Atopic dermatitis: ways to optimize treatment with the use of Bionorm

The aim of the study was to determine the effectiveness of treating patients with atopic dermatitis using the dietary supplement “Bionorm” based on the study of endotoxicosis, intestinal and skin microbiocenosis, as well as to assess the quality of life of patients.
Materials and methods. Ninety-six patients with atopic dermatitis (63 women and men aged 18–45 and 33 adolescents aged 12–17) were examined and divided into two groups: the experimental group (33 adults and 18 adolescents), who received standard therapy in combination with the dietary supplement Bionorm, and a comparison group (30 adults and 15 adolescents) who received standard treatment for 2 weeks. The control group included 47 healthy individuals (26 adults and 21 adolescents) . All patients were examined in accordance with current standards. Biochemical and microbiological tests were performed, and the severity of atopic dermatitis was determined using the SCORAD, EASI, and IGA scales. The quality of life of patients was assessed using the Dermatology Life Quality Index (Ukrainian version of the Dermatology Life Quality Index — DLQI) . To evaluate the effectiveness of the proposed treatment, the percentage decrease in the DLQI score (ΔDLQI, %) was determined, as well as the percentage of patients whose DLQI at the end of treatment was less than 5 points (DLQI < 5, %). The results were statistically processed using standard computer programs.

Results and discussion. In patients with atopic dermatitis, 1 month after the start of taking the dietary supplement “Bionorm,” a statistically significant decrease in the severity score of the disease according to the SCORAD, EASI, and IGA scales was noted, which indicates its positive clinical effect. This is also confirmed by the presence of a statistically significant difference between the standard therapy group and the group with additional use of the dietary supplement “Bionorm” in terms of the total number of bacteria, the number of Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Streptococcus pyogenes, and fungi of the genus Candida. The results obtained indicate the high effectiveness of the dietary supplement Bionorm not only in terms of the regression of clinical manifestations of atopic dermatitis, but also in terms of a significant improvement in the quality of life of patients.

Conclusions. It has been established that the course of atopic dermatitis is accompanied by disturbances in the intestinal and skin microbiocenosis, the presence of endotoxicosis, and a decrease in the quality of life of patients. The additional use of the dietary supplement “Bionorm” in the treatment of patients with atopic dermatitis contributed to the normalization of the intestinal microbiome, a decrease in the overall contamination of the skin, a significant reduction in the severity of the disease according to the SCORAD, EASI, and IGA scales, as well as an improvement in the quality of life of patients

Keywords Atopic dermatitis, treatment effectiveness,

endotoxicosis, microbiocenosis, quality of life, Bionorm.
In recent years, there has been an increase in the incidence of allergic dermatoses, especially atopic dermatitis, due to the adverse effects of the environment, urbanization, an increase in the frequency of stressful situations, and an expansion of the range of trigger factors [1, 2, 8] . The high incidence of atopic dermatitis, constant relapses of the disease, insufficient effectiveness of standard therapy, and reduced quality of life of patients [3, 6] make the search for alternative treatment methods relevant.

In the pathogenesis of atopic dermatitis, many authors attach great importance to the disruption of the barrier function and changes in the skin microbiocenosis [26, 29] . Normal microflora plays an important role in protecting the body from pathogenic microorganisms [9, 14, 24]. Bacterial, mycotic, and viral microflora can have an allergenic effect on the human body and thus lead to the onset and progression of atopic dermatitis [21, 22]. The leading role of Staphylococcus aureus in the development of atopic dermatitis is widely recognized [23, 31].

The prolonged course of atopic dermatitis with impaired skin integrity can result in the development of secondary infections, which exacerbate the severity of the disease, complicate the choice of therapeutic tactics (especially regarding the selection of topical agents) and increased resistance to it [25]. This argues for the need for timely preventive and therapeutic measures to restore the skin’s microbiocenosis, which contributes to the stabilization of atopic dermatitis and its long-term remission [18, 28].

In recent years, approaches to the treatment of atopic dermatitis have been proposed, but they are not always effective or are limited in use due to contraindications and the risk of side effects [10, 19, 30, 33]. .

It is known that the basis for the treatment of atopic dermatitis is a comprehensive approach that affects various pathogenetic links, including elimination measures, adherence to a hypoallergenic diet, the prescription of systemic biological drugs,
JAK inhibitors, classic immunosuppressants, hyposensitizing agents, enterosorbents, antihistamines, vitamins, topical glucocorticosteroids, calcineurin inhibitors, and the basic use of emollients.

There is ongoing debate in the literature regarding the need to use probiotics in the treatment of patients with atopic dermatitis. It has been established that the intestinal microflora plays a key role not only in the metabolism of nutrients, but also in the formation of immunity [16, 20]. The intestinal microbiome is even called the central organ of the immune system, as it has a significant impact on the development of allergic diseases [13, 20]. Disruption of the intestinal microbiota is considered one of the factors responsible for the increase in the number of cases of atopic dermatitis in developed countries [16]. It has been proven that the severity of atopic dermatitis depends on the state of the intestinal microbiota [11].

Discussions on the use of probiotics in the treatment of patients with atopic dermatitis have ranged from determining the feasibility of their use in therapy to mandatory prescription [2, 5, 7, 13, 15]. This prompts a comparative study of the effectiveness of probiotics in the treatment of such patients.

In view of this, our attention was drawn to the possibility of using the dietary supplement “Bionorm”, which contains activated lignin, lactulose, and microcrystalline cellulose, in patients with atopic dermatitis. Bionorm is an additional source of dietary fiber for normalizing the motor function of the digestive tract, promoting the normalization of intestinal microflora, removing toxic substances from the body, and has sorption and prebiotic properties.

Activated lignin is a natural enterosorbent that exhibits high sorption activity and has a nonspecific detoxifying effect, capable of binding and removing toxins, allergens, heavy metals, and other harmful compounds from the body.

Lactulose is a synthetic disaccharide obtained by isomerization of lactose contained in milk whey. It is not absorbed in the small intestine, is not broken down by enzymes, reaches the large intestine, where bacteria break down lactulose into low-molecular organic acids, which increases osmotic pressure in the intestine, retaining water and increasing the volume of feces. In addition, lactulose has a prebiotic effect, as it promotes the growth of bifidobacteria and lactobacilli, which suppress pathogenic microflora
and the elimination of toxic substances from the body. Lactulose participates in the normalization of protein, fat, and carbohydrate metabolism, the absorption of vitamins, micro- and macroelements, and the stimulation of nonspecific immunity.

Microcrystalline cellulose is a polysaccharide that is a source of dietary fiber and a natural sorbent, removes toxins, radionuclides, and heavy metals from the body, and also helps normalize the digestive tract and reduce body weight.

The complex effect of the components of the dietary supplement “Bionorm” promotes the formation of normal intestinal microflora and has an enterosorbent effect, which provides a positive clinical effect on many dermatological diseases.

The above confirms the relevance of studying the etiopathogenesis and clinical features of atopic dermatitis, and also indicates the importance of finding ways to improve its treatment.

The aim of the study was to determine the effectiveness of treating patients with atopic dermatitis using the dietary supplement “Bionorm” based on the study of endotoxicosis, intestinal and skin microbiocenosis, as well as to assess the quality of life of patients.
Materials and methods
96 patients with atopic dermatitis (63 women and men aged 18-45 and 33 adolescents aged 12-17) were examined and divided into two groups. The experimental group included 33 adults and 18 adolescents who, in addition to standard therapy, used Bionorm for two weeks in addition to standard therapy, while the comparison group included 30 adults and 15 adolescents who received only standard treatment for two weeks [5].

For an objective assessment of clinical manifestations and their dynamic changes during treatment, a point-based assessment of the severity of atopic dermatitis was used according to the SCORAD, EASI, and IGA [12] scales, and the difference in the assessment of the severity of atopic dermatitis before and 1 month after the start of therapy was determined — ΔSCORAD, ΔEASI, ΔIGA [17, 27, 32]. Quality of life was assessed using the Dermatology Life Quality Index (Ukrainian version of the Dermatology Life Quality Index — DLQI) [4].

Patients and doctors were surveyed 1 month after the start of therapy to assess its effectiveness on a point scale: unsatisfactory was taken as –1, no change as 0, satisfactory as 1, good as 2, excellent as 3.

At the beginning of the study, the participants in the experimental group and the comparison group did not differ, which made it possible to combine them for further statistical processing and data analysis. The control group included 47 healthy individuals (26 adults and 21 adolescents) who underwent medical history collection, clinical examination, biochemical and microbiological studies. Endogenous intoxication of the body was also studied by the level of medium molecules at wavelengths of 254 nm (SM1) and 280 nm (SM2) using the method of N.I.
Gabrielyan and V.I. Lipatova, modified by S.S. Kireev et al. (1997), the sorption capacity of erythrocytes (SCE) was determined by the degree of methylene blue absorption (D.S. Dodkhoev, 1998) and the level of circulating immune complexes (CIC) [6]. The study was approved by the ethics committees of medical institutions.
Criteria for inclusion in the study:

• diagnosis of atopic dermatitis;
• age from 12 to 45 years;
• signed informed consent to participate in the study.

The criterion for inclusion in the control group was the absence of somatic and dermatological diseases.
Exclusion criteria:

• presence of other dermatological diseases;
• known or suspected hypersensitivity to the components of the dietary supplement;
• the presence of severe concomitant diseases and mental illnesses;
• lack of patient compliance with treatment.

The effectiveness of treatment was assessed 1 month after its start.

Statistical analysis of the results was performed using standard computer programs with the application of Student’s paired t-test with the calculation of the arithmetic mean (M) and standard error of the arithmetic mean (m) or Wilcoxon’s sign test, depending on the normality of the distribution of differences. To compare the clinical effectiveness of treatment, a rank dispersion analysis was performed using the Kruskal-Wallis method with a posteriori comparisons using Dunn’s criterion (between three or more independent samples). The normality of the data distribution was checked using the Shapiro-Wilk criterion Shapiro-Wilk test at a significance level of 0.01. When applying all statistical methods, except for the Shapiro-Wilk test, the significance level was set at 0.05 — the difference between the data was considered reliable at p < 0.05. To determine structural relationships , correlation analysis was used to determine the pairwise correlation coefficients — r.

The novelty of the study lies in the scientific justification for the use of the dietary supplement “Bionorm” in the treatment of patients with atopic dermatitis.

Results and discussion
According to the results of the examination of patients during screening, the assessment of the severity of atopic dermatitis according to the SCORAD, EASI, and IGA scales corresponded mainly to a moderate course (Table 1).

As can be seen from Table 1, during the course of treatment, the clinical picture and score of the disease according to the SCORAD, EASI, and IGA scales changed in patients with atopic dermatitis. In the standard therapy group, a statistically significant reduction in the severity of atopic dermatitis according to the above scales was noted, but their values corresponded to a moderate mild severity. This indicates the need for a longer course of treatment or the advisability of using additional methods of therapy. In patients in the experimental group who were additionally prescribed Bionorm, a statistically significant reduction in the severity of the disease according to the SCORAD, EASI, and IGA scales; its severity corresponded to a mild degree. A statistically significant difference was found between the values of the above scales in patients in the experimental and comparative groups. A statistically significant difference between the data obtained on the SCORAD, EASI, and IGA scales (p < 0. 05) was also established based on the analysis of the results of the rank variance analysis using the Kruskal-Wallis method. All mathematical methods confirmed a statistically significant better assessment of the severity of atopic dermatitis in the group of patients after the additional use of the dietary supplement “Bionorm.” A statistically significant difference was obtained for ΔSCORAD , ΔEASI, and ΔIGA at the end of treatment between patients in the experimental and control groups, indicating a positive clinical effect of using the dietary supplement “Bionorm” in the treatment of patients with atopic dermatitis.

To objectively assess satisfaction with treatment one month after its start, a survey of patients and doctors was conducted. According to the results, patients mostly positively assessed the effectiveness of standard therapy for atopic dermatitis, and its conditional average value was (1.56 ± 0.09) points. After a course of standard treatment, most patients assessed its effectiveness as satisfactory, while patients who additionally received Bionorm rated it as good. A statistically significant difference was found between the groups of patients after treatment: in the case of additional prescription of the dietary supplement Bionorm, the conditional average value of the effectiveness of therapy was statistically significantly higher than in the comparison group ((1.93 ± 0.11) points; p < 0.05).

The assessment of treatment effectiveness by patients and doctors showed approximately the same results. The conditional mean value of treatment effectiveness, as assessed by physicians, was (1.58 ± 0.09) points in the comparison group and (1.96 ± 0.10) points in the experimental group. Thus, treatment with the additional prescription of the dietary supplement “Bionorm” was assessed by doctors as more effective. The results of a paired correlation between the assessment of the effectiveness of therapy by doctors and patients 1 month after its start were analyzed. The paired correlation of conditional average values (r = +0.71) had a statistically significant high power, which indicates a predominantly identical assessment of the effectiveness of treatment by doctors and patients.

 

Table 1. Dynamics of SCORAD, EASI, and IGA scores in patients with atopic dermatitis during treatment

Indicator	Patients with atopic dermatitis
	Before treatment	After standard treatment	After standard treatment with the inclusion of the dietary supplement “Bionorm”
SCORAD scale, points	41.3 ± 3.1	32.5 ± 2.0*	26.3 ± 1.6* #
ΔSCORAD before treatment, %	—	21.8 ± 2.4	36.1 ± 3.9 #
EASI score, points	50.7 ± 4.2	31.7 ± 3.3*	20.6 ± 2.7* #
ΔEASI before treatment, %	—	37.8 ± 4.4	59.1 ± 5.7 #
IGA scale, score	3.2 ± 0.15	2.7 ± 0.12*	2.1 ± 0.11* #
ΔIGA before treatment, %	—	15.3 ± 2.1	34.9 ± 3.6 #
Note. * Significant difference (p < 0.05) based on comparison with corresponding indicators in the group of patients before treatment; # significant difference (p < 0.05) based on comparison with corresponding indicators in the group of patients after standard treatment.

 

An assessment was made of the paired correlation of the conditional mean value of the effectiveness of therapy by doctors or patients with a score for the severity of the disease according to the SCORAD, EASI, and IGA scales and the difference in the assessment according to these scales. It was established
that the paired correlation coefficient according to the patients’ assessment of effectiveness and disease severity on the SCORAD scale was r = +0.78, on the EASI scale — r = +0.73, on the IGA scale — r = +0.77, with a difference in the severity score on the SCORAD scale — r = +0.54, on the EASI scale — r = +0.57, on the IGA scale — r = +0.51. At the same time, the pair correlation coefficient for the assessment of effectiveness by doctors and disease severity on the SCORAD scale was r = +0.54, on the EASI scale — r = +0.52, on the IGA scale — r = +0.59, with a difference in severity scores on the SCORAD scale — r = +0.75, on the EASI scale — r = +0.71, on the IGA scale — r = +0.77. In summary, we note that in assessing the effectiveness of treatment for patients with atopic dermatitis, doctors attached greater importance to the dynamics of clinical manifestations of the disease, while patients attached greater importance to the severity of the disease.

The data obtained on endotoxicosis in patients with atopic dermatitis deserve attention, as evidenced by higher levels of medium molecules, CIK, and increased SCE compared to healthy individuals (Table 2).

 

Table 2. Levels of medium-sized molecules, CIK, and SCE in patients with atopic dermatitis

Indicator	Healthy individuals	Patients with atopic dermatitis
		Before treatment	After standard treatment	After standard treatment with the dietary supplement “Bionorm”
CM1, relative units	0.337 ± 0.18	0.426 ± 0.019 °	0.398 ± 0.013 °	0.357 ± 0.010* #
CM2, relative units	0.164 ± 0.08	0.225 ± 0.015 °	0.195 ± 0.011 °	0.171 ± 0.010*
CCE, %	37.2 ± 0.95	43.2 ± 1.07 °	41.2 ± 0.83 °	38.3 ± 0.87* #
CIC, units/ml	46.7 ± 2.4	67.9 ± 3.8 °	59.2 ± 3.0 °	49.1 ± 2.7* #
Note. ° Significant difference (p < 0.05) based on comparison with corresponding indicators in the group of healthy individuals; * significant difference (p < 0.05) based on comparison with corresponding indicators in the groups of patients before and after treatment; # significant difference (p < 0.05) based on comparison with the corresponding indicators in the groups of patients after treatment. The same applies to Table 3.

 

The use of the dietary supplement “Bionorm” as part of complex therapy for patients with atopic dermatitis contributed to a more rapid reduction in the manifestations of endotoxicosis compared with the indicators in the standard therapy group. This confirms the presence of a statistically significant difference in the level of average molecules, CSE, and CIC in groups of patients after standard therapy and after additional use of the dietary supplement Bionorm.

One of the important factors in the development and progression of chronic dermatoses is the disruption of the microbiocenosis [2, 3, 6, 7, 24]. During the study, patients with atopic dermatitis were found to have intestinal dysbiosis, which manifested itself in a statistically significant decrease in the number of bifidobacteria and lactobacilli and an increase in staphylococcus, non-fermenting Escherichia coli, Proteus, fungi of the genus Candida (Table 3).

 

Table 3. Results of bacteriological examination of feces in patients with atopic dermatitis during treatment (Lg CFU/g)

Indicator	Healthy individuals	Patients with atopic dermatitis
		Before treatment	After standard treatment	After standard treatment with the dietary supplement “Bionorm”
Bifidobacteria	9.11 ± 0.17	7.68 ± 0.14 °	8.07 ± 0.23 °	8.75 ± 0.17* #
Lactobacteria	7.36 ± 0.24	6.39 ± 0.18 °	6.70 ± 0.12 °	7.26 ± 0.19* #
Staphylococcus	1.60 ± 0.18	2.34 ± 0.21 °	1.98 ± 0.23	1.74 ± 0.12*
Streptococcus	6.54 ± 0.23	6.84 ± 0.31	6.85 ± 0.57	6.73 ± 0.39
E. coli	7.25 ± 0.20	8.09 ± 0.17 °	7.83 ± 0.26	7.44 ± 0.28
E. coli non fermentans	0.47 ± 0.28	1.79 ± 0.31 °	1.36 ± 0.17 °	0.67 ± 0.18* #
Proteus	0.45 ± 0.10	0.89 ± 0.11 °	0.63 ± 0.14	0.52 ± 0.10*
Enterobacter	2.47 ± 0.21	2.32 ± 0.18	2.19 ± 0.20	2.56 ± 0.19
Candida	0.76 ± 0.09	1.74 ± 0.14 °	1.43 ± 0.16 °	0.98 ± 0.10* #

 

After standard treatment, patients with atopic dermatitis showed positive dynamics in the state of the intestinal microbiocenosis.

As can be seen in Table 3, one month after the start of standard therapy, patients had a statistically significantly lower number of Bifidobacteria and Lactobacteria and a higher number of — E. coli non fermentans and Candida, indicating the impossibility of normalizing the intestinal microbiome using standard therapeutic methods. The absence of complete normalization of the clinical picture of the disease within 1 month from the start of therapy (see Table 1) also confirms the need for other approaches to treatment. This may be a targeted effect on the normalization of the intestinal microbiome in patients with atopic dermatitis, which will contribute to the restoration of immune processes in the body and, consequently, correcting the course of the disease. With this in mind, the effectiveness of the dietary supplement “Bionorm,” which contains insoluble dietary fiber (lignin and cellulose) and a prebiotic (lactulose), was evaluated.

According to the results of bacteriological examination of feces in patients with atopic dermatitis after additional use of the dietary supplement “Bionorm,” , a significant increase in the number of Bifidobacteria and Lactobacteria and a decrease in Staphylococcus (Staph.), E. coli non fermentans, Proteus, and Fungi Candida was noted compared to the indicators in the group of patients before treatment. A statistically significant difference in the number of Bifidobacteria, Lactobacteria, E. coli non fermentans, and Candida one month after the start of treatment in the experimental group and in the comparison group. Thus, the prophylactic use of the dietary supplement “Bionorm ” dietary supplement not only increases the number of Bifidobacteria and Lactobacteria, but also reduces the conditionally pathogenic flora in the intestine, which has a positive effect on the clinical manifestations of atopic dermatitis, which are pathogenetically associated with disorders of the digestive tract. The number of Bifidobacteria and Lactobacteria, according to the results of a bacteriological biological study of feces in patients after treatment with the additional use of the dietary supplement “Bionorm” was close to that in healthy individuals. This indicates the corrective effect of this supplement on changes in the intestinal microbiocenosis in patients with atopic dermatitis.

The results of the study of the skin microbiocenosis in patients with atopic dermatitis showed its differences from that in healthy individuals (Table 4). Thus, patients with atopic dermatitis had statistically significantly higher levels of total skin colonization, the number of Staphylococcus (Staph.) aureus, Streptococcus (Strept.) pyogenes, Candida, and Malassezia; lower levels of Staph. epidermidis and Staph. hominis than in the control group. This indicates the presence of a microbiological shift, with Staph. epidermidis and Staph. hominis being replaced by more pathogenic Staph. aureus, Strept. pyogenes, Candida, and Malassezia.

 

Table 4. State of microbial contamination of the skin in healthy individuals and patients with atopic dermatitis (Lg CFU/cm2)

Microbiome	Healthy individuals	Patients with chronic allergic dermatoses
		Before treatment	After standard treatment	After standard treatment with the inclusion of the dietary supplement “Bionorm”
Total number of bacteria	3.5 ± 0.19	5.3 ± 0.20 °	4.6 ± 0.17 °*	3.8 ± 0.18* #
Staph. aureus	0.47 ± 0.08	1.70 ± 0.16 °	1.05 ± 0.12 °*	0.54 ± 0.08* #
Staph. epidermidis	0.50 ± 0.08	0.26 ± 0.05 °	0.34 ± 0.04 °	0.47 ± 0.05* #
Staph. haemolyticus	0.35 ± 0.07	0.44 ± 0.07	0.33 ± 0.06	0.35 ± 0.05
Staph. saprophiticus	0.40 ± 0.05	0.46 ± 0.06	0.33 ± 0.09	0.37 ± 0.07
Staph. hominis	0.39 ± 0.04	0.12 ± 0.03 °	0.22 ± 0.05	0.37 ± 0.04* #
Strept. pyogenes	0	0.38 ± 0.04 °	0.23 ± 0.04 °*	0.10 ± 0.03 °* #
Fungi Candida	1.43 ± 0.15	2.65 ± 0.18 °	2.03 ± 0.16 °*	1.48 ± 0.13* #
Fungi Malassezia	1.10 ± 0.13	1.67 ± 0.21 °	1.54 ± 0.16	1.19 ± 0.11 °
Note. ° Significant difference (p < 0.05) based on comparison with corresponding indicators in the group of healthy individuals; * significant difference (p < 0. 05) based on comparison with the corresponding indicators in the group of patients before treatment; # significant difference (p < 0.05) based on comparison with the corresponding indicators in the group of patients after standard treatment with additional use of the dietary supplement “Bionorm”.

 

In the standard treatment group, 1 month after the start of the study, there was a statistically significant decrease in the total number of bacteria, the number of Staph. aureus, Strept. pyogenes, and Candida. Despite a significant decrease in the total number of bacteria and some of the microorganisms mentioned above in the group of patients after standard treatment, their number did not decrease to the levels seen in healthy individuals, indicating a lack of normalization of the skin microbiome and the need to search for methods to improve the effectiveness of therapy. In the group that additionally used Bionorm, 1 month after the start of treatment, there was a statistically significant decrease in the total number of skin bacteria, the number of Staph. aureus and Strept. pyogenes, fungi of the genus Candida and Malassezia, and the number of Staph. epidermidis and Staph. hominis significantly increased. It can be stated that in the group of patients with atopic dermatitis who additionally received Bionorm, the skin microbiocenosis was almost completely normalized. The effectiveness of the additional use of the dietary supplement Bionorm in the treatment of atopic dermatitis is also indicated by the statistically significant difference in the indicators between the experimental and control groups in terms of the total number of bacteria, the number of Staph. aureus, Staph. epidermidis, Staph. hominis, Strept. pyogenes, and Candida after completion of therapy.

The above results confirm the effectiveness of the dietary supplement Bionorm in the complex therapy of patients with atopic dermatitis.

An important indicator of the effectiveness of treatment is the determination of the quality of life of patients (Table 5).

 

Table 5. DLQI dynamics in patients with atopic dermatitis during treatment (Lg CFU/g)

Indicator	Patients with atopic dermatitis
	Before treatment	After standard treatment	After standard treatment with the inclusion of the dietary supplement “Bionorm”
DLQI, points	18.7 ± 2.1	10.0 ± 1.7*	4.4 ± 0.8* #
ΔDLQI before standard treatment, %	—	46.3 ± 4.9	75.8 ± 7.8*
DLQI < 5, %	0	17.3*	65.6* #
Note. * Significant difference (p < 0.05) based on comparison with corresponding indicators in the group of patients before treatment; # Significant difference (p < 0.05) based on comparison with the corresponding indicators in the group of patients after standard treatment with the additional use of the dietary supplement “Bionorm”.

 

As can be seen from Table 5, the DLQI at the beginning of the study was (18.7 ± 2. 1) points, indicating a significant impact of atopic dermatitis on the quality of life of patients. In the standard therapy group, a significant decrease in DLQI was observed after 1 month compared to the pre-treatment indicator. In the comparison group, a statistically significant difference in indicators was found compared to those in the experimental group, where the ΔDLQI value was 1.5 times higher, and DLQI < 5 — 4 times higher.

These results indicate a significant improvement in the quality of life of patients with atopic dermatitis due to the use of the dietary supplement “Bionorm” and confirm its high effectiveness not only in terms of regression of clinical manifestations, but also in terms of a significant improvement in the quality of life of patients.

During the study, the relationship between the score for the severity of atopic dermatitis and the quantitative assessment of the microflora in the intestine and on the skin was of interest. The dependence of these indicators was determined by paired correlation, the results of which are presented in Table 6.

 

Table 6. Paired correlation coefficients between the severity score of atopic dermatitis (points), the number of microorganisms in feces (Lg CFU/g) and on the skin (Lg CFU/cm2)

Indicator	EASI	IGA	Fecal microbiota					Skin microbiota
			Bifidobacteria	Lactobacteria	Staph.	E. coli non fermentans	Candida	Bacteria	Staph. aureus	Staph. epidermidis	Candida	Malassezia
SCORAD	+0.81	+0.77	−0.56	−0.51	+0.32	+0.36	+0.34	+0.39	+0.43	−0.39	+0.38	+0.33
EASI		+0.85	−0.53	−0.45	+0.36	+0.37	+0.32	+0.34	+0.39	−0.34	+0.37	+0.31
IGA			−0.51	−0.44	+0.35	+0.34	+0.27	+0.37	+0.37	−0.31	+0.33	+0.35
Bifidobacteria				+0.67	−0.37	−0.35	−0.34	−0.35	−0.25	+0.34	−0.37	−0.35
Lactobacteria					−0.31	−0.28	−0.27	−0.32	−0.19	+0.27	−0.33	−0.28
Staph.						+0.31	+0.18	+0.23	+0.27	−0.29	+0.24	+0.17
E. coli non fermentans							+0.34	+0.21	+0.17	−0.29	+0.25	+0.32
Candida								+0.34	+0.27	−0.27	+0.21	+0.26
Bacteria on the skin									+0.28	−0.27	+0.34	+0.31
Staph. aureus										−0.24	+0.33	+0.27
Staph. epidermidis											−0.23	−0.26
Candida												0.41

 

As can be seen from Table 6, a strong correlation was found between the score for the severity of atopic dermatitis according to the SCORAD, EASI, and IGA scales. The absence of a 100% correlation confirms the different assessment of disease severity on each of the scales. The above indicates the advisability of using all scales for a more objective assessment of the severity of atopic dermatitis.

Among the scores for the severity of atopic dermatitis and the amount of microbiota, the strongest correlation was found with Lactobacteria and Bifidobacteria, which was negative and of medium strength. This confirms that it is the decrease in the number of Bifidobacteria that corresponds to a more severe course of atopic dermatitis. Positive correlations were also found between the severity scores of atopic dermatitis and the number of Staph. , E. coli non fermentans, Candida in feces, and the total number of bacteria on the skin, Candida, and Malassezia on the skin; negative correlations were found with the number of Staph. epidermidis on the skin.

The results of clinical and microbiological examinations, the study of endotoxicosis and quality of life obtained during the study indicate the effectiveness of the dietary supplement “Bionorm” in the treatment of patients with atopic dermatitis, which is confirmed by the regression of pathological skin rashes and microbiocenosis disorders, as well as an improvement in the quality of It should be noted that none of the patients experienced a worsening of atopic dermatitis or the occurrence of undesirable phenomena, side effects, or toxic effects while taking the dietary supplement “Bionorm.”

All this indicates the high effectiveness of the dietary supplement “Bionorm” in the treatment of patients with atopic dermatitis.

Conclusions

1. The course of atopic dermatitis is accompanied by such aggravating factors as disturbances in the intestinal microflora (due to a decrease in the number of Bifidobacteria and Lactobacteria, an increase in the number of Staph. E. coli non fermentans, and fungi of the genus Candida) and changes in the skin microbiocenosis (due to an increase in bacterial contamination, the number of Staph. aureus, Strept. pyogenes, fungi of the genus Candida, Malassezia, and a decrease in the number of Staph. epidermidis and Staph. pominis).

2. Standard treatment of patients with atopic dermatitis 1 month after its onset did not ensure complete regression of clinical manifestations, patient and physician satisfaction with the effectiveness of therapy, restoration of the microflora of feces and skin, normalization of endotoxicosis manifestations, and restoration of quality of life.

3. The use of the dietary supplement “Bionorm” for 2 weeks as part of the therapy of patients with atopic dermatitis had a positive effect on the clinical manifestations of the disease, contributed to a significant reduction in the assessment of the severity of the disease according to the SCORAD, EASI, and IGA scales, as well as to the achievement of a high assessment of the effectiveness of treatment by both patients and doctors.

4. The use of the dietary supplement Bionorm in the complex therapy of patients with atopic dermatitis had a positive effect on the state of endotoxicosis, the gut and skin microbiome, and the quality of life of patients. During the use of the dietary supplement Bionorm dietary supplement for 2 weeks in the complex therapy of atopic dermatitis, a more rapid reduction in the manifestations of endotoxicosis was noted compared to that observed during standard therapy. This is confirmed by the presence of a statistically significant difference in the levels of medium molecules, CSE, and CIC in the standard therapy groups and in the group of additional use of the dietary supplement “Bionorm.” A significant increase in the number of Bifidobacteria and Lactobacteria and a decrease in the number of Staphylococcus, E. coli non fermentans, Proteus, and Fungi Candida were noted compared to the corresponding indicators before treatment. In the group of additional use of the dietary supplement Bionorm, the total number of skin bacteria, the number of Staph. aureus, Strept. pyogenes, fungi of the genus Candida and Malassezia decreased statistically significantly 1 month after the start of treatment, while the number of Staph. epidermidis and Staph. hominis increased significantly.

5. The results obtained provide grounds for recommending the widespread use of the dietary supplement Bionorm as part of complex therapy for patients with atopic dermatitis.

 

Prospects for further research: determining the effectiveness of the dietary supplement “Bionorm” for the treatment of patients with chronic multifactorial dermatoses.