Background. Irritable bowel syndrome (IBS) is one of the most common functional disorders of the gastrointestinal tract. According to Russian guidelines, a standard examination using laboratory and instrumental evaluation methods, including colonoscopy, should be performed to establish the diagnosis of IBS. Aim. To characterize the Russian population of IBS patients. Materials and methods. A multicenter observational prospective study ROMERUS was conducted at 35 clinical centers in the Russian Federation. The study included male and female patients aged 18 to 50 with a diagnosis of IBS based on the Rome IV criteria, with no signs of structural gastrointestinal disease. The follow-up duration was 6 months and included three patients' visits to the study site. During the study, data were collected on patients' demographic and clinical characteristics, medical history, and drug therapy. The secondary parameters included the assessment of the proportion of patients with a diagnosis of IBS confirmed by a standard examination among all patients meeting the Rome IV criteria, the evaluation of the change over time of the IBS symptoms, quality of life (QoL), and adherence to therapy. Characterization of the population was performed using descriptive statistics methods. The standard examination results were presented as the percentage of patients with IBS confirmed by the standard examination among all patients meeting the Rome IV criteria, with a two-sided 95% confidence interval. Results. The study included 1004 patients with a diagnosis of IBS according to the Rome IV criteria, with 790 (78.7%) patients included in the final analysis. The mean age of patients was 34.07.5 years; they were predominantly female (70.4%), Caucasian (99.4%), married (55.1%), urban residents (97.5%) with higher education (64.5%) and a permanent position (74.9%). Patients enrolled in the study have low physical activity and lack a healthy diet. The smoking rate was 26.3%. IBS symptoms with predominant constipation (IBS-C) were observed in 28.1% of patients; 28.9% had IBS with predominant diarrhea (IBS-D), 11.9% had mixed-type IBS, and 31.1% had non-classified IBS. The main IBS symptoms were pain (99.7%), abdominal distension (71.1%), and fullness (36.8%). Biliary tract dysfunction (18.9%) and gastritis (17.2%) were the most frequently reported comorbidities. Prior to enrollment, 28% of patients received drug therapy. The most commonly prescribed drug during the study was mebeverine (54.1%). At 6 months of follow-up, there was a significant reduction of abdominal pain, bloating, and distention, and a twofold reduction in the incidence of constipation and diarrhea in the subgroups of patients with IBS-C and IBS-D, respectively. The overall QoL score measured by the IBS-QoL questionnaire increased from 83.0 to 95.2 points (p0.05) during the study. In the overall assessment of their condition, 69.6% of patients noted no symptoms and 25.3% reported marked improvement, 35% were asymptomatic according to the physician's overall assessment of the patient's condition, and 51.8% showed significant improvement. Conclusion. IBS patients in the Russian Federation were characterized. The diagnosis of IBS, established following the Rome IV criteria, is confirmed by the results of a standard examination in 96.3% of patients. The Rome IV criteria for the IBS diagnosis make it possible to establish a diagnosis with a probability of 94.7%. For 6 months of follow-up, there was a clinical improvement with a decrease in the severity of symptoms and a QoL improvement.
Aim. This study is aimed at investigating the efficacy and safety of alimemazine (Teraligen®) therapy in patients with irritable bowel syndrome (IBS) associated with comorbid mental disorders (distress, anxiety, somatisation and depression).Materials and methods. During an open-label, non-comparative and non-interventional study, 60 patients diagnosed with the K58 (K 58.0, K58.9) irritable bowel syndrome were observed (12 men and 48 women, average age 39.6 ± 11.1 years) and treated with Teraligen® (alimemazine) with a gradual dose increase from 2.5 to 15 mg per day against the background of the standard symptomatic treatment used for such states. The observational study lasted for 4 weeks. The Four-Dimensional Symptom Questionnaire (4DSQ) was used to assess the dynamics and effectiveness of the treatment in terms of the patients’ mental state, while the “7 symptoms per 7 days” (“7 × 7”) questionnaire was used to assess the dynamics of IBS symptoms and concomitant functional dyspepsia (FD). Both questionnaires were offered to the patients three times: before the start of the treatment and following 2 and 4 weeks of the therapy.Results. Teraligen therapy along with the standard symptomatic treatment has shown a significant positive dynamics of the patients’ state due to the reduction of such symptoms, as pain and burning sensation in the epigastrium, postprandial fullness, early satiety, abdominal pain before defecation, abdominal distension, impaired frequency and quality of defecation. This is confirmed by a reliable and consistent decrease in the total scores of the “7 × 7” questionnaire, with the scores changing from 19.7 ± 7.1 to 11.6 ± 5.9 and 7.3 ± 5.6 before treatment, on the 14th day (p <0.0001) and on the 28th day of therapy (p <0.0001), respectively. The number of patients reporting no symptoms increased by 18.3 %, indicating a complete reduction of severe disorders. The proportion of patients with the minimal or mild severity of complaints increased by 36.7 % and 8.2 % (from 3.3 % to 40.0 % and from 11.8 % to 20.0 %), respectively. In addition, alimemazine treatment contributed to a statistically significant positive dynamics of the patients’ psychoemotional state. The average level of distress decreased from 14.9 ± 10.0 to 7.5 ± 6.2 (14th day) and to 4.4 ± 5.8 scores (28th day). The number of patients reporting no distress symptoms increased by 49.4 %, reaching 91.1 % (n = 51) on the 28th day of treatment. The mean level of depression decreased from 1.7 ± 2.7 to 0.5 ± 1.2 (14th day) and to 0.5 ± 1.6 (28th day), while the proportion of patients without depression increased by 17.9 % and reached 94.6 % (n = 53). The anxiety level was reduced from 6.0 ± 6.3 to 2.9 ± 4.3 (14th day) and to 1.5 ± 3.8 scores (28th day), and the proportion of patients without anxiety increased by 21.4 % reaching 96.4 % (n = 54) (28th day). The level of somatisation decreased from 13.5 ± 7.3 to 8.7 ± 5.6 (14th day) and to 5.1 ± 4.4 scores (28th day), and the proportion of patients without somatisation increased by 52.9 % and comprised 92.9 % (n = 52) (28th day) (according to the 4DSQ). Most of the patients tolerated alimemazine at a dose of 15 mg/day. In 15 patients, minor adverse reactions were observed; however, no cases of pronounced and severe side effects were recorded. In 4 patients, the treatment was cancelled due to increased drowsiness.Conclusion. It is shown that the application of alimemazine (Teraligen®) in patients with IBS and concomitant FD associated with comorbid mental disorders (distress, anxiety, somatisation and depression) reduces gastroenterological (somatic) and mental (affective, somatoform) symptoms, improves the patients’ state of health, thus being confirmed as effective and safe.
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