Pathogenetic approach to the treatment of functional disorders of the gastrointestinal tract and their intersection: results of the Russian observation retrospective program COMFORT

Abstract

BackgroundThe aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-α and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap.MethodsThe subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12 weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the “7*7” questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the “healthy” or “borderline ill” severity categories; and the change in the score in domains 1–7.ResultsThe final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%).ConclusionThe COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.

Sex and Gender Differences in Overlap Syndrome of Functional Gastrointestinal Disorder and Effect of Genetic Polymorphisms in South Korea: A Long-term Follow-up Study

“…Similar to our results, as in most observational studies, FGID symptoms improved during the follow-up period. 51 , 52 This may be related to treatment in any form (medication or education, etc) or reassurance when visiting a hospital for FGID symptoms. However, as has already been found, FGID symptoms are often associated with other factors, especially psychological factors such as anxiety and depression, 53 , 54 so that symptoms may not improve or rather worsen during the follow-up period.…”

Development of Terahertz Time-Domain Spectroscopy for Properties Analysis of Highly Diluted Antibodies

“…To date, more and more data on their effectiveness appear. In particular, it has been shown that high dilutions of antibodies can be used to treat various diseases [24][25][26][27][28]. High dilutions exert a modifying effect on the properties of the starting material [29][30][31][32][33], despite the colossal difference in the quantities of mixed substances (of the original substance and its high dilution).…”

Diagnosis and Treatment of Irritable Bowel Syndrome: Clinical Recommendations of the Russian Gastroenterological Association and Association of Coloproctologists of Russia

“…• Пациентам с СРК рекомендуется назначение комбинированного лекарственного препарата, содержащего антитела к мозгоспецифическому белку S-100, антитела к человеческому фактору некроза опухоли альфа аффинно очищенные, для уменьшения боли в животе, нормализации частоты и консистенции стула [70][71][72].…”

“…Комментарии: Данный препарат оказывает спазмолитическое, противовоспалительное и анксиолитическое действие. Эффективность препарата была доказана в рандомизированных плацебо-контролируемых исследованиях [70][71][72]. Курс лечения 1-3 месяца; при необходимости курс лечения можно продлить до 6 месяцев и/или повторить через 1-2 месяца.…”

“…Являясь хроническим заболеванием, ассоциированным с рядом эмоциональных нарушений, в большинстве случаев при длительном течении СРК целесообразно психологическое (психотерапевтическое) консультирование по коррекции факторов риска развития неинфекционных заболеваний, первичное [65]. Согласно систематическому обзору, эффективными при СРК являются когнитивная поведенческая терапия [67][68][69], гипнотерапия [70] и психологическая поддержка [71][72][73].…”