Background Irritable bowel syndrome (IBS) affects 9,2% of the global population and places a considerable burden on healthcare systems. Most medications for treating IBS, including spasmolytics, laxatives, and antidiarrheals, have low efficacy. Effective and safe therapeutic treatments have yet to be developed for IBS. Purpose This study assessed the efficacy and safety of a food supplement containing standardized menthol, limonene, and gingerol in human participants with IBS or IBS/functional dyspepsia (FD). Design A double-blind, randomized, placebo-controlled trial. Methods We randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d. Three outpatient visits were conducted during the study. Symptom severity was measured at each visit using a 7×7 questionnaire. Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing. Results At visit 1 (before treatment), the median total 7×7 questionnaire score was in the moderately ill range for both groups, with no difference between the groups (p = 0.1). At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4). At visit 3, the total score for group 1 indicated borderline illness and for group 2 remained indicated mild illness (p = 0.009). Even though we observed some variations in gut microbiota between the groups, we did not find any statistically significant changes. Conclusion The food supplement with standardized menthol, limonene, and gingerol content increased the efficacy of standard therapy in IBS and FD patients. The use of the supplement did not cause any obvious side effects. Registration ClinicalTrials.gov Identifier: NCT04484467
Aim. To review data on the efficiency and safety of using Ustekinumab in patients with Crohn’s disease.Key findings. Ustekinumab is a fully human monoclonal antibody of the IgG1k class to the p40 subunit of IL-12 and IL-23. The drug interrupts the cascade of humoral and cellular reactions leading to transmural inflammation of the intestinal wall by blocking the interaction of the p40 subunit with the IL-12Rβ1 chain on the surface of T-lymphocytes and NK cells. A number of placebo-controlled studies have demonstrated the effectiveness of Ustekinumab in the induction and the maintenance of remission in those patients with Crohn’s disease who showed no response to conventional therapy (glucocorticosteroids and immunosuppressants) and therapy with TNF-α antagonists. In addition, the efficiency of Ustekinumab in maintaining a clinical response and clinical remission over two years of therapy has been shown. The drug has a favourable safety profile and a low immunogenicity.Conclusion. The reviewed studies show Ustekinumab to be an effective and safe drug for the induction and the maintenance of clinical remission in patients with Crohn’s disease.
Первый Московский государственный медицинский университет имени И.М. Сеченова Россия, 119991, Москва, ул. Трубецкая, 8 стр. 2 В статье рассматриваются возможности и перспективы применения в клинической практике такого метода лечения, как усиленная наружная контрпульсация (УНКП), уже давно зарекомендовавшего себя во всем мире. Рассматриваются исторические предпосылки, а также этапы раз-работки данного метода для лечения пациентов с ишемической болезнью сердца (ИБС) и хронической сердечной недостаточностью (ХСН). Детально разбирается механизм действия УНКП и основные гемодинамические, нейрогуморальные и тканевые эффекты, лежащие в осно-ве применения данного вида лечения. Отдельно рассматривается влияние УНКП на эндотелиальную функцию и коронарный резерв, нару-шение которых имеет место при большинстве сердечно-сосудистых заболеваний. Среди наиболее изученных показаний для применения УНКП является лечение пациентов с ИБС, в том числе, осложненной ХСН. В статье представлена доказательная база лечения больных этими на-рушениями с использованием УНКП. Также представлены перспективные направления применения этого метода лечения в других направ-лениях медицины.Ключевые слова: усиленная наружная контрпульсация, эндотелиальная функция, коронарный резерв, ишемическая болезнь сердца, хроническая сердечная недостаточность. Possibilities and prospects for the clinical use of enhanced external counterpulsation (EECP), which has long established itself throughout the world, are discussed in the article. Historical background, as well as the development stages of EECP for the treatment of patients with coronary heart disease (CHD) and chronic heart failure (CHF) are considered. The mechanism of action of the EECP and the main hemodynamic, neurohumoral and tissue effects that justify its use are presented. The effect of EECP on endothelial function and coronary reserve, disorders of which occurs in the majority of cardiovascular diseases, is considered separately. Treatment of patients with CHD, including complicated by CHF, are the most studied indications for EECP using in medical practice. The evidence base for treatment of patients with these disorders by EECP is presented in the article. Prospects for the EECP application in other areas of medicine are also presented.Keywords: enhanced external counterpulsation, endothelial function, coronary reserve, ischemic heart disease, chronic heart failure. ВведениеИшемическая болезнь сердца (ИБС) и сердечная не-достаточность по-прежнему сохраняют лидирующие по-зиции среди причин инвалидизации и смертности на-селения во всем мире. Несмотря на значительные до-стижения последних лет в диагностике и терапии дан-ных состояний, у определенной доли пациентов фар-макотерапия оказывается недостаточно эффективной, а использование эндоваскулярных и хирургических ме-тодов лечения не представляется возможным из-за осо-бенностей анатомии коронарного русла, предше-ствующей реваскуляризации или наличия тяжелых сопутствующих заболеваний. В этой ситуации воз-можно использование современных методов тера-
Aim: evaluation of the effectiveness of the nutraceutical “Standard Zdorovia: Gastro” (“SZ Gastro”) in the treatment of patients with irritable bowel syndrome (IBS).Materials and methods. 52 patients (62 % women) diagnosed with IBS and IBS in combination with functional dyspepsia (FD) were included in the study and divided into two groups. Both groups received basic therapy according to the guidelines. The experimental group received as add-on the nutraceutical “SZ Gastro” (containing a standardized amount of menthol, gingerol and D-limonene); patients in the control group — placebo. The duration of the study was 30 days. The severity of somatic symptoms was assessed with the 7×7 questionnaire. Emotional state was assessed with the Four Dimensional Distress, Depression, Anxiety, and Somatization Questionnaire (4DSQ).Results. Patients of the experimental and control groups did not differ from each other either in terms of demographics, basic treatment, or in the severity of symptoms at the beginning of the study.The effectiveness of the treatment in the patients, who received add-on “SZ Gastro” was significantly higher than in the patients of the control group: in the control group the percentage of improvement of somatic symptoms was 22.35 %, in the experimental group it amounted to 49.18 % (χ2 = 15.9; p = 0.0001). The percentage of patients with significant decrease of emotional disturbances was also higher in the experimental group: distress (χ2 = 18.7; p = 0.0000), anxiety (χ2 = 6.9; p = 0.0097) and somatization (χ2 = 14.99; p = 0.0001). No significant side effects were registered in any of the groups.Conclusions. Add-on of nutraceutical “SZ Gastro” to basic treatment is safe and significantly increases effectiveness of the therapy in the patients with IBS and IBS in combination with PD.
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