distribution of patients by the nature of mental disorders
Syndrome | Number of patients | |
abs. | % | |
Somatoform disorders – F45 | nine | thirty |
Mild depressive episode – F32 5 | five | 17 |
Other Anxiety Disorders F41 | 3 | ten |
Severe stress response and adjustment disorders – F43 | 3 | ten |
Other neurotic disorders F48 | ten | 33 |
Total… | thirty | one hundred |
Table 2.
Distribution of patients by the nature of somatic diseases (nosological distribution)
Somatic diagnosis | Number of patients |
Hypertension stage I-II | 2 |
Coronarocardosclerosis, Ischemic heart disease |
2 |
Cerebral atherosclerosis | 2 |
Vegetovascular dystonia | 7 |
Chronic gastritis without exacerbation | 6 |
Chronic cholecystitis without exacerbation | 3 |
BPH | 2 |
Thrombophlebitis | 1 |
Changeopause | 7 |
Total… | 32 |
Assessment of the dynamics of the patient’s condition The dynamics of the patient’s condition was assessed
using two scales of medical observation: the Hamilton scale for depression (17 points) and the scale of general clinical impression and two self-assessment scales: the Zung scale and the Beck questionnaire for depression (13 points).
Therapy regimen
The drug was prescribed 1-2 tablets 3 times a day. The average dose of the drug was 5 tablets per day. All patients received the drug as monotherapy.
Material characteristics
The study included 30 patients (21 women and 9 men) aged 18 to 67 years. The average age was 37 ± 3.6 years. The severity of depression was shallow and averaged 20.8 ± 1.4 points on the Hamilton scale.
Table 1. presents the distribution of patients by the nature of mental disorders.
Mental disorders in 19 patients were combined with chronic somatic diseases without exacerbations, and in some cases, 1 patient was diagnosed with several somatic diseases.
The distribution of patients by the nature of somatic diseases is presented in table. 2.
Research results
As can be seen from the table. 3, an improvement in the condition of patients was noted in terms of indicators of all used scales. By the end of the study, the most clear and stable change in state was observed between the 3rd and 4th visit of patients (between the 14th and 21st day of therapy). This applied to both the observation scales (the Hamilton scale for depression and global clinical impression) and the subjective scales (the Beck scale and the Zung scale).
It should be noted that at the beginning of therapy in 8 (27%) patients, in whose clinical picture signs of anxiety and depression were equally expressed, there was a clear difference between the subjective and objective assessment of the state. Assessment using the HKV and Hamilton scales was clearly more difficult than the self-assessment of patients using the Tsung and Beck scales. With the course of therapy, this difference decreased and disappeared at the end of the study. The fastest effect was observed in patients whose clinical picture was dominated by the anxiety component or autonomic dysfunction as a somatic equivalent of anxiety (tachycardia, feeling of incomplete inspiration, neurotic fever). In these cases, a significant effect was noted already at the 1st week of treatment.
In patients with a predominance of depressive elements in the symptom complex in the form of lethargy, apathy, asthenia, depression, tearfulness, as well as with a somatic depressive complex (constipation, weight loss, loss or decrease in appetite) and sleep disorders, the effect came somewhat later – by the end of 3 th week of therapy. In many cases, a characteristic feature of such depressions was that depressive symptoms in most cases were combined with somatic symptoms (algias, functional disorders of organs and systems, itching of the skin and mucous membranes), which in some cases even prevailed over the depressive manifestations themselves, which the patients themselves considered secondary to their somatic ill-being. These somatic complaints also disappeared by the end of the 2nd to the 3rd week.
Table 3. Dynamics of indicators of clinical scales
Scale | Study days | ||||
0 | 7th | 14th | 21st | 28th | |
Tsung scale | 50.7 | 48.3 | 43.2 | 34.4 | 28.9 |
Beck scale | 15 | 13 | eleven | 6,3 | 3.8 |
Hamilton scale for anxiety | 20.3 | 18.6 | 12.2 | 8.3 | 4.8 |
GKV-1 scale (disease severity) |
3.4 | 3.2 | 2.7 | 1.3 | 0.8 |
GKV-2 scale (severity of improvement) |
3.1 | 1.9 | 1.3 | 0.6 |
The effect of the drug on sleep was different in patients with a predominance of anxiety and with a predominance of depression:
– with the predominance of anxiety, sleep improved already in the first days of therapy, but then, after 5-6 days, the hypnotic effect itself disappeared;
– with a predominance of depression, the positive effect of the drug on sleep was combined with a general improvement in the state.
By the end of the 4th week, the condition of all patients was characterized by significant improvement or very significant improvement (according to the GCV scale). On the Hamilton scale, the mean at the end of the study indicated no depression. However, after discontinuation of therapy in connection with the end of the study, in patients with a predominance of depressive disorders, painful phenomena returned again, which required their transfer to antidepressant therapy. Such patients noted that they tolerated St. John’s wort much better than chemical antidepressants with a similar therapeutic effect.
No signs of addiction were found when the drug was discontinued.
With good tolerance, the optimal dose and regimen was 2 tablets 3 times a day. In 5 patients, temporary loosening of the stool was noted. This phenomenon took place when the dose was reduced to 1 tablet 3 times a day. In no case were there any symptoms of increased photosensitivity or additional changes in physiological parameters such as blood pressure and heart rate described when taking this drug. In no case did the side effects lead to premature termination of the study.
Discussion The
study showed that St. John’s wort was effective for both anxiety and depression in patients with mild depression, arising either through neurotic mechanisms or as a response to stressful situations. The drug had a positive effect on the somatization component if it arose in close connection with affective disorder. Most of the patients tolerated the drug well, although many were burdened with somatic diseases.
It is interesting that many patients in the past took various herbal infusions and tinctures, including St. John’s wort, but did not notice a significant sustained effect of such courses. Therefore, the very fact of therapy with a “natural, non-chemical, natural” remedy could not play a decisive role in this case, although some patients with great pleasure paid attention to the “natural” origin of the drug and spoke with disgust about “chemistry”. This circumstance and the lag of the indicators of the medical observation scales from self-questionnaires indicate a possible significant component of the placebo effect, especially in the early period of therapy (the first 2 weeks).
Another important observation concerns the response of patients to traditional “chemical” antidepressants (overwhelmingly tricyclic antidepressants), which patients received to complete therapy. No significant increase or decrease in the antidepressant or anxiolytic effect was found, while the usual side effects were noted no less often, but not more often than described in the literature.
In general, according to the results of this study, it seems that St. John’s wort preparations can find their place in the treatment of patients with mild affective disorders, including cases of somatization, as well as in people who have undergone a stressful situation. The development of research projects aimed at identifying the effects of such drugs in different nosological and age groups, as well as comparative placebo-controlled studies to identify the role of the placebo effect, seem to be important and promising.