Treatment of Irritable Bowel Syndrome in Patients with Elevated Levels of Anxiety and/or Depression: Results of the Prospective Non-interventional Observational Program «KOMETA»

Aim: to evaluate the efficacy and safety of Kolofort^® in patients with irritable bowel syndrome accompanied by an anxiety-depressive disorder.

Materials and methods. A total of 70 patients with irritable bowel syndrome confirmed by Rome IV criteria and a HADS (Hospital Anxiety and Depression Scale) score of ≥ 8 points were included in an open, prospective, observational, non-interventional program. Patients received Kolofort^® at a dose of 2 tablets twice daily for 8 weeks. The efficacy of the therapy was assessed according to the HADS, the Visual Analogue Scale for pain (VAS), and the Epworth Sleepiness Scale.

Results. After 8 weeks of therapy, the severity of anxiety and depression was significantly reduced (p < 0.0001): the mean score on the anxiety subscale decreased from 11.1 ± 2.4 to 5.3 ± 3.0, and from 7.6 ± 3.3 to 3.5 ± 2.8 on the depression subscale. The intensity of abdominal pain according to the VAS decreased from 4.8 ± 1.8 to 1.0 ± 1.0  (p < 0.0001). Clinically significant pain reduction (≥30 % from baseline) was recorded in 92.9 % of patients. The level of daytime sleepiness according to the Epworth scale decreased from 6.7 ± 4.2 to 4.0 ± 2.2 (p < 0.0001). Analysis of variance showed an association between reduced anxiety and decreased abdominal pain (p = 0.0058).

Conclusion. The results of the observational program demonstrate the efficacy and safety of Kolofort^® in the treatment of irritable bowel syndrome accompanied by elevated anxiety and/or depression. The synergistic effect of the drug components provides improvement in both somatic and psycho-emotional symptoms of irritable bowel syndrome.

1. Corsetti M., Shin A., Lacy B.E., Cash B.D., Simrén M., Schmulson M.J., et al. Bowel disorders. Gastroenterology. 2026;170(6):1261–82. DOI: 10.1053/j.gastro.2026.02.003

2. Hu Z., Li M., Yao L., Wang Y., Wang E., Yuan J., et al. The level and prevalence of depression and anxiety among patients with different subtypes of irritable bowel syndrome: A network meta-analysis. BMC Gastroenterol. 2021;21(1):23. DOI: 10.1186/s12876-020-01593-5

3. Zheng M., Sun S., Lv B. Impact of different stress paradigms on irritable bowel syndrome: Evidence from clinical and animal studies. J Int Med Res. 2026;54(5):3000605261447130. DOI: 10.1177/03000605261447130

4. Staudacher H.M., Black C.J., Teasdale S.B., Mikocka-Walus A., Keefer L. Irritable bowel syndrome and mental health comorbidity: Approach to multidisciplinary management. Nat Review Gastroenterol Hepatol. 2023;20(9):582–96. DOI: 10.1038/s41575-023-00794-z

5. Hanna-Jairala I., Drossman D.A. Central neuromodulators in irritable bowel syndrome: Why, how, and when. Am J Gastroenterol. 2024;119(7):1272–84. DOI: 10.14309/ajg.0000000000002800

6. Irritable bowel syndrome. Clinical guidelines of the Russian Federation, 2024. (In Russ.)]. URL: https://cr.minzdraIV.goIV.ru/IView-cr/892_1

7. Avalueva E.B., Adasheva T.V., Babaeva A.R., Burdina E.G., Kireeva N.V., Lenskaya L.G., et al. Efficacy and safety of preparation Kolofort® in treatment of irritable bowel syndrome: Results of multicentral double blind placebo controlled clinical trial. Consilium Medicum. Gastrojenterologija. 2014;1:43–50. (In Russ.)].

8. Ivashkin V.T., Abdulkhakov R.A., Bakulin I.G., Zaitsev S.V., Luchina V.I., Mekhtiyev S.N., et al. COIVID-19 Pandemic and IBS. Results of the All-Russian Observational Non-interventional Program to Study the Effectiveness of the Drug Kolofort® in Real Clinical Practice in Patients with Irritable Bowel Syndrome After a New Coronavirus Infection (VESNA). Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2023;33(5):41–53. (In Russ.)]. DOI: 10.22416/1382-4376-2023-33-5-41-53

9. Uspenskiy Yu.P., Mirzoev O.S., Fominykh Yu.A., Gnutov A.A., Polyushkin S.V. Efficacy of Kolofort in combined functional gastroenterological pathology: an open study. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2020;30(5):30–41. (In Russ.)]. DOI: 10.22416/1382-4376-2020-30-5-30-41

10.